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									ajh                                                       2


AT    DEPARTMENT OF HEALTH AND HUMAN SERVICES

                           PUBLIC HEALTH SERVICE

                       FOOD AND DRUG ADMINISTRATION




                 NATIONAL MAMMOGRAPHY QUALITY ASSURANCE

                           ADVISORY COMMITTEE




                           Tuesday, October 28, 1997

                                   9:05 a.m.




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      Sheraton Premiere at Tysons Corner
             Conference Room 6
             8661 Leesburg Pike
                Vienna, Virginia




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                                        PARTICIPANTS

      Barbara Monsees, M.D., Chairperson
      Charles Finder, M.D., Executive Secretary

      MEMBERS

      Lawrence W. Bassett, M.D., F.A.C.R.
      Peter Dempsey, M.D.
      Roland G. Fletcher, M.S.
      Patricia Hawkins, M.P.H.
      Rita Heinlein, R.T.
      Edward R. Hendrick, Ph.D.
      Ellen Mendelson, M.D.
      Michael Mobley, M.S., M.P.A.
      Laura Moore-Farrell, Ph.D.
      Robert Pizzutiello, M.S.
      Edward Sickles, M.D.
      Robert Smith, Ph.D.
      Patricia Wilson, R.T.
      David P. Winchester, M.D.

      FDA

      Florence Houn, M.D.




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                                        CONTENTS

                                                                     Page No.

      Opening Remarks and Conflict of Interest               4

      Committee Business                                         7

      Alternative Standards Requests
           Charles Finder, M.D.                              9

      Open Public Hearing

          Margaret F. Fay, Ph.D. (By Eleanor Sherman)         11
          Eleanor Sherman                                     18
          Alan Kravitz, M.D.                               26
          Malee Shay, L.M.P.                                 36
          R. Philip Burns, M.D.                            45
          Kambiz Dowlat, M.D.                                50
          Philip Israel, M.D.                             60
          Armando Santelices, M.D.                           73
          Robert Caplan (By Armando Santelices, M.D.)          84

      Overview of Interventional Mammographic Procedures

          Presenter: Rebecca Zuurbier, M.D.                  96

      Joint Presentation: American College of Surgeons-
      American College of Radiology

          Robert Pizzutiello, M.S.                        130
          David Winchester, M.D.                            153
          D. David Dershaw, M.D.                            166

      Stereotactic Core Biopsy - Personnel                 222




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            1                        PROCEEDINGS

            2       DR. MONSEES: Good morning. I am Barbara Monsees, the

      chair of the NMQAAC.
            3

            4       Before we get started with the actual agenda of the meeting, we are

            to
      going 5 turn the mike over to our Executive Secretary, Dr. Finder, who is going

      to address conflict of interest.
            6

            7       DR. FINDER: First, I would like to welcome everybody to the

      National Mammography Quality Assurance Advisory Committee, and I would like
           8

      to begin by reading the conflict of interest statement.
            9

           10       The following announcement addresses conflict of interest issues

      associated with this meeting and is made a part of the record to preclude even
          11

      the appearance of any impropriety.
           12

           13       To determine if any conflict existed, the agency reviewed the

      submitted agenda and all financial interests reported by the committee
          14

      participants. The conflict of interest statutes prohibit special government
           15

      employees from participating in matters that could affect their or their employer's
          16

      financial interests, however, the agency has determined that participation of
           17

      certain consultants and members, the need for whose services outweighs the
           18

      potential conflict of interest involved, is in the best interests of the government.
          19

      Full waivers are in effect for 13 out of 17 participants because of their financial
           20

      involvement with facilities that will be subject to FDA's regulations on
           21

      mammography quality standards, with accrediting, certifying, or inspecting bodies
         22

      or with the manufacturers of mammography equipment since these organizations
           23


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            be
      could 1 affected by the committee's deliberations.

            2        The participants include Dr. Tamsen Bassford, Ms. Rita Heinlein,

      Ms. Maria Romero, Mr. Roland Fletcher, Dr. Peter Dempsey, Dr. Ellen
           3

      Mendelson, Dr. Laura Moore-Farrell, Dr. Barbara Monsees, Dr. Edward Sickles,
          4

      Mr. Michael Mobley, Ms. Patricia Wilson, Ms. Patricia Hawkins, and Mr. Robert
           5

      Pizzutiello.
           6

            7        Copies of these waivers may be obtained from the Agency's

      Freedom of Information Office, Room 12A-15 of the Parklawn Building.
           8

            9        Since Mr. Robert Pizzutiello, Dr. David Winchester, Dr. Edward

      Hendrick, and Dr. Lawrence Bassett participated in the development of the
         10

      ACR-ACS agreement on quality standards for stereotactic breast biopsy, we
         11

           limited their participation in this matter to a presentation of details of the
      have12

      agreement. They can talk about the facts of the agreement and how they were
          13

      developed, but will refrain from giving their opinions or voting on the agreement.
          14

           15        Out of abundance of caution, we have also limited Dr. Edward

      Sickles, Dr. Lawrence Bassett, and Dr. Edward Hendrick's participation in
           16

      equipment standards because of their involvement with mammography devices.
          17

           are
      They18 allowed to discuss mammography technologies including digital

      devices, as well as talk about their observations and experiences with these
           19

      products, however, they will refrain from voting on specific equipment standards.
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            1       Although we don't anticipate any discussion of state certifications at

      this meeting, we would like to note for the record that when this issue is
            2

      discussed, we will limit the participation of Mr. Pizzutiello, Ms. Hawkins, Mr.
           3

      Mobley, and Dr. Moore-Farrell because each is affiliated with a state-run
           4

      regulatory body.
            5

            6       Also, several of our members and consultants reported that they

      received compensation for lectures they have given or will give on
            7

      mammography-related topics, however, they have affirmed that these lectures
         8

      were offered to them because of their expertise in the subject matter, and not
           9

      because of their membership on the committee.
          10

          11        In the event that the discussions involve any other matters not

      already on the agenda, in which an FDA participant has a financial interest, the
           12

      participants should exclude themselves from such involvement, and their
           13

      exclusion will be noted for the record.
           14

          15        We would also like to acknowledge that the Executive Secretary,

      Dr. Charles Finder, is a member of the ACR. We also have a guest speaker, Dr.
           16

      Rebecca Zuurbier from Georgetown University Hospital in Washington, D.C.
         17

          18        With respect to all other participants, we ask in the interest of

      fairness that all persons making statements or presentations disclose any current
           19

      or previous financial involvement with accreditation bodies, states doing
           20
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      mammography inspections under contract to FDA, certifying bodies, mobile units,
         1

      breast implant imaging, consumer complaints, and mammography equipment.
           2

            3       I would like to make an announcement for those who have been

      anxiously awaiting the publication of the Mammography Final Regulations. I do
           4

      believe that they were published today and we will try and get copies of the
            5

      document to the committee as soon as possible. We hope to get it to them
          6

      before the end of the meeting, but if not, we will certainly mail it to the people.
           7

            8       DR. MONSEES: Thank you very much.

            9       This is for the most part a new committee. There are many new

      committee members and I am the new chair of this committee, so what I ask is
         10

      that people indulge me and let me get used to this new role while we are trying to
           11

           the
      keep12 ball rolling in the right direction.

           13       This is, of course, not a free-for-all. We would like to have an

      organized discussion of interventional mammography over the next two days.
          14

      The questions which were mailed to the panelists ahead of time, I hope you have
          15

      considered and you are ready to speak on some of these issues.
          16

           17       Please speak your mind. If your opinion is not concordant with

      others on the panel, that's okay. That is what your job is, is to speak your mind
          18

      here. So please ask to be recognized even if you have a dissenting opinion.
          19

      We don't expect, I don't believe we expect to find that we are going to achieve
          20
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      consensus on this panel.
           1

            2       What we want to do is air all of the issues that are important to this

      matter, so that consideration can be made as to whether or not interventional
           3

      mammography should be regulated and how, if it is, it will benefit the practice of
         4

      medicine and our patients in the community.
           5

            6       I will ask those of you who would like to speak to raise your hand.

      Your mikes will be turned on by these gentlemen over here when you are
           7

      recognized. Please briefly state what you would like to, please don't go off on a
           8

      tangent. If so, I will be forced to ask you to go back on track. We do want to try
           9

      to keep the agenda.
           10

           11       If you feel that you have a conflict of interest about something that

      you are about to say, think again and ask for advice from Dr. Finder, who we are
          12

      all going to be asking for advice for these matters, and he will point us in the right
           13

      direction.
           14

           15       Likewise, when we have the public hearing, we had 10 people on

      the agenda, we now have nine people on the agenda. When you come to the
           16

      microphone, we want to hear if you have a conflict of interest. I want to know
          17

          you
      who 18 are, who you represent. If you did not pay your own way, I would like

      to hear who did, so that we will know whether there is a conflict of interest from
           19

      those of you who are going to be speaking in the audience.
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            1       We are going to be doing didactic sessions after the public hearing

      this morning and then this afternoon the committee really starts its discussion,
            2

      although I am sure we will find some time and I am sure we will find some way to
            3

      interject some questions of the public speakers and the people who are
             4

      presenting during the course of the meeting.
           5

            6       Tomorrow, we will conclude the discussion of interventional

      mammography. We are to skew it, so that today we talk primarily about
         7

      stereotactic core biopsy and tomorrow I think we will probably start talking about
            8

           of
      some 9 the other interventional procedures.

           10       With that, I think we will go ahead and get started.

           11                  Alternative Standards Requests

           12       DR. FINDER: Let me briefly go over - we have a 10-minute

      session here to talk about alternative standards.
          13                                                For the new members on the

      committee, let me just go over a little what I am talking about.
         14

           15       In the regulations, there is a section that allows certain groups,

      including facilities, to apply for an alternative standard to the standard
           16

      regulations. The committee in the past has asked that they be updated on any
          17

      requests for alternative standards, and we have set aside this time for that.
          18

           19       To make it brief, there were no requests for alternative standards,

      so that is the end of that unless anybody has any questions about the alternative
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      standard process.
           1

            2                      Open Public Hearing

            3      DR. MONSEES: Thank you all for being here and I think we are

            to
      going 4 be a very patient group. We are going to respect each other's

      comments and we are going to say what we need to say to get this job done.
          5

            6      We have nine speakers. Let me read to you the order that we

      intend7to hear people. Since we are starting early, if somebody is not here, we

      will give an opportunity to those who have come late.
             8

            9      We have Eleanor Sherman, Margaret Fay, Alan Kravitz, Joseph

      Rush, Malee Shay, Philip Burns, Kambiz Dowlat, Philip Israel, Armando
          10

      Santelices, and Robert Caplan.
          11

           12      That is the order that we have. There are a few changes from this

      list. 13

           14      Is Eleanor Sherman here? Ten minutes, Ms. Sherman.

           15      MS. SHERMAN: First, I am going to present for Dr. Margaret Fay,

          is
      who 16 unable to be here, and she asked me to deliver it.

           17      To the National Mammography Quality Assurance Advisory Panel

      Members: I regret that I cannot be present to express my interest and concern
         18

      regarding appropriate quality standards and regulations for mammography
          19

      facilities In my absence, I have asked Eleanor Sherman to read my statement
            20
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      into the record.
             1

            2       As a patient who recently underwent breast screening, ultrasound,

      and subsequent bilateral surgery for multiple lesions, I would like to express my
           3

      support for interventional mammography standards and ask that this panel
           4

      incorporate specific infection control guidelines for mammography equipment and
            5

      practices.
            6

            7       Most women who enter a radiology procedure room to have a

      routine mammogram or undergo an invasive diagnostic procedure do not
            8

      consider the possibility that contact with equipment or interventional biopsy
           9

      instruments may expose them to infection through contamination of bloodborne
           10

      contaminated equipment. For women with non-intact skin, damage dermatitis
          11

           radiation therapy, postmastectomy wounds, or open wound contamination
      from 12

      during the course of biopsy, the risk is substantial.
           13

          14        In May 1997, I was subjected to an elective mammogram, which

      confirmed the presence of multiple masses in both breasts. The procedure was
           15

      carried out at a highly respected university-based women's health center.
           16

          17        After registration, I changed into a gown and was escorted from the

      changing room to the mammography procedure room. As I was entering the
          18

      room, another woman was exiting. I observed that no attempt was made to
          19

      disinfect the mammography unit, no handwashing facilities or sink were available
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             room.
      in the 1

           2         No attempt was made by the mammography technologist to

      disinfect the unit or wash her hands. No antiseptic creams or disinfectant
            3

      agents by which the technologist could disinfect her hands prior to touching me
           4

      were noted in the room.
           5

           6         Further, the technologist did not wear gloves when handling my

      breasts. I have multiple cutaneous skin lesions on my torso, arms, legs, and
           7

      back from an autoimmune condition. My non-intact skin places me at greater
            8

      risk of9infection from contact exposure to contaminated surface than women with

      intact skin do. Yet, no steps were taken to ensure the equipment was properly
           10

      disinfected. The risk of cross-contamination from the unwashed hands of the
           11

      mammography technologist placed me at risk.
         12

          13         Hippocrates relied on wine-soaked linen to protect wounds. The

      English surgeon Joseph Lister described and introduced aseptic technique in the
          14

      1860s. Today, adherence to principles of asepsis are accepted standards of
          15

      practice and a key factor in reducing the risk of nosocomial infection.
          16

          17         In a surgeon's office, when a needle biopsy is carried out, aseptic

      practice is followed. The woman lies on a clean table surface, equipment is
          18

      sterilized, the biopsy site is prepped with appropriate antimicrobial. The
            19

      physician dons sterile gloves, and the pathology specimen is contained and
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      labeled by a nurse wearing exam gloves. The same standard of care is given in
            1

      outpatient settings, urgent care facilities, and even nursing homes.
           2

            3       When an I.V. is started, a dressing changed, a laceration sutured,

      or a liver transplanted, health professionals carry out routine asepsis to protect
             4

      the patient. They adhere to principles of aseptic practice in an effort to reduce
            5

      the risk of cross-contamination and to ensure patient safety. However, if the
             6

      needle biopsy is carried out in the radiologist's office, or in a hospital radiology
           7

      department, most offices will not have autoclaves. This is a double standard.
           8

            9       I believe the same standard of care should be applied in

      mammography and radiology procedures as is applied in hospital, surgical, and
         10

      outpatient care centers.
          11

           12       I applaud the steps taken by the Center for Devices and

      Radiological Health to date, however, I would urge this committee to consider
          13

      incorporating the following recommendations into the 21 CFR MQSA regulations
           14

      to ensure, so far as possible, patient health and safety.
           15

           16       1. Principles of infection control should be specified in the MQSA

      21 CRF regulations for mammography, and also, all radiological procedures. A
          17

      method of auditing compliance should be also delineated in the regulation.
          18

           19       2. Routine handwashing should be carried out before and after

      patient contact.
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           1       3. Powder-free gloves should be worn by personnel when

      touching patient's skin or tissue, when handling soiled instruments, or touching
           2

      potentially contaminated equipment. Contamination may be caused by
           3

      spontaneous nipple discharge during patient breast compression, causing
           4

      contamination of the bucky and compression paddles with potential bloodborne
           5

      pathogens.
           6

           7       Literature shows that direct touch contamination or aerosolized

      powder particulate may be the cause of artifacts on x-ray films, possibly leading
          8

      to diagnostic errors and/or misdiagnosis.
            9

          10       4. All patient contact surfaces should be thoroughly cleaned with a

           level
      high 11 disinfectant immediately after use before the next patient is brought

      into the room. If equipment cannot be safely disinfected due to construction and
            12

      design of the equipment time constraints, some form of nonattenuating
          13

      FDA-approved barrier drape should be employed to prevent direct contact
         14

      between the contaminated equipment and the patient.
          15

          16       5. During interventional procedures in which blood or body fluid

      exposure is anticipated, the same aseptic practices and infection control
          17

      standards employed in other clinical units, such as OR, ER, labor and delivery,
          18

      the cardiac cath lab should be adhered to in mammography and all radiology
           19

      procedure rooms.
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           1       6. The material used in cleaning equipment should be regarded as

      clinical waste and should be disposed of accordingly.
             2

           3       7. I would like to thank this committee for its ongoing interest and

      for concern for the well-being of women undergoing diagnostic interventional and
            4

      stereotactic procedures.
            5

           6       Sincerely, Margaret F. Fay, R.N., Ph.D.

           7       DR. MONSEES: Thank you. if there are panel members that

      have a question, do you feel that you can field those?
           8

           9       MS. SHERMAN: I think I can. Dr. Fay also wrote an additional

      letter, which is on the table. She specified much more deeply the kinds of
            10

      infections that the patient would be exposed.
           11

          12       DR. MONSEES: Does anybody on the panel have a question for

      the person who is not here, perhaps Ms. Sherman can help to answer that
           13

      question?
          14

          15       Yes, Dr. Hendrick.

          16       DR. HENDRICK: It is Margaret Fay, is that right?

          17       MS. SHERMAN: Yes.

          18       DR. HENDRICK: Is she claiming to have contracted an infection?

          19       MS. SHERMAN: You asked me that a couple of years ago. You

      wanted to know if another registered nurse, who was contaminated, actually
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      contracted --
            1

            2         DR. HENDRICK: That was a different case.

            3         MS. SHERMAN: I know, but you wanted to see a body. I mean

      you told me you wanted to see a body. She just had this. I mean this was a
            4

      very early procedure. I don't know whether she contracted a disease, and I
            5

             don't think it really matters whether she did because there are 2 million
      really 6

      cases7of contracted infections done in a hospital that we don't know where it is

      contracted from.
            8

            9         I don't think we have to see a woman dead in a coffin before we do

      anything.
          10

          11          DR. HENDRICK: But her implication is that she felt -- I mean she

      makes statements about the technologist not washing her hands.
         12

          13          MS. SHERMAN: This is standard procedure. This is from the

      CDC. I mean this is not new stuff.
         14

          15          DR. HENDRICK: I am asking about the specific case. There is

      always the implication that something happened in the letters or the people that
          16

      you bring forward, but there is no evidence that something happened here.
          17

          18          MS. SHERMAN: She is still alive, thank God.

          19          DR. HENDRICK: Well, good.

          20          MS. SHERMAN: I mean I think it is a ridiculous question and I
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             find it offensive that you want to see a body before we start cleaning.
      really 1

           2        DR. HENDRICK: I don't want to see a body. I want to know the

      full story about what happened.
             3

           4        MS. SHERMAN: I can just report that she was exposed to

      contaminated equipment.
           5

           6        DR. MONSEES: All right. I have a question also, if you don't

      mind. 7

           8        This lady has an unusual circumstance in that she had skin lesions,

      most women don't. Did she express her concern to the technologist when she
           9

      entered the room, so that the technologist could take certain precautions? Did
          10

      she give that opportunity to the technologist?
          11

          12        MS. SHERMAN: I was not in the room, but I could tell you that

      Margaret Fay was scared to death. She was facing major reconstruction
          13

      surgery, and she was the patient, not the health care worker, and she -- this letter
          14

             just
      that I15 read into testimony spoke as the patient.

          16        DR. MONSEES: Okay. Let's move on to you speaking as

      Eleanor Sherman.
          17

          18        MS. SHERMAN: My name is Eleanor Sherman.

          19        DR. MONSEES: Would you reset the clock, please.

          20        MS. SHERMAN: And by the way, Margaret Fay has no reason to
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           any money on this or is not affiliated with anybody that is making -- so,
      make 1

            is
      there 2 no conflict of interest that I know of anyway.

           3        DR. MONSEES: How about yourself?

           4        MS. SHERMAN: My name is Eleanor Sherman. I am the

      president of Technowipe, Incorporated, which has nothing to do really -- my voice
            5

      is gone.
            6

           7        DR. MONSEES: Can you help us out with the mike? She is

      having a hard time speaking up.
           8

           9        MS. SHERMAN: I manufacture lint-free wipes to clean cassettes.

           in
      Back10 1991, I was an x-ray technologist, a mammographer, and I became very

      concerned about the possibility of disease transmission, and since then I have
          11

      become an inventor and hold a patent on a disposable protective barrier for the
          12

      bucky and compression paddle. I have not made a dime on it, so there is no
          13

      economic, and I am not licensed.
          14

          15        I will go on. I would like to take this opportunity to thank the

      National Mammography Quality Assurance Advisory Panel for the opportunity to
           16

      share my concerns. I am requesting specific protocols and education for
          17

      infection control procedures be incorporated into the MQSA regulations, as well
           18

      as an audit system to assure compliance.
          19

          20        I would like to commend this panel for their continued dedication
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      and commitment to developing mammography quality standards that will better
           1

      assure early detection of breast cancer.
           2

           3        I would also like to thank you for acknowledging the potential risk of

      cross-contamination of bloodborne pathogens by incorporating the need for
           4

      infection control procedures specified on page 14920 of 21 CFR Part 900, dated
             5

      April 3, 1996, in the Federal Register.
            6

           7        Again addressing your concerns about the need for infection control

      procedures for mammography equipment as published in the winter 1997 issue
           8

      of Mammography Matters, Volume 4, Issue 1, stating that the FDA expects the
           9

      device manufacturers to provide adequate cleaning and disinfecting instructions
           10

      or for providing the use of barrier devices as preventive measures based on
           11

      well-established infection control procedures outlined in the Center for Disease
           12

      Control and Prevention Guidance documents on infection control practices.
          13

          14        The winter issue of Mammography Matter alerts all mammography

      facilities and their personnel they should be aware of, and follow the cleaning and
            15

      disinfecting procedures recommended by each manufacturer for its own devices.
           16

           wish
      This 17 for proper disinfecting cannot be accomplished chemically and the

      device manufacturers have not made barriers available for use for their specific
           18

      mammography equipment, not have the device manufacturers provided
         19

      appropriate disinfecting instructions for bloodborne contaminated equipment that
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      makes any practical sense.
          1

            2       I have brought today and disseminated to the panel members and

      left some issues on the table outside the most recent issue of Clinical Focus,
             3

      Volume 4, 1997, published in the United Kingdom by Green Moon Healthcare.
           4

            5       Page 8 of this article has a peer review called, "Breast Screening,

      Life-Saving or Life Threatening." Reviewing an article that I co-authored with
            6

      Margaret Fay back in July of 1996, before Peggy's five masses were found, and
          7

      published in advance for science professions. The article was titled, "MQSA, do
            8

      Proposed Rules Fully Address Infection Control?"
           9

           10       Clinical Focus highlights the following: Screening mammography

      equipment is a source of carrying out significant risk of cross-contamination
          11

      between patients caused by nipple discharge during the compression of the
          12

      breast. It validated that shaving under arms, eczema, Paget's disease are likely
          13

      to result in deposits of blood-stained, serous fluid on the mammography
           14

      equipment.
          15

           16       Certain pathogens, such as hepatitis or resistant bacterial strains,

      can survive in dried secretion for prolonged periods. The implications are clear,
          17

      the article cites, mammography equipment must not merely look clinically clean,
           18

      it must be clinically clean.
           19

           20       Clinical Focus peer reviewers go on to say that although MQSA
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      guidelines appear simple, in fact, they are difficult to interpret. The article lists
           1

      the potential risks associated with a recommended high level chemical
            2

      disinfectants, such as damaging equipment, risking the health of the
            3

      mammographer, and the serious problems of high level disinfectants pose to the
         4

      patient.
            5

            6       It was apparent to the reviewers that high level disinfecting, which

      requires soaking for 45 minutes and rinsing with sterile water, is not possible.
            7

      The reviewers recommend for optimum infection control the use of protective
           8

      radiolucent sleeves over the equipment for use, and concludes the mammogram
            9

            particular interest because it readily becomes part of the well woman
      is of 10

      practice.
          11

           12       The article also brings to light a very important issue that is unique

      to mammography x-ray equipment. They comment that most women will have
          13

      at least one mammogram during their adult lives in which healthy people mix
           14

      potentially on a very intimate level with ill people. Professionals must therefore
          15

      ensure that the mammography center does not become a source of nosocomial
          16

      colonization. How many medical devices can you think of that are actually
          17

      shared by healthy population and ill people alike? The answer is not many.
          18

      Women should not have to share body fluids of others to have a mammogram to
         19

      detect saving their lives from breast cancer and be forced to risk contracting a
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      bacteria or virus during this exam.
           1

           2       There are over 2 million nosocomial infections occurring in the

      United States annually. We know that many of these infections are caused by
           3

      health4care workers not following aseptic technique, not washing their hands, and

      studies have not been conducted how many are caused by lack of cleanliness
            5

      and disinfecting of medical devices.
           6

           7       Sinks and washing facilities are not placed in most x-ray rooms.

      Technologists do not wash their hands between patients and gloves are not
           8

      worn. 9 Consideration of the powder that may be incorporated in those gloves is

      not given. X-ray technologists touch body fluids, sick patients, contaminating
           10

      equipment.
          11

          12       Technologists pass these pathogens by touch by

      cross-contaminating the control panel knobs and buttons that are shared by
          13

      many technologists through the course of the working day without ever cleaning
         14

      these surfaces.
          15

          16       Instructions for proper disinfecting, sanitation, and hygiene are

      never given to technologists in their training, and unique consideration due to the
          17

      procedures we do should be given.
          18

          19       For instance, Clinical Focus recommends the use of disposable

      gloves, but if the gloves are selected that have powder, this powder will create
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      havoc1for proper film reading because of the artifacts the powder will create.

           2       I have just read Peggy Fay's recent experience as a patients since

      co-authoring our article 16 months ago. Peggy has an autoimmune disease that
           3

      causes her lesions on her body. Peggy Fay could not have a safe mammogram
           4

      because there was no manufacturer of any mammography equipment that made
           5

      an FDA-approved barrier to protect the equipment from potential
           6

      cross-contamination coming between Peggy and potentially contaminated
           7

      equipment surfaces.
           8

           9       High level disinfecting was not possible for her. What was Peggy's

      choice? Peggy was forced to risk having a mammogram, which found five
          10

      masses at the expense of exposing her non-intact skin to potentially dangerous
         11

      pathogens.
          12

          13       Patients receiving radiation therapy are also forced to make the

      same choice after receiving radiation therapy, having compromised skin from the
         14

      radiation treatment, and others face the same risk from other disorders.
           15

          16       The difference is that the other patients are not informed and not

      told of their risk. This is wrong, this is bad medicine, and this must be changed.
           17

           panel has the power to make that change. Your panel is meeting today to
      This 18

            to
      start 19 develop guidelines for interventional procedures performed during

      mammography, such as stereotactic needle biopsies. These procedures draw
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            and that blood will ooze onto the equipment surfaces, contaminating the
      blood 1

      bucky2and compression paddles. Only high level disinfecting or sterilization or

      the approved infection control procedures to follow. Technologists and
            3

      physicians cannot offer only an impression of hygiene, but must offer appropriate
           4

      disinfecting or barriers to protect the patients.
            5

            6        DR. MONSEES: Ms. Sherman, please sum up. We have one

      minute left.
           7

            8        MS. SHERMAN: Clinical Focus confirms high level chemical

      disinfecting is not possible. There is no reason why a woman should have to
            9

      share contaminated equipment that may appear to be visibly clean, but that is
          10

      actually contaminated with bloodborne viruses or perhaps even
          11

      antibiotic-resistant bacteria.
           12

           13        I am therefore requesting this panel to incorporate in the protocol

      for their inspection in order to assure that the medical device manufacturers have
            14

      provided the facilities with instructions for low, intermediate, and high level
           15

      disinfecting in accordance with the Center for Disease Control.
           16

           17        If barriers are available, that the amount of barriers ordered match

      the patient load to assure that these barriers are used and not reused. The
           18

      device manufacturers have not taken the lead, and have ignored the potential
           19

      risk posed by contaminated equipment.
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            1       I believe that only through assuring that infection control guidelines

      published in MQA will be implemented and no longer ignored is to have MQSA
            2

      inspectors ordered for infection control protocols during the facilities.
           3

      Technologists must be better informed through education and standards
           4

      developed that meet their unique specifications. Proper education will save
           5

             reduce infections, and reduce ultimate costs for health care.
      lives, 6

            7       I urge this committee to incorporate specific infection control

      procedures in the MQSA guidelines along with auditing them to assure safer and
           8

      better9mammography and biopsy exams.

           10       Thank you.

           11       DR. MONSEES: Do we have any questions or comments from

      panel members?
          12

           13       MS. SHERMAN: I would like to make one more comment. You

           most women do not have autoimmune disease or skin lesions. That is not
      said 14

      true. 15Many women, particularly large-breasted women, will have dermatitis.

      Other women will have scratch marks, bite marks, and there are many diseases
          16

      that do have irritation, bra irritation. So, women are exposed. Women shave
           17

      under their arms.
          18

           19       DR. MONSEES: Thank you for your comments.

           20       We will move on to the next speaker, please. Dr. Alan Kravitz. Is
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      he in the audience?
            1

            2       DR. KRAVITZ: Yes.

            3       My name is Dr. Alan Kravitz and I am a general surgeon from

      Rockville, Maryland.
           4

            5       First of all, I would like to thank the committee for allowing me to

      speak6before it. I have never testified before a government committee before,

      and I hope you will find my thoughts appropriate and helpful.
            7

            8       I am Chief of Surgery at Shady Grove Adventist Hospital in

      Rockville, Maryland. Almost three years ago, minimally invasive breast surgery
           9

      became a reality. My fellow surgeons in Montgomery County were concerned
          10

      that none of our local hospitals had the capability to perform stereotactic breast
           11

      biopsies.
          12

           13       We organized into a corporation and purchased a Lorad machine,

      so that we could offer our patients the most up-to-date and minimally invasive
           14

      capabilities to evaluate mammographic abnormalities.
          15                                                      We have done over 800

      biopsies, which is more than any other facility in our area. Still, not all of the
          16

            hospitals have acquired a stereotactic machine.
      local17

           18       I am very proud to say that almost all of the general surgeons in our

      county are performing stereotactic biopsies, and the number of open, wire
          19

      localization biopsies performed is much less than it had been.
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           1       I come to you today to share my concerns about possible federal

      regulation of physicians performing these biopsies and the adverse and
            2

      unforeseen consequences that ma await us.
           3

           4       It is important to realize the processes by which surgeon learn new

      techniques. It has been said that surgeons do not learn only operations in their
           5

      residency, but they also learn how to operate. The most recent example of a
            6

      new operation in my specialty was the laparoscopic cholecystectomy, which was
           7

      a radically new and less invasive method of removing a diseased gallbladder. I
            8

      am sure that there are members of this audience and perhaps some on the
           9

      committee who have had this operation. It was a dramatic departure from
         10

      conventional open surgery. Although we surgeons had removed many
          11

      gallbladders, very few of us had done much laparoscopy. Surgeons generally
           12

      taught each other this new operation. It was a very tricky operation at first and
          13

      the early ones lasted three hours with two to three surgeons on each case.
           14

           of
      Now,15 course, most of us can do it in 45 minutes with two nurses as assistants.

           12
      With 16 months, the surgeons in the United States radically changed their

      treatment of gallbladder disease to minimally invasive technique without the
           17

      Federal Government helping their credentialing.
          18

          19       This was done by hospitals, as is all credentialing. In fact, new

      operations and surgical techniques are continuously learned by surgeons in all
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      specialties without a hint of federal regulation. The surgeons are bound by their
           1

      duty to provide safe care for their patients and by the need to avoid substandard
            2

      care which might leave them exposed to malpractice suits.
           3

            4       Credentialing for these new procedures is done b hospitals and

      surgery centers. Indeed, these facilities are required to perform the
           5

      credentialing in order to obtain their certification.
           6

            7       The stereotactic breast biopsy was no different than any of these

            new surgical techniques. For years, surgeons have needed to be familiar
      other 8

      with using the two-dimensional mammogram to guide a three-dimensional
            9

      surgical biopsy. The wire localization procedure that the stereotactic biopsy is
           10

      replacing required the surgeon to be able to do this. Performing a stereotactic
           11

      breast biopsy is just an extension of this skill.
          12

           13       It should also be noted that looking a mammograms is part of the

            work of most breast surgeons, although I know of no surgeons who interpret
      daily14

      mammograms independently of a radiologist. In fact, it is the radiologists who
         15

      trigger most of the referrals we see.
           16

           17       Although the Mammography Quality Standards Act has done a

            job
      great18 of standardizing the mammographic equipment, there is still great

      variability in the interpretations by the radiologists. Some of our radiologists
           19

      seem more likely than others to label a mammogram as "indeterminate." These
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      mammograms also usually include the recommendation that, "surgical
         1

      consultation is advised."
           2

            3        This means that it is often up to the surgeon to decide which

      patients need immediate biopsy and which can be followed with another
            4

      mammogram. Fortunately, surgeons have also been trained to perform breast
         5

      examinations, and so we generally feel comfortable following these patients in
          6

      our offices.
            7

            8        Most of the surgeons are very selective when referring patients for

      any type of biopsy, in fact, at our stereotactic facility, 23 percent of all biopsies
            9

           either malignant or atypical.
      were10

           11        But I am very concerned that the approaching hoof beats of the

      federal cavalry may disrupt this established system of breast screening. It would
          12

      be counterproductive to make it difficult for general surgeons to perform
          13

      minimally invasive biopsy surgery. We should be encouraging surgeons to do
          14

      this procedure. It should be public policy to steer women to have stereotactic
           15

      biopsies performed as opposed to an open procedure.
          16

           17        Logically, a surgeon who is not allowed to perform stereotactic

      biopsies will be more likely to recommend that a patient get a wire localization
          18

      biopsy -- which, by the way, pays much better than the stereotactic procedure.
          19

           20        Just we are all trying to minimize the number of mastectomies
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      performed, imagine, if you will, what would happen if the Federal Government in
            1

      its infinite wisdom began limiting the number of surgeons who are permitted to
              2

      perform lumpectomies. Those surgeons who are not allowed to do
            3

      lumpectomies would then do more mastectomies.
           4

            5        Confusing and difficult to enforce federal regulations could make it

      hard for some patients to have access to this new technique. It would also not
            6

           that much sense for the Federal Government to begin credentialing this
      make 7

      minimally invasive technique, when similar credentialing would not be done for
           8

           difficult and dangerous operations, such as mastectomies and wire
      more 9

      localization techniques.
           10

           11        The other dark cloud that I see on the horizon is the American

      College of Radiology, which I suspect would like nothing better than to force
           12

      women to have the procedures performed only by radiologists. In my county,
         13

           of
      most14 the radiologists have never even done one, and many of them have

      never even seen one, and it would not be in the public interest to funnel patients
          15

      in their direction.
           16

           17        I also review claims for the Cigna Health Plan in the

      Baltimore-Washington area, and I can assure this committee that surgeons all
           18

           the
      over 19 area are doing these stereotactic procedures.

           20        The other problem with having only radiologists perform these
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      procedures is that it will certainly increase the number of unnecessary biopsies
           1

      that are being done, and many patients with so-called indeterminate
            2

      mammograms will get referred by the mammogram facility to a stereotactic
         3

      machine conveniently located at the same location.
          4

           5         This happens frequently with breast ultrasound, and I have seen

           patients get talked into an unwanted and unnecessary breast ultrasound by
      many 6

      an overly cautious radiologist.
           7

           8         I know that this committee is aware of cases where patients have

      received apparently substandard care with regard to stereotactic breast biopsies.
            9

      Unfortunately, suboptimal outcomes can occur with any surgical procedure
          10

      including wire localization biopsy, lumpectomy, and mastectomy. Even the
           11

      safest surgical procedure in the most capable of hands has the potential to turn
          12

      into a bad outcome. With this new procedure, dissatisfied patients have been
           13

      few and far between.
          14

          15         Mechanisms dealing with substandard medical care are already in

      place at the state level. In Maryland, for example, the Board of Physician
          16

      Quality Assurance deals with all patient complaints regarding inappropriate care.
          17

      Credentialing, as I have mentioned, is already done at the hospitals and the
          18

      facilities. It is unnecessary to add a duplicate layer of federal regulation and
            19

      bureaucracy.
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            1       In the hands of the community surgeons, stereotactic breast biopsy

      has been very safe in our experience and in our practice there have been no
           2

      missed cancers. The physicians are moving over to minimally invasive breast
           3

      surgery without any help from the Federal Government, and we would like to
           4

      continue doing so.
            5

            6       We appreciate the need to make sure that the equipment is safe

      and accurate and that the technicians are well trained. I hope that the Food and
           7

      Drug Administration will not take the plunge into credentialing physicians for a
           8

      surgical procedure. It is a task that they have had no experience with and one
            9

      which will not be the best interests of our patients.
          10

          11        Thank you very much.

          12        DR. MONSEES: Thank you for your comments.

          13        Do we have any questions or comments from the panel? Yes.

          14        MR. MOBLEY: You noted in your comments that -- and I might not

      express this exactly as you did -- but you noted that a number or referrals are
          15

      made by radiologists to surgeons because of the radiologist not clearly being
         16

           to
      able 17 see one way or the other, make a determination.

          18        Of those referrals, how many does the surgeon make the clear

      determination not to do surgery, not to do further followup or whatever just from
          19

      evaluating the patient's film or whatever?
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            1       DR. KRAVITZ: In this area -- let me explain a little bit how the

      patient flow works -- in this area, this is very heavily into managed care, so
            2

      patients generally don't see anybody without a referral. The general sequence
            3

      of events is that the patient has a mammogram, and sometimes that
            4

      mammogram will be interpreted as indeterminate with the proviso that a surgical
         5

      consultation is advised.
           6

            7       That report goes back to the primary care physician. The primary

      care physician is then looking at this report, and they don't want to deal with it.
            8

      They don't know what to do with it. So, that patient then always gets referred to
           9

      a surgeon -- I mean almost always.
           10

           11       The referral doesn't actually come from the radiologist, they are not

      allowed to make referrals, but it is what is written in the report that triggers the
           12

      referral to the surgeon. The surgeon then is left with looking at this patient and
           13

      wondering, you know, should we do a biopsy or can we watch it.
         14

           15       A lot of times these are women in their 30s getting mammograms,

      and still, you know, many of these patients can be observed.
          16                                                              We know that

      mammography for women in their 30s is not that accurate and that often just
         17

      observation and followup mammogram is safe in six months, but that decision is
          18

      made by the surgeons, because we are the ones who see the patient with the
         19

      mammogram, and we are the ones who have to make that decision.
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           1        MR. MOBLEY: I understand that. I am just trying to get a handle

      on exactly where the decision is made regarding the followup, and you are
           2

      saying it is made with the surgeon.
           3

           4        DR. KRAVITZ: Yes, it is.

           5        MR. MOBLEY: Can you then give me an idea of how many

      patients would not have surgery at that point in time?
            6

           7        DR. KRAVITZ: I don't really know. I have never tabulated in our

      practice which percentage of patients with indeterminate mammograms end up
            8

      getting a biopsy. I am guessing it is about -- it might be about half.
            9

          10        MR. MOBLEY: Thank you.

          11        DR. MONSEES: Any other questions or comments from the

      panelists? Yes.
          12

          13        DR. HENDRICK: I think I understood from your comments that

      you are concerned about the Federal Government regulating credentialing of
          14

      physicians doing this procedure. Do you also have concerns about credentialing
          15

      of others involved in the procedure, say, technologists, medical physicists?
           16

          17        DR. KRAVITZ: No, I do not.

          18        DR. HENDRICK: Or equipment standards being propagated by

      the FDA?
           19

          20        DR. KRAVITZ: No. In fact, we are very happy with that. We
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      have been very -- surgeons, as a group, have been very happy with the
           1

      standardization of the mammograms. We, as a specialty, used to struggle with
           2

      substandard mammograms, and now the mammograms, the films generally have
           3

      been of good quality, and we appreciate that.
           4

           5       DR. HENDRICK: Thank you.

           6       DR. MONSEES: Thank you for your comments.

           7       DR. KRAVITZ: Thank you very much.

           8       DR. MONSEES: We will move on to the next speaker.

           9       Dr. Joseph Rush. Is he in the audience?

          10       [No response.]

          11       DR. MONSEES: We will move then to the next speaker. Malee

      Shay.
          12

          13       Please state who you are and who you represent.

          14       MS. SHAY: My name is Malee Shay. I am a patient, a concerned

      patient, and I am speaking on my own behalf and on the behalf of other women
           15

      that perhaps experienced what I experienced.
           16

          17       DR. MONSEES: Can you speak into the microphone and let me

      remind you, Ms. Shay, that you have 10 minutes.
          18

          19       MS. SHAY: Yes. I paid my own way this year and last year.

      Okay. I reside in Seattle, Washington. One year ago I spoke before this
         20
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      committee as a concerned patient regarding my experience in undergoing a
          1

      stereotactic breast biopsy in 1993. I do not intend to repeat my statements of
            2

      1996 today, as a copy of my prior comments have been enclosed in the
           3

      notebooks I have provided to you. I have also provided newspaper articles and
           4

      discovery exhibits.
           5

            6       Since I am advised that presently two-thirds of the committee is

      new, I7believe a brief description of my experience is in order.

            8       In the fall of 1993, I was advised following a routine mammogram

      that I had suspicious findings and following magnified view, that I needed an
             9

      immediate biopsy of my left breast.
         10

          11        I was never shown the films, given a copy of the report, or advised

      in any way by the radiologist of the nature of the findings other than to be told
           12

      that they were suspicious for cancer.
           13

          14        I was caused to believe that the situation was urgent, although I

            found that the written report described the findings as only mildly suspicious.
      later 15

      My primary care provider was a nurse practitioner who relied solely on the
          16

      recommendation of this radiologist, who was a so-called expert in stereotactic
          17

           biopsies.
      core 18

          19        On the day of my magnified views, I was told by several members

      of the staff that the radiologist would meed with me regarding her findings and
           20
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      the upcoming biopsy procedure, however, she chose to leave the clinic while I
            1

      was waiting for our meeting in the lobby. No meeting ever occurred.
           2

            3       I am typically a very conscientious and informed consumer. I was

      terrified. The staff reassured me that I was in the hands of an expert and lucky
              4

      to be in their clinic. I agreed to the biopsy virtually without question.
            5

            6       In the radiologist's own words to my subsequent doctor, the

      procedure was a disaster. In brief, I was not properly anesthetized and
           7

      experienced excruciating pain with the taking of each of the 10 samples. There
           8

      were two physicians in the room, the radiologist who presumably had read my
           9

      films, and one who was never introduced to me, nor identified in my medical
           10

      records.
          11

           12       These physicians engaged in a continued argument throughout the

      procedure as to how it ought to be performed. Immediately after the first five
          13

      samples were taken, I was told they were all useless. Another five samples
         14

           then taken.
      were15

           16       The unidentified doctor did not return for the second attempt. No

      vital signs were taken even though the procedure took over two hours and I was
            17

      administered Valium throughout the entire procedure. I was black from bruising
          18

      on my entire left side completely down my rib cage.
          19

           20       Following the procedure, as a result of expressing numerous
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      concerns to my nurse practitioner, I was referred to a highly regard breast
           1

      surgeon who remains my current physician. The radiologist clinic at which my
           2

      biopsy had been performed refused to release my records, thus obstructing my
           3

      medical care and requiring me to retain an attorney to secure my records.
           4

            5          My new physician told me that in her view I had not needed the

      biopsy at all and a blind second read of my films by a second radiologist resulted
           6

      in a clear diagnosis of milk of calcium. To add insult to injury, one year later
             7

           my
      when 8 mammograms were compared to the previous views, it was discovered

      that the radiologist who performed my biopsy had missed a clearly visible mass
             9

      in my right breast, which thankfully turned out to be benign.
          10

          11           I later raised questions concerning the lack of a bill from the

      radiology clinic, and was cheerfully advised there would be no bill because the
           12

      procedure was considered experimental. The clinic said the first hundred
          13

      patients would not be billed, only the insurance carriers would pay, and pay they
           14

      did as the clinic triple-billed my insurance company, who later requested a partial
           15

      refund.
           16

          17           In answer to my complaint that I was subjected to an experimental

      procedure without my consent, the clinic started also billing me and continued to
          18

      do so on a monthly basis until our state medical board started their formal
          19

      investigation.
           20
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            1       My efforts to work with our state Quality Assurance Commission

      were both frustrating and useless. State medical boards cannot be relied upon
           2

      to initiate or enforce regulations. Although I submitted a 350-page complaint
              3

      with detailed documentation, in the end, which was 26 months later, they did not
            4

      even address the refusal of the clinic to release my records, which was a clear
           5

      violation of our State Health Care Information Act.
             6

            7       I also submitted my documentation to the American College of

      Radiology, the King County Medical Society, and the FDA. My present doctor,
           8

      who is considered an expert in breast disease, also wrote to your state board
           9

      indicating that my biopsy was predicated upon the acquisition of a new piece of
           10

      equipment rather than medical necessity.
          11

           12       In an effort to obtain full information about the reasons behind my

      unfortunate experience with this procedure, and in an effort to find some
          13

      accountability for what had occurred, I reluctantly commenced litigation against
          14

      the clinic and the radiologist in 1996.
           15

           16       That litigation has recently been resolved and although I cannot

      discuss the terms of the agreement, I want this committee to know that my
           17

      primary motivation in resolving the litigation was that I consider the work of this
          18

      committee and consumer awareness to be a much greater issue.
         19

           20       I would like to share with the committee some of the disturbing facts
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      which1were confirmed through our investigation and the discovery process.

      Some2issues don't pertain directly to the stereotactic procedure, but show what a

      consumer might face going through the process.
           3

            4       The radiologist who performed my procedure was and is a

      well-educated, highly-credentialed physician, who appears to have been well
            5

      trained in breast imaging. She came to Washington State and became
            6

      employed at the clinic where my procedure was performed approximately two
           7

      months prior to my biopsy.
           8

            9       None of the institutions at which she had worked previously

      possessed a stereotactic table. She has since been terminated by the facility
          10

      and according to our information, she is now in her second position since being
          11

      terminated. She is no longer practicing in Washington State.
          12

          13        Mysteriously, after my suit was filed, the radiology clinic seemed to

      dissolve and reappear under a new corporate name. The table on which my
           14

      biopsy took place was manufactured by the Lorad Company. Although my
          15

      physician had apparently attended a seminar regarding the Fischer table, she
          16

      had absolutely no training or experience on the Lorad table prior to coming to
          17

      Seattle.
          18

          19        In spite of numerous requests for information over three years, it

           filing of a lawsuit for me to determine that I was at the beginning of this
      took 20
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      physician's learning curve. Documents obtained through litigation demonstrated
           1

      clearly that this physician was having repeated serious problems performing this
            2

      procedure prior to my biopsy. It is on record that she had refused training in
           3

      spite of repeated recommendations by the manufacturer and distributor of the
            4

      table. 5

            6       Documents also stated that the technicians at this facility were

      overworked, distracted, and ill trained.
           7

            8       DR. MONSEES: Ms. Shay, sum up. You have between one and

      two minutes left.
           9

           10       MS. SHAY: I have enclosed for you some of this documentation

            would urge you to review it. I believe it clearly demonstrates that the
      and I11

      radiologist in my cases was not competent in the procedure at the time of my
           12

      biopsy.
          13

           14       This is information I deserve to be informed of prior to making a

           important decision regarding my health care. I have also enclosed a letter
      very 15

      written by the radiologist to the manufacturer of the table. This letter was written
           16

      in response to a letter from the distributor of the table to the director of the clinic.
           17

           18       In this correspondence, the radiologist admits that other radiologists

      at this facility were having problems and the table is blamed. She further
            19

      describes a case she was performing in which the needle passed completely
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      through the patient's breast. This incident apparently occurred in the presence
           1

      of an application specialist who was attempted to train my radiologist.
            2

           3        These documents and other information obtained in our lawsuit

      clearly paint the picture of a physician who was not properly trained and who was
            4

      knowingly experimenting on unsuspecting patients.
           5

           6        Members of the committee, the issues before you are extremely

      important to the thousands of American women each year who find themselves
           7

             same position as I was in the fall of 1993. I consider these issues so
      in the 8

      important that I have traveled here for the second time from Seattle, Washington,
           9

      to speak to you today.
           10

          11        I have chosen to resolve my lawsuit, so that my interest in these

      greater issues will not be misconstrued. According to one stereotactic expert
          12

      with whom my attorney has spoken, there are hundreds of physicians throughout
           13

      the country performing this procedure who are not properly trained to do so.
           14

          15        He described it as the biggest mess he has ever seen in the course

      of his long and distinguished medical career. The health issues involved are too
           16

      important to be caught in the crossfire of a turf war between surgeons and
          17

      radiologists. I wish I had been given the opportunity to consult with a surgeon
           18

          would have had much more experience in the area of counseling patients
      who 19

      regarding the need for, and the specifics of, surgery.
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            1       Instead, I received no counsel whatsoever from a radiologist who

      likely had spent her career detached from the every-day physician-patient
             2

      contact routinely experienced by a breast surgeon.
           3

            4       However, I understand that there are aspects of this procedure

      which5demand expertise in radiologic interpretation. Whatever the result of the

      struggle between these two specialty areas, however, the overriding and guiding
            6

      principle must be that the physician performing the procedure is adequately
            7

      trained.
            8

            9       I am currently in the process of preparing a document to submit to

      the Governor and selected legislators in Washington State, focusing continued
           10

      attention on this issue, as well as exposing the ineffectiveness of our state
           11

      medical board.
          12

          13        My work has already generated media interest on the state and

      national level, and I intend to continue to pursue the issue of regulation and
           14

      consumer awareness.
          15

          16        I am once again confirming the need for the committee to

      implement strict guidelines and regulations to ensure that this important medical
          17

      procedure be performed on informed patients by competently trained physicians.
          18

      Please keep the patient in mind.
          19

          20        Thank you.
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            1       DR. MONSEES: Thank you for your comments.

            2       Is there anybody on the panel who would like to make a comment

      or a question of Ms. Shay?
            3

            4       Thank you. Thank you very much.

            5       We will move down to R. Philip Burns, physician.

            6       DR. BURNS: Thank you, Dr. Monsees.

            7       I am Philip Burns and I am a surgeon from Chattanooga,

      Tennessee, and I represent the Advisory Council of the American College of
          8

      Surgeons here.
           9

          10        I appreciate the opportunity to address you and to introduce my

      colleagues who are pioneers in the field of image-guided breast biopsy,
           11

      specifically stereotactic breast biopsy.
          12

          13        I am a general surgeon. I am the Chairman of the Department of

      Surgery at the University of Tennessee in Chattanooga, and I serve in several
          14

      capacities as regards the College of Surgeons and the Southeastern Surgical
          15

      Congress in terms of program development and education.
         16

          17        I am also a practicing general surgeon with an emphasis on breast

      disease, but I also perform vascular surgery, as well as laparoscopic surgery in a
          18

      variety of disease states.
           19

          20        In our community, as has already been alluded here, surgeons are
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      the primary caregivers for breast disease. We find that a lot of women are
            1

      confused about the status of breast disease and breast evaluation, and
           2

      mammogram is not enough to decide which patients absolutely must and must
         3

      not be treated. Physical examination and clinical judgment are very important,
            4

             falls to a lot of the surgeons in our community to do that.
      and it 5

            6        Three years ago we purchased a stereotactic biopsy unit for our

      faculty. We placed it in our clinic. We have made this technique available to
            7

      both private and indigent patients that we care for. We also utilize aggressively
            8

      ultrasound evaluation and ultrasound image biopsy, as well as we have had a
            9

      long-standing interest in ultrasound through evaluation of vascular disease, as
           10

      well. 11

           12        Our residents are trained in the techniques of breast disease

      evaluation and thusly, in our facilities, stereotactic breast biopsy, ultrasound
          13

      guided biopsy. They perform these procedures under faculty guidance, and
          14

      when they leave our training program now, they are credentialed in our mind to
         15

      perform these procedures as they go into practice. So, it has become an
           16

      integral part of our education program in Chattanooga.
           17

           18        We have published our data in peer-reviewed journals in

      relationship to our statistics involving patients from the initiation of utilization of
            19

      this procedure, but we have also published our data in terms of the
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      needle-directed excisional breast biopsy, as well. And, by the way, our results in
           1

             of
      terms 2 malignancy rate, incidents of biopsy related to BIRAD's classification of

      breast lesions, is essentially the same between those two studies which involves
           3

      essentially patient cohorts that we assume would be the same as they come to
           4

      our clinic or through our practice for their treatment.
            5

            6       We currently participate in the newly developed image-guided

      breast biopsy registry that is coordinated at the University of Louisville by Dr.
           7

      Mike Edwards, and we look forward to results from this nationwide in terms of the
           8

      assessment of this technique further in addition to that, that we have in our local
           9

      community.
         10

           11       We think that it is extremely important for long term followup to be

      documented. This registry will help with that a great deal in addition to
          12

      augmenting our own prospective analysis of this.
         13

           14       We perform approximately 600 core biopsies a year in our facility.

      We frankly do a few more ultrasound-guided biopsies than we do stereotactic
          15

      biopsies, and again it depends on the clinical judgment of the physician at the
          16

           as
      time 17 to which you use.

           18       It has already alluded to the fact that across the country, this

      technology has exploded in the surgical community, and that is because it is
          19

      proven effective in both the evaluation of breast disease and certainly, we think,
          20
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      in reducing the fear and anxiety that women have of breast disease, in that it is
            1

      less invasive and in most circumstances certainly far less painful to the patient.
            2

            3       My primary mission other than defining what I do myself is to take

      the opportunity and the privilege to identify or introduce you to my two colleagues
            4

      who are here. Some of you met them last year, those that are new to the
           5

      committee might not have met them. Dr. Phil Israel and Dr. Kambiz Dowlat.
          6

            7       Dr. Israel is a pioneer in the clinical application of stereotactic core

      biopsy, utilizing this aggressively in his practice which is isolated to the treatment
           8

      of breast disease at the Breast Center in Marietta, Georgia.
            9

           10       In addition to performing this procedure in over 5,000 patients, he

      has maintained a prospective analysis, he and his group of physicians,
          11

      maintained a prospective analysis of their patients and have published them in
          12

      peer-reviewed journals, the earliest one being in the American Surgeon in 1994
          13

      that detailed well over 500 cases performed in the stereotactic setting.
           14

           15       He has also trained in a well-organized training program 750

      surgeons and 100 radiologists in the techniques of stereotactic breast biopsy,
          16

      and he has also been very much involved in the development of the training
          17

      courses that have been offered in this technology at the Southeastern Surgical
          18

      Congress and at the American College of Surgeons.
         19

           20       My other colleague is Dr. Kambiz Dowlat, who is really the pioneer
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      in both the research and clinical applications of this technology. He is a
            1

      professor at Rush Medical School in Chicago, but early on developed a research
            2

      interest in this technique, spent a lot of time in Sweden, then came back to the
            3

      United States and brought the first stereotactic biopsy unit to this country.
           4

            5       He applied it to the research setting first, then to clinical application,

      and the published his first data in 1987. He has had multiple other publications
            6

            that time.
      since 7

            8       His current research interestingly includes interest in application of

      this stereotactic technique to the treatment of breast cancer through the
             9

      utilization of laser technology and perhaps he will explain that to you some when
            10

      he talks.
           11

           12       We are really fortunate to have him agree, at the College of

      Surgeons level, to spearhead the development of our education courses in
          13

      offering the opportunity for surgeons around the country to come and learn the
           14

      techniques of image-guided breast biopsy. He has done a wonderful job with
          15

             We
      this. 16 have regularly scheduled courses sponsored and developed by the

      American College of Surgeons through Dr. Dowlat's leadership.
         17

           18       At this point, I would like to let Dr. Dowlat take the floor and

      proceed from this point.
          19

           20       Thank you very much.
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           1         DR. MONSEES: Thank you for your comments. We will call upon

      Dr. Dowlat, please.
           2

           3         DR. DOWLAT: Good morning, ladies and gentlemen.

           4         I would like to thank you for giving me the opportunity to briefly go

      over specifically the course that the American College of Surgeons has
            5

      organized to teach and train the individual physicians, surgeons, or radiologists,
           6

      or otherwise, to use this interventional technique.
            7

           8         DR. MONSEES: Sir, are you representing the American College

      of Surgeons at this meeting?
            9

          10         DR. DOWLAT: I am sorry, no. Yes, I am, as Dr. Burns said, I am

      a surgeon in Chicago, and the American College of Surgeons has asked me to
           11

           an
      give 12 account of the course that is given for training of the surgeons all over

      the country.
           13

          14         DR. MONSEES: So you are representing the American College of

      Surgeons at this meeting here?
          15

          16         DR. DOWLAT: Yes, I suppose that is correct.

          17         DR. MONSEES: Thank you.

          18         DR. DOWLAT: As Dr. Burns alluded early on, I was involved in

      training and teaching of this technique from years ago, independently, at the
            19

      University of Chicago and subsequently at Rush, to radiologists and to surgeons,
          20
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      and more recently, because of the increased interest of the surgeons from all
           1

      over the country, we have organized these regular courses on a three-monthly
            2

            for
      basis 3 whoever wants to have the training.

            4        Specifically, the courses are organized on a two-day basis, didactic

      the first day, and the second day is work stations where the trainees actually do
             5

      procedures on phantoms and examine live patients by ultrasound, so this is a
           6

      course given for image-guided breast biopsy including both ultrasound and
           7

      stereotaxic.
            8

            9        The faculty, we have a roster of 40 faculty, all very distinguished

      individuals from all over the country including radiologists. We have had the
           10

      pleasure of having Dr. Larry Bassett and Dr. Carl Dorsey. I would like to
          11

      acknowledge their teaching and their lecturing at this course.
          12

          13         We also have had Dr. Laslo Tobar, an internationally known

      lecturer and pioneer in mammography, give a whole day course lecture and
           14

      presentation to the individuals. Also, I would like to acknowledge Dr. Robert
          15

      Pizzutiello, who has given the lecture on the medical physics, as well as risks of
          16

      radiation to the physicians.
           17

          18         These courses have been very successful. The evaluation has

           extremely favorable. More recently, we have tried to also test the
      been19

      individuals who have taken the course and to see how much they have actually
           20
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      learned, and this again we are in the process of learning how to perform this
            1

      evaluation.
           2

            3       The trainees are asked questions before and after using error

      system which seems to be very effective. It was used for the ATLS training and
           4

      we are trying to do the same for the image-guided breast biopsy.
           5

            6       On the skill stations, we also tried to test the individuals at the end

      of the 7day to see how much they have actually learned, how to examine patients

      and how to evaluate and obviously conduct interventional steps on phantoms.
           8

            9       What are the future plans for us? We are offering these course on

      a quarterly basis all over the country, and we would like to come up with some
          10

           of
      kind 11 guidelines, which I think Dr. Winchester and others will refer to later on in

      terms of credentialing the physicians who take this course.
          12

           13       Obviously, they too require some preceptorship after they take the

      course, and in order to start the practice at their individual hospitals.
          14

           15       I think at this point I stop and take any questions that you have.

           16       DR. MONSEES: Thank you.

           17       Do we have any questions from the panel or any comments? Yes.

           18       MR. MOBLEY: Is there any requirement that before a surgeon

      would start doing this technique, that they would have to take this course or a
          19

      similar course?
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            1       DR. DOWLAT: Any particular requirement you mean by previous

      training? The surgeons who come and register for this course are those who
             2

      have breast surgery as part of their practice, and they would like to perform
           3

      minimally interventional biopsy technique, and there is no particular qualification
           4

      for that.
            5

            6       MR. MOBLEY: You said you hoped to develop credentialing

      criteria or something to that effect, but in essence, is there any requirement or
             7

      any specific necessity for a surgeon going through this training, or is it just simply
           8

            that desire the training, get it, and those that don't desire it, don't get it?
      those 9

           10       DR. DOWLAT: That is correct. These are the individuals who

      desire to learn this, and because they probably plan to perform the needle biopsy
           11

      in their community hospitals or wherever they practice.
           12

           13       I am sorry. They have to be board-certified surgeons and

      obviously, to have their credentials in place. I think this was well documented in
          14

      statement by the College of Surgeon published three years ago in the Bulletin of
           15

      the College of Surgeons.
           16

           17       DR. MONSEES: Another question.

           18       MR. FLETCHER: Roland Fletcher. Do you have any idea of the

            between those who have taken this training and those who have not, who
      ratio 19

      are performing?
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            1       DR. DOWLAT: That is a very difficult question. I guess we

      thought that there are about 2,000 surgeons in the United States who practice
           2

      breast surgery. The ones who have taken to date, we have offered five courses,
           3

      and I would say over 500 of them, 500 surgeons have taken these courses.
            4

            5       Besides this formal course, there are the private courses given in

      the country. Maybe Dr. Philip Israel will enlarge on that. I would say I think Dr.
            6

      Burns7mentioned that 700 other surgeons have taken this course. There are

      courses given by radiologists that surgeons participate and learn this procedure,
           8

      so some of them do it once, maybe some do it twice, and so on.
           9

          10        MR. FLETCHER: Thank you.

          11        DR. MONSEES: Yes. First, Dr. Smith.

          12        DR. SMITH: Do you have an opinion, though, as to whether these

      courses should be required or very strongly encouraged rather than the pursuit
          13

      of, let's say, on-the-job training or just a general sense that this is doable? Ms.
            14

      Shay's material portrayed I think an extreme example of someone who thought
          15

      that they could get away without having a course.
           16

          17        I guess the next question I would have is your opinion as to

      whether or not there should be some standardization, formal or informal, of
          18

      course materials and what sorts of materials are presented.
          19

          20        DR. DOWLAT: The answer to your first question is yes, I think the
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      technology has become quite complex now. The first unit that I brought to the
           1

      United States was very simple. It was like an old car with four wheels and a
           2

      steering wheel and an engine, and you got into it and went from A to B, but now
            3

      you have got highly computerized technology and it is becoming more and more
           4

      complex.
          5

            6         There is quite a competition in the country, therefore, the formal

      courses are necessary, I believe, in order for the individuals who are going to
           7

      practice this to do it properly.
            8

            9         The answer to your second question is that we are trying to

      standardize this and it is not very easy because of the rapidly changing scene,
          10

           in
      both 11 stereotaxic and ultrasound. We are, in fact, in the process of

      standardizing the whole course from A to Z, so that each part or each segment of
          12

      it is given to an individual without duplication or redundancies.
             13

           14         DR. MONSEES: We have another question down here. Dr.

      Sickles next.
           15

           16         DR. SICKLES: Just to amplify on that, I understand from your

      answer, then, that it is your opinion that physicians, not just surgeons, but
          17

      physicians who perform these procedures should be educated and credentialed
          18

      in doing this, or just educated?
           19

           20         To amplify that, do you think that if they are to be credentialed as
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      opposed simply educated, that this should require not only an initial education
           1

      period, but continuing education?
            2

            3       DR. DOWLAT: You are putting it in a very broad term, Dr. Sickles.

      Education, that covers a whole lot of things. Specifically, if you refer to the
          4

      stereotaxic needle biopsy, you really mean training in that particular technology.
            5

            6       I think they should be trained in this technology. Whether the

      credentialing I think should be renewable because, for two reasons. This is
           7

      something which an individual may go back and don't practice it, and then maybe
          8

      two or9three years later, comes and says no, I want to do it. So, there should be

      some kind of monitoring or regulation in that respect.
         10

           11       There is also the question of the complexity of this technology.

      Initially, we used very simple, a fine- needle aspiration, then core biopsy, then
            12

      bigger cores, and now ABBI system, and so on, and so on, and we are moving
          13

      into the area of treatment of these small breast tumors with either excision of
            14

      in-situ coagulation with laser.
            15

           16       So, the maintenance of proficiency, I think is important, that it

      should be included in the future plans.
          17

           18       DR. MONSEES: Dr. Winchester, please.

           19       DR. WINCHESTER: Following up on the sort of theme of the

      questions of the committee, do you think it is possible for any surgeon or any
          20
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      radiologist to just pick up an article and seem to be interested in this procedure,
            1

      and then just start doing it in their hospital, or do you think that local credentialing
            2

      committees have some guidelines in place locally to have some requirements for
          3

      education and proctoring at their local level based upon emerging technologies?
           4

            5       I think it would be good to standardize that -- going back to Dr.

      Smith6or Dr. Sickles -- it would be good to have some kind of standard algorithm

      for the physicians who would like to do this in order to help the credentialing
            7

      committees of the hospitals.
          8

            9       The credential committees are looking to the bodies like American

      College of Radiology and American College of Surgeons, and it would be good to
           10

           a
      have11 joint statement say these are the minimum amount of training needed for

      the individual surgeon to start, and these are the requirements for maintenance
           12

      of proficiency.
           13

           14       DR. MONSEES: Mr. Pizzutiello.

           15       MR. PIZZUTIELLO: Dr. Dowlat, we have been talking primarily

      about surgeons who are currently in practice. Can you tell us a little bit about
          16

          young surgeons going through their residency training are learning this new
      how 17

      procedure and how that might be documented, so that it is clear that they know
          18

           they are doing?
      what19

           20       DR. DOWLAT: I think that is also recently being agreed upon --
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      correct me, Dr. Winchester, if I am wrong -- that the American Board of Surgery
            1

      has accepted to or is planning to have this training system introduced or
           2

      implemented in the residency program, so that the residents in their senior years
           3

      take the course or take the training, if they are going to be specifically breast
            4

      surgeons, to be competent.
           5

            6       DR. WINCHESTER: If I could just clarify that.

            7       DR. MONSEES: Yes. Dr. Winchester.

            8       DR. WINCHESTER: It has officially become part of the required

      curriculum in general surgery, and thus will be subject to review after completion
            9

      of training in the form of board certification. Both the written and qualifying
            10

      examinations will include this as part of the exam.
          11

          12        DR. MONSEES: Do we have any other comments? Yes, Dr.

      Hendrick.
         13

          14        DR. HENDRICK: I have a couple of sort of clean-up questions that

      I would like to ask. There was some allusion to needing to be a board-certified
          15

      surgeon to do these kinds of procedures, is that correct now or not?
          16

          17        DR. DOWLAT: I think so. This is board-certified surgeons are

      asked by their local credential committees, surgeons, to be board certified in
          18

      order to practice in their committees. Again, Dr. Winchester, am I correct?
          19

          20        DR. MONSEES: Go ahead. Yes, you may.
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            1       DR. WINCHESTER: Not really. That is not stated as a board

      certification requirement, and that was just in an article in the Bulletin of the
             2

      college a couple of years ago. I don't believe we allude to it in the personnel
            3

      qualifications for either radiology or surgery.
             4

            5       DR. HENDRICK: Then, I had a couple of other questions.

            6       In your course that is I assume mainly aimed at surgeons, can

            people attend beyond the surgeons, radiologists, or other physicians who
      other 7

             surgeons?
      aren't 8

            9       DR. DOWLAT: The course is offered to all physicians, be it

      radiologists, surgeons, or gynecologists.
           10

           11       DR. HENDRICK: And in the course curriculum, as it currently

      stands, are you including treatment guided by stereotactic?
          12

           13       DR. DOWLAT: No, not currently. Currently, we just focus on the

      diagnosis.
          14

           15       DR. HENDRICK: Thank you.

           16       DR. DOWLAT: I also would like to thank you for your contribution

      to the course. I forgot to mention that early on.
           17

           18       DR. MONSEES: Are there any other questions?

           19       If not, we will move on. Thank you very much.

           20       DR. DOWLAT: My pleasure.
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           1        DR. MONSEES: Our next speaker is Dr. Philip Israel.

           2        Please state who you are.

           3        DR. ISRAEL: Thank you. Members of the committee and

      participants, thank you for the opportunity to speak today. My name is Dr. Philip
            4

             and I am Director of the Breast Center in Marietta/Atlanta.
      Israel 5

           6        I address the issue before us today from the viewpoint of an

      individual private practice surgeon and also on behalf of the American College of
            7

      Surgeons. The purpose of this hearing today is to consider the issue should
           8

      interventional mammography be regulated.
            9

          10        My remarks I would like to be underlined by an overriding concern

      for quality of care and for the safety of the patient. I personally have been
           11

      involved in stereotactic breast biopsy since 1991. I have had the unique
           12

      opportunity to observe this technology evolve both in the radiology community,
          13

      locally and nationally, and in the surgical community.
           14

          15        I trained with Steve Parker in Denver. I have had the opportunity

           the
      over 16 last two and a half years to participate in Dr. Parker's stereotactic and

      ultrasound courses as a member of his faculty, so I have taught both surgeons
           17

      and radiologists, and I have seen them both perform.
          18

          19        In our own center, we have six surgeons. I would like to give you

      just a little background from where I am coming. We have six surgeons in our
           20
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      center. We do only breast work. We have access to three stereotactic units,
           1

      two of2which are in surgery centers, one of which is in my office.

           3        We have done over 5,000 stereotactic breast biopsies. We have

             think extremely complete outcome data. We have published our data in
      kept I 4

      the American Surgeon in 1995, looking at the sensitivity and specificity and
           5

      accuracy of the procedure.
           6

           7        We have also been involved in training, and as been mentioned, we

      have trained almost 1,000 radiologists and surgeons over the last five years.
           8

           9        This committee, of course, is interested in quality of care and

      assuring that the American woman gets the best possible service. We want to
          10

      know that experienced and responsible individuals are doing these procedures.
          11

          12        From my viewpoint and my experience, I have been very gratified in

      that the surgeons that we have taught have self-selected themselves out of a
           13

            number of surgeons, and these are surgeons that have large breast
      large14

      practices, they know about this technology, they want to be involved, and from
          15

      my experience, they are eminently qualified into moving into this area of
          16

      stereotactic breast biopsy.
           17

          18        I have seen them go out into their communities around the country.

      Many of them have opened breast centers themselves since they were primarily
         19

      doing a majority of their work in breast, and they have all kept good auditing
          20
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      outcome data. I am in constant touch with these doctors, and I am very pleased
           1

      that they have made sure that they have received the maximum training.
             2

            3       They attend, not just one and not just two courses, they attend

      multiple courses, they do it annually, they work on their imaging skills, and I am
            4

      very proud to say that I think they have been very responsible.
            5

            6       On the other hand, in my own community, I have offered to train

      any surgeon, free of charge, that wants to do stereotactic breast biopsy. Many
           7

      of these surgeons do very little breast work. Some of those surgeons, out of
            8

      curiosity I think, have taken advantage of my offer and they have been trained,
            9

      but interestingly enough, they have not shown up to do stereotactic work.
           10

          11        I think this self-selection process on the part of the surgeon is

      probably the best credentialing that we can rely on, and what I am seeing is that
          12

      the surgeons who are not interested, who are not heavily involved in breast work,
           13

      are not trying to do this procedure.
           14

          15        Surgeons are embracing this technology in an amazing manner

      around this country, and all of the major surgical organizations, including the
          16

      American College of Surgeons, the American Society of General Surgeons, the
         17

      Southeastern Surgical Congress, and all the state surgical societies are offering
          18

      courses to interested individuals, and these courses almost always are
          19

      oversubscribed by the surgeons.
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            1      The stereotactic units that are being installed around this country,

            has
      there 2 been an enormous shift in where these units are going. For the first

      four or five years, they went into radiology departments and mammography
            3

      centers. That is no longer the case.
           4

            5      Recently, the majority of these units are going into operating rooms

      and into free-standing surgical centers.
            6

            7      An interesting advance is all of this technology has been the

      explosion of the needle technology. The engineers for the surgical companies in
           8

      this country are really becoming involved. They are producing new types of
            9

      instruments to collect tissue. Some of these instruments collect very large
           10

      portions of tissue, such as the ABBI and a new instrument that I saw at the
           11

      American College of Surgeons in Chicago a few weeks ago.
         12

           13      These collection devices or biopsy devices require almost a

      surgical procedure. They require a large incision. It results in harvesting a
           14

            amount of tissue. It involves suturing an incision and bleeding control and
      large15

      wound management, of course, of which surgeons are, I think, eminently
         16

      qualified.
           17

           18      As a second thought, I see that if the FDA does become involved in

      credentialing and monitoring this type of operative procedure, it is going to make
          19

      a drastic change in the makeup of your committee.
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            1       You will have to have surgeons, a lot more surgeons involved.

      You will have to have operating room supervisors, operating room technicians,
           2

      and probably even monitors going into operating rooms to evaluate sterility,
           3

      wound management, and all the other myriad of things that go into surgical
          4

      biopsies.
            5

            6       The surgeons have started a national data registry, looking at and

      tracking the indications for breast biopsies, for stereotactic breast biopsies, the
            7

      type of breast biopsy is this stereotactic or ultrasound, the type of instrument
            8

      used to collect the tissue, of which, as I have mentioned, there are a myriad of
           9

      instruments today, and this will track the false negatives, the false positives, the
           10

      accuracy of the procedure, as well as the complications.
          11                                                          This has been set

      up by Dr. Mike Edwards at the University of Louisville, and all of the surgeons in
          12

      the country that have been recognized, that are doing these procedures, have
           13

           sent data collection sheets, and are contributing data.
      been14

          15        I was very interested in the public testimony this morning because

           of
      most16 the complaints and the problems in the public sector have to do with the

      surgical aspect of this procedure, and not the imaging aspect.
           17

          18        It has to do with non-surgeons who are now moving into the arena

      of performing breast biopsies, where they have to deal with sterility, informed
           19

      consent. This is where I think the public is having a problem.
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            1       Fortunately, these are issues that surgeons will have no problem

      with. 2Surgeons have dealt with sterility for decades, we deal with it every day.

      Informed consent, we tried stereotactic breast biopsy as if it is an operative
            3

      procedure, not an extension of the mammogram, which means we get informed
           4

      consent, we talk to the patient about options. There is a bonding with the
           5

      patient. We do a good physical examination to make sure there is no coexisting
            6

      disease. This is part of our modus operandi on a regular basis.
           7

            8       Other, non-surgeons, are going to have go acquire these skills in

            to
      order 9 satisfy the consumer, and not create the kind of problems that we are

      hearing testimony about today.
          10

           11       I will end my comments at this point and entertain any questions

      that there are.
           12

           13       DR. MONSEES: Thank you.

           14       Do we have any questions or comments from the panel? Yes, Dr.

      Farrell.
          15

           16       DR. MOORE-FARRELL: What needle system are you

      predominantly using or do you have one that you use mostly?
          17

           18       DR. ISRAEL: Fortunately, we have had experience with almost all

      of the needle technology. We have not abandoned the standard, 14-gauge
           19

      TruCut. That is part of our armamentarium. Certainly, suction device
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      instruments like the Mammatome. We do all of our microcalcifications with
            1

      Mammatome. We do most of our nodular densities with 14-gauge or 12-gauge
         2

      TruCut.
           3

            4       DR. MOORE-FARRELL: On the Mammatome, are you using the

      14 gauge or the 11 gauge?
           5

            6       DR. ISRAEL: Initially, we used both, but all of the seven doctors in

      my group have migrated towards the larger needle. We collect more tissue with
           7

      that, and we don't have any additional pain or bleeding.
             8

            9       DR. MONSEES: Dr. Sickles.

          10        DR. SICKLES: Is it your contention from your experience as a

      teacher and going around the country, that all surgeons now performing this
          11

      procedure are fully trained in doing it?
          12

          13        DR. ISRAEL: Of course, I can't answer that because I don't know

             the
      all of14 surgeons that are doing stereotactic biopsy, but I am impressed at

      those that I am aware of that are doing it, appear to be doing it in a very, very
          15

      responsible manner, and are showing up at meeting after meeting after meeting
          16

      and really making a conscientious effort to become trained and specialist in this
          17

      area.
          18

          19        DR. SICKLES: Do you tend to see the same people coming back?

          20        DR. ISRAEL: We see a lot of the same people coming back in
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      addition to individuals who are testing the water to see if they want to become
            1

      involved, and as I have said before, generally, this is a self-selection process and
            2

            doctors who have high volume breast practices are the ones that want to
      those 3

      and are getting involved.
           4

            5       DR. SICKLES: I understand that. Are you aware of any surgeons

      or, for6that matter non-surgeons, who are doing this procedure, who are not

      trained?
            7

            8       DR. ISRAEL: Yes.

            9       DR. SICKLES: So there are such.

           10       DR. ISRAEL: Yes.

           11       DR. MONSEES: Dr. Dempsey.

           12       DR. DEMPSEY: Dr. Israel, I just want to clarify your statement at

      the end there. Are you saying that only surgeons talk to the patient and obtain
           13

      informed consent for this procedure, because that is what your statement kind of
           14

      --   15

           16       DR. ISRAEL: No, I think that the complaints that we hear before

      this committee are involved with lack of informed consent, lack of bonding, lack
           17

      of communication with the doctors they have encountered, and I limit my remarks
           18

      to that. Certainly, radiologists talk to patients, surgeons talk to patients. I think
           19

      that there will be certainly varying degrees of personal involvement by the
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      physician.
           1

            2       I would say that I think that surgeons are more accustomed to

      interacting with patients prior to a procedure, doing physical examinations, giving
            3

      options, and receiving informed consent, but I think this is an area that the
            4

      radiologists will have to improve upon since it is not, has not been in the past a
            5

      part of their general approach would be my opinion.
            6

            7       DR. DEMPSEY: Even in things like interventional radiology?

            8       DR. ISRAEL: I don't want to extend my remarks to that area

      because I have no information about that.
           9

           10       DR. DEMPSEY: The blanket statement was out there and I just

      wanted to clarify that.
          11

           12       DR. ISRAEL: I don't want to leave any false impression.

      Certainly, I think that radiologists, as mammographers in particular, who focus in
          13

      this area, can do all of these facets of interacting as well as a surgeon.
           14

           15       DR. MONSEES: Dr. Smith.

           16       DR. SMITH: Two questions on the last point. The issue of

      dealing with informed consent, patient reassurance, that sort of thing, could be
           17

      strongly emphasized in courses any physicians were taking.
           18

           19       DR. ISRAEL: Yes.

           20       DR. SMITH: I presume that is in the courses that you are
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      teaching.
           1

            2       DR. ISRAEL: Yes.

            3       DR. SMITH: The next question is, is it your opinion that after one

      of these courses, which typically runs over two to three days, the physician who
            4

      has taken this course for the first time, are they fully competent to begin
            5

      performing these procedures on their own?
            6

            7       You emphasized that you get a lot of repeat attendance, so

      obviously people are coming back to hear new ideas, but perhaps they are also
           8

      coming back to reinforce the training that they have already had, benefiting from
           9

      some redundancy.
         10

          11        So, the question is, I mean a weekend happens to be a period of

           off,
      time 12 it works out that way, and it is only so long. Do people coming back

           these courses, are they ready to go in your judgment or what else might be
      from 13

      required?
          14

          15        DR. ISRAEL: I think we weekend course is a beginning. It's not

      the middle and it's not the end. It's the beginning of a learning process for
          16

      surgeon and radiologists. I think both radiologists and surgeons will recognize
          17

      that you will not learn to do this procedure in a weekend. It is more like an art
           18

      form. It's like asking a painter, when they are fully trained, I think every day an
          19

             learns to improve his technique, and I think these procedures are no
      artist20
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      different.
             1

            2       The imaging skills, the surgical skills, the communication skills can

      always be improved. It's a continuing learning process.
           3

            4       DR. MONSEES: Yes.

            5       MS. HEINLEIN: Dr. Israel, what personnel are involved in the

      procedure? I mean is it you and a nurse, is it you and a technologist, is it only
           6

      you? 7 Can you share that with us?

            8       DR. ISRAEL: It is myself and a technologist. In our teaching, we

      certainly recommend that no radiologist and no surgeon do this procedure
            9

      without a double-registered technologist. However, I think that the physician
           10

      always has to be in control, the technologist does not make the decision this is
          11

      the lesion to be biopsied. The technologist does not mark the area of access for
           12

      the cores. That relationship has to be established and maintained.
           13

           14       In our center, we do not involve a radiologist. A radiologist has

      never been in our center for the 5,000 cores that we have harvested. This was
          15

      a very hard decision for us, because in a way we were very much pioneers at this
           16

      time.17

           18       When we started doing this procedure -- do I have a moment to

      answer that question, maybe a minute -- when we started doing this procedure, I
          19

      actually lobbied the radiologists in my community to get a stereotactic unit for two
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      years,1and it was never done.

            2       A surgical center offered to buy the equipment and I said, yes,

      please buy it, this technology needs to be offered in this community. At that
           3

      time, I4already had four years of breast only, and I had improved my imaging

              but
      skills, 5 I had to make the decision am I competent with my imaging skills to do

      this without radiology assistance, and I gave this a lot of serious consideration.
            6

            7       In the end, I said yes, I think I can do this, and so we embarked in

      that manner, and we have not had any radiology assistance in image
            8

      interpretation in our center.
            9

           10       DR. MONSEES: Do we have any other questions here?

           11       I would like to just ask a brief question. I am a little confused

      because one of the major advantages that accrue to patients who undergo
          12

      stereotactic core biopsy is that it has moved the biopsy procedure out of the
           13

      operating room into an office type practice, and we have done less and less
          14

      invasive things.
           15

           16       Do I get from the drift of what you described having seen at the

      American College of Surgeons with more invasive biopsy devices, that you see
         17

      an advantage to those larger core devices, one, and two, are you predicting a
          18

      move back to the operating room when, in fact, we were raving over the last
         19

      couple of years about a major advantage that we have moved out of the
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      operating room?
           1

            2       DR. ISRAEL: Thank you for asking those questions because they

      are very important. Personally, I don't like the larger core biopsy instruments.
            3

      They don't serve my purpose. I want to make a diagnosis with this instrument.
           4

      I can do it with much smaller needle devices.
            5

            6       The second part of your question, do we want to see these

      procedures moved back into the operating room? Absolutely not. When the
           7

      device is placed in an operating room arena, it usually is placed in an area where
           8

      outpatient surgery is performed, separate from the actual operating room area.
           9

          10        So, I think that we must, first of all, make a commitment to continue

      minimally invasive work. We don't need to make a 2-centimeter incision to
          11

      achieve a diagnosis, but there are some doctors that don't agree with me, and
          12

           feel
      they 13 more comfortable using larger core instruments.

          14        I think the practicing habits of the doctors will eventually determine

      which of these biopsy instruments will survive and which will fail, but I certainly
          15

      support minimally invasive work in an outpatient setting.
          16

          17        DR. MONSEES: Thank you.

          18        Do we have any other final questions here?

          19        Thank you very much.

          20        DR. ISRAEL: Thank you.
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            1       We will move on to Dr. Armando Santelices.

            2       DR. SANTELICES: Good morning and, first of all, thank you very

           for
      much 3 allowing me the opportunity to come once again and testify before this

      panel.4 I bring you greetings from South Florida, the world champions.

            5       DR. MONSEES: Dr. Santelices, are you representing yourself or

      an organization?
           6

            7       DR. SANTELICES: I am going to give you a long list.

            8       DR. MONSEES: Thank you.

            9       DR. SANTELICES: First and foremost, I am representing myself.

      I have a breast center which was opened in 1991. My numbers are not as
           10

      staggering as Dr. Israel, but I have done over 2,000 biopsies. The machine that
          11

      was placed in my center was machine number 98, manufactured by the Fischer
          12

      Company.
         13

           14       Like Dr. Israel, I took my first training with Dr. Parker, which by the

            created the first turf battle because at the end of his lecture, he had a
      way, 15

      radiologist stabbing a surgeon with a Bard-Parker needle and saying that in the
           16

      future, breast biopsies would be in the domain of radiologists, not surgeons. So,
           17

      that is one conflict, because obviously I am representing my personal interest,
            18

      but obviously, my interests are of my patients.
           19

           20       I am also the new medical director of a center of excellence for
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      Health South that has been created in South Florida, which will have a
           1

      multidisciplinary approach to breast diseases including radiologists, nutritionists,
            2

      psychologists, internists, and surgeons.
           3

            4       My plane ticket was purchased by the American Society of Breast

      Surgeons. Yesterday, I received a phone call from Dr. Caplan, who said if I
           5

      wouldn't mind reading a letter that he would prepare for you, and that as a return,
           6

      he would pay for the plane ticket. I would have read the letter anyway, but if he
           7

      was going to pay for the plane ticket, of course, I took it.
           8

            9       Last but not least, I am currently under negotiations to enter into a

      contract agreement with U.S. Surgical, because of the research and
           10

      development that is being done with regards to new needles. In addition to this,
          11

           Surgical Corporation just bought out a company called Neovision, who does
      U.S. 12

      sonographically-guided, computer-guided biopsies, and my center was one of the
          13

      clinical trial centers, and we have done over 100 ultrasound-guided biopsies uses
            14

      computer technology.
         15

           16       So, I think that will give you a brief overview of all my conflict of

      interest. I would like for the record also to state that I am not board certified, and
           17

      therefore, if we follow the board certification route, I would be out of the picture
           18

      immediately. I have been 17 years in private practice, I have never been sued
         19

      once. I am the Chief of Surgery at Palmetto General Hospital and I have been
          20
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            for
      there 1 the last eight years.

            2       Giving you an overview of where I come from, I still think of myself

      as a country doctor. My credentials are not gigantic and I have never published
            3

      a paper on stereotactic biopsies, basically, because every time I saw a paper, the
           4

      numbers that I saw mimic mine, and I didn't think I had anything else to add.
          5

            6       They say an expert is one who creates and writes a lot of papers,

      so I guess in that respect I am not an expert, but I know the definition of an
            7

      expert is somebody who come and travels 500 miles away from their home and
           8

      testifies, so in that case I may be an expert.
             9

          10        When stereotactic biopsy started to become something that was

      written in the literature, it started out in Sweden with Dr. Laslo Tobar, and he
           11

      started doing work with fine-needle aspirations.
           12

          13        As a surgical resident, every time we need a needle wire

      localization, and we had to go in there and extract a piece of tissue,
           14

      humongously large, and sometimes the incision would be done at what I call
         15

      Tallahassee, Florida, and the needle wire would be at Key West, I always kept
           16

      asking myself is there a better mousetrap, is there a better way.
           17

          18        When I started reading up on it, and I became aware of the advent

      of this machine, I went ahead and leased one, I didn't purchase one, no down
            19

      payment with the lease, and I took a risk and I put the machine to work.
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            1       As I stated, I took the course with Dr. Parker, and following that,

      and we did lots of eggplants, never a patient, I prepared myself to start
           2

      stereotactic biopsy work utilizing a very, very narrow group of patients. I didn't
            3

      go for4the micros at first, and I didn't go for lesions that were less than 1

      centimeter in order to acquire a learning curve of my own.
            5

            6       No course and no weekend course can give you that kind of

      experience unfortunately, and no matter how much they charge you for it, they
           7

      are not ever going to let you make the cut in the lady and put the needle. That is
           8

      something that sooner or later you have to do on your own or with preceptorship,
          9

      which is not what is coming about.
          10

           11       Because I was a surgeon, the first surgeon in the State of Florida to

      do this, I felt it was very important to keep numbers, because I know sooner or
           12

            somebody was going to try to hammer me in the head with it, I was called a
      later 13

      quack. My own surgical group felt that this was inappropriate, and the
          14

      radiologists weren't buying into it at the time. I am happy to see that now it has
           15

      become a matter of who is going to do it and when.
          16

           17       So, obviously, those of us who had first started at this, and like Dr.

      Israel, can sit here and feel gratified that our forethought or our vision came to.
           18

           19       I am here to say that I am very concerned when something

      becomes so regulated that it may exclude the likes of myself. I know this
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      sounds self-serving, but it is the truth. I am not board certified and I don't have
           1

      four hours of radiation physics. Does that mean I can't do it?
            2

            3       At the same token, if I was board certified, and I took a weekend

      course, does that mean I know how to do it? So, my presence here is to make
           4

      sure that when you make your decision, first of all, it is not political; second of all,
            5

      that you take in consideration that there are individuals, such as myself, that may
            6

      be adversely affected; but, most important, whatever decision you do be for the
           7

      patients' welfare.
            8

            9       I don't have a problems with radiologists doing this procedure if

           are
      they 10 trained in surgical techniques, just like the radiologists should not have a

      problem if I told them I know how to interpret a mammogram. I don't read them,
          11

      I know my BIRADs.
           12

           13       As a matter of fact, as a surgeon, I go to probably more radiology

      meetings than I go to surgical meetings, because in order to be "a breast
         14

      surgeon with imaging experience," that is where I need to go.
          15

           16       The American College has not put a course yet on how to interpret

      mammography, and you don't sit there and go from screen to screen to screen,
         17

      and look at 40 cases and test yourself, but the American College of Radiologists
           18

      does, and I have taken that course.
          19

           20       So, what I am asking you to do is please consider the possibility of
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      creating a set of regulations that does not exclude, but actually includes, that it
            1

      makes sure that it addresses the real needs, which may not be some of the
          2

      needs3that have been addressed today, it may be all the needs that were

      addressed today.
           4

            5       The patient is the ultimate recipient of our knowledge, our

      technology, and our care and our love and our attention, and a lot of that cannot
           6

      be learned in a two-day course, and certainly board certification does not give
            7

      you that.
            8

            9       The light still is green. I think I have about 2.8 minutes, so what I

      will do is I will leave it open for any questions, because a question sometimes
            10

      allows me to expand on a subject. I didn't come with a written testimony, so I
           11

             off
      did it12 the cuff, so I would rather just answer questions.

          13        DR. MONSEES: Thank you, sir.

          14        Do we have any questions from the panel? Yes.

          15        DR. SICKLES: You had sort of side statement that I would clarify.

      I understand your concerns about regulations that require board certification
           16

      because that is an extremely difficult thing to acquire.
          17

          18        On the other hand, in with that you talked about a few hours of

      education in radiation physics. Do you not feel it is important to have some
          19

      understanding of the way in which the equipment that produces the x-rays that
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      you are using works, so that if it isn't working, you might understand how it would
           1

      --    2

            3       DR. SANTELICES: I certainly agree with that. As a trained

      surgeon, I did interpretive cholangiograms for God know how many years, and I
           4

      certainly utilized fluoroscopy at the time, and part of my training was learning
            5

             the
      about 6 radiation hazards that occur, and the stuff that occurs with that. And

      by the7way, at 2 o'clock in the morning, interpretive cholangiogram seldom gets

      read by a radiologist at that moment, so I was also taught to interpret radiologic
           8

      findings at the time of an emergency, and when I trained in trauma, and we did a
            9

      peripheral vascular study for a gunshot wound and did an arteriogram, I certainly
           10

      was almost self-trained in the sense that your senior resident teaches you, and
          11

      you teach the lower resident to interpret.
           12

           13       So, yes, I don't disagree that the training has to occur. I am very

      concerned of starting to put four hours of this, three hours of that, two hours of
          14

      the other, because in the State of Florida, I have five of HIV, two of domestic
           15

      violence -- I can give you a list, and it goes on and goes on. That's all.
           16

           17       DR. SICKLES: But you do understand that a certain amount of

      basic training might be needed?
          18

           19       DR. SANTELICES: Of course, yes, sir. I have no qualms with

      that. 20
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            1          DR. MONSEES: Yes.

            2          MR. FLETCHER: At the time that you began and essentially

      self-taught --
             3

            4          DR. SANTELICES: No, I was trained by Dr. Parker with an

      eggplant and an olive inside. By the way, I got green, red, green, and that
           5

      means I got it right in the center, the pimento, you know, the pimento-filled olive.
          6

            7          MR. FLETCHER: I guess my question is, with the courses that are

      available now, how would you advise a young surgeon who wanted to do this?
            8

            9          DR. SANTELICES: I would not only recommend, but as the

      Chairman of the Credentials Committee of my hospital, I demanded that whoever
          10

      wanted to do stereotactic biopsies present with a course, knowing quite well that
          11

      the course may only be the beginning, but at least gave us an idea that this
           12

      individual had at least went somewhere and took the necessary preliminary
           13

      teachings required for this. I took the course, you know.
          14

           15          But the question still remains is that course the end-all to the

      end-all, and I think Dr. Israel stated quite clearly that it's just the beginning, it's a
          16

      continuous learning process.
           17

           18          Yes, sir?

           19          MR. MOBLEY: You noted the lack of a requirement for a

      preceptorship or you made some statement regarding that, and you are saying
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            that there is a need from your perspective as the chair at your hospital,
      there 1

            is
      there 2 a need for the basic training.

            3       What kind of proposal would you make regarding the

      preceptorship?
           4

            5       DR. SANTELICES: I think that there has been a document that

           out
      came 6 between the American College of Surgeons and American College of

      Radiology, that pretty much deals with it. The proposal -- I am not here to
           7

      actually, and I am sorry, I may be here not fixing the wheel, but at the same
           8

      token,9I am not going to give you numbers -- there is a proposal on the table, 12

      has been the number that I think has come out.
          10

          11        It is not a scientific number, by the way. There is no way or no

      mathematic equation to come out that if you did 12, then, you are an expert,
          12

      because Shay here, her doctor may have done 13, and she got into trouble.
          13

          14        At the same token, I think that 12 was a result of one per month,

      480 mammograms was the result in my mind of 40 per month, 10 per week. Is
          15

      there a scientific basis into a learning curve? I don't think so. I think that better
           16

      off would be to have the preceptor sign off on the candidate. It may take him
           17

           it
      one, 18may take him 200. He might should change the job if it's 200.

          19        MR. MOBLEY: I asked you the question because you seemed to

      be out there --
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            1        DR. SANTELICES: In the fringes. I am disenfranchised. I don't

      even get a letter requesting my information. You know, if you don't publish, you
           2

      perish, but I am, like I told you, I am not here to pretentious, I am just a Hialeah
            3

      boy and doing my job.
           4

            5        MR. MOBLEY: Thank you. By the way, I am not a boy anymore,

      I am getting older.
            6

            7        MS. HEINLEIN: You used a table --

            8        DR. SANTELICES: Yes, ma'am, I use the Fischer. I have had it

      for six9years. I started out the oldfangled little thing you put the films on, and I

      am now into digital, I am into computer guidance, and I am still paying the lease
          10

      company because every time I buy a new piece of equipment, there goes the bill
         11

      again.
          12

           13        MS. HEINLEIN: What personnel are involved while the procedure

      is going on?
           14

           15        DR. SANTELICES: I have a double-certified mammographer. I

            her
      stole16 from the hospital. She has over 20 years experience. But she was

      being asked to do barium enemas and upper GI's, and the like, so when I gave
          17

      her the opportunity to do strictly breast, she took it, and I took her, and she has
           18

           with me ever since.
      been19

           20        DR. MONSEES: Any other questions from the panel?
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            1       Okay. We will move on to our last scheduled speaker.

            2       DR. SANTELICES: Thank you very much.

            3       DR. MONSEES: That you very much.

            4       DR. SANTELICES: Now comes my plane ticket.

            5       DR. MONSEES: Excuse me?

            6       DR. SANTELICES: I have to read the letter.

            7       DR. MONSEES: I am sorry, you are Number 10 also, is that right?

            8       DR. SANTELICES: Yes, ma'am.

            9       DR. MONSEES: That's correct.

           10       DR. SANTELICES: Dr. Caplan called me yesterday at my office

            to
      prior 11 leaving and said can I fax you a letter that I want you to read. This

      morning when I spoke to Dr. Winchester, I discussed it with him, and I think it is
          12

      appropriate that I read the letter.
          13

           14       I also think it is appropriate that it is understood that I am not

      speaking on his behalf, but rather just reading a letter that he wrote. Okay?
          15

           16       DR. MONSEES: Thank you very much. Why don't you go ahead.

           17       DR. SANTELICES: He wrote in little tiny letters, and I need to get

      my glasses and go slowly here.
          18

           19       This letter is written to obviously -- not obviously -- it is written to Dr.

      Charles A. Finder, National Mammography Quality -- I am sorry, Madam
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      Chairman, it was not addressed to you, but Dr. Finder, at the time I guess was in
           1

      contact with Dr. Caplan -- and to the members of the committee.
           2

            3       Dear Committee Members: It is my testimony before this

      committee one year ago as a breast surgeon and President of the American
          4

      Society of Breast Surgeons, I stated that regulations of a surgical procedure
           5

      should not be, in my opinion, within the jurisdiction of the FDA.
           6

            7       I am today still convinced that this is the correct position. The fact

      that the American College of Surgeons and the American College of Radiologists
             8

      have signed off on a document stating their position on joint credentialing for
           9

      performance of stereotactic breast biopsy procedures does not justify an FDA
           10

      position in this matter.
           11

           12       I am reading verbatim.

           13       This document is a feeble attempt to compromise political positions

      and to end an unpleasant turf battle. It contains no proven guidelines that would
          14

      guarantee the quality of the service to our citizens. In fact, I firmly believe that it
          15

      would do just the opposite.
          16

           17       As a breast surgeon, I have more than three years experience and

           400
      over 18 cases in stereotactic biopsies with a record equal to the best

      radiologists in the country, and yet under this guidelines, even I could no longer
           19

      qualify to perform this procedure, because I cannot document four hours of CME
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      in radiation physics.
            1

            2       Nowhere in the document does it state that a physician must have

      four hours of CME in breast biopsy procedures. I could offer objections to every
            3

            part of this document, but this not the purpose of my statement today.
      other 4

            5       I am against the FDA accepting such a document under any

      circumstances or compromises for the purpose of regulating a surgical
            6

      procedure. Instead, I would like to offer the following.
           7

            8       The FDA should regulate stereotactic breast biopsy procedures

      because it is an imaging procedure and, as such, should come under an MQSA,
           9

            believe that only the stereotactic site should be regulated to ensure the
      but I 10

      public that it is safe as far as an imaging device is concerned and that certain
           11

      guidelines are followed regardless of the specialty of the physician performing
          12

      the procedure.
           13

           14       As to whether this physician is qualified to perform a stereotactic

      procedure, it should be left up to the credential committee at the local medical
          15

      facility that determines credentials for all the physicians on its staff.
            16

           17       How could this be done effectively?       The stereotactic biopsy

      facility would be regulated much the same way as mammography facility.
            18

      Certain installations and quality assurance measures would be required, as well
          19

      as initial and yearly inspection by the radiation physicist.
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           1        A mammographic technologist would be required to operate the

      equipment and record all case histories and maintain appropriate review of
           2

      records, films of every procedure, as well as copies of the initial mammographic
           3

      report, pathology report, and the biopsies, as well as a followup report from the
            4

      radiologist stating that the biopsy was either in concordance with the
            5

      mammogram or that an open surgical biopsy would be required.
         6

           7        Also, a recommended followup exam would be stated in the report.

      This method of documentation is considerably more reliable in determining the
           8

      qualifications and expertise of the operator than any arbitrary number of
             9

      mammograms that an individual must review or the number of cases that must
         10

      be performed on an annual basis.
          11

          12        This determination is best left up to the local credentialing body,

          should have better knowledge of the physician's experience in these areas.
      who 13

          14        In summary, then, my recommendation to this committee will be to

      establish an accreditation process for a stereotactic biopsy site with annual
          15

      inspections by the FDA and radiation physicists. All the local credential
          16

      committees to credential the physicians as they do in all other medical and
         17

      surgical procedures.
           18

          19        This would assure the public of a safe and qualified stereotactic

            while at the same time not require that the FDA involve itself in medical
      site, 20
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      credentialing.
           1

            2          These recommendations may not satisfy those whose intent is only

      to politicize the issue for their own interests, but it will guarantee to the women in
            3

      this country continuing access to quality breast cares which are both safe and
            4

      responsible.
           5

            6          Thank you. Robert B. Caplan, M.D.

            7          DR. MONSEES: Thank you. Well read. I don't know whether or

      not you feel that you can answer any questions, but there was one part that I
            8

             quite hear, that maybe you can just clarify for me by referring to that
      didn't 9

      document.
          10

           11          DR. SANTELICES: Yes, ma'am.

           12          DR. MONSEES: It was the concordance/discordance issue. Did

      he feel that it was the technologist's job to establish whether there was -- I didn't
           13

            get
      quite14 that.

           15          DR. SANTELICES: Not from reading the letter, I didn't get the gist.

      I thought from reading the letter, he meant the radiologist. Now, like Dr. Israel, I
           16

      do not use a radiologist for that purpose, concordance or discordance. I use him
          17

      to read about 2,500 mammograms that are done in my breast centers on an
           18

      annual basis, but the concordance really comes at the time of reading the
          19

      pathology report.
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            1       If I was looking for micros, and I didn't get them, the first thing I do, I

      ask the pathologist to do more serial cuts. If he tells me, "You didn't get them," I
            2

      will then repeat the mammogram and work on that basis, however, I do specimen
             3

      films and many times I have told the pathologist you may not seen them, but here
            4

      they are, and there is two cores and there are all the little micros right there.
            5

            6       So, at times you can have a path report that doesn't say you have

      micros, but yet your specimen film shows it. Now, if I am looking for something
           7

      that should be at least fibrocystic, and I just get fibroadipose tissue, I don't feel I
            8

      have concordance. In cases like that, we repeat the mammogram.
           9

           10       DR. MONSEES: Thank you.

           11       MS. HEINLEIN: I, too, got the gist from the reading of the

      document that it was the responsibility of the technologist to do the followup and
          12

      medical audit information. Would you mind just going back to the document and
          13

      reading that sentence that is in there?
          14

           15       DR. SANTELICES: Yes, ma'am. I may start a little before, so I

      can get the whole meaning.
          16

           17       A mammographic technologist would be required to operate the

      equipment, and records of quality and case histories would be maintained for
          18

      review during an annual inspection as is currently required for a mammography
           19

      facility. In addition, either the local credentialing body and/or the FDA would
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      also require the facility to maintain the digital film records of every procedure, as
            1

      well as copies of the initial mammographic report, pathology report on the
            2

      biopsies, and a followup report from the radiologist stating that the biopsy either
            3

      was concordant with the mammogram or that an open surgical biopsy would be
           4

      required.
            5

            6       Also, I recommend the followup exam would be stated in the report.

      This method of documentation is considerably more reliable in determining the
           7

      qualifications and expertise of the operator than any arbitrary number.
             8

            9       So, I didn't see, I didn't read that.

           10       DR. MONSEES: Thank you. I didn't hear that initially. What he

      is saying is that the surgeon would do the biopsy and the radiologist would
           11

      determine whether there is concordance or discordance.
          12

           13       DR. SANTELICES: That is what the letter states. I brought to

           attention that in my case, I don't, and Dr. Israel doesn't.
      your 14

           15       DR. MONSEES: Right. Thank you.

           16       I think probably we should put a copy of the letter in the record.

      Likewise, the letter that you read, we would like to have probably also put.
          17

      Thank you.
          18

           19       DR. HENDRICK: There is a new concept introduced in this letter,

      which is that the medical board -- I think is the phrase that was used -- should be
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      sufficient to ensure the credentials of the physician performing this procedure,
             1

      and I don't fully understand the realm of governance of medical boards, but I
            2

      thought they had to do with hospitals.
           3

            4        DR. SANTELICES: Right, and he stated credentialing body of the

      hospital or/and facility.
            5                     As the Chairman of the Credentials Committee and

      dealing with something that was brought up as a matter of record, laparoscopic
            6

      cholecystectomies, when they first started out, we really didn't know how many
           7

      numbers to ask of the physician, and each hospital sort of set up their own little
          8

      guidelines, three on your own, three with preceptorship, bring a copy of the
           9

      course, but what I do know as far as credentialing, that any new procedure that is
          10

           in
      done11 the hospital needs to be approved by the Credential Ethics Committee,

      and then anybody who is going to do it, whether it is transesophageal
          12

      sonography, whether it is transcutaneous pacemaker, or percutaneous,
          13

      whatever, first, the procedure gets approved, and then the physicians have to
          14

      provide qualifications for the procedure.
           15

           16        Each hospital does take different parameters. Some hospitals

      require three, some hospitals require five, some hospitals say if you prove it on
          17

      the first shot, you don't need to do it on the second or the third.
            18

           19        DR. HENDRICK: Just to follow up on that, what is the issue with

      non-hospital settings for performing stereotactic biopsies?
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            1       DR. SANTELICES: Well, non-hospitals, short of a Dr. Israel or

      myself or maybe two out of three, don't really exist. This machine is very
           2

      expensive and nowadays the financial remuneration for the biopsy has gone
           3

           so
      down 4 low, I don't think that one person alone can ever be involved.

            5       So, it usually falls into a single day surgery, outpatient surgery, that

      has their own credentialing body. They all have their own bylaws. Nowadays,
            6

      starting in 1998, they are going to be checked out by the Joint Commission also.
             7

            now they are in a voluntary state of being evaluated, but starting next year I
      Right 8

      think that the outpatient facilities are going to fall in the Joint Commission also.
             9

           10       So, there is a whole set of credentialing and guidelines that go on.

           11       DR. HENDRICK: I know of some non-hospital settings in which

      stereotactic is being done.
           12

           13       DR. SANTELICES: Of course, because when this first started, like

      Dr. Dowlat said, it was first a car with four wheels and a steering wheel, and a lot
           14

      of people got access to it.
           15

           16       As it has grown in complexity, and with complexity and as it has

      grown in expenses, not very many people have a quarter of a million dollars to
          17

      spend on a machine whose remuneration is about $350 combined global fee.
          18

      You have to do a lot of breast biopsies to be able to pay for that machine if you
          19

      are by yourself.
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            1        But you are an institution that has 10, 12 surgeons, four or five

      radiologists, all working in unison, then, you can afford the machine, and that is
            2

      where3that machine is going.

            4        I think, like everything else, when the Wright Brothers got into the

      first airplane, you know, and the FAA and 1997, there is a whole variety of
             5

      circumstances.
            6

            7        DR. MONSEES: I think we have another question from the panel.

      Dr. Sickles.
            8

            9        DR. SICKLES: I just wanted to clarify this a little bit. It would

      seem to me there might be a problem had there been reasonable numbers of
          10

      outpatient facilities operated just by the individual or a few individuals who were
          11

      doing it and credentialing themselves.
          12

          13         DR. SANTELICES: Right.

          14         DR. SICKLES: What you are trying to tell us is that those facilities

      are few and far between?
           15

          16         DR. SANTELICES: Yes, sir. Again, I never came here professing

            an
      to be17 expert in the worldwide use of this equipment, just in Hialeah, along

      which by now has three in the city that one is enough.
          18

          19         The machine is very expensive and the complexity of all the

      apparatus that are added on is also very expensive. Very few centers right now,
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      unless they have a very large budget backing them, can afford it.
           1

            2       Now, you are going to have, you know, your grandfather period of

      the first four or five years of anything that you are going to have to deal with
             3

      somehow, but I think that if you put it under MQSA as a site facility, if you do
          4

      stereos, you are probably doing mammos.
            5

            6       DR. SICKLES: Are you concerned with proliferation of this

      equipment beyond its need? This is actually something that happens frequently
           7

      with imaging equipment.
            8

            9       DR. SANTELICES: I think that the medical economists are always

      concerned that new technology calls for new testing, and the proliferation of that
          10

      technology calls for the overusage of the technology. I want to echo Dr. Israel's
          11

           and
      word12 the first surgeon -- I apologize I can't remember his name -- as

      surgeons, and we don't read mammography, we really act upon a read
          13

      mammographic report.
         14

          15        I encourage this body to encourage the American College of

      Radiology to encourage the BIRAD's reading, because still to this date, I get a
          16

      two-page mammographic report that has got a lot of flowers in it, but at the end it
          17

      leaves you like whoa, where is this coming from, and it is sitting in your hands.
          18

           are
      They19 the ones who are actually telling you surgical correlation, surgical

      consultation requested, and it falls at the end, the surgeon decide I am going to
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      biopsy this, I am not going to biopsy, depending on the surgeon and the psyche
           1

      of the 2lady, because many times the surgeon may feel comfortable not biopsying

              if
      it, but 3 he is smart, he is astute, and he knows how to read his patients well, he

      knows that this lady is going to be better off with a biopsy, because if you tell her
          4

      no, she is going to go someplace else anyway because she is certain she needs
            5

      to have it done. That is what bedside manner are.
            6

            7       DR. MONSEES: Thank you, Dr. Santelices.

            8       DR. SICKLES: Getting back to the question that I was trying to get

      at -- 9

           10       DR. SANTELICES: I didn't elude you, did I?

           11       DR. SICKLES: No, but you went beyond. I have some concern in

      allowing facilities to credential themselves if there is proliferation of equipment to
           12

      the point where facilities are at an individual level, because then the individual
           13

      would be credentialing himself or herself.
          14

           15       DR. SANTELICES: Correct. I agree with you.

           16       DR. SICKLES: And that is my concern, and I am just wondering

      whether in your experience you see this coming. I know you can't testify for the
          17

          who
      man 18 wrote the letter.

           19       DR. SANTELICES: No, I don't see it coming for the economic

      reasons that I told you. I also don't see it coming because with the MQSA Act,
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      the centers which are doing stereos, if they can afford stereo machine, rest
            1

      assured they have a mammogram machine. I think that what Dr. Caplan was
           2

             to
      trying 3 lead to is that what you would be looking at is to make sure that the site

      is regulated, and once you set a regulation in the site, the site has no choice but
            4

      to go ahead and hire physicists to come once a month to do the quality
            5

      assurance, to do the followups, to keep you tracking, which is what MQSA was
           6

      all about.
            7

            8       DR. MONSEES: With that, I thank you very much for your

      comments.
          9

           10       I would like to make one more call, because we started early, for

      Joseph Rush. Has he come?
          11

           12       Okay. We will at this time move to our break. Let me tell you we

      will reconvene promptly. At 11:45, we will begin the session, so please be
            13

      seated a few moments before then.
          14

           15       [Recess.]

           16      Overview of Interventional Mammographic Procedures

           17       DR. MONSEES: This morning we have heard important

      statements from people from the community and now we are going to hear an
           18

      overview of interventional mammographic procedures by Dr. Rebecca Zuurbier,
          19

      Assistant Professor of Radiology and Director of Breast Imaging at Georgetown
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      University Medical Center.
           1

            2       She will be outlining, for those of us who are less familiar, with the

      different interventional breast procedures, so that when we go into our more
             3

      detailed discussion of what needs to be addressed, those of you are less familiar
            4

      will be conversant with this.
             5

            6       Following her presentation, which she estimates will be less than

      the appointed time, there will be some time hopefully for a question and answer
            7

      session.
           8

            9       Can we do anything else for you?

           10       DR. ZUURBIER: No, thanks.

           11       DR. MONSEES: She has been invited by the FDA to make this

      presentation, and we thank her very much for doing that. Please go ahead.
          12

           13       DR. ZUURBIER: It is a pleasure. I appreciate the invitation.

           14       [Slides.]

           15       I know that Dr. Finder, when he called me up, said that this was

      going to be a mixture of initiated and uninitiated individuals, and I am afraid I
          16

      might see more initiated individuals in the crowd than not, so I apologize. I hope
          17

           of
      most18 you don't assume the demeanor of the young lady on the left.

           19       In any event, I know, especially when I teach my residents, that it is

           important to limit the topic to no more than four or five things, otherwise, the
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      attention span goes down as the heat in the room goes up, and hunger levels
            1

      increase, as well.
            2

            3        So, my talk today is going to be focusing -- and please excuse my

            I
      back, 4 will try and minimize my shadow here -- to four topics: stereotactic

      breast biopsy, which most of you are familiar with, fine-needle aspiration
           5

      cytology, preoperative needle localization, and galactography, in other words,
            6

           x-rays and needles collide, and these are the four things that can happen.
      when 7

            8        [Slides.]

            9        My first focus will be on stereotactic core breast biopsy. Now, that

      is a multiple line slide, which I want you to read and digest again. Stereotactic
           10

           breast biopsy. I think we all realize by now that it is an accurate, reliable,
      core 11

      cost-saving alternative to open surgical biopsy when we have to manage
           12

      mammographically detected breast lesions.
         13

           14        I like to say that mammography isn't free, just like freedom isn't

            mammography isn't free. It's a wonderful test widely available, known to
      free, 15

      decrease the number of deaths from biopsy cancer for women screened 40 and
          16

      above -- ironically, we actually have more proof of this efficacy for women in their
          17

      40s now than for the 50 and above level -- but it comes with a price tag, and the
          18

      largest induced price tag is that incurred with the surgical consultation and biopsy
           19

      it is estimated at $2.3 billion.
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           1        Not only is there a fiscal price tag, there is one that is physical and

      psychological and mammographic when we consider the psychological scarring,
           2

      the physical scarring, and the scarring that can occur on a mammogram
            3

      subsequent to the open surgical biopsy.
           4

           5        So, we have a great debt, and I think Dr. Parker's name has been

      invoked before here for developing a technology and having the skill, as it were,
           6

      to put 7together the need with the answer, the technology with the answer.

           8        [Slides.]

           9        Stereotactic core breast biopsy involves about four things. We use

      a prone table with an aperture, preferring the prone table because it eliminates
           10

      the potential complications of the vasovagal reaction, the fainting that might
           11

      occur, as well as the motion as a woman is approached with a 14- or 11-gauge
          12

      needle into her breast.
          13

          14        Digital imaging capability has really revitalized the technology.

      Before, you had to take a film, run it through your rollers in your processing room,
          15

      hopefully, have a speedy technologist with sneakers, and that could take a
          16

      three-minute process in between these diagnostic mammograms.
           17

          18        Now we have digital imaging capability, which simply means you

      press a button and the image comes up on a computer screen within a matter of
          19

      seconds, a biopsy device, and this is an area of high interest, I will be showing
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      you what is typically used and then a couple evolutions on that theme, and
           1

      finally, a patients with a mammographic lesion, and I say that tongue in cheek,
             2

      but not really.
            3

            4           We really want to commit ourselves to biopsying only those things

      that required biopsy. It shouldn't be an excuse for a lazy mammographic workup
            5

      or inappropriate counseling of a patient with a probably benign lesion for which
            6

      we would otherwise recommend mammographic followup. So a patient needs
          7

      to have a mammographic lesion, a real one, a true one, one for which a
            8

      radiologist would recommend biopsy.
            9

           10           [Slides.]

           11           I give equal time to the manufacturers that are preeminent currently

      in the field. The Lorad and the Fischer tables. The Lorad table, the patient can
           12

      lie with their head either to the left or the right, affording a 360-degree access to
           13

      the patient's breast.
           14

           15           The Fischer table, the patient lies with their head on one end, the

      breast is suspended through an aperture, and the system works, if I can just take
          16

      a minute to step up, just like getting a mammogram taken except you are lying on
          17

           stomach.
      your 18

           19           So, we have the table. We have the x-ray device. The patient

      lies prone, and many mammograms are taken. These mammograms are
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      typically 2 inches by 2 inches in diameter.
            1

            2       In between this mini-mammographic unit is the biopsy device, and

      this is3where we will be focusing a little more later on. I throw in the computer

      here because this is that 2-inch by 2-inch mammographic picture that is blown up
           4

      on the computer screen, and being on a computer, that affords us an ability to
            5

      manipulate the image. We can adjust the contrast and the magnification.
           6

            7       [Slides.]

            8       I think this the hardest part of the procedure, and that is not making

      sure you are well coiffed with lipstick and nails done for the stock slide. The
            9

      hardest part is occurring right down here, which is getting that mammographic
          10

      lesion reliably depicted in again a small area. Here is that 2-inch by 2-inch
           11

      window, and it is noncompressed, so we can't separate structures as effectively
          12

      as we can out here on either side.
          13

          14        So, I find as a radiologist that that is probably the most challenging

      portion of the procedure, both for the technologist and the radiologist working
           15

      together. What we do is take two stereo pictures, and simply put, a stereotactic
          16

      device is easily found in between your shoulders. It is your head, two eyes and
           17

           brain, which is to say that if you put your finger in front of your nose, and
      your 18

      you only had one eye open, you couldn't tell how far your finger was from your
          19

      nose. So, your eyes act like stereotactic devices. One eye opens. If you
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      alternate, you see your finger seems to shift in space. We do this when things
            1

      get slow in the radiology department.
            2

            3        But you need two eyes, and that is where the computer is, to tell

      you exactly where that finger is in relationship to your nose. So, if I only had one
           4

      picture, I would only be able to tell you, for example, that the lesion was here. I
            5

           where it is in my horizontal plane, right here, I know where it is in my
      know 6

      vertical plane, the y axis here, but how deep does my needle need to go in to get
            7

      to it, and so these stereo views are taken.
              8

            9        This is the same breast, nobody is moving, the camera is moving,

      and it looks like the lesion moves in space. In fact, it doesn't. Then, we target
           10

      it, and here are these two squares there targeting the center of the lesion, and
            11

      the circles around it are the other offsets or areas of the lesion which we will be
           12

      sampling.
         13

           14        Now, this is what is used most often now, which is a spring-loaded

      gun device. We will be talking a little bit about other evolutions on that theme,
          15

      but the idea of core biopsy is to sample the lesion, and so we sample it that way.
           16

      We identify it, we find it.
          17

           18        [Slides.]

           19        Then, as I said before, this is just the computer depiction of it. We

      can magnify this area. Again, we are targeting with the square, providing
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      offsets, and here is the information. This is the depth that my needle has to go
            1

      into the breast. So, there is very little human error that can be applied except for
             2

      the depth adjustment using -- this is with the Fischer table that we use currently.
            3

            4       [Slides.]

            5       The patient is then anesthetized. This is the surgical portion here

      where6we apply a lidocaine that is buffered, so there is very little, if any, burning

      experienced by the patient. We make a small nick in the skin, and then we will
           7

      be introducing the needle.
            8

            9       [Slides.]

           10       We obtain what are called pre-fire pictures to ascertain that the

      lesion is indeed in the vicinity of the needle. In fact, we want the needle tip to be
           11

      just proximal to it in both views.
           12

           13       I apologize. This is a separate lesion here. You will note this is a

      soft tissue mass. These are microcalcifications. Here is the pre-fire picture.
            14

      We press the button. The spring-loaded gun is deployed and with the velocity of
          15

      a .22-gauge or caliber -- somebody in the military corrected me, and I was too
           16

      flustered to remember which one -- it is really darn fast. It will sample the lesion.
           17

           18       [Slides.]

           19       The typical specimen that we obtain is with a 14-gauge gun is

      about the caliber of a number 2 pencil lead, and it is about an inch long, and this
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      is how you can see it before we place it into the test tube to send off to the
            1

      pathologist.
           2

            3        Now, I want you to again focus on what is happening underneath

      the table. This is what I think is most commonly used right now, is a
            4

      spring-loaded gun. We use the Biopty gun. We can use it to sample -- it has
            5

      been used to sample solid organs, the kidney, the liver, the prostate, and so it
           6

      samples it.
          7

            8        So, basically, after you are done sampling your lesion, your lesion

            like
      looks 9 one of those FBI target things that you use when you are practicing

           aim. It has little holes in it. As big as that guy is, that's how many holes
      your 10

          be
      may 11 carpeting that guy.

          12         We typically take about nine samples. Five is the minimum

      number recommended. It is done by placing the needle in, bang, withdraw.
         13

      Put it in your saline for subsequent transfer to your formalin. Put it in again,
           14

      bang, and the whole procedure takes less than an hour if everybody is doing
          15

      everything right and everything can be found.
          16

          17         [Slides.]

          18         The interesting variations are evolutions of this, are clouding the

           in
      area 19 between minimally invasive to excisional biopsy. We can move into now

           is
      what20 called mammotomy or the Mammatome device, which is vacuum
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      assisted. Now you only have to put the needle in once, and a vacuum actually
            1

      will suck the material of concern into a similarly sized notch there. It can actually
             2

             to
      be up 3 11 gauge in size.

            4       What is the advantage here? The advantage is you only need to

            the
      place 5 needle in once. You obtain continuous samples that maybe have

      higher integrity. It has been shown that you have a more reliable collection of
           6

      microcalcifications and larger size of your material to send to the pathologist, and
           7

             pathologist's world, more is more, so the more tissue you give them, the
      in the 8

      better9and more confident their diagnosis is.

           10       So, the vacuum assist device is another evolution on the way.

      Some concerns, well, sometimes you can actually eliminate the whole lesion.
         11

      For example, if that were the microcalcification cluster, that ended up being a
           12

      in-situ or invasive carcinoma, where do you go back to tell the surgeon, you kind
            13

      of apologize and say, it's in that area and you hope you still have a tatoo with
           14

      some air holes or some hematoma.
         15

           16       But somebody answered that question, too, and said let's deploy a

      little titanium clip, and so a clip can be deployed into that area to mark the site if
             17

      there is concern that the whole lesion has been sampled.
           18

           19       [Slides.]

           20       Let's advance one more step toward excisional biopsy, and that is
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      the ABBI system. Now, those of your that are still alert will note that this is not
           1

      actual2diameter size, but just to point out that the ABBI system can vary the

      caliber lesion accumulation.
            3

            4       Let's go back to our analogy of that little target that you use in firing

      range5practice, and with the spring-loaded gun, you get a guy that looks like he

      has Swiss cheese hold in him. With the vacuum assist device, you can core out
           6

      and core out, and you can take out heart, and if the lesion is as big as his lungs,
           7

      you can just keep vacuuming that area out.
           8

            9       With the ABBI device, you can just take that whole poster and bring

      it with you. The advantage to that may be that you have, again in the
            10

      pathologist's world, more is more. There may be some down sides, which I
          11

            feel
      don't12 comfortable commenting on whether they are going to be cumulative

      enough or non-cumulative enough to warrant further use, but there is concern
          13

      about cosmesis.
          14

          15        [Slide.]

          16        All the things that made stereotactic core breast biopsy a beautiful

      thing, cost savings, improved cosmesis, no mammographic scarring, very low
           17

      complication rate with hematoma, are now called into question a little bit on the
         18

           of
      side 19 getting more tissue for the pathologist, which is to say Langer's lines,

      which are important to most breast surgeons, which follow the curvature of the
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      biopsy, help eliminate any notable scarring. You might not be able to appreciate
           1

      a Langer's line when a patient is prone on a table and when you are making a
           2

      2-centimeter incision to take out that column of tissue, you do have greater worry
           3

      about 4hemostasis, about extraneous tissue collection because you are taking

      that whole column in front of the lesion. So bleeding and infection concerns, you
            5

      have to use suture material if it's a big incision to address that.
           6

            7       Then, we have unanswered questions about what is the effect on

      the mammogram also, so is there going to be mammographic scarring as a result
           8

      of a larger core accumulation. So I just point out that there are advantages and
             9

      disadvantages to all of these, and it is kind of a progression of invasiveness from
          10

      the stereotactic spring-loaded biopsy device through the vacuum assist, through
           11

      the ABBI system, which can afford larger core sampling, until we get to, well, why
           12

            we
      don't13 just a preoperative needle localization.

           14       [Slides.]

           15       Well, I offer this vignette. My sister, who is a breast surgeon, an

      excellent breast surgeon actually, and she will be the first to tell you that, will
          16

      chide me at the Thanksgiving dinner table -- and I am really looking forward to
          17

      the holidays -- for the radiologists at her facility have a needle localization that
           18

      she orders preoperatively is really helpful only to her to identify which breast the
          19

      lesion is in, and then it is only right 50 percent of the time. So, this is what I deal
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      with. 1This is what we deal with as radiologists.

            2       It is funny, but it is not. I point out the need to have very good

      communication with the radiologist and the surgeon. This is a very cooperative
          3

      effort.4 You need to know the limits of your talents and their talents, what they

      will tolerate, but let me just go through and show you how this works.
             5

            6       Preoperative needle localization, when do we use it? When you

      can't feel it, and it has got to come out. So, it is for a nonpalpable
             7

      mammographic lesion which was recommended for biopsy.
         8

            9       Our objective is to position the needle/wire system in or through a

      lesion to guide the surgeon to the area of concern.
           10

          11        [Slide.]

          12        Before the localization again, do the dance with the surgeon or the

      surgeon should do the dance with the radiologist, review the imaging workup.
          13

      There is nothing I hate more than canceling a needle localization because
          14

      somebody had not worked that milk of calcium appropriately on the outside, or
         15

      had not found it appropriately. This delays your schedule and creates all kinds
          16

      of hand wringing and the patient of course is not happy about it either.
           17

          18        We avoid premedicating the patient. We like to obtain lucid

      informed consent. We also need their cooperation to sit and maintain position
           19

            we
      while20 are doing this procedure. It is a procedure that I like to tell my patients
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      sounds worse than it is, not that is great and I would want to have this done in my
           1

      lifetime, but it is very well tolerated by the patients especially after good
             2

      counseling.
           3

            4       The idea is to take the shortest approach to the lesion and most

      people do it parallel to the chest wall. Some people do it free hand, but we are
           5

            to
      going 6 be addressing how I think the mainstream does it.

            7       So, first we identify the lesion on the mammogram, and if you aren't

      familiar with mammography, this is the view basically from the side of the breast,
            8

      side to side, so the head is up here, the feet are down here, the nipple is here.
            9

           10       So, the shortest distance to the lesion is looking right here, but let's

           at
      look 11 the view from top to bottom of the breast. We call it the craniocaudal

      view.12 So, the nipple is here, her lungs are here safely out of the way, her armpit

      is here, her sternum is here.
           13

           14       The lesion is here. It is not going to be very prudent to come a

           way
      long 15 here, long way here. Let's take the shortest distance. It helps the

      surgeon, helps the patient, so we choose the shortest distance to the lesion.
          16

           17       [Slides.]

           18       My thanks to Dr. Kopans, whom I have lifted these films from his

      book. I trained under him, so I feel I contributed somehow and could copy these
          19

      films. This is a picture from his book, which demonstrates how we do it.
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            1        We need an alphanumeric grid. Sometimes people have little

      Swiss2cheese grids, one of those grids that has a bunch of holes in them. I like

      this one. It is very accurate for the purposes of the surgeon.
            3

            4        We take a picture. Now we have decided we will come from the

      top, and so we make a little X at -- this is kind of like Battleship -- E and 1.5.
            5

            6        [Slides.]

            7        We put a little X there, and then I turn on the light that is provided

      by the8mammographic unit, and I turn off the lights in the room, because that light

      shining down is going to help me avoid any shadowing of the needle, so I can
            9

           a
      have10 very precise downward placement of the needle without any angulation.

           11        Dr. Kopans has done just a few of these. In fact, this is his

      needle/wire system, and so we can see that he has placed the needle beautifully.
          12

      There is very minimal angulation of the needle. That is a long needle and that is
          13

      the only part of the shaft that we see.
           14

           15        We typically don't use a skin anesthetic. We used to use a spray

      anesthetic. They are not manufacturing that anymore, but they found that the
          16

      patients actually, when they did a study, had a higher perception of pain when
           17

      you gave them lidocaine than if you just stuck the darn needle in. A needle stick
          18

      is a needle stick. Again, I haven't had one done yet. I don't know if I can
           19

      justifiably say.
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            1        [Slides.]

            2        We then take a picture from the side or from the opposite view of

      where3we started with the needle in place. Now, we intentionally overshoot the

      lesion. If you leave the surgeon with a needle like that, he or she is going to be
            4

      irritated because once they get that far, this is a 360-degree question that they
              5

            which way do I go.
      have, 6

            7        So, we want to get across the lesion with the needle, and then with

      the Kopans wire system, we would place in through that needle a very thin wire
           8

      that has a little barb on the end of it, and when that deploys, that stays and
            9

      anchors the needle in the breast, and to give the surgeon a tactile orientation, it
          10

      has a thickened segment indicated by those short arrows. This is a nice
          11

      placement with the lesion right at the center of that thickened segment.
          12

           13        The surgeon has the option of dissecting down from the top to the

      lesion or perhaps make a periareolar incision which may be more cosmetically
           14

      appropriate, and work their way back to the lesion.
          15

           16        At Georgetown, we actually also use the Homer needle, which has

      some variations on it, as well. I call it resident-proof, because the wire at the
         17

      end of it isn't a barb, it's a retractable, like a fishhook thing, so if the resident
          18

      makes a mistake, we can just start over and provide another positioning.
         19

           20        [Slides.]
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            1       The lesion is then dissected and to make sure that there has been

      an appropriate sampling of the lesion or excision of the lesion, we actually take
           2

      an x-ray, and we like to see the bulk of the lesion contained within it.
            3

            4       The potential complications are similar to when you get a blood

      sample taken - bleeding and infection. I don't usually mention vasovagal
          5

      reaction because that is a very suggestive thing, but I monitor the patient very
            6

      carefully, and I have smelling salts available in case there is any problem, and
            7

      pneumothorax, I don't indicate as a potential complication if I am going parallel to
          8

      the chest wall. Like I said, some people still do it freehand and kind of
            9

      guesstimate where it is, and go back and take some pictures. Pneumothorax is
          10

      reported with those types of approaches.
          11

           12       [Slides.]

           13       We are going to move on to our number three issue, and that is the

      fine-needle aspiration cytology. When would you use fine-needle aspiration
           14

      cytology? If you have a new mammographic lesion and you want to sample it,
           15

      but you really don't want to take it out. When it is something that the surgeon
           16

      can feel, and when you, as a radiologist, just can't tell the patient if it is a complex
           17

      cyst meaning it's okay, but it has some debris, hemorrhage, proteinaceous
           18

      material in it that could mimic a solid lesion.
          19

           20       So, in those cases, I, as a radiologist, like to do a needle aspiration.
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      Typically, if it's a palpable mass, the surgeon will use their fingers as a guidance,
           1

      and I don't typically use mammography to guide me.
            2

            3       [Slides.]

            4       However, there is a suggested method for it. I think it is used

      especially if you are concerned that what you are sampling mammographically is
           5

      or is not the same thing that you see at ultrasound. So, if there is a correlation
             6

      concern, I may use mammographic guidance.
           7

            8       [Slides.]

            9       But the typical scenario would be this new nodule that we find on

      the mammogram, ultrasound shows us this circle that is not completely round,
          10

      and it's a little gray in the middle of it. Is this a solid lesion? Is this a complex
           11

      cyst? I don't know. Let's stick a needle into it and find out.
           12

           13       [Slides.]

           14       One can do that actually using a grid localization device. One

      would proceed, just as with a needle localization, using an x-ray picture with a
          15

      grid superimposed to guide placement of the needle.
           16

           17       Aspiration is applied, and the material is put on a slide and fixed,

      and preferably you will have a cytopathologist there, if it is a solid lesion, to
          18

      identify whether there is sufficient material. If it is fluid, we just send off the test
           19

           and
      tube 20 that is a controversial area also. Some people don't send off the fluid
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      at all. 1

             2      [Slides.]

             3      I want to emphasize that fine-needle aspiration cytology is usually

      performed with ultrasound guidance, because we can, under real-time, follow
            4

      that needle going into the breast, and frankly, we don't hardly use
            5

      mammographically-guided fine-needle aspiration cytology at all.
         6

             7      [Slides.]

             8      Now, let's step back and do a little comparison shopping thing.

           is
      What 9 the difference then between the fine-needle aspiration cytology and the

           breast biopsy? Needle size. Thin needle for fine-needle aspiration
      core 10

      cytology. I can bend it with my finger, a 20- to 25-gauge.
           11

            12      Core biopsy, I have to use my arms and maybe my foot to step on

             it's
      it, so13 a longer, thicker, bigger needle, 11 to 14 gauge. It results in a different

           of
      type 14 tissue and material that we are looking at.

            15      We only get to look at the cells when we do cytology, so it only

      sucks up those little tiny wispy little cells. With the core biopsy, we get the
          16

      tissue. We can see the structure that the cells are forming, and we can make a
           17

      more accurate diagnosis.
          18

            19      Not only can we say benign versus malignant, which is basically

           fine-needle aspiration cytology can do, core biopsy can allow us to say
      what20
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      invasive, non-invasive, we can do all kind of estrogen/progesterone testing on it,
            1

      so it gives us a lot of information for your buck.
             2

            3       With fine-needle aspiration cytology, you have to trust your

      pathologist who has been specially trained to look at just the cells, where with
           4

      core biopsy, you don't need a trained cytopathologist.
            5

            6       Fine-needle aspiration cytology, possibly less accurate. As I

      described before, it only gives you an idea of benign versus malignant, and if that
           7

      is all you really want, that is all you are going to get. Thirty percent of the time,
              8

      though, up to 30 percent of the time, the pathologist will say insufficient material,
           9

            tell
      can't10 you either way.

           11       Core biopsy, very accurate. Tissue is the issue, and they can

      make a definitive diagnosis, and insufficient sample would be very rare. So, the
         12

      cheaper versus expensive aspect, I think is very debatable and I tend not to use
          13

      the fine-needle aspiration cytology. If you are going to use imaging guidance to
            14

            needle in there, make sure you are getting the answer when you are there,
      get a15

      but some people still like fine-needle aspiration cytology, like I said with
           16

      ultrasound guidance.
           17

           18       [Slides.]

           19       We are going to move on to the final topic, which is a galactography

      or the alternate is ductography. I think this is most underutilized and most fun
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      procedure to do. When do we do it? Well, again, okay, I haven't had one, but
           1

      it's fun for me down the other side.
             2

            3       It is to aid evaluation of a clinically suspicious nipple discharge, and

      what is clinically suspicious? Usually, one that is unilateral and spontaneous.
            4

      Most of us can get some -- most of us women can get some type of an aspirate
           5

      from our nipple. In fact, we use it at Georgetown as a test to see if we can
           6

      actually predict cancer in the duct system, but the important one isn't the one that
           7

      you can express with aspiration, but rather the one that is spontaneous.
           8

            9       You might see a spotting in the bra and typically, it is unilateral, so

      it is for a clinically suspicious nipple discharge.
             10

           11       [Slides.]

           12       The galactogram is a very elegant road map. I am not sure how

      some of the surgeons in here use it or appreciate it, but at Georgetown, many of
         13

      our surgeons appreciate its ability to answer several important questions before
           14

           would go in and do the duct dissection, which is where does the duct go.
      they 15

           16       You have about 8 to 10 separate holes on the surface of the nipple,

      and not all of them predict accurately which way they are going to go. For
          17

      example, on the nipple at 12 o'clock, the duct system might actually subtend the
          18

           more toward 3 o'clock. It might communicate with a different duct system.
      area 19

           20       So, how does it branch, does it communicate with another system?
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             duct system normal-looking, is it abnormal-looking? Are there lesions?
      Is the 1

      Where are the lesions, nearer to the nipple, way back yonder? Those are the
          2

      questions that we can answer with a diagnostic study.
           3

            4       We also aid the surgeon preoperatively by doing a study that has

      contrast mixed with a blue dye, so that we can tell them this is where the
            5

      branching duct system goes.
           6

            7       [Slides.]

            8       So, what do we need? These are galactography essentials. I use

      a 30-gauge blunt tip needle. A 27-gauge is the largest that I think you would feel
           9

      comfortable using, and it is a needle that we actually use also to cannulate your
          10

      salivary glands, a very small, fine needle, blunt-tipped. We don't want to do any
           11

      damage to the orifice.
         12

          13        We use high-density contrast. Why? Because it is going to be

      mixing in with all that duct discharge, and it is going to be getting diluted. Goofy
           14

      magnifying glasses, the most critical part. You need not only your glasses or a 2
         15

      times magnifying glass, at least a 5 to 10 times magnifying system to see exactly
          16

      where that little discharge is coming from on the surface of the nipple.
          17

          18        Of course, the nipple discharge, if the patient doesn't present that

           or
      day, 19 you can't elicit the nipple discharge on the day of the study, you ain't

      doing the study.
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            1       [Slides.]

            2       The patient is out of the field of view save for her nipple right here.

      Here are the aforementioned Goofy glasses. This is the contrast material. It is
           3

      connected by tubing and this person has successfully cannulated or it looks like
           4

      they are about to successfully cannulate that tiny orifice on the nipple.
            5

            6       After we inject contrast into the nipple system, and we inject just to

      the level of when the patients may say I feel fullness, we have efflux of material
            7

      from around the needle, or I actually feel some pressure or some pushing back
           8

      on the syringe plunger, I will stop and take a few pictures.
            9

           10       My initial pictures are made with the needle in place. Now, I say

      this is fun, because it really doesn't hurt that much, maybe a little uncomfortable
            11

      as I trying to cannulate it, but we are not piercing skin. If it hurts, you are doing it
            12

      wrong. We want to go through an established hole in the breast that is usually
          13

      lubricated by the discharge itself.
           14

           15       So, once you plump it in there, you take some pictures and there

      are fun things that you can find in there, and unexpected things. This patient
           16

      has an abnormally dilated duct system.
          17

           18       I can tell the surgeon the duct system goes, for example here, and

      it actually branches off here, and here is a large filling defect. That is where you
            19

           got
      have20 to be real careful while you are doing your dissection.
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            1       This other patient alternatively had a pretty simple non-dilated duct

      system, but multiple filling defects, and they extend far posteriorly. So, again, to
           2

      tell them where the duct system goes, where the lesions are, and how many
             3

            may be, a very important system.
      there 4

            5       [Slides.]

            6       I will close my talk here by just saying that this is not my child,

      although I think I feel like I have to get home early now for some reason.
            7

            8       But mammography is a wonderful tool, it saves lives, but there are

      mammography problem children where things where we just need a needle to
         9

      collide with a mammogram and the breast to find out the answers to some of the
            10

      questions that mammography raises.
          11

          12        [Slides.]

          13        So, I offer again, in summary, stereotactic core breast biopsy,

      which I think is a revolutionary, probably the quietest revolution in health care
          14

      today, as a cost saving alternative to open surgical biopsy of the breast.
          15

          16        [Slides.]

          17        Preoperative needle localization. It is a dance the radiologist and

      the surgeon should do in concert and accurately, and that is also an acceptable
           18

      procedure.
          19

          20        [Slides.]
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            1       Mammographically guided fine-needle aspiration cytology, don't

             do
      really 2 it much under mammography. I show this picture, which is actually a

      ultrasound picture, and here is a needle approaching a lesion, and I can, under
            3

      real-time, follow this needle into and through the lesion.
             4

            5       So, I tend to use fine-needle aspiration cytology using ultrasound

      guidance.
           6

            7       [Slides.]

            8       Finally, galactography, just because you don't know what you will

      find, and this is an abnormal dilated duct system with multiple filling defects in it.
             9

           10       With that, I will thank you for your kind attention. I hope I didn't

           too
      bore 11 many of you. If Dr. Monsees pleases, I would be glad to answer any

      questions.
          12

           13       DR. MONSEES: If you don't mind, any questions that may come

      up, you want to field them, or there are other qualified members of the panel that
           14

      might be able to answer specific questions.
          15

           16       Does anybody on this panel have any specific questions? Dr.

      Winchester is going to ask a question.
          17

           18       DR. WINCHESTER: How many radiologists really care about

      galactography?
          19

           20       DR. ZUURBIER: I would say, in the metropolitan area, there are
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      probably five to 10 radiologists that do it reliably and happily. The vast majority
           1

      are afraid of it and that is why I say it is underutilized, I think.
            2

            3        Our surgeons, most of them favor it. I would say half of them say I

      can do without it, thank you anyway, but I think it affords, without a lot of pain or
           4

      hassle, good information for an accurate duct dissection.
           5

            6        DR. WINCHESTER: Our surgical experience is that it takes a

      radiologist with a special interest in this, and there aren't as many around as we
            7

      would8like to see.

            9        Do you think regulating this procedure would encourage more or

      discourage more radiologists to do this?
           10

           11        DR. WINCHESTER: I think I would just favor more fellowships

      that would excite and emphasize the field itself. I don't think the regulation is
           12

      going to improve the interest in it from a personal standpoint.
          13

           14        DR. MONSEES: Yes.

           15        MS. HAWKINS: You mentioned that in the issue of informed

      consent, that you don't really go into a couple of the issues there, potentials. Do
          16

      you think that this gives a consumer enough information to make an informed
           17

      decision?
          18

           19        DR. ZUURBIER: I mentioned that. Since I don't use freehand

      technique, I don't mention pneumothorax. I think that is a legitimate exclusion of
          20
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      that potential complication.
            1

            2       As a physician and seeing my personal experience in how you may

      faint, actually suggests the process, and I am going to watch them anyway, I
             3

      typically don't suggest it. Fortunately, I don't have that as a complication. I
            4

      think I5can't even tell you that anybody has really fainted in recent history.

            6       So, it is something that can happen to anybody walking into the

      mammography suite can faint, and we watch out for it, but I don't like to mention
         7

      it. Some people do and will, and that's fine, but I think it is a personal style point
           8

      that I have more success if I don't necessarily mention it.
             9

           10       MS. HAWKINS: But do you think, though, that puts the consumer

      at a disadvantage by not having that information?
           11

           12       DR. ZUURBIER: No, because we are prepared for it as an

      eventuality, and we assume that all patients will faint.
          13

           14       MS. HAWKINS: You don't think it will affect somebody's decision

            whether or not they would undergo it?
      as to15

           16       DR. ZUURBIER: Having trained at an institution where we did

      mention it, it did not dissuade anyone from having the procedure. If the panel
         17

      has experience otherwise, there are more years of experience here than
          18

      probably in my end.
          19

           20       DR. MONSEES: Does any other mammographer here care to
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      mention their experience with that and informed consent?
           1

            2       Dr. Sickles.

            3       DR. SICKLES: I have probably done 10,000 of these procedures

            career. There have been women who fainted. We always mention that
      in my 4

      to patients in our consenting. I have not had any woman decline to have the
            5

      procedure done because of it. That doesn't stop me from mentioning it. But I
           6

      have never had a woman say now that you tell me that, I don't want to have the
           7

      procedure.
           8

            9       MS. HAWKINS: Well, see, one of my concerns would be is that it

      is not something that the average woman can pick up, you know, from the TV
           10

      shows where they get much medical advice, from the magazines, and so forth,
          11

            is
      so it 12 not something that is very well known, and so coming into a physician's

      office, you are not really in a position to question.
           13

           14       I know that oftentimes physician, you know, recommendations, can

      be somewhat persuasive. So, that would be my concern.
          15

           16       DR. SICKLES: The important part of discussing this with a woman

            not
      is to 17 bring it up in a threatening way because as you have heard, if it is

      described as a frequent -- and that it not true, it is infrequent -- complication,
          18

            you
      then,19 can sometimes bring it about in a woman who is marginal in terms of

      staying with the procedure. You don't want to overly concern a woman about a
           20
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      very infrequent complication.
            1

            2       There are ways of discussing this very effectively without alarming

      a woman.
           3

            4       DR. ZUURBIER: I think the complication level is similar to getting

      a blood sample taken. So, when I get my blood sample taken, I am sitting up,
            5

      nobody tells me that I am going to faint even though I feel like I will once in a
           6

      while.7

            8       DR. MONSEES: Yes.

            9       DR. HENDRICK: Isn't there also a written informed consent that

      accompanies the procedure that would mention adverse effects like this?
          10

           11       DR. ZUURBIER: The informed consent that we use at

      Georgetown is a standard one, so the patient has signed one just like that for the
          12

      actual surgical procedure prior to coming into my suite. I will list on the side the
          13

      specific potential complications which are bleeding and infection of which I think
          14

      she should be aware of and it would be helpful to her in making her decision.
          15

           16       DR. MONSEES: Yes. Dr. Moore-Farrell.

           17       DR. MOORE-FARRELL: Do you ever use your stereotactic table

      for wire localization?
           18

           19       DR. ZUURBIER: Since our residents primarily use the Homer

      needle system in which the needle is kept in the breast, we don't use it. In my
          20
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      experience, we are pretty speedy and also our core biopsy room is located
           1

      around the corner, so we typically do not use it, but some people do, and if
           2

      anyone want to comment on the pleasure or displeasure with it, but we are just
           3

      as fast without it and you don't have to rev up the machine, do your calibration.
            4

              little simpler from the prep standpoint.
      It is a 5

            6       DR. MONSEES: Yes.

            7       MS. HEINLEIN: You mentioned with the stereo that you used the

      table. 8 Have you had any experience with an add-on unit at all?

            9       DR. ZUURBIER: None.

           10       MS. HEINLEIN: I wonder if there is anyone else on the panel that

      has had experience with an add-on unit. Can you comment on the motion that
          11

      you talked about, that with the table that you don't have a motion problem?
           12

           13       DR. MONSEES: Dr. Sickles.

           14       DR. SICKLES: I have had considerable experience with add-on

            although I don't use them currently. Earlier on, before the tabletop units
      units15

           available, there were add-on units, and we probably did 500 patients with
      were16

      that approach.
           17

           18       It takes longer. I does result in vasovagal reactions in somewhere

      between maybe 1 percent and 5 percent of patients. It requires a women -- any
          19

      stereotactic procedure requires a women to stay perfectly still, and it is harder to
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      stay perfectly still when you are sitting up than when you are lying down. So,
            1

            are
      those 2 the difficulties with the add-on units -- which does not mean that the

      don't work well. If they are operating correctly by people who know how to use
            3

      them, 4they can operate very successfully.

            5       DR. MONSEES: Yes.

            6       DR. HOUN: Florence Houn. Can you just comment on your

      background and training in terms of issues like sterility and wound control, wound
           7

      care as it pertains to these invasive procedures?
            8

            9       DR. ZUURBIER: My training just as a medical student and a

      student in surgery, and participant in Dr. Parker's eggplant course affords me just
          10

      basic principles of sterility. Our technologists are the ones that handle the
          11

      equipment sterility end of things. I handle the patient sterility end of things.
          12

           13       So, we will use appropriate handwashing. We use sterile

      technique in terms of maintaining sterility of the needle shaft itself. It all goes
          14

      asunder when you are touching the actual biopsy device housing, so really, the
          15

           thing that you can maintain sterility of reliably is the needle itself.
      only 16

           17       In our experience, having done almost done 500 in three years of

      operation is that we have had no complications of infection and one complication
          18

      of hematoma.
           19

           20       DR. MONSEES: Do I have any other questions pertaining to this?
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            1       Thank you very, very much.

            2       It is now 12:30. We have actually managed to stay ahead of

      schedule which is wonderful. You will be the beneficiaries of this, because what
           3

      we will do is extend the lunch break a little bit, but please be cautioned that we
           4

      will begin the actual presentation promptly at 2 o'clock.
             5

            6       DR. WINCHESTER: Do we need an hour and a half for lunch?

            7       DR. MONSEES: I am just afraid that maybe people are scheduled

      to come and hear the presentation at 2 o'clock, and that if we start early -- let me
           8

      just ask Dr. Houn whether or not we can do that. Could we start early if we
            9

      wanted to? Before you leave, let's answer this question.
          10

           11       DR. HOUN: I think that since this presentation is going to be

      rather lengthy, you could start early, and if people missed parts, I still think they
           12

      would be able to hear the majority of this presentation.
          13

           14       DR. MONSEES: With that okay, then, we will begin at 1:45, so

      please be here promptly. We will begin at 1:45. Thank you.
          15

           16       [Whereupon, at 12:30 p.m., the proceedings were recessed, to be

      resumed at 1:45 p.m. the same day.]
          17

           18




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           1                   AFTERNOON PROCEEDINGS

           2                                                                   [1:50 p.m.]

           3       DR. MONSEES: We are going to begin this afternoon's session

      15 minutes early, so we have some additional time.
           4

           5                         Joint Presentation:

           6                  American College of Surgeons/

           7                  American College of Radiology

           8       We are going to start with a presentation by these three gentlemen

      who are sitting at this front table. They are Drs. David Dershaw, David
           9

      Winchester, and Robert Pizzutiello, and not necessarily in that order.
          10

          11       This is a joint presentation of the American College of Radiology

      and the American College of Surgeons. I will have Dr. Dershaw make some
          12

      introductory remarks and then the three of you, if you don't mind, can speak in
           13

      the order that you have agreed to. Hopefully, there will be some time for a
           14

      question and answer at the completion of that.
          15

          16       DR. DERSHAW: Thank you, Dr. Monsees.

          17       I am here representing the American College of Radiology and I

      appreciate the opportunity to come before the committee to make some
          18

      comments. I have been asked, and Dr. Winchester has been asked, to put
         19

      together a presentation on an established accreditation program, and we have
          20
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      asked1Robert Pizzutiello to address the issues that are involved in equipment

      specifically, and then I think Dr. Winchester and I will more specifically address
            2

            issues that are involved in accreditation and/or regulations.
      other 3

            4        I am going to ask Bob to first start, again addressing equipment

      issues in these programs.
           5

            6        MR. PIZZUTIELLO: Good afternoon. My name is Bob Pizzutiello

      and I am a medical physicist.
            7

            8        [Slide.]

            9        I am involved with the American College of Radiology in their

      accreditation program, and I have been asked to speak on some of the technical
          10

      aspects of stereotactic breast biopsy primarily quality control and the medical
          11

      physics aspects.
          12

           13        In the earlier presentation before lunch, we heard a very nice and

      thorough and delightfully pleasant discussion of many of the clinical aspects
           14

      involving interventional breast procedures, and we know that there is also a
           15

      significant technical component involved in these procedures, and that is what I
           16

      would like to cover for the next little bit.
          17

           18        [Slide.]

           19        What I am going to discuss is I will start off by talking about the

      difference between mammography and stereotactic breast biopsy, to clarify that
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      distinction since we have heretofore been talking primarily about diagnostic and
            1

      screening mammography.
           2

            3       I would like to make the case for quality control, talk about the

      physics of stereotactic localization, some words about the stereotactic breast
           4

      biopsy equipment, the x-ray system, the patient positioning system, whether they
           5

      be for6prone or add-on units, and the image receptor and image processing.

      These are aspects of the stereotactic equipment.
           7

            8       I will address some issues about patient dose in stereotactic breast

      biopsy.
           9    Radiation dose to the patient is something we always need to be

      careful about whenever we are using x-rays for imaging.
          10

          11        I will finally talk about the details of quality control.

          12        Maybe I will first start with some reflections on the case for quality

      control. I was doing a site survey for the American College of Radiology one
           13

           a
      time 14year or so ago, and we reviewed a facility which had extremely fine clinical

      images. It was a relatively new facility, they had been open about a year. But
          15

      in reviewing the quality control program, there were significant holes in the quality
           16

      control program. Many of the quality control tests were not being done or were
           17

      not being done properly, and they were not being followed up on.
           18

          19        So, the question arose how can this be. Maybe quality control isn't

      so important because here is a facility that is obviously doing extremely good
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      clinical work, but yet the quality control program seems like it's not working.
             1

            2       I pondered that for a few moments, and I think the answer is

      relevant here, and that is that in human life we have learned that when things are
            3

            well, there are no problems, when the wind is at our back, as the Irish
      going 4

      blessing says. But we also know that things do go wrong and if you are medical
            5

      physicist or a physicist, you might know about the law of entropy that says that in
           6

      the universe, things get more disordered unless we make an effort and put
            7

      energy into the system to make them more ordered.
           8

            9       If you are a religious person, you might think about original sin, but

      whatever the cause, things do go wrong. We all experience that in our lives.
          10

           11       In this facility, nothing had yet gone wrong, so the fact that the

      clinicians were doing an extremely good job was evident in the fact that the
            12

      quality of the service was good, but without an adequate quality control program,
           13

      not if, but when things did go wrong, they were at risk of having significant loss in
            14

      the quality of their work, and in fact, the quality of their work, in the absence of a
           15

      QC program, would not be noticed until the images got so bad that the radiologist
          16

            you
      said,17 know, I am really not comfortable with what is happening here.

           18       I think that is the issue that quality control addresses is to detect

      problems in an imaging modality before they become so serious that the clinician
          19

      is uncomfortable and feels that something may be compromising the patient
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      care. 1 So, that is the case for quality control in all of imaging.

            2       [Slide.]

            3       For just a moment, let's distinguish between detection and

      diagnosis. Detection is accomplished by breast self-exam, physician physical
           4

      exam,5diagnostic or screening mammography, and ultrasound. The purpose

            is
      there 6 to detect abnormalities from a large quantity of patients who are

      predominantly normal.
           7

            8       Diagnosis is really more the issue for stereotactic breast biopsy,

      whether it be done with biopsy cytology or histology. It is performed on a
           9

      selected subpopulation who have been found to be at higher risk for malignancy,
          10

      so diagnosis is really what we are trying to accomplish with stereotactic breast
           11

      biopsy.
          12

           13       [Slide.]

           14       As a result of the distinction, there are some differences in the

      equipment that we use. In diagnostic and screening mammography, we are
          15

      looking for detection of abnormalities in a population that is overwhelmingly
           16

      normal. The background is very complex and primarily what we are looking for
          17

      is microcalcifications, masses, architectural distortion of some sort.
           18

           19       The field of view that is used for diagnostic and screening

      mammography is sufficient to image the entire breast, 18 by 24 centimeters, or
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            30
      24 by 1 centimeters in the larger format for the larger breast.

            2       It is also important to be able to image the borders of

      microcalcifications and masses to help to decide whether we are very concerned
           3

      or only slightly concerned about these lesions as being potentially abnormal.
            4

            5       Again, since we are screening a predominantly normal population,

      the radiation risk is to a very large number of women who are predominantly
            6

      normal.
          7

            8       [Slide.]

            9       Now, if we contrast that to stereotactic breast biopsy, we are

      looking for localization, not detection of abnormalities, and specifically what that
           10

      means is that the abnormalities have already been detected on a diagnostic
         11

      quality mammogram, and now it is important to localize those that the needle can
           12

            the
      go to13 right location.

           14       There are a limited number of normals in comparison with

      diagnostic mammography. The background is just as complex. We are still
          15

      looking microcalcifications and masses. A limited field of view is needed
           16

      because we don't need to look at the whole breast, we need to concentrate only
          17

      on the area of interest in the breast.
           18

           19       Again, the radiation risk is to a selected population who are at

      higher risk for malignancy. That is why they are having this interventional
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      procedure in the first place.
           1

            2       [Slide.]

            3       The distinction between mammography and stereotactic has to do

      with the localization. Whenever you have any radiographic image, a single
            4

      radiographic image, it takes a 3-dimensional anatomy and projects it down onto a
            5

      2-dimensional image. In order to position the needle in the right location for
           6

      stereotactic work, we need to do a 3-dimensional localization, and the principle of
            7

      triangulation is needed to determine the depth coordinate.
            8

            9       [Slide.]

           10       Now, there are probably lots of highly scientific ways to conceive of

      stereotactic imaging, and the example we saw this morning about looking from
           11

      one eye to the next is also a very good one. This is one that I thought of and I
          12

      figured that Newton discovered gravity by having an apple fall on his head, and I
           13

      wondered if the person who developed the stereotactic technique was a bowler.
         14

      Bowling is one of the most popular activities, and I kind of hesitate to call it sport
          15

      in the United States, but when you bowl, you probably all have had the
           16

      experience of you are starting off looking a full set of tenpins, and when you look,
          17

           brain interprets a series of pins because you are looking straight on at these
      your 18

      pins.19

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            1       And if you are sort of a marginal bowler like I am, since I don't do it

      very often, you throw your first ball and you don't get all the pins down. I
            2

      remember this happened to me very distinctly. I was looking down at the mess I
          3

      had created, and I found that there were four pins that I didn't hit. Then, I rolled
           4

      the ball and there was one more pin that I never saw. That is this pin right over
            5

      here. 6

            7       [Slide.]

            8       This slide shows perhaps the origin of the stereotactic view, and

      that is, if you move to the side when you are bowling, and go out towards one of
             9

      the alleys and look down, then, you can see this pin which was previously
           10

      obscured. It is giving you a view of perhaps about 15 degrees, and that is the
          11

      way we are able to determine the difference between overlying structures and of
          12

      course in the stereotactic breast biopsy, that is what gives us the depth
          13

      coordinate.
          14

           15       [Slide.]

           16       The purpose of having the depth coordinate is so that we can

      position the needle in the right location. In this slide, this round circle is the
           17

      lesion, and the tan tissue is shown here. The needle is positioned before the
           18

      lesion, then, the stylet is advanced through the lesion, and the cutting needle
           19

      comes through to collect the core sample.
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            1       So, it is very critical that we be able to position the tip of this needle

      in exactly the right location to sample the tissue that is desired.
            2

            3       [Slide.]

            4       Since I am a physicist, you can't hear one without having at least

      one equation, so this is the mandatory minimum one equation, and it is basic
           5

      trigonometry. What we are looking to do is to image this lesion. The x-ray
            6

      beam 7comes from the floor. Here is the breast, here is the lesion we are trying

      to image. The image receptor is back here, and the breast is compressed
            8

      between the compression paddle and the breast support.
           9

           10       In order to position the needle at exactly the right location, what we

           to
      need11 really do is to calculate the distance from the needle to the image

      receptor, and that distance we will call Z.
          12

           13       Since we know that the stereo images are taken at 15-degree

      angles, we have a fairly simple trigonometry problem, and that says that the
          14

      distance coordinate Z equals Xls, which is the stereo shift divided by twice the
           15

      tangent of 15 degrees. If you do the numbers, it means that the Z coordinate is
          16

      about 2 times the stereo shift.
          17

           18       [Slide.]

           19       If we see how this is accomplished in a piece of equipment, an

      image might be taken at minus 15 degrees with the image receptor, and perhaps
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              if
      a grid 1 it is used, taken at this angle, and then the machine is toggled over to the

      alternate position in the detent, and another image is taken at plus 15 degrees.
            2

            3       When we look at the two images, this is a well-targeted lesion. At

      least it shows the needle in the center of the lesion. Normally, we went the
             4

      needle before the tip of the lesion, but in this case, for demonstration purposes,
           5

      you can see that in the two, 15-degree views, we are right there in the center.
           6

            7       But things aren't always as good as we would like them to be. This

      image8on the right shows that if the needle is not properly positioned with respect

      to the 9lesion, then, we get stereo images which are different from what we are

      trying to achieve, and that would tell the physician who is performing the
           10

      procedure that the tip of the needle is not in the right location.
          11

           12       All this has to happen with approximately 1 millimeter accuracy in

      order to adequately sample the lesions that we are looking for.
          13

           14       [Slide.]

           15       There are different types of stereotactic breast biopsy equipment.

      There are dedicated prone tables which we have heard about this morning and
          16

      seen, and they have advantages of speed of a procedure, they are considered
          17

      rather patient-friendly in terms of comfort and lack of problems with fainting, and
           18

      so on, and they are also very convenient for scheduling, because you can have
          19

      one dedicated room that is always used for stereotactic procedures.
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            1       In trying to schedule a busy department, if all of a sudden you

      decide that a stereotactic procedure is needed, it may tie up an extra 45 minutes
           2

            hour in a room and interrupt the schedule for the day.
      or an 3

            4       So, those are the dedicated prone tables.

            5       Another type of technology that is used is an add-on stereotactic

      unit where a basic mammography unit is used with a stereotactic system that
            6

      allows precise positioning of the needle. It is almost an identical positioning
            7

      system to what is used in the prone table, but this difference is that the patient
           8

      may be sitting up or the patient may be recumbent depending upon the model
           9

      and the chairs, and some of the patient-friendly things that are used.
          10

          11        Add-on units are available at less cost because most of the cost is

      in the mammography unit, and you just need to buy the additional add-on device.
           12

           don't take up the space of an additional room, they are ideal for a small
      They13

      number of biopsies, and many facilities use them where they are only doing a
         14

      few biopsies perhaps a week.
          15

          16        So, those are the two types of x-ray equipment.

          17        The imaging modality is primarily in the past was done with screen

      film imaging, and that uses a film image like we are familiar with in
            18

      mammography, and those films then get digitized into the computer, so that the
         19

      computer can calculate the Z coordinate.
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           1        In recent years, it has become much preferable to use digital image

      receptors, and these have the advantages of fast turnaround and shorter
           2

      procedure time. As we heard this morning, once that digital image is exposed,
           3

      the image comes up on the computer screen within just a couple of seconds.
            4

           5        Common to all units is digital targeting software. This is the

      computer software that performs the triangulation calculation and informs the
          6

      physician where to put the tip of the needle.
           7

           8        [Slide.]

           9        This slide shows the picture that you have already seen for the

      prone table, and if we move up here to the right, you can see a conventional
          10

      mammography unit with the stereotactic device literally being added on in this
         11

      photograph.
          12

          13        [Slide.]

          14        Because digital imaging is an important part of the way most

      stereotactic procedures are performed now, just a word to distinguish between
           15

      screen film and digital. In screen film imaging, film is used to capture the image,
          16

      display the image, and to store it. So, since one sheet of film has to accomplish
           17

      those three different tasks, there is always a tradeoff between how we can
          18

      achieve the right performance.
          19

          20        In a digital imaging system, it is possible to have individual
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      modalities to individual components to capture the image, to display the image,
          1

      and to store the image. As such, engineers can design and optimize each of
            2

            three individual components.
      those 3

            4       [Slide.]

            5       The basic method that is used in stereotactic systems for digital

      imaging is the CCD, the charge-coupled device image receptor, and it is not
           6

      terribly different from the charge-coupled devices that have become popular in
             7

      home 8camcorders.

            9       These camcorders use an integrated circuit, a chip, which contains

      light-sensitive detectors on the surface, and these detectors collect a light image
            10

      and then, through amplifiers, generate an electronic image that can go into the
          11

      computer.
         12

           13       [Slide.]

           14       In order to have a light image in the first place, we also have to

      convert the x-ray image into a light image, and in this slide, what you can see on
          15

      the right is that here is the x-ray target, the patient is in position here, and then
           16

      this is an x-ray image that is created. That image gets converted into a light
            17

      image using a screen similar as to what would be found in a mammography
          18

      cassette or radiography cassette.
          19

           20       That image then is relatively large and gets minified down to fit onto
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      the size for this CCD.
            1

            2       [Slide.]

            3       Other important components of the equipment for digital imagine

      and stereotactic is the CRT, the computer monitor, a standard VGA monitor, has
           4

      a resolution of about 640 by 480 pixels, and a pixel is an individual element of a
            5

      digital6image that can be any one of 4,000 or so shades of gray.

            7       What is also highly important for being able to use these images in

      stereotactic imaging is the fact that image processing is available. Once that
            8

      image9is taken, the x-ray picture is taken, then, by adjusting the display on the

      computer, we can window and level that image to adjust the contrast, and we can
         10

      adjust that contrast to visualize dense tissue, to visualize fatty tissue, and to bring
          11

      up microcalcifications so that they are more visible.
          12

           13       [Slide.]

           14       This is sort of a closeup view of a prone table and this is the digital

      image receptor. It sits on the back of the machine. The x-ray tube is over here.
          15

      The x-rays travel down. The patient is compressed in this position, and the
          16

      digital image receptor sits here.
           17

           18       [Slide.]

           19       This slide shows what the computer station looks like. This is sort

      of a familiar computer keyboard with some software that allows the images to be
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      shown, some magnification. The images can be inverted, and so on.
          1

           2        [Slide.]

           3        It is important, as I said earlier, to be aware of the dose in any

      procedure that we do involving x-rays. When the medical physicist evaluates
           4

      the dose, we use the data from the technique chart. We want to measure the
            5

      entrance skin exposure from a standard condition, from the ACR phantom.
           6

           7        We know that the dose varies considerably with the different breast

      composition and the different breast thickness, and the technique factors. So,
          8

      rather9than measure the dose for every individual patient, it has been agreed

            as
      that, 10 medical physicists, we measure the dose under a standard set of

      conditions, and those standard set of conditions are for the ACR phantom, which
          11

      is a specific thickness made up of a mixture of fat and glandular tissue or at least
           12

      made to simulate that tissue.
         13

          14        The medical physicist measures the half-value layer, which allows

            determine a factor called the DgN, and from looking up these values in the
      us to15

      table, we can calculate the average glandular dose.
           16

          17        This is determined by an article written in the late seventies and this

      is the standard way of measuring dose average through the glandular tissue at
           18

             That dose is required to be less than 300 millirads per view in
      risk. 19

      mammography as a regulatory issue. There is no current requirements since
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      stereotactic breast biopsy is not regulated.
            1

            2       For screen film imaging, the dose is related to the optical density.

      If the image is too light, then there is a good chance that inadequate dose was
             3

            and if the image is too dark, it is probably the other way around, but there
      used, 4

      is a significant factor of film processing which also has to be addressed.
             5

            6       With digital imaging it is not like that. The dose, the noise, and the

      image7processing are all interrelated in a way that is not always obvious to the

      operator.
           8

            9       [Slide.]

          10        These are the factors that affect the breast dose in stereotactic

      breast biopsy with digital imaging. The kVp and the mAs that are either set, or
          11

      the machine chooses if it is in automatic mode. If film is used, then the
          12

      exposure time can also have a small effect on the dose. Primary factors are the
          13

      breast thickness and composition. Thicker breasts require more dose and
          14

      dense breasts require more dose.
          15

          16        As I said earlier, the optical density of the film was a prime

      indicator, but that is not the case in digital imaging. In any case, multiple
           17

      exposures, every time an individual patient exposure is made in a stereotactic
          18

      procedure, the patient receives that dose of radiation. If it takes six x-ray
          19

      exposures to image during the procedure, then the patient receives six times that
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      dose. 1 If it takes 20, then it takes 20 times that dose.

            2       [Slide.]

            3       The quality control issues are such that the team approach is

      necessary in order to maintain the quality of the service, and that is that the
           4

      medical physicist must work together with the radiologist or the physician
           5

      performing the procedure, and the x-ray technologists.
            6

            7       It is important that there be training and that the personnel

      understand the issues of targeting accuracy and the errors that are involved. It
           8

      is important that the personnel understand the factors that can contribute to
            9

      degradation of image quality or to increase in dose, and be able to manage that
          10

            environment where the patient may experience some pain and discomfort.
      in an11

           12       [Slide.]

           13       There are some unique problems associated with stereotactic

      breast biopsy quality control. For example, many medical physicists have not
          14

           these units. They are relatively small in number compared with the vast
      seen15

      number of mammography units, perhaps 12- or 14,000 out there in this country.
         16

      So, medical physicists may be unfamiliar with the equipment, the procedure, or
          17

      the need for quality control.
           18

           19       This may also be true of physicians who have not previously been

      involved in the accreditation program and accreditation process. Radiologists
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      are not always involved.
           1

            2       There is a limited regulatory history. We stand in the face of a

      greater than 10-year experience with the mammography accreditation program
           3

      from the American College of Radiology, but roughly a year and a half
            4

      experience with the stereotactic accreditation program.
           5

            6       The horizontal configuration of the prone table causes some

      problems in quality control, particularly for the medical physicist. In standard
            7

      mammography units, gravity works very nicely to allow us to set up our
         8

      equipment in a reproducible way, and that is not the case with the prone units.
           9

           10       The small field of view causes some problems in the digital image

      receptors, and these problems occur with the phantom images and the ion
          11

      chamber measurements. Medical physicists must be trained to know what is the
          12

      proper method to make these measurements, so that they can avoid problems.
          13

           14       [Slide.]

           15       There are some quality control problems that are also unique.

      There is a large heel effect on many x-ray units which again makes the
          16

      positioning of the instruments very critical for the medical physicist.
           17

           18       In mammography, we make all our measurements through the

      compression paddle, but since in a stereotactic unit there is an open window that
         19

      is always in place for imaging, medical physics measurements must be made
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            the
      using 1 compression device window open.

            2       For many institutions that use digital imaging only, there may be a

      lack of a quality hardcopy device. It is not required that there be hardcopy.
            3

      There4may also be a lack of digital image storage. Again, it is not required that

            be
      there 5 digital image storage. Among my clients, we have eight facilities that

      do stereotactic imaging, and some have no hardcopy and some have no
            6

      long-term digital image storage.
            7

            8       For the medical physicists who are accustomed to working with

      instruments and computers, we have to work with pointy needles and gushy
            9

      phantoms, because we too have to be present and be involved in the localization
          10

      simulation. So, that is something else that we have to learn.
          11

           12       The software for digital field uniformity analysis is something that is

      available on some digital systems, and that is a measurement that we hope to
           13

      make in the stereotactic quality control program for the medical physicist, and we
         14

           to
      need15 learn how to do that.

           16       [Slide.]

           17       This slide shows that it is actually not terribly trivial to position a test

      instrument in the horizontal position reproducibly, but we found that it works well
           18

      to use a stanchion like this and a little support, but if you don't have that, people
           19

      try using tape and tissue boxes, and it can get very difficult and certainly not
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      reproducible and not scientific.
           1

            2       [Slide.]

            3       So since things go wrong, the quality control programs were

      developed by the American College of Radiology Stereotactic Breast Biopsy
           4

      Accreditation Program, and there are a number of tests that are required by the
           5

      x-ray technologists, and these tests are listed here, at varying frequencies from
            6

      before each patient to every day, down to quarterly and semiannually.
           7

            8       [Slide.]

            9       If screen film imaging is used, then there are additional quality

      control tests which are not required for facilities that do digital, and these tests
           10

      largely mimic the quality control requirements from the mammography
           11

      accreditation program.
          12

           13       [Slide.]

           14       Now, like in the mammography program, under the stereotactic

      accreditation program, medical physicists have quality control tests, 11 tests that
          15

      are specified, and you can see them listed here. I won't go through them at all
           16

      except to say that the ones in yellow are significantly different than the quality
          17

      control tests that medical physicists are accustomed to performing under the
           18

      mammography accreditation program.
         19

           20       So, physicists need to have specific training in performing more
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      than half of these tests, so that they can be knowledgeable and provide valuable
            1

      input to the facility performing stereotactic breast biopsy.
            2

            3       [Slide.]

            4       There are two phantoms that can be used for image quality

      analysis and for dose measurement under the stereotactic systems. The
           5

      phantom on the right is the familiar mammography accreditation phantom that
           6

      has been around for a long time.
           7

            8       The phantom on the left was developed out at Mayo Clinic. It is

      marketed by Nuclear Associates, and that was specifically designed to contain
           9

           of
      most10 the information we need from an image quality point of view in a smaller

            of
      field 11 view, in a field of view designed to fit within the 5 by 5 centimeter field of

      the stereotactic unit.
           12

           13       [Slide.]

           14       Since the digital imaging system has different imaging capabilities,

      there are different scoring requirements for the different phantoms. Shown here
           15

      are the mammography accreditation program requirements for passing scores of
           16

      fibers, specks, and masses. This uses the ACR accreditation phantom.
           17

           18       In the digital mode, under the stereotactic accreditation program,

      these are the required passing scores. If the mini-phantom is used from Nuclear
          19

      Associates, the passing scores are quite different. So, it is important that
          20
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      individuals who are using these phantoms understand the difference. It is not
            1

      possible to obtain this score or this score for fibers, for example, on the digital
           2

      mini-phantom on most units.
            3

            4       [Slide.]

            5       This slide shows the technical problem of imaging the full field

      mammography accreditation phantom with the digital field of view that is about
         6

      the size of the yellow image. So, for facilities that use the large phantom, they
            7

      need to take four separate images of the phantom, and then take a fifth image
           8

      that demonstrates the TLC chip, and these TLDs are used by the American
            9

      College of Radiology program to measure the dose in the half-value layer.
           10

           11       [Slide.]

           12       Since the medical physics requirements are somewhat different,

      there are some different requirements in terms of knowledge and experience, the
           13

      medical physics qualifications are shown here - a board certification or alternate
          14

      requirements, 15 hours of continuing education in mammography physics every
          15

      three years. Those are the mammography type requirements.
           16

           17       Prior to June of '97, medical physicists would be qualified to do

      stereotactic breast biopsy surveys if they performed three hands-on surveys or if
           18

           performed one hands-on survey under the guidance of a qualified medical
      they 19

      physicist who has done stereotactic breast biopsy.
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            1       That window has closed and effective June of '97, medical

      physicists who have not done anything previously must do one hands-on
           2

      stereotactic survey under the guidance of a medical physicist who has been
            3

      previously qualified.
            4

            5       In addition, for a medical physicist to be qualified, they must

      perform at least one stereotactic breast biopsy medical physics survey per year
            6

      and receive three hours of continuing education in stereotactic breast biopsy
           7

      physics every three years.
           8

            9       So, the medical physicists need to receive some specific training in

      stereotactic physics.
           10

           11       [Slide.]

           12       So, to summarize, mammography is about detection, stereotactic

      breast biopsy is about diagnosis. Quality control is necessary because things
          13

      do go wrong. It is not a question of if, it is only a question of when they go
          14

      wrong.
          15

           16       We talked about the physics of stereotactic localization, some of

      the specific equipment requirements, and I would like to kind of close with an
           17

      important comment about patient dose in stereotactic breast biopsy.
          18

           19       One of the problems with digital imaging is that if operators are not

      familiar with all the factors that contribute to dose, then, patients can receive
           20
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      unacceptably high doses from these stereotactic digital systems.
           1

           2        The reason is that if excessive dose is used on the front end, the

      image3processing can be used to adjust the window and level, so that the image

            very good, and that is something that obviously we need to avoid. So, it is
      looks 4

      important that everyone be educated and that the medical physicist be part of the
           5

      team that performs quality stereotactic breast biopsy.
           6

           7        Thank you.

           8        DR. MONSEES: Thank you very much.

           9        Can we have the lights, and we will move on to the next portion of

      the presentation before we have questions and answers.
           10

          11        DR. WINCHESTER: Dr. Monsees, members, and consultants of

      the National Mammography Quality Assurance Advisory Committee, FDA staff,
           12

      thank you for the opportunity to make this presentation on behalf of the American
          13

      College of Surgeons.
           14

          15        I would like to emphasize at the outset that the representatives from

      the American College of Surgeons and from the American College of Radiology
           16

      on the joint task force have worked together over many months in a collegial
           17

      manner with the dedication to quality patient care and a real attempt to avoid turf
         18

      issue discussions.
           19

          20        You have in your packet a publication entitled Stereotactic Core
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      Needle Biopsy of the Breast, a report of the Joint Task Force of the American
           1

      College of Radiology, American College of Surgeons, and College of American
           2

      Pathologists.
           3

            4         We believe that this represents an important summary of the best

      available scientific knowledge with regard to this procedure. The trick now is to
            5

      find out how many people will read this and what the diffusion time into the
            6

      practicing community will be.
            7

            8         We have had past experiences with guidelines, standards, and

      diffusion into the community is very slow, so I would hope that this is read. Our
             9

      committee, really our joint task force in this exercise, undertook the task of doing
         10

      this for that very reason. We thought it was necessary with relatively new
            11

      technology to define the indications, contraindications, and some of the subtleties
          12

      that the people who were beginning to do this might not appreciate.
           13

          14          A separate task, consisting of four surgeons from the American

      College of Surgeons and four radiologists from the American College of
           15

      Radiology, along with senior staff from the American College of Radiology,
          16

      developed the document included in your packet entitled Physician Qualifications
          17

      for Stereotactic Breast Biopsy.
           18

          19          The Board of Regents of the American College of Surgeons and

      the Board of Chancellors of the American College of Radiology officially
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      approved this document after some minor modifications.
           1

            2       The September 1997 issue of the Bulletin of the American College

      of Surgeons published the document regarding personnel requirements in its
            3

      entirety, along with an overview which I provided.
            4

            5       Our joint task force completed the Physician Qualification document

      with the realization that precise numbers are somewhat arbitrary and subject to
            6

      considerable debate along with many other elements in the document.
           7

            8       We attempted to simplify and systematize practice qualifications in

      an exceedingly complex national environment. Nonetheless, we identified the
           9

      two major models of practice in the United States, that is, physicians working in a
          10

      collaborative setting or physicians working independent of one another.
           11

           12       Clearly, the joint task force favored the collaborative model, but

      recognized in some centers the procedure could be done independently.
          13

           14       I think it is important for me to take a few minutes now to describe

      the major objections which have been expressed by the surgical community in
          15

      response to physician qualifications for stereotactic breast biopsy.
          16

           17       Madam Chairman, I could list all the names and origin of the 12 or

      15 surgeons, but if I may not do that, I think that in the interest of time --
          18

           19       DR. MONSEES: A summary would be appreciated. Thank you.

           20       DR. WINCHESTER: So, these are quotes from a wide variety of
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      surgeons from a wide variety of sites around the country:
           1

            2        Surgeons have always played a central role in the complete

      continuum of care and the management of the breast patient. We need to draw
            3

      attention to the fact that the performance of a surgical minimally invasive biopsy
            4

      procedure utilizing imaging is only one small part in the total evaluation and care
           5

      of the 6patient.

            7        The surgeon evaluates patients fully prior to any form of biopsy.

      The surgeon correlates the approach used for the biopsy in preplanning for any
           8

      eventual larger cancer-directed procedure.
           9

           10        Addressing the radiology community doing this in a totally

      independent setting without surgical consultation, some of the remarks are as
          11

      follow:
           12

           13        If a radiologist is to perform this procedure independently as a

      direct referral from the primary care physician without the benefit of surgical
           14

      consultation, then many of our surgeons believe that the requirements for a
          15

      radiologist practicing independently as stated in the document are inadequate.
           16

           17        The 15 hours of CME in breast imaging including "benign and

      malignant breast disease," should focus not on breast imaging, but an
          18

      understanding of benign and malignant breast disease.
          19

           20        It has been pointed out that radiologists may lack clinical skills
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           practicing independently, and some of the points along those lines that
      when 1

      have been brought forth by surgeons and suggestions for improving those clinical
           2

      skills are as follows:
             3

            4       That the radiologist observe at least 12 open surgical breast

      biopsies performed by a board-certified general surgeon with attention to sterile
            5

      technique, tissue handling, wound management, and hemostasis, clinically
           6

      interact for at least 12 hours with a board-certified general surgeon for physical
            7

      examination of the breast and for presentation of surgical options to the potential
          8

      stereotactic patient including benefits, risks, and complications.
            9

           10       Attend on a regular basis hospital tumor board conferences or

      breast conferences. In our institution, for example, we have a weekly
          11

      multidisciplinary breast cancer conference review with Pathology, Radiology,
           12

      Surgical Oncology, Medical Oncology, everybody who takes care of the breast
          13

      cancer patient, and the radiologists I think benefit, and have told us that they
          14

      benefit considerably from being present at that conference.
          15

           16       Take a one-week rotation through the hospital pathology

      department. That might be kind of tough to do. Be responsible for face-to-face
          17

      postbiopsy communication with the patient including the diagnosis of benign and
          18

      malignant disease. Again, all these suggestions are for a radiologist practicing
          19

      in a totally independent setting.
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           1       Future treatment options for cancer, referral to surgeons,

      oncologists, and radiation therapists. Communicate with the primary referring
           2

      physician regarding appropriate clinical, mammographic, and surgical followup,
           3

      and risk assessment, and attend a national multidisciplinary breast cancer
            4

      symposium every three years.
          5

           6       Further comments. Imaging is performed as an adjunct to the

      biopsy, to allow positioning of the biopsy device itself. The physician locates the
           7

      abnormality previously identified by a qualified MQSA physician. There are
           8

           other instances where x-ray imaging is used as an adjunct in the
      many 9

      performance of diagnostic and therapeutic procedures by surgeons.
           10

          11       A few examples of these include stereotactic intracranial

      neurosurgical procedures, intraoperative fluoroscopy for the placement of central
          12

      venous catheters, intraoperative fluoroscopy in numerous orthopedic procedures,
          13

      fluoroscopy used in coronary angioplasty, and cholangiography.
           14

          15       None of these examples require the supervision of radiologists,

           though they utilize x-ray imaging. To require stereotactic breast biopsy to
      even16

      come under MQSA merely because screening mammography identified the
         17

      abnormality in the first place, in one surgeon's words, "was inappropriate and
          18

      unnecessary."
          19

          20       Many surgeons have expressed the opinion that the number of
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      mammogram reviews of 480 is arbitrary and too high. This has been the most
         1

      commonly voice objection to the document. Surgeons do not believe that
          2

      MQSA requirements for interpretive skills of 480 mammograms per year for
         3

      screening mammography applied to the skills required for a surgeon practicing in
           4

      an independent setting to review an abnormal mammogram which has been
            5

      officially interpreted by an MQSA radiologist, target the lesion, and perform the
             6

      biopsy.
           7

            8       Finally, a quote from a surgeon in Georgia, "The surgeons in our

      community are the only physicians performing stereotactic breast biopsy. Our
          9

      results indicate that we are doing it in a quality manner. We do not individually
           10

      review 480 mammograms per year per surgeon. Does this mean that no
           11

      stereotactic breast biopsies could be performed in our community?"
           12

          13        There are many other communications I have received from

      surgeons around the country, but in the interest of time, I will no longer dwell on
          14

      this broad-based surgical feedback, but simply acknowledge that the "final draft"
           15

      of any document must take into account criticisms such as those which I have
           16

      described.
          17

          18        Having just attended the annual clinical congress of the American

      College of Surgeons, and viewing the wares of the stereotactic manufacturers, it
           19

      is apparent that this equipment is becoming increasingly sophisticated.
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           1        The BIRAD system of the American College of Radiology has

      promoted proper selection of patients with mammographic abnormalities for
          2

      stereotactic breast biopsy. Even so, the demand for the performance of this
            3

      procedure is exceedingly high and legitimate.
           4

           5        Practicing surgeons around the country are learning this procedure

      through formal courses, such as those described this morning by Dr. Israel and
           6

      Dr. Dowlat from American College of Surgeons, and the Society of Surgical
           7

      Oncology.
           8

           9        These physicians are then going back to their home institution and

      being proctored by other surgeons or radiologists according to local credentialing
          10

           requirements. Many of them are being trained to not only perform the
      body11

      procedure, but to train others.
          12

          13        The American College of Surgery has now formally included this

      procedure in their curriculum so that future graduates of training programs in
          14

      surgery will become board-certified, will be qualified to perform this procedure
          15

      much in the same way that board-certified radiologists qualify as interpreters of
         16

      screening mammography under MQSA.
          17

          18        As you know, the American College of Radiology has a voluntary

      accreditation program for stereotactic core needle biopsy in place. The Board of
          19

      Regents of the American College of Surgeons, which met in Chicago this month,
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      unanimously approved the concept of the establishment of a voluntary
           1

      accreditation program for the performance of stereotactic breast biopsy through
           2

      the American College of Surgeons.
           3

           4        A task force of the college is in the process of developing the

      details of this accreditation program. We have discussed this with the American
            5

      College of Radiology. They have offered to help us put this together. They
           6

            in
      have, 7 fact, offered to have representatives from the college sit on their

      committee that developed their accreditation program.
          8

           9        Following this resolution, the American College of Surgeons and

      the American College of Radiology communicated with one another and have
           10

      forwarded letters to FDA, suggesting that consideration be given to a voluntary
          11

      accreditation program or approach rather than the development of regulations
          12

      under MQSA.
          13

          14        Finally, if FDA determines that interventional radiology should be

      included under MQSA, then the composition of the National Mammography
           15

      Quality Assurance Advisory Committee needs to be changed to represent a
          16

      proper balance of clinicians on the committee from the disciplines of radiology,
          17

      surgery, and pathology.
          18

          19        A final remark is in the form of a question to FDA. It is hard to sit

      down and read the 1992 Act word for word, but somehow I did it and got through
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      it, and1when I did that, I was looking specifically for language which indicated to

      me why we are here talking about the regulation of interventional mammography.
          2

            3       The Act states that the National Mammography Quality Assurance

      Advisory Committee shall, "report on new developments concerning breast
           4

      imaging that should be considered in the oversight of mammography facilities."
           5

            6       The only other reference in the Act to anything other than screening

      mammography is under Section 35-4A under Definitions. "The term facility
         7

      means a hospital, outpatient department, clinic, radiology practice or mobile unit,
          8

      an office of a physician, or other facility as determined by the Secretary, that
            9

      conducts breast cancer screening or diagnosis through mammography activities."
          10

          11        I couldn't find anything else and, Dr. Finder, I had talked to you

      before about the Advisory Committee and the advice about not to regulate this,
          12

      there wasn't enough state-of-the-art information. Could you please clarify for me
           13

      this question?
           14

          15        DR. FINDER: I will try. Basically, when you go to the definition of

           mammography is or what a mammogram is, it refers to radiography or
      what16

      radiographic images produced of the breast. Under that, the interventional
           17

      procedures which are used for radiography of the breast or mammography are
          18

      included under that definition.
           19

          20        When the Interim Regulations were first promulgated, at the time
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            wasn't enough information, there were no standards available to include
      there 1

      interventional procedures, so at that time these procedures were specifically
            2

      excluded from regulation, but there was always the impression and always the
           3

      feeling that at some point this issue would be looked at again to see if the
            4

      science had progressed enough and if the standards had progressed enough to
           5

      bring these procedures under regulation.
            6

           7        DR. WINCHESTER: But who initiated the request to look at it in

      the first place? I can't find the language of stereotactic breast biopsy, needle
             8

      localization, galactography. I can't find any of that language in the 1992 MQSA
             9

            Where is the language? Where did it come from? Who authorized it? I
      Act. 10

      just don't understand where it came from. It is not in the Act.
           11

          12        DR. FINDER: Right, and as I say, those terms were not used, but

      in terms of regulation of mammography, anything that uses radiography of the
            13

      breast is included. As I said, it was specifically excluded because at that time
          14

      we had no standards or accreditation bodies or any mechanism to deal with it.
          15

           is
      That 16 why it was excluded.

          17        Now as for the calls to bring interventional mammographic

      procedures, one of the areas that called for it was this committee. I can't
          18

      remember which meeting it was at.
          19

          20        DR. HOUN: That was in May of 1994, the Advisory Committee at
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      that time, we were faced with an October 1 deadline of making sure all facilities
             1

             U.S. were certified by FDA. Otherwise, if they were not certified, they
      in the 2

      would3be performing mammography illegally.

           4        At that May 1994 meeting, we were discussing this area of

      stereotactic and interventional procedures using x-rays that had not had an
            5

      accreditation process developed and that if we did not do something about them
           6

      by October 1 of 1994, these procedures would be banned by law because we did
           7

      not have an accreditation and certification process in place.
            8

           9        So, at that time most of the members of the Advisory Committee

      did advise us to not regulate this and to exempt stereotactic and other
           10

      interventional mammography procedures. Not all of them did, but most did, and
           11

      we had the American College of Surgeons participate in that discussion, as well.
          12

          13        So, what Dr. Finder is saying is that the Act, by defining

      mammography very broadly, and with our history of wanting to make sure that
         14

      breast cancer screening and diagnosis using that technology is of high quality
          15

      standards, this committee has helped us in giving advice on what we should do
          16

      with this new technology.
           17

          18        DR. WINCHESTER: I raise the question because this committee

      has gone through a metamorphosis, there are a lot of new members, and I have
          19

           here for a year, and I still don't understand it. So, I was hoping that this
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            be
      could 1 clarified.

            2       It seems to me that if this moves forward, there needs to be an

      amendment to the Act, because the language does not reflect the intent.
          3

            4       DR. HOUN: I don't think so, because we have --

            5       DR. WINCHESTER: I don't think so either.

            6       DR. HOUN: I think what happened is that in terms of legality,

            matters are reviewed by our general counsel, and that has already been
      those 7

      reviewed several times, that this particular technology, if FDA chose to regulate
            8

      it, would be covered by the Act.
            9

          10        DR. WINCHESTER: And has that been challenged?

          11        DR. HOUN: It has not been challenged.

          12        DR. MONSEES: Let's put that issue aside for now and continue

      with this presentation.
           13

          14        Dr. Dershaw.

          15        DR. DERSHAW: Thank you, Dr. Monsees.

          16        Again, thank you for the opportunity to be here to represent the

      American College of Radiology. I will try not to take up too much time, so that
         17

      we can have time left for questioning.
          18

          19        The procedures that we have been talking about this morning and

      this afternoon compromise a very difficult number of procedures for women in the
           20
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      United States to calculate.
           1

            2       Based on HCFA CPT coding, estimating that these codes represent

      about 3one-third of procedures that are performed, we have estimated that there

      are between 4- and 500,000 of these interventional x-ray-guided breast
           4

      procedures that are performed.
           5

            6       About half of these are needle localizations, slightly over 200,000,

      and again these numbers are very rough estimates.
           7

            8       Galactograms or ductograms compromise a paltry 4,000 or so

      procedures, and the most difficult number to ascertain is the number of needle
           9

      biopsies that are actually performed, but it appears that there are 200,000 plus of
          10

      those procedures.
          11

          12        Needle localizations appear to be done by radiologists about 90

      percent of the time. Ductograms, I think we can reasonably assume are almost
          13

      always done by radiologists, certainly a 90 percent plus number is a reasonable
          14

      guesstimate on that, and the number of imaging-guided needle biopsy
          15

      procedures that we are talking about here today is really difficult to calculate, but
          16

      maybe as high as 80 percent of those procedures are done by radiologists.
         17

          18        Now, let me very briefly just discuss the non-biopsy procedures that

           been mentioned here so far today. Needle localizations, you heard a very
      have19

      beautiful discussion off this morning. If one looks at the published literature on
          20
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      needle localization, there is an institutional failure rate that is reported in the 1 to
           1

      4 percent rate in peer-reviewed literature.
           2

            3       What goes in the community in this procedure, as in other

      procedures that don't get into the literature, are not peer reviewed, I think it is
           4

      very difficult to ascertain. However, I think there is a general sense of these
            5

      procedures being performed in a competent fashion in the general community,
           6

      and I do not think that there is a sense that there is a need for regulation of
            7

      needle localization procedures.
           8

            9       Ductograms, as you can appreciate, are unusual procedures.

      Failure rates are not published on this procedure. Again, I do not believe that
           10

      there is any consensus that these need to be under any kind of regulation.
           11

           12       I will be happy to talk more about those procedures during the

      question period if there are any questions about those procedures.
          13

           14       Let me go on to image-guided breast biopsies. You have heard a

      lot about these. I don't think there is any need to redefine these procedures, but
           15

      let me just remind you that the purpose of these procedures is in a safe,
           16

      comfortable, non-deforming, rapid, and inexpensive fashion to obtain cells or
          17

      pieces of tissue from the breast which make it possible in most cases to make a
          18

      definitive decision about what else needs to be done with a patient who has
           19

      usually a nonpalpable mammographically detected abnormality.
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            1       It is accepted that in some cases, a surgical biopsy will be needed

      for definitive diagnosis. So, that is the purpose of those procedures, and I will
            2

      spend3the rest of the few minutes that I am up here addressing you looking at

      methods in which it is possible to optimize the quality of the procedure that is
           4

            performed, so that one can do with these biopsy procedures what it has
      being 5

      been possible to do with mammography in the United States, and that is
           6

      essentially guaranteed to a woman that there will be a reasonable level of quality
           7

      of care and a reasonable level of safety when she, in a relatively blindly fashion,
            8

      goes to a facility to have one of these procedures done.
           9

          10        By definition, the areas that are undergoing biopsy are small,

      nonpalpable lesions. These are sometimes, as you can all appreciate, difficult
          11

      to see on a mammogram where there has been full compression that has been
           12

           and
      done13 where we have an imaging system which has undergone a level of

      quality control to optimize the quality of imaging that results from that system.
           14

          15        The difficulty in seeing these lesions can be increased, not only by

      the lack of compression, as has been demonstrated, but also by the fact that
           16

      there is an anesthetic that is injected into the breast which may obscure the
           17

      lesion. There is hemorrhage that occurs during the procedure which can further
           18

      obscure the lesion.
          19

          20        Difficulty in appreciating the lesion can be increased by the fact
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      that, in fact, the area of the breast containing the lesion may be displaced by the
             1

      needle tip during the biopsy, changing its location within the breast, changing its
           2

      location on the image that is obtained.
            3

           4        Now, what kind of skills are necessary to perform these procedures

      in an acceptable fashion? Let me go through the steps that are involved in
            5

      actually performing the procedures and address the kinds of skills that are
           6

      necessary to optimize the quality of care during each stage of the procedure.
           7

           8        The first step again, as you have already heard, is the imaging,

      making sure that the patient has gone through the appropriate imaging steps, so
           9

      that a reliable decision has been made, an appropriate decision has been made
           10

      whether or not the patient needs a biopsy.
          11

          12        A biopsy is not -- I don't think it is acceptable to anyone in this room

      -- a biopsy is not a replacement for imaging, and biopsies that can be eliminated
            13

      by appropriate imaging should of course be eliminated.
          14

          15        So, the physician who is selecting a patient must, first of all,

      appreciate that, understand that an appropriate imaging, a reliable imaging
          16

      workup has been done and that the patient in fact needs a biopsy.
          17

          18        When it has been ascertained that a patient needs a biopsy, the

      physician then needs to determine what kind of biopsy may, in fact, be
          19

      appropriate for the patient, not what kind of biopsy the patient must undergo
          20
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      because this remains her decision.
           1

            2       In some cases, I think we would all agree that, in fact, a surgical

      biopsy may be a better biopsy procedure than a needle biopsy. That may be
           3

      because of patient preference. That may be because we are worried about a
           4

      certain kind of histology that requires a larger volume of tissue to be excised
            5

      rather6than a smaller volume of tissue to make a definitive diagnosis, and in

            situations, a surgical biopsy may be more appropriate.
      those 7

            8       We have already heard that there are two kinds of needle biopsies

      that can be performed - fine-needle aspiration for cytology, or a large core needle
            9

      biopsy for histologic assessment of the specimen.
          10

          11        A decision about which of those procedures should be done needs

            made. In addition to that, although we are talking about x-ray-guided
      to be12

      procedures, a decision needs to be made if a core biopsy is being done or an
          13

           is
      FNA,14 stereo guidance optimal, should sonographic guidance be performed

      instead.
           15

          16        So, the physician needs to understand what the indications and the

      contraindications are for these procedures, the relative risks that are involved for
           17

      the patients, and must also appreciate other medical problems that may be
           18

      involved - does the patient have a bleeding diathesis, is the patient on medication
           19

      that may increase the likelihood of complication.
           20
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            1       Once we have made the decision that a patient will undergo one of

            biopsies, we have to be certain, if we are guaranteeing quality of care to
      these 2

      the patient, that the equipment that we are using for the procedure has been
            3

      appropriately selected and has been appropriately maintained.
           4

            5       Certainly, we wouldn't expect in a surgical procedure that a scalpel

      that wasn't adequately sharp to cut into the tissue that we were going to cut
            6

      through would be used in the procedure.
           7

            8       You have already heard a very elegant discussion on the

      complexities of the kind of imaging equipment, the stereo biopsy units that are
          9

      available, the kinds of imaging that is available with those biopsy units, how
           10

      complex this equipment is, and how complicated the acceptance testing at the
         11

           of
      time 12 purchase, as well as the quality control programs that are necessary to

      hopefully abort the overwhelming number of problems that may occur.
          13

          14        If you have equipment that has been well maintained, and if you

           selected the appropriate equipment, you then need to understand how to
      have15

      operate the equipment - what are the appropriate exposure settings, kVp and
          16

          for
      mAs 17 different patients, how do these need to be altered in different densities

      of breasts, in different thicknesses of breasts, how must you alter your settings if
           18

      you are doing calcifications rather than masses.
          19

          20        Just as difficult, I think, is dealing with the individual geometry of the
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      patient, not just the configurations of different pieces of equipment - how do we
            1

      position the patient on the table appropriately, so that we have enough thickness
            2

      to accommodate the positioning of the needle in the breast and the movement of
            3

      the needle through the breast, how do we select the different gun needle
            4

      combinations that may be available to us, so that we minimize the likelihood of
          5

      complication, but optimize the likelihood of making a diagnosis.
          6

            7       When we are actually performing the procedure, perhaps the most

      difficult part of the procedure, and certainly one of the key elements of the
             8

      procedure, is knowing what the relationship of our biopsy device is to the lesion
           9

      that we are seeing within the breast. This is what the procedure is all about,
           10

      getting the needle into a small nonpalpable lesion.
           11

          12        We must be competent in understanding what it is that is going on

      in either the film that we are exposing or on the digital imaging system that we
            13

      are using. We must understand when we are biopsying masses that do not
           14

      contain calcifications what the relationship of the needle is before we fire and
          15

            we
      after 16 fire. It is the only documentation we have during the procedure to know

      whether or not we have done something of service to the patient.
          17

          18        When we are biopsying calcifications, you have already seen

      specimen radiographs that we take during the procedure, but as simple as the
          19

      specimen radiographs appear to be to interpret when they are shown up on
          20
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      slides, I must remind you that there are artifacts that can appear on specimen
            1

      radiographs, most commonly dust that can mimic calcifications. The physician
            2

      performing the procedure needs to be sensitive to these mimickers of disease
            3

      and has to understand when they may or may not be present and when to repeat
           4

      the specimen radiograph.
            5

            6       After the specimen has been retrieved, the physician performing

      the procedure must adequately handle the specimen, so that there is not
            7

      degradation of the specimen, making it more difficult for the pathologist to
           8

      interpret. The physician must understand what information needs to be
            9

      communicated to the pathologist to make it easier for him or her to make an
         10

      appropriate diagnosis.
          11

          12        Once the pathologist has done his or her deed, the physician next

      needs to understand what the pathology report means, understand what it means
          13

      in terms of what it is that has been seen on imaging studies. It is, in fact, the
            14

            step
      final 15 at which we ascertain whether or not the lesion in question has been

      biopsied.
          16

          17        If it looks like a cancer, and we don't get something back that says

      cancer, we must be very concerned that, in fact, we missed a cancer. If we get
          18

      something back that says, for example, fibrocystic change with
         19

      microcalcifications, does that make sense in terms of what it is we actually
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      biopsied.
            1

            2       So, we have to be able to know on the basis of that report, looking

      back on the imaging, whether or not we missed a lesion, and if so, we have to
           3

      repeat the biopsy or a biopsy has to be repeated.
           4

            5       Once we get the report, we need to know how the report fits into

      patient management, and we have to be able to do that ourselves or we have to
            6

      be able to appreciate when the patient needs to be referred to a subspecialist
           7

      who will deal with breast disease.
           8

            9       So, if we get back a high risk lesion, we have to appropriately deal

      with the patient who now has the diagnosis of that high risk lesion. The
           10

      diagnosis of cancer is reasonably straightforward in dealing with that issue, I
          11

      think.
           12

          13        We have to be certain that results will be appropriately

      communicated. I think there is nothing more tragic than delivering good medical
         14

           to
      care 15 the patient and then failing to follow through. Communication of results I

      do not think is a problem, but certainly it is part of the performance of these
          16

      procedures.
          17

          18        Those are things that the doc who is doing the procedure has to do,

      but this is not solely a procedure that is done by physicians, and it is not solely a
           19

      physician procedure.
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            1        We have talked a lot about equipment maintenance and equipment

      calibration, and your procedure will only be as good as the equipment that you
            2

      are using. If your calibration is not good, there is no way you are going to get
            3

      the needle to where it needs to go.
            4

            5        If you are delivering the patient an excessive amount of radiation

      during the procedure, then you may not be doing her a service.
            6

            7        In addition to have quality equipment, it needs to be set up

      appropriately. It needs to be set up appropriately, so that it is functioning well,
           8

      so that is has been calibrated well, so that it is clean, in fact, it is sterile, the parts
            9

      that need to be sterile during the procedure, and sterile technique is an important
           10

      part of this, and personnel involved in these procedures need to adequately use
           11

      a sterile technique during these procedures.
           12

           13        Now, there has obviously been concern over the utilization of these

      biopsy procedures and perhaps the lack of skill in some professionals performing
          14

      these procedures. That is why we are talking about this today.
          15

           16        As you all know, this has resulted in the established of an

      accreditation program by the American College of Radiology, the
          17

      stereotactic-guided breast biopsies, and concerns, in fact, over the utilization of
           18

      ultrasound for the same thing, have resulted in the development of a program for
           19

      ultrasound also.
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            1       The concepts in the development of the accreditation program are

      based2on an understanding that the quality of the service delivered to the patient

      is based on the ability of the facility, not the individual components, but all the
            3

      components of the whole, performing the biopsy, to appropriately select and
          4

      manage patients who are to be biopsied, the ability to perform the biopsy with the
          5

      skill that comes from adequate training and experience, the ability to use
              6

      equipment that has been well maintained and tested, so that practitioners can
           7

      minimize the likelihood of mechanical failure during the procedure, optimize the
           8

      imaging capabilities of the equipment, and keep the radiation dose adequately
           9

      low during the procedure to increase safety to the patient.
           10

           11       If those goals are achieved, the likelihood of failed biopsies should

      be minimized, facilities should fully understand, in addition, how the results of the
          12

      biopsy should be used for patient management including in whom these
          13

      procedures have failed and the biopsy needs to be repeated.
          14

           15       The risk for patient complication and excessive exposure to

      radiation should be reduced by these kinds of accreditation programs. The
           16

      likelihood of excessive pain and prolonged or incompetently performed
            17

      procedures we hope will also be reduced.
          18

           19       In assessing the quality of a facility, the ACR program includes

      accessing the equipment, assessing the personnel including the physician, the
          20
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      technologist, and the medical physicist, and looking at facility outcome data and
           1

      results of any individual facility.
            2

            3        As you have already heard, and you have I believe among your

      handouts are an agreement between the College of Radiology and the College of
           4

      Surgeons indicating a belief that the qualifications for personnel, for physicians,
           5

      can be adequately met either by an individual physician or by a team of
           6

      physicians at an individual facility.
           7

            8        However, we do believe that these qualifications need to be met.

      Technologists and physicists individually must fulfill the qualifications for
           9

      technologists and physicists.
          10

           11        The requirements for personnel include requirements for adequacy

      of initial training including understanding of the rule of techniques in patient care,
            12

      and hands-on training in performing these biopsies. Also, requires maintenance
          13

      of skills by continued performance of procedures and by CME.
           14

           15        I am not going to go through what is in your handout. For those of

          wish
      who 16 to peruse that, it is there. Perhaps if you have trouble sleeping

      tonight, these documents might help you with that.
           17

           18        The equipment maintenance requirements have already been

      reviewed for you.
           19

           20        Facility outcome data are collected and include during an indicated
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      period of time, the volume of procedures which are the basis for the analysis
            1

            submitted by the facility. It looks at the complication rate, it looks at the
      being 2

      repeat biopsy rate, the reasons for repeat biopsy, and it looks at the outcome of
           3

      all the4biopsies, how many benign, how many malignant, and how many in other

      categories.
           5

             6      The facility outcome data is, first of all, educational for the individual

      facility. Secondly, we hope that some point in time, numbers such as repeat
              7

      biopsy rate due to inadequate sampling and complication rates may, in fact, be
           8

      able to be fitted into a wider body of data to indicate perhaps the quality of care
            9

      that is available at an individual facility. It is also educational for an individual
            10

      facility.
            11

            12      Additionally, accumulating these data mandate that an individual

      facility adequately track patients, and we believe increases the likelihood that
            13

      appropriate care after cancer or high risk diagnoses will be delivered to an
          14

      individual patient.
           15

            16      Finally, let me say that patients undergoing percutaneous

      imaging-guided needle biopsy procedures cannot be assured of the skill of
          17

      practitioners performing these procedures or of the safety of the equipment being
          18

      operated when they select facilities at random without any kind of neutral third
          19

            establishing standards for these facilities.
      party20
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            1       We believe that this is not unlike the situation in mammography

      before the American College of Radiology began its accreditation program. The
           2

      accreditation program for a stereotaxic biopsy that was established by the ACR
           3

      was done in the believe that it is possible to maximize the safety and quality of
           4

            interventions.
      these 5

            6       The success of the ACR mammography accreditation program

      followed by MQSA regulation has demonstrated that this expectation is I believe
            7

      a realistic one.
            8

            9       Regulation of interventional breast procedures may not be

      necessary if accreditation programs are utilized to establish appropriate
          10

      standards for facilities and to attest to the public that individual facilities have
          11

      attained these high standards, and if there is a motivation for facilities to become
           12

      accredited.
          13

           14       We believe that the imaging-guided breast biopsy accreditation

      programs established by the ACR define the standards that are necessary to
          15

      accomplish these goals. Training, experience, and quality control programs can
          16

      improve the general quality of these interventions and can help assure women of
          17

      competence and safety of facilities offering these procedures.
         18

           19       Thank you for your attention.

           20       DR. MONSEES: Thank you.
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            1       Now what I would like to do is ask panel members if they have

      specific questions to the three presenters here, and I would like to start out and
            2

      just ask a quick question of Dr. Winchester.
            3

            4       The joint agreement which the American College of Surgeons and

      the American College of Radiology agreed to the qualifications, was agreed to
           5

      prior to the American College of Surgeons volunteering that they were going to
             6

            an
      begin 7 accreditation program.

            8       DR. WINCHESTER: That's right.

            9       DR. MONSEES: How would you propose or have they discussed

      this at all that a facility decide who would accredit them? If it were a practitioner,
           10

           a
      say, 11radiologist by themselves, you would propose that they apply to the

      American College of Radiology, if it is a solo surgeon, they apply to the American
         12

      College of Surgeons, and what if they work in conjunction, do they apply to both?
           13

      Has any thought and discussion been given to having two different bodies
          14

      perhaps with two different sets of standards?
          15

           16       DR. WINCHESTER: This just happened two weeks ago, so not

      much has happened in terms of concrete development at the College of
         17

      Surgeons level. Conceptually, it seems to me if it is a radiologist, it should be
          18

          voluntarily accredited, if it is a surgeon, for surgical skills, it should be the
      ACR19

      College of Surgeons accreditation, but the College of Surgeons, I do not believe
           20
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      at this1point in time has any interest in all in getting into the field of facility and

      equipment certification. They are not qualified to do that. So, that would be
           2

           a
      come 3 joint effort, I would think, between the two voluntary accreditation

      programs.
           4

            5        DR. MONSEES: So, what you would see would be two ways to

            the
      enter 6 system, but that it would be some sort of merged endeavor, is that what

      you would envision?
           7

            8        DR. WINCHESTER: I would think it would have to be because it is

      not just the personnel, as it has been pointed out here, that is important in the
            9

      performance of this procedure. It would have to be some kind of a joint
           10

      arrangement.
           11

           12        DR. MONSEES: I would like to ask the panel if they have any

      specific questions.
          13

           14        DR. MOORE-FARRELL: I have concerns on the same issue

      because I am in just such a practice where approximately five radiologists and
          15

      five general surgeons share one stereotactic machine, and I cannot be
           16

      ACR-certified even though I meet all the requirements because individually, I
         17

            I
      think18would fit, but by the facility I can't because the surgeons use it, so I have

            concerns on that very matter.
      great19

           20        MS. HEINLEIN: In that same vein, if there is an accrediting body
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      that --1I mean you talked about that there would have to be a merger somewhere

           the
      down 2 line -- it sounds as if the American College of Surgeons feels that they

      are capable at this point to accredit personnel only. Is that correct?
            3

            4       DR. WINCHESTER: The task force hasn't met yet. I can't predict

      what they are going to say. That is just my concept of it. In a general sense,
            5

      the American College of Surgeons has been involved for decades in accrediting
           6

      facilities for trauma through ATLS. That is both people and facilities.
              7

            8       They have, for 75, 80 years accredited programs and people within

      it for cancer programs through the Commission on Cancer, so, you know, we
              9

           the
      have10 history of being able to do something like this, but a stereotactic unit is

      somewhat foreign to surgeons, and I don't know what the task force is going to
         11

      say about this, but I think we are going to work with the College of Radiology on
          12

      that one, and I think that that is quite feasible given our track record of working
           13

      together on this project.
          14

          15        MS. HEINLEIN: Especially to ensure that there will be comparable

      standards, then, between the accrediting body, so that everyone is making sure
          16

      that everyone is being accredited to the same level of standards.
           17

          18        DR. WINCHESTER: Nobody in the committee or in the audience

      has seen the letter, because it came out late, but it is a common letter from the
          19

      American College of Surgeons and the American College of Radiology, which I
         20
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            read if you want me to, but if you don't -- it is not very long. It answers
      could 1

           of
      some 2 the questions about a voluntary accreditation program versus a

      regulatory program.
            3

            4       DR. MONSEES: Is there any new information in it that we haven't

      heard5in summary?

            6       DR. WINCHESTER: I would say two things perhaps, and that was

      the question about comparability. "Both our organizations are committed to
            7

      comparable quality accreditation programs on a voluntary basis and believe
          8

            programs will assist in providing optimal health care to patients afflicted
      these 9

      with breast disease."
           10

          11        Secondly, a final statement that, "The American College of

      Radiology and the American College of Surgeons would monitor the
          12

      effectiveness of the voluntary process."
           13

          14        MS. HEINLEIN: Speaking on the voluntary process, which I guess

      is a question I pose to all three panel members, if this is a voluntary process,
           15

           what motivation, what would encourage facilities to go through the process if
      then 16

      it was voluntary?
           17

          18        DR. WINCHESTER: Reimbursement. It might come to that.

      Looking at the ACS initiatives and the ACR initiatives and quality care for
          19

      screening mammography, I think the consumers, the women of this country are
          20
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      looking for some indications there is a quality program in place. I think it would
            1

      be patient driven, and probably industry -- I don't know, what do you think?
           2

            3       DR. DERSHAW: I think it makes no sense to talk about these kind

      of programs as true voluntary programs, because there is no motivation for
            4

      anybody to use them. The overwhelming majority of facilities out there can, in
           5

      fact, ignore these programs.
             6

            7       So, there has to be some kind of non-voluntary component to these

      voluntary programs. The most obvious one is tying accreditation to
            8

      reimbursement schedules.
           9

          10        DR. WINCHESTER: The other thing that has happened

      historically with the cancer programs of the college is a good example. The
           11

      Commission on Cancer surveys cancer programs every four years now, and we
         12

           1,600 programs, which doesn't sound like a big number, but it represents
      have13

      80 percent of all newly diagnosed cancer patients in the United States. It is a
          14

      voluntary program.
          15

          16        Why would hospitals want to pay a tumor registrar and put together

      a whole team of people that has to respond to a survey, and the answer is
          17

      marketing. They market themselves as a quality cancer program to their service
          18

      area. The American Cancer Society is now establishing an Infonet program, a
          19

      1-800 number that a cancer patient or a family will call. I know this is off the
          20
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      subject, but it just another way of answering your question.
           1

            2       They will be given so far two levels of information. One is

      hospitals that are approved by the Commission on Cancer, and those who are
            3

      not approved will not be listed for these callers.
            4

            5       Secondly, caseload. My mother has a colon cancer. How many

            cancers were done at Highland Park Hospital last year versus three or four
      colon 6

            hospitals in the geographic area? The third tier of information, which I
      other 7

      think is going to come forth is outcome, survival rates.
             8

            9       So, that is just another example of how the public will use this.

           10       MR. PIZZUTIELLO: I would like to add something to that. In my

      practice as a consultant physicist, I have been asked by many of my clients why
          11

      do the accreditation programs when they are not mandated.
           12

           13       If you look at the mammography accreditation program as a history

      and model, there were very many facilities who were doing good work, lots of
          14

      facilities learned that they can do better, and they continued to learn that they
            15

      can do better as we see that not all facilities pass accreditation on the first try
          16

      these days, even 1997.
          17

           18       So, there was a continuing education process and improving of

      quality that we have seen through mammography accreditation program. We
           19

           saw,
      also 20 as Dr. Houn mentioned, the sort of charge to get certified at the end of
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      1994. 1 There were a large number of facilities who continued to ignore the

      general trend towards let's do better, let's show our quality, let's market ourselves
           2

      by being accredited. There were a large number of facilities who never did
           3

      anything until the time it was required whether either they get accredited, get in
           4

      the process, or shut down.
            5

            6       So, that is always a problem. It would be very sensible in the free

      market economy of this country to have all the control be exercised through
           7

      reimbursement, however, I don't know that this committee has very much to say
           8

      about 9reimbursement.

           10       I also will say that some of the facilities that I see that are marginal,

      say that, well, this is really a lot of work for us to do, but we provide this
           11

      procedure as a service to our patients, why should we have to jump through
          12

      these high quality hoops.
          13

           14       My response to those facilities is that if you are providing a service

      that is not out of standard of care, then, you are providing a convenience to the
            15

      patient which may, in fact, be a disservice. So, I think that that is something we
           16

           to
      need17 be aware of, that not all facilities will take the high road.

           18       DR. MONSEES: Ms. Hawkins.

           19       MS. HAWKINS: I wanted to ask Mr. Pizzutiello, related to your

      remarks on quality assurance, do you see the role for another entity to look at
          20
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      patient satisfaction under quality assurance, that perhaps some consumer group,
            1

      for instance, especially as we deal with many older adults that will come into this
             2

      process, we have a national aging network that is out there?
           3

            4       MR. PIZZUTIELLO: I should clarify first that the role of the medical

      physicist is primarily in quality control, which is more in equipment and
           5

      technical-related aspects. Quality control is a subset of quality assurance, and a
           6

      distinct part of all quality assurance program that I know of is are we satisfying
            7

      the customer.
            8

            9       So, I think that any facility in 1997 will be remiss if they didn't pay

      some attention to how they are handling the patients. I don't know that that
         10

      needs to be done through an outside agency. I think it is probably being done
          11

            now.
      right 12

           13       DR. WINCHESTER: In today's tough competitive environment, in

            hospitals that are not measuring patient satisfaction, and facilities that are
      fact, 14

      not measuring patient satisfaction in responding to deficiencies are not doing
          15

            and
      well, 16 they all realize that they must do this and it is a very important. I think

      it is being done at the local level rather vigorously.
             17

           18       DR. MONSEES: For mammography, which is regulated, there is a

      complaint mechanism that is stipulated, I believe, and likewise, if a voluntary
         19

      accreditation program would supplant some sort of regulated activity, I think that
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      it should be considered that there be a complaint mechanism by the college or
            1

      whichever college or combination of colleges might consider having a voluntary
           2

      accreditation program.
           3

            4       DR. MOORE-FARRELL: I have a question for Dr. Dershaw and

      then kind of a followup for Dr. Winchester.
            5

            6       At a facility such as mine, where the radiologists and surgeons

      practice together, is there a mechanism now with the ACR, where the radiologist
            7

            become accredited?
      could 8

            9       DR. DERSHAW: The ACR accreditation program now includes

      the parameters for accreditation that have been jointly adopted by the ACR and
           10

      the ACS. So, a facility that has physicians involved in these procedures, that
           11

           those criteria, is an accreditable facility.
      meet12

           13       DR. MOORE-FARRELL: Who do you apply to?

           14       DR. DERSHAW: The ACR. A facility cannot be accredited if

      practitioners at that facility actually involved in the procedure do not meet the
          15

      standards. So, if some of the people who are there are qualified, but some of
          16

      the people who are doing the procedure are not qualified, then, accreditation by
           17

      any accrediting body would be of no value to the public because it would not
          18

      guarantee to them that, in fact, qualified personnel were the only ones that would
          19

            that
      offer 20 procedure to them.
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            1       DR. MOORE-FARRELL: So, if certain people chose to, but the

      others did not wish to participate because it was voluntary, then, there would be
           2

      no way you could be accredited.
           3

            4       DR. DERSHAW: That is correct.

            5       DR. MONSEES: So, there is no way to be accredited under the

      collaborative model proposed by the joint task force, is that correct?
            6

            7       DR. DERSHAW: The criteria for MQSA-qualified physicians and

      non-MQSA-qualified physicians performing the procedure have been
           8

      incorporated into the ACR accreditation program. So, you do not have to be an
            9

      MQSA-qualified physician participating in stereo in order for your facility to be
         10

      accredited by the ACR. The joint recommendation of the two colleges --
          11

          12        DR. MOORE-FARRELL: But it has to be everyone.

          13        DR. DERSHAW: We will not accredit a facility which only some

      participants in the procedure being accreditable, meeting the criteria for
           14

      accreditation, whether that is physicians, technologists, or your medical physicist.
          15

          16        DR. MOORE-FARRELL: And, Dr. Winchester, the same would go

      for you since it is collaborative, if the surgeons there wanted to, but the
           17

      radiologists weren't interested, there would still be no way.
           18

          19        DR. WINCHESTER: Or if the radiologists weren't qualified after

      the voluntary accreditation program is developed.
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            1       DR. MONSEES: Dr. Hendrick.

            2       DR. HENDRICK: A year ago when we met on this issue, it was my

      impression, and perhaps incorrectly, but my impression that the committee was
           3

      in favor of having stereotactic breast biopsy included under MQSA. That is not
            4

      as a voluntary accreditation program, but as a mandated certification program
            5

      under6MQSA.

            7       What I am hearing today I think is somewhat different from that,

      both from the American College of Surgeons and the American College of
            8

      Radiology.
           9

          10        I just want to make sure what I am hearing, my impression today is

      correct, and that you are saying both colleges feel that this is better done as a
           11

      voluntary program not under the auspices of MQSA at all then as a required
          12

      certification program. Is that correct?
            13

          14        DR. WINCHESTER: If I may quote the letter signed by both

      colleges, "The American College of Radiology and the American College of
           15

      Surgeons are writing to you to reinforce their belief that voluntary accreditation
          16

      operational in each college is the best method to serve the public in the area of
          17

      stereotactic breast biopsy."
           18

          19        DR. DERSHAW: Might I add to that, though, that accrediting

      bodies must all have the same high standards that compromise the standards
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      among a menu of accrediting bodies is not acceptable, and that accreditation, if it
          1

      is going to mean something, has to have some force behind it. It can't just be,
            2

      you know, fill out the coupon in the back of your monthly journal and you will be
           3

      accredited.
           4

           5        We have established standards for accreditation. We believe that

            are
      those 6 the appropriate standards for accreditation, and those should

      standards should be required by all bodies that are offering their services as
           7

      accrediting bodies.
           8

           9        DR. MONSEES: This side of the table. I am sorry I have

      neglected this side. We will start with Dr. Smith.
          10

          11        DR. SMITH: This question is directed to both Drs. Dershaw and

      Winchester representing the two colleges. We all watched the American
          12

      College of Radiology's accreditation program gain momentum over time, but
           13

      during the period of time leading up to MQSA, there was lots of press coverage,
           14

      lots of problems that were continually identified that the accreditation program on
           15

      a voluntary basis just really wasn't enough.
           16

          17        In hindsight, can you now, as proposing a voluntary standard as

      opposed to a regulatory standard, see new ways to have accreditation not only
          18

           new teeth, but gain the kind of momentum at a faster pace that under
      have19

      mammography it did not?
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            1        I think there probably are potentially new incentives now because

      the whole climate of health care has changed under managed care, but there is
           2

      an opportunity I think to get the kind of support from the various consumer
           3

      groups, in particular the Cancer Society, if the accreditation program serves its
           4

      purposes.
           5

            6        I mean that kind of tradeoff would have to be demonstrated. So, I

      am wondering what kind of plans the two colleges have to make accreditation a
          7

      reality8in all facilities and a reality that means something, and what kind of

      timetable would you be looking for.
            9

           10        Right now you can't start saying to consumers look for an

      accredited facility, because it is a little soon.
          11

           12        DR. MONSEES: Which one of you gentlemen would like to start

      answering that one? You can answer collaboratively, yes.
          13

           14        DR. WINCHESTER: I think you should comment on the historical

      question about the evolution of the ACR accreditation program and how it gained
          15

      momentum.
         16

           17        DR. DERSHAW: Well, let me just tell you where the ACR

      accreditation program is now as a start. I think part of your question actually you
          18

           answered yourself, part of it doesn't have an answer, and part of is kind of
      have19

      hanging out there in space at the moment.
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             1         We have had about 300 facilities that have applied for

      accreditation, slightly less than 100 facilities have so far been accredited. I must
           2

      say that when the program was first instituted, we were happy not to be
            3

      overwhelmed with numbers of facilities applying because, as you can all
           4

      appreciate, the initial mechanics of putting a new program into action are often
           5

      not very well oiled, so we were happy to get the program up and going a little bit.
            6

             7         Some of the initial problems in the program also I believe, I hope

      have been dealt with by the agreement with the American College of Surgery.
           8

      As I think probably all of you appreciate, these procedures are done sometimes
            9

      by radiologists, sometimes by surgeons, but I think, in a very large number of
           10

      facilities, in fact, are a joint endeavor of surgeons and radiologists.
            11

            12         The difficulty in establishing criteria for non-MQSA physicians to

      participate in these procedures was, in fact, overcome by efforts with the
           13

      American College of Surgery and has made it possible to offer accreditation
         14

      through the ACR to a much greater number of facilities than it was possible for us
           15

      to offer it initially.
           16

            17         A list of certified facilities is made available to the public through the

      Cancer Society. I think the sophistication on the part of the public having
         18

      learned about certification for accreditation or regulation through the experience
           19

      with mammography has resulted in I hope a greater awareness on the part of the
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      public1in terms of the value of accreditation, whether it comes from the ACR or

      whether it comes from another body.
           2

            3       I think that is where we are with it so far. It remains a voluntary

      program. I think one difference perhaps in this than in other procedures that we
           4

      may talk about is often a patient, when she gets to the point that she needs a
           5

      breast biopsy, is in a system, is in a medical system, is in a hospital system, is in
           6

      a referral pattern, had a radiologist or a surgeon or a gynecologist whom she
            7

             to
      trusts 8 make an appropriate referral for her.

            9       So, I think the awareness of the value of accreditation through

      these kind of programs may, in fact, be diminished in the eyes of the individual
          10

      patient because she has already placed herself, I think, often in a medical
           11

      situation of trust. She has established her health care network at that point.
           12

          13        But anyway, I think that is where we are today with the program.

          14        DR. WINCHESTER: I think the level of consciousness and of the

      efficacy of this procedure and the publication in the media about this procedure is
           15

      reaching a high level and that there will be a public demand for this to be done in
          16

      a quality way.
          17

          18        I think that the ACR and ACOS or ACS logos together on a

      document is an important historical precedent. It makes a strong statement
          19

      about two very large organizations primarily involved in this procedure, the fact
          20
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      that they were able to get together and put something together, which I regard as
             1

      a stopgap measure, because remember, we are dealing with a technology that is
            2

            applied out in the community by radiologists and surgeons who were never
      being 3

      trained to do this.
            4

            5       So, we have a problem to deal with in a few year window of

      opportunity here to educate, and prospectively, through our training programs in
           6

      radiology and in surgery, we will produce radiologists and surgeons who will be
            7

      certified by their respective boards and tested in this procedure.
             8

            9       Laparoscopic cholecystectomy is a good example. This hit the

      papers. The American College of Surgeons, such a big machine, it couldn't
          10

           respond in time with educational programs. There were courses that
      even11

      jumped up all over the country, and surgeons were scrambling, and I was one of
          12

      them, to find a course that I could quickly get enrolled in, so I could learn this and
          13

            in
      do it 14 a couple of weeks after I was proctored maybe three weeks.

           15       Those courses went on for about three or four years. You can't

      find one now, they are gone. Why are they gone? They are gone because the
           16

      surgeons that are being produced in this country now are skilled when they come
          17

      out of their training program, and they are certified by the American College of
           18

      Surgery to perform this procedure in a competent way.
          19

           20       The courses aren't there anymore. The courses on stereotactic
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      core needle biopsy are going to go away. They are going to go away in a few
            1

            because we are going to produce prospectively skilled people to do this
      years 2

      procedure, and of course, that will change. There will be new technology and in
           3

      year 2004, we will be going through this again with, you know, we have got a
            4

      new gadget now, how are we going to respond to all the people that are out there
           5

            it.
      doing 6 Well, we can teach the residents and they will learn it. We are going

      to go through cycles like this, on and on.
            7

           8        DR. MONSEES: We are going to go to break shortly and we will

      have to come back and finish this, because there is no way, it looks like, we are
           9

      about to come to closure here with this group of individuals.
          10

          11        I would like to ask a quick question. You mentioned the

      numerator, 300 facilities have applied and 100 were accredited. How many
         12

      facilities are there out there, do we know?
            13

          14        DR. DERSHAW: No.

          15        DR. MONSEES: Is there anybody in the audience from industry

          is
      who 16 willing to stand up here and tell us a number, how many units do we have

      in the United States? Does anybody have that knowledge that is willing to
           17

      volunteer that information to us?
          18

          19        DR. HENDRICK: Maybe you should specify what kind of units.

          20        DR. MONSEES: We are talking about stereotactic units, either
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      prone1and/or add-ons. Let's start with prone units. Is there any manufacturer

      out here that is willing to tell us?
            2

            3        [No response.]

            4        DR. MONSEES: That is what I thought.

            5        Dr. Israel?

            6        DR. ISRAEL: I haven't seen this number tabulated, but I have

      asked7both the Lorad and the Fischer, who make the prone tables, and this does

      not include upright tables, but it is my impression there are between 1,300 and
            8

      1,500 9prone stereotactic units that have been sold and installed in the United

      States.
           10

           11        That is my estimate. I don't have those figures, but that is my

      impression.
          12

           13        DR. MONSEES: Thank you.

           14        I think we will go to break now. We will reconvene promptly at the

      appointed time, 3:45, and we will continue this discussion. Thank you.
          15

           16        [Recess.]

           17        DR. MONSEES: We are going to reconvene.

           18        We want to continue the discussion that was occurring just before

      the break. I will ask Dr. Dershaw to contribute to the discussion and to answer
           19

      questions as they come up from the other panel members.
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            1       Where we left off, I believe there was a question on this side. Dr.

      Sickles, go ahead and ask a question.
            2

            3       DR. SICKLES: My concern relates, not to the agreement that the

      two organizations have come to -- which I think is a big step in the right direction
           4

             rather to the issue of voluntary versus mandatory.
      -- but 5

            6       I think back to the period of time when ACR accreditation for

      mammography was voluntary, and became mandatory with implementation of
         7

      MQSA. For those of you on the panel who weren't involved in this, at that point,
         8

      my understanding is about 50 percent of the mammography facilities in the
           9

      country were accredited, another 25 percent or so were in the process of being
          10

      accredited, and some of that might have been due to the fact that they knew that
          11

      it was coming in a mandatory fashion.
           12

           13       But then there were approximately 25 percent of facilities in the

      country that did not even attempt accreditation until it was mandatory by MQSA.
          14

      My opinion -- and apparently it is shared by Dr. Dershaw and I would presume by
          15

      Dr. Winchester -- is that a voluntary program that attempts to establish standards
           16

      for the whole country will succeed only if it is virtually 100 percent utilized,
            17

      because if we have a voluntary program that is utilized by, say, 75 percent of the
          18

      people in the country, and there is no really firm impetus to be sure that that
          19

      remaining 25 percent get certified appropriately, that they are not going to do it.
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            1       Unfortunately, the 25 percent that won't do it until they have to, are

      the 25 percent that really must do it because they are the ones who look at these
            2

      many,3many tests and say, you know, not only is it difficult, but we may not be

      able to meet those standards.
            4

            5       So, I think we have to be very cautious about adopting voluntary

      programs until we have some very good assurance that the compliance level with
           6

      the voluntary programs will approach 100 percent.
            7

            8       If this can somehow be tied with reimbursement, that will come to

            I
      pass, 9 have no doubt about that, but there is, to my knowledge -- and maybe you

      can educate me -- no steps right immediately in the pipeline or even I am not
          10

      aware of anything in the not too distant future which will force the issue of tying
          11

      this type of accreditation to reimbursement.
            12

          13        If you are aware of any of this, I think the panel should know,

      because I think that would overcome the objection that I am addressing. If you
          14

      are not aware of it, then perhaps any approach that started with a voluntary
           15

      program should have a time frame beyond which if we didn't get close to 100
          16

      percent compliance, we would have to kick into a mandatory program.
          17

          18        Do the two of you have opinions on this?

          19        DR. WINCHESTER: What was the question? I get the gist of it.

          20        I would think that if the voluntary accreditation program for
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      stereotactic breast biopsy, the two colleges became part of the American Cancer
            1

      Society Infonet, and that people called in the 1-800 number to find out what
           2

      facility in their geographic area was accredited by the two national organizations,
              3

      that you would see a mighty rapid rush for accreditation. I know we are going to
            4

      see the same thing in the cancer programs now. We already have 80 percent of
            5

      the cancer patients. I think when Infonet kicks in, that it is going to come up to
            6

      any facility that feels like they can do it above 90 percent, we are going to be
            7

      virtually population-based then. It hasn't happened yet, but folks, it is coming.
            8

            9       I think public pressure, public demand for quality care and some

           of
      kind 10 a national certification program with reputable college names like your

      college and my college -- and that is why, by the way, your college I believe sent
           11

      this letter along with our college recommending accreditation. Both the colleges
            12

            that
      think13 it can happen. We really believe that it can happen, and there are

      various ways of getting from point A to point B.
           14

          15        But I understand what you are saying. I think you are quite

      perceptive in asking about timetables and asking about how you are going to get
          16

      some teeth into this. That is one just off the top of my head, one mechanism to
         17

      do that. We have seen that with the cancer program and ATLS.
           18

          19        DR. DERSHAW: I would agree with everything you said, Dr.

      Sickles. I am not aware of anything going on with reimbursement that you are
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      not aware of going on with reimbursement.
           1

           2       That issue was solely raised as an example, I think not a very bad

      example, of how you can make a voluntary program somewhat less than
          3

      voluntary.
            4

           5       I also agree that the proof of the pudding is in the tasting. If you

      have accreditation programs out there, and they are not being utilized as
           6

      voluntary programs, then, they are not accomplishing what the accreditation
            7

      programs are designed to accomplish.
           8

           9       DR. WINCHESTER: Part of this agreement was for the two

      colleges to monitor the effectiveness of the process. So, what would happen if
           10

      we monitored this for 12 months and found that the compliance was 28 percent?
          11

          possible step would be to make it mandatory, that if the surgeons or
      One 12

      radiologists wish to perform this, they have to show us with surveys objectively
           13

      that they are meeting the criteria that have been outlined, and that could happen.
           14

          15       DR. SICKLES: I have one practical followup question. It has to

      be addressed to Dr. Dershaw now because it is premature to address it to you.
          16

          17       Let's say that publicity gets out to the radiology community in the

           few
      next 18 months that this would be a really good thing to do, for whatever the

      reason. Could the ACR handle the 1,300 units that are out there in a
          19

      reasonable amount of time?
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            1        DR. DERSHAW: Could you define a reasonable amount of time,

      Dr. Sickles?
            2

            3        DR. SICKLES: Well, tell me what you think a reasonable time

      would4be.

            5        DR. DERSHAW: Well, I don't know. Maybe staff could better

      answer that question than I could, and I would, if I might, refer that question.
          6

            7        DR. SICKLES: The reason I am asking you is that it is unfair to

      establish a deadline if people cannot meet the accreditation because the
           8

      mechanisms just go too slow to make it happen, and I understand in the
          9

      institution of a program, and the ACR program, although it has been around for a
            10

           and
      year 11 a half, still is not in high gear, that is a difficult task.

           12        DR. DERSHAW: Could I just be reminded how long it took FDA to

      regulate screening mammography? I have lost track of the time. From start to
          13

      finish, how long was it?
            14

           15        DR. HOUN: I can tell you that for about 4,500 facilities who had

      not been accredited previously, came in t meet the 10-1-94 deadline, and it took
           16

      4,500 facilities to go through mammography accreditation roughly six months
          17

           three months, so a total of nine months. Most of them made it through
      plus 18

      within nine months.
           19

           20        DR. MONSEES: Dr. Hendrick.
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            1       DR. HENDRICK: I share Dr. Sickles' concerns especially about

      the sites that would not participate in this voluntarily. One of the concerns I have
             2

      is that3we may not know the state of practice even if there is a voluntary ACR

      program and voluntary ACS program.
           4

            5       The big concern I have is that we will have very little in the way of

      good surveillance of the practice of stereotactic breast biopsy throughout the
           6

      country. Even if we monitor the voluntary sites and their practices in both of
           7

            programs, we won't know how many sites are accredited by either
      those 8

      program.
           9

          10        So, I would just like to put that as a challenge to the Advisory

      Committee and the FDA to try to come up with a methodology by which we would
         11

      know what is really happening, at least in terms of how many sites there are
          12

      doing different types of stereotactic breast biopsy, how many are accredited and
          13

           the
      what14 state of quality is in those that aren't.

          15        A second concern I have is that I heard discussion of two different

      accreditation programs, one by the ACR and one by the ACS, and I heard two
          16

      completely different things. One was more on the model of the mammography
         17

      accreditation program, which includes all the personnel, equipment, QA, and
          18

      other which was really more of a physician credentialing accreditation, if you
          19

           to
      want20 put it that way.
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            1       I shared some concerns that were expressed previously about the

      difference between those types of models of accreditation and the results that
             2

      they would have on the facilities working under those different accreditations.
            3

      So, that is also a concern under this voluntary model.
            4

            5       DR. MONSEES: Yes. Go ahead, Mr. Pizzutiello.

            6       MR. PIZZUTIELLO: I have a comment about the difference

      between board certification and accreditation. I am not certain that the problem
           7

      will go away when all the surgeons come through training, receive this training in
             8

      their residency, and are tested in their certification process, because almost all
             9

      the radiologists that do mammography are board certified, yet, it became
           10

      important and clear that the quality of mammography was not being ensured just
          11

      by having radiologists be board certified.
          12

           13       So, there is yet another level beyond board certification that says

      can you demonstrate a minimum proficiency with this procedure, the examination
          14

      of mammography. So, I am not sure that board certification by itself will do it for
          15

      surgeons as it hasn't for radiologists.
          16

           17       Also, just to clarify Ed Hendrick's point, the number that I have

      heard about the number of stereotactic units out in the country is more like 3,000
          18

      instead of the 1,500 that Dr. Israel suggested. Now, nobody knows that number,
           19

             we
      but if20 are trying to monitor the ability of the voluntary accreditation programs
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      to see1how close they are to getting at the whole universe of stereo units, we

      don't know what if the denominator is 1,500 or 3,000. That makes a very big
            2

      difference.
             3

            4       DR. WINCHESTER: I was speculating that once we get this

      prospective, then we have trainees out who have been trained to do this at the
           5

      entry level, that they would be qualified at entry to do it, but I didn't mean to
            6

      imply,7I think I mentioned CME, that there would need to be a focused continuing

      program on a voluntary accreditation basis that would monitor in terms of CME
           8

      and medical audit performance and evidence that there had been ongoing
           9

      education and procedure.
          10

           11       DR. FINDER: I just want to make one point at this juncture about

      conflict of interest. I want to bring that back in. The people that were
           12

      mentioned in the conflict of interest statement that had been involved in this issue
         13

      should keep their statements just to the facts, and not really opinions.
          14

           15       So, if you can either just stick to the exact facts of the document or

      the program or how that program was developed, that would be appropriate, but
           16

      we have to be very careful about people giving opinions who have written these
          17

      documents.
          18

           19       DR. MONSEES: There are surely some additional questions for

      this group of individuals who presented this afternoon, and I would like to
           20
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      address some of those questions that other panel members have, but just to let
           1

      you know where we are going, what I would like to do, after we are finished with
           2

      that, is move towards talking about personnel issues this afternoon.
             3

            4       Then, tomorrow morning resume talking about voluntary versus

      regulation, because that is what is on the agenda, and I would like to make sure
            5

      that we cover particularly the physician personnel issues this afternoon, but also
            6

      probably some of the technologist personnel issues.
           7

            8       I have a quick question for Dr. Houn. Is there any way to mandate

      that core biopsy be a reportable event, so that we can have an accurate number?
            9

            are
      If we10 going to data keep and look at what is going on and if the voluntary

      accreditation programs are going to join together and they are going to monitor
          11

      themselves, you need to know how many are going on.
          12

          13        Is there any way to mandate it as a reportable event and the

      number of units that they have to register or something like that, is this possible?
         14

          15        DR. HOUN: I really don't know at this time. I know that the law

            that
      says 16 in applying for FDA certification, they have to supply numbers of units,

      personnel involved, but you are saying without certification can FDA collect this
          17

      information on an exempt technology, and I think that is a real -- it sounds difficult
           18

      for us to do, and it would have to be looked at by general counsel, but since it is
           19

      exempt now, I think that carries a lot of weight in terms of what we can do and
          20
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      what we can ask of these entities.
           1

            2       DR. MONSEES: We have some questions on this side of the

      table. 3 Yes, Mr. Mobley.

            4       MR. MOBLEY: In terms of answering this specific question, it

      would5seem to me FDA has equipment reports regarding installed equipment or

      equipment sales that could be used to at least define the universe of equipment
           6

            that had occurred.
      sales 7

            8       I presume these would be reportable pieces of medical diagnostic

      x-ray equipment -- these may not be diagnostic. I don't know, I was just thinking
            9

      there is an equipment standard. There are reports regarding that equipment
           10

      that have to be filed, and that is one way to get a picture of the universe in terms
           11

      of installed equipment.
           12

          13        I may be overstating the case, but that seems you could go in and

      you query the computer on these units and there they are.
          14

          15        DR. MONSEES: Is that possible?

          16        DR. FINDER: I don't think it is as easy as it should be. We have

           trying to look and get numbers, and so far we have not got a
      been17

      comprehensive number yet, but we are continuing to look and to search the
         18

      databases that we do have access to, but we don't have an exact number.
          19

          20        MR. MOBLEY: Whether it is 3,001 or 3,002 --
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            1       DR. FINDER: It's not even that. I am not talking about.

            2       MR. MOBLEY: We have got 1,300, 1,500, 3,000.

            3       DR. MONSEES: Dr. Dempsey.

            4       DR. DEMPSEY: I would like to ask Dr. Winchester a question that

             exactly equipment related at all, but I think it bears a great deal on what will
      is not 5

      happen in the future.
           6

            7       It is obvious that this joint statement from both colleges has been

      reached by people who are very conscientious and level-headed, and I think
           8

      have the patients' best interests at heart. Over the past two years,
           9

      unfortunately, I think there has been a sense of deep contentiousness that has
          10

      existed, and there are probably many reasons for that out there, but this idea of a
           11

      turf war that encompasses patient control and remuneration and division of work,
           12

      et cetera, and I think it is important to get a sense, Dr. Winchester, as how you
           13

           your
      view 14 membership at large as responding to this effort that has been

      published.
           15

           16       Is that same level of cooperation, do you think, out there, is it going

      to change the other feeling that I think, unfortunately, has been out there for at
           17

            a
      least18 couple of years?

           19       DR. WINCHESTER: Well, of course, feelings run both ways, in

           directions, and they are hard to assess. The college has 54,000 fellows.
      both 20
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      We have about 30,000 general surgeons. I don't know how many of those
          1

      general surgeons are doing this procedure, but I brought along my file, and I felt
           2

      obligated to report to this group the feedback that I had had.
            3

            4        I have 15 letters out of 30,000 surgeons, and sometimes the vocal

      minority makes a lot of an impression. I didn't get 30,000 letters, I didn't get
           5

      2,000 6letters. I didn't get a lot of compliments either. I don't have a good file

      and a 7bad file.

            8        So, it hasn't been overwhelming. We all look at our experiences,

      at our9settings, and in my setting, everything is fine. We have a collegial

      relationship, a good breast center, we work together. Someone else made the
            10

      statement earlier. I think by and large, a great majority of facilities that are doing
           11

            are
      this, 12 doing it in that manner, and not in a contentious manner.

           13        So, I think we need to be careful about the degree to which we

            to
      react14 pointed criticism.

           15        DR. MONSEES: Mr. Fletcher had a question.

           16        MR. FLETCHER: I wanted to do an add-on to what Mike was

      asking, because I know that for every device, every machine, x-ray machine that
           17

      comes in the State of Maryland has a document trail. If we don't know right now
         18

           we
      what19 have, is there a way we can find out, because there has got to be a

      document trail to let us know where these devices are. I am just curious to know
          20
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      do we1intend to look into identifying how to keep track of these devices.

           2        DR. FINDER: Yes. I mean we are attempting to get that

      information, we just don't have it now. We are going through various
            3

      mechanisms. It is not as simple as hitting a computer button and getting the
          4

      data to spit out, but there are mechanisms that we can go down to try and get
            5

      this information, and we are trying to do that now.
             6

           7        DR. MONSEES: Ms. Heinlein.

           8        MS. HEINLEIN: A question for Dr. Dershaw. This morning the

      number of surgeons presented and discussed the training programs that are
          9

      available in the country right now for surgeons to learn how to do stereotactic
           10

      breast biopsy. Can you tell us about what type of programs -- are there
          11

      programs available for radiologists, and what kind of programs there are
          12

      available?
           13

          14        DR. DERSHAW: There are programs in stereotactic breast biopsy

      in CME courses, and these include didactic lectures and hands-on experience,
          15

      not with patients, but hands-on with apples and phantoms and eggplants, and a
           16

      variety of other grocery store products.
           17

          18        The training is included in breast fellowship programs, in residency

      programs. The ACR is in the process of establishing a formalized, standardized
          19

      program that will include not only again CME credits in courses and hands-on
          20
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      experience, but a videotape of information and procedures that can be
           1

      distributed.
             2

            3        So, I think there is a fairly wide training experience that is available.

            4        DR. MONSEES: Yes, Dr. Hendrick.

            5        DR. HENDRICK: I wanted to go back to the document that you

      have brought before us, the personnel, physician qualifications, and in particular,
           6

      I want7to try to see if I can understand the model in which the radiologist and

      breast surgeon or other physician practice collaboratively.
           8

            9        Under number 1 on page 1, the last statement in there is, "The

      physician should be present at the appropriate time during the procedure." I
          10

            know what that means.
      don't11                           Does that mean the radiologist should be there

      when the button is pushed to fire the biopsy gun, and the surgeon should be
         12

      somewhere else, or does it mean that either the radiologist or the surgeon should
         13

      be there at that point? I was just hoping for some clarification about what that
           14

      sentence really means.
          15

           16        DR. WINCHESTER: I think the intent was related to the

      environment that we are now working in and the challenge of billing for a
           17

      procedure when you are not there, whether it is a stereotactic breast biopsy or a
          18

      thoracotomy or you name it, whatever, the wire localization, and training
           19

      programs with fellows and residents.
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            1        DR. MONSEES: This pertains to Medicare basically

      reimbursement under Medicare stipulates that the physician be present during
           2

      the key part of the procedure to bill it, the billing issue.
            3

            4        DR. WINCHESTER: It relates to that technicality rather than the

      surgeon or the radiologist being there, or both of them being there, the intent was
           5

      it depends on who is doing it. They don't need both need to be there.
            6

            7        DR. HENDRICK: But is the model that either the radiologist or the

      surgeon could be performing the procedure, but the point is that if they are billing
           8

      for the procedure, they had better be there when it is being performed?
            9

           10        DR. WINCHESTER: Yes.

           11        DR. HENDRICK: Another question I had was toward the end of

      the document, on page 4 under B, in the situation where a surgeon or other
           12

      physician practices stereotactic breast biopsy independently, "the surgeon or
          13

      other physician is required to -- and the first dot there under Initial Training and
          14

      Qualifications is, "have evaluated at least 480 mammograms per year in the prior
          15

      two years in consultation with a physician who is qualified to interpret them."
           16

           17        I guess my question is what does evaluate mean?

           18        DR. WINCHESTER: That is in almost all these letters. It does

      require clarification I think by the process we are going through today, I would
          19

           that
      hope20 it would clarify, but the intent of this was that if a surgeon is doing this
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      independently, say they have rented a building, they have bought a piece of
           1

      equipment, and they have hired a radiologic technologist, and they have satisfied
           2

      all the3equipment standards, they are not MQSA, so they are not interpreting

      mammograms.
         4

            5       They are referred a patient with need for a stereotactic breast

      biopsy with a mammographic abnormality, which has been interpreted by MQSA
           6

             setting we are talking about now. That doesn't mean that the radiologist
      is the 7

      needs8to walk in with that mammogram in that suite and put it up with the

      surgeon and say here is what I said in my report.
           9

           10       What it means is that the surgeon quite logically is not going to

      perform this procedure without reviewing the mammogram and the report by an
           11

      MQSA radiologist or physician before embarking upon this.
         12

           13       So, review in our sense as our task force looked at it, review was in

      that spirit, and a couple of members of that committee here could agree or
           14

      disagree.
          15

           16       DR. BASSETT: The surgeon wouldn't be interpreting and making

      a report on the examination, but would be reviewing the images, reviewing the
           17

      findings, reviewing the report on a number of cases to ensure that they knew how
           18

      to identify abnormalities.
           19

           20       DR. SICKLES: This 480 mammograms doesn't relate, though,
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      does it, to the specific patient who is undergoing stereotactic biopsy.
           1

            2       DR. BASSETT: No.

            3       DR. SICKLES: This 480 relates to some experience in breast

      imaging, not necessarily producing an interpretation with your name on the
           4

      report, but rather some kind of consultative review with an MQSA radiologist.
            5

            6       DR. BASSETT: It usually occurs when they are seeing the patient.

            7       DR. SICKLES: And this certainly does not have to include the

      specific women undergoing stereotactic biopsy. It can undergo all women in
            8

      that surgeon's practice who have mammograms.
            9

          10        DR. WINCHESTER: That is a very important point. You are not

      going to get to 480 very many places without that.
          11

          12        DR. HENDRICK: Farther down on page 4, actually, the second

      bullet from the bottom, "be responsible for the supervision of the radiologic
           13

      technologist and the medical physicist."
          14

          15        How would the surgeon or other physician know how to supervise

      the medical physicist?
          16

          17        DR. MONSEES: I wondered that myself.

          18        DR. DERSHAW: In the mammography program, MQSA program,

      the responsibility for the entire quality assurance of the procedure is the
           19

      physician's responsibility, and the responsibility for the entire quality assurance of
          20
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      the procedure, performance and quality performance of the procedure remains
            1

      the physician's responsibility in this procedure whether it is a radiologist, whether
            2

              surgeon, whether it is an MQSA-certified physician or not.
      it is a 3

            4       This is merely to indicate that the responsibility for all the

      professional personnel and all the quality assurance of the procedure is the
            5

      physician's responsibility.
           6

            7       DR. HENDRICK: I understand that, but I hesitate to accept that,

      say, four hours of radiation physics as an educational background would really
            8

            a
      equip 9 physician, even a highly educated physician like the surgeon, to be able

      to supervise a medical physicist and know what the medical physicist had done is
           10

      really appropriate, inappropriate, how to take action on the interpretation, say, at
           11

      the medical physicist's report, things like that.
          12

           13       DR. MONSEES: Likewise, the same may be the case for

      supervising the radiologic technologist.
          14

           15       DR. WINCHESTER: I guess I have a practical question because I

            know what happens in the real world, but does the radiologist supervise the
      don't16

      physicist? Be honest now.
          17

           18       DR. MONSEES: Yes, the radiologist interacts with --

           19       DR. WINCHESTER: Interacts, but supervises? Is the word

      supervisor the wrong word?
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            1       DR. MONSEES: What you do is you make sure that the physicist

      not only provides the appropriate service, but that is called in when appropriate.
            2

      That is not always so easy to know. Anytime there is any question in quality
            3

      control, you consult your physicist. You make sure you do. If something
            4

      changes with the equipment, you consult your physicist, and you have to be able
           5

      to speak the same lingo to understand what is going on. You can't just -- at
            6

      least in my estimation -- have somebody tell you everything is okay, you could
             7

      just go on now without really understanding some of what that means.
            8

            9       Any other comments from any other radiologists here who deal with

      this in their practice? Do you have anything to add?
            10

           11       DR. WINCHESTER: I guess the question really hasn't been

      answered yet, it is an important question. Is four hours of something enough to
          12

      qualify somebody who has graduated from medical school and gone through the
           13

      rigors of a surgical residency to supervise a radiologic technologist and a medical
           14

      physicist.
          15

           16       I believe it is legal. Charley, I don't want to do something bad

      here. Is it legal for me to ask, for example, Dr. Israel or somebody in the
          17

      audience who does this procedure frequently in this model, where they are
          18

      independent, of how they would answer the question?
          19

           20       DR. FINDER: I think it is up to the chair. I don't think it is illegal.
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           1        DR. MONSEES: No, it is not illegal.

           2        DR. FINDER: But if it is, we will arrest you later.

           3        [Laughter.]

           4        DR. MONSEES: They haven't give me handcuffs, so I will allow it.

      Who would you like to have answer this question?
          5

           6        DR. WINCHESTER: Dr. Israel is sitting closest here, Dr. Dowlat

      also. 7

           8        DR. MONSEES: Let's try and make it brief if we can rather than

             large number of people. Let's see if Dr. Israel can handle this.
      call a 9

          10        DR. ISRAEL: What we do is comply with state regulations in terms

      of imaging equipment. We have a medical physicist review our facility and our
           11

      equipment twice a year. We also have our service contractor with whom we
          12

           a
      have13 commitment to service our facility to come quarterly. This is the way we

      operate.
          14

          15        We meet all of the requirements of the state in terms of the

      safeguards of the equipment.
          16

          17        DR. MONSEES: Have you yourself ever noticed anything where

      you got on the phone and called your physicist and asked him to come in for a
          18

      consultation because you were concerned about an issue?
          19

          20        DR. ISRAEL: No, I have not.
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            1       DR. MONSEES: How many years have you been doing this, does

      the technologist do this for you?
            2

            3       DR. ISRAEL: We do it collaboratively, the technologist and myself.

      We have the routine surveys and we have not encountered any problems in
          4

      between those surveys. Hopefully, if we had imaging deterioration, et cetera,
           5

      that we would recognize it and we would call for assistance.
            6

            7       DR. MONSEES: Fair enough. Any other questions from the

            of
      panel 8 Dr. Israel?

            9       Dr. Mendelson has a question.

           10       DR. MENDELSON: I wondered if Dr. Israel would tell us, please,

           independence the radiologic technologist has in working collaboratively with
      what11

           a
      you, 12the surgeon acting alone -- and this is the area of this document we are

      working with -- if a surgeon acting alone is responsible for patient selection, but
          13

      relies on the radiologist's interpretation, how is that patient selection made, who
           14

           the
      does15 actual targeting, this patient eligibility for core biopsy? Is that your

      assessment of the mammograms? That was one question.
          16

           17       Once that decision has been made, how do you interact with the

      radiologic technologist, does he or she have an independent that you respect by
           18

      virtue of their training and yours?
           19

           20       DR. ISRAEL: Not in terms of image interpretation. We see these
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      patients generally in the office after they have had a screening mammogram, an
            1

      abnormality has been identified. We inspect the images, and there are times
           2

           I
      when 3 see images that have been graded a BIRAD's 4, that I think should be a

      BIRAD's 3.
          4

            5        When that happens, I call my radiologist and I ask them if they

      would6like to or feel it would be appropriate to amend their report, so that there is

      a place for monitoring this patient.
            7

            8        I take the responsibility along with the patient. Sometimes if there

      is a BIRAD's 3 recommendation, and I am looking at the mammograms with the
            9

      patient, if this patient's mother and sister have had a breast cancer, and this is an
           10

      indeterminate lesion, even though it may be of low suspicion, I will proceed to do
           11

      a stereotactic biopsy, and I will not contact the radiologist. The patient and I will
           12

      make that decision.
         13

           14        The technologist plays no part, zero or minus zero, in making these

      decisions. In terms of the images that are acquired during the course of the
          15

      procedure, I make all of the interpretations. I decide if the image that has been
          16

      portrayed on the digital monitor is indeed the image that we are targeting for.
           17

           18        I do my own targeting. The technologist is not responsible for any

      of that. I accept full responsibility for that.
           19

           20        DR. HENDRICK: Dr. Israel, who at your site reviews the
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      preventive maintenance reports, the technologist QC records, and the medical
           1

      physics reports?
           2

            3       DR. ISRAEL: The technologist reviews those records, and she

      brings4to my attention anything that she may have a question about.

            5       DR. HENDRICK: So, she reviews her own QC surveys of, let's

      say, the processor or phantom image quality, and stuff like that?
            6

            7       DR. ISRAEL: Yes.

            8       DR. HENDRICK: I rest my case.

            9       DR. MONSEES: Thank you.

           10               Stereotactic Core Biopsy - Personnel

           11       I would like to move now towards discussing specific personnel

      issues. This is something that we have danced around a little bit. We need to
           12

      talk about what qualifications do we think -- I will ask people here at this table --
           13

           to
      need14 be the qualifications of a physician who is going to be doing this

      procedure, and I would like to talk more. We have talked very little about the
          15

      technologist's qualifications, and I will rely on some of the technologists on this
          16

      panel to help pinpoint some of the important issues here.
          17

           18       Let's start with the physician, but please, let's keep in mind that we

           to
      need19 move on and talk about technologist issues, as well. Tomorrow, I think

      we may have some time to talk more about quality control issues and physicist
          20
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      qualifications.
             1

            2       So, with that I would like to start by asking perhaps the people on

      the panel if they have any specific comments about what the qualifications
            3

      should be for somebody who is going to do this procedure independently.
           4

            5       Do we agree that 480 mammograms is the appropriate number,

      that these numbers for the ongoing requirements are appropriate, et cetera?
             6

      We can't just I think accept what is given to us without looking at it at least.
          7

            8       I would like to go around the table and see if people think this is

      about 9where we should be. Does anybody want to start? I would like to talk

      about what the ballpark is, are we in the right ballpark here? We are not
          10

      accepting this as what we are going to recommend, but I think we should start
          11

      the conversation with this, and we can go from there.
           12

           13       Do I see any hands? Yes, Dr. Sickles.

           14       DR. SICKLES: If your question relates to the 480 mammograms

      for the non-MQSA physician, as long as the review with MQSA radiologist is a
            15

      meaningful review, it would seem to me that is perfectly appropriate because it is
         16

      the same number that radiologists have to meet to be an MQSA physician.
           17

           18       The difference is that the non-MQSA physician doesn't have to fulfill

             the
      all of19 requirements because what he or she is doing is in consultation, so they

            have to go through all the other steps, but the number, it seems to me
      don't20
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      reasonable because it is the same number that radiologists have to meet.
           1

            2       I would be very interested from Dr. Winchester or from anyone else

      as to whether that is an onerous number for the average non-MQSA physician
            3

      who would be performing these procedures, who you would be happy performing
           4

            procedures.
      these 5

            6       Remember that these, as we were told this morning, tend to be

      non-MQSA physicians who do a lot of these, who are interested in it, who are
           7

      building a practice that heavily involves it. So, I would be interested in knowing
            8

      whether 480 is unrealistic, but historically, it makes sense.
           9

          10        DR. MONSEES: Well, the reason that I am bringing this up is that

      it is one of the objections that Dr. Winchester said that he had almost uniformly in
             11

      the angry letters that he received. So, I think we need to put this on the table
           12

      and see do we think that it is reasonable or not.
          13

          14        DR. SICKLES: I agree fully, but what I don't know, and maybe we

      can get the answer, is whether these are just 15 out of 36,000, or whether this is
          15

      really a substantial problem.
           16

          17        DR. WINCHESTER: One of the issues I think is the central issue

           is
      here 18 whether the same requirements, the interpretive skills for screening

      mammography applied to working in collaboration with the radiologist or working
         19

      alone and getting an MQSA report.
          20
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           1        I think Dr. Dershaw's presentation today would suggest that the 480

      is appropriate for a surgeon even though he or she is "evaluating" and working
            2

      with an MQSA radiologist. Maybe that is not true, but that is the central
            3

      question, are the two really equivalent.
           4

           5        The other issue that I have gotten feedback from is access to care

            in
      issue 6 community hospitals. They are not big, high-powered academic

      centers, they don't have the caseload, and while we don't want this procedure
           7

      done by somebody who doesn't see very much of this, I think there needs to be
           8

           realistic sensitivity to access to care in smaller communities where one of
      some 9

      the specific letters I cited where the surgeons were doing the procedure and
           10

      doing it well by their own audit, but they didn't have 480 per surgeon, which
          11

      would be necessary under these requirements, and those patients would have to
          12

      travel someplace else in Texas to a "bigger" center to get these things done.
           13

          14        So, I guess that those are the two issues I would raise and ask

            and perhaps Dave to respond to since I have worked with both of them in
      Larry15

      the genesis of this. We certainly, as surgeons, don't believe that surgeons
           16

      should be doing this as an occasional thing.
          17

          18        It is going to take a lot more than a casual interest in

      mammography and breast disease. It is going to take a major interest in breast
         19

      disease, and I think, as has been pointed out, that surgeons have self-selected
          20
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      themselves in this process, and if they are not interested in breast disease, they
           1

      are not doing this.
           2

            3       We have seen a large volume of it, they are very much interested in

            this.
      doing 4

            5       DR. MONSEES: Dr. Bassett.

            6       DR. BASSETT: I just wanted to remind everyone that or the

      interpreting physician doesn't have to read 480 original mammograms, that they
            7

      can share some that were done by someone else, so in the practice, if there isn't
           8

      480 apiece for those surgeons, they could double up reading on some of the
           9

      same cases, not reading, but reviewing of the same cases that have
         10

      interpretations with them.
           11

           12       I am not saying that I know that 480 is the magic, correct number.

           just
      I am 13 saying that you can, it is I think appropriate to look at cases that you are

      not necessarily seeing as the primary consultant yourself, and that is how
           14

      radiologists or interpreting physicians in low-volume areas overcome the 480
           15

      number. They either share cases with someone else or look at cases from
         16

      somebody else's practice. So, there are ways around that.
         17

           18       I think what they want is the experience. It doesn't have to be on

      original cases of their own.
           19

           20       DR. MONSEES: Does anybody else have any comments about
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      this number, 480, and about the experience? Yes.
            1

            2       DR. MOORE-FARRELL: I don't have a question about the

      number. I just have a question about how would you document the 480, does
          3

      someone sign off, I mean do you have a plan for that, either the American
          4

      College of Surgeons or the ACR?
           5

            6       DR. MONSEES: If it were voluntary or if it were regulated?

            7       DR. HOUN: I think he has already given advice on how to

      document it for radiologists who are double reading. Certainly, if there is a
          8

      mammography report that says interpreted by so-and-so, double read or reread
         9

      by such and such, you have got firm documentation on the medical report, but if
          10

      that doesn't happen, you can keep -- physicians are keeping their own logs of
           11

      patients they are reading.
           12

           13       They cannot submit them without having the facility sign that indeed

      these films were double read. So, FDA does not accept attestation on this. It
          14

      has to be confirmed by some other senior member of the group, senior member
           15

      of the facility, some other party.
           16

           17       DR. MONSEES: Dr. Israel, I don't mean to pick on you, but as a

      physician who obviously is committed to breast surgical practice, we are relying
          18

      on some of your opinions here. Do you think that a surgeon who is going to
          19

      perform this procedure, as Dr. Sickles was asking, should see 10 mammograms
           20
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      per week in order to keep his eye up and be able to do this appropriately? Do
           1

      you think that is an appropriate number, should they do at least that?
            2

            3       DR. ISRAEL: I think it is too high, and I have given this a lot of

      thought over a lot of years. I also have a lot of feedback from surgeons around
           4

      the country as does Dr. Winchester. I think it is too high. I think it is
            5

      appropriate for screening mammography. I think it is too high for identifying or
           6

      reproducing a lesion that has been identified in order to do a biopsy.
           7

            8       Also, I really don't like the numbers game because we do have to

      have some numbers, I suppose, but it doesn't in any way equate with
           9

      responsibility or relate to competency. There are some people, I think, who
          10

      could read 1,000 and not be competent.
          11

          12        Of course, we do have to have some numbers. I personally think

      the number is too high and I can tell you that this is as big, big contention with the
           13

      surgeons. I would have no problems in complying with this myself, nobody in
          14

      my group would have any problem, but there are other surgeons who are heavily
          15

      involved in breast care work in this country that don't do only breast work.
           16

          17        They may do 30, 40, or 50 percent of their practice. I think they

      might have a problem complying.
          18

          19        I have a couple of questions relating to this that I think really need

            clarified in terms of what we mean by interpretation. It has been
      to be20
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      addressed today, just a few minutes ago, but I wasn't sure what was said.
           1

           2       Now, am I to believe, then, that these 480, if that number persists,

      that a 3surgeon must take 480 mammograms for two years, sit down with a

      radiologist person to person, and review each one of those mammogram, is that
            4

            or
      a yes 5 a no, or is there some flexibility here where the surgeon can review a

      number of mammograms, can keep a log of what he reviews, review it along with
          6

      the mammogram report, come to his own conclusions, keep this in a log without
           7

      having a consultation with the radiologist?
           8

           9       I don't want to compound the question, but one other part of the

      question is, if we have a course that is led by someone like Dr. Laslo Tobar, and
          10

      in the course of this three or four day meeting, a surgeon reviews 400
           11

      mammograms, does this count, and if so, where does it fit into the picture?
         12

          13       DR. MONSEES: Dr. Bassett, would you like to take a stab at that,

      please?
          14

          15       DR. BASSETT: Yes.

          16       DR. MONSEES: Since you were involved and you know the spirit

      of what was written here.
          17

          18       DR. BASSETT: Well, my understanding, the way I would see it is

      that the latter explanation you gave would be the correct one. However, there
           19

      are differences in different practices. For example, in our practice, we are
           20
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      actually down in the breast center when the surgeons are seeing their patients,
           1

      and they bring us every case out and we talk about it and discuss the
            2

      abnormality, and what should be done next.
           3

            4       So, that would count for them, I believe, as having reviewed it.

      There5may be other circumstances, the one you described, where you are

      reviewing the case, the patient you are seeing, you review the mammogram, you
            6

      look at the abnormality, that would count, as well.
            7

            8       Then, I also mentioned the third scenario where you are looking at

           cases that were from your associate in order to make up the numbers you
      some 9

            have, which we might equate with double reading, although it is not the
      don't10

      same thing.
         11

          12        So, I think that the intent was to have reviewed the case, reviewed

      the interpretation, identified the abnormality, in a process that did involve looking
           13

      at the images and looking at the interpretation, whether it is given orally or on a
           14

      report.
          15

          16        And then the issue about doing them in a course that is CME

      approved. I would have to have Flo address that, but I think that was
          17

      acceptable, as well.
          18

          19        DR. MONSEES: Dr. Sickles.

          20        DR. SICKLES: I am addressing it to the people who were involved
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      in planning this, and maybe Dr. Israel would have a comment, as well.
            1

            2       I get the sense from what I am hearing now that the purpose of this

      480 or whatever number, and this would certainly be my belief, would be to try to
           3

      include rather than exclude as many physicians as possible with the ultimate aim
            4

      of being sure that they have enough skill in looking at mammograms to know that
            5

      they are looking at important lesions rather than unimportant lesions.
            6

            7       Is that the intent?

            8       DR. BASSETT: Yes.

            9       DR. MONSEES: While you are still there, before you sit down,

      please, do you think that the number of biopsies that is listed in this document,
          10

      the initial number and then 12 per year is an appropriate ballpark for somebody
           11

      that is going to be proficient and that is going to be involved in this, and for
            12

      patient safety issues, all of the important things, what we are really trying to get
           13

      at here? Is that number, that minimum number okay?
           14

           15       DR. ISRAEL: No. In my opinion, no, it's too low.

           16       DR. MONSEES: It's too low.

           17       DR. ISRAEL: Too low.

           18       DR. MONSEES: What would you suggest then?

           19       DR. ISRAEL: One biopsy per month will not promote proficiency.

           20       DR. MONSEES: So what do you think the learning curve takes to
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      become proficient and then to what level would you say that somebody needs to
          1

      continue to perform these procedures in order to operate at a satisfactory level?
            2

      We are not talking about the best level here, we are talking about an adequate
           3

      level. 4

            5       DR. ISRAEL: I think that 15 to 20 would be a more appropriate

      level. 6 A doctor that is doing one procedure a month, be it a radiologist or a

      surgeon, what that tells me is they don't have a very busy practice, they don't
           7

      have the volume to accomplish or beat the learning curve. I think that is too low.
           8

            9       I mentioned that last year, and I didn't get much support from the

      radiologist community. I think the radiologist community wanted to keep it at
           10

      that level. But I do believe that radiologists and surgeons who have a sufficient
            11

      volume -- and I think a surgeon who has a 30 percent breast practice is going to
          12

      see enough cases where he will do at least 15 to 20 per year.
          13

           14       DR. MONSEES: Thank you. Don't sit down. And Dr. Dowlat

          want to answer this.
      may 15

           16       MR. MOBLEY: I have a similar question I think. I am not a

      physician, so I need to help myself understand this. Some of the questions that
          17

      you just asked helped me, but I want to see if I have a handle on how this
           18

      process works, because I really liked the process discussion that we had earlier.
          19

           20       A screening mammogram is made and then if there are suspicious
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      findings, that patient would be recommended to the surgeon or radiologist for
            1

      further review as to whether a stereo procedure should be performed.
            2

            3       So, at that point, the physician reviewing that film is not looking at

      the film to determine is there something suspicious here, there has already been
             4

      something suspicious identified and pointed out as to where it is, et cetera.
          5

            6       So, the question in my mind is I don't understand why the 480

      number is the magic number here or what the real importance there is. The real
          7

      importance is can I identify this, having it pointed out to me, and can I take action
           8

      pursuant thereto based on my interpretation of the information I have.
           9

          10        So, it wouldn't seem like that that physician at that point needs to

           the
      meet11 same basic criteria as the screening physician. So, I am wondering,

      and you answered this to some extent, it seems like then that the issue of the
          12

      stereo procedure is maybe more important than the issue of the 480
           13

      mammograms, which I think is some of what you said, but is my understanding
         14

      there correct?
           15

          16        DR. ISRAEL: Yes, it is correct, and I think you have put it very

      properly, and this has been a problem that I have had to address all along, and
          17

      that is trying to equate the skill that is needed to be an MQSA screening
            18

      physician. Surgeons have no aspirations to do screening mammography.
          19

          20        We only want to take a lesion that has been identified. We want to
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      reproduce that lesion and we want to do what we have always done with
           1

      patients, biopsy that lesion.
            2

            3       This does require some skills and it does require some imaging

      skills. 4 To be fair about it, there are deficiencies in the radiology community, and

            are
      there 5 deficiencies in the surgical community. At these hearings, we really

      only seem to address the deficiencies in the surgical community, and surgeons
            6

      will readily admit they need to enhance their image interpretation skills, and they
             7

      are working to do that and they will make that accomplishment.
           8

            9       On the other hand, there are deficiencies in the radiology

      community which need to be bolstered and worked on that are very important,
         10

      that have been highlighted by the public discussions this morning. I think they
           11

      are equally important, and I would like the committee to address both of those
           12

      deficiencies both in the radiology community and in the surgeon community.
           13

          14        But getting back to the number 480, I do not think it is necessary for

      a surgeon who is reproducing a lesion for a biopsy to do 480 mammogram
           15

      interpretations. Certainly, a number needs to be put in there. I would say half
           16

      that would be adequate.
           17

          18        Surgeons are going to accept responsibility for what they do when

           biopsy these lesions. They are very responsible, they are not going to
      they 19

      biopsy lesions that they cannot interpret, and I have a rule in my center, when we
          20
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      reproduce a lesion and it comes up on the digital monitor, and I look at that, I
           1

      don't biopsy that lesion if I have to say to myself I think that is the lesion. The
            2

      patient doesn't get a biopsy.
            3

            4       I have to say that is the lesion. Then, that patient will get a biopsy.

      We are not going to take chances, we are not going to put patients at jeopardy.
           5

      I don't6think that the imaging skills need to be at the level of an MQSA

      interpreting physician to do stereotactic biopsy. They need to be good and they
            7

      need to be worked on and enhanced, but they don't need to be at that level.
           8

            9       DR. MONSEES: Thank you, sir.

           10       Dr. Dowlat, would you like to give us your impression about the

      numbers that we are talking about, the ongoing experience, the number of
         11

      biopsies that need to be performed, are we too high or too low here, and the
          12

      number of mammograms, what do you think, what is your opinion?
         13

           14       DR. DOWLAT: I think the 480, I don't know the history of it, but I

           it,
      take 15 it was developed because of the MQSA physicians or radiologists were

      required to be exposed to that many cases a year in order to be proficient and to
          16

      be certified, am I correct in that?
          17

           18       DR. MONSEES: That is correct.

           19       DR. DOWLAT: Those 480, 10 percent of them, 5 percent had

      abnormalities. The rest of them were normal mammograms. Now, here, we
          20
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      are transferring that number to surgeons who are facing an abnormal
            1

      mammogram, and asking them to look at 480 abnormal mammograms. I don't
         2

      think that is right. I think that number is too high.
             3

            4       Admittedly, during the year, the surgeon will come across some

      normal mammograms, but the majority of the time that the patient comes to him
          5

      or her, is with a set of films and the report saying there is something to be
            6

      biopsied, surgical consultation is required. So, I think maybe they are talking
            7

      about 8apples and oranges here.

            9       The second thing is about the number you ask for initial training

      and subsequent proficiency of a physician who is doing the stereotaxic needle
          10

      biopsy. I agree with Dr. Israel that one a month is not enough. I personally do
          11

      about five a week, an average of five a week, and if I go away for a week or two,
          12

            come back, I find myself a little bit rusty.
      and I13

           14       As I said earlier today, the technology, the table is not as simple as

      it used to be. There is a lot of complexities attached to it. Already I am seeing
           15

      during the courses that some people have become a specialist in the ABBI
           16

      system only. They have difficulty in doing the needle biopsy, ordinary core
           17

      biopsy. Why? Because there is so much, they have to focus their attention on
          18

            on
      that, 19 doing ABBI system or doing ABBI biopsy.

           20       DR. MONSEES: It is kind of like a reconstructive surgeon using
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      only one method for all people, isn't it?
            1

            2       DR. DOWLAT: Well, I am just saying that this has become a

      sub-subspecialization. So, I would like to see the person who is coming and
           3

      who wants to do image-guided breast biopsies especially with the stereotaxic
           4

      should do more than one a month.
           5

            6       I think one a month is inadequate. I think they will start cutting

      corners and they run into trouble.
           7

            8       DR. MONSEES: Thank you.

            9       MS. HEINLEIN: So far, both Dr. Israel and Dr. Dowlat have said

      that one is not enough, one a month is not enough, but there is no -- any idea, I
           10

      mean would you say one a week? He said 15 to 20, but 15 is just three more
         11

           12.
      than 12 So, I don't get how that does anything.

           13       DR. DOWLAT: Rita, I think one a week is minimal. I think a

      person should do something like 50 a year in order to remain proficient.
          14

           15       DR. MONSEES: Dr. Bassett.

           16       DR. BASSETT: I would be careful about this, and here is the

      reason. You have got practices where you have, for example, in our practice we
          17

           three radiologists who are doing the procedures, and many of the
      have18

      procedures are better done with ultrasound guidance.
          19

           20       What we were concerned about in looking at these numbers was
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      would1we be compelling facilities to do biopsies that weren't necessary, in other

      words, if you had a certain number you had to do, would you change some of
           2

            probably benigns to suspicious because you wanted to get your numbers,
      those 3

             didn't, you might lose your accreditation and lose the ability to practice?
      if you 4

            5       Would you take cases that really should undergo -- in our practice,

      we have seen a trend over the last couple of years to go from stereotactic to
           6

      ultrasound guided much more frequently that we did before, where now it is
            7

      almost just calcifications that undergo stereotactic.
           8

            9       So, could we just switch some of those ultrasound over to

      stereotactic in order to get our numbers up? And I don't want to see it become a
           10

      numbers game.
         11

          12        So, in a practice like ours, where there is three of us who are doing

      it, teaching it, and so on, it would become a task to try to continue to keep our
            13

           on
      mind14 these numbers. In fact, not too long ago, my chief technologist said to

      me, well, maybe you had better do this under stereotactic to make sure you have
          15

      enough stereotactic numbers for your accreditation, because I had been out of
          16

           for
      town17 a while.

          18        I just don't want to see it go to that. I think that we can keep good

      quality without having that.
           19

          20        Peter, could you comment on that, because you are a practice
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      where1you do a lot of ultrasound guided, and don't you think that there is more of

      a trend to go that way, and that we might compel people to do stereotactic cases
            2

      that should have been done under ultrasound?
            3

            4       I am sorry, Barbara.

            5       DR. MONSEES: That is okay. I am anxious to hear the answer.

            6       DR. DEMPSEY: No, absolutely, I couldn't agree more. In our

      particular practice -- and we have no ax to grind -- we have a prone table and we
            7

      do ultrasound guided, but I can tell you the statistics right now, 87 percent of our
            8

      core biopsies are done with ultrasound guidance, 87 percent.
            9

          10        MS. HEINLEIN: Can I do a followup to that?

          11        DR. MONSEES: Yes, please.

          12        MS. HEINLEIN: Then, I think that that is that extreme, but you

           don't want to say, well, let's make the number so low that then we won't
      also 13

           a
      have14 numbers game, but we also won't have proficiency in the performance of

      the exam.
           15

          16        DR. BASSETT: Well, if people have to do one a month, that will

           them involved, and then their partners are also doing it assumingly. I
      keep17

      mean it becomes a problem when you have more than one person in your
         18

      practice who is doing these, because then you start fighting over the cases.
          19

          20        MS. HEINLEIN: But maybe you don't need to have all five
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      radiologists doing stereotactic --
            1

            2       DR. BASSETT: I said three, first of all.

            3       MS. HEINLEIN: Well, all right. Maybe all three don't need to do

      it.   4

            5       DR. BASSETT: And when you say you have to do 50, well, if you

      are doing 87 percent under ultrasound, start thinking about your numbers.
           6

            7       MS. HEINLEIN: I understand that, but what I am saying is that this

             dilemma in trying to find a balance between not making it a numbers game
      is the 8

      either9way.

            10      DR. BASSETT: I understand, but you can't run a practice where

      we can only do the stereotactic biopsy on this patient on Thursday because that
          11

      is that Maria is there, and I am not allowed to do them anymore. So, there is as
           12

             practicalities in running a practice, that don't mean that you are going to
      lot of13

      lower the quality of the performance of the examination to keep people involved.
          14

            15      I am just concerned if we make the number high, that we may be

      really making people do procedures or at least leading them into the pathway of
           16

      doing procedures either that are not necessary or that could have been better
          17

           with another modality.
      done18

            19      MS. HEINLEIN: And I agree with you in that. So, what would you

      suggest would be an appropriate number, so that that would not happen?
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           1        DR. BASSETT: This number of 12 a year was come up as a

      compromise on that.
          2

           3        MS. HEINLEIN: And you feel that that one a month would help to

      maintain someone's proficiency then?
           4

           5        DR. BASSETT: I think it is unlikely that most people are going to

      be in that position. I know we are going to do more than that per person, but I
            6

      think at least that will guarantee, and then if you are also really concerned about
            7

      the underserved areas or the areas that have few procedures, which I have
            8

      heard9many times today, those are the ones who are really going to be affected

      by this. They may end up having to put all their patients on stereotactic biopsy
           10

      in order to meet a higher number.
           11

          12        DR. MOORE-FARRELL: I also think that one a month is a

      reasonable number. I am from not an urban area, and as I said before, in my
          13

      practice general surgeons use the table as well, and out of all the core biopsies, I
          14

      will say 70 percent are done under ultrasound and 30 percent are done under
            15

      stereotactic guidance, and the surgeons are very good about sending the
           16

      appropriate cases for ultrasound-guided biopsies, because it is efficient and it's
          17

           effective, but I believe that if there was a question of keeping those numbers
      cost 18

      up, they would not. They would keep those patients to keep their numbers up.
           19

          20        DR. HENDRICK: I would just like to suggest that maybe a better
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      measure of quality is how many image-guided biopsies are performed overall,
          1

      not trying to break it down into x-ray or ultrasound guided, and perhaps another,
             2

      better3surrogate of quality would be whether the physician adjusts the biopsy

      device to suit the patient or the particular type of lesion rather than using the one
           4

      technology that they may have just obtained.
           5

            6       DR. MONSEES: Along those lines, Dr. Winchester, if a voluntary

      accreditation program were going to be designed that would be a cooperative
           7

             between ACS and ACR, do you think that the American College of
      effort 8

      Surgeons would be willing to expand this into all image-guided biopsy, and not
           9

      just stereotactic biopsy?
           10

          11        DR. WINCHESTER: That is not covered under MQSA.

          12        DR. MONSEES: I realize that, but if we are talking about a

      voluntary program, then we are talking about may be doing it a different way,
          13

      maybe a better way.
         14

          15        DR. WINCHESTER: Both colleges are in the process of working

      on the ultrasound component of this, not just in breast. ACR I think is just breast
           16

      so far, right? But the college surgeons are looking at a broader ultrasound
           17

      accreditation program. The answer is I think yes.
          18

          19        DR. MONSEES: I will move to you and then we have a couple of

      questions from these gentlemen that we have pressed upon, so I am going to let
          20
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      them ask questions. Go ahead.
           1

            2       DR. DEMPSEY: I think there is one other factor that has to be

      looked at in a department's total biopsy experience, and that is that in the
           3

      departments that do have excellent cytology backup, that much of your biopsy
           4

      work is actually done FNA under ultrasound guidance, not core, which is an
            5

      image-guided biopsy, which is extremely efficient for patient care, because you
           6

      get the diagnosis in 15 minutes.
            7

            8       I think that also has to be put into the continuum. You know, we

      are lucky enough in our department, we have a prone table, we have ultrasound
            9

      guidance, we do FNA, we do core. We do it all. I think that Dr. Bassett's point
          10

      that if you are going to have to say, well, let's see, I have got three of Category 1,
            11

            have got one of Category 2, so tomorrow I had better do them all this way
      and I12

             that
      or all13 way, and you are not thinking about what is best for the patient, but you

      are thinking about getting your numbers. That is extremely dangerous and
           14

      counterproductive to what we are trying to do here.
          15

           16       What we are trying to do here is what is best for the patient and

          is
      who 17 the most qualified to do it.

           18       DR. MONSEES: Dr. Dowlat.

           19       DR. DOWLAT: I wholeheartedly support Dr. Dempsey, but I have

      one question for you. You said 83 percent of your biopsies are ultrasound
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      guided?
           1

            2        DR. DEMPSEY: 87.

            3        DR. DOWLAT: You mean you do some microcalcifications with

      ultrasound, too?
            4

            5        DR. DEMPSEY: From 1991 until 1996, we very definitely skewed

      our population, so that we stayed away from microcalcifications. We did that for
           6

      a very7good reason. We were on certain protocols and we were trying to prove

      a certain point.
            8

            9        We increased the positive predicted value of nodules going to

      surgery from 30 percent positive to, in 1996, 78 percent positive. So, what we
          10

           trying to do was to make the surgeons' work more efficient, that the only
      were11

            the
      thing12 surgeon operated on primarily was cancer. So, we have proven that

            with nodules, and now we are going into microcalcifications more.
      point13

           14        So, I suspect, as you allude to, that that number in the mid to high

      80s will come down as we are doing more microcalcifications. That is true, but
          15

      by the same token, if you have a number of image-guided procedures, you want
           16

            guided by what is best for the patient, not how many numbers you have in
      to be17

      that particular slot.
           18

           19        DR. MONSEES: That is a very important point.

           20        Dr. Israel.
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            1       DR. ISRAEL: Not to belabor this issue -- which is what I am going

      to do -- I would like to respond, and to Dr. Bassett, I would like to say that we do
            2

      a lot of ultrasound-guided biopsies. We do all -- I would say 95 percent of our
             3

      nodular densities we do with ultrasound, but all of our microcalcifications -- and
           4

      50 percent of your lesions are going to be microcalcifications -- and when Dr.
           5

      Dempsey starts doing all the microcalcifications, he is going to do a lot more core
          6

      biopsies.
            7

            8       The issue of 12 being enough, I said it wasn't enough. I believe

      that. 9It is not enough to maintain proficiency. If a surgeon asks me, he says I

      am going to do one stereotactic breast biopsy a month, my advice to him don't do
          10

      it at all. I would say the same thing to a radiologist, if you can only do one a
            11

      month, don't do them.
         12

          13        In Dr. Bassett's case, maybe only one of those radiologists needs

            doing this procedure. One a month is not enough. And I don't think that
      to be14

      we should compromise that number to satisfy other situations. If 12 is not
          15

      enough, it is not enough.
          16

          17        DR. MONSEES: Thank you.

          18        I would like to move on technologist issues, but I don't want to cut

      anybody off if they have any other comments about these numbers and about
          19

      physician qualifications. Are there any other pressing issues here? Do people
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      on the panel have any questions or comments before we move on to technologist
            1

      issues?
           2

            3       We have probably another half-hour, maybe another hour if we go

      until 6:00. I would like to try and see if we can reach closure at 5:30.
             4

            5       MS. HEINLEIN: Just one issue that was actually brought up by Ed

      Hendrick to see if there was any consensus or other feelings about the four hours
          6

      of the 7CME and medical radiation physics for surgeons practicing independently

      and whether or not that was felt to be sufficient for supervision of the technologist
           8

      and medical physicist.
           9

          10        DR. MONSEES: Let's put that on the table. Would you like to

      comment on that?
         11

          12        MS. HEINLEIN: No.

          13        DR. MONSEES: Anybody on this panel like to comment on that?

      Dr. Winchester, do you have something to say? You were headed towards the
           14

      microphone.
          15

          16        DR. WINCHESTER: I have had a fair amount of feedback from

      the surgical community about that, and they think that number is excessive. I
           17

            know anything about this subject. I think others, coming from the other
      don't18

      perspective, they think it ought be 12 hours or 10 hours, and I don't know the
          19

      answer to that.
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           1        After watching the presentation from Bob today, I think I would

      need a couple days.
           2

           3        DR. MONSEES: He only showed one formula, don't forget.

           4        Dr. Bassett, you helped to formulate this report. Can you tell us

      where5you got that number and maybe -- I know you didn't just pull it out of the

      air, but do you want to give us some more information about this?
             6

           7        DR. BASSETT: I think there was an attempt to compare it to what

      was being required for other things like what the interpreting physician was
           8

      required to do, and the alternative pathway that was an alternative for doing
            9

      interpretation. Part of it came out of the air, I guess, but I think there was some
           10

      attempt to try to make it a reasonable amount.
          11

          12        David, do you want to comment on that?

          13        DR. DERSHAW: Yes. Let me make a specific comment and a

      general comment. I have kind of mixed them all up. There was I think an
          14

      appreciation that the skills that are involved in doing this procedure are the same
          15

      whatever the postgraduate medical education is that a physician has had,
          16

      whether he or she is a radiologist or a surgeon or whatever, the same skills are
          17

      involved in performing these procedures with a high level of competence.
           18

          19        It is not expected, and it is an inappropriate expectation, that

      radiologists will become surgeons in order to perform this and that surgeons will
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      become radiologists in order to perform this, that there are surgeons and
          1

      radiologists who are extremely expert in performing these procedures, and there
            2

      are surgeons and radiologists who are performing these procedures who are not
            3

      very good at it, and, in fact, probably shouldn't be performing these procedures.
            4

            5       The numbers that constitute this document are obviously

      compromise numbers. Do they guarantee an extraordinary level of expertise in
          6

      any physician who is performing these procedures? No, they certainly do not.
           7

            8       May they, in fact, end up excluding some physicians who might do

      this procedure very well? Perhaps they might, but they are an attempt to look at
            9

      the skills that are required in order to perform the procedures well, and try and
           10

      see what kind of training and what kind of experience is necessary for physicians
          11

      in various specialty groups to perform those procedures well.
           12

           13       I think that the document is a reasonable document and I think that

      the level of skill that a physician has, if he or she has met the criteria spelled out
           14

      in this document, is reasonably high in terms of performing these procedures.
            15

           16       We may argue about this number or that number, and this

      committee can go through the same kind of arguments that our committee went
         17

      through in terms of this. These were not an attempt to make people happy.
           18

           19       These were not an attempt to go back to our members -- and we

           very successful in that -- these were not an attempt either to go back to the
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      membership of the individual colleges and say look what we have done for you.
          1

      These were an attempt to look at physicians and other personnel involved in
           2

            procedures and say what kind of training and experience do you have to
      these 3

      have initially and in an ongoing fashion in order to be competent in this.
           4

            5       Four hours of CME in physics does not give a surgeon the same

      level of competence that a radiologist has in looking at these numbers, but it
            6

      hopefully gives a non-radiologist some level of sophistication, some level of
           7

      insight in order to be able to have a discussion with the medical physicist and the
            8

      technologist involved in the procedures, so there is a level of understanding
           9

      about what the equipment is and what the problems that arise in the equipment
          10

          be.
      may 11

           12       I agree with you that three weeks of physics would, in fact, be

      better, but it is unrealistic that non-radiologists are going to have that kind of
           13

      experience.
          14

           15       DR. HENDRICK: On the other hand, if you are serious about

      having these as the responsible physician, anyone, I don't care who it is, as the
          16

      responsible physician overseeing all of quality control, overseeing the work of the
          17

      technologist, the work of the medical physicist, you can't substitute the
          18

      background of a radiologist who has gone through four years of residency getting
          19

      physics, training in mammography, getting physics specifically directed at
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      mammography.
         1

            2       I mean I can't tell you how many hundreds of lectures I have given

      on quality control in mammography to radiologists, you know, how to review a
           3

      physicist's report, how to work with the technologist and the medical physicist.
           4

            5       I would like to think that that has had some value in mammography,

      and I don't think it is really replaced by four hours, especially for someone who
            6

      hasn't7been involved in the radiology environment the way radiologists have.

      That's8all.

            9       DR. MONSEES: Which brings me to ask a question about the

      technologist, which is something I would like to get to this afternoon.
          10

           11       Do you think that as a substitute perhaps that if a technologist had

      added qualifications, and were going to take on more responsibility in a type of
          12

      practice where the surgeons were running the show, that that would suffice, that
          13

      if there were some additional education for a technologist that was running this
            14

      practice in conjunction with the surgeon, that that would be an alternative?
          15

      Would you care to answer that?
         16

           17       DR. HENDRICK: Yes. The technologist is not running the

      practice.
          18

           19       DR. MONSEES: No, in conjunction. If that technologist had

      some additional -- I am not saying that this is what I suggest, I am asking you is
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             possibility.
      this a 1

            2        DR. HENDRICK: No, I think it is a model that doesn't work,

      because I think the medical responsibility lies with the physician, the supervision
           3

      responsibility lies with the physician, and to try to supplant that in the case where
           4

      the physician isn't really knowledgeable about all the things the tech does, or the
            5

      physicist does, is just complicating the issue, because they never have the
           6

      control or the power to exercise that responsibility even if you assign it to them.
            7

            8        DR. MONSEES: The reason I asked that is that at least in our

      community and what I have noticed is that there are some surgeons not of the
          9

      caliber of these surgeons in the audience today who do a large number of these
           10

      procedures, but that do the occasional case, and I think they rely heavily on a
          11

      technologist that is very facile with the equipment, to set it up, position the
          12

      patient, target the lesion, and do everything but shoot.
           13

           14        I think that we all know that this exists, and what I would like to

      know is do we think that that is satisfactory or not.
          15

           16        MR. MOBLEY: Maybe it is because this is my first meeting, but as

      I read this in preparing for the meeting, I did not see that there was any -- and it
           17

      is not intended to address that -- but I did not see that there were any basic
           18

      requirements there in terms of the technologist or the medical physicist. They
          19

      are just listed radiologic technologist.
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            1       In looking at it, I would think, well, maybe that is a technologist that

      is certified in mammography, maybe that is a medical physicist that meets certain
             2

      criteria, but that is not listed here or elucidated here or anywhere else that I am
             3

      aware4of. Now, maybe it is elsewhere.

            5       DR. MONSEES: You are correct.

            6       MR. MOBLEY: The question is do you just roll over the

      requirements for technologist from the basic mammography standard, or is there
            7

      something else that I am missing here?
          8

            9       MS. HEINLEIN: It is in the ACR. It is in this folder here, this one.

          10        DR. MONSEES: You are talking about the MQSA qualifications?

          11        MS. HEINLEIN: It's in the ACR stereo.

          12        DR. MONSEES: Oh, yes, for the voluntary accreditation program.

          13        MS. HEINLEIN: Right.

          14        MR. MOBLEY: Can I then assume that this is the basic that we

      are working from in reference to this?
          15

          16        DR. MONSEES: Well, the ACR accreditation program did not

      include the collaborative or the surgeon working alone, and therefore this other
           17

      document was drawn up for the physician component, but I think what they are
          18

      saying is that the technologist and the physicist qualifications would remain the
           19

      same regardless of what type of practice. Is that correct?
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            1        DR. DERSHAW: That is correct. First of all, let me say that what

      was distributed was the old application form, so you will get a new one tomorrow
           2

      morning, and those of you who are going to apply for certification for your
           3

      practices, don't use this form, but it is correct that this document, which is the
            4

      College of Surgeons and College of Radiology joint document, pertains only to
           5

      physician qualifications, the physician requirements, the requirements for
           6

      technologists, for medical physicists, for quality control, and for practice outcome
           7

      data are all included in the application document.
            8

            9        DR. MONSEES: Dr. Winchester.

           10        DR. WINCHESTER: Ed Hendrick, I had a question. You have

      had a lot of experience in teaching surgeons through the college courses, and I
          11

            other courses, you have interfaced with them on many occasions. How
      think12

      many hours do you think you need with surgeons to teach them what they need
         13

      to know to do this?
           14

           15        DR. HENDRICK: I have only taught the surgeons course once.

      Bob Pizzutiello, I think has taught it a number of other times. But in that course,
          16

            I
      I had17 believe it was either an hour or an hour and a half, and it was painfully

      deficient at that level.
           18

           19        I discussed with Dr. Dowlat much longer periods, but this was trying

            fit
      to be20 into a weekend course, and the physics got trimmed down to I think it
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      was an hour. Is that right, Bob?
           1

            2       MR. PIZZUTIELLO: About an hour.

            3       DR. HENDRICK: But I think that seeing what the questions were

      back and the issues, I think much more than an hour is needed, probably much
           4

           than five hours is needed to really get at -- if you wanted to get a surgeon
      more 5

      to the 6point of being the responsible physician in a breast biopsy practice, that is,

      responsible for the technologist and the medical physicist and the quality of the
           7

      images that are coming out of that equipment.
           8

            9       So, I don't have a number for you, but I do think four hours is

      deficient, and I just wanted to add one other thing, that I thought we were talking
           10

      about these basic requirements for technologists and physicists from this
          11

      document that is entitled, "Basic Requirements for ACR Stereotactic Breast
          12

      Biopsy Accreditation." Is that correct?
          13

           14       MR. PIZZUTIELLO: Yes.

           15       DR. HENDRICK: And that is not going to change, right?

           16       MR. PIZZUTIELLO: Correct.

           17       DR. HENDRICK: It is the application that is changed.

           18       DR. MONSEES: Dr. Dowlat, I am sorry. By this time I am seeing

      hands all over the place. Yes.
          19

           20       DR. DERSHAW: Dr. Hendrick, you have mentioned that you have
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            lots of lectures to radiologists. How did they perform? What was your
      given 1

      evaluation of their understanding of what is needed in order to do a stereotaxic
           2

      needle biopsy?
           3

            4       DR. HENDRICK: Well, unfortunately, they don't have to perform at

      all. They just have to stay there in the room. But we have tried in the context of
            5

      a number of educational efforts through the ACR to actually test what they get
           6

              the
      out of 7 QC components of the coursework like ACR viewbox symposium,

      things8like that, and the QC, I mean Ed Sickles and other people here can

      address this more, Larry Bassett, but we have tried to embed the QC types of
           9

      questions into viewing of images at the viewbox and assessment of image quality
          10

      and what do you do about -- what is the problem, do you find a problem, and
          11

           what do you about it if there is a problem.
      then 12

           13       So, it has been addressed. Not all radiologists test well on QC.

           14       DR. MONSEES: I will point out also that radiologists do take

      written boards on radiation biology and basic radiation physics, so we do have
           15

      some certain qualifications now. Of course, many of us were boarded before
         16

      stereotactic biopsy came in, so the specifics pertaining to that would be new, but
           17

      it is taught in training programs.
             18

           19       Now, I don't know whether or not the written board questions --

           anybody know whether the written board questions will pertain to this part
      does20
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      of physics, do you know, written board questions?
            1

            2       DR. HENDRICK: Some do.

            3       DR. MONSEES: Dr. Sickles?

            4       DR. SICKLES: I can answer your question about radiologists'

      performance. The American College of Radiology has developed a
            5

      self-assessment examination for radiologists, tests, image interpretation, and
            6

      embedded in this, as you have heard, are questions that relate to image quality
          7

      and image quality physics. They are purposely put in there.
           8

            9       Radiologists who take this test -- and there have been hundreds

      and hundreds of radiologists who have taken the test in various installations --
          10

      performed just as well, no better, no worse, on image quality and image quality
           11

      physics as they do in areas like detection of lesions and analysis of lesions. So,
          12

      there is no reason to believe that education of radiologists in physics is any better
           13

      or any worse than it is in regular education.
           14

           15       DR. DOWLAT: Dr. Sickles, I am trying to be constructive here,

            really want to learn, I want to take a message away as how to incorporate
      and I16

      that test or that instruction into the courses that we are giving in the future, so if
           17

      there is a lesson that I can learn or I can convey, please let me know.
           18

           19       DR. SICKLES: I could make a suggestion to you that that

      particular test is geared more to image interpretation, which is really not what the
           20
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      non-MQSA physician has to do. They have already been told there is a finding
           1

            that needs a biopsy. They need to know how to target it and how to
      there 2

      evaluate that it is an appropriate lesion to be targeted.
           3

            4       But what I would suggest that you do in planning your courses, if

      you are the one who is in charge of the course, is to direct the physicists who are
           5

      teaching to concentrate their lectures on what the non-MQSA physician needs to
           6

           about working with a physicist as opposed to all of medical physics that has
      know 7

      to do with mammography.
            8

            9       I think you should direct them to the areas where they have to

      perform as opposed to all areas where maybe i it is not so important they
           10

      perform.
           11

          12        DR. DOWLAT: Nevertheless, the area at the time when the

      surgeon and radiologist are doing the interventional procedure using this
          13

      stereotaxic, which these days is mostly digital, and the quality of the image is
           14

      good, is not adequate, at that time they should know what the problem is. I think
          15

      this is what Hendrick was alluding to earlier on.
            16

          17        DR. SICKLES: Exactly, and with digital systems, as well as with

      film systems, the quality is not guaranteed to be good, as you may know.
           18

          19        DR. DOWLAT: Correct.

          20        DR. SICKLES: At least at a minimum, whatever the background of
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      the physician performing a stereotactic biopsy, the image quality is not adequate
            1

      to proceed, they have to know, number one, it is not adequate to proceed, and
            2

      number two, what to do about it.
          3

            4       If what to do about it is simply not to do the procedure and call the

      physicist, that's fine, but they have to know that much, and I think the education
           5

      has to6be directed to that.

            7       DR. DOWLAT: I think that is the probably most important lesson

      that a 8surgeon can learn from medical physicist while doing this procedure,

      because if the machine breaks down and the lights go out, I mean anyone can
           9

      say that.
           10

           11       DR. MONSEES: We need to cover a few more things today. Is it

      going to be quick?
          12

           13       DR. ISRAEL: It has to do with the issue that we were just

      discussing. There is no way that Dr. Hendrick can teach me in probably any
           14

      amount of time to supervise a medical physicist. There is no way.
         15

           16       So, what I would suggest is that my situation, having a stereotactic

      unit in a facility where there are no radiologists, if we are talking about the
            17

      equipment, let's say that I and all surgeons who use equipment will have a
          18

      radiologist to work with the radiation physicist in making sure the equipment is
           19

           and
      safe 20 operative. I certainly will be willing to do that, and I think all other
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      surgeons would, I think -- and I shouldn't speak so fully -- but I think that those
           1

      surgeons who have equipment and there are no radiologists around, that we get
           2

      a radiologist to supervise the physicist.
            3

            4       DR. MONSEES: Shall we tell Dr. Winchester to forward those

      letters5and E-mails to you?

            6       DR. ISRAEL: I am not sure, but now, on the other hand -- you

      haven't heard the other hand yet -- on the other hand, those surgeons who are
           7

      working on a stereotactic unit that is in a radiology department or where there is
           8

      radiology support, that those surgeons not be required to take four hours of
            9

      radiation physics.
           10

           11       DR. MONSEES: They are not in the collaborative practice. This

      is only in the setting where they were solely --
           12

           13       DR. ISRAEL: I think we are talking about such a small number, so

           those surgeons that do the procedure independently, I think a lot of them
      even14

      are doing them on stereotactic units that are located in radiology departments or
           15

      where a radiologist is present. I think it is a very small number who represent
          16

      doctors like myself and Dr. Dowlat.
          17

           18       DR. MONSEES: Thank you.

           19       I think Mr. Pizzutiello wanted to make a comment and then I am

      going to ask you all about technologists and about physicists. Start thinking
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      about 1this because you need to answer quickly, are the qualifications outlined in

      the ACR voluntary accreditation program appropriate for technologist and
           2

      physicists, and before we get to that, did you want to ask a question?
           3

           4        MR. PIZZUTIELLO: I just wanted to comment on what I saw as a

      starting point for the physics portion for the surgeons, which was some basic
             5

      understandings of what radiation is and the issues of radiosensitivity of the breast
           6

      and radiation dose, and just the scratching the surface of the equipment.
           7

           8        I guess I don't want to give opinions, so I will just say that that is

      what I9have done. The plan is for that to be the beginning. It is in no way -- I

           to
      want10 make it clear that one hour of physics is in no way considered to be

      adequate, and more hours are planned.
          11

          12        DR. MONSEES: Let's turn to first technologist issues. Does

      anybody want to talk about this first? How about a technologist? Rita Heinlein.
          13

          14        MS. HEINLEIN: I think that what is here is fine, only I would add

      "include training in QC procedures related to stereotactic breast biopsy
           15

      procedures," because there is nothing, nowhere does it say that they have to
          16

           any
      have17 training in QC procedures, so I would add that.

          18        DR. MONSEES: Any other comments on the technologist? How

      much training?
         19

          20        MS. HEINLEIN: I wasn't going to touch how much, I mean
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      because I think many of them will have come with some understanding of basic
           1

      QC, and that is why I said just training in the QC procedures related to stereo as
           2

      opposed to putting a number to it, unless, Patricia, you feel that there should be
           3

      one. 4

           5          DR. MONSEES: Dr. Sickles.

           6          DR. SICKLES: I have a question for Rita. As with plain

      mammography in terms of QC, would you be comfortable with a lead QC
         7

      technologist during stereo and having the other technologist simply perform the
           8

      procedures, but having a lead technologist do the stereo QC?
           9

          10          MS. HEINLEIN: Yes, I would be very comfortable with that.

          11          DR. MONSEES: That would be very parallel to the current

      program.
          12

          13          MS. HEINLEIN: Yes, I think that would be good.

          14          DR. MONSEES: Did you have a comment? I am pointing to you,

      Dr. Hendrick.
           15

          16          DR. HENDRICK: I wanted to give an opportunity for Pat to

      comment.
         17

          18          DR. MONSEES: Speak up.

          19          MS. WILSON: I think that the qualifications for 12 per year is not

      enough in my opinion for a technologist to stay adequate. I would think 12 every
          20
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      six months.
           1

            2       DR. MONSEES: So double it is what you would think. We can

      ask you how you designed it and how you got the 12, but I think we will be going
           3

      around about.
           4

            5       Let's just hear opinions. Is there anybody else on this panel that

      has an opinion about whether or not it is too high or too low or appropriate?
           6

           anybody want to venture a comment?
      Does 7

            8       MS. HEINLEIN: I think we are back to the same position that we

      were in with the physician. I think one a month is not enough, however, you
           9

      know, you get back to the same situation, then, do you have just one or two
          10

      technologists doing it. I think you are back at the same situation that you had
          11

      with the physicians and how do you run your practice and maintain proficiency.
           12

          13        So, I mean I think you are dealing basically with the same situation.

          14        DR. MONSEES: Any other comments?

          15        DR. FINDER: I promised I wouldn't ask questions, but it is late in

      the day and I figured I have to get at least one in.
           16

          17        DR. MONSEES: Go for it.

          18        DR. FINDER: I would like some clarification on the initial

      qualification for the technologist where they took about five hands-on procedures
           19

      under the guidance of a qualified physician or technologist.
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            1       I am wondering under what conditions would a technologist not be

      under2the guidance of a qualified physician at least.

            3       DR. MONSEES: Dr. Dershaw, would you like to comment on that?

            4       DR. DERSHAW: We weren't sure, but we wanted to make sure

              was under these circumstances.
      that it 5

            6       DR. MONSEES: So you just want to stipulate that it had to be. I

      see. 7

            8       DR. SICKLES: Perhaps what they were referring to is if qualified

      meant MQSA qualified physician, but they were a non-MQSA physician. Maybe
          9

      that is what they were talking about.
            10

          11        DR. FINDER: Well, that is why we are here and that's what we

      could use the clarification on.
          12

          13        DR. DERSHAW: By "qualified," we meant someone who had been

      accredited by the program is what a qualified physician is.
          14

          15        DR. SICKLES: Stereo qualified.

          16        DR. DERSHAW: Stereo qualified. Not an application specialist.

          17        DR. MONSEES: Do you need any more clarification on that or are

      you okay? Dr. Hendrick.
          18

          19        DR. HENDRICK: I would just like to also ask the technologists

           if
      here 20 three hours of category A continuing education in stereotactic breast
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      biopsy is a sufficient initial qualification, and then three hours every three years is
           1

      sufficient continuing education for a qualified tech in this area.
             2

            3       DR. MONSEES: Can we hear from our technologist

      representatives on the panel?
           4

            5       MS. HEINLEIN: My first look was the 15 hours, and I was thinking

      no, I think 15 hours is more than sufficient, but I see that is just in mammography.
             6

      I don't7know that three hours -- three hours would be the didactic training in

      stereo breast biopsy.
            8

            9       DR. HENDRICK: It doesn't have to be didactic. It has to be

      category A, though.
          10

           11       MS. HEINLEIN: I see it as didactic and then the clinical part would

      be the five hands-on procedures.
           12

           13       DR. MONSEES: Okay.

           14       MS. HEINLEIN: I don't know, how did you come up with the

      number 3?
         15

           16       DR. DERSHAW: It parallels the physician.

           17       DR. MONSEES: Any other comments on that?

           18       DR. HOUN: Just for reference sake, I know while we were

      discussing the MQSA final regs for new modalities, we did put in training needed
           19

            to
      prior 20 new modalities, and that was eight hours that I think the committee had
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      discussion on.
           1

            2        DR. HENDRICK: I thought we said six.

            3        DR. MONSEES: For the technologist?

            4        DR. HOUN: I think six hours was related to continuing education

      in your new modality.
            5

            6        DR. MONSEES: That would be significantly higher than what is in

      the voluntary accreditation.
            7

            8        MR. MOBLEY: Under technologist there are two bullets that seem

      to be much the same. I am trying to understand exactly what the intent there is.
            9

      The third bullet says three hours of category A, continuing education, et cetera,
          10

      and then the last bullet says three hours of category A, continuing education
          11

      every three years after initial qualifications are met.
          12

           13        DR. MONSEES: That is a continuing requirement.

           14        MR. MOBLEY: That is an initial requirement. Okay. It just

      wasn't really clear that that is what that was. That is the initial requirement.
          15

      Okay. I just wondered was there supposed to be some other difference there,
         16

      but that first one is initial requirement.
           17

           18        DR. MONSEES: Last but not least, I would like to move on to -- in

      the last few minutes, and then we are going to break for the night -- the medical
           19

      physicist. I am sorry we are going to have to do this tonight.
          20
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            1         Did you want to comment on that Dr. Winchester?

            2         DR. WINCHESTER: I wasn't done with the physicians.

            3         DR. MONSEES: I am sorry. Well, we will be taking that up again

      tomorrow. Are you going to be here?
           4

            5         DR. WINCHESTER: Yes.

            6         DR. MONSEES: We will do that first thing in the morning.

            7         Can we move on to the physicist now, and then we will continue the

      discussion pertaining to personnel first thing in the morning and then we will
           8

           on
      move 9 to non-personnel issues.

           10         MS. HEINLEIN: Can I bring up one other thing about the

      technologist?
          11

           12         DR. MONSEES: Yes.

           13         MS. HEINLEIN: I just want to make sure I get clarification from Dr.

      Houn. It was eight hours for initial training in a new modality, right? Then,
         14

      perhaps it should be eight hours here then, too. This would be initial training in
          15

      stereo.
           16

           17         DR. HOUN: This is not an FDA program. You can recommend

      this to the voluntary folks, but I just wanted to give you --
            18

           19         MS. HEINLEIN: What I am wondering is are we bringing up any of

      this to make suggestions? I mean is this going to go under regulation?
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            1        DR. MONSEES: These are suggestions, so that if it decided that

      this will be regulated, that they would have a ballpark for the first draft if they
            2

            a
      wrote 3 draft for regulations. So, if you would like to suggest that three is not

      enough, they are listening. If it should come to this being regulated, they want to
           4

           what you have to say about it. It doesn't matter what the ACR says. It
      know 5

      doesn't matter what somebody else says, what do you think.
           6

            7        MS. HEINLEIN: Well, since this committee and the FDA has made

      a decision that for a new modality, it would be eight hours, then, I would suggest
           8

              becomes regulated that there be consistency and that that number turn into
      if this 9

            hours.
      eight10

           11        DR. MONSEES: The hour is late. I would like to know whether or

      not we should try and discuss the medical physicist today or should we attack
           12

      that the first thing in the morning?
           13

           14        May I see a show of hands who would like to adjourn now and

      attack that in the morning, and then go on to other personnel issues?
           15

           16        Okay. The physicists. Are you happy about talking about this in

      the morning or would you like to talk about this tonight? Let's do it. One more
          17

      notch on the belt.
          18

           19        Would you like to start using perhaps the document here as a

      starting point, comment on that, and make any suggestions that you would like to
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      add to it, any disagreements perhaps, how do you feel about it?
            1

            2       DR. HENDRICK: Like the discussion about technologists, I think

            does need to be --
      there 3

            4       DR. MONSEES: Did he write it? Did you write this?

            5       DR. HENDRICK: No. Well, I was involved in writing this.

            6       DR. FINDER: If we can get factual information, but we really can't

      get your opinion because we assume that you agreed with what you wrote.
            7

            8       DR. MONSEES: So, we won't ask you.

            9       DR. HENDRICK: This was written by committee. It certainly

      wasn't my dictation, but it will shorten if I don't say anything.
          10

           11       DR. MONSEES: Did you write this?

           12       MR. PIZZUTIELLO: Yes.

           13       DR. MONSEES: Do we have anybody here who didn't write this?

           sir.
      Yes, 14

           15       MR. MOBLEY: I just need some information and maybe Ed can

      respond or Ed or Bob. In the hearing discussions today, we heard the
          16

      discussions of the digital imaging, and I know that digital imaging has been
           17

      discussed for years as being the coming thing, but I don't think it has got there
           18

      except just in very certain areas, this one area in particular.
          19

           20       That is different than the normal kinds of imaging operations that
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      medical physicists usually see, and as I read this, I didn't see anything on here
           1

      that led me to believe that there was a lot of extra effort necessary and I heard
             2

      this morning that because of the differences in the digital imaging systems, there
            3

      is some extra effort and some extra understanding, and I have not heard a lot
            4

      addressing that in the other areas, the technologist, the physician, and somebody
           5

      needs6to be very cognizant of what these differences are and how this equipment

      needs7to perform and then how it needs to be modified to perform like it is

      supposed to once it is installed and put into operation.
           8

            9       Has that been addressed?

           10       DR. MONSEES: I think that is a very important point and, in fact,

           starting point it is probably most important for the physicist, so can you
      as a 11

      address that, please? Should we -- I know you wrote this -- but would you
          12

      reconsider and do you think that we should specify in here that there needs to be
          13

      some CME pertaining to digital?
         14

           15       DR. HENDRICK: In Bob's presentation, he mentioned that six or

      seven of what used to be 10, now are 11, QC tests for the medical physicist are
          16

      changed in stereotactic by the implementation, primarily the implementation of
          17

      digital and the small field of view that comes with digital.
           18

           19       So, I think initially there will be need for education specifically on

      the QC tests done by the medical physicist in order to be cognizant of all those
           20
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      changes and really know how to do the test correctly, and I don't think this gets at
           1

      that in2its present form.

            3       DR. MONSEES: As a matter of fact, Rita suggested the same

      thing for the technologist, so I think we can be specific, not only QC, but QC
            4

      related to digital technology, which should probably be put in there and the
            5

      wording perhaps should be considered at least to put in there.
           6

            7       How many hours do you think additional training would that take,

      would8you like to take that question pertaining to digital, additional hours?

            9       MR. PIZZUTIELLO: I guess I want to say, first, that when we

      came up with these qualifications, it was probably a year and a half before we
         10

      really coalesced what we felt the 11 tests needed to be, so this was written
           11

      before we knew exactly what the 11 tests are.
          12

           13       So, I would say that some training in digital and digital QC is

      important, and it is probably on the order of two to three hours to review, as I say,
          14

           minimum, two to three hours to review the actual performance of the digital
      as a 15

      QC test.
          16

           17       Does that seem reasonable, Ed?

           18       DR. HENDRICK: I would say at least three.

           19       MR. PIZZUTIELLO: I would be happy with three.

           20       DR. MONSEES: Any other comments from any other individuals
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      on this panel pertaining to the technologist or the physicist qualifications, initial
            1

      and ongoing?
           2

            3       MS. HEINLEIN: I just want to make sure I understand where we

      are now. We are adding that for both the technologist and the medical physicist,
           4

      that that would include training and QC procedures related to stereo and digital?
             5

            6       DR. MONSEES: Yes.

            7       MS. HEINLEIN: A minimum of three hours is what was discussed,

      and then as far as the technologist, if this becomes regulation to be consistent
            8

      with what is currently in the regulation as far as eight hours of continuing
            9

      education as part of the initial training, and then six hours as part of the
          10

      continuing education, and that would make it consistent with what is in the
           11

      regulation.
          12

           13       DR. MONSEES: I don't think those numbers are written in stone.

      Those were just the numbers that were thrown from this panel previously, talking
          14

      about new technologies, is that correct? Okay.
          15

           16       MS. HEINLEIN: Just to be consistent with whatever is written in

      stone.
          17

           18       DR. MONSEES: I don't think anybody is writing anything in stone

            now.
      right 19

           20       DR. HENDRICK: As far as stereotactic.
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            1        DR. MONSEES: Correct, as far as stereotactic, correct.

            2        Any other comments about physicist and the technologist

      qualifications? Yes.
             3

            4        MR. MOBLEY: I just want to be sure I understand exactly what it

      is that5we are suggesting here. The three-hour minimum you were talking

      about, Ed, was initial training for digital systems. What would be additional
           6

      training for the QC that is necessary for these digital systems?
             7

            8        DR. HENDRICK: I think when I was addressing that, it was three

            of
      hours9 initial training in QC of stereotactic, which would include the digital

      components, and we talk about what you do if it is a film screen system. So,
         10

      basically, an overall, at least three hours on QC of stereotactic without specifying
          11

      specifically digital or film.
          12

           13        DR. MONSEES: Yes, ma'am.

           14        MR. HAWKINS: Pat Hawkins. I just wanted to ask in regards to

      looking at qualifications for technologist and medical physicist, especially as it
           15

      relates to previous requirements that have been set by FDA. Have these
           16

      created access problems in rural areas?
          17

           18        DR. MONSEES: Funny you should ask.

           19        DR. HOUN: No, they have not in terms of the availability of

      technologists and a physicist. I think we have had a couple of studies done, one
          20
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      was a1subcommittee of this committee last year submitted a review on the

      qualified physicist and potential shortage areas under MQSA, and I think the one
             2

      area of the country that seemed vulnerable was Montana.
           3

            4       But in terms of technologists, we have not encountered a problem

      with that. I think initially when the new regulations on 10-1-94 came down, there
            5

      was a6lot of concern, but a lot of courses and teaching has come around and

      actually have proliferated to try to get the proper training that was required.
           7

            8       I don't know if Rita or Pat would like to comment on technologists,

      what they think about access.
            9

          10        MS. WILSON: We have found that we have, with the onset of

      MQSA, had much more access to technologist training. The BCCCP program
         11

      has provided many, many hours, workshops, weekends, and working with a local
          12

      AHECs, like some years our technologists will have 40 hours of training in
         13

      mammography. We think it has helped our program tremendously having these
         14

      regulations because people have recognized the fact that a good technologist
          15

           not
      does16 end at their training, that it is an ongoing process.

          17        DR. MONSEES: Plus the courses are more available obviously,

      because they are needed.
          18

          19        DR. HENDRICK: I think part of it is having this as a regulation has

      enabled technologists to get the time off and to get sometimes the support.
          20
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            they pay their own way, but to get at least the time off and the
      Often 1

      encouragement to get these hours that are required rather than the way it used
           2

      to be which was that they were discouraged from taking time away from the
            3

      practice to even get continuing education.
            4

           5        So it has recognized the need and it has encouraged the

      acquisition regardless of whether they are rural or urban.
           6

           7        DR. MONSEES: If there are no other additional comments on

      technologist or physicists, I think we are going to adjourn for the evening. We
           8

      will start up tomorrow morning at 8:00 a.m., and we will start revisiting personnel
             9

      issues until we have resolved that, and then we will move on to non-personnel
           10

      issues.
           11

          12        [Whereupon, at 5:45 p.m., the hearing was recessed, to reconvene

      at 8:00 a.m., Wednesday, October 29, 1997.]
           13




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