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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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C O N T E N T S
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 P R O C E E D I N G S
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 going to turn the mike over to our Executive
5
Secretary, Dr. Finder, who is going to address conflict of
6
interest.
7
8 DR. FINDER: First, I would like to welcome everybody
to the National Mammography Quality Assurance Advisory
9
Committee, and I would like to begin by reading the conflict
10
of interest statement.
11
12 The following announcement addresses conflict of
interest issues associated with this meeting and is made a part
13
of the record to preclude even the appearance of any
14
impropriety.
15
16 To determine if any conflict existed, the agency
reviewed the submitted agenda
17 and all financial interests
reported by the committee participants.
18 The conflict of
interest statutes prohibit special government employees from
19
participating in matters that could affect their or their
20
employer's financial interests, however, the agency has
21
determined that participation of certain consultants and
22
members, the need for whose services outweighs the potential
23
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conflict of interest involved, is in the best interests of the
1
government.
2 Full waivers are in effect for 13 out of 17
participants because of their financial involvement with
3
facilities that will be subject to FDA's regulations on
4
mammography quality standards, with accrediting, certifying,
5
or inspecting bodies or with the manufacturers of mammography
6
equipment since these organizations could be affected by the
7
committee's deliberations.
8
9 The participants include Dr. Tamsen Bassford, Ms.
Rita Heinlein, Ms. Maria Romero, Mr. Roland Fletcher, Dr. Peter
10
Dempsey, Dr. Ellen Mendelson, Dr. Laura Moore-Farrell, Dr.
11
Barbara Monsees, Dr. Edward Sickles, Mr. Michael Mobley, Ms.
12
Patricia Wilson, Ms. Patricia Hawkins, and Mr. Robert
13
Pizzutiello.
14
15 Copies of these waivers may be obtained from the
Agency's Freedom of Information Office, Room 12A-15 of the
16
Parklawn Building.
17
18 Since Mr. Robert Pizzutiello, Dr. David Winchester,
Edward Hendrick, and Dr. Lawrence Bassett participated in
Dr. 19
development of the ACR-ACS agreement on quality standards
the 20
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for stereotactic breast biopsy, we have limited their
1
participation in this matter to a presentation of details of
2
the agreement.
3 They can talk about the facts of the agreement
and how they were developed, but will refrain from giving their
4
opinions or voting on the agreement.
5
6 Out of abundance of caution, we have also limited Dr.
Edward Sickles, Dr. Lawrence Bassett, and Dr. Edward Hendrick's
7
participation in equipment standards because of their
8
involvement with mammography devices.
9 They are allowed to
discuss mammography technologies including digital devices, as
10
well as talk about their observations and experiences with these
11
products, however, they will refrain from voting on specific
12
equipment standards.
13
14 Although we don't anticipate any discussion of state
certifications at this meeting, we would like to note for the
15
record that when this issue is discussed, we will limit the
16
participation of Mr. Pizzutiello, Ms. Hawkins, Mr. Mobley, and
17
Moore-Farrell because each is affiliated with a state-run
Dr. 18
regulatory body.
19
20 Also, several of our members and consultants reported
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that 1they received compensation for lectures they have given
or will give on mammography-related topics, however, they have
2
affirmed that these lectures were offered to them because of
3
their expertise in the subject matter, and not because of their
4
membership on the committee.
5
6 In the event that the discussions involve any other
matters not already on the agenda, in which an FDA participant
7
has a financial interest, the participants should exclude
8
themselves from such involvement, and their exclusion will be
9
noted for the record.
10
11 We would also like to acknowledge that the Executive
Secretary, Dr. Charles Finder, is a member of the ACR.
12 We also
have a guest speaker, Dr. Rebecca Zuurbier from Georgetown
13
University Hospital in Washington, D.C.
14
15 With respect to all other participants, we ask in the
interest of fairness that all persons making statements or
16
presentations disclose any current or previous financial
17
involvement with accreditation bodies, states doing
18
mammography inspections under contract to FDA, certifying
19
bodies, mobile units, breast implant imaging, consumer
20
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complaints, and mammography equipment.
1
2 I would like to make an announcement for those who
have 3been anxiously awaiting the publication of the Mammography
Final Regulations.
4 I do believe that they were published today
and we will try and get copies of the document to the committee
5
as soon as possible.
6 We hope to get it to them before the end
of the meeting, but if not, we will certainly mail it to the
7
people.
8
9 DR. MONSEES: Thank you very much.
10 This is for the most part a new committee. There are
many new committee members and I am the new chair of this
11
committee, so what I ask is that people indulge me and let me
12
used to this new role while we are trying to keep the ball
get 13
rolling in the right direction.
14
15 This is, of course, not a free-for-all. We would
like to have an organized discussion of interventional
16
mammography over the next two days.
17 The questions which were
mailed to the panelists ahead of time, I hope you have considered
18
you are ready to speak on some of these issues.
and 19
20 Please speak your mind. If your opinion is not
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concordant with others on the panel, that's okay.
1 That is what
your 2job is, is to speak your mind here. So please ask to be
recognized even if you have a dissenting opinion.
3 We don't
expect, I don't believe we expect to find that we are going to
4
achieve consensus on this panel.
5
6 What we want to do is air all of the issues that are
important to this matter, so that consideration can be made as
7
to whether or not interventional mammography should be
8
regulated and how, if it is, it will benefit the practice of
9
medicine and our patients in the community.
10
11 I will ask those of you who would like to speak to
raise your hand.
12 Your mikes will be turned on by these
gentlemen over here when you are recognized.
13 Please briefly
state what you would like to, please don't go off on a tangent.
14
If so, I will be forced to ask you to go back on track.
15 We do
want to try to keep the agenda.
16
17 If you feel that you have a conflict of interest about
something that you are about to say, think again and ask for
18
advice from Dr. Finder, who we are all going to be asking for
19
advice for these matters, and he will point us in the right
20
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direction.
1
2 Likewise, when we have the public hearing, we had 10
people on the agenda, we now have nine people on the agenda.
3
When 4you come to the microphone, we want to hear if you have
a conflict of interest.
5 I want to know who you are, who you
represent.
6 If you did not pay your own way, I would like to
hear 7who did, so that we will know whether there is a conflict
of interest from those of you who are going to be speaking in
8
the audience.
9
10 We are going to be doing didactic sessions after the
public hearing this morning and then this afternoon the
11
committee really starts its discussion, although I am sure we
12
will find some time and I am sure we will find some way to
13
interject some questions of the public speakers and the people
14
are presenting during the course of the meeting.
who 15
16 Tomorrow, we will conclude the discussion of
interventional mammography.
17 We are to skew it, so that today
we talk primarily about stereotactic core biopsy and tomorrow
18
I think we will probably start talking about some of the other
19
interventional procedures.
20
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1 With that, I think we will go ahead and get started.
2 Alternative Standards Requests
3 DR. FINDER: Let me briefly go over - we have a
10-minute session here to talk about alternative standards.
4
For the new members on the committee, let me just go over a little
5
what 6I am talking about.
7 In the regulations, there is a section that allows
certain groups, including facilities, to apply for an
8
alternative standard to the standard regulations.
9 The
committee in the past has asked that they be updated on any
10
requests for alternative standards, and we have set aside this
11
time for that.
12
13 To make it brief, there were no requests for
alternative standards, so that is the end of that unless anybody
14
any questions about the alternative standard process.
has 15
16 Open Public Hearing
17 DR. MONSEES: Thank you all for being here and I think
we are going to be a very patient group.
18 We are going to respect
each other's comments and we are going to say what we need to
19
to
say 20 get this job done.
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1 We have nine speakers. Let me read to you the order
that 2we intend to hear people. Since we are starting early,
if somebody is not here, we will give an opportunity to those
3
who have come late.
4
5 We have Eleanor Sherman, Margaret Fay, Alan Kravitz,
Joseph Rush, Malee Shay, Philip Burns, Kambiz Dowlat, Philip
6
Israel, Armando Santelices, and Robert Caplan.
7
8 That is the order that we have. There are a few
changes from this list.
9
10 Is Eleanor Sherman here? Ten minutes, Ms. Sherman.
11 MS. SHERMAN: First, I am going to present for Dr.
Margaret Fay, who is unable to be here, and she asked me to
12
deliver it.
13
14 To the National Mammography Quality Assurance
Advisory Panel Members:
15 I regret that I cannot be present to
express my interest and concern regarding appropriate quality
16
standards and regulations for mammography facilities
17 In my
absence, I have asked Eleanor Sherman to read my statement into
18
record.
the 19
20 As a patient who recently underwent breast screening,
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ultrasound, and subsequent bilateral surgery for multiple
1
lesions, I would like to express my support for interventional
2
mammography standards and ask that this panel incorporate
3
specific infection control guidelines for mammography
4
equipment and practices.
5
6 Most women who enter a radiology procedure room to
have 7a routine mammogram or undergo an invasive diagnostic
procedure do not consider the possibility that contact with
8
equipment or interventional biopsy instruments may expose them
9
to infection through contamination of bloodborne contaminated
10
equipment.
11 For women with non-intact skin, damage dermatitis
from radiation therapy, postmastectomy wounds, or open wound
12
contamination during the course of biopsy, the risk is
13
substantial.
14
15 In May 1997, I was subjected to an elective mammogram,
which confirmed the presence of multiple masses in both breasts.
16
procedure was carried out at a highly respected
The 17
university-based women's health center.
18
19 After registration, I changed into a gown and was
escorted from the changing room to the mammography procedure
20
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room.
1 As I was entering the room, another woman was exiting.
I observed that no attempt was made to disinfect the mammography
2
unit, no handwashing facilities or sink were available in the
3
room.
4
5 No attempt was made by the mammography technologist
to disinfect the unit or wash her hands.
6 No antiseptic creams
or disinfectant agents by which the technologist could
7
disinfect her hands prior to touching me were noted in the room.
8
9 Further, the technologist did not wear gloves when
handling my breasts.
10 I have multiple cutaneous skin lesions
on my torso, arms, legs, and back from an autoimmune condition.
11
My non-intact skin places me at greater risk of infection from
12
contact exposure to contaminated surface than women with intact
13
skin do.
14 Yet, no steps were taken to ensure the equipment was
properly disinfected.
15 The risk of cross-contamination from
unwashed hands of the mammography technologist placed me
the 16
at risk.
17
18 Hippocrates relied on wine-soaked linen to protect
wounds.
19 The English surgeon Joseph Lister described and
introduced aseptic technique in the 1860s.
20 Today, adherence
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to principles of asepsis are accepted standards of practice and
1
a key factor in reducing the risk of nosocomial infection.
2
3 In a surgeon's office, when a needle biopsy is carried
out, 4aseptic practice is followed. The woman lies on a clean
table surface, equipment is sterilized, the biopsy site is
5
prepped with appropriate antimicrobial.
6 The physician dons
sterile gloves, and the pathology specimen is contained and
7
labeled by a nurse wearing exam gloves.
8 The same standard of
care 9is given in outpatient settings, urgent care facilities,
even nursing homes.
and 10
11 When an I.V. is started, a dressing changed, a
laceration sutured, or a liver transplanted, health
12
professionals carry out routine asepsis to protect the patient.
13
They adhere to principles of aseptic practice in an effort to
14
reduce the risk of cross-contamination and to ensure patient
15
safety.
16 However, if the needle biopsy is carried out in the
radiologist's office, or in a hospital radiology department,
17
most offices will not have autoclaves.
18 This is a double
standard.
19
20 I believe the same standard of care should be applied
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in mammography and radiology procedures as is applied in
1
hospital, surgical, and outpatient care centers.
2
3 I applaud the steps taken by the Center for Devices
and Radiological Health to date, however, I would urge this
4
committee to consider incorporating the following
5
recommendations into the 21 CFR MQSA regulations to ensure, so
6
far as possible, patient health and safety.
7
8 1. Principles of infection control should be
specified in the MQSA 21 CRF regulations for mammography, and
9
also, all radiological procedures.
10 A method of auditing
compliance should be also delineated in the regulation.
11
12 2. Routine handwashing should be carried out before
after patient contact.
and 13
14 3. Powder-free gloves should be worn by personnel
when touching patient's skin or tissue, when handling soiled
15
instruments, or touching potentially contaminated equipment.
16
Contamination may be caused by spontaneous nipple discharge
17
during patient breast compression, causing contamination of the
18
bucky and compression paddles with potential bloodborne
19
pathogens.
20
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1 Literature shows that direct touch contamination or
aerosolized powder particulate may be the cause of artifacts
2
on x-ray films, possibly leading to diagnostic errors and/or
3
misdiagnosis.
4
5 4. All patient contact surfaces should be
thoroughly cleaned with a high level disinfectant immediately
6
after use before the next patient is brought into the room.
7 If
equipment cannot be safely disinfected due to construction and
8
design of the equipment time constraints, some form of
9
nonattenuating FDA-approved barrier drape should be employed
10
to prevent direct contact between the contaminated equipment
11
the patient.
and 12
13 5. During interventional procedures in which blood
or body fluid exposure is anticipated, the same aseptic
14
practices and infection control standards employed in other
15
clinical units, such as OR, ER, labor and delivery, the cardiac
16
cath lab should be adhered to in mammography and all radiology
17
procedure rooms.
18
19 6. The material used in cleaning equipment should
be regarded as clinical waste and should be disposed of
20
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accordingly.
1
2 7. I would like to thank this committee for its
ongoing interest and for concern for the well-being of women
3
undergoing diagnostic interventional and stereotactic
4
procedures.
5
6 Sincerely, Margaret F. Fay, R.N., Ph.D.
7 DR. MONSEES: Thank you. if there are panel members
that 8have a question, do you feel that you can field those?
9 MS. SHERMAN: I think I can. Dr. Fay also wrote an
additional letter, which is on the table.
10 She specified much
more deeply the kinds of infections that the patient would be
11
exposed.
12
13 DR. MONSEES: Does anybody on the panel have a
question for the person who is not here, perhaps Ms. Sherman
14
help to answer that question?
can 15
16 Yes, Dr. Hendrick.
17 DR. HENDRICK: It is Margaret Fay, is that right?
18 MS. SHERMAN: Yes.
19 DR. HENDRICK: Is she claiming to have contracted an
infection?
20
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1 MS. SHERMAN: You asked me that a couple of years ago.
You wanted to know if another registered nurse, who was
2
contaminated, actually contracted --
3
4 DR. HENDRICK: That was a different case.
5 MS. SHERMAN: I know, but you wanted to see a body.
I mean you told me you wanted to see a body.
6 She just had this.
I mean this was a very early procedure.
7 I don't know whether
she contracted a disease, and I really don't think it really
8
matters whether she did because there are 2 million cases of
9
contracted infections done in a hospital that we don't know
10
where it is contracted from.
11
12 I don't think we have to see a woman dead in a coffin
before we do anything.
13
14 DR. HENDRICK: But her implication is that she felt
-- I mean she makes statements about the technologist not
15
washing her hands.
16
17 MS. SHERMAN: This is standard procedure. This is
from the CDC.
18 I mean this is not new stuff.
19 DR. HENDRICK: I am asking about the specific case.
There is always the implication that something happened in the
20
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letters or the people that you bring forward, but there is no
1
evidence that something happened here.
2
3 MS. SHERMAN: She is still alive, thank God.
4 DR. HENDRICK: Well, good.
5 MS. SHERMAN: I mean I think it is a ridiculous
question and I really find it offensive that you want to see
6
a body before we start cleaning.
7
8 DR. HENDRICK: I don't want to see a body. I want
to know the full story about what happened.
9
10 MS. SHERMAN: I can just report that she was exposed
to contaminated equipment.
11
12 DR. MONSEES: All right. I have a question also, if
don't mind.
you 13
14 This lady has an unusual circumstance in that she had
skin lesions, most women don't.
15 Did she express her concern
to the technologist when she entered the room, so that the
16
technologist could take certain precautions?
17 Did she give that
opportunity to the technologist?
18
19 MS. SHERMAN: I was not in the room, but I could tell
that Margaret Fay was scared to death.
you 20 She was facing major
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reconstruction surgery, and she was the patient, not the health
1
care 2worker, and she -- this letter that I just read into
testimony spoke as the patient.
3
4 DR. MONSEES: Okay. Let's move on to you speaking
as Eleanor Sherman.
5
6 MS. SHERMAN: My name is Eleanor Sherman.
7 DR. MONSEES: Would you reset the clock, please.
8 MS. SHERMAN: And by the way, Margaret Fay has no
reason to make any money on this or is not affiliated with
9
anybody that is making -- so, there is no conflict of interest
10
that I know of anyway.
11
12 DR. MONSEES: How about yourself?
13 MS. SHERMAN: My name is Eleanor Sherman. I am the
president of Technowipe, Incorporated, which has nothing to do
14
really -- my voice is gone.
15
16 DR. MONSEES: Can you help us out with the mike? She
is having a hard time speaking up.
17
18 MS. SHERMAN: I manufacture lint-free wipes to clean
cassettes.
19 Back in 1991, I was an x-ray technologist, a
mammographer, and I became very concerned about the possibility
20
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of disease transmission, and since then I have become an
1
inventor and hold a patent on a disposable protective barrier
2
for the bucky and compression paddle.
3 I have not made a dime
on it, so there is no economic, and I am not licensed.
4
5 I will go on. I would like to take this opportunity
to thank the National Mammography Quality Assurance Advisory
6
Panel for the opportunity to share my concerns.
7 I am requesting
specific protocols and education for infection control
8
procedures be incorporated into the MQSA regulations, as well
9
as an audit system to assure compliance.
10
11 I would like to commend this panel for their continued
dedication and commitment to developing mammography quality
12
standards that will better assure early detection of breast
13
cancer.
14
15 I would also like to thank you for acknowledging the
potential risk of cross-contamination of bloodborne pathogens
16
by incorporating the need for infection control procedures
17
specified on page 14920 of 21 CFR Part 900, dated April 3, 1996,
18
in the Federal Register.
19
20 Again addressing your concerns about the need for
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infection control procedures for mammography equipment as
1
published in the winter 1997 issue of Mammography Matters,
2
Volume 4, Issue 1, stating that the FDA expects the device
3
manufacturers to provide adequate cleaning and disinfecting
4
instructions or for providing the use of barrier devices as
5
preventive measures based on well-established infection
6
control procedures outlined in the Center for Disease Control
7
and Prevention Guidance documents on infection control
8
practices.
9
10 The winter issue of Mammography Matter alerts all
mammography facilities and their personnel they should be aware
11
and follow the cleaning and disinfecting procedures
of, 12
recommended by each manufacturer for its own devices.
13 This
wish for proper disinfecting cannot be accomplished chemically
14
the device manufacturers have not made barriers available
and 15
use for their specific mammography equipment, not have the
for 16
device manufacturers provided appropriate disinfecting
17
instructions for bloodborne contaminated equipment that makes
18
practical sense.
any 19
20 I have brought today and disseminated to the panel
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members and left some issues on the table outside the most recent
1
issue of Clinical Focus, Volume 4, 1997, published in the United
2
Kingdom by Green Moon Healthcare.
3
4 Page 8 of this article has a peer review called,
"Breast Screening, Life-Saving or Life Threatening."
5
Reviewing an article that I co-authored with Margaret Fay back
6
in July of 1996, before Peggy's five masses were found, and
7
published in advance for science professions.
8 The article was
titled, "MQSA, do Proposed Rules Fully Address Infection
9
Control?"
10
11 Clinical Focus highlights the following: Screening
mammography equipment is a source of carrying out significant
12
risk of cross-contamination between patients caused by nipple
13
discharge during the compression of the breast.
14 It validated
that shaving under arms, eczema, Paget's disease are likely to
15
result in deposits of blood-stained, serous fluid on the
16
mammography equipment.
17
18 Certain pathogens, such as hepatitis or resistant
bacterial strains, can survive in dried secretion for prolonged
19
periods.
20 The implications are clear, the article cites,
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mammography equipment must not merely look clinically clean,
1
it must be clinically clean.
2
3 Clinical Focus peer reviewers go on to say that
although MQSA guidelines appear simple, in fact, they are
4
difficult to interpret.
5 The article lists the potential risks
associated with a recommended high level chemical
6
disinfectants, such as damaging equipment, risking the health
7
of the mammographer, and the serious problems of high level
8
disinfectants pose to the patient.
9
10 It was apparent to the reviewers that high level
disinfecting, which requires soaking for 45 minutes and rinsing
11
with sterile water, is not possible.
12 The reviewers recommend
optimum infection control the use of protective radiolucent
for 13
sleeves over the equipment for use, and concludes the mammogram
14
is of particular interest because it readily becomes part of
15
well woman practice.
the 16
17 The article also brings to light a very important
issue that is unique to mammography x-ray equipment.
18 They
comment that most women will have at least one mammogram during
19
their adult lives in which healthy people mix potentially on
20
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a very intimate level with ill people.
1 Professionals must
therefore ensure that the mammography center does not become
2
a source of nosocomial colonization.
3 How many medical devices
can you think of that are actually shared by healthy population
4
and ill people alike?
5 The answer is not many. Women should
not have to share body fluids of others to have a mammogram to
6
detect saving their lives from breast cancer and be forced to
7
risk 8contracting a bacteria or virus during this exam.
9 There are over 2 million nosocomial infections
occurring in the United States annually.
10 We know that many of
these infections are caused by health care workers not following
11
aseptic technique, not washing their hands, and studies have
12
been conducted how many are caused by lack of cleanliness
not 13
disinfecting of medical devices.
and 14
15 Sinks and washing facilities are not placed in most
x-ray rooms.
16 Technologists do not wash their hands between
patients and gloves are not worn.
17 Consideration of the powder
that may be incorporated in those gloves is not given.
18 X-ray
technologists touch body fluids, sick patients, contaminating
19
equipment.
20
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1 Technologists pass these pathogens by touch by
cross-contaminating the control panel knobs and buttons that
2
are shared by many technologists through the course of the
3
working day without ever cleaning these surfaces.
4
5 Instructions for proper disinfecting, sanitation,
and hygiene are never given to technologists in their training,
6
and unique consideration due to the procedures we do should be
7
given.
8
9 For instance, Clinical Focus recommends the use of
disposable gloves, but if the gloves are selected that have
10
powder, this powder will create havoc for proper film reading
11
because of the artifacts the powder will create.
12
13 I have just read Peggy Fay's recent experience as a
patients since co-authoring our article 16 months ago.
14 Peggy
an
has 15 autoimmune disease that causes her lesions on her body.
Peggy Fay could not have a safe mammogram because there was no
16
manufacturer of any mammography equipment that made an
17
FDA-approved barrier to protect the equipment from potential
18
cross-contamination coming between Peggy and potentially
19
contaminated equipment surfaces.
20
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1 High level disinfecting was not possible for her.
What 2was Peggy's choice? Peggy was forced to risk having a
mammogram, which found five masses at the expense of exposing
3
her non-intact skin to potentially dangerous pathogens.
4
5 Patients receiving radiation therapy are also forced
to make the same choice after receiving radiation therapy,
6
having compromised skin from the radiation treatment, and
7
others face the same risk from other disorders.
8
9 The difference is that the other patients are not
informed and not told of their risk.
10 This is wrong, this is
medicine, and this must be changed.
bad 11 This panel has the
power to make that change.
12 Your panel is meeting today to start
to develop guidelines for interventional procedures performed
13
during mammography, such as stereotactic needle biopsies.
14
These procedures draw blood and that blood will ooze onto the
15
equipment surfaces, contaminating the bucky and compression
16
paddles.
17 Only high level disinfecting or sterilization or the
approved infection control procedures to follow.
18
Technologists and physicians cannot offer only an impression
19
of hygiene, but must offer appropriate disinfecting or barriers
20
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to protect the patients.
1
2 DR. MONSEES: Ms. Sherman, please sum up. We have
one minute left.
3
4 MS. SHERMAN: Clinical Focus confirms high level
chemical disinfecting is not possible.
5 There is no reason why
a woman should have to share contaminated equipment that may
6
appear to be visibly clean, but that is actually contaminated
7
with 8bloodborne viruses or perhaps even antibiotic-resistant
bacteria.
9
10 I am therefore requesting this panel to incorporate
in the protocol for their inspection in order to assure that
11
medical device manufacturers have provided the facilities
the 12
with instructions for low, intermediate, and high level
13
disinfecting in accordance with the Center for Disease Control.
14
15 If barriers are available, that the amount of
barriers ordered match the patient load to assure that these
16
barriers are used and not reused.
17 The device manufacturers
have not taken the lead, and have ignored the potential risk
18
posed by contaminated equipment.
19
20 I believe that only through assuring that infection
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control guidelines published in MQA will be implemented and no
1
longer ignored is to have MQSA inspectors ordered for infection
2
control protocols during the facilities.
3 Technologists must
be better informed through education and standards developed
4
that 5meet their unique specifications. Proper education will
save 6lives, reduce infections, and reduce ultimate costs for
health care.
7
8 I urge this committee to incorporate specific
infection control procedures in the MQSA guidelines along with
9
auditing them to assure safer and better mammography and biopsy
10
exams.
11
12 Thank you.
13 DR. MONSEES: Do we have any questions or comments
from panel members?
14
15 MS. SHERMAN: I would like to make one more comment.
said most women do not have autoimmune disease or skin
You 16
lesions.
17 That is not true. Many women, particularly
large-breasted women, will have dermatitis.
18 Other women will
have scratch marks, bite marks, and there are many diseases that
19
do have irritation, bra irritation. So, women are exposed.
20
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Women shave under their arms.
1
2 DR. MONSEES: Thank you for your comments.
3 We will move on to the next speaker, please. Dr. Alan
Kravitz.
4 Is he in the audience?
5 DR. KRAVITZ: Yes.
6 My name is Dr. Alan Kravitz and I am a general surgeon
from 7Rockville, Maryland.
8 First of all, I would like to thank the committee for
allowing me to speak before it.
9 I have never testified before
a government committee before, and I hope you will find my
10
thoughts appropriate and helpful.
11
12 I am Chief of Surgery at Shady Grove Adventist
Hospital in Rockville, Maryland.
13 Almost three years ago,
minimally invasive breast surgery became a reality.
14 My fellow
surgeons in Montgomery County were concerned that none of our
15
local hospitals had the capability to perform stereotactic
16
breast biopsies.
17
18 We organized into a corporation and purchased a Lorad
machine, so that we could offer our patients the most up-to-date
19
minimally invasive capabilities to evaluate mammographic
and 20
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abnormalities.
1 We have done over 800 biopsies, which is more
any other facility in our area.
than 2 Still, not all of the local
hospitals have acquired a stereotactic machine.
3
4 I am very proud to say that almost all of the general
surgeons in our county are performing stereotactic biopsies,
5
and the number of open, wire localization biopsies performed
6
is much less than it had been.
7
8 I come to you today to share my concerns about
possible federal regulation of physicians performing these
9
biopsies and the adverse and unforeseen consequences that ma
10
await us.
11
12 It is important to realize the processes by which
surgeon learn new techniques.
13 It has been said that surgeons
do not learn only operations in their residency, but they also
14
learn how to operate.
15 The most recent example of a new
operation in my specialty was the laparoscopic cholecystectomy,
16
which was a radically new and less invasive method of removing
17
a diseased gallbladder.
18 I am sure that there are members of
this audience and perhaps some on the committee who have had
19
this operation.
20 It was a dramatic departure from conventional
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open 1surgery. Although we surgeons had removed many
gallbladders, very few of us had done much laparoscopy.
2
Surgeons generally taught each other this new operation.
3 It
was a very tricky operation at first and the early ones lasted
4
three hours with two to three surgeons on each case.
5 Now, of
course, most of us can do it in 45 minutes with two nurses as
6
assistants.
7 With 12 months, the surgeons in the United States
radically changed their treatment of gallbladder disease to
8
minimally invasive technique without the Federal Government
9
helping their credentialing.
10
11 This was done by hospitals, as is all credentialing.
In fact, new operations and surgical techniques are
12
continuously learned by surgeons in all specialties without a
13
hint of federal regulation.
14 The surgeons are bound by their
duty to provide safe care for their patients and by the need
15
to avoid substandard care which might leave them exposed to
16
malpractice suits.
17
18 Credentialing for these new procedures is done b
hospitals and surgery centers.
19 Indeed, these facilities are
required to perform the credentialing in order to obtain their
20
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certification.
1
2 The stereotactic breast biopsy was no different than
any of these other new surgical techniques.
3 For years,
surgeons have needed to be familiar with using the
4
two-dimensional mammogram to guide a three-dimensional
5
surgical biopsy.
6 The wire localization procedure that the
stereotactic biopsy is replacing required the surgeon to be able
7
to do this.
8 Performing a stereotactic breast biopsy is just
an extension of this skill.
9
10 It should also be noted that looking a mammograms is
part of the daily work of most breast surgeons, although I know
11
of no surgeons who interpret mammograms independently of a
12
radiologist.
13 In fact, it is the radiologists who trigger most
of the referrals we see.
14
15 Although the Mammography Quality Standards Act has
done a great job of standardizing the mammographic equipment,
16
there is still great variability in the interpretations by the
17
radiologists.
18 Some of our radiologists seem more likely than
others to label a mammogram as "indeterminate."
19 These
mammograms also usually include the recommendation that,
20
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"surgical consultation is advised."
1
2 This means that it is often up to the surgeon to decide
which patients need immediate biopsy and which can be followed
3
with 4another mammogram. Fortunately, surgeons have also been
trained to perform breast examinations, and so we generally feel
5
comfortable following these patients in our offices.
6
7 Most of the surgeons are very selective when
referring patients for any type of biopsy, in fact, at our
8
stereotactic facility, 23 percent of all biopsies were either
9
malignant or atypical.
10
11 But I am very concerned that the approaching hoof
beats of the federal cavalry may disrupt this established system
12
of breast screening.
13 It would be counterproductive to make it
difficult for general surgeons to perform minimally invasive
14
biopsy surgery.
15 We should be encouraging surgeons to do this
procedure.
16 It should be public policy to steer women to have
stereotactic biopsies performed as opposed to an open
17
procedure.
18
19 Logically, a surgeon who is not allowed to perform
stereotactic biopsies will be more likely to recommend that a
20
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patient get a wire localization biopsy -- which, by the way,
1
pays 2much better than the stereotactic procedure.
3 Just we are all trying to minimize the number of
mastectomies performed, imagine, if you will, what would happen
4
if the Federal Government in its infinite wisdom began limiting
5
the number of surgeons who are permitted to perform
6
lumpectomies.
7 Those surgeons who are not allowed to do
lumpectomies would then do more mastectomies.
8
9 Confusing and difficult to enforce federal
regulations could make it hard for some patients to have access
10
to this new technique.
11 It would also not make that much sense
the Federal Government to begin credentialing this
for 12
minimally invasive technique, when similar credentialing would
13
be
not 14 done for more difficult and dangerous operations, such
as mastectomies and wire localization techniques.
15
16 The other dark cloud that I see on the horizon is the
American College of Radiology, which I suspect would like
17
nothing better than to force women to have the procedures
18
performed only by radiologists.
19 In my county, most of the
radiologists have never even done one, and many of them have
20
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never even seen one, and it would not be in the public interest
1
to funnel patients in their direction.
2
3 I also review claims for the Cigna Health Plan in the
Baltimore-Washington area, and I can assure this committee that
4
surgeons all over the area are doing these stereotactic
5
procedures.
6
7 The other problem with having only radiologists
perform these procedures is that it will certainly increase the
8
number of unnecessary biopsies that are being done, and many
9
patients with so-called indeterminate mammograms will get
10
referred by the mammogram facility to a stereotactic machine
11
conveniently located at the same location.
12
13 This happens frequently with breast ultrasound, and
I have seen many patients get talked into an unwanted and
14
unnecessary breast ultrasound by an overly cautious
15
radiologist.
16
17 I know that this committee is aware of cases where
patients have received apparently substandard care with regard
18
to stereotactic breast biopsies.
19 Unfortunately, suboptimal
outcomes can occur with any surgical procedure including wire
20
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localization biopsy, lumpectomy, and mastectomy.
1 Even the
safest surgical procedure in the most capable of hands has the
2
potential to turn into a bad outcome.
3 With this new procedure,
dissatisfied patients have been few and far between.
4
5 Mechanisms dealing with substandard medical care are
already in place at the state level.
6 In Maryland, for example,
the Board of Physician Quality Assurance deals with all patient
7
complaints regarding inappropriate care.
8 Credentialing, as I
have 9mentioned, is already done at the hospitals and the
facilities.
10 It is unnecessary to add a duplicate layer of
federal regulation and bureaucracy.
11
12 In the hands of the community surgeons, stereotactic
breast biopsy has been very safe in our experience and in our
13
practice there have been no missed cancers.
14 The physicians are
moving over to minimally invasive breast surgery without any
15
help from the Federal Government, and we would like to continue
16
doing so.
17
18 We appreciate the need to make sure that the equipment
is safe and accurate and that the technicians are well trained.
19
I hope that the Food and Drug Administration will not take the
20
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plunge into credentialing physicians for a surgical procedure.
1
It is a task that they have had no experience with and one which
2
will 3not be the best interests of our patients.
4 Thank you very much.
5 DR. MONSEES: Thank you for your comments.
6 Do we have any questions or comments from the panel?
Yes. 7
8 MR. MOBLEY: You noted in your comments that -- and
I might not express this exactly as you did -- but you noted
9
that a number or referrals are made by radiologists to surgeons
10
because of the radiologist not clearly being able to see one
11
or
way 12 the other, make a determination.
13 Of those referrals, how many does the surgeon make
clear determination not to do surgery, not to do further
the 14
followup or whatever just from evaluating the patient's film
15
or whatever?
16
17 DR. KRAVITZ: In this area -- let me explain a little
how the patient flow works -- in this area, this is very
bit 18
heavily into managed care, so patients generally don't see
19
anybody without a referral.
20 The general sequence of events is
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that 1the patient has a mammogram, and sometimes that mammogram
will 2be interpreted as indeterminate with the proviso that a
surgical consultation is advised.
3
4 That report goes back to the primary care physician.
The primary care physician is then looking at this report, and
5
they 6don't want to deal with it. They don't know what to do
with 7it. So, that patient then always gets referred to a
surgeon -- I mean almost always.
8
9 The referral doesn't actually come from the
radiologist, they are not allowed to make referrals, but it is
10
what is written in the report that triggers the referral to the
11
surgeon.
12 The surgeon then is left with looking at this patient
wondering, you know, should we do a biopsy or can we watch
and 13
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
16
observed.
17 We know that mammography for women in their 30s is
that accurate and that often just observation and followup
not 18
mammogram is safe in six months, but that decision is made by
19
surgeons, because we are the ones who see the patient with
the 20
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the mammogram, and we are the ones who have to make that
1
decision.
2
3 MR. MOBLEY: I understand that. I am just trying to
get a handle on exactly where the decision is made regarding
4
the followup, and you are saying it is made with the surgeon.
5
6 DR. KRAVITZ: Yes, it is.
7 MR. MOBLEY: Can you then give me an idea of how many
patients would not have surgery at that point in time?
8
9 DR. KRAVITZ: I don't really know. I have never
tabulated in our practice which percentage of patients with
10
indeterminate mammograms end up getting a biopsy.
11 I am
guessing it is about -- it might be about half.
12
13 MR. MOBLEY: Thank you.
14 DR. MONSEES: Any other questions or comments from
panelists?
the 15 Yes.
16 DR. HENDRICK: I think I understood from your
comments that you are concerned about the Federal Government
17
regulating credentialing of physicians doing this procedure.
18
Do you also have concerns about credentialing of others involved
19
in the procedure, say, technologists, medical physicists?
20
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1 DR. KRAVITZ: No, I do not.
2 DR. HENDRICK: Or equipment standards being
propagated by the FDA?
3
4 DR. KRAVITZ: No. In fact, we are very happy with
that.
5 We have been very -- surgeons, as a group, have been very
happy with the standardization of the mammograms.
6 We, as a
specialty, used to struggle with substandard mammograms, and
7
now the mammograms, the films generally have been of good
8
quality, and we appreciate that.
9
10 DR. HENDRICK: Thank you.
11 DR. MONSEES: Thank you for your comments.
12 DR. KRAVITZ: Thank you very much.
13 DR. MONSEES: We will move on to the next speaker.
14 Dr. Joseph Rush. Is he in the audience?
15 [No response.]
16 DR. MONSEES: We will move then to the next speaker.
Malee Shay.
17
18 Please state who you are and who you represent.
19 MS. SHAY: My name is Malee Shay. I am a patient,
a concerned patient, and I am speaking on my own behalf and on
20
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the behalf of other women that perhaps experienced what I
1
experienced.
2
3 DR. MONSEES: Can you speak into the microphone and
let me remind you, Ms. Shay, that you have 10 minutes.
4
5 MS. SHAY: Yes. I paid my own way this year and last
year.
6 Okay. I reside in Seattle, Washington. One year ago
I spoke before this committee as a concerned patient regarding
7
my experience in undergoing a stereotactic breast biopsy in
8
1993.
9 I do not intend to repeat my statements of 1996 today,
as a copy of my prior comments have been enclosed in the
10
notebooks I have provided to you.
11 I have also provided
newspaper articles and discovery exhibits.
12
13 Since I am advised that presently two-thirds of the
committee is new, I believe a brief description of my experience
14
is in order.
15
16 In the fall of 1993, I was advised following a routine
mammogram that I had suspicious findings and following
17
magnified view, that I needed an immediate biopsy of my left
18
breast.
19
20 I was never shown the films, given a copy of the
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report, or advised in any way by the radiologist of the nature
1
of the findings other than to be told that they were suspicious
2
for cancer.
3
4 I was caused to believe that the situation was urgent,
although I later found that the written report described the
5
findings as only mildly suspicious.
6 My primary care provider
was a nurse practitioner who relied solely on the recommendation
7
of this radiologist, who was a so-called expert in stereotactic
8
core 9biopsies.
10 On the day of my magnified views, I was told by several
members of the staff that the radiologist would meed with me
11
regarding her findings and the upcoming biopsy procedure,
12
however, she chose to leave the clinic while I was waiting for
13
meeting in the lobby.
our 14 No meeting ever occurred.
15 I am typically a very conscientious and informed
consumer.
16 I was terrified. The staff reassured me that I was
in the hands of an expert and lucky to be in their clinic.
17 I
agreed to the biopsy virtually without question.
18
19 In the radiologist's own words to my subsequent
doctor, the procedure was a disaster.
20 In brief, I was not
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properly anesthetized and experienced excruciating pain with
1
the taking of each of the 10 samples.
2 There were two physicians
in the room, the radiologist who presumably had read my films,
3
and one who was never introduced to me, nor identified in my
4
medical records.
5
6 These physicians engaged in a continued argument
throughout the procedure as to how it ought to be performed.
7
Immediately after the first five samples were taken, I was told
8
they 9were all useless. Another five samples were then taken.
10 The unidentified doctor did not return for the second
attempt.
11 No vital signs were taken even though the procedure
took over two hours and I was administered Valium throughout
12
entire procedure.
the 13 I was black from bruising on my entire
left side completely down my rib cage.
14
15 Following the procedure, as a result of expressing
numerous concerns to my nurse practitioner, I was referred to
16
a highly regard breast surgeon who remains my current physician.
17
radiologist clinic at which my biopsy had been performed
The 18
refused to release my records, thus obstructing my medical care
19
requiring me to retain an attorney to secure my records.
and 20
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1 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
2
by a 3second radiologist resulted in a clear diagnosis of milk
of calcium.
4 To add insult to injury, one year later when my
mammograms were compared to the previous views, it was
5
discovered that the radiologist who performed my biopsy had
6
missed a clearly visible mass in my right breast, which
7
thankfully turned out to be benign.
8
9 I later raised questions concerning the lack of a bill
from the radiology clinic, and was cheerfully advised there
10
would be no bill because the procedure was considered
11
experimental.
12 The clinic said the first hundred patients would
be
not 13 billed, only the insurance carriers would pay, and pay
they did as the clinic triple-billed my insurance company, who
14
later requested a partial refund.
15
16 In answer to my complaint that I was subjected to an
experimental procedure without my consent, the clinic started
17
also billing me and continued to do so on a monthly basis until
18
state medical board started their formal investigation.
our 19
20 My efforts to work with our state Quality Assurance
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Commission were both frustrating and useless.
1 State medical
boards cannot be relied upon to initiate or enforce regulations.
2
Although I submitted a 350-page complaint with detailed
3
documentation, in the end, which was 26 months later, they did
4
not even address the refusal of the clinic to release my records,
5
which was a clear violation of our State Health Care Information
6
Act. 7
8 I also submitted my documentation to the American
College of Radiology, the King County Medical Society, and the
9
FDA. My present doctor, who is considered an expert in breast
10
disease, also wrote to your state board indicating that my
11
biopsy was predicated upon the acquisition of a new piece of
12
equipment rather than medical necessity.
13
14 In an effort to obtain full information about the
reasons behind my unfortunate experience with this procedure,
15
in
and 16 an effort to find some accountability for what had
occurred, I reluctantly commenced litigation against the clinic
17
the radiologist in 1996.
and 18
19 That litigation has recently been resolved and
although I cannot discuss the terms of the agreement, I want
20
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this 1committee to know that my primary motivation in resolving
the litigation was that I consider the work of this committee
2
and consumer awareness to be a much greater issue.
3
4 I would like to share with the committee some of the
disturbing facts which were confirmed through our investigation
5
and the discovery process.
6 Some issues don't pertain directly
to the stereotactic procedure, but show what a consumer might
7
face 8going through the process.
9 The radiologist who performed my procedure was and
well-educated, highly-credentialed physician, who appears
is a10
to have been well trained in breast imaging.
11 She came to
Washington State and became employed at the clinic where my
12
procedure was performed approximately two months prior to my
13
biopsy.
14
15 None of the institutions at which she had worked
previously possessed a stereotactic table.
16 She has since been
terminated by the facility and according to our information,
17
is
she 18 now in her second position since being terminated. She
is no longer practicing in Washington State.
19
20 Mysteriously, after my suit was filed, the radiology
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clinic seemed to dissolve and reappear under a new corporate
1
name.
2 The table on which my biopsy took place was manufactured
by the Lorad Company.
3 Although my physician had apparently
attended a seminar regarding the Fischer table, she had
4
absolutely no training or experience on the Lorad table prior
5
to coming to Seattle.
6
7 In spite of numerous requests for information over
three years, it took filing of a lawsuit for me to determine
8
that 9I was at the beginning of this physician's learning curve.
Documents obtained through litigation demonstrated clearly
10
that this physician was having repeated serious problems
11
performing this procedure prior to my biopsy.
12 It is on record
that she had refused training in spite of repeated
13
recommendations by the manufacturer and distributor of the
14
table.
15
16 Documents also stated that the technicians at this
facility were overworked, distracted, and ill trained.
17
18 DR. MONSEES: Ms. Shay, sum up. You have between one
two minutes left.
and 19
20 MS. SHAY: I have enclosed for you some of this
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documentation and I would urge you to review it.
1 I believe it
clearly demonstrates that the radiologist in my cases was not
2
competent in the procedure at the time of my biopsy.
3
4 This is information I deserve to be informed of prior
to making a very important decision regarding my health care.
5
I have also enclosed a letter written by the radiologist to the
6
manufacturer of the table.
7 This letter was written in response
to a 8letter from the distributor of the table to the director
of the clinic.
9
10 In this correspondence, the radiologist admits that
other radiologists at this facility were having problems and
11
table is blamed.
the 12 She further describes a case she was
performing in which the needle passed completely through the
13
patient's breast.
14 This incident apparently occurred in the
presence of an application specialist who was attempted to train
15
my radiologist.
16
17 These documents and other information obtained in our
lawsuit clearly paint the picture of a physician who was not
18
properly trained and who was knowingly experimenting on
19
unsuspecting patients.
20
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1 Members of the committee, the issues before you are
extremely important to the thousands of American women each year
2
who find themselves in the same position as I was in the fall
3
of 1993.
4 I consider these issues so important that I have
traveled here for the second time from Seattle, Washington, to
5
speak to you today.
6
7 I have chosen to resolve my lawsuit, so that my
interest in these greater issues will not be misconstrued.
8
According to one stereotactic expert with whom my attorney has
9
spoken, there are hundreds of physicians throughout the country
10
performing this procedure who are not properly trained to do
11
so. 12
13 He described it as the biggest mess he has ever seen
in the course of his long and distinguished medical career.
14 The
health issues involved are too important to be caught in the
15
crossfire of a turf war between surgeons and radiologists.
16 I
wish I had been given the opportunity to consult with a surgeon
17
would have had much more experience in the area of counseling
who 18
patients regarding the need for, and the specifics of, surgery.
19
20 Instead, I received no counsel whatsoever from a
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radiologist who likely had spent her career detached from the
1
every-day physician-patient contact routinely experienced by
2
a breast surgeon.
3
4 However, I understand that there are aspects of this
procedure which demand expertise in radiologic interpretation.
5
Whatever the result of the struggle between these two specialty
6
areas, however, the overriding and guiding principle must be
7
that 8the physician performing the procedure is adequately
trained.
9
10 I am currently in the process of preparing a document
to submit to the Governor and selected legislators in Washington
11
State, focusing continued attention on this issue, as well as
12
exposing the ineffectiveness of our state medical board.
13
14 My work has already generated media interest on the
state and national level, and I intend to continue to pursue
15
issue of regulation and consumer awareness.
the 16
17 I am once again confirming the need for the committee
to implement strict guidelines and regulations to ensure that
18
this important medical procedure be performed on informed
19
patients by competently trained physicians.
20 Please keep the
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patient in mind.
1
2 Thank you.
3 DR. MONSEES: Thank you for your comments.
4 Is there anybody on the panel who would like to make
a comment or a question of Ms. Shay?
5
6 Thank you. Thank you very much.
7 We will move down to R. Philip Burns, physician.
8 DR. BURNS: Thank you, Dr. Monsees.
9 I am Philip Burns and I am a surgeon from Chattanooga,
Tennessee, and I represent the Advisory Council of the American
10
College of Surgeons here.
11
12 I appreciate the opportunity to address you and to
introduce my colleagues who are pioneers in the field of
13
image-guided breast biopsy, specifically stereotactic breast
14
biopsy.
15
16 I am a general surgeon. I am the Chairman of the
Department of Surgery at the University of Tennessee in
17
Chattanooga, and I serve in several capacities as regards the
18
College of Surgeons and the Southeastern Surgical Congress in
19
terms of program development and education.
20
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1 I am also a practicing general surgeon with an
emphasis on breast disease, but I also perform vascular surgery,
2
as well as laparoscopic surgery in a variety of disease states.
3
4 In our community, as has already been alluded here,
surgeons are the primary caregivers for breast disease.
5 We
find 6that a lot of women are confused about the status of breast
disease and breast evaluation, and mammogram is not enough to
7
decide which patients absolutely must and must not be treated.
8
Physical examination and clinical judgment are very important,
9
it
and 10 falls to a lot of the surgeons in our community to do
that.
11
12 Three years ago we purchased a stereotactic biopsy
unit for our faculty.
13 We placed it in our clinic. We have made
this technique available to both private and indigent patients
14
that we care for.
15 We also utilize aggressively ultrasound
evaluation and ultrasound image biopsy, as well as we have had
16
a long-standing interest in ultrasound through evaluation of
17
vascular disease, as well.
18
19 Our residents are trained in the techniques of breast
disease evaluation and thusly, in our facilities, stereotactic
20
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breast biopsy, ultrasound guided biopsy.
1 They perform these
procedures under faculty guidance, and when they leave our
2
training program now, they are credentialed in our mind to
3
perform these procedures as they go into practice.
4 So, it has
become an integral part of our education program in Chattanooga.
5
6 We have published our data in peer-reviewed journals
in relationship to our statistics involving patients from the
7
initiation of utilization of this procedure, but we have also
8
published our data in terms of the needle-directed excisional
9
breast biopsy, as well.
10 And, by the way, our results in terms
of malignancy rate, incidents of biopsy related to BIRAD's
11
classification of breast lesions, is essentially the same
12
between those two studies which involves essentially patient
13
cohorts that we assume would be the same as they come to our
14
clinic or through our practice for their treatment.
15
16 We currently participate in the newly developed
image-guided breast biopsy registry that is coordinated at the
17
University of Louisville by Dr. Mike Edwards, and we look
18
forward to results from this nationwide in terms of the
19
assessment of this technique further in addition to that, that
20
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we have in our local community.
1
2 We think that it is extremely important for long term
followup to be documented.
3 This registry will help with that
a great deal in addition to augmenting our own prospective
4
analysis of this.
5
6 We perform approximately 600 core biopsies a year in
our facility.
7 We frankly do a few more ultrasound-guided
biopsies than we do stereotactic biopsies, and again it depends
8
on the clinical judgment of the physician at the time as to which
9
use.
you 10
11 It has already alluded to the fact that across the
country, this technology has exploded in the surgical
12
community, and that is because it is proven effective in both
13
evaluation of breast disease and certainly, we think, in
the 14
reducing the fear and anxiety that women have of breast disease,
15
in that it is less invasive and in most circumstances certainly
16
less painful to the patient.
far 17
18 My primary mission other than defining what I do
myself is to take the opportunity and the privilege to identify
19
or introduce you to my two colleagues who are here.
20 Some of
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you met them last year, those that are new to the committee might
1
not have met them.
2 Dr. Phil Israel and Dr. Kambiz Dowlat.
3 Dr. Israel is a pioneer in the clinical application
of stereotactic core biopsy, utilizing this aggressively in his
4
practice which is isolated to the treatment of breast disease
5
at the Breast Center in Marietta, Georgia.
6
7 In addition to performing this procedure in over
5,000 patients, he has maintained a prospective analysis, he
8
and his group of physicians, maintained a prospective analysis
9
of their patients and have published them in peer-reviewed
10
journals, the earliest one being in the American Surgeon in 1994
11
that detailed well over 500 cases performed in the stereotactic
12
setting.
13
14 He has also trained in a well-organized training
program 750 surgeons and 100 radiologists in the techniques of
15
stereotactic breast biopsy, and he has also been very much
16
involved in the development of the training courses that have
17
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
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the pioneer in both the research and clinical applications of
1
this 2technology. He is a professor at Rush Medical School in
Chicago, but early on developed a research interest in this
3
technique, spent a lot of time in Sweden, then came back to the
4
United States and brought the first stereotactic biopsy unit
5
to this country.
6
7 He applied it to the research setting first, then to
clinical application, and the published his first data in 1987.
8
He has had multiple other publications since that time.
9
10 His current research interestingly includes interest
in application of this stereotactic technique to the treatment
11
of breast cancer through the utilization of laser technology
12
perhaps he will explain that to you some when he talks.
and 13
14 We are really fortunate to have him agree, at the
College of Surgeons level, to spearhead the development of our
15
education courses in offering the opportunity for surgeons
16
around the country to come and learn the techniques of
17
image-guided breast biopsy.
18 He has done a wonderful job with
this.
19 We have regularly scheduled courses sponsored and
developed by the American College of Surgeons through Dr.
20
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Dowlat's leadership.
1
2 At this point, I would like to let Dr. Dowlat take
the floor and proceed from this point.
3
4 Thank you very much.
5 DR. MONSEES: Thank you for your comments. We will
call 6upon Dr. Dowlat, please.
7 DR. DOWLAT: Good morning, ladies and gentlemen.
8 I would like to thank you for giving me the
opportunity to briefly go over specifically the course that the
9
American College of Surgeons has organized to teach and train
10
individual physicians, surgeons, or radiologists, or
the 11
otherwise, to use this interventional technique.
12
13 DR. MONSEES: Sir, are you representing the American
College of Surgeons at this meeting?
14
15 DR. DOWLAT: I am sorry, no. Yes, I am, as Dr. Burns
said, I am a surgeon in Chicago, and the American College of
16
Surgeons has asked me to give an account of the course that is
17
given for training of the surgeons all over the country.
18
19 DR. MONSEES: So you are representing the American
College of Surgeons at this meeting here?
20
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1 DR. DOWLAT: Yes, I suppose that is correct.
2 DR. MONSEES: Thank you.
3 DR. DOWLAT: As Dr. Burns alluded early on, I was
involved in training and teaching of this technique from years
4
ago, 5independently, at the University of Chicago and
subsequently at Rush, to radiologists and to surgeons, and more
6
recently, because of the increased interest of the surgeons from
7
all over the country, we have organized these regular courses
8
three-monthly basis for whoever wants to have the training.
on a 9
10 Specifically, the courses are organized on a two-day
basis, didactic the first day, and the second day is work
11
stations where the trainees actually do procedures on phantoms
12
examine live patients by ultrasound, so this is a course
and 13
given for image-guided breast biopsy including both ultrasound
14
stereotaxic.
and 15
16 The faculty, we have a roster of 40 faculty, all very
distinguished individuals from all over the country including
17
radiologists.
18 We have had the pleasure of having Dr. Larry
Bassett and Dr. Carl Dorsey.
19 I would like to acknowledge their
teaching and their lecturing at this course.
20
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1 We also have had Dr. Laslo Tobar, an internationally
known lecturer and pioneer in mammography, give a whole day
2
course lecture and presentation to the individuals.
3 Also, I
would like to acknowledge Dr. Robert Pizzutiello, who has given
4
the lecture on the medical physics, as well as risks of radiation
5
to the physicians.
6
7 These courses have been very successful. The
evaluation has been extremely favorable.
8 More recently, we
tried to also test the individuals who have taken the course
have 9
to
and 10 see how much they have actually learned, and this again
we are in the process of learning how to perform this evaluation.
11
12 The trainees are asked questions before and after
using error system which seems to be very effective.
13 It was
used for the ATLS training and we are trying to do the same for
14
image-guided breast biopsy.
the 15
16 On the skill stations, we also tried to test the
individuals at the end of the day to see how much they have
17
actually learned, how to examine patients and how to evaluate
18
obviously conduct interventional steps on phantoms.
and 19
20 What are the future plans for us? We are offering
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these course on a quarterly basis all over the country, and we
1
would like to come up with some kind of guidelines, which I think
2
Dr. Winchester and others will refer to later on in terms of
3
credentialing the physicians who take this course.
4
5 Obviously, they too require some preceptorship after
they 6take the course, and in order to start the practice at their
individual hospitals.
7
8 I think at this point I stop and take any questions
that 9you have.
10 DR. MONSEES: Thank you.
11 Do we have any questions from the panel or any
comments?
12 Yes.
13 MR. MOBLEY: Is there any requirement that before a
surgeon would start doing this technique, that they would have
14
to take this course or a similar course?
15
16 DR. DOWLAT: Any particular requirement you mean by
previous training?
17 The surgeons who come and register for this
course are those who have breast surgery as part of their
18
practice, and they would like to perform minimally
19
interventional biopsy technique, and there is no particular
20
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qualification for that.
1
2 MR. MOBLEY: You said you hoped to develop
credentialing criteria or something to that effect, but in
3
essence, is there any requirement or any specific necessity for
4
a surgeon going through this training, or is it just simply those
5
that 6desire the training, get it, and those that don't desire
it, don't get it?
7
8 DR. DOWLAT: That is correct. These are the
individuals who desire to learn this, and because they probably
9
plan to perform the needle biopsy in their community hospitals
10
or wherever they practice.
11
12 I am sorry. They have to be board-certified surgeons
obviously, to have their credentials in place.
and 13 I think this
well documented in statement by the College of Surgeon
was 14
published three years ago in the Bulletin of the College of
15
Surgeons.
16
17 DR. MONSEES: Another question.
18 MR. FLETCHER: Roland Fletcher. Do you have any
idea of the ratio between those who have taken this training
19
those who have not, who are performing?
and 20
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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
2
United States who practice breast surgery.
3 The ones who have
taken to date, we have offered five courses, and I would say
4
over 5500 of them, 500 surgeons have taken these courses.
6 Besides this formal course, there are the private
courses given in the country.
7 Maybe Dr. Philip Israel will
enlarge on that.
8 I would say I think Dr. Burns mentioned that
700 other surgeons have taken this course.
9 There are courses
given by radiologists that surgeons participate and learn this
10
procedure, so some of them do it once, maybe some do it twice,
11
so
and 12 on.
13 MR. FLETCHER: Thank you.
14 DR. MONSEES: Yes. First, Dr. Smith.
15 DR. SMITH: Do you have an opinion, though, as to
whether these courses should be required or very strongly
16
encouraged rather than the pursuit of, let's say, on-the-job
17
training or just a general sense that this is doable?
18 Ms.
Shay's material portrayed I think an extreme example of someone
19
thought that they could get away without having a course.
who 20
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1 I guess the next question I would have is your opinion
as to whether or not there should be some standardization,
2
formal or informal, of course materials and what sorts of
3
materials are presented.
4
5 DR. DOWLAT: The answer to your first question is
yes, 6I think the technology has become quite complex now. The
first unit that I brought to the United States was very simple.
7
It was like an old car with four wheels and a steering wheel
8
and an engine, and you got into it and went from A to B, but
9
you have got highly computerized technology and it is
now 10
becoming more and more complex.
11
12 There is quite a competition in the country,
therefore, the formal courses are necessary, I believe, in order
13
the individuals who are going to practice this to do it
for 14
properly.
15
16 The answer to your second question is that we are
trying to standardize this and it is not very easy because of
17
rapidly changing scene, both in stereotaxic and ultrasound.
the 18
We are, in fact, in the process of standardizing the whole course
19
from A to Z, so that each part or each segment of it is given
20
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to an individual without duplication or redundancies.
1
2 DR. MONSEES: We have another question down here.
Dr. Sickles next.
3
4 DR. SICKLES: Just to amplify on that, I understand
from 5your answer, then, that it is your opinion that physicians,
not just surgeons, but physicians who perform these procedures
6
should be educated and credentialed in doing this, or just
7
educated?
8
9 To amplify that, do you think that if they are to be
credentialed as opposed simply educated, that this should
10
require not only an initial education period, but continuing
11
education?
12
13 DR. DOWLAT: You are putting it in a very broad term,
Sickles.
Dr. 14 Education, that covers a whole lot of things.
Specifically, if you refer to the stereotaxic needle biopsy,
15
really mean training in that particular technology.
you 16
17 I think they should be trained in this technology.
Whether the credentialing I think should be renewable because,
18
two reasons.
for 19 This is something which an individual may go
back and don't practice it, and then maybe two or three years
20
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later, comes and says no, I want to do it.
1 So, there should
be some kind of monitoring or regulation in that respect.
2
3 There is also the question of the complexity of this
technology.
4 Initially, we used very simple, a fine- needle
aspiration, then core biopsy, then bigger cores, and now ABBI
5
system, and so on, and so on, and we are moving into the area
6
of treatment of these small breast tumors with either excision
7
of in-situ coagulation with laser.
8
9 So, the maintenance of proficiency, I think is
important, that it should be included in the future plans.
10
11 DR. MONSEES: Dr. Winchester, please.
12 DR. WINCHESTER: Following up on the sort of theme
of the questions of the committee, do you think it is possible
13
any surgeon or any radiologist to just pick up an article
for 14
seem to be interested in this procedure, and then just start
and 15
doing it in their hospital, or do you think that local
16
credentialing committees have some guidelines in place locally
17
to have some requirements for education and proctoring at their
18
local level based upon emerging technologies?
19
20 I think it would be good to standardize that -- going
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back 1to Dr. Smith or Dr. Sickles -- it would be good to have
some 2kind of standard algorithm for the physicians who would
like 3to do this in order to help the credentialing committees
of the hospitals.
4
5 The credential committees are looking to the bodies
like 6American College of Radiology and American College of
Surgeons, and it would be good to have a joint statement say
7
these are the minimum amount of training needed for the
8
individual surgeon to start, and these are the requirements for
9
maintenance of proficiency.
10
11 DR. MONSEES: Mr. Pizzutiello.
12 MR. PIZZUTIELLO: Dr. Dowlat, we have been talking
primarily about surgeons who are currently in practice.
13 Can
tell us a little bit about how young surgeons going through
you 14
their residency training are learning this new procedure and
15
that might be documented, so that it is clear that they know
how 16
what they are doing?
17
18 DR. DOWLAT: I think that is also recently being
agreed upon -- correct me, Dr. Winchester, if I am wrong -- that
19
American Board of Surgery has accepted to or is planning
the 20
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to have this training system introduced or implemented in the
1
residency program, so that the residents in their senior years
2
take 3the course or take the training, if they are going to be
specifically breast surgeons, to be competent.
4
5 DR. WINCHESTER: If I could just clarify that.
6 DR. MONSEES: Yes. Dr. Winchester.
7 DR. WINCHESTER: It has officially become part of the
required curriculum in general surgery, and thus will be subject
8
to review after completion of training in the form of board
9
certification.
10 Both the written and qualifying examinations
will include this as part of the exam.
11
12 DR. MONSEES: Do we have any other comments? Yes,
Hendrick.
Dr. 13
14 DR. HENDRICK: I have a couple of sort of clean-up
questions that I would like to ask.
15 There was some allusion
to needing to be a board-certified surgeon to do these kinds
16
of procedures, is that correct now or not?
17
18 DR. DOWLAT: I think so. This is board-certified
surgeons are asked by their local credential committees,
19
surgeons, to be board certified in order to practice in their
20
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committees.
1 Again, Dr. Winchester, am I correct?
2 DR. MONSEES: Go ahead. Yes, you may.
3 DR. WINCHESTER: Not really. That is not stated as
a board certification requirement, and that was just in an
4
article in the Bulletin of the college a couple of years ago.
5
I don't believe we allude to it in the personnel qualifications
6
for either radiology or surgery.
7
8 DR. HENDRICK: Then, I had a couple of other
questions.
9
10 In your course that is I assume mainly aimed at
surgeons, can other people attend beyond the surgeons,
11
radiologists, or other physicians who aren't surgeons?
12
13 DR. DOWLAT: The course is offered to all physicians,
be it radiologists, surgeons, or gynecologists.
14
15 DR. HENDRICK: And in the course curriculum, as it
currently stands, are you including treatment guided by
16
stereotactic?
17
18 DR. DOWLAT: No, not currently. Currently, we just
focus on the diagnosis.
19
20 DR. HENDRICK: Thank you.
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1 DR. DOWLAT: I also would like to thank you for your
contribution to the course.
2 I forgot to mention that early on.
3 DR. MONSEES: Are there any other questions?
4 If not, we will move on. Thank you very much.
5 DR. DOWLAT: My pleasure.
6 DR. MONSEES: Our next speaker is Dr. Philip Israel.
7 Please state who you are.
8 DR. ISRAEL: Thank you. Members of the committee
and participants, thank you for the opportunity to speak today.
9
My name is Dr. Philip Israel and I am Director of the Breast
10
Center in Marietta/Atlanta.
11
12 I address the issue before us today from the viewpoint
of an individual private practice surgeon and also on behalf
13
of the American College of Surgeons.
14 The purpose of this
hearing today is to consider the issue should interventional
15
mammography be regulated.
16
17 My remarks I would like to be underlined by an
overriding concern for quality of care and for the safety of
18
patient.
the 19 I personally have been involved in stereotactic
breast biopsy since 1991.
20 I have had the unique opportunity
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to observe this technology evolve both in the radiology
1
community, locally and nationally, and in the surgical
2
community.
3
4 I trained with Steve Parker in Denver. I have had
the opportunity over the last two and a half years to participate
5
in Dr. Parker's stereotactic and ultrasound courses as a member
6
of his faculty, so I have taught both surgeons and radiologists,
7
and I have seen them both perform.
8
9 In our own center, we have six surgeons. I would like
to give you just a little background from where I am coming.
10
We have six surgeons in our center.
11 We do only breast work.
We have access to three stereotactic units, two of which are
12
in surgery centers, one of which is in my office.
13
14 We have done over 5,000 stereotactic breast biopsies.
We have kept I think extremely complete outcome data.
15 We have
published our data in the American Surgeon in 1995, looking at
16
sensitivity and specificity and accuracy of the procedure.
the 17
18 We have also been involved in training, and as been
mentioned, we have trained almost 1,000 radiologists and
19
surgeons over the last five years.
20
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1 This committee, of course, is interested in quality
of care and assuring that the American woman gets the best
2
possible service.
3 We want to know that experienced and
responsible individuals are doing these procedures.
4
5 From my viewpoint and my experience, I have been very
gratified in that the surgeons that we have taught have
6
self-selected themselves out of a large number of surgeons, and
7
these are surgeons that have large breast practices, they know
8
about this technology, they want to be involved, and from my
9
experience, they are eminently qualified into moving into this
10
area of stereotactic breast biopsy.
11
12 I have seen them go out into their communities around
country.
the 13 Many of them have opened breast centers
themselves since they were primarily doing a majority of their
14
work in breast, and they have all kept good auditing outcome
15
data.
16 I am in constant touch with these doctors, and I am very
pleased that they have made sure that they have received the
17
maximum training.
18
19 They attend, not just one and not just two courses,
they attend multiple courses, they do it annually, they work
20
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on their imaging skills, and I am very proud to say that I think
1
they 2have been very responsible.
3 On the other hand, in my own community, I have offered
to train any surgeon, free of charge, that wants to do
4
stereotactic breast biopsy.
5 Many of these surgeons do very
little breast work.
6 Some of those surgeons, out of curiosity
I think, have taken advantage of my offer and they have been
7
trained, but interestingly enough, they have not shown up to
8
do stereotactic work.
9
10 I think this self-selection process on the part of
surgeon is probably the best credentialing that we can rely
the 11
and what I am seeing is that the surgeons who are not
on, 12
interested, who are not heavily involved in breast work, are
13
trying to do this procedure.
not 14
15 Surgeons are embracing this technology in an amazing
manner around this country, and all of the major surgical
16
organizations, including the American College of Surgeons, the
17
American Society of General Surgeons, the Southeastern Surgical
18
Congress, and all the state surgical societies are offering
19
courses to interested individuals, and these courses almost
20
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always are oversubscribed by the surgeons.
1
2 The stereotactic units that are being installed
around this country, there has been an enormous shift in where
3
these units are going.
4 For the first four or five years, they
went 5into radiology departments and mammography centers. That
is no longer the case.
6
7 Recently, the majority of these units are going into
operating rooms and into free-standing surgical centers.
8
9 An interesting advance is all of this technology has
been the explosion of the needle technology.
10 The engineers for
surgical companies in this country are really becoming
the 11
involved.
12 They are producing new types of instruments to
collect tissue.
13 Some of these instruments collect very large
portions of tissue, such as the ABBI and a new instrument that
14
I saw at the American College of Surgeons in Chicago a few weeks
15
ago.
16
17 These collection devices or biopsy devices require
almost a surgical procedure.
18 They require a large incision.
It results in harvesting a large amount of tissue.
19 It involves
suturing an incision and bleeding control and wound management,
20
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of course, of which surgeons are, I think, eminently qualified.
1
2 As a second thought, I see that if the FDA does become
involved in credentialing and monitoring this type of operative
3
procedure, it is going to make a drastic change in the makeup
4
of your committee.
5
6 You will have to have surgeons, a lot more surgeons
involved.
7 You will have to have operating room supervisors,
operating room technicians, and probably even monitors going
8
into 9operating rooms to evaluate sterility, wound management,
all the other myriad of things that go into surgical
and 10
biopsies.
11
12 The surgeons have started a national data registry,
looking at and tracking the indications for breast biopsies,
13
stereotactic breast biopsies, the type of breast biopsy is
for 14
this stereotactic or ultrasound, the type of instrument used
15
to collect the tissue, of which, as I have mentioned, there are
16
a myriad of instruments today, and this will track the false
17
negatives, the false positives, the accuracy of the procedure,
18
as well as the complications.
19 This has been set up by Dr.
Mike Edwards at the University of Louisville, and all of the
20
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surgeons in the country that have been recognized, that are
1
doing these procedures, have been sent data collection sheets,
2
and are contributing data.
3
4 I was very interested in the public testimony this
morning because most of the complaints and the problems in the
5
public sector have to do with the surgical aspect of this
6
procedure, and not the imaging aspect.
7
8 It has to do with non-surgeons who are now moving into
the arena of performing breast biopsies, where they have to deal
9
with sterility, informed consent.
10 This is where I think the
public is having a problem.
11
12 Fortunately, these are issues that surgeons will have
no problem with.
13 Surgeons have dealt with sterility for
decades, we deal with it every day.
14 Informed consent, we tried
stereotactic breast biopsy as if it is an operative procedure,
15
an
not 16 extension of the mammogram, which means we get informed
consent, we talk to the patient about options.
17 There is a
bonding with the patient.
18 We do a good physical examination
to make sure there is no coexisting disease.
19 This is part of
modus operandi on a regular basis.
our 20
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1 Other, non-surgeons, are going to have go acquire
these skills in order to satisfy the consumer, and not create
2
the kind of problems that we are hearing testimony about today.
3
4 I will end my comments at this point and entertain
any questions that there are.
5
6 DR. MONSEES: Thank you.
7 Do we have any questions or comments from the panel?
Yes, 8Dr. Farrell.
9 DR. MOORE-FARRELL: What needle system are you
predominantly using or do you have one that you use mostly?
10
11 DR. ISRAEL: Fortunately, we have had experience
with almost all of the needle technology.
12 We have not abandoned
standard, 14-gauge TruCut.
the 13 That is part of our
armamentarium.
14 Certainly, suction device instruments like the
Mammatome.
15 We do all of our microcalcifications with
Mammatome.
16 We do most of our nodular densities with 14-gauge
or 12-gauge TruCut.
17
18 DR. MOORE-FARRELL: On the Mammatome, are you using
14
the 19 gauge or the 11 gauge?
20 DR. ISRAEL: Initially, we used both, but all of the
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seven doctors in my group have migrated towards the larger
1
needle.
2 We collect more tissue with that, and we don't have
any additional pain or bleeding.
3
4 DR. MONSEES: Dr. Sickles.
5 DR. SICKLES: Is it your contention from your
experience as a teacher and going around the country, that all
6
surgeons now performing this procedure are fully trained in
7
doing it?
8
9 DR. ISRAEL: Of course, I can't answer that because
I don't know all of the surgeons that are doing stereotactic
10
biopsy, but I am impressed at those that I am aware of that are
11
doing it, appear to be doing it in a very, very responsible
12
manner, and are showing up at meeting after meeting after
13
meeting and really making a conscientious effort to become
14
trained and specialist in this area.
15
16 DR. SICKLES: Do you tend to see the same people
coming back?
17
18 DR. ISRAEL: We see a lot of the same people coming
back in addition to individuals who are testing the water to
19
if
see 20 they want to become involved, and as I have said before,
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generally, this is a self-selection process and those doctors
1
who have high volume breast practices are the ones that want
2
to and are getting involved.
3
4 DR. SICKLES: I understand that. Are you aware of
any surgeons or, for that matter non-surgeons, who are doing
5
this 6procedure, who are not trained?
7 DR. ISRAEL: Yes.
8 DR. SICKLES: So there are such.
9 DR. ISRAEL: Yes.
10 DR. MONSEES: Dr. Dempsey.
11 DR. DEMPSEY: Dr. Israel, I just want to clarify your
statement at the end there.
12 Are you saying that only surgeons
talk to the patient and obtain informed consent for this
13
procedure, because that is what your statement kind of --
14
15 DR. ISRAEL: No, I think that the complaints that we
hear before this committee are involved with lack of informed
16
consent, lack of bonding, lack of communication with the doctors
17
they have encountered, and I limit my remarks to that.
18
Certainly, radiologists talk to patients, surgeons talk to
19
patients.
20 I think that there will be certainly varying degrees
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of personal involvement by the physician.
1
2 I would say that I think that surgeons are more
accustomed to interacting with patients prior to a procedure,
3
doing physical examinations, giving options, and receiving
4
informed consent, but I think this is an area that the
5
radiologists will have to improve upon since it is not, has not
6
been 7in the past a part of their general approach would be my
opinion.
8
9 DR. DEMPSEY: Even in things like interventional
radiology?
10
11 DR. ISRAEL: I don't want to extend my remarks to that
area because I have no information about that.
12
13 DR. DEMPSEY: The blanket statement was out there and
I just wanted to clarify that.
14
15 DR. ISRAEL: I don't want to leave any false
impression.
16 Certainly, I think that radiologists, as
mammographers in particular, who focus in this area, can do all
17
of these facets of interacting as well as a surgeon.
18
19 DR. MONSEES: Dr. Smith.
20 DR. SMITH: Two questions on the last point. The
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issue of dealing with informed consent, patient reassurance,
1
that 2sort of thing, could be strongly emphasized in courses any
physicians were taking.
3
4 DR. ISRAEL: Yes.
5 DR. SMITH: I presume that is in the courses that you
are teaching.
6
7 DR. ISRAEL: Yes.
8 DR. SMITH: The next question is, is it your opinion
that 9after one of these courses, which typically runs over two
to three days, the physician who has taken this course for the
10
first time, are they fully competent to begin performing these
11
procedures on their own?
12
13 You emphasized that you get a lot of repeat
attendance, so obviously people are coming back to hear new
14
ideas, but perhaps they are also coming back to reinforce the
15
training that they have already had, benefiting from some
16
redundancy.
17
18 So, the question is, I mean a weekend happens to be
a period of time off, it works out that way, and it is only so
19
long.
20 Do people coming back from these courses, are they ready
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to go in your judgment or what else might be required?
1
2 DR. ISRAEL: I think we weekend course is a
beginning.
3 It's not the middle and it's not the end. It's the
beginning of a learning process for surgeon and radiologists.
4
I think both radiologists and surgeons will recognize that you
5
will 6not learn to do this procedure in a weekend. It is more
like 7an art form. It's like asking a painter, when they are
fully trained, I think every day an artist learns to improve
8
his technique, and I think these procedures are no different.
9
10 The imaging skills, the surgical skills, the
communication skills can always be improved.
11 It's a continuing
learning process.
12
13 DR. MONSEES: Yes.
14 MS. HEINLEIN: Dr. Israel, what personnel are
involved in the procedure?
15 I mean is it you and a nurse, is
it you and a technologist, is it only you?
16 Can you share that
with us?
17
18 DR. ISRAEL: It is myself and a technologist. In our
teaching, we certainly recommend that no radiologist and no
19
surgeon do this procedure without a double-registered
20
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technologist.
1 However, I think that the physician always has
to be in control, the technologist does not make the decision
2
this 3is the lesion to be biopsied. The technologist does not
mark 4the area of access for the cores. That relationship has
to be established and maintained.
5
6 In our center, we do not involve a radiologist. A
radiologist has never been in our center for the 5,000 cores
7
that 8we have harvested. This was a very hard decision for us,
because in a way we were very much pioneers at this time.
9
10 When we started doing this procedure -- do I have a
moment to answer that question, maybe a minute -- when we started
11
doing this procedure, I actually lobbied the radiologists in
12
my community to get a stereotactic unit for two years, and it
13
never done.
was 14
15 A surgical center offered to buy the equipment and
I said, yes, please buy it, this technology needs to be offered
16
in this community.
17 At that time, I already had four years of
breast only, and I had improved my imaging skills, but I had
18
to make the decision am I competent with my imaging skills to
19
do this without radiology assistance, and I gave this a lot of
20
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serious consideration.
1
2 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
3
assistance in image interpretation in our center.
4
5 DR. MONSEES: Do we have any other questions here?
6 I would like to just ask a brief question. I am a
little confused because one of the major advantages that accrue
7
to patients who undergo stereotactic core biopsy is that it has
8
moved the biopsy procedure out of the operating room into an
9
office type practice, and we have done less and less invasive
10
things.
11
12 Do I get from the drift of what you described having
seen at the American College of Surgeons with more invasive
13
biopsy devices, that you see an advantage to those larger core
14
devices, one, and two, are you predicting a move back to the
15
operating room when, in fact, we were raving over the last couple
16
of years about a major advantage that we have moved out of the
17
operating room?
18
19 DR. ISRAEL: Thank you for asking those questions
because they are very important.
20 Personally, I don't like the
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larger core biopsy instruments.
1 They don't serve my purpose.
I want to make a diagnosis with this instrument.
2 I can do it
with 3much smaller needle devices.
4 The second part of your question, do we want to see
these procedures moved back into the operating room?
5
Absolutely not.
6 When the device is placed in an operating room
arena, it usually is placed in an area where outpatient surgery
7
is performed, separate from the actual operating room area.
8
9 So, I think that we must, first of all, make a
commitment to continue minimally invasive work.
10 We don't need
to make a 2-centimeter incision to achieve a diagnosis, but
11
there are some doctors that don't agree with me, and they feel
12
more comfortable using larger core instruments.
13
14 I think the practicing habits of the doctors will
eventually determine which of these biopsy instruments will
15
survive and which will fail, but I certainly support minimally
16
invasive work in an outpatient setting.
17
18 DR. MONSEES: Thank you.
19 Do we have any other final questions here?
20 Thank you very much.
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1 DR. ISRAEL: Thank you.
2 We will move on to Dr. Armando Santelices.
3 DR. SANTELICES: Good morning and, first of all,
thank you very much for allowing me the opportunity to come once
4
again and testify before this panel.
5 I bring you greetings from
South Florida, the world champions.
6
7 DR. MONSEES: Dr. Santelices, are you representing
yourself or an organization?
8
9 DR. SANTELICES: I am going to give you a long list.
10 DR. MONSEES: Thank you.
11 DR. SANTELICES: First and foremost, I am
representing myself.
12 I have a breast center which was opened
in 1991.
13 My numbers are not as staggering as Dr. Israel, but
I have done over 2,000 biopsies.
14 The machine that was placed
in my center was machine number 98, manufactured by the Fischer
15
Company.
16
17 Like Dr. Israel, I took my first training with Dr.
Parker, which by the way, created the first turf battle because
18
at the end of his lecture, he had a radiologist stabbing a
19
surgeon with a Bard-Parker needle and saying that in the future,
20
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breast biopsies would be in the domain of radiologists, not
1
surgeons.
2 So, that is one conflict, because obviously I am
representing my personal interest, but obviously, my interests
3
are of my patients.
4
5 I am also the new medical director of a center of
excellence for Health South that has been created in South
6
Florida, which will have a multidisciplinary approach to breast
7
diseases including radiologists, nutritionists,
8
psychologists, internists, and surgeons.
9
10 My plane ticket was purchased by the American Society
of Breast Surgeons.
11 Yesterday, I received a phone call from
Caplan, who said if I wouldn't mind reading a letter that
Dr. 12
he would prepare for you, and that as a return, he would pay
13
the
for 14 plane ticket. I would have read the letter anyway, but
if he was going to pay for the plane ticket, of course, I took
15
it. 16
17 Last but not least, I am currently under negotiations
to enter into a contract agreement with U.S. Surgical, because
18
of the research and development that is being done with regards
19
to new needles.
20 In addition to this, U.S. Surgical Corporation
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just 1bought out a company called Neovision, who does
sonographically-guided, computer-guided biopsies, and my
2
center was one of the clinical trial centers, and we have done
3
over 4100 ultrasound-guided biopsies uses computer technology.
5 So, I think that will give you a brief overview of
all my conflict of interest.
6 I would like for the record also
to state that I am not board certified, and therefore, if we
7
follow the board certification route, I would be out of the
8
picture immediately.
9 I have been 17 years in private practice,
I have never been sued once.
10 I am the Chief of Surgery at
Palmetto General Hospital and I have been there for the last
11
eight years.
12
13 Giving you an overview of where I come from, I still
think of myself as a country doctor.
14 My credentials are not
gigantic and I have never published a paper on stereotactic
15
biopsies, basically, because every time I saw a paper, the
16
numbers that I saw mimic mine, and I didn't think I had anything
17
else to add.
18
19 They say an expert is one who creates and writes a
of
lot 20 papers, so I guess in that respect I am not an expert,
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but I know the definition of an expert is somebody who come and
1
travels 500 miles away from their home and testifies, so in that
2
case 3I may be an expert.
4 When stereotactic biopsy started to become something
that 5was written in the literature, it started out in Sweden
with 6Dr. Laslo Tobar, and he started doing work with fine-needle
aspirations.
7
8 As a surgical resident, every time we need a needle
wire 9localization, and we had to go in there and extract a piece
of tissue, humongously large, and sometimes the incision would
10
be done at what I call Tallahassee, Florida, and the needle wire
11
would be at Key West, I always kept asking myself is there a
12
better mousetrap, is there a better way.
13
14 When I started reading up on it, and I became aware
of the advent of this machine, I went ahead and leased one, I
15
didn't purchase one, no down payment with the lease, and I took
16
a risk and I put the machine to work.
17
18 As I stated, I took the course with Dr. Parker, and
following that, and we did lots of eggplants, never a patient,
19
I prepared myself to start stereotactic biopsy work utilizing
20
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a very, very narrow group of patients.
1 I didn't go for the
micros at first, and I didn't go for lesions that were less than
2
1 centimeter in order to acquire a learning curve of my own.
3
4 No course and no weekend course can give you that kind
of experience unfortunately, and no matter how much they charge
5
you for it, they are not ever going to let you make the cut in
6
the lady and put the needle.
7 That is something that sooner or
later you have to do on your own or with preceptorship, which
8
is not what is coming about.
9
10 Because I was a surgeon, the first surgeon in the
State of Florida to do this, I felt it was very important to
11
keep numbers, because I know sooner or later somebody was going
12
to try to hammer me in the head with it, I was called a quack.
13
My own surgical group felt that this was inappropriate, and the
14
radiologists weren't buying into it at the time.
15 I am happy
to see that now it has become a matter of who is going to do
16
it and when.
17
18 So, obviously, those of us who had first started at
this, and like Dr. Israel, can sit here and feel gratified that
19
forethought or our vision came to.
our 20
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1 I am here to say that I am very concerned when
something becomes so regulated that it may exclude the likes
2
of myself.
3 I know this sounds self-serving, but it is the
truth.
4 I am not board certified and I don't have four hours
of radiation physics.
5 Does that mean I can't do it?
6 At the same token, if I was board certified, and I
took 7a weekend course, does that mean I know how to do it? So,
my presence here is to make sure that when you make your
8
decision, first of all, it is not political; second of all, that
9
take in consideration that there are individuals, such as
you 10
myself, that may be adversely affected; but, most important,
11
whatever decision you do be for the patients' welfare.
12
13 I don't have a problems with radiologists doing this
procedure if they are trained in surgical techniques, just like
14
radiologists should not have a problem if I told them I know
the 15
to
how 16 interpret a mammogram. I don't read them, I know my
BIRADs.
17
18 As a matter of fact, as a surgeon, I go to probably
more radiology meetings than I go to surgical meetings, because
19
in order to be "a breast surgeon with imaging experience," that
20
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is where I need to go.
1
2 The American College has not put a course yet on how
to interpret mammography, and you don't sit there and go from
3
screen to screen to screen, and look at 40 cases and test
4
yourself, but the American College of Radiologists does, and
5
I have taken that course.
6
7 So, what I am asking you to do is please consider the
possibility of creating a set of regulations that does not
8
exclude, but actually includes, that it makes sure that it
9
addresses the real needs, which may not be some of the needs
10
that have been addressed today, it may be all the needs that
11
were addressed today.
12
13 The patient is the ultimate recipient of our
knowledge, our technology, and our care and our love and our
14
attention, and a lot of that cannot be learned in a two-day
15
course, and certainly board certification does not give you
16
that.
17
18 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
19
questions, because a question sometimes allows me to expand on
20
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a subject.
1 I didn't come with a written testimony, so I did
it off the cuff, so I would rather just answer questions.
2
3 DR. MONSEES: Thank you, sir.
4 Do we have any questions from the panel? Yes.
5 DR. SICKLES: You had sort of side statement that I
would clarify.
6 I understand your concerns about regulations
that 7require board certification because that is an extremely
difficult thing to acquire.
8
9 On the other hand, in with that you talked about a
hours of education in radiation physics.
few 10 Do you not feel
it is important to have some understanding of the way in which
11
equipment that produces the x-rays that you are using works,
the 12
so that if it isn't working, you might understand how it would
13
-- 14
15 DR. SANTELICES: I certainly agree with that. As a
trained surgeon, I did interpretive cholangiograms for God know
16
many years, and I certainly utilized fluoroscopy at the
how 17
time, and part of my training was learning about the radiation
18
hazards that occur, and the stuff that occurs with that.
19 And
by the way, at 2 o'clock in the morning, interpretive
20
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cholangiogram seldom gets read by a radiologist at that moment,
1
so I 2was also taught to interpret radiologic findings at the
time 3of an emergency, and when I trained in trauma, and we did
a peripheral vascular study for a gunshot wound and did an
4
arteriogram, I certainly was almost self-trained in the sense
5
that 6your senior resident teaches you, and you teach the lower
resident to interpret.
7
8 So, yes, I don't disagree that the training has to
occur.
9 I am very concerned of starting to put four hours of
this, three hours of that, two hours of the other, because in
10
State of Florida, I have five of HIV, two of domestic
the 11
violence -- I can give you a list, and it goes on and goes on.
12
That's all.
13
14 DR. SICKLES: But you do understand that a certain
amount of basic training might be needed?
15
16 DR. SANTELICES: Of course, yes, sir. I have no
qualms with that.
17
18 DR. MONSEES: Yes.
19 MR. FLETCHER: At the time that you began and
essentially self-taught --
20
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1 DR. SANTELICES: No, I was trained by Dr. Parker with
an eggplant and an olive inside.
2 By the way, I got green, red,
green, and that means I got it right in the center, the pimento,
3
you know, the pimento-filled olive.
4
5 MR. FLETCHER: I guess my question is, with the
courses that are available now, how would you advise a
6 young
surgeon who wanted to do this?
7
8 DR. SANTELICES: I would not only recommend, but as
the Chairman of the Credentials Committee of my hospital, I
9
demanded that whoever wanted to do stereotactic biopsies
10
present with a course, knowing quite well that the course may
11
only be the beginning, but at least gave us an idea that this
12
individual had at least went somewhere and took the necessary
13
preliminary teachings required for this.
14 I took the course,
know.
you 15
16 But the question still remains is that course the
end-all to the end-all, and I think Dr. Israel stated quite
17
clearly that it's just the beginning, it's a continuous learning
18
process.
19
20 Yes, sir?
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1 MR. MOBLEY: You noted the lack of a requirement for
a preceptorship or you made some statement regarding that, and
2
you are saying there that there is a need from your perspective
3
as the chair at your hospital, there is a need for the basic
4
training.
5
6 What kind of proposal would you make regarding the
preceptorship?
7
8 DR. SANTELICES: I think that there has been a
document that came out between the American College of Surgeons
9
American College of Radiology, that pretty much deals with
and 10
it. 11The proposal -- I am not here to actually, and I am sorry,
I may be here not fixing the wheel, but at the same token, I
12
am not going to give you numbers -- there is a proposal on the
13
table, 12 has been the number that I think has come out.
14
15 It is not a scientific number, by the way. There is
no way or no mathematic equation to come out that if you did
16
then, you are an expert, because Shay here, her doctor may
12, 17
have done 13, and she got into trouble.
18
19 At the same token, I think that 12 was a result of
per month, 480 mammograms was the result in my mind of 40
one 20
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per month, 10 per week.
1 Is there a scientific basis into a
learning curve?
2 I don't think so. I think that better off
would be to have the preceptor sign off on the candidate.
3 It
may take him one, it may take him 200.
4 He might should change
the job if it's 200.
5
6 MR. MOBLEY: I asked you the question because you
seemed to be out there --
7
8 DR. SANTELICES: In the fringes. I am
disenfranchised.
9 I don't even get a letter requesting my
information.
10 You know, if you don't publish, you perish, but
I am, like I told you, I am not here to pretentious, I am just
11
a Hialeah boy and doing my job.
12
13 MR. MOBLEY: Thank you. By the way, I am not a boy
anymore, I am getting older.
14
15 MS. HEINLEIN: You used a table --
16 DR. SANTELICES: Yes, ma'am, I use the Fischer. I
have had it for six years.
17 I started out the oldfangled little
thing you put the films on, and I am now into digital, I am into
18
computer guidance, and I am still paying the lease company
19
because every time I buy a new piece of equipment, there goes
20
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the bill again.
1
2 MS. HEINLEIN: What personnel are involved while the
procedure is going on?
3
4 DR. SANTELICES: I have a double-certified
mammographer.
5 I stole her from the hospital. She has over 20
years experience.
6 But she was being asked to do barium enemas
and upper GI's, and the like, so when I gave her the opportunity
7
to do strictly breast, she took it, and I took her, and she has
8
been 9with me ever since.
10 DR. MONSEES: Any other questions from the panel?
11 Okay. We will move on to our last scheduled speaker.
12 DR. SANTELICES: Thank you very much.
13 DR. MONSEES: That you very much.
14 DR. SANTELICES: Now comes my plane ticket.
15 DR. MONSEES: Excuse me?
16 DR. SANTELICES: I have to read the letter.
17 DR. MONSEES: I am sorry, you are Number 10 also, is
that right?
18
19 DR. SANTELICES: Yes, ma'am.
20 DR. MONSEES: That's correct.
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1 DR. SANTELICES: Dr. Caplan called me yesterday at
my office prior to leaving and said can I fax you a letter that
2
I want you to read.
3 This morning when I spoke to Dr. Winchester,
I discussed it with him, and I think it is appropriate that I
4
read 5the letter.
6 I also think it is appropriate that it is understood
that 7I am not speaking on his behalf, but rather just reading
a letter that he wrote.
8 Okay?
9 DR. MONSEES: Thank you very much. Why don't you go
ahead.
10
11 DR. SANTELICES: He wrote in little tiny letters, and
I need to get my glasses and go slowly here.
12
13 This letter is written to obviously -- not obviously
-- it is written to Dr. Charles A. Finder, National Mammography
14
Quality -- I am sorry, Madam Chairman, it was not addressed to
15
you, but Dr. Finder, at the time I guess was in contact with
16
Caplan -- and to the members of the committee.
Dr. 17
18 Dear Committee Members: It is my testimony before
this committee one year ago as a breast surgeon and President
19
of the American Society of Breast Surgeons, I stated that
20
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regulations of a surgical procedure should not be, in my
1
opinion, within the jurisdiction of the FDA.
2
3 I am today still convinced that this is the correct
position.
4 The fact that the American College of Surgeons and
the American College of Radiologists have signed off on a
5
document stating their position on joint credentialing for
6
performance of stereotactic breast biopsy procedures does not
7
justify an FDA position in this matter.
8
9 I am reading verbatim.
10 This document is a feeble attempt to compromise
political positions and to end an unpleasant turf battle.
11 It
contains no proven guidelines that would guarantee the quality
12
of the service to our citizens.
13 In fact, I firmly believe that
it would do just the opposite.
14
15 As a breast surgeon, I have more than three years
experience and over 400 cases in stereotactic biopsies with a
16
record equal to the best radiologists in the country, and yet
17
under this guidelines, even I could no longer qualify to perform
18
this procedure, because I cannot document four hours of CME in
19
radiation physics.
20
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1 Nowhere in the document does it state that a physician
must 2have four hours of CME in breast biopsy procedures. I
could offer objections to every other part of this document,
3
but this not the purpose of my statement today.
4
5 I am against the FDA accepting such a document under
any circumstances or compromises for the purpose of regulating
6
a surgical procedure.
7 Instead, I would like to offer the
following.
8
9 The FDA should regulate stereotactic breast biopsy
procedures because it is an imaging procedure and, as such,
10
should come under an MQSA, but I believe that only the
11
stereotactic site should be regulated to ensure the public that
12
it is safe as far as an imaging device is concerned and that
13
certain guidelines are followed regardless of the specialty of
14
physician performing the procedure.
the 15
16 As to whether this physician is qualified to perform
a stereotactic procedure, it should be left up to the credential
17
committee at the local medical facility that determines
18
credentials for all the physicians on its staff.
19
20 How could this be done effectively? The
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stereotactic biopsy facility would be regulated much the same
1
way as mammography facility.
2 Certain installations and
quality assurance measures would be required, as well as initial
3
and yearly inspection by the radiation physicist.
4
5 A mammographic technologist would be required to
operate the equipment and record all case histories and maintain
6
appropriate review of records, films of every procedure, as well
7
as copies of the initial mammographic report, pathology report,
8
and the biopsies, as well as a followup report from the
9
radiologist stating that the biopsy was either in concordance
10
with the mammogram or that an open surgical biopsy would be
11
required.
12
13 Also, a recommended followup exam would be stated in
report.
the 14 This method of documentation is considerably more
reliable in determining the qualifications and expertise of the
15
operator than any arbitrary number of mammograms that an
16
individual must review or the number of cases that must be
17
performed on an annual basis.
18
19 This determination is best left up to the local
credentialing body, who should have better knowledge of the
20
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physician's experience in these areas.
1
2 In summary, then, my recommendation to this committee
be
will 3 to establish an accreditation process for a stereotactic
biopsy site with annual inspections by the FDA and radiation
4
physicists.
5 All the local credential committees to credential
the physicians as they do in all other medical and surgical
6
procedures.
7
8 This would assure the public of a safe and qualified
stereotactic site, while at the same time not require that the
9
involve itself in medical credentialing.
FDA 10
11 These recommendations may not satisfy those whose
intent is only to politicize the issue for their own interests,
12
it
but 13 will guarantee to the women in this country continuing
access to quality breast cares which are both safe and
14
responsible.
15
16 Thank you. Robert B. Caplan, M.D.
17 DR. MONSEES: Thank you. Well read. I don't know
whether or not you feel that you can answer any questions, but
18
there was one part that I didn't quite hear, that maybe you can
19
just clarify for me by referring to that document.
20
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1 DR. SANTELICES: Yes, ma'am.
2 DR. MONSEES: It was the concordance/discordance
issue.
3 Did he feel that it was the technologist's job to
establish whether there was -- I didn't quite get that.
4
5 DR. SANTELICES: Not from reading the letter, I
didn't get the gist.
6 I thought from reading the letter, he
meant the radiologist.
7 Now, like Dr. Israel, I do not use a
radiologist for that purpose, concordance or discordance.
8 I
use him to read about 2,500 mammograms that are done in my breast
9
centers on an annual basis, but the concordance really comes
10
at the time of reading the pathology report.
11
12 If I was looking for micros, and I didn't get them,
first thing I do, I ask the pathologist to do more serial
the 13
cuts.
14 If he tells me, "You didn't get them," I will then repeat
mammogram and work on that basis, however, I do specimen
the 15
films and many times I have told the pathologist you may not
16
seen them, but here they are, and there is two cores and there
17
all the little micros right there.
are 18
19 So, at times you can have a path report that doesn't
you
say 20 have micros, but yet your specimen film shows it. Now,
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if I 1am looking for something that should be at least
fibrocystic, and I just get fibroadipose tissue, I don't feel
2
I have concordance.
3 In cases like that, we repeat the
mammogram.
4
5 DR. MONSEES: Thank you.
6 MS. HEINLEIN: I, too, got the gist from the reading
of the document that it was the responsibility of the
7
technologist to do the followup and medical audit information.
8
Would you mind just going back to the document and reading that
9
sentence that is in there?
10
11 DR. SANTELICES: Yes, ma'am. I may start a little
before, so I can get the whole meaning.
12
13 A mammographic technologist would be required to
operate the equipment, and records of quality and case histories
14
would be maintained for review during an annual inspection as
15
is currently required for a mammography facility.
16 In addition,
either the local credentialing body and/or the FDA would also
17
require the facility to maintain the digital film records of
18
every procedure, as well as copies of the initial mammographic
19
report, pathology report on the biopsies, and a followup report
20
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from 1the radiologist stating that the biopsy either was
concordant with the mammogram or that an open surgical biopsy
2
would be required.
3
4 Also, I recommend the followup exam would be stated
in the report.
5 This method of documentation is considerably
more 6reliable in determining the qualifications and expertise
of the operator than any arbitrary number.
7
8 So, I didn't see, I didn't read that.
9 DR. MONSEES: Thank you. I didn't hear that
initially.
10 What he is saying is that the surgeon would do the
biopsy and the radiologist would determine whether there is
11
concordance or discordance.
12
13 DR. SANTELICES: That is what the letter states. I
brought to your attention that in my case, I don't, and Dr.
14
Israel doesn't.
15
16 DR. MONSEES: Right. Thank you.
17 I think probably we should put a copy of the letter
in the record.
18 Likewise, the letter that you read, we would
like to have probably also put.
19 Thank you.
20 DR. HENDRICK: There is a new concept introduced in
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this 1letter, which is that the medical board -- I think is the
phrase that was used -- should be sufficient to ensure the
2
credentials of the physician performing this procedure, and I
3
don't fully understand the realm of governance of medical
4
boards, but I thought they had to do with hospitals.
5
6 DR. SANTELICES: Right, and he stated credentialing
body 7of the hospital or/and facility. As the Chairman of the
Credentials Committee and dealing with something that was
8
brought up as a matter of record, laparoscopic
9
cholecystectomies, when they first started out, we really
10
didn't know how many numbers to ask of the physician, and each
11
hospital sort of set up their own little guidelines, three on
12
your own, three with preceptorship, bring a copy of the course,
13
what I do know as far as credentialing, that any new
but 14
procedure that is done in the hospital needs to be approved by
15
Credential Ethics Committee, and then anybody who is going
the 16
to do it, whether it is transesophageal sonography, whether it
17
is transcutaneous pacemaker, or percutaneous, whatever, first,
18
procedure gets approved, and then the physicians have to
the 19
provide qualifications for the procedure.
20
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1 Each hospital does take different parameters. Some
hospitals require three, some hospitals require five, some
2
hospitals say if you prove it on the first shot, you don't need
3
to do it on the second or the third.
4
5 DR. HENDRICK: Just to follow up on that, what is the
issue with non-hospital settings for performing stereotactic
6
biopsies?
7
8 DR. SANTELICES: Well, non-hospitals, short of a Dr.
Israel or myself or maybe two out of three, don't really exist.
9
This machine is very expensive and nowadays the financial
10
remuneration for the biopsy has gone down so low, I don't think
11
that one person alone can ever be involved.
12
13 So, it usually falls into a single day surgery,
outpatient surgery, that has their own credentialing body.
14
They all have their own bylaws.
15 Nowadays, starting in 1998,
they are going to be checked out by the Joint Commission also.
16
Right now they are in a voluntary state of being evaluated, but
17
starting next year I think that the outpatient facilities are
18
going to fall in the Joint Commission also.
19
20 So, there is a whole set of credentialing and
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guidelines that go on.
1
2 DR. HENDRICK: I know of some non-hospital settings
in which stereotactic is being done.
3
4 DR. SANTELICES: Of course, because when this first
started, like Dr. Dowlat said, it was first a car with four
5
wheels and a steering wheel, and a lot of people got access to
6
it. 7
8 As it has grown in complexity, and with complexity
and as it has grown in expenses, not very many people have a
9
quarter of a million dollars to spend on a machine whose
10
remuneration is about $350 combined global fee.
11 You have to
do a lot of breast biopsies to be able to pay for that machine
12
if you are by yourself.
13
14 But you are an institution that has 10, 12 surgeons,
four or five radiologists, all working in unison, then, you can
15
afford the machine, and that is where that machine is going.
16
17 I think, like everything else, when the Wright
Brothers got into the first airplane, you know, and the FAA and
18
1997, there is a whole variety of circumstances.
19
20 DR. MONSEES: I think we have another question from
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the panel.
1 Dr. Sickles.
2 DR. SICKLES: I just wanted to clarify this a little
bit. 3 It would seem to me there might be a problem had there
been 4reasonable numbers of outpatient facilities operated just
by the individual or a few individuals who were doing it and
5
credentialing themselves.
6
7 DR. SANTELICES: Right.
8 DR. SICKLES: What you are trying to tell us is that
those facilities are few and far between?
9
10 DR. SANTELICES: Yes, sir. Again, I never came here
professing to be an expert in the worldwide use of this
11
equipment, just in Hialeah, along which by now has three in the
12
city that one is enough.
13
14 The machine is very expensive and the complexity of
the apparatus that are added on is also very expensive.
all 15
Very few centers right now, unless they have a very large budget
16
backing them, can afford it.
17
18 Now, you are going to have, you know, your grandfather
period of the first four or five years of anything that you are
19
going to have to deal with somehow, but I think that if you put
20
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it under MQSA as a site facility, if you do stereos, you are
1
probably doing mammos.
2
3 DR. SICKLES: Are you concerned with proliferation
of this equipment beyond its need?
4 This is actually something
that 5happens frequently with imaging equipment.
6 DR. SANTELICES: I think that the medical economists
are always concerned that new technology calls for new testing,
7
and the proliferation of that technology calls for the overusage
8
of the technology.
9 I want to echo Dr. Israel's word and the
first surgeon -- I apologize I can't remember his name -- as
10
surgeons, and we don't read mammography, we really act upon a
11
read mammographic report.
12
13 I encourage this body to encourage the American
College of Radiology to encourage the BIRAD's reading, because
14
still to this date, I get a two-page mammographic report that
15
got a lot of flowers in it, but at the end it leaves you
has 16
like whoa, where is this coming from, and it is sitting in your
17
hands.
18 They are the ones who are actually telling you surgical
correlation, surgical consultation requested, and it falls at
19
end, the surgeon decide I am going to biopsy this, I am not
the 20
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going to biopsy, depending on the surgeon and the psyche of the
1
lady, because many times the surgeon may feel comfortable not
2
biopsying it, but if he is smart, he is astute, and he knows
3
how to read his patients well, he knows that this lady is going
4
to be better off with a biopsy, because if you tell her no, she
5
is going to go someplace else anyway because she is certain she
6
needs to have it done.
7 That is what bedside manner are.
8 DR. MONSEES: Thank you, Dr. Santelices.
9 DR. SICKLES: Getting back to the question that I was
trying to get at --
10
11 DR. SANTELICES: I didn't elude you, did I?
12 DR. SICKLES: No, but you went beyond. I have some
concern in allowing facilities to credential themselves if
13
there is proliferation of equipment to the point where
14
facilities are at an individual level, because then the
15
individual would be credentialing himself or herself.
16
17 DR. SANTELICES: Correct. I agree with you.
18 DR. SICKLES: And that is my concern, and I am just
wondering whether in your experience you see this coming.
19 I
know you can't testify for the man who wrote the letter.
20
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1 DR. SANTELICES: No, I don't see it coming for the
economic reasons that I told you.
2 I also don't see it coming
because with the MQSA Act, the centers which are doing stereos,
3
if they can afford stereo machine, rest assured they have a
4
mammogram machine.
5 I think that what Dr. Caplan was trying to
lead 6to is that what you would be looking at is to make sure
that 7the site is regulated, and once you set a regulation in
the site, the site has no choice but to go ahead and hire
8
physicists to come once a month to do the quality assurance,
9
to do the followups, to keep you tracking, which is what MQSA
10
all about.
was 11
12 DR. MONSEES: With that, I thank you very much for
your comments.
13
14 I would like to make one more call, because we started
early, for Joseph Rush.
15 Has he come?
16 Okay. We will at this time move to our break. Let
me tell you we will reconvene promptly.
17 At 11:45, we will begin
session, so please be seated a few moments before then.
the 18
19 [Recess.]
20Overview of Interventional Mammographic Procedures
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1 DR. MONSEES: This morning we have heard important
statements from people from the community and now we are going
2
to hear an overview of interventional mammographic procedures
3
by Dr. Rebecca Zuurbier, Assistant Professor of Radiology and
4
Director of Breast Imaging at Georgetown University Medical
5
Center.
6
7 She will be outlining, for those of us who are less
familiar, with the different interventional breast procedures,
8
so that when we go into our more detailed discussion of what
9
needs to be addressed, those of you are less familiar will be
10
conversant with this.
11
12 Following her presentation, which she estimates will
be less than the appointed time, there will be some time
13
hopefully for a question and answer session.
14
15 Can we do anything else for you?
16 DR. ZUURBIER: No, thanks.
17 DR. MONSEES: She has been invited by the FDA to make
this presentation, and we thank her very much for doing that.
18
Please go ahead.
19
20 DR. ZUURBIER: It is a pleasure. I appreciate the
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invitation.
1
2 [Slides.]
3 I know that Dr. Finder, when he called me up, said
that 4this was going to be a mixture of initiated and uninitiated
individuals, and I am afraid I might see more initiated
5
individuals in the crowd than not, so I apologize.
6 I hope most
of you don't assume the demeanor of the young lady on the left.
7
8 In any event, I know, especially when I teach my
residents, that it is very important to limit the topic to no
9
more than four or five things, otherwise, the attention span
10
goes down as the heat in the room goes up, and hunger levels
11
increase, as well.
12
13 So, my talk today is going to be focusing -- and please
excuse my back, I will try and minimize my shadow here -- to
14
four topics:
15 stereotactic breast biopsy, which most of you are
familiar with, fine-needle aspiration cytology, preoperative
16
needle localization, and galactography, in other words, when
17
x-rays and needles collide, and these are the four things that
18
happen.
can 19
20 [Slides.]
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1 My first focus will be on stereotactic core breast
biopsy.
2 Now, that is a multiple line slide, which I want you
to read and digest again.
3 Stereotactic core breast biopsy. I
think we all realize by now that it is an accurate, reliable,
4
cost-saving alternative to open surgical biopsy when we have
5
to manage mammographically detected breast lesions.
6
7 I like to say that mammography isn't free, just like
freedom isn't free, mammography isn't free.
8 It's a wonderful
test 9widely available, known to decrease the number of deaths
from biopsy cancer for women screened 40 and above --
10
ironically, we actually have more proof of this efficacy for
11
women in their 40s now than for the 50 and above level -- but
12
it comes with a price tag, and the largest induced price tag
13
is that incurred with the surgical consultation and biopsy it
14
is estimated at $2.3 billion.
15
16 Not only is there a fiscal price tag, there is one
that is physical and psychological and mammographic when we
17
consider the psychological scarring, the physical scarring, and
18
scarring that can occur on a mammogram subsequent to the
the 19
open surgical biopsy.
20
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1 So, we have a great debt, and I think Dr. Parker's
name 2has been invoked before here for developing a technology
and having the skill, as it were, to put together the need with
3
the answer, the technology with the answer.
4
5 [Slides.]
6 Stereotactic core breast biopsy involves about four
things.
7 We use a prone table with an aperture, preferring the
prone table because it eliminates the potential complications
8
of the vasovagal reaction, the fainting that might occur, as
9
well as the motion as a woman is approached with a 14- or 11-gauge
10
needle into her breast.
11
12 Digital imaging capability has really revitalized
technology.
the 13 Before, you had to take a film, run it through
your rollers in your processing room, hopefully, have a speedy
14
technologist with sneakers, and that could take a three-minute
15
process in between these diagnostic mammograms.
16
17 Now we have digital imaging capability, which simply
means you press a button and the image comes up on a computer
18
screen within a matter of seconds, a biopsy device, and this
19
is an area of high interest, I will be showing you what is
20
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typically used and then a couple evolutions on that theme, and
1
finally, a patients with a mammographic lesion, and I say that
2
tongue in cheek, but not really.
3
4 We really want to commit ourselves to biopsying only
those things that required biopsy.
5 It shouldn't be an excuse
for a lazy mammographic workup or inappropriate counseling of
6
a patient with a probably benign lesion for which we would
7
otherwise recommend mammographic followup.
8 So a patient needs
to have a mammographic lesion, a real one, a true one, one for
9
which a radiologist would recommend biopsy.
10
11 [Slides.]
12 I give equal time to the manufacturers that are
preeminent currently in the field.
13 The Lorad and the Fischer
tables.
14 The Lorad table, the patient can lie with their head
either to the left or the right, affording a 360-degree access
15
to the patient's breast.
16
17 The Fischer table, the patient lies with their head
on one end, the breast is suspended through an aperture, and
18
system works, if I can just take a minute to step up, just
the 19
like getting a mammogram taken except you are lying on your
20
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stomach.
1
2 So, we have the table. We have the x-ray device.
The patient lies prone, and many mammograms are taken.
3 These
mammograms are typically 2 inches by 2 inches in diameter.
4
5 In between this mini-mammographic unit is the biopsy
device, and this is where we will be focusing a little more later
6
on. 7I throw in the computer here because this is that 2-inch
by 2-inch mammographic picture that is blown up on the computer
8
screen, and being on a computer, that affords us an ability to
9
manipulate the image.
10 We can adjust the contrast and the
magnification.
11
12 [Slides.]
13 I think this the hardest part of the procedure, and
that is not making sure you are well coiffed with lipstick and
14
nails done for the stock slide.
15 The hardest part is occurring
right down here, which is getting that mammographic lesion
16
reliably depicted in again a small area.
17 Here is that 2-inch
by 2-inch window, and it is noncompressed, so we can't separate
18
structures as effectively as we can out here on either side.
19
20 So, I find as a radiologist that that is probably the
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most 1challenging portion of the procedure, both for the
technologist and the radiologist working together.
2 What we do
is take two stereo pictures, and simply put, a stereotactic
3
device is easily found in between your shoulders.
4 It is your
head, two eyes and your brain, which is to say that if you put
5
your 6finger in front of your nose, and you only had one eye open,
you couldn't tell how far your finger was from your nose.
7 So,
your 8eyes act like stereotactic devices. One eye opens. If
you alternate, you see your finger seems to shift in space.
9 We
do this when things get slow in the radiology department.
10
11 But you need two eyes, and that is where the computer
to
is, 12 tell you exactly where that finger is in relationship
to your nose.
13 So, if I only had one picture, I would only be
able to tell you, for example, that the lesion was here.
14 I know
where it is in my horizontal plane, right here, I know where
15
it is in my vertical plane, the y axis here, but how deep does
16
my needle need to go in to get to it, and so these stereo views
17
taken.
are 18
19 This is the same breast, nobody is moving, the camera
is moving, and it looks like the lesion moves in space.
20 In fact,
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it doesn't.
1 Then, we target it, and here are these two squares
there targeting the center of the lesion, and the circles around
2
it are the other offsets or areas of the lesion which we will
3
be sampling.
4
5 Now, this is what is used most often now, which is
a spring-loaded gun device.
6 We will be talking a little bit
about other evolutions on that theme, but the idea of core biopsy
7
is to sample the lesion, and so we sample it that way.
8 We
identify it, we find it.
9
10 [Slides.]
11 Then, as I said before, this is just the computer
depiction of it.
12 We can magnify this area. Again, we are
targeting with the square, providing offsets, and here is the
13
information.
14 This is the depth that my needle has to go into
breast.
the 15 So, there is very little human error that can be
applied except for the depth adjustment using -- this is with
16
Fischer table that we use currently.
the 17
18 [Slides.]
19 The patient is then anesthetized. This is the
surgical portion here where we apply a lidocaine that is
20
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buffered, so there is very little, if any, burning experienced
1
by the patient.
2 We make a small nick in the skin, and then we
will 3be introducing the needle.
4 [Slides.]
5 We obtain what are called pre-fire pictures to
ascertain that the lesion is indeed in the vicinity of the
6
needle.
7 In fact, we want the needle tip to be just proximal
to it in both views.
8
9 I apologize. This is a separate lesion here. You
will note this is a soft tissue mass.
10 These are
microcalcifications.
11 Here is the pre-fire picture. We press
button.
the 12 The spring-loaded gun is deployed and with the
velocity of a .22-gauge or caliber -- somebody in the military
13
corrected me, and I was too flustered to remember which one --
14
it is really darn fast.
15 It will sample the lesion.
16 [Slides.]
17 The typical specimen that we obtain is with a 14-gauge
is
gun 18 about the caliber of a number 2 pencil lead, and it is
about an inch long, and this is how you can see it before we
19
place it into the test tube to send off to the pathologist.
20
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1 Now, I want you to again focus on what is happening
underneath the table.
2 This is what I think is most commonly
used 3right now, is a spring-loaded gun. We use the Biopty gun.
We can use it to sample -- it has been used to sample solid
4
organs, the kidney, the liver, the prostate, and so it samples
5
it. 6
7 So, basically, after you are done sampling your
lesion, your lesion looks like one of those FBI target things
8
that 9you use when you are practicing your aim. It has little
holes in it.
10 As big as that guy is, that's how many holes may
be carpeting that guy.
11
12 We typically take about nine samples. Five is the
minimum number recommended.
13 It is done by placing the needle
bang, withdraw.
in, 14 Put it in your saline for subsequent
transfer to your formalin.
15 Put it in again, bang, and the whole
procedure takes less than an hour if everybody is doing
16
everything right and everything can be found.
17
18 [Slides.]
19 The interesting variations are evolutions of this,
clouding the area in between minimally invasive to
are 20
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excisional biopsy.
1 We can move into now what is called
mammotomy or the Mammatome device, which is vacuum assisted.
2
Now you only have to put the needle in once, and a vacuum actually
3
will 4suck the material of concern into a similarly sized notch
there.
5 It can actually be up to 11 gauge in size.
6 What is the advantage here? The advantage is you
only 7need to place the needle in once. You obtain continuous
samples that maybe have higher integrity.
8 It has been shown
that 9you have a more reliable collection of microcalcifications
larger size of your material to send to the pathologist,
and 10
in
and 11 the pathologist's world, more is more, so the more tissue
give them, the better and more confident their diagnosis
you 12
is. 13
14 So, the vacuum assist device is another evolution on
way.
the 15 Some concerns, well, sometimes you can actually
eliminate the whole lesion.
16 For example, if that were the
microcalcification cluster, that ended up being a in-situ or
17
invasive carcinoma, where do you go back to tell the surgeon,
18
kind of apologize and say, it's in that area and you hope
you 19
still have a tatoo with some air holes or some hematoma.
you 20
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1 But somebody answered that question, too, and said
let's deploy a little titanium clip, and so a clip can be
2
deployed into that area to mark the site if there is concern
3
that 4the whole lesion has been sampled.
5 [Slides.]
6 Let's advance one more step toward excisional biopsy,
and that is the ABBI system.
7 Now, those of your that are still
alert will note that this is not actual diameter size, but just
8
to point out that the ABBI system can vary the caliber lesion
9
accumulation.
10
11 Let's go back to our analogy of that little target
that you use in firing range practice, and with the
12
spring-loaded gun, you get a guy that looks like he has Swiss
13
cheese hold in him.
14 With the vacuum assist device, you can core
and core out, and you can take out heart, and if the lesion
out 15
is as big as his lungs, you can just keep vacuuming that area
16
out.
17
18 With the ABBI device, you can just take that whole
poster and bring it with you.
19 The advantage to that may be that
have, again in the pathologist's world, more is more.
you 20 There
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may be some down sides, which I don't feel comfortable
1
commenting on whether they are going to be cumulative enough
2
or non-cumulative enough to warrant further use, but there is
3
concern about cosmesis.
4
5 [Slide.]
6 All the things that made stereotactic core breast
biopsy a beautiful thing, cost savings, improved cosmesis, no
7
mammographic scarring, very low complication rate with
8
hematoma, are now called into question a little bit on the side
9
of getting more tissue for the pathologist, which is to say
10
Langer's lines, which are important to most breast surgeons,
11
which follow the curvature of the biopsy, help eliminate any
12
notable scarring.
13 You might not be able to appreciate a
Langer's line when a patient is prone on a table and when you
14
making a 2-centimeter incision to take out that column of
are 15
tissue, you do have greater worry about hemostasis, about
16
extraneous tissue collection because you are taking that whole
17
column in front of the lesion.
18 So bleeding and infection
concerns, you have to use suture material if it's a big incision
19
to address that.
20
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1 Then, we have unanswered questions about what is the
effect on the mammogram also, so is there going to be
2
mammographic scarring as a result of a larger core accumulation.
3
just point out that there are advantages and disadvantages
So I 4
to all of these, and it is kind of a progression of invasiveness
5
from 6the stereotactic spring-loaded biopsy device through the
vacuum assist, through the ABBI system, which can afford larger
7
core 8sampling, until we get to, well, why don't we just a
preoperative needle localization.
9
10 [Slides.]
11 Well, I offer this vignette. My sister, who is a
breast surgeon, an excellent breast surgeon actually, and she
12
will be the first to tell you that, will chide me at the
13
Thanksgiving dinner table -- and I am really looking forward
14
to the holidays -- for the radiologists at her facility have
15
a needle localization that she orders preoperatively is really
16
helpful only to her to identify which breast the lesion is in,
17
then it is only right 50 percent of the time.
and 18 So, this is
what I deal with.
19 This is what we deal with as radiologists.
20 It is funny, but it is not. I point out the need to
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have 1very good communication with the radiologist and the
surgeon.
2 This is a very cooperative effort. You need to know
the limits of your talents and their talents, what they will
3
tolerate, but let me just go through and show you how this works.
4
5 Preoperative needle localization, when do we use it?
When 6you can't feel it, and it has got to come out. So, it is
for a nonpalpable mammographic lesion which was recommended for
7
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
10
concern.
11
12 [Slide.]
13 Before the localization again, do the dance with the
surgeon or the surgeon should do the dance with the radiologist,
14
review the imaging workup.
15 There is nothing I hate more than
canceling a needle localization because somebody had not worked
16
that milk of calcium appropriately on the outside, or had not
17
found it appropriately.
18 This delays your schedule and creates
kinds of hand wringing and the patient of course is not happy
all 19
about it either.
20
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1 We avoid premedicating the patient. We like to
obtain lucid informed consent.
2 We also need their cooperation
to sit and maintain position while we are doing this procedure.
3
It is a procedure that I like to tell my patients sounds worse
4
than 5it is, not that is great and I would want to have this done
in my lifetime, but it is very well tolerated by the patients
6
especially after good counseling.
7
8 The idea is to take the shortest approach to the
lesion and most people do it parallel to the chest wall.
9 Some
people do it free hand, but we are going to be addressing how
10
I think the mainstream does it.
11
12 So, first we identify the lesion on the mammogram,
if
and 13 you aren't familiar with mammography, this is the view
basically from the side of the breast, side to side, so the head
14
is up here, the feet are down here, the nipple is here.
15
16 So, the shortest distance to the lesion is looking
right here, but let's look at the view from top to bottom of
17
breast.
the 18 We call it the craniocaudal view. So, the nipple
is here, her lungs are here safely out of the way, her armpit
19
is here, her sternum is here.
20
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1 The lesion is here. It is not going to be very
prudent to come a long way here, long way here.
2 Let's take the
shortest distance.
3 It helps the surgeon, helps the patient,
so we choose the shortest distance to the lesion.
4
5 [Slides.]
6 My thanks to Dr. Kopans, whom I have lifted these
films from his book.
7 I trained under him, so I feel I
contributed somehow and could copy these films.
8 This is a
picture from his book, which demonstrates how we do it.
9
10 We need an alphanumeric grid. Sometimes people have
little Swiss cheese grids, one of those grids that has a bunch
11
of holes in them.
12 I like this one. It is very accurate for
purposes of the surgeon.
the 13
14 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
15
like Battleship -- E and 1.5.
16
17 [Slides.]
18 We put a little X there, and then I turn on the light
that is provided by the mammographic unit, and I turn off the
19
lights in the room, because that light shining down is going
20
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to help me avoid any shadowing of the needle, so I can have a
1
very 2precise downward placement of the needle without any
angulation.
3
4 Dr. Kopans has done just a few of these. In fact,
this 5is his needle/wire system, and so we can see that he has
placed the needle beautifully.
6 There is very minimal
angulation of the needle.
7 That is a long needle and that is
the only part of the shaft that we see.
8
9 We typically don't use a skin anesthetic. We used
to use a spray anesthetic.
10 They are not manufacturing that
anymore, but they found that the patients actually, when they
11
a
did 12 study, had a higher perception of pain when you gave them
lidocaine than if you just stuck the darn needle in.
13 A needle
stick is a needle stick.
14 Again, I haven't had one done yet.
I don't know if I can justifiably say.
15
16 [Slides.]
17 We then take a picture from the side or from the
opposite view of where we started with the needle in place.
18
Now, we intentionally overshoot the lesion.
19 If you leave the
surgeon with a needle like that, he or she is going to be
20
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irritated because once they get that far, this is a 360-degree
1
question that they have, which way do I go.
2
3 So, we want to get across the lesion with the needle,
and then with the Kopans wire system, we would place in through
4
that 5needle a very thin wire that has a little barb on the end
of it, and when that deploys, that stays and anchors the needle
6
in the breast, and to give the surgeon a tactile orientation,
7
it has a thickened segment indicated by those short arrows.
8
This 9is a nice placement with the lesion right at the center
of that thickened segment.
10
11 The surgeon has the option of dissecting down from
top to the lesion or perhaps make a periareolar incision
the 12
which may be more cosmetically appropriate, and work their way
13
back to the lesion.
14
15 At Georgetown, we actually also use the Homer needle,
which has some variations on it, as well.
16 I call it
resident-proof, because the wire at the end of it isn't a barb,
17
it's a retractable, like a fishhook thing, so if the resident
18
makes a mistake, we can just start over and provide another
19
positioning.
20
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1 [Slides.]
2 The lesion is then dissected and to make sure that
there has been an appropriate sampling of the lesion or excision
3
of the lesion, we actually take an x-ray, and we like to see
4
the bulk of the lesion contained within it.
5
6 The potential complications are similar to when you
get a blood sample taken - bleeding and infection.
7 I don't
usually mention vasovagal reaction because that is a very
8
suggestive thing, but I monitor the patient very carefully, and
9
I have smelling salts available in case there is any problem,
10
pneumothorax, I don't indicate as a potential complication
and 11
if I am going parallel to the chest wall.
12 Like I said, some
people still do it freehand and kind of guesstimate where it
13
and go back and take some pictures.
is, 14 Pneumothorax is
reported with those types of approaches.
15
16 [Slides.]
17 We are going to move on to our number three issue,
that is the fine-needle aspiration cytology.
and 18 When would
use fine-needle aspiration cytology?
you 19 If you have a new
mammographic lesion and you want to sample it, but you really
20
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don't want to take it out.
1 When it is something that the surgeon
can feel, and when you, as a radiologist, just can't tell the
2
patient if it is a complex cyst meaning it's okay, but it has
3
some 4debris, hemorrhage, proteinaceous material in it that
could mimic a solid lesion.
5
6 So, in those cases, I, as a radiologist, like to do
a needle aspiration.
7 Typically, if it's a palpable mass, the
surgeon will use their fingers as a guidance, and I don't
8
typically use mammography to guide me.
9
10 [Slides.]
11 However, there is a suggested method for it. I think
it is used especially if you are concerned that what you are
12
sampling mammographically is or is not the same thing that you
13
at
see 14 ultrasound. So, if there is a correlation concern, I
use mammographic guidance.
may 15
16 [Slides.]
17 But the typical scenario would be this new nodule that
we find on the mammogram, ultrasound shows us this circle that
18
is not completely round, and it's a little gray in the middle
19
of it.
20 Is this a solid lesion? Is this a complex cyst? I
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don't know.
1 Let's stick a needle into it and find out.
2 [Slides.]
3 One can do that actually using a grid localization
device.
4 One would proceed, just as with a needle localization,
using an x-ray picture with a grid superimposed to guide
5
placement of the needle.
6
7 Aspiration is applied, and the material is put on a
slide and fixed, and preferably you will have a cytopathologist
8
there, if it is a solid lesion, to identify whether there is
9
sufficient material.
10 If it is fluid, we just send off the test
tube and that is a controversial area also.
11 Some people don't
send off the fluid at all.
12
13 [Slides.]
14 I want to emphasize that fine-needle aspiration
cytology is usually performed with ultrasound guidance, because
15
we can, under real-time, follow that needle going into the
16
breast, and frankly, we don't hardly use
17
mammographically-guided fine-needle aspiration cytology at
18
all.
19
20 [Slides.]
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1 Now, let's step back and do a little comparison
shopping thing.
2 What is the difference then between the
fine-needle aspiration cytology and the core breast biopsy?
3
Needle size.
4 Thin needle for fine-needle aspiration cytology.
I can bend it with my finger, a 20- to 25-gauge.
5
6 Core biopsy, I have to use my arms and maybe my foot
to step on it, so it's a longer, thicker, bigger needle, 11 to
7
14 gauge.
8 It results in a different type of tissue and material
that 9we are looking at.
10 We only get to look at the cells when we do cytology,
so it only sucks up those little tiny wispy little cells.
11 With
core biopsy, we get the tissue.
the 12 We can see the structure
that the cells are forming, and we can make a more accurate
13
diagnosis.
14
15 Not only can we say benign versus malignant, which
is basically what fine-needle aspiration cytology can do, core
16
biopsy can allow us to say invasive, non-invasive, we can do
17
kind of estrogen/progesterone testing on it, so it gives
all 18
us a lot of information for your buck.
19
20 With fine-needle aspiration cytology, you have to
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trust your pathologist who has been specially trained to look
1
at just the cells, where with core biopsy, you don't need a
2
trained cytopathologist.
3
4 Fine-needle aspiration cytology, possibly less
accurate.
5 As I described before, it only gives you an idea of
benign versus malignant, and if that is all you really want,
6
that 7is all you are going to get. Thirty percent of the time,
though, up to 30 percent of the time, the pathologist will say
8
insufficient material, can't tell you either way.
9
10 Core biopsy, very accurate. Tissue is the issue, and
they can make a definitive diagnosis, and insufficient sample
11
would be very rare.
12 So, the cheaper versus expensive aspect,
I think is very debatable and I tend not to use the fine-needle
13
aspiration cytology.
14 If you are going to use imaging guidance
to get a needle in there, make sure you are getting the answer
15
when you are there, but some people still like fine-needle
16
aspiration cytology, like I said with 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.
20 I think this
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is most underutilized and most fun procedure to do.
1 When do
we do it?
2 Well, again, okay, I haven't had one, but it's fun
for me down the other side.
3
4 It is to aid evaluation of a clinically suspicious
nipple discharge, and what is clinically suspicious?
5 Usually,
one that is unilateral and spontaneous.
6 Most of us can get some
-- most of us women can get some type of an aspirate from our
7
nipple.
8 In fact, we use it at Georgetown as a test to see if
we can actually predict cancer in the duct system, but the
9
important one isn't the one that you can express with
10
aspiration, but rather the one that is spontaneous.
11
12 You might see a spotting in the bra and typically,
it is unilateral, so it is for a clinically suspicious nipple
13
discharge.
14
15 [Slides.]
16 The galactogram is a very elegant road map. I am not
sure how some of the surgeons in here use it or appreciate it,
17
at
but 18 Georgetown, many of our surgeons appreciate its ability
to answer several important questions before they would go in
19
do
and 20 the duct dissection, which is where does the duct go.
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1 You have about 8 to 10 separate holes on the surface
of the nipple, and not all of them predict accurately which way
2
they 3are going to go. For example, on the nipple at 12 o'clock,
the duct system might actually subtend the area more toward 3
4
o'clock.
5 It might communicate with a different duct system.
6 So, how does it branch, does it communicate with
another system?
7 Is the duct system normal-looking, is it
abnormal-looking?
8 Are there lesions? Where are the lesions,
nearer to the nipple, way back yonder?
9 Those are the questions
that we can answer with a diagnostic study.
10
11 We also aid the surgeon preoperatively by doing a
study that has contrast mixed with a blue dye, so that we can
12
tell them this is where the branching duct system goes.
13
14 [Slides.]
15 So, what do we need? These are galactography
essentials.
16 I use a 30-gauge blunt tip needle. A 27-gauge is
largest that I think you would feel comfortable using, and
the 17
it is a needle that we actually use also to cannulate your
18
salivary glands, a very small, fine needle, blunt-tipped.
19 We
don't want to do any damage to the orifice.
20
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1 We use high-density contrast. Why? Because it is
going to be mixing in with all that duct discharge, and it is
2
going to be getting diluted.
3 Goofy magnifying glasses, the
most 4critical part. You need not only your glasses or a 2 times
magnifying glass, at least a 5 to 10 times magnifying system
5
to see exactly where that little discharge is coming from on
6
the surface of the nipple.
7
8 Of course, the nipple discharge, if the patient
doesn't present that day, or you can't elicit the nipple
9
discharge on the day of the study, you ain't doing the study.
10
11 [Slides.]
12 The patient is out of the field of view save for her
nipple right here.
13 Here are the aforementioned Goofy glasses.
This is the contrast material.
14 It is connected by tubing and
this person has successfully cannulated or it looks like they
15
about to successfully cannulate that tiny orifice on the
are 16
nipple.
17
18 After we inject contrast into the nipple system, and
we inject just to the level of when the patients may say I feel
19
fullness, we have efflux of material from around the needle,
20
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or I 1actually feel some pressure or some pushing back on the
syringe plunger, I will stop and take a few pictures.
2
3 My initial pictures are made with the needle in place.
I
Now, 4 say this is fun, because it really doesn't hurt that much,
maybe a little uncomfortable as I trying to cannulate it, but
5
we are not piercing skin.
6 If it hurts, you are doing it wrong.
We want to go through an established hole in the breast that
7
is usually lubricated by the discharge itself.
8
9 So, once you plump it in there, you take some pictures
there are fun things that you can find in there, and
and 10
unexpected things.
11 This patient has an abnormally dilated duct
system.
12
13 I can tell the surgeon the duct system goes, for
example here, and it actually branches off here, and here is
14
a large filling defect.
15 That is where you have got to be real
careful while you are doing your dissection.
16
17 This other patient alternatively had a pretty simple
non-dilated duct system, but multiple filling defects, and they
18
extend far posteriorly.
19 So, again, to tell them where the duct
system goes, where the lesions are, and how many there may be,
20
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a very important system.
1
2 [Slides.]
3 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
4
early now for some reason.
5
6 But mammography is a wonderful tool, it saves lives,
but there are mammography problem children where things where
7
we just need a needle to collide with a mammogram and the breast
8
to find out the answers to some of the questions that mammography
9
raises.
10
11 [Slides.]
12 So, I offer again, in summary, stereotactic core
breast biopsy, which I think is a revolutionary, probably the
13
quietest revolution in health care today, as a cost saving
14
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,
18
that is also an acceptable procedure.
and 19
20 [Slides.]
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1 Mammographically guided fine-needle aspiration
cytology, don't really do it much under mammography.
2 I show
this 3picture, which is actually a ultrasound picture, and here
is a 4needle approaching a lesion, and I can, under real-time,
follow this needle into and through the lesion.
5
6 So, I tend to use fine-needle aspiration cytology
using ultrasound guidance.
7
8 [Slides.]
9 Finally, galactography, just because you don't know
what you will find, and this is an abnormal dilated duct system
10
with multiple filling defects in it.
11
12 With that, I will thank you for your kind attention.
I hope I didn't bore too many of you.
13 If Dr. Monsees pleases,
I would be glad to answer any questions.
14
15 DR. MONSEES: If you don't mind, any questions that
come up, you want to field them, or there are other qualified
may 16
members of the panel that might be able to answer specific
17
questions.
18
19 Does anybody on this panel have any specific
questions?
20 Dr. Winchester is going to ask a question.
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1 DR. WINCHESTER: How many radiologists really care
about galactography?
2
3 DR. ZUURBIER: I would say, in the metropolitan area,
there are probably five to 10 radiologists that do it reliably
4
and happily.
5 The vast majority are afraid of it and that is
why I say it is underutilized, I think.
6
7 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
8
it affords, without a lot of pain or hassle, good information
9
an
for 10 accurate duct dissection.
11 DR. WINCHESTER: Our surgical experience is that it
takes a radiologist with a special interest in this, and there
12
aren't as many around as we would like to see.
13
14 Do you think regulating this procedure would
encourage more or discourage more radiologists to do this?
15
16 DR. WINCHESTER: I think I would just favor more
fellowships that would excite and emphasize the field itself.
17
I don't think the regulation is going to improve the interest
18
in it from a personal standpoint.
19
20 DR. MONSEES: Yes.
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1 MS. HAWKINS: You mentioned that in the issue of
informed consent, that you don't really go into a couple of the
2
issues there, potentials.
3 Do you think that this gives a
consumer enough information to make an informed decision?
4
5 DR. ZUURBIER: I mentioned that. Since I don't use
freehand technique, I don't mention pneumothorax.
6 I think that
is a 7legitimate exclusion of that potential complication.
8 As a physician and seeing my personal experience in
how you may faint, actually suggests the process, and I am going
9
to watch them anyway, I typically don't suggest it.
10
Fortunately, I don't have that as a complication.
11 I think I
can't even tell you that anybody has really fainted in recent
12
history.
13
14 So, it is something that can happen to anybody walking
into the mammography suite can faint, and we watch out for it,
15
I
but 16 don't like to mention it. Some people do and will, and
that's fine, but I think it is a personal style point that I
17
have more success if I don't necessarily mention it.
18
19 MS. HAWKINS: But do you think, though, that puts the
consumer at a disadvantage by not having that information?
20
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1 DR. ZUURBIER: No, because we are prepared for it as
an eventuality, and we assume that all patients will faint.
2
3 MS. HAWKINS: You don't think it will affect
somebody's decision as to whether or not they would undergo it?
4
5 DR. ZUURBIER: Having trained at an institution
where we did mention it, it did not dissuade anyone from having
6
the procedure.
7 If the panel has experience otherwise, there
are more years of experience here than probably in my end.
8
9 DR. MONSEES: Does any other mammographer here care
to mention their experience with that and informed consent?
10
11 Dr. Sickles.
12 DR. SICKLES: I have probably done 10,000 of these
procedures in my career.
13 There have been women who fainted.
We always mention that to patients in our consenting.
14 I have
had any woman decline to have the procedure done because
not 15
of it.
16 That doesn't stop me from mentioning it. But I have
never had a woman say now that you tell me that, I don't want
17
to have the procedure.
18
19 MS. HAWKINS: Well, see, one of my concerns would be
is that it is not something that the average woman can pick up,
20
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you know, from the TV shows where they get much medical advice,
1
from 2the magazines, and so forth, so it is not something that
is very well known, and so coming into a physician's office,
3
you are not really in a position to question.
4
5 I know that oftentimes physician, you know,
recommendations, can be somewhat persuasive.
6 So, that would
be my concern.
7
8 DR. SICKLES: The important part of discussing this
with 9a woman is to not bring it up in a threatening way because
as you have heard, if it is described as a frequent -- and that
10
it not true, it is infrequent -- complication, then, you can
11
sometimes bring it about in a woman who is marginal in terms
12
of staying with the procedure.
13 You don't want to overly concern
a woman about a very infrequent complication.
14
15 There are ways of discussing this very effectively
without alarming a woman.
16
17 DR. ZUURBIER: I think the complication level is
similar to getting a blood sample taken.
18 So, when I get my blood
sample taken, I am sitting up, nobody tells me that I am going
19
to faint even though I feel like I will once in a while.
20
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1 DR. MONSEES: Yes.
2 DR. HENDRICK: Isn't there also a written informed
consent that accompanies the procedure that would mention
3
adverse effects like this?
4
5 DR. ZUURBIER: The informed consent that we use at
Georgetown is a standard one, so the patient has signed one just
6
like 7that for the actual surgical procedure prior to coming into
my suite.
8 I will list on the side the specific potential
complications which are bleeding and infection of which I think
9
should be aware of and it would be helpful to her in making
she 10
decision.
her 11
12 DR. MONSEES: Yes. Dr. Moore-Farrell.
13 DR. MOORE-FARRELL: Do you ever use your
stereotactic table for wire localization?
14
15 DR. ZUURBIER: Since our residents primarily use the
Homer needle system in which the needle is kept in the breast,
16
we don't use it.
17 In my experience, we are pretty speedy and
also our core biopsy room is located around the corner, so we
18
typically do not use it, but some people do, and if anyone want
19
to comment on the pleasure or displeasure with it, but we are
20
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as
just 1 fast without it and you don't have to rev up the machine,
do your calibration.
2 It is a little simpler from the prep
standpoint.
3
4 DR. MONSEES: Yes.
5 MS. HEINLEIN: You mentioned with the stereo that you
used 6the table. Have you had any experience with an add-on unit
at all?
7
8 DR. ZUURBIER: None.
9 MS. HEINLEIN: I wonder if there is anyone else on
panel that has had experience with an add-on unit.
the 10 Can you
comment on the motion that you talked about, that with the table
11
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 units although I don't use them currently.
15 Earlier
before the tabletop units were available, there were add-on
on, 16
units, and we probably did 500 patients with that approach.
17
18 It takes longer. I does result in vasovagal
reactions in somewhere between maybe 1 percent and 5 percent
19
of patients.
20 It requires a women -- any stereotactic procedure
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requires a women to stay perfectly still, and it is harder to
1
stay 2perfectly still when you are sitting up than when you are
lying down.
3 So, those are the difficulties with the add-on
units -- which does not mean that the don't work well.
4 If they
are operating correctly by people who know how to use them, they
5
can operate very successfully.
6
7 DR. MONSEES: Yes.
8 DR. HOUN: Florence Houn. Can you just comment on
your 9background and training in terms of issues like sterility
wound control, wound care as it pertains to these invasive
and 10
procedures?
11
12 DR. ZUURBIER: My training just as a medical student
a
and 13 student in surgery, and participant in Dr. Parker's
eggplant course affords me just basic principles of sterility.
14
technologists are the ones that handle the equipment
Our 15
sterility end of things.
16 I handle the patient sterility end
of things.
17
18 So, we will use appropriate handwashing. We use
sterile technique in terms of maintaining sterility of the
19
needle shaft itself.
20 It all goes asunder when you are touching
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the actual biopsy device housing, so really, the only thing that
1
you can maintain sterility of reliably is the needle itself.
2
3 In our experience, having done almost done 500 in
three years of operation is that we have had no complications
4
of infection and one complication of hematoma.
5
6 DR. MONSEES: Do I have any other questions
pertaining to this?
7
8 Thank you very, very much.
9 It is now 12:30. We have actually managed to stay
ahead of schedule which is wonderful.
10 You will be the
beneficiaries of this, because what we will do is extend the
11
lunch break a little bit, but please be cautioned that we will
12
begin the actual presentation promptly at 2 o'clock.
13
14 DR. WINCHESTER: Do we need an hour and a half for
lunch?
15
16 DR. MONSEES: I am just afraid that maybe people are
scheduled to come and hear the presentation at 2 o'clock, and
17
that if we start early -- let me just ask Dr. Houn whether or
18
we
not 19 can do that. Could we start early if we wanted to?
Before you leave, let's answer this question.
20
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1 DR. HOUN: I think that since this presentation is
going to be rather lengthy, you could start early, and if people
2
missed parts, I still think they would be able to hear the
3
majority of this presentation.
4
5 DR. MONSEES: With that okay, then, we will begin at
1:45, so please be here promptly.
6 We will begin at 1:45. Thank
you. 7
8 [Whereupon, at 12:30 p.m., the proceedings were
recessed, to be resumed at 1:45 p.m. the same day.]
9
10
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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.
9 They are
Drs. David Dershaw, David Winchester, and Robert Pizzutiello,
10
not necessarily in that order.
and 11
12 This is a joint presentation of the American College
of Radiology and the American College of Surgeons.
13 I will have
Dershaw make some introductory remarks and then the three
Dr. 14
of you, if you don't mind, can speak in the order that you have
15
agreed to.
16 Hopefully, there will be some time for a question
answer at the completion of that.
and 17
18 DR. DERSHAW: Thank you, Dr. Monsees.
19 I am here representing the American College of
Radiology and I appreciate the opportunity to come before the
20
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committee to make some comments.
1 I have been asked, and Dr.
Winchester has been asked, to put together a presentation on
2
an established accreditation program, and we have asked Robert
3
Pizzutiello to address the issues that are involved in equipment
4
specifically, and then I think Dr. Winchester and I will more
5
specifically address other issues that are involved in
6
accreditation and/or regulations.
7
8 I am going to ask Bob to first start, again addressing
equipment issues in these programs.
9
10 MR. PIZZUTIELLO: Good afternoon. My name is Bob
Pizzutiello and I am a medical physicist.
11
12 [Slide.]
13 I am involved with the American College of Radiology
in their accreditation program, and I have been asked to speak
14
on some of the technical aspects of stereotactic breast biopsy
15
primarily quality control and the medical physics aspects.
16
17 In the earlier presentation before lunch, we heard
a very nice and thorough and delightfully pleasant discussion
18
of many of the clinical aspects involving interventional breast
19
procedures, and we know that there is also a significant
20
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technical component involved in these procedures, and that is
1
what 2I would like to cover for the next little bit.
3 [Slide.]
4 What I am going to discuss is I will start off by
talking about the difference between mammography and
5
stereotactic breast biopsy, to clarify that distinction since
6
we have heretofore been talking primarily about diagnostic and
7
screening mammography.
8
9 I would like to make the case for quality control,
talk about the physics of stereotactic localization, some words
10
about the stereotactic breast biopsy equipment, the x-ray
11
system, the patient positioning system, whether they be for
12
prone or add-on units, and the image receptor and image
13
processing.
14 These are aspects of the stereotactic equipment.
15 I will address some issues about patient dose in
stereotactic breast biopsy.
16 Radiation dose to the patient is
something we always need to be careful about whenever we are
17
using x-rays for imaging.
18
19 I will finally talk about the details of quality
control.
20
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1 Maybe I will first start with some reflections on the
case 2for quality control. I was doing a site survey for the
American College of Radiology one time a year or so ago, and
3
we reviewed a facility which had extremely fine clinical images.
4
It was a relatively new facility, they had been open about a
5
year.
6 But in reviewing the quality control program, there were
significant holes in the quality control program.
7 Many of the
quality control tests were not being done or were not being done
8
properly, and they were not being followed up on.
9
10 So, the question arose how can this be. Maybe
quality control isn't so important because here is a facility
11
that is obviously doing extremely good clinical work, but yet
12
quality control program seems like it's not working.
the 13
14 I pondered that for a few moments, and I think the
answer is relevant here, and that is that in human life we have
15
learned that when things are going well, there are no problems,
16
when the wind is at our back, as the Irish blessing says.
17 But
we also know that things do go wrong and if you are medical
18
physicist or a physicist, you might know about the law of entropy
19
that says that in the universe, things get more disordered
20
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unless we make an effort and put energy into the system to make
1
them 2more ordered.
3 If you are a religious person, you might think about
original sin, but whatever the cause, things do go wrong.
4 We
all experience that in our lives.
5
6 In this facility, nothing had yet gone wrong, so the
fact 7that the clinicians were doing an extremely good job was
evident in the fact that the quality of the service was good,
8
but without an adequate quality control program, not if, but
9
when things did go wrong, they were at risk of having significant
10
loss in the quality of their work, and in fact, the quality of
11
their work, in the absence of a QC program, would not be noticed
12
until the images got so bad that the radiologist said, you know,
13
I am really not comfortable with what is happening here.
14
15 I think that is the issue that quality control
addresses is to detect problems in an imaging modality before
16
they become so serious that the clinician is uncomfortable and
17
feels that something may be compromising the patient care.
18 So,
that is the case for quality control in all of imaging.
19
20 [Slide.]
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1 For just a moment, let's distinguish between
detection and diagnosis.
2 Detection is accomplished by breast
self-exam, physician physical exam, diagnostic or screening
3
mammography, and ultrasound.
4 The purpose there is to detect
abnormalities from a large quantity of patients who are
5
predominantly normal.
6
7 Diagnosis is really more the issue for stereotactic
breast biopsy, whether it be done with biopsy cytology or
8
histology.
9 It is performed on a selected subpopulation who
have been found to be at higher risk for malignancy, so diagnosis
10
is really what we are trying to accomplish with stereotactic
11
breast biopsy.
12
13 [Slide.]
14 As a result of the distinction, there are some
differences in the equipment that we use.
15 In diagnostic and
screening mammography, we are looking for detection of
16
abnormalities in a population that is overwhelmingly normal.
17
background is very complex and primarily what we are looking
The 18
is
for 19 microcalcifications, masses, architectural distortion
of some sort.
20
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1 The field of view that is used for diagnostic and
screening mammography is sufficient to image the entire breast,
2
18 by 24 centimeters, or 24 by 30 centimeters in the larger
3
format for the larger breast.
4
5 It is also important to be able to image the borders
of microcalcifications and masses to help to decide whether we
6
are very concerned or only slightly concerned about these
7
lesions as being potentially abnormal.
8
9 Again, since we are screening a predominantly normal
population, the radiation risk is to a very large number of women
10
are predominantly normal.
who 11
12 [Slide.]
13 Now, if we contrast that to stereotactic breast
biopsy, we are looking for localization, not detection of
14
abnormalities, and specifically what that means is that the
15
abnormalities have already been detected on a diagnostic
16
quality mammogram, and now it is important to localize those
17
that the needle can go to the right location.
18
19 There are a limited number of normals in comparison
with diagnostic mammography.
20 The background is just as
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complex.
1 We are still looking microcalcifications and masses.
A limited field of view is needed because we don't need to look
2
at the whole breast, we need to concentrate only on the area
3
of interest in the breast.
4
5 Again, the radiation risk is to a selected population
who are at higher risk for malignancy.
6 That is why they are
having this interventional procedure in the first place.
7
8 [Slide.]
9 The distinction between mammography and stereotactic
to
has 10 do with the localization. Whenever you have any
radiographic image, a single radiographic image, it takes a
11
3-dimensional anatomy and projects it down onto a 2-dimensional
12
image.
13 In order to position the needle in the right location
stereotactic work, we need to do a 3-dimensional
for 14
localization, and the principle of triangulation is needed to
15
determine the depth coordinate.
16
17 [Slide.]
18 Now, there are probably lots of highly scientific
ways to conceive of stereotactic imaging, and the example we
19
this morning about looking from one eye to the next is also
saw 20
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a very good one.
1 This is one that I thought of and I figured
that 2Newton discovered gravity by having an apple fall on his
head, and I wondered if the person who developed the
3
stereotactic technique was a bowler.
4 Bowling is one of the most
popular activities, and I kind of hesitate to call it sport in
5
the United States, but when you bowl, you probably all have had
6
the experience of you are starting off looking a full set of
7
tenpins, and when you look, your brain interprets a series of
8
pins 9because you are looking straight on at these pins.
10 [Slide.]
11 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
12
don't get all the pins down.
you 13 I remember this happened to
me very distinctly.
14 I was looking down at the mess I had
created, and I found that there were four pins that I didn't
15
hit. Then, I rolled the ball and there was one more pin that
16
I never saw.
17 That is this pin right over here.
18 [Slide.]
19 This slide shows perhaps the origin of the
stereotactic view, and that is, if you move to the side when
20
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you are bowling, and go out towards one of the alleys and look
1
down, then, you can see this pin which was previously obscured.
2
It is giving you a view of perhaps about 15 degrees, and that
3
is the way we are able to determine the difference between
4
overlying structures and of course in the stereotactic breast
5
biopsy, that is what gives us the depth coordinate.
6
7 [Slide.]
8 The purpose of having the depth coordinate is so that
we can position the needle in the right location.
9 In this
slide, this round circle is the lesion, and the tan tissue is
10
shown here.
11 The needle is positioned before the lesion, then,
stylet is advanced through the lesion, and the cutting
the 12
needle comes through to collect the core sample.
13
14 So, it is very critical that we be able to position
tip of this needle in exactly the right location to sample
the 15
tissue that is desired.
the 16
17 [Slide.]
18 Since I am a physicist, you can't hear one without
having at least one equation, so this is the mandatory minimum
19
equation, and it is basic trigonometry.
one 20 What we are looking
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to do is to image this lesion.
1 The x-ray beam comes from the
floor.
2 Here is the breast, here is the lesion we are trying
to image.
3 The image receptor is back here, and the breast is
compressed between the compression paddle and the breast
4
support.
5
6 In order to position the needle at exactly the right
location, what we need to really do is to calculate the distance
7
from 8the needle to the image receptor, and that distance we will
call 9Z.
10 Since we know that the stereo images are taken at
15-degree angles, we have a fairly simple trigonometry problem,
11
that says that the distance coordinate Z equals Xls, which
and 12
is the stereo shift divided by twice the tangent of 15 degrees.
13
If you do the numbers, it means that the Z coordinate is about
14
2 times the stereo shift.
15
16 [Slide.]
17 If we see how this is accomplished in a piece of
equipment, an image might be taken at minus 15 degrees with the
18
image receptor, and perhaps a grid if it is used, taken at this
19
angle, and then the machine is toggled over to the alternate
20
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position in the detent, and another image is taken at plus 15
1
degrees.
2
3 When we look at the two images, this is a
well-targeted lesion.
4 At least it shows the needle in the
center of the lesion.
5 Normally, we went the needle before the
tip of the lesion, but in this case, for demonstration purposes,
6
you can see that in the two, 15-degree views, we are right there
7
in the center.
8
9 But things aren't always as good as we would like them
to be.
10 This image on the right shows that if the needle is not
properly positioned with respect to the lesion, then, we get
11
stereo images which are different from what we are trying to
12
achieve, and that would tell the physician who is performing
13
procedure that the tip of the needle is not in the right
the 14
location.
15
16 All this has to happen with approximately 1
millimeter accuracy in order to adequately sample the lesions
17
that we are looking for.
18
19 [Slide.]
20 There are different types of stereotactic breast
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biopsy equipment.
1 There are dedicated prone tables which we
have 2heard about this morning and seen, and they have advantages
of speed of a procedure, they are considered rather
3
patient-friendly in terms of comfort and lack of problems with
4
fainting, and so on, and they are also very convenient for
5
scheduling, because you can have one dedicated room that is
6
always used for stereotactic procedures.
7
8 In trying to schedule a busy department, if all of
a sudden you decide that a stereotactic procedure is needed,
9
it may tie up an extra 45 minutes or an hour in a room and
10
interrupt the schedule for the day.
11
12 So, those are the dedicated prone tables.
13 Another type of technology that is used is an add-on
stereotactic unit where a basic mammography unit is used with
14
a stereotactic system that allows precise positioning of the
15
needle.
16 It is almost an identical positioning system to what
is used in the prone table, but this difference is that the
17
patient may be sitting up or the patient may be recumbent
18
depending upon the model and the chairs, and some of the
19
patient-friendly things that are used.
20
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1 Add-on units are available at less cost because most
of the cost is in the mammography unit, and you just need to
2
buy the additional add-on device.
3 They don't take up the space
of an additional room, they are ideal for a small number of
4
biopsies, and many facilities use them where they are only doing
5
a few biopsies perhaps a week.
6
7 So, those are the two types of x-ray equipment.
8 The imaging modality is primarily in the past was done
with 9screen film imaging, and that uses a film image like we
familiar with in mammography, and those films then get
are 10
digitized into the computer, so that the computer can calculate
11
Z
the 12 coordinate.
13 In recent years, it has become much preferable to use
digital image receptors, and these have the advantages of fast
14
turnaround and shorter procedure time.
15 As we heard this
morning, once that digital image is exposed, the image comes
16
up on the computer screen within just a couple of seconds.
17
18 Common to all units is digital targeting software.
This is the computer software that performs the triangulation
19
calculation and informs the physician where to put the tip of
20
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the needle.
1
2 [Slide.]
3 This slide shows the picture that you have already
seen 4for the prone table, and if we move up here to the right,
you can see a conventional mammography unit with the
5
stereotactic device literally being added on in this
6
photograph.
7
8 [Slide.]
9 Because digital imaging is an important part of the
most stereotactic procedures are performed now, just a word
way 10
to distinguish between screen film and digital.
11 In screen film
imaging, film is used to capture the image, display the image,
12
to
and 13 store it. So, since one sheet of film has to accomplish
those three different tasks, there is always a tradeoff between
14
we
how 15 can achieve the right performance.
16 In a digital imaging system, it is possible to have
individual modalities to individual components to capture the
17
image, to display the image, and to store the image.
18 As such,
engineers can design and optimize each of those three individual
19
components.
20
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1 [Slide.]
2 The basic method that is used in stereotactic systems
for digital imaging is the CCD, the charge-coupled device image
3
receptor, and it is not terribly different from the
4
charge-coupled devices that have become popular in home
5
camcorders.
6
7 These camcorders use an integrated circuit, a chip,
which contains light-sensitive detectors on the surface, and
8
these detectors collect a light image and then, through
9
amplifiers, generate an electronic image that can go into the
10
computer.
11
12 [Slide.]
13 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
14
in this slide, what you can see on the right is that here is
15
x-ray target, the patient is in position here, and then this
the 16
is an x-ray image that is created.
17 That image gets converted
into a light image using a screen similar as to what would be
18
found in a mammography cassette or radiography cassette.
19
20 That image then is relatively large and gets minified
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down 1to fit onto the size for this CCD.
2 [Slide.]
3 Other important components of the equipment for
digital imagine and stereotactic is the CRT, the computer
4
monitor, a standard VGA monitor, has a resolution of about 640
5
by 480 pixels, and a pixel is an individual element of a digital
6
image that can be any one of 4,000 or so shades of gray.
7
8 What is also highly important for being able to use
these images in stereotactic imaging is the fact that image
9
processing is available.
10 Once that image is taken, the x-ray
picture is taken, then, by adjusting the display on the
11
computer, we can window and level that image to adjust the
12
contrast, and we can adjust that contrast to visualize dense
13
tissue, to visualize fatty tissue, and to bring up
14
microcalcifications so that they are more visible.
15
16 [Slide.]
17 This is sort of a closeup view of a prone table and
this is the digital image receptor.
18 It sits on the back of the
machine.
19 The x-ray tube is over here. The x-rays travel down.
patient is compressed in this position, and the digital
The 20
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image receptor sits here.
1
2 [Slide.]
3 This slide shows what the computer station looks
like.
4 This is sort of a familiar computer keyboard with some
software that allows the images to be shown, some magnification.
5
The images can be inverted, and so on.
6
7 [Slide.]
8 It is important, as I said earlier, to be aware of
the dose in any procedure that we do involving x-rays.
9 When
medical physicist evaluates the dose, we use the data from
the 10
technique chart.
the 11 We want to measure the entrance skin
exposure from a standard condition, from the ACR phantom.
12
13 We know that the dose varies considerably with the
different breast composition and the different breast
14
thickness, and the technique factors.
15 So, rather than measure
dose for every individual patient, it has been agreed that,
the 16
as medical physicists, we measure the dose under a standard set
17
of conditions, and those standard set of conditions are for the
18
phantom, which is a specific thickness made up of a mixture
ACR 19
of fat and glandular tissue or at least made to simulate that
20
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tissue.
1
2 The medical physicist measures the half-value layer,
which allows us to determine a factor called the DgN, and from
3
looking up these values in the table, we can calculate the
4
average glandular dose.
5
6 This is determined by an article written in the late
seventies and this is the standard way of measuring dose average
7
through the glandular tissue at risk.
8 That dose is required
to be less than 300 millirads per view in mammography as a
9
regulatory issue.
10 There is no current requirements since
stereotactic breast biopsy is not regulated.
11
12 For screen film imaging, the dose is related to the
optical density.
13 If the image is too light, then there is a
good chance that inadequate dose was used, and if the image is
14
dark, it is probably the other way around, but there is a
too 15
significant factor of film processing which also has to be
16
addressed.
17
18 With digital imaging it is not like that. The dose,
noise, and the image processing are all interrelated in a
the 19
that is not always obvious to the operator.
way 20
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1 [Slide.]
2 These are the factors that affect the breast dose in
stereotactic breast biopsy with digital imaging.
3 The kVp and
the mAs that are either set, or the machine chooses if it is
4
in automatic mode.
5 If film is used, then the exposure time can
also 6have a small effect on the dose. Primary factors are the
breast thickness and composition.
7 Thicker breasts require
more 8dose and dense breasts require more dose.
9 As I said earlier, the optical density of the film
a
was 10 prime indicator, but that is not the case in digital
imaging.
11 In any case, multiple exposures, every time an
individual patient exposure is made in a stereotactic
12
procedure, the patient receives that dose of radiation.
13 If it
takes six x-ray exposures to image during the procedure, then
14
patient receives six times that dose.
the 15 If it takes 20, then
it takes 20 times that dose.
16
17 [Slide.]
18 The quality control issues are such that the team
approach is necessary in order to maintain the quality of the
19
service, and that is that the medical physicist must work
20
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together with the radiologist or the physician performing the
1
procedure, and the x-ray technologists.
2
3 It is important that there be training and that the
personnel understand the issues of targeting accuracy and the
4
errors that are involved.
5 It is important that the personnel
understand the factors that can contribute to degradation of
6
image quality or to increase in dose, and be able to manage that
7
in an environment where the patient may experience some pain
8
and discomfort.
9
10 [Slide.]
11 There are some unique problems associated with
stereotactic breast biopsy quality control.
12 For example, many
medical physicists have not seen these units.
13 They are
relatively small in number compared with the vast number of
14
mammography units, perhaps 12- or 14,000 out there in this
15
country.
16 So, medical physicists may be unfamiliar with the
equipment, the procedure, or the need for quality control.
17
18 This may also be true of physicians who have not
previously been involved in the accreditation program and
19
accreditation process.
20 Radiologists are not always involved.
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1 There is a limited regulatory history. We stand in
the face of a greater than 10-year experience with the
2
mammography accreditation program from the American College of
3
Radiology, but roughly a year and a half experience with the
4
stereotactic accreditation program.
5
6 The horizontal configuration of the prone table
causes some problems in quality control, particularly for the
7
medical physicist.
8 In standard mammography units, gravity
works very nicely to allow us to set up our equipment in a
9
reproducible way, and that is not the case with the prone units.
10
11 The small field of view causes some problems in the
digital image receptors, and these problems occur with the
12
phantom images and the ion chamber measurements.
13 Medical
physicists must be trained to know what is the proper method
14
to make these measurements, so that they can avoid problems.
15
16 [Slide.]
17 There are some quality control problems that are also
unique.
18 There is a large heel effect on many x-ray units which
again makes the positioning of the instruments very critical
19
the medical physicist.
for 20
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1 In mammography, we make all our measurements through
the compression paddle, but since in a stereotactic unit there
2
is an open window that is always in place for imaging, medical
3
physics measurements must be made using the compression device
4
window open.
5
6 For many institutions that use digital imaging only,
there may be a lack of a quality hardcopy device.
7 It is not
required that there be hardcopy.
8 There may also be a lack of
digital image storage.
9 Again, it is not required that there
be digital image storage.
10 Among my clients, we have eight
facilities that do stereotactic imaging, and some have no
11
hardcopy and some have no long-term digital image storage.
12
13 For the medical physicists who are accustomed to
working with instruments and computers, we have to work with
14
pointy needles and gushy phantoms, because we too have to be
15
present and be involved in the localization simulation.
16 So,
that is something else that we have to learn.
17
18 The software for digital field uniformity analysis
is something that is available on some digital systems, and that
19
measurement that we hope to make in the stereotactic quality
is a20
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control program for the medical physicist, and we need to learn
1
how to do that.
2
3 [Slide.]
4 This slide shows that it is actually not terribly
trivial to position a test instrument in the horizontal position
5
reproducibly, but we found that it works well to use a stanchion
6
like 7this and a little support, but if you don't have that,
people try using tape and tissue boxes, and it can get very
8
difficult and certainly not reproducible and not scientific.
9
10 [Slide.]
11 So since things go wrong, the quality control
programs were developed by the American College of Radiology
12
Stereotactic Breast Biopsy Accreditation Program, and there are
13
a number of tests that are required by the x-ray technologists,
14
these tests are listed here, at varying frequencies from
and 15
before each patient to every day, down to quarterly and
16
semiannually.
17
18 [Slide.]
19 If screen film imaging is used, then there are
additional quality control tests which are not required for
20
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facilities that do digital, and these tests largely mimic the
1
quality control requirements from the mammography
2
accreditation program.
3
4 [Slide.]
5 Now, like in the mammography program, under the
stereotactic accreditation program, medical physicists have
6
quality control tests, 11 tests that are specified, and you can
7
see them listed here.
8 I won't go through them at all except
to say that the ones in yellow are significantly different than
9
quality control tests that medical physicists are
the 10
accustomed to performing under the mammography accreditation
11
program.
12
13 So, physicists need to have specific training in
performing more than half of these tests, so that they can be
14
knowledgeable and provide valuable input to the facility
15
performing stereotactic breast biopsy.
16
17 [Slide.]
18 There are two phantoms that can be used for image
quality analysis and for dose measurement under the
19
stereotactic systems.
20 The phantom on the right is the familiar
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mammography accreditation phantom that has been around for a
1
long 2time.
3 The phantom on the left was developed out at Mayo
Clinic.
4 It is marketed by Nuclear Associates, and that was
specifically designed to contain most of the information we need
5
from 6an image quality point of view in a smaller field of view,
field of view designed to fit within the 5 by 5 centimeter
in a 7
field of the stereotactic unit.
8
9 [Slide.]
10 Since the digital imaging system has different
imaging capabilities, there are different scoring requirements
11
the different phantoms.
for 12 Shown here are the mammography
accreditation program requirements for passing scores of
13
fibers, specks, and masses.
14 This uses the ACR accreditation
phantom.
15
16 In the digital mode, under the stereotactic
accreditation program, these are the required passing scores.
17
If the mini-phantom is used from Nuclear Associates, the passing
18
scores are quite different.
19 So, it is important that
individuals who are using these phantoms understand the
20
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difference.
1 It is not possible to obtain this score or this
score for fibers, for example, on the digital mini-phantom on
2
most 3units.
4 [Slide.]
5 This slide shows the technical problem of imaging the
full 6field mammography accreditation phantom with the digital
field of view that is about the size of the yellow image.
7 So,
for facilities that use the large phantom, they need to take
8
four 9separate images of the phantom, and then take a fifth image
that demonstrates the TLC chip, and these TLDs are used by the
10
American College of Radiology program to measure the dose in
11
half-value layer.
the 12
13 [Slide.]
14 Since the medical physics requirements are somewhat
different, there are some different requirements in terms of
15
knowledge and experience, the medical physics qualifications
16
shown here - a board certification or alternate
are 17
requirements, 15 hours of continuing education in mammography
18
physics every three years.
19 Those are the mammography type
requirements.
20
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1 Prior to June of '97, medical physicists would be
qualified to do stereotactic breast biopsy surveys if they
2
performed three hands-on surveys or if they performed one
3
hands-on survey under the guidance of a qualified medical
4
physicist who has done stereotactic breast biopsy.
5
6 That window has closed and effective June of '97,
medical physicists who have not done anything previously must
7
do one hands-on stereotactic survey under the guidance of a
8
medical physicist who has been previously qualified.
9
10 In addition, for a medical physicist to be qualified,
they must perform at least one stereotactic breast biopsy
11
medical physics survey per year and receive three hours of
12
continuing education in stereotactic breast biopsy physics
13
every three years.
14
15 So, the medical physicists need to receive some
specific training in stereotactic physics.
16
17 [Slide.]
18 So, to summarize, mammography is about detection,
stereotactic breast biopsy is about diagnosis.
19 Quality
control is necessary because things do go wrong.
20 It is not a
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question of if, it is only a question of when they go wrong.
1
2 We talked about the physics of stereotactic
localization, some of the specific equipment requirements, and
3
I would like to kind of close with an important comment about
4
patient dose in stereotactic breast biopsy.
5
6 One of the problems with digital imaging is that if
operators are not familiar with all the factors that contribute
7
to dose, then, patients can receive unacceptably high doses from
8
these stereotactic digital systems.
9
10 The reason is that if excessive dose is used on the
front end, the image processing can be used to adjust the window
11
level, so that the image looks very good, and that is
and 12
something that obviously we need to avoid.
13 So, it is important
that everyone be educated and that the medical physicist be part
14
of the team that performs quality stereotactic breast biopsy.
15
16 Thank you.
17 DR. MONSEES: Thank you very much.
18 Can we have the lights, and we will move on to the
next portion of the presentation before we have questions and
19
answers.
20
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1 DR. WINCHESTER: Dr. Monsees, members, and
consultants of the National Mammography Quality Assurance
2
Advisory Committee, FDA staff, thank you for the opportunity
3
to make this presentation on behalf of the American College of
4
Surgeons.
5
6 I would like to emphasize at the outset that the
representatives from the American College of Surgeons and from
7
the American College of Radiology on the joint task force have
8
worked together over many months in a collegial manner with the
9
dedication to quality patient care and a real attempt to avoid
10
turf issue discussions.
11
12 You have in your packet a publication entitled
Stereotactic Core Needle Biopsy of the Breast, a report of the
13
Joint Task Force of the American College of Radiology, American
14
College of Surgeons, and College of American Pathologists.
15
16 We believe that this represents an important summary
of the best available scientific knowledge with regard to this
17
procedure.
18 The trick now is to find out how many people will
read this and what the diffusion time into the practicing
19
community will be.
20
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1 We have had past experiences with guidelines,
standards, and diffusion into the community is very slow, so
2
I would hope that this is read.
3 Our committee, really our joint
task 4force in this exercise, undertook the task of doing this
for that very reason.
5 We thought it was necessary with
relatively new technology to define the indications,
6
contraindications, and some of the subtleties that the people
7
who were beginning to do this might not appreciate.
8
9 A separate task, consisting of four surgeons from the
American College of Surgeons and four radiologists from the
10
American College of Radiology, along with senior staff from the
11
American College of Radiology, developed the document included
12
in your packet entitled Physician Qualifications for
13
Stereotactic Breast Biopsy.
14
15 The Board of Regents of the American College of
Surgeons and the Board of Chancellors of the American College
16
of Radiology officially approved this document after some minor
17
modifications.
18
19 The September 1997 issue of the Bulletin of the
American College of Surgeons published the document regarding
20
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personnel requirements in its entirety, along with an overview
1
which I provided.
2
3 Our joint task force completed the Physician
Qualification document with the realization that precise
4
numbers are somewhat arbitrary and subject to considerable
5
debate along with many other elements in the document.
6
7 We attempted to simplify and systematize practice
qualifications in an exceedingly complex national environment.
8
Nonetheless, we identified the two major models of practice in
9
United States, that is, physicians working in a
the 10
collaborative setting or physicians working independent of one
11
another.
12
13 Clearly, the joint task force favored the
collaborative model, but recognized in some centers the
14
procedure could be done independently.
15
16 I think it is important for me to take a few minutes
to
now 17 describe the major objections which have been expressed
by the surgical community in response to physician
18
qualifications for stereotactic breast biopsy.
19
20 Madam Chairman, I could list all the names and origin
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of the 12 or 15 surgeons, but if I may not do that, I think that
1
in the interest of time --
2
3 DR. MONSEES: A summary would be appreciated. Thank
you. 4
5 DR. WINCHESTER: So, these are quotes from a wide
variety of surgeons from a wide variety of sites around the
6
country:
7
8 Surgeons have always played a central role in the
complete continuum of care and the management of the breast
9
patient.
10 We need to draw attention to the fact that the
performance of a surgical minimally invasive biopsy procedure
11
utilizing imaging is only one small part in the total evaluation
12
care of the patient.
and 13
14 The surgeon evaluates patients fully prior to any
form of biopsy.
15 The surgeon correlates the approach used for
biopsy in preplanning for any eventual larger
the 16
cancer-directed procedure.
17
18 Addressing the radiology community doing this in a
totally independent setting without surgical consultation,
19
some of the remarks are as follow:
20
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1 If a radiologist is to perform this procedure
independently as a direct referral from the primary care
2
physician without the benefit of surgical consultation, then
3
many 4of our surgeons believe that the requirements for a
radiologist practicing independently as stated in the document
5
are inadequate.
6
7 The 15 hours of CME in breast imaging including
"benign and malignant breast disease," should focus not on
8
breast imaging, but an understanding of benign and malignant
9
breast disease.
10
11 It has been pointed out that radiologists may lack
clinical skills when practicing independently, and some of the
12
points along those lines that have been brought forth by
13
surgeons and suggestions for improving those clinical skills
14
as
are 15 follows:
16 That the radiologist observe at least 12 open
surgical breast biopsies performed by a board-certified general
17
surgeon with attention to sterile technique, tissue handling,
18
wound management, and hemostasis, clinically interact for at
19
least 12 hours with a board-certified general surgeon for
20
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physical examination of the breast and for presentation of
1
surgical options to the potential stereotactic patient
2
including benefits, risks, and complications.
3
4 Attend on a regular basis hospital tumor board
conferences or breast conferences.
5 In our institution, for
example, we have a weekly multidisciplinary breast cancer
6
conference review with Pathology, Radiology, Surgical
7
Oncology, Medical Oncology, everybody who takes care of the
8
breast cancer patient, and the radiologists I think benefit,
9
have told us that they benefit considerably from being
and 10
present at that conference.
11
12 Take a one-week rotation through the hospital
pathology department.
13 That might be kind of tough to do. Be
responsible for face-to-face postbiopsy communication with the
14
patient including the diagnosis of benign and malignant
15
disease.
16 Again, all these suggestions are for a radiologist
practicing in a totally independent setting.
17
18 Future treatment options for cancer, referral to
surgeons, oncologists, and radiation therapists.
19 Communicate
with the primary referring physician regarding appropriate
20
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clinical, mammographic, and surgical followup, and risk
1
assessment, and attend a national multidisciplinary breast
2
cancer symposium every three years.
3
4 Further comments. Imaging is performed as an
adjunct to the biopsy, to allow positioning of the biopsy device
5
itself.
6 The physician locates the abnormality previously
identified by a qualified MQSA physician.
7 There are many other
instances where x-ray imaging is used as an adjunct in the
8
performance of diagnostic and therapeutic procedures by
9
surgeons.
10
11 A few examples of these include stereotactic
intracranial neurosurgical procedures, intraoperative
12
fluoroscopy for the placement of central venous catheters,
13
intraoperative fluoroscopy in numerous orthopedic procedures,
14
fluoroscopy used in coronary angioplasty, and cholangiography.
15
16 None of these examples require the supervision of
radiologists, even though they utilize x-ray imaging.
17 To
require stereotactic breast biopsy to come under MQSA merely
18
because screening mammography identified the abnormality in the
19
first place, in one surgeon's words, "was inappropriate and
20
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unnecessary."
1
2 Many surgeons have expressed the opinion that the
number of mammogram reviews of 480 is arbitrary and too high.
3
This 4has been the most commonly voice objection to the document.
Surgeons do not believe that MQSA requirements for interpretive
5
skills of 480 mammograms per year for screening mammography
6
applied to the skills required for a surgeon practicing in an
7
independent setting to review an abnormal mammogram which has
8
been 9officially interpreted by an MQSA radiologist, target the
lesion, and perform the biopsy.
10
11 Finally, a quote from a surgeon in Georgia, "The
surgeons in our community are the only physicians performing
12
stereotactic breast biopsy.
13 Our results indicate that we are
doing it in a quality manner.
14 We do not individually review
mammograms per year per surgeon.
480 15 Does this mean that no
stereotactic breast biopsies could be performed in our
16
community?"
17
18 There are many other communications I have received
from surgeons around the country, but in the interest of time,
19
I will no longer dwell on this broad-based surgical feedback,
20
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but simply acknowledge that the "final draft" of any document
1
must 2take into account criticisms such as those which I have
described.
3
4 Having just attended the annual clinical congress of
the American College of Surgeons, and viewing the wares of the
5
stereotactic manufacturers, it is apparent that this equipment
6
is becoming increasingly sophisticated.
7
8 The BIRAD system of the American College of Radiology
has promoted proper selection of patients with mammographic
9
abnormalities for stereotactic breast biopsy.
10 Even so, the
demand for the performance of this procedure is exceedingly high
11
legitimate.
and 12
13 Practicing surgeons around the country are learning
this procedure through formal courses, such as those described
14
this morning by Dr. Israel and Dr. Dowlat from American College
15
of Surgeons, and the Society of Surgical Oncology.
16
17 These physicians are then going back to their home
institution and being proctored by other surgeons or
18
radiologists according to local credentialing body
19
requirements.
20 Many of them are being trained to not only
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perform the procedure, but to train others.
1
2 The American College of Surgery has now formally
included this procedure in their curriculum so that future
3
graduates of training programs in surgery will become
4
board-certified, will be qualified to perform this procedure
5
much 6in the same way that board-certified radiologists qualify
as interpreters of screening mammography under MQSA.
7
8 As you know, the American College of Radiology has
a voluntary accreditation program for stereotactic core needle
9
biopsy in place.
10 The Board of Regents of the American College
of Surgeons, which met in Chicago this month, unanimously
11
approved the concept of the establishment of a voluntary
12
accreditation program for the performance of stereotactic
13
breast biopsy through the American College of Surgeons.
14
15 A task force of the college is in the process of
developing the details of this accreditation program.
16 We have
discussed this with the American College of Radiology.
17 They
have offered to help us put this together.
18 They have, in fact,
offered to have representatives from the college sit on their
19
committee that developed their accreditation program.
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1 Following this resolution, the American College of
Surgeons and the American College of Radiology communicated
2
with 3one another and have forwarded letters to FDA, suggesting
that 4consideration be given to a voluntary accreditation
program or approach rather than the development of regulations
5
under MQSA.
6
7 Finally, if FDA determines that interventional
radiology should be included under MQSA, then the composition
8
of the National Mammography Quality Assurance Advisory
9
Committee needs to be changed to represent a proper balance of
10
clinicians on the committee from the disciplines of radiology,
11
surgery, and pathology.
12
13 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
14
somehow I did it and got through it, and when I did that, I was
15
looking specifically for language which indicated to me why we
16
here talking about the regulation of interventional
are 17
mammography.
18
19 The Act states that the National Mammography Quality
Assurance Advisory Committee shall, "report on new developments
20
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concerning breast imaging that should be considered in the
1
oversight of mammography facilities."
2
3 The only other reference in the Act to anything other
than 4screening mammography is under Section 35-4A under
Definitions.
5 "The term facility means a hospital, outpatient
department, clinic, radiology practice or mobile unit, an
6
office of a physician, or other facility as determined by the
7
Secretary, that conducts breast cancer screening or diagnosis
8
through mammography activities."
9
10 I couldn't find anything else and, Dr. Finder, I had
talked to you before about the Advisory Committee and the advice
11
about not to regulate this, there wasn't enough
12
state-of-the-art information.
13 Could you please clarify for me
this question?
14
15 DR. FINDER: I will try. Basically, when you go to
definition of what mammography is or what a mammogram is,
the 16
it refers to radiography or radiographic images produced of the
17
breast.
18 Under that, the interventional procedures which are
used for radiography of the breast or mammography are included
19
under that definition.
20
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1 When the Interim Regulations were first promulgated,
at the time there wasn't enough information, there were no
2
standards available to include interventional procedures, so
3
at that time these procedures were specifically excluded from
4
regulation, but there was always the impression and always the
5
feeling that at some point this issue would be looked at again
6
to see if the science had progressed enough and if the standards
7
had progressed enough to bring these procedures under
8
regulation.
9
10 DR. WINCHESTER: But who initiated the request to
look at it in the first place?
11 I can't find the language of
stereotactic breast biopsy, needle localization,
12
galactography.
13 I can't find any of that language in the 1992
MQSA Act.
14 Where is the language? Where did it come from? Who
authorized it?
15 I just don't understand where it came from. It
is not in the Act.
16
17 DR. FINDER: Right, and as I say, those terms were
used, but in terms of regulation of mammography, anything
not 18
that uses radiography of the breast is included.
19 As I said,
it was specifically excluded because at that time we had no
20
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standards or accreditation bodies or any mechanism to deal with
1
it. 2That is why it was excluded.
3 Now as for the calls to bring interventional
mammographic procedures, one of the areas that called for it
4
was this committee.
5 I can't remember which meeting it was at.
6 DR. HOUN: That was in May of 1994, the Advisory
Committee at that time, we were faced with an October 1 deadline
7
of making sure all facilities in the U.S. were certified by FDA.
8
Otherwise, if they were not certified, they would be performing
9
mammography illegally.
10
11 At that May 1994 meeting, we were discussing this area
of stereotactic and interventional procedures using x-rays that
12
not had an accreditation process developed and that if we
had 13
not do something about them by October 1 of 1994, these
did 14
procedures would be banned by law because we did not have an
15
accreditation and certification process in place.
16
17 So, at that time most of the members of the Advisory
Committee did advise us to not regulate this and to exempt
18
stereotactic and other interventional mammography procedures.
19
all
Not 20 of them did, but most did, and we had the American College
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of Surgeons participate in that discussion, as well.
1
2 So, what Dr. Finder is saying is that the Act, by
defining mammography very broadly, and with our history of
3
wanting to make sure that breast cancer screening and diagnosis
4
using that technology is of high quality standards, this
5
committee has helped us in giving advice on what we should do
6
with 7this new technology.
8 DR. WINCHESTER: I raise the question because this
committee has gone through a metamorphosis, there are a lot of
9
members, and I have been here for a year, and I still don't
new 10
understand it.
11 So, I was hoping that this could be clarified.
12 It seems to me that if this moves forward, there needs
to be an amendment to the Act, because the language does not
13
reflect the intent.
14
15 DR. HOUN: I don't think so, because we have --
16 DR. WINCHESTER: I don't think so either.
17 DR. HOUN: I think what happened is that in terms of
legality, those matters are reviewed by our general counsel,
18
that has already been reviewed several times, that this
and 19
particular technology, if FDA chose to regulate it, would be
20
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covered by the Act.
1
2 DR. WINCHESTER: And has that been challenged?
3 DR. HOUN: It has not been challenged.
4 DR. MONSEES: Let's put that issue aside for now and
continue with this presentation.
5
6 Dr. Dershaw.
7 DR. DERSHAW: Thank you, Dr. Monsees.
8 Again, thank you for the opportunity to be here to
represent the American College of Radiology.
9 I will try not
to take up too much time, so that we can have time left for
10
questioning.
11
12 The procedures that we have been talking about this
morning and this afternoon compromise a very difficult number
13
of procedures for women in the United States to calculate.
14
15 Based on HCFA CPT coding, estimating that these codes
represent about one-third of procedures that are performed, we
16
have estimated that there are between 4- and 500,000 of these
17
interventional x-ray-guided breast procedures that are
18
performed.
19
20 About half of these are needle localizations,
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slightly over 200,000, and again these numbers are very rough
1
estimates.
2
3 Galactograms or ductograms compromise a paltry 4,000
or so procedures, and the most difficult number to ascertain
4
is the number of needle biopsies that are actually performed,
5
but it appears that there are 200,000 plus of those procedures.
6
7 Needle localizations appear to be done by
radiologists about 90 percent of the time.
8 Ductograms, I think
we can reasonably assume are almost always done by radiologists,
9
certainly a 90 percent plus number is a reasonable guesstimate
10
on that, and the number of imaging-guided needle biopsy
11
procedures that we are talking about here today is really
12
difficult to calculate, but maybe as high as 80 percent of those
13
procedures are done by radiologists.
14
15 Now, let me very briefly just discuss the non-biopsy
procedures that have been mentioned here so far today.
16 Needle
localizations, you heard a very beautiful discussion off this
17
morning.
18 If one looks at the published literature on needle
localization, there is an institutional failure rate that is
19
reported in the 1 to 4 percent rate in peer-reviewed literature.
20
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1 What goes in the community in this procedure, as in
other procedures that don't get into the literature, are not
2
peer 3reviewed, I think it is very difficult to ascertain.
However, I think there is a general sense of these procedures
4
being performed in a competent fashion in the general community,
5
and I do not think that there is a sense that there is a need
6
for regulation of needle localization procedures.
7
8 Ductograms, as you can appreciate, are unusual
procedures.
9 Failure rates are not published on this procedure.
Again, I do not believe that there is any consensus that these
10
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
13
those procedures.
14
15 Let me go on to image-guided breast biopsies. You
have heard a lot about these.
16 I don't think there is any need
to redefine these procedures, but let me just remind you that
17
purpose of these procedures is in a safe, comfortable,
the 18
non-deforming, rapid, and inexpensive fashion to obtain cells
19
or pieces of tissue from the breast which make it possible in
20
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most 1cases to make a definitive decision about what else needs
to be done with a patient who has usually a nonpalpable
2
mammographically detected abnormality.
3
4 It is accepted that in some cases, a surgical biopsy
will 5be needed for definitive diagnosis. So, that is the
purpose of those procedures, and I will spend the rest of the
6
few minutes that I am up here addressing you looking at methods
7
in which it is possible to optimize the quality of the procedure
8
that 9is being performed, so that one can do with these biopsy
procedures what it has been possible to do with mammography in
10
United States, and that is essentially guaranteed to a woman
the 11
that there will be a reasonable level of quality of care and
12
a reasonable level of safety when she, in a relatively blindly
13
fashion, goes to a facility to have one of these procedures done.
14
15 By definition, the areas that are undergoing biopsy
small, nonpalpable lesions.
are 16 These are sometimes, as you
all
can 17 appreciate, difficult to see on a mammogram where there
been full compression that has been done and where we have
has 18
an imaging system which has undergone a level of quality control
19
to optimize the quality of imaging that results from that
20
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system.
1
2 The difficulty in seeing these lesions can be
increased, not only by the lack of compression, as has been
3
demonstrated, but also by the fact that there is an anesthetic
4
that 5is injected into the breast which may obscure the lesion.
There is hemorrhage that occurs during the procedure which can
6
further obscure the lesion.
7
8 Difficulty in appreciating the lesion can be
increased by the fact that, in fact, the area of the breast
9
containing the lesion may be displaced by the needle tip during
10
biopsy, changing its location within the breast, changing
the 11
location on the image that is obtained.
its 12
13 Now, what kind of skills are necessary to perform
these procedures in an acceptable fashion?
14 Let me go through
steps that are involved in actually performing the
the 15
procedures and address the kinds of skills that are necessary
16
to optimize the quality of care during each stage of the
17
procedure.
18
19 The first step again, as you have already heard, is
imaging, making sure that the patient has gone through the
the 20
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appropriate imaging steps, so that a reliable decision has been
1
made, an appropriate decision has been made whether or not the
2
patient needs a biopsy.
3
4 A biopsy is not -- I don't think it is acceptable to
anyone in this room -- a biopsy is not a replacement for imaging,
5
and biopsies that can be eliminated by appropriate imaging
6
should of course be eliminated.
7
8 So, the physician who is selecting a patient must,
first of all, appreciate that, understand that an appropriate
9
imaging, a reliable imaging workup has been done and that the
10
patient in fact needs a biopsy.
11
12 When it has been ascertained that a patient needs a
biopsy, the physician then needs to determine what kind of
13
biopsy may, in fact, be appropriate for the patient, not what
14
kind of biopsy the patient must undergo because this remains
15
decision.
her 16
17 In some cases, I think we would all agree that, in
fact, a surgical biopsy may be a better biopsy procedure than
18
a needle biopsy.
19 That may be because of patient preference.
That may be because we are worried about a certain kind of
20
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histology that requires a larger volume of tissue to be excised
1
rather than a smaller volume of tissue to make a definitive
2
diagnosis, and in those situations, a surgical biopsy may be
3
more 4appropriate.
5 We have already heard that there are two kinds of
needle biopsies that can be performed - fine-needle aspiration
6
for cytology, or a large core needle biopsy for histologic
7
assessment of the specimen.
8
9 A decision about which of those procedures should be
done needs to be made.
10 In addition to that, although we are
talking about x-ray-guided procedures, a decision needs to be
11
made if a core biopsy is being done or an FNA, is stereo guidance
12
optimal, should sonographic guidance be performed instead.
13
14 So, the physician needs to understand what the
indications and the contraindications are for these procedures,
15
relative risks that are involved for the patients, and must
the 16
also appreciate other medical problems that may be involved -
17
does the patient have a bleeding diathesis, is the patient on
18
medication that may increase the likelihood of complication.
19
20 Once we have made the decision that a patient will
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undergo one of these biopsies, we have to be certain, if we are
1
guaranteeing quality of care to the patient, that the equipment
2
that 3we are using for the procedure has been appropriately
selected and has been appropriately maintained.
4
5 Certainly, we wouldn't expect in a surgical procedure
that 6a scalpel that wasn't adequately sharp to cut into the
tissue that we were going to cut through would be used in the
7
procedure.
8
9 You have already heard a very elegant discussion on
complexities of the kind of imaging equipment, the stereo
the 10
biopsy units that are available, the kinds of imaging that is
11
available with those biopsy units, how complex this equipment
12
and how complicated the acceptance testing at the time of
is, 13
purchase, as well as the quality control programs that are
14
necessary to hopefully abort the overwhelming number of
15
problems that may occur.
16
17 If you have equipment that has been well maintained,
if
and 18 you have selected the appropriate equipment, you then
need to understand how to operate the equipment - what are the
19
appropriate exposure settings, kVp and mAs for different
20
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patients, how do these need to be altered in different densities
1
of breasts, in different thicknesses of breasts, how must you
2
alter your settings if you are doing calcifications rather than
3
masses.
4
5 Just as difficult, I think, is dealing with the
individual geometry of the patient, not just the configurations
6
of different pieces of equipment - how do we position the patient
7
on the table appropriately, so that we have enough thickness
8
to accommodate the positioning of the needle in the breast and
9
movement of the needle through the breast, how do we select
the 10
different gun needle combinations that may be available to
the 11
so
us, 12 that we minimize the likelihood of complication, but
optimize the likelihood of making a diagnosis.
13
14 When we are actually performing the procedure,
perhaps the most difficult part of the procedure, and certainly
15
of
one 16 the key elements of the procedure, is knowing what the
relationship of our biopsy device is to the lesion that we are
17
seeing within the breast.
18 This is what the procedure is all
about, getting the needle into a small nonpalpable lesion.
19
20 We must be competent in understanding what it is that
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is going on in either the film that we are exposing or on the
1
digital imaging system that we are using.
2 We must understand
when 3we are biopsying masses that do not contain calcifications
what 4the relationship of the needle is before we fire and after
we fire.
5 It is the only documentation we have during the
procedure to know whether or not we have done something of
6
service to the patient.
7
8 When we are biopsying calcifications, you have
already seen specimen radiographs that we take during the
9
procedure, but as simple as the specimen radiographs appear to
10
be to interpret when they are shown up on slides, I must remind
11
that there are artifacts that can appear on specimen
you 12
radiographs, most commonly dust that can mimic calcifications.
13
physician performing the procedure needs to be sensitive
The 14
to these mimickers of disease and has to understand when they
15
or
may 16 may not be present and when to repeat the specimen
radiograph.
17
18 After the specimen has been retrieved, the physician
performing the procedure must adequately handle the specimen,
19
so that there is not degradation of the specimen, making it more
20
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difficult for the pathologist to interpret.
1 The physician must
understand what information needs to be communicated to the
2
pathologist to make it easier for him or her to make an
3
appropriate diagnosis.
4
5 Once the pathologist has done his or her deed, the
physician next needs to understand what the pathology report
6
means, understand what it means in terms of what it is that has
7
been 8seen on imaging studies. It is, in fact, the final step
at which we ascertain whether or not the lesion in question has
9
been biopsied.
10
11 If it looks like a cancer, and we don't get something
back that says cancer, we must be very concerned that, in fact,
12
we missed a cancer.
13 If we get something back that says, for
example, fibrocystic change with microcalcifications, does
14
that make sense in terms of what it is we actually biopsied.
15
16 So, we have to be able to know on the basis of that
report, looking back on the imaging, whether or not we missed
17
a lesion, and if so, we have to repeat the biopsy or a biopsy
18
to
has 19 be repeated.
20 Once we get the report, we need to know how the report
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fits 1into patient management, and we have to be able to do that
ourselves or we have to be able to appreciate when the patient
2
needs to be referred to a subspecialist who will deal with breast
3
disease.
4
5 So, if we get back a high risk lesion, we have to
appropriately deal with the patient who now has the diagnosis
6
of that high risk lesion.
7 The diagnosis of cancer is reasonably
straightforward in dealing with that issue, I think.
8
9 We have to be certain that results will be
appropriately communicated.
10 I think there is nothing more
tragic than delivering good medical care to the patient and then
11
failing to follow through.
12 Communication of results I do not
think is a problem, but certainly it is part of the performance
13
of these procedures.
14
15 Those are things that the doc who is doing the
procedure has to do, but this is not solely a procedure that
16
is done by physicians, and it is not solely a physician
17
procedure.
18
19 We have talked a lot about equipment maintenance and
equipment calibration, and your procedure will only be as good
20
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as the equipment that you are using.
1 If your calibration is
not good, there is no way you are going to get the needle to
2
where it needs to go.
3
4 If you are delivering the patient an excessive amount
of radiation during the procedure, then you may not be doing
5
her a service.
6
7 In addition to have quality equipment, it needs to
be set up appropriately.
8 It needs to be set up appropriately,
so that it is functioning well, so that is has been calibrated
9
well, so that it is clean, in fact, it is sterile, the parts
10
that need to be sterile during the procedure, and sterile
11
technique is an important part of this, and personnel involved
12
in these procedures need to adequately use a sterile technique
13
during these procedures.
14
15 Now, there has obviously been concern over the
utilization of these biopsy procedures and perhaps the lack of
16
skill in some professionals performing these procedures.
17 That
is why we are talking about this today.
18
19 As you all know, this has resulted in the established
of an accreditation program by the American College of
20
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Radiology, the stereotactic-guided breast biopsies, and
1
concerns, in fact, over the utilization of ultrasound for the
2
same 3thing, have resulted in the development of a program for
ultrasound also.
4
5 The concepts in the development of the accreditation
program are based on an understanding that the quality of the
6
service delivered to the patient is based on the ability of the
7
facility, not the individual components, but all the components
8
of the whole, performing the biopsy, to appropriately select
9
manage patients who are to be biopsied, the ability to
and 10
perform the biopsy with the skill that comes from adequate
11
training and experience, the ability to use equipment that has
12
been well maintained and tested, so that practitioners can
13
minimize the likelihood of mechanical failure during the
14
procedure, optimize the imaging capabilities of the equipment,
15
keep the radiation dose adequately low during the procedure
and 16
to increase safety to the patient.
17
18 If those goals are achieved, the likelihood of failed
biopsies should be minimized, facilities should fully
19
understand, in addition, how the results of the biopsy should
20
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be used for patient management including in whom these
1
procedures have failed and the biopsy needs to be repeated.
2
3 The risk for patient complication and excessive
exposure to radiation should be reduced by these kinds of
4
accreditation programs.
5 The likelihood of excessive pain and
prolonged or incompetently performed procedures we hope will
6
also 7be reduced.
8 In assessing the quality of a facility, the ACR
program includes accessing the equipment, assessing the
9
personnel including the physician, the technologist, and the
10
medical physicist, and looking at facility outcome data and
11
results of any individual facility.
12
13 As you have already heard, and you have I believe
among your handouts are an agreement between the College of
14
Radiology and the College of Surgeons indicating a belief that
15
qualifications for personnel, for physicians, can be
the 16
adequately met either by an individual physician or by a team
17
of physicians at an individual facility.
18
19 However, we do believe that these qualifications need
to be met.
20 Technologists and physicists individually must
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fulfill the qualifications for technologists and physicists.
1
2 The requirements for personnel include requirements
for adequacy of initial training including understanding of the
3
rule 4of techniques in patient care, and hands-on training in
performing these biopsies.
5 Also, requires maintenance of
skills by continued performance of procedures and by CME.
6
7 I am not going to go through what is in your handout.
For those of who wish to peruse that, it is there.
8 Perhaps if
you have trouble sleeping tonight, these documents might help
9
with that.
you 10
11 The equipment maintenance requirements have already
been reviewed for you.
12
13 Facility outcome data are collected and include
during an indicated period of time, the volume of procedures
14
which are the basis for the analysis being submitted by the
15
facility.
16 It looks at the complication rate, it looks at the
repeat biopsy rate, the reasons for repeat biopsy, and it looks
17
at the outcome of all the biopsies, how many benign, how many
18
malignant, and how many in other categories.
19
20 The facility outcome data is, first of all,
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educational for the individual facility.
1 Secondly, we hope
that 2some point in time, numbers such as repeat biopsy rate due
to inadequate sampling and complication rates may, in fact, be
3
able 4to be fitted into a wider body of data to indicate perhaps
the quality of care that is available at an individual facility.
5
It is also educational for an individual facility.
6
7 Additionally, accumulating these data mandate that
an individual facility adequately track patients, and we
8
believe increases the likelihood that appropriate care after
9
cancer or high risk diagnoses will be delivered to an individual
10
patient.
11
12 Finally, let me say that patients undergoing
percutaneous imaging-guided needle biopsy procedures cannot be
13
assured of the skill of practitioners performing these
14
procedures or of the safety of the equipment being operated when
15
they select facilities at random without any kind of neutral
16
third party establishing standards for these facilities.
17
18 We believe that this is not unlike the situation in
mammography before the American College of Radiology began its
19
accreditation program.
20 The accreditation program for a
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stereotaxic biopsy that was established by the ACR was done in
1
the believe that it is possible to maximize the safety and
2
quality of these interventions.
3
4 The success of the ACR mammography accreditation
program followed by MQSA regulation has demonstrated that this
5
expectation is I believe a realistic one.
6
7 Regulation of interventional breast procedures may
not be necessary if accreditation programs are utilized to
8
establish appropriate standards for facilities and to attest
9
to the public that individual facilities have attained these
10
high standards, and if there is a motivation for facilities to
11
become accredited.
12
13 We believe that the imaging-guided breast biopsy
accreditation programs established by the ACR define the
14
standards that are necessary to accomplish these goals.
15
Training, experience, and quality control programs can improve
16
general quality of these interventions and can help assure
the 17
women of competence and safety of facilities offering these
18
procedures.
19
20 Thank you for your attention.
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1 DR. MONSEES: Thank you.
2 Now what I would like to do is ask panel members if
they 3have specific questions to the three presenters here, and
I would like to start out and just ask a quick question of Dr.
4
Winchester.
5
6 The joint agreement which the American College of
Surgeons and the American College of Radiology agreed to the
7
qualifications, was agreed to prior to the American College of
8
Surgeons volunteering that they were going to begin an
9
accreditation program.
10
11 DR. WINCHESTER: That's right.
12 DR. MONSEES: How would you propose or have they
discussed this at all that a facility decide who would accredit
13
them?
14 If it were a practitioner, say, a radiologist by
themselves, you would propose that they apply to the American
15
College of Radiology, if it is a solo surgeon, they apply to
16
American College of Surgeons, and what if they work in
the 17
conjunction, do they apply to both?
18 Has any thought and
discussion been given to having two different bodies perhaps
19
with two different sets of standards?
20
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1 DR. WINCHESTER: This just happened two weeks ago,
so not much has happened in terms of concrete development at
2
the College of Surgeons level.
3 Conceptually, it seems to me
if it is a radiologist, it should be ACR voluntarily accredited,
4
if it is a surgeon, for surgical skills, it should be the College
5
of Surgeons accreditation, but the College of Surgeons, I do
6
not believe at this point in time has any interest in all in
7
getting into the field of facility and equipment certification.
8
They 9are not qualified to do that. So, that would be come a
joint effort, I would think, between the two voluntary
10
accreditation programs.
11
12 DR. MONSEES: So, what you would see would be two ways
to enter the system, but that it would be some sort of merged
13
endeavor, is that what you would envision?
14
15 DR. WINCHESTER: I would think it would have to be
because it is not just the personnel, as it has been pointed
16
here, that is important in the performance of this
out 17
procedure.
18 It would have to be some kind of a joint
arrangement.
19
20 DR. MONSEES: I would like to ask the panel if they
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have 1any specific questions.
2 DR. MOORE-FARRELL: I have concerns on the same issue
because I am in just such a practice where approximately five
3
radiologists and five general surgeons share one stereotactic
4
machine, and I cannot be ACR-certified even though I meet all
5
the requirements because individually, I think I would fit, but
6
by the facility I can't because the surgeons use it, so I have
7
great concerns on that very matter.
8
9 MS. HEINLEIN: In that same vein, if there is an
accrediting body that -- I mean you talked about that there would
10
have to be a merger somewhere down the line -- it sounds as if
11
American College of Surgeons feels that they are capable
the 12
at this point to accredit personnel only.
13 Is that correct?
14 DR. WINCHESTER: The task force hasn't met yet. I
can't predict what they are going to say.
15 That is just my
concept of it.
16 In a general sense, the American College of
Surgeons has been involved for decades in accrediting
17
facilities for trauma through ATLS.
18 That is both people and
facilities.
19
20 They have, for 75, 80 years accredited programs and
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people within it for cancer programs through the Commission on
1
Cancer, so, you know, we have the history of being able to do
2
something like this, but a stereotactic unit is somewhat foreign
3
to surgeons, and I don't know what the task force is going to
4
say about this, but I think we are going to work with the College
5
of Radiology on that one, and I think that that is quite feasible
6
given our track record of working together on this project.
7
8 MS. HEINLEIN: Especially to ensure that there will
be comparable standards, then, between the accrediting body,
9
so that everyone is making sure that everyone is being
10
accredited to the same level of standards.
11
12 DR. WINCHESTER: Nobody in the committee or in the
audience has seen the letter, because it came out late, but it
13
is a common letter from the American College of Surgeons and
14
American College of Radiology, which I could read if you
the 15
want me to, but if you don't -- it is not very long.
16 It answers
some of the questions about a voluntary accreditation program
17
versus a regulatory program.
18
19 DR. MONSEES: Is there any new information in it that
we haven't heard in summary?
20
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1 DR. WINCHESTER: I would say two things perhaps, and
that 2was the question about comparability. "Both our
organizations are committed to comparable quality
3
accreditation programs on a voluntary basis and believe these
4
programs will assist in providing optimal health care to
5
patients afflicted with breast disease."
6
7 Secondly, a final statement that, "The American
College of Radiology and the American College of Surgeons would
8
monitor the effectiveness of the voluntary process."
9
10 MS. HEINLEIN: Speaking on the voluntary process,
which I guess is a question I pose to all three panel members,
11
if this is a voluntary process, then what motivation, what would
12
encourage facilities to go through the process if it was
13
voluntary?
14
15 DR. WINCHESTER: Reimbursement. It might come to
that.
16 Looking at the ACS initiatives and the ACR initiatives
quality care for screening mammography, I think the
and 17
consumers, the women of this country are looking for some
18
indications there is a quality program in place.
19 I think it
would be patient driven, and probably industry -- I don't know,
20
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what 1do you think?
2 DR. DERSHAW: I think it makes no sense to talk about
these kind of programs as true voluntary programs, because there
3
is no motivation for anybody to use them.
4 The overwhelming
majority of facilities out there can, in fact, ignore these
5
programs.
6
7 So, there has to be some kind of non-voluntary
component to these voluntary programs.
8 The most obvious one
is tying accreditation to reimbursement schedules.
9
10 DR. WINCHESTER: The other thing that has happened
historically with the cancer programs of the college is a good
11
example.
12 The Commission on Cancer surveys cancer programs
every four years now, and we have 1,600 programs, which doesn't
13
sound like a big number, but it represents 80 percent of all
14
newly diagnosed cancer patients in the United States.
15 It is
a voluntary program.
16
17 Why would hospitals want to pay a tumor registrar and
together a whole team of people that has to respond to a
put 18
survey, and the answer is marketing.
19 They market themselves
quality cancer program to their service area.
as a20 The American
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Cancer Society is now establishing an Infonet program, a 1-800
1
number that a cancer patient or a family will call.
2 I know this
is off the subject, but it just another way of answering your
3
question.
4
5 They will be given so far two levels of information.
One is hospitals that are approved by the Commission on Cancer,
6
and those who are not approved will not be listed for these
7
callers.
8
9 Secondly, caseload. My mother has a colon cancer.
many colon cancers were done at Highland Park Hospital last
How 10
year versus three or four other hospitals in the geographic
11
area?
12 The third tier of information, which I think is going
to come forth is outcome, survival rates.
13
14 So, that is just another example of how the public
will use this.
15
16 MR. PIZZUTIELLO: I would like to add something to
that.
17 In my practice as a consultant physicist, I have been
asked by many of my clients why do the accreditation programs
18
when they are not mandated.
19
20 If you look at the mammography accreditation program
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history and model, there were very many facilities who were
as a 1
doing good work, lots of facilities learned that they can do
2
better, and they continued to learn that they can do better as
3
we see that not all facilities pass accreditation on the first
4
try these days, even 1997.
5
6 So, there was a continuing education process and
improving of quality that we have seen through mammography
7
accreditation program.
8 We also saw, as Dr. Houn mentioned, the
sort 9of charge to get certified at the end of 1994. There were
a large number of facilities who continued to ignore the general
10
trend towards let's do better, let's show our quality, let's
11
market ourselves by being accredited.
12 There were a large
number of facilities who never did anything until the time it
13
required whether either they get accredited, get in the
was 14
process, or shut down.
15
16 So, that is always a problem. It would be very
sensible in the free market economy of this country to have all
17
control be exercised through reimbursement, however, I
the 18
don't know that this committee has very much to say about
19
reimbursement.
20
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1 I also will say that some of the facilities that I
see that are marginal, say that, well, this is really a lot of
2
work 3for us to do, but we provide this procedure as a service
to our patients, why should we have to jump through these high
4
quality hoops.
5
6 My response to those facilities is that if you are
providing a service that is not out of standard of care, then,
7
you are providing a convenience to the patient which may, in
8
fact, be a disservice.
9 So, I think that that is something we
need to be aware of, that not all facilities will take the high
10
road.
11
12 DR. MONSEES: Ms. Hawkins.
13 MS. HAWKINS: I wanted to ask Mr. Pizzutiello,
related to your remarks on quality assurance, do you see the
14
role for another entity to look at patient satisfaction under
15
quality assurance, that perhaps some consumer group, for
16
instance, especially as we deal with many older adults that will
17
come into this process, we have a national aging network that
18
is out there?
19
20 MR. PIZZUTIELLO: I should clarify first that the
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role 1of the medical physicist is primarily in quality control,
which is more in equipment and technical-related aspects.
2
Quality control is a subset of quality assurance, and a distinct
3
part 4of all quality assurance program that I know of is are we
satisfying the customer.
5
6 So, I think that any facility in 1997 will be remiss
if they didn't pay some attention to how they are handling the
7
patients.
8 I don't know that that needs to be done through an
outside agency.
9 I think it is probably being done right now.
10 DR. WINCHESTER: In today's tough competitive
environment, in fact, hospitals that are not measuring patient
11
satisfaction, and facilities that are not measuring patient
12
satisfaction in responding to deficiencies are not doing well,
13
they all realize that they must do this and it is a very
and 14
important.
15 I think it is being done at the local level rather
vigorously.
16
17 DR. MONSEES: For mammography, which is regulated,
there is a complaint mechanism that is stipulated, I believe,
18
likewise, if a voluntary accreditation program would
and 19
supplant some sort of regulated activity, I think that it should
20
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be considered that there be a complaint mechanism by the college
1
or whichever college or combination of colleges might consider
2
having a voluntary 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
7
the ACR, where the radiologist could become accredited?
8
9 DR. DERSHAW: The ACR accreditation program now
includes the parameters for accreditation that have been
10
jointly adopted by the ACR and the ACS.
11 So, a facility that
physicians involved in these procedures, that meet those
has 12
criteria, is an accreditable facility.
13
14 DR. MOORE-FARRELL: Who do you apply to?
15 DR. DERSHAW: The ACR. A facility cannot be
accredited if practitioners at that facility actually involved
16
in the procedure do not meet the standards.
17 So, if some of the
people who are there are qualified, but some of the people who
18
doing the procedure are not qualified, then, accreditation
are 19
by any accrediting body would be of no value to the public
20
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because it would not guarantee to them that, in fact, qualified
1
personnel were the only ones that would offer that procedure
2
to them.
3
4 DR. MOORE-FARRELL: So, if certain people chose to,
but the others did not wish to participate because it was
5
voluntary, then, there would be no way you could be accredited.
6
7 DR. DERSHAW: That is correct.
8 DR. MONSEES: So, there is no way to be accredited
under the collaborative model proposed by the joint task force,
9
is that correct?
10
11 DR. DERSHAW: The criteria for MQSA-qualified
physicians and non-MQSA-qualified physicians performing the
12
procedure have been incorporated into the ACR accreditation
13
program.
14 So, you do not have to be an MQSA-qualified physician
participating in stereo in order for your facility to be
15
accredited by the ACR.
16 The joint recommendation of the two
colleges --
17
18 DR. MOORE-FARRELL: But it has to be everyone.
19 DR. DERSHAW: We will not accredit a facility which
only some participants in the procedure being accreditable,
20
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meeting the criteria for accreditation, whether that is
1
physicians, technologists, or your medical physicist.
2
3 DR. MOORE-FARRELL: And, Dr. Winchester, the same
would go for you since it is collaborative, if the surgeons there
4
wanted to, but the radiologists weren't interested, there would
5
still be no way.
6
7 DR. WINCHESTER: Or if the radiologists weren't
qualified after the voluntary accreditation program is
8
developed.
9
10 DR. MONSEES: Dr. Hendrick.
11 DR. HENDRICK: A year ago when we met on this issue,
it was my impression, and perhaps incorrectly, but my impression
12
that the committee was in favor of having stereotactic breast
13
biopsy included under MQSA.
14 That is not as a voluntary
accreditation program, but as a mandated certification program
15
under MQSA.
16
17 What I am hearing today I think is somewhat different
from that, both from the American College of Surgeons and the
18
American College of Radiology.
19
20 I just want to make sure what I am hearing, my
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impression today is correct, and that you are saying both
1
colleges feel that this is better done as a voluntary program
2
not under the auspices of MQSA at all then as a required
3
certification program.
4 Is that correct?
5 DR. WINCHESTER: If I may quote the letter signed by
both 6colleges, "The American College of Radiology and the
American College of Surgeons are writing to you to reinforce
7
their belief that voluntary accreditation operational in each
8
college is the best method to serve the public in the area of
9
stereotactic breast biopsy."
10
11 DR. DERSHAW: Might I add to that, though, that
accrediting bodies must all have the same high standards that
12
compromise the standards among a menu of accrediting bodies is
13
acceptable, and that accreditation, if it is going to mean
not 14
something, has to have some force behind it.
15 It can't just be,
know, fill out the coupon in the back of your monthly journal
you 16
you will be accredited.
and 17
18 We have established standards for accreditation. We
believe that those are the appropriate standards for
19
accreditation, and those should standards should be required
20
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by all bodies that are offering their services as accrediting
1
bodies.
2
3 DR. MONSEES: This side of the table. I am sorry I
have 4neglected this side. We will start with Dr. Smith.
5 DR. SMITH: This question is directed to both Drs.
Dershaw and Winchester representing the two colleges.
6 We all
watched the American College of Radiology's accreditation
7
program gain momentum over time, but during the period of time
8
leading up to MQSA, there was lots of press coverage, lots of
9
problems that were continually identified that the
10
accreditation program on a voluntary basis just really wasn't
11
enough.
12
13 In hindsight, can you now, as proposing a voluntary
standard as opposed to a regulatory standard, see new ways to
14
have accreditation not only have new teeth, but gain the kind
15
of momentum at a faster pace that under mammography it did not?
16
17 I think there probably are potentially new incentives
because the whole climate of health care has changed under
now 18
managed care, but there is an opportunity I think to get the
19
kind of support from the various consumer groups, in particular
20
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the Cancer Society, if the accreditation program serves its
1
purposes.
2
3 I mean that kind of tradeoff would have to be
demonstrated.
4 So, I am wondering what kind of plans the two
colleges have to make accreditation a reality in all facilities
5
and a reality that means something, and what kind of timetable
6
would you be looking for.
7
8 Right now you can't start saying to consumers look
for an accredited facility, because it is a little soon.
9
10 DR. MONSEES: Which one of you gentlemen would like
to start answering that one?
11 You can answer collaboratively,
yes.
12
13 DR. WINCHESTER: I think you should comment on the
historical question about the evolution of the ACR
14
accreditation program and how it gained momentum.
15
16 DR. DERSHAW: Well, let me just tell you where the
accreditation program is now as a start.
ACR 17 I think part of
your question actually you have answered yourself, part of it
18
doesn't have an answer, and part of is kind of hanging out there
19
in space at the moment.
20
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1 We have had about 300 facilities that have applied
for accreditation, slightly less than 100 facilities have so
2
far been accredited.
3 I must say that when the program was first
instituted, we were happy not to be overwhelmed with numbers
4
of facilities applying because, as you can all appreciate, the
5
initial mechanics of putting a new program into action are often
6
not very well oiled, so we were happy to get the program up and
7
going a little bit.
8
9 Some of the initial problems in the program also I
believe, I hope have been dealt with by the agreement with the
10
American College of Surgery.
11 As I think probably all of you
appreciate, these procedures are done sometimes by
12
radiologists, sometimes by surgeons, but I think, in a very
13
large number of facilities, in fact, are a joint endeavor of
14
surgeons and radiologists.
15
16 The difficulty in establishing criteria for non-MQSA
physicians to participate in these procedures was, in fact,
17
overcome by efforts with the American College of Surgery and
18
made it possible to offer accreditation through the ACR to
has 19
a much greater number of facilities than it was possible for
20
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us to offer it initially.
1
2 A list of certified facilities is made available to
the public through the Cancer Society.
3 I think the
sophistication on the part of the public having learned about
4
certification for accreditation or regulation through the
5
experience with mammography has resulted in I hope a greater
6
awareness on the part of the public in terms of the value of
7
accreditation, whether it comes from the ACR or whether it comes
8
from 9another body.
10 I think that is where we are with it so far. It
remains a voluntary program.
11 I think one difference perhaps
in this than in other procedures that we may talk about is often
12
a patient, when she gets to the point that she needs a breast
13
biopsy, is in a system, is in a medical system, is in a hospital
14
system, is in a referral pattern, had a radiologist or a surgeon
15
or a gynecologist whom she trusts to make an appropriate
16
referral for her.
17
18 So, I think the awareness of the value of
accreditation through these kind of programs may, in fact, be
19
diminished in the eyes of the individual patient because she
20
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has already placed herself, I think, often in a medical
1
situation of trust.
2 She has established her health care
network at that point.
3
4 But anyway, I think that is where we are today with
the program.
5
6 DR. WINCHESTER: I think the level of consciousness
and of the efficacy of this procedure and the publication in
7
the media about this procedure is reaching a high level and that
8
there will be a public demand for this to be done in a quality
9
way.
10
11 I think that the ACR and ACOS or ACS logos together
on a document is an important historical precedent.
12 It makes
a strong statement about two very large organizations primarily
13
involved in this procedure, the fact that they were able to get
14
together and put something together, which I regard as a stopgap
15
measure, because remember, we are dealing with a technology that
16
is being applied out in the community by radiologists and
17
surgeons who were never trained to do this.
18
19 So, we have a problem to deal with in a few year window
of opportunity here to educate, and prospectively, through our
20
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training programs in radiology and in surgery, we will produce
1
radiologists and surgeons who will be certified by their
2
respective boards and tested in this procedure.
3
4 Laparoscopic cholecystectomy is a good example.
This 5hit the papers. The American College of Surgeons, such
a big machine, it couldn't even respond in time with educational
6
programs.
7 There were courses that jumped up all over the
country, and surgeons were scrambling, and I was one of them,
8
to find a course that I could quickly get enrolled in, so I could
9
learn this and do it in a couple of weeks after I was proctored
10
maybe three weeks.
11
12 Those courses went on for about three or four years.
can't find one now, they are gone.
You 13 Why are they gone? They
gone because the surgeons that are being produced in this
are 14
country now are skilled when they come out of their training
15
program, and they are certified by the American College of
16
Surgery to perform this procedure in a competent way.
17
18 The courses aren't there anymore. The courses on
stereotactic core needle biopsy are going to go away.
19 They are
going to go away in a few years because we are going to produce
20
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prospectively skilled people to do this procedure, and of
1
course, that will change.
2 There will be new technology and in
year 32004, we will be going through this again with, you know,
we have got a new gadget now, how are we going to respond to
4
all the people that are out there doing it.
5 Well, we can teach
the residents and they will learn it.
6 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
9
way, it looks like, we are about to come to closure here with
10
this group of individuals.
11
12 I would like to ask a quick question. You mentioned
numerator, 300 facilities have applied and 100 were
the 13
accredited.
14 How many facilities are there out there, do we
know?
15
16 DR. DERSHAW: No.
17 DR. MONSEES: Is there anybody in the audience from
industry who is willing to stand up here and tell us a number,
18
many units do we have in the United States?
how 19 Does anybody
have that knowledge that is willing to volunteer that
20
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information to us?
1
2 DR. HENDRICK: Maybe you should specify what kind of
units.
3
4 DR. MONSEES: We are talking about stereotactic
units, either prone and/or add-ons.
5 Let's start with prone
units.
6 Is there any manufacturer out here that is willing to
tell 7us?
8 [No response.]
9 DR. MONSEES: That is what I thought.
10 Dr. Israel?
11 DR. ISRAEL: I haven't seen this number tabulated,
I
but 12 have asked both the Lorad and the Fischer, who make the
prone tables, and this does not include upright tables, but it
13
is my impression there are between 1,300 and 1,500 prone
14
stereotactic units that have been sold and installed in the
15
United States.
16
17 That is my estimate. I don't have those figures, but
that is my impression.
18
19 DR. MONSEES: Thank you.
20 I think we will go to break now. We will reconvene
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promptly at the appointed time, 3:45, and we will continue this
1
discussion.
2 Thank you.
3 [Recess.]
4 DR. MONSEES: We are going to reconvene.
5 We want to continue the discussion that was occurring
just 6before the break. I will ask Dr. Dershaw to contribute
to the discussion and to answer questions as they come up from
7
the other panel members.
8
9 Where we left off, I believe there was a question on
this side.
10 Dr. Sickles, go ahead and ask a question.
11 DR. SICKLES: My concern relates, not to the
agreement that the two organizations have come to -- which I
12
think is a big step in the right direction -- but rather to the
13
issue of voluntary versus mandatory.
14
15 I think back to the period of time when ACR
accreditation for mammography was voluntary, and became
16
mandatory with implementation of MQSA.
17 For those of you on the
panel who weren't involved in this, at that point, my
18
understanding is about 50 percent of the mammography facilities
19
in the country were accredited, another 25 percent or so were
20
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in the process of being accredited, and some of that might have
1
been 2due to the fact that they knew that it was coming in a
mandatory fashion.
3
4 But then there were approximately 25 percent of
facilities in the country that did not even attempt
5
accreditation until it was mandatory by MQSA.
6 My opinion --
and apparently it is shared by Dr. Dershaw and I would presume
7
by Dr. Winchester -- is that a voluntary program that attempts
8
to establish standards for the whole country will succeed only
9
if it is virtually 100 percent utilized, because if we have a
10
voluntary program that is utilized by, say, 75 percent of the
11
people in the country, and there is no really firm impetus to
12
be sure that that remaining 25 percent get certified
13
appropriately, that they are not going to do it.
14
15 Unfortunately, the 25 percent that won't do it until
they have to, are the 25 percent that really must do it because
16
they are the ones who look at these many, many tests and say,
17
know, not only is it difficult, but we may not be able to
you 18
meet those standards.
19
20 So, I think we have to be very cautious about adopting
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voluntary programs until we have some very good assurance that
1
the compliance level with the voluntary programs will approach
2
100 percent.
3
4 If this can somehow be tied with reimbursement, that
will 5come to pass, I have no doubt about that, but there is,
to my knowledge -- and maybe you can educate me -- no steps right
6
immediately in the pipeline or even I am not aware of anything
7
in the not too distant future which will force the issue of tying
8
this 9type of accreditation to reimbursement.
10 If you are aware of any of this, I think the panel
should know, because I think that would overcome the objection
11
that I am addressing.
12 If you are not aware of it, then perhaps
approach that started with a voluntary program should have
any 13
a time frame beyond which if we didn't get close to 100 percent
14
compliance, we would have to kick into a mandatory program.
15
16 Do the two of you have opinions on this?
17 DR. WINCHESTER: What was the question? I get the
gist of it.
18
19 I would think that if the voluntary accreditation
program for stereotactic breast biopsy, the two colleges became
20
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part 1of the American Cancer Society Infonet, and that people
called in the 1-800 number to find out what facility in their
2
geographic area was accredited by the two national
3
organizations, that you would see a mighty rapid rush for
4
accreditation.
5 I know we are going to see the same thing in
the cancer programs now.
6 We already have 80 percent of the
cancer patients.
7 I think when Infonet kicks in, that it is
going to come up to any facility that feels like they can do
8
it above 90 percent, we are going to be virtually
9
population-based then.
10 It hasn't happened yet, but folks, it
is coming.
11
12 I think public pressure, public demand for quality
care and some kind of a national certification program with
13
reputable college names like your college and my college -- and
14
that is why, by the way, your college I believe sent this letter
15
along with our college recommending accreditation.
16 Both the
colleges think that it can happen.
17 We really believe that it
happen, and there are various ways of getting from point
can 18
A to point B.
19
20 But I understand what you are saying. I think you
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are quite perceptive in asking about timetables and asking about
1
how you are going to get some teeth into this.
2 That is one just
off the top of my head, one mechanism to do that.
3 We have seen
that 4with the cancer program and ATLS.
5 DR. DERSHAW: I would agree with everything you said,
Dr. Sickles.
6 I am not aware of anything going on with
reimbursement that you are not aware of going on with
7
reimbursement.
8
9 That issue was solely raised as an example, I think
a
not 10 very bad example, of how you can make a voluntary program
somewhat less than voluntary.
11
12 I also agree that the proof of the pudding is in the
tasting.
13 If you have accreditation programs out there, and
they are not being utilized as voluntary programs, then, they
14
not accomplishing what the accreditation programs are
are 15
designed to accomplish.
16
17 DR. WINCHESTER: Part of this agreement was for the
colleges to monitor the effectiveness of the process.
two 18 So,
what would happen if we monitored this for 12 months and found
19
that the compliance was 28 percent?
20 One possible step would
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be to make it mandatory, that if the surgeons or radiologists
1
wish 2to perform this, they have to show us with surveys
objectively that they are meeting the criteria that have been
3
outlined, and that could happen.
4
5 DR. SICKLES: I have one practical followup
question.
6 It has to be addressed to Dr. Dershaw now because
it is premature to address it to you.
7
8 Let's say that publicity gets out to the radiology
community in the next few months that this would be a really
9
good thing to do, for whatever the reason.
10 Could the ACR handle
1,300 units that are out there in a reasonable amount of
the 11
time?
12
13 DR. DERSHAW: Could you define a reasonable amount
of time, Dr. Sickles?
14
15 DR. SICKLES: Well, tell me what you think a
reasonable time would be.
16
17 DR. DERSHAW: Well, I don't know. Maybe staff could
better answer that question than I could, and I would, if I
18
might, refer that question.
19
20 DR. SICKLES: The reason I am asking you is that it
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is unfair to establish a deadline if people cannot meet the
1
accreditation because the mechanisms just go too slow to make
2
it happen, and I understand in the institution of a program,
3
and the ACR program, although it has been around for a year and
4
a half, still is not in high gear, that is a difficult task.
5
6 DR. DERSHAW: Could I just be reminded how long it
took 7FDA to regulate screening mammography? I have lost track
of the time.
8 From start to finish, how long was it?
9 DR. HOUN: I can tell you that for about 4,500
facilities who had not been accredited previously, came in t
10
meet the 10-1-94 deadline, and it took 4,500 facilities to go
11
through mammography accreditation roughly six months plus three
12
months, so a total of nine months.
13 Most of them made it through
within nine months.
14
15 DR. MONSEES: Dr. Hendrick.
16 DR. HENDRICK: I share Dr. Sickles' concerns
especially about the sites that would not participate in this
17
voluntarily.
18 One of the concerns I have is that we may not know
state of practice even if there is a voluntary ACR program
the 19
voluntary ACS program.
and 20
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1 The big concern I have is that we will have very little
in the way of good surveillance of the practice of stereotactic
2
breast biopsy throughout the country.
3 Even if we monitor the
voluntary sites and their practices in both of those programs,
4
we won't know how many sites are accredited by either program.
5
6 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
7
methodology by which we would know what is really happening,
8
at least in terms of how many sites there are doing different
9
types of stereotactic breast biopsy, how many are accredited
10
what the state of quality is in those that aren't.
and 11
12 A second concern I have is that I heard discussion
of two different accreditation programs, one by the ACR and one
13
by the ACS, and I heard two completely different things.
14 One
more on the model of the mammography accreditation program,
was 15
which includes all the personnel, equipment, QA, and other which
16
really more of a physician credentialing accreditation, if
was 17
want to put it that way.
you 18
19 I shared some concerns that were expressed previously
about the difference between those types of models of
20
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accreditation and the results that they would have on the
1
facilities working under those different accreditations.
2 So,
that 3is also a concern under this voluntary model.
4 DR. MONSEES: Yes. Go ahead, Mr. Pizzutiello.
5 MR. PIZZUTIELLO: I have a comment about the
difference between board certification and accreditation.
6 I
am not certain that the problem will go away when all the
7
surgeons come through training, receive this training in their
8
residency, and are tested in their certification process,
9
because almost all the radiologists that do mammography are
10
board certified, yet, it became important and clear that the
11
quality of mammography was not being ensured just by having
12
radiologists be board certified.
13
14 So, there is yet another level beyond board
certification that says can you demonstrate a minimum
15
proficiency with this procedure, the examination of
16
mammography.
17 So, I am not sure that board certification by
itself will do it for surgeons as it hasn't for radiologists.
18
19 Also, just to clarify Ed Hendrick's point, the number
that I have heard about the number of stereotactic units out
20
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in the country is more like 3,000 instead of the 1,500 that Dr.
1
Israel suggested.
2 Now, nobody knows that number, but if we are
trying to monitor the ability of the voluntary accreditation
3
programs to see how close they are to getting at the whole
4
universe of stereo units, we don't know what if the denominator
5
is 1,500 or 3,000.
6 That makes a very big difference.
7 DR. WINCHESTER: I was speculating that once we get
this 8prospective, then we have trainees out who have been
trained to do this at the entry level, that they would be
9
qualified at entry to do it, but I didn't mean to imply, I think
10
I mentioned CME, that there would need to be a focused continuing
11
program on a voluntary accreditation basis that would monitor
12
in terms of CME and medical audit performance and evidence that
13
there had been ongoing education and procedure.
14
15 DR. FINDER: I just want to make one point at this
juncture about conflict of interest.
16 I want to bring that back
in. 17The people that were mentioned in the conflict of interest
statement that had been involved in this issue should keep their
18
statements just to the facts, and not really opinions.
19
20 So, if you can either just stick to the exact facts
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of the document or the program or how that program was developed,
1
that 2would be appropriate, but we have to be very careful about
people giving opinions who have written these documents.
3
4 DR. MONSEES: There are surely some additional
questions for this group of individuals who presented this
5
afternoon, and I would like to address some of those questions
6
that 7other panel members have, but just to let you know where
we are going, what I would like to do, after we are finished
8
with 9that, is move towards talking about personnel issues this
afternoon.
10
11 Then, tomorrow morning resume talking about
voluntary versus regulation, because that is what is on the
12
agenda, and I would like to make sure that we cover particularly
13
physician personnel issues this afternoon, but also
the 14
probably some of the technologist personnel issues.
15
16 I have a quick question for Dr. Houn. Is there any
to
way 17 mandate that core biopsy be a reportable event, so that
we can have an accurate number?
18 If we are going to data keep
look at what is going on and if the voluntary accreditation
and 19
programs are going to join together and they are going to monitor
20
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themselves, you need to know how many are going on.
1
2 Is there any way to mandate it as a reportable event
and the number of units that they have to register or something
3
like 4that, is this possible?
5 DR. HOUN: I really don't know at this time. I know
that 6the law says that in applying for FDA certification, they
have 7to supply numbers of units, personnel involved, but you
are saying without certification can FDA collect this
8
information on an exempt technology, and I think that is a real
9
-- it sounds difficult for us to do, and it would have to be
10
looked at by general counsel, but since it is exempt now, I think
11
that carries a lot of weight in terms of what we can do and what
12
we can ask of these entities.
13
14 DR. MONSEES: We have some questions on this side of
table.
the 15 Yes, Mr. Mobley.
16 MR. MOBLEY: In terms of answering this specific
question, it would seem to me FDA has equipment reports
17
regarding installed equipment or equipment sales that could be
18
used to at least define the universe of equipment sales that
19
occurred.
had 20
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1 I presume these would be reportable pieces of medical
diagnostic x-ray equipment -- these may not be diagnostic.
2 I
don't know, I was just thinking there is an equipment standard.
3
There are reports regarding that equipment that have to be
4
filed, and that is one way to get a picture of the universe in
5
terms of installed equipment.
6
7 I may be overstating the case, but that seems you
could go in and you query the computer on these units and there
8
they 9are.
10 DR. MONSEES: Is that possible?
11 DR. FINDER: I don't think it is as easy as it should
be. 12We have been trying to look and get numbers, and so far
we have not got a comprehensive number yet, but we are continuing
13
to look and to search the databases that we do have access to,
14
we
but 15 don't have an exact number.
16 MR. MOBLEY: Whether it is 3,001 or 3,002 --
17 DR. FINDER: It's not even that. I am not talking
about.
18
19 MR. MOBLEY: We have got 1,300, 1,500, 3,000.
20 DR. MONSEES: Dr. Dempsey.
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1 DR. DEMPSEY: I would like to ask Dr. Winchester a
question that is not exactly equipment related at all, but I
2
think it bears a great deal on what will happen in the future.
3
4 It is obvious that this joint statement from both
colleges has been reached by people who are very conscientious
5
and level-headed, and I think have the patients' best interests
6
at heart.
7 Over the past two years, unfortunately, I think there
has been a sense of deep contentiousness that has existed, and
8
there are probably many reasons for that out there, but this
9
idea of a turf war that encompasses patient control and
10
remuneration and division of work, et cetera, and I think it
11
is important to get a sense, Dr. Winchester, as how you view
12
your membership at large as responding to this effort that has
13
been published.
14
15 Is that same level of cooperation, do you think, out
there, is it going to change the other feeling that I think,
16
unfortunately, has been out there for at least a couple of years?
17
18 DR. WINCHESTER: Well, of course, feelings run both
ways, in both directions, and they are hard to assess.
19 The
college has 54,000 fellows.
20 We have about 30,000 general
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surgeons.
1 I don't know how many of those 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.
5 I
didn't get 30,000 letters, I didn't get 2,000 letters.
6 I didn't
get a lot of compliments either.
7 I don't have a good file and
a bad file.
8
9 So, it hasn't been overwhelming. We all look at our
experiences, at our settings, and in my setting, everything is
10
fine.
11 We have a collegial relationship, a good breast center,
we work together.
12 Someone else made the statement earlier. I
think by and large, a great majority of facilities that are doing
13
this, are doing it in that manner, and not in a contentious
14
manner.
15
16 So, I think we need to be careful about the degree
to which we react to pointed criticism.
17
18 DR. MONSEES: Mr. Fletcher had a question.
19 MR. FLETCHER: I wanted to do an add-on to what Mike
asking, because I know that for every device, every machine,
was 20
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x-ray machine that comes in the State of Maryland has a document
1
trail.
2 If we don't know right now what we have, is there a way
we can find out, because there has got to be a document trail
3
to let us know where these devices are.
4 I am just curious to
know 5do we intend to look into identifying how to keep track
of these devices.
6
7 DR. FINDER: Yes. I mean we are attempting to get
that 8information, we just don't have it now. We are going
through various mechanisms.
9 It is not as simple as hitting a
computer button and getting the data to spit out, but there are
10
mechanisms that we can go down to try and get this information,
11
we
and 12 are trying to do that now.
13 DR. MONSEES: Ms. Heinlein.
14 MS. HEINLEIN: A question for Dr. Dershaw. This
morning the number of surgeons presented and discussed the
15
training programs that are available in the country right now
16
surgeons to learn how to do stereotactic breast biopsy.
for 17 Can
tell us about what type of programs -- are there programs
you 18
available for radiologists, and what kind of programs there are
19
available?
20
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1 DR. DERSHAW: There are programs in stereotactic
breast biopsy in CME courses, and these include didactic
2
lectures and hands-on experience, not with patients, but
3
hands-on with apples and phantoms and eggplants, and a variety
4
of other grocery store products.
5
6 The training is included in breast fellowship
programs, in residency programs.
7 The ACR is in the process of
establishing a formalized, standardized program that will
8
include not only again CME credits in courses and hands-on
9
experience, but a videotape of information and procedures that
10
be
can 11 distributed.
12 So, I think there is a fairly wide training experience
that is available.
13
14 DR. MONSEES: Yes, Dr. Hendrick.
15 DR. HENDRICK: I wanted to go back to the document
that you have brought before us, the personnel, physician
16
qualifications, and in particular, I want to try to see if I
17
understand the model in which the radiologist and breast
can 18
surgeon or other physician practice collaboratively.
19
20 Under number 1 on page 1, the last statement in there
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is, "The physician should be present at the appropriate time
1
during the procedure."
2 I don't know what that means. Does
that 3mean the radiologist should be there when the button is
pushed to fire the biopsy gun, and the surgeon should be
4
somewhere else, or does it mean that either the radiologist or
5
the surgeon should be there at that point?
6 I was just hoping
for some clarification about what that sentence really means.
7
8 DR. WINCHESTER: I think the intent was related to
the environment that we are now working in and the challenge
9
of billing for a procedure when you are not there, whether it
10
is a stereotactic breast biopsy or a thoracotomy or you name
11
whatever, the wire localization, and training programs with
it, 12
fellows and residents.
13
14 DR. MONSEES: This pertains to Medicare basically
reimbursement under Medicare stipulates that the physician be
15
present during the key part of the procedure to bill it, the
16
billing issue.
17
18 DR. WINCHESTER: It relates to that technicality
rather than the surgeon or the radiologist being there, or both
19
of them being there, the intent was it depends on who is doing
20
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it. 1They don't need both need to be there.
2 DR. HENDRICK: But is the model that either the
radiologist or the surgeon could be performing the procedure,
3
but the point is that if they are billing for the procedure,
4
they 5had better be there when it is being performed?
6 DR. WINCHESTER: Yes.
7 DR. HENDRICK: Another question I had was toward the
end of the document, on page 4 under B, in the situation where
8
a surgeon or other physician practices stereotactic breast
9
biopsy independently, "the surgeon or other physician is
10
required to -- and the first dot there under Initial Training
11
Qualifications is, "have evaluated at least 480 mammograms
and 12
year in the prior two years in consultation with a physician
per 13
is
who 14 qualified to interpret them."
15 I guess my question is what does evaluate mean?
16 DR. WINCHESTER: That is in almost all these letters.
It does require clarification I think by the process we are going
17
through today, I would hope that it would clarify, but the intent
18
of this was that if a surgeon is doing this independently, say
19
they have rented a building, they have bought a piece of
20
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equipment, and they have hired a radiologic technologist, and
1
they 2have satisfied all the equipment standards, they are not
MQSA, so they are not interpreting mammograms.
3
4 They are referred a patient with need for a
stereotactic breast biopsy with a mammographic abnormality,
5
which has been interpreted by MQSA is the setting we are talking
6
about now.
7 That doesn't mean that the radiologist needs to walk
in with that mammogram in that suite and put it up with the
8
surgeon and say here is what I said in my report.
9
10 What it means is that the surgeon quite logically is
going to perform this procedure without reviewing the
not 11
mammogram and the report by an MQSA radiologist or physician
12
before embarking upon this.
13
14 So, review in our sense as our task force looked at
review was in that spirit, and a couple of members of that
it, 15
committee here could agree or disagree.
16
17 DR. BASSETT: The surgeon wouldn't be interpreting
making a report on the examination, but would be reviewing
and 18
images, reviewing the findings, reviewing the report on a
the 19
number of cases to ensure that they knew how to identify
20
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abnormalities.
1
2 DR. SICKLES: This 480 mammograms doesn't relate,
though, does it, to the specific patient who is undergoing
3
stereotactic biopsy.
4
5 DR. BASSETT: No.
6 DR. SICKLES: This 480 relates to some experience in
breast imaging, not necessarily producing an interpretation
7
with 8your name on the report, but rather some kind of
consultative review with an MQSA radiologist.
9
10 DR. BASSETT: It usually occurs when they are seeing
patient.
the 11
12 DR. SICKLES: And this certainly does not have to
include the specific women undergoing stereotactic biopsy.
13 It
undergo all women in that surgeon's practice who have
can 14
mammograms.
15
16 DR. WINCHESTER: That is a very important point.
are not going to get to 480 very many places without that.
You 17
18 DR. HENDRICK: Farther down on page 4, actually, the
second bullet from the bottom, "be responsible for the
19
supervision of the radiologic technologist and the medical
20
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physicist."
1
2 How would the surgeon or other physician know how to
supervise the medical physicist?
3
4 DR. MONSEES: I wondered that myself.
5 DR. DERSHAW: In the mammography program, MQSA
program, the responsibility for the entire quality assurance
6
of the procedure is the physician's responsibility, and the
7
responsibility for the entire quality assurance of the
8
procedure, performance and quality performance of the procedure
9
remains the physician's responsibility in this procedure
10
whether it is a radiologist, whether it is a surgeon, whether
11
it is an MQSA-certified physician or not.
12
13 This is merely to indicate that the responsibility
all
for 14 the professional personnel and all the quality assurance
of the procedure is the physician's responsibility.
15
16 DR. HENDRICK: I understand that, but I hesitate to
accept that, say, four hours of radiation physics as an
17
educational background would really equip a physician, even a
18
highly educated physician like the surgeon, to be able to
19
supervise a medical physicist and know what the medical
20
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physicist had done is really appropriate, inappropriate, how
1
to take action on the interpretation, say, at the medical
2
physicist's report, things like that.
3
4 DR. MONSEES: Likewise, the same may be the case for
supervising the radiologic technologist.
5
6 DR. WINCHESTER: I guess I have a practical question
because I don't know what happens in the real world, but does
7
the radiologist supervise the physicist?
8 Be honest now.
9 DR. MONSEES: Yes, the radiologist interacts with --
10 DR. WINCHESTER: Interacts, but supervises? Is the
word supervisor the wrong word?
11
12 DR. MONSEES: What you do is you make sure that the
physicist not only provides the appropriate service, but that
13
is called in when appropriate.
14 That is not always so easy to
know.
15 Anytime there is any question in quality control, you
consult your physicist.
16 You make sure you do. If something
changes with the equipment, you consult your physicist, and you
17
have to be able to speak the same lingo to understand what is
18
going on.
19 You can't just -- at least in my estimation -- have
somebody tell you everything is okay, you could just go on now
20
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without really understanding some of what that means.
1
2 Any other comments from any other radiologists here
who deal with this in their practice?
3 Do you have anything to
add? 4
5 DR. WINCHESTER: I guess the question really hasn't
been 6answered yet, it is an important question. Is four hours
of something enough to qualify somebody who has graduated from
7
medical school and gone through the rigors of a surgical
8
residency to supervise a radiologic technologist and a medical
9
physicist.
10
11 I believe it is legal. Charley, I don't want to do
something bad here.
12 Is it legal for me to ask, for example,
Israel or somebody in the audience who does this procedure
Dr. 13
frequently in this model, where they are independent, of how
14
they would answer the question?
15
16 DR. FINDER: I think it is up to the chair. I don't
think it is illegal.
17
18 DR. MONSEES: No, it is not illegal.
19 DR. FINDER: But if it is, we will arrest you later.
20 [Laughter.]
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1 DR. MONSEES: They haven't give me handcuffs, so I
will 2allow it. Who would you like to have answer this question?
3 DR. WINCHESTER: Dr. Israel is sitting closest here,
Dr. Dowlat also.
4
5 DR. MONSEES: Let's try and make it brief if we can
rather than call a large number of people.
6 Let's see if Dr.
Israel can handle this.
7
8 DR. ISRAEL: What we do is comply with state
regulations in terms of imaging equipment.
9 We have a medical
physicist review our facility and our equipment twice a year.
10
We also have our service contractor with whom we have a
11
commitment to service our facility to come quarterly.
12 This is
way we operate.
the 13
14 We meet all of the requirements of the state in terms
of the safeguards of the equipment.
15
16 DR. MONSEES: Have you yourself ever noticed
anything where you got on the phone and called your physicist
17
asked him to come in for a consultation because you were
and 18
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.
4 We have the routine surveys and we
have 5not encountered any problems in between those surveys.
Hopefully, if we had imaging deterioration, et cetera, that we
6
would recognize it and we would call for assistance.
7
8 DR. MONSEES: Fair enough. Any other questions from
the panel of Dr. Israel?
9
10 Dr. Mendelson has a question.
11 DR. MENDELSON: I wondered if Dr. Israel would tell
please, what independence the radiologic technologist has
us, 12
in working collaboratively with you, a the surgeon acting alone
13
-- and this is the area of this document we are working with
14
-- if a surgeon acting alone is responsible for patient
15
selection, but relies on the radiologist's interpretation, how
16
is that patient selection made, who does the actual targeting,
17
this patient eligibility for core biopsy?
18 Is that your
assessment of the mammograms?
19 That was one question.
20 Once that decision has been made, how do you interact
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with 1the radiologic technologist, does he or she have an
independent that you respect by virtue of their training and
2
yours?
3
4 DR. ISRAEL: Not in terms of image interpretation.
We see these patients generally in the office after they have
5
had a screening mammogram, an abnormality has been identified.
6
We inspect the images, and there are times when I see images
7
that 8have been graded a BIRAD's 4, that I think should be a
BIRAD's 3.
9
10 When that happens, I call my radiologist and I ask
them if they would like to or feel it would be appropriate to
11
amend their report, so that there is a place for monitoring this
12
patient.
13
14 I take the responsibility along with the patient.
Sometimes if there is a BIRAD's 3 recommendation, and I am
15
looking at the mammograms with the patient, if this patient's
16
mother and sister have had a breast cancer, and this is an
17
indeterminate lesion, even though it may be of low suspicion,
18
I will proceed to do a stereotactic biopsy, and I will not
19
contact the radiologist.
20 The patient and I will make that
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decision.
1
2 The technologist plays no part, zero or minus zero,
in making these decisions.
3 In terms of the images that are
acquired during the course of the procedure, I make all of the
4
interpretations.
5 I decide if the image that has been portrayed
on the digital monitor is indeed the image that we are targeting
6
for. 7
8 I do my own targeting. The technologist is not
responsible for any of that.
9 I accept full responsibility for
that.
10
11 DR. HENDRICK: Dr. Israel, who at your site reviews
preventive maintenance reports, the technologist QC
the 12
records, and the medical physics reports?
13
14 DR. ISRAEL: The technologist reviews those records,
she brings to my attention anything that she may have a
and 15
question about.
16
17 DR. HENDRICK: So, she reviews her own QC surveys of,
let's say, the processor or phantom image quality, and stuff
18
like that?
19
20 DR. ISRAEL: Yes.
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1 DR. HENDRICK: I rest my case.
2 DR. MONSEES: Thank you.
3 Stereotactic Core Biopsy - Personnel
4 I would like to move now towards discussing specific
personnel issues.
5 This is something that we have danced around
a little bit.
6 We need to talk about what qualifications do we
think -- I will ask people here at this table -- need to be the
7
qualifications of a physician who is going to be doing this
8
procedure, and I would like to talk more.
9 We have talked very
little about the technologist's qualifications, and I will rely
10
on some of the technologists on this panel to help pinpoint some
11
of the important issues here.
12
13 Let's start with the physician, but please, let's
keep in mind that we need to move on and talk about technologist
14
issues, as well.
15 Tomorrow, I think we may have some time to
talk more about quality control issues and physicist
16
qualifications.
17
18 So, with that I would like to start by asking perhaps
people on the panel if they have any specific comments about
the 19
what the qualifications should be for somebody who is going to
20
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do this procedure independently.
1
2 Do we agree that 480 mammograms is the appropriate
number, that these numbers for the ongoing requirements are
3
appropriate, et cetera?
4 We can't just I think accept what is
given to us without looking at it at least.
5
6 I would like to go around the table and see if people
think this is about where we should be.
7 Does anybody want to
start?
8 I would like to talk about what the ballpark is, are
we in the right ballpark here?
9 We are not accepting this as
what we are going to recommend, but I think we should start the
10
conversation with this, and we can go from there.
11
12 Do I see any hands? Yes, Dr. Sickles.
13 DR. SICKLES: If your question relates to the 480
mammograms for the non-MQSA physician, as long as the review
14
with MQSA radiologist is a meaningful review, it would seem to
15
me that is perfectly appropriate because it is the same number
16
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 all of the requirements because what he or she
19
is doing is in consultation, so they don't have to go through
20
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all the other steps, but the number, it seems to me reasonable
1
because it is the same number that radiologists have to meet.
2
3 I would be very interested from Dr. Winchester or from
anyone else as to whether that is an onerous number for the
4
average non-MQSA physician who would be performing these
5
procedures, who you would be happy performing these procedures.
6
7 Remember that these, as we were told this morning,
tend 8to be non-MQSA physicians who do a lot of these, who are
interested in it, who are building a practice that heavily
9
involves it.
10 So, I would be interested in knowing whether 480
is unrealistic, but historically, it makes sense.
11
12 DR. MONSEES: Well, the reason that I am bringing
this up is that it is one of the objections that Dr. Winchester
13
said that he had almost uniformly in the angry letters that he
14
received.
15 So, I think we need to put this on the table and see
do we think that it is reasonable or not.
16
17 DR. SICKLES: I agree fully, but what I don't know,
maybe we can get the answer, is whether these are just 15
and 18
of
out 19 36,000, or whether this is really a substantial problem.
20 DR. WINCHESTER: One of the issues I think is the
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central issue here is whether the same requirements, the
1
interpretive skills for screening mammography applied to
2
working in collaboration with the radiologist or working alone
3
and getting an MQSA report.
4
5 I think Dr. Dershaw's presentation today would
suggest that the 480 is appropriate for a surgeon even though
6
he or she is "evaluating" and working with an MQSA radiologist.
7
Maybe that is not true, but that is the central question, are
8
the two really equivalent.
9
10 The other issue that I have gotten feedback from is
access to care issue in community hospitals.
11 They are not big,
high-powered academic centers, they don't have the caseload,
12
while we don't want this procedure done by somebody who
and 13
doesn't see very much of this, I think there needs to be some
14
realistic sensitivity to access to care in smaller communities
15
where one of the specific letters I cited where the surgeons
16
were doing the procedure and doing it well by their own audit,
17
they didn't have 480 per surgeon, which would be necessary
but 18
under these requirements, and those patients would have to
19
travel someplace else in Texas to a "bigger" center to get these
20
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things done.
1
2 So, I guess that those are the two issues I would raise
and ask Larry and perhaps Dave to respond to since I have worked
3
with 4both of them in the genesis of this. We certainly, as
surgeons, don't believe that surgeons should be doing this as
5
an occasional thing.
6
7 It is going to take a lot more than a casual interest
in mammography and breast disease.
8 It is going to take a major
interest in breast disease, and I think, as has been pointed
9
out, that surgeons have self-selected themselves in this
10
process, and if they are not interested in breast disease, they
11
not doing this.
are 12
13 We have seen a large volume of it, they are very much
interested in doing this.
14
15 DR. MONSEES: Dr. Bassett.
16 DR. BASSETT: I just wanted to remind everyone that
or the interpreting physician doesn't have to read 480 original
17
mammograms, that they can share some that were done by someone
18
else, so in the practice, if there isn't 480 apiece for those
19
surgeons, they could double up reading on some of the same cases,
20
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not reading, but reviewing of the same cases that have
1
interpretations with them.
2
3 I am not saying that I know that 480 is the magic,
correct number.
4 I am just saying that you can, it is I think
appropriate to look at cases that you are not necessarily seeing
5
as the primary consultant yourself, and that is how radiologists
6
or interpreting physicians in low-volume areas overcome the 480
7
number.
8 They either share cases with someone else or look at
cases from somebody else's practice.
9 So, there are ways around
that.
10
11 I think what they want is the experience. It doesn't
have to be on original cases of their own.
12
13 DR. MONSEES: Does anybody else have any comments
about this number, 480, and about the experience?
14 Yes.
15 DR. MOORE-FARRELL: I don't have a question about the
number.
16 I just have a question about how would you document
480, does someone sign off, I mean do you have a plan for
the 17
that, either the American College of Surgeons or the ACR?
18
19 DR. MONSEES: If it were voluntary or if it were
regulated?
20
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1 DR. HOUN: I think he has already given advice on how
to document it for radiologists who are double reading.
2
Certainly, if there is a mammography report that says
3
interpreted by so-and-so, double read or reread by such and
4
such, you have got firm documentation on the medical report,
5
but if that doesn't happen, you can keep -- physicians are
6
keeping their own logs of patients they are reading.
7
8 They cannot submit them without having the facility
sign 9that indeed these films were double read. So, FDA does
accept attestation on this.
not 10 It has to be confirmed by some
other senior member of the group, senior member of the facility,
11
some other party.
12
13 DR. MONSEES: Dr. Israel, I don't mean to pick on you,
as
but 14 a physician who obviously is committed to breast surgical
practice, we are relying on some of your opinions here.
15 Do you
think that a surgeon who is going to perform this procedure,
16
as Dr. Sickles was asking, should see 10 mammograms per week
17
in order to keep his eye up and be able to do this appropriately?
18
Do you think that is an appropriate number, should they do at
19
least that?
20
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1 DR. ISRAEL: I think it is too high, and I have given
this 2a lot of thought over a lot of years. I also have a lot
of feedback from surgeons around the country as does Dr.
3
Winchester.
4 I think it is too high. I think it is appropriate
for screening mammography.
5 I think it is too high for
identifying or reproducing a lesion that has been identified
6
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
9
way equate with responsibility or relate to competency.
any 10
There are some people, I think, who could read 1,000 and not
11
be competent.
12
13 Of course, we do have to have some numbers. I
personally think the number is too high and I can tell you that
14
this is as big, big contention with the surgeons.
15 I would have
no problems in complying with this myself, nobody in my group
16
would have any problem, but there are other surgeons who are
17
heavily involved in breast care work in this country that don't
18
do only breast work.
19
20 They may do 30, 40, or 50 percent of their practice.
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I think they might have a problem complying.
1
2 I have a couple of questions relating to this that
I think really need to be clarified in terms of what we mean
3
by interpretation.
4 It has been addressed today, just a few
minutes ago, but I wasn't sure what was said.
5
6 Now, am I to believe, then, that these 480, if that
number persists, that a surgeon must take 480 mammograms for
7
two years, sit down with a radiologist person to person, and
8
review each one of those mammogram, is that a yes or a no, or
9
is there some flexibility here where the surgeon can review a
10
number of mammograms, can keep a log of what he reviews, review
11
it along with the mammogram report, come to his own conclusions,
12
keep this in a log without having a consultation with the
13
radiologist?
14
15 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
16
someone like Dr. Laslo Tobar, and in the course of this three
17
or four day meeting, a surgeon reviews 400 mammograms, does this
18
count, and if so, where does it fit into the picture?
19
20 DR. MONSEES: Dr. Bassett, would you like to take a
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stab 1at that, please?
2 DR. BASSETT: Yes.
3 DR. MONSEES: Since you were involved and you know
the spirit of what was written here.
4
5 DR. BASSETT: Well, my understanding, the way I would
see it is that the latter explanation you gave would be the
6
correct one.
7 However, there are differences in different
practices.
8 For example, in our practice, we are actually down
in the breast center when the surgeons are seeing their
9
patients, and they bring us every case out and we talk about
10
it and discuss the abnormality, and what should be done next.
11
12 So, that would count for them, I believe, as having
reviewed it.
13 There may be other circumstances, the one you
described, where you are reviewing the case, the patient you
14
seeing, you review the mammogram, you look at the
are 15
abnormality, that would count, as well.
16
17 Then, I also mentioned the third scenario where you
looking at some cases that were from your associate in order
are 18
to make up the numbers you don't have, which we might equate
19
with double reading, although it is not the same thing.
20
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1 So, I think that the intent was to have reviewed the
case, reviewed the interpretation, identified the abnormality,
2
process that did involve looking at the images and looking
in a 3
at the interpretation, whether it is given orally or on a report.
4
5 And then the issue about doing them in a course that
is CME approved.
6 I would have to have Flo address that, but
I think that was acceptable, as well.
7
8 DR. MONSEES: Dr. Sickles.
9 DR. SICKLES: I am addressing it to the people who
were involved in planning this, and maybe Dr. Israel would have
10
a comment, as well.
11
12 I get the sense from what I am hearing now that the
purpose of this 480 or whatever number, and this would certainly
13
be my belief, would be to try to include rather than exclude
14
as many physicians as possible with the ultimate aim of being
15
sure that they have enough skill in looking at mammograms to
16
know that they are looking at important lesions rather than
17
unimportant lesions.
18
19 Is that the intent?
20 DR. BASSETT: Yes.
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1 DR. MONSEES: While you are still there, before you
sit down, please, do you think that the number of biopsies that
2
is listed in this document, the initial number and then 12 per
3
year 4is an appropriate ballpark for somebody that is going to
be proficient and that is going to be involved in this, and for
5
patient safety issues, all of the important things, what we are
6
really trying to get at here? Is that number, that minimum number
7
okay?
8
9 DR. ISRAEL: No. In my opinion, no, it's too low.
10 DR. MONSEES: It's too low.
11 DR. ISRAEL: Too low.
12 DR. MONSEES: What would you suggest then?
13 DR. ISRAEL: One biopsy per month will not promote
proficiency.
14
15 DR. MONSEES: So what do you think the learning curve
takes to become proficient and then to what level would you say
16
that somebody needs to continue to perform these procedures in
17
order to operate at a satisfactory level?
18 We are not talking
about the best level here, we are talking about an adequate
19
level.
20
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1 DR. ISRAEL: I think that 15 to 20 would be a more
appropriate level.
2 A doctor that is doing one procedure a
month, be it a radiologist or a surgeon, what that tells me is
3
they 4don't have a very busy practice, they don't have the volume
to accomplish or beat the learning curve.
5 I think that is too
low. 6
7 I mentioned that last year, and I didn't get much
support from the radiologist community.
8 I think the
radiologist community wanted to keep it at that level.
9 But I
do believe that radiologists and surgeons who have a sufficient
10
volume -- and I think a surgeon who has a 30 percent breast
11
practice is going to see enough cases where he will do at least
12
15 to 20 per year.
13
14 DR. MONSEES: Thank you. Don't sit down. And Dr.
Dowlat may want to answer this.
15
16 MR. MOBLEY: I have a similar question I think. I
am not a physician, so I need to help myself understand this.
17
Some of the questions that you just asked helped me, but I want
18
to see if I have a handle on how this process works, because
19
I really liked the process discussion that we had earlier.
20
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1 A screening mammogram is made and then if there are
suspicious findings, that patient would be recommended to the
2
surgeon or radiologist for further review as to whether a stereo
3
procedure should be performed.
4
5 So, at that point, the physician reviewing that film
is not looking at the film to determine is there something
6
suspicious here, there has already been something suspicious
7
identified and pointed out as to where it is, et cetera.
8
9 So, the question in my mind is I don't understand why
480 number is the magic number here or what the real
the 10
importance there is.
11 The real importance is can I identify
this, having it pointed out to me, and can I take action pursuant
12
thereto based on my interpretation of the information I have.
13
14 So, it wouldn't seem like that that physician at that
point needs to meet the same basic criteria as the screening
15
physician.
16 So, I am wondering, and you answered this to some
extent, it seems like then that the issue of the stereo procedure
17
is maybe more important than the issue of the 480 mammograms,
18
which I think is some of what you said, but is my understanding
19
there correct?
20
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1 DR. ISRAEL: Yes, it is correct, and I think you have
put it very properly, and this has been a problem that I have
2
had to address all along, and that is trying to equate the skill
3
is
that 4 needed to be an MQSA screening physician. Surgeons have
no aspirations to do screening mammography.
5
6 We only want to take a lesion that has been
identified.
7 We want to reproduce that lesion and we want to
do what we have always done with patients, biopsy that lesion.
8
9 This does require some skills and it does require some
imaging skills.
10 To be fair about it, there are deficiencies
in the radiology community, and there are deficiencies in the
11
surgical community.
12 At these hearings, we really only seem to
address the deficiencies in the surgical community, and
13
surgeons will readily admit they need to enhance their image
14
interpretation skills, and they are working to do that and they
15
will make that accomplishment.
16
17 On the other hand, there are deficiencies in the
radiology community which need to be bolstered and worked on
18
that are very important, that have been highlighted by the
19
public discussions this morning.
20 I think they are equally
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important, and I would like the committee to address both of
1
those deficiencies both in the radiology community and in the
2
surgeon community.
3
4 But getting back to the number 480, I do not think
it is necessary for a surgeon who is reproducing a lesion for
5
a biopsy to do 480 mammogram interpretations.
6 Certainly, a
number needs to be put in there.
7 I would say half that would
be adequate.
8
9 Surgeons are going to accept responsibility for what
they do when they biopsy these lesions.
10 They are very
responsible, they are not going to biopsy lesions that they
11
cannot interpret, and I have a rule in my center, when we
12
reproduce a lesion and it comes up on the digital monitor, and
13
I look at that, I don't biopsy that lesion if I have to say to
14
myself I think that is the lesion.
15 The patient doesn't get a
biopsy.
16
17 I have to say that is the lesion. Then, that patient
will get a biopsy.
18 We are not going to take chances, we are
going to put patients at jeopardy.
not 19 I don't think that the
imaging skills need to be at the level of an MQSA interpreting
20
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physician to do stereotactic biopsy.
1 They need to be good and
they 2need to be worked on and enhanced, but they don't need to
be at that level.
3
4 DR. MONSEES: Thank you, sir.
5 Dr. Dowlat, would you like to give us your impression
about the numbers that we are talking about, the ongoing
6
experience, the number of biopsies that need to be performed,
7
are we too high or too low here, and the number of mammograms,
8
what 9do you think, what is your opinion?
10 DR. DOWLAT: I think the 480, I don't know the history
of it, but I take it, it was developed because of the MQSA
11
physicians or radiologists were required to be exposed to that
12
many cases a year in order to be proficient and to be certified,
13
am I correct in that?
14
15 DR. MONSEES: That is correct.
16 DR. DOWLAT: Those 480, 10 percent of them, 5 percent
abnormalities.
had 17 The rest of them were normal mammograms.
Now, here, we are transferring that number to surgeons who are
18
facing an abnormal mammogram, and asking them to look at 480
19
abnormal mammograms.
20 I don't think that is right. I think
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that 1number is too high.
2 Admittedly, during the year, the surgeon will come
across some normal mammograms, but the majority of the time that
3
the patient comes to him or her, is with a set of films and the
4
report saying there is something to be biopsied, surgical
5
consultation is required.
6 So, I think maybe they are talking
about apples and oranges here.
7
8 The second thing is about the number you ask for
initial training and subsequent proficiency of a physician who
9
is doing the stereotaxic needle biopsy.
10 I agree with Dr. Israel
that one a month is not enough.
11 I personally do about five a
week, an average of five a week, and if I go away for a week
12
or two, and I come back, I find myself a little bit rusty.
13
14 As I said earlier today, the technology, the table
is not as simple as it used to be.
15 There is a lot of complexities
attached to it.
16 Already I am seeing during the courses that
some people have become a specialist in the ABBI system only.
17
They have difficulty in doing the needle biopsy, ordinary core
18
biopsy.
19 Why? Because there is so much, they have to focus
their attention on that, on doing ABBI system or doing ABBI
20
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biopsy.
1
2 DR. MONSEES: It is kind of like a reconstructive
surgeon using only one method for all people, isn't it?
3
4 DR. DOWLAT: Well, I am just saying that this has
become a sub-subspecialization.
5 So, I would like to see the
person who is coming and who wants to do image-guided breast
6
biopsies especially with the stereotaxic should do more than
7
one a month.
8
9 I think one a month is inadequate. I think they will
start cutting corners and they run into trouble.
10
11 DR. MONSEES: Thank you.
12 MS. HEINLEIN: So far, both Dr. Israel and Dr. Dowlat
have said that one is not enough, one a month is not enough,
13
there is no -- any idea, I mean would you say one a week?
but 14
He said 15 to 20, but 15 is just three more than 12.
15 So, I don't
how that does anything.
get 16
17 DR. DOWLAT: Rita, I think one a week is minimal. I
think a person should do something like 50 a year in order to
18
remain proficient.
19
20 DR. MONSEES: Dr. Bassett.
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1 DR. BASSETT: I would be careful about this, and here
is the reason.
2 You have got practices where you have, for
example, in our practice we have three radiologists who are
3
doing the procedures, and many of the procedures are better done
4
with 5ultrasound guidance.
6 What we were concerned about in looking at these
numbers was would we be compelling facilities to do biopsies
7
that 8weren't necessary, in other words, if you had a certain
number you had to do, would you change some of those probably
9
benigns to suspicious because you wanted to get your numbers,
10
if you didn't, you might lose your accreditation and lose the
11
ability to practice?
12
13 Would you take cases that really should undergo --
in our practice, we have seen a trend over the last couple of
14
years to go from stereotactic to ultrasound guided much more
15
frequently that we did before, where now it is almost just
16
calcifications that undergo stereotactic.
17
18 So, could we just switch some of those ultrasound over
to stereotactic in order to get our numbers up?
19 And I don't
want to see it become a numbers game.
20
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1 So, in a practice like ours, where there is three of
us who are doing it, teaching it, and so on, it would become
2
a task to try to continue to keep our mind on these numbers.
3
In fact, not too long ago, my chief technologist said to me,
4
well, maybe you had better do this under stereotactic to make
5
sure 6you have enough stereotactic numbers for your
accreditation, because I had been out of town for a while.
7
8 I just don't want to see it go to that. I think that
we can keep good quality without having that.
9
10 Peter, could you comment on that, because you are a
practice where you do a lot of ultrasound guided, and don't you
11
think that there is more of a trend to go that way, and that
12
we might compel people to do stereotactic cases that should have
13
been done under ultrasound?
14
15 I am sorry, Barbara.
16 DR. MONSEES: That is okay. I am anxious to hear the
answer.
17
18 DR. DEMPSEY: No, absolutely, I couldn't agree more.
In our particular practice -- and we have no ax to grind -- we
19
have a prone table and we do ultrasound guided, but I can tell
20
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you the statistics right now, 87 percent of our core biopsies
1
are done with ultrasound guidance, 87 percent.
2
3 MS. HEINLEIN: Can I do a followup to that?
4 DR. MONSEES: Yes, please.
5 MS. HEINLEIN: Then, I think that that is that
extreme, but you also don't want to say, well, let's make the
6
number so low that then we won't have a numbers game, but we
7
also 8won't have proficiency in the performance of the exam.
9 DR. BASSETT: Well, if people have to do one a month,
that will keep them involved, and then their partners are also
10
doing it assumingly.
11 I mean it becomes a problem when you have
more than one person in your practice who is doing these, because
12
then you start fighting over the cases.
13
14 MS. HEINLEIN: But maybe you don't need to have all
five radiologists doing stereotactic --
15
16 DR. BASSETT: I said three, first of all.
17 MS. HEINLEIN: Well, all right. Maybe all three
don't need to do it.
18
19 DR. BASSETT: And when you say you have to do 50,
well, if you are doing 87 percent under ultrasound, start
20
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thinking about your numbers.
1
2 MS. HEINLEIN: I understand that, but what I am
saying is that this is the dilemma in trying to find a balance
3
between not making it a numbers game either way.
4
5 DR. BASSETT: I understand, but you can't run a
practice where we can only do the stereotactic biopsy on this
6
patient on Thursday because that is that Maria is there, and
7
I am 8not allowed to do them anymore. So, there is as lot of
practicalities in running a practice, that don't mean that you
9
going to lower the quality of the performance of the
are 10
examination to keep people involved.
11
12 I am just concerned if we make the number high, that
we may be really making people do procedures or at least leading
13
them into the pathway of doing procedures either that are not
14
necessary or that could have been better done with another
15
modality.
16
17 MS. HEINLEIN: And I agree with you in that. So,
what would you suggest would be an appropriate number, so that
18
that would not happen?
19
20 DR. BASSETT: This number of 12 a year was come up
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as a 1compromise on that.
2 MS. HEINLEIN: And you feel that that one a month
would help to maintain someone's proficiency then?
3
4 DR. BASSETT: I think it is unlikely that most people
are going to be in that position.
5 I know we are going to do
more 6than that per person, but I think at least that will
guarantee, and then if you are also really concerned about the
7
underserved areas or the areas that have few procedures, which
8
I have heard many times today, those are the ones who are really
9
going to be affected by this.
10 They may end up having to put
their patients on stereotactic biopsy in order to meet a
all 11
higher number.
12
13 DR. MOORE-FARRELL: I also think that one a month is
a reasonable number.
14 I am from not an urban area, and as I said
before, in my practice general surgeons use the table as well,
15
out
and 16 of all the core biopsies, I will say 70 percent are done
under ultrasound and 30 percent are done under stereotactic
17
guidance, and the surgeons are very good about sending the
18
appropriate cases for ultrasound-guided biopsies, because it
19
is efficient and it's cost effective, but I believe that if there
20
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was a question of keeping those numbers up, they would not.
1
They 2would keep those patients to keep their numbers up.
3 DR. HENDRICK: I would just like to suggest that
maybe a better measure of quality is how many image-guided
4
biopsies are performed overall, not trying to break it down into
5
x-ray or ultrasound guided, and perhaps another, better
6
surrogate of quality would be whether the physician adjusts the
7
biopsy device to suit the patient or the particular type of
8
lesion rather than using the one technology that they may have
9
just obtained.
10
11 DR. MONSEES: Along those lines, Dr. Winchester, if
a voluntary accreditation program were going to be designed that
12
would be a cooperative effort between ACS and ACR, do you think
13
that the American College of Surgeons would be willing to expand
14
this into all image-guided biopsy, and not just stereotactic
15
biopsy?
16
17 DR. WINCHESTER: That is not covered under MQSA.
18 DR. MONSEES: I realize that, but if we are talking
about a voluntary program, then we are talking about may be doing
19
it a different way, maybe a better way.
20
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1 DR. WINCHESTER: Both colleges are in the process of
working on the ultrasound component of this, not just in breast.
2
ACR I think is just breast so far, right?
3 But the college
surgeons are looking at a broader ultrasound accreditation
4
program.
5 The answer is I think yes.
6 DR. MONSEES: I will move to you and then we have a
couple of questions from these gentlemen that we have pressed
7
upon, so I am going to let them ask questions.
8 Go ahead.
9 DR. DEMPSEY: I think there is one other factor that
to
has 10 be looked at in a department's total biopsy experience,
that is that in the departments that do have excellent
and 11
cytology backup, that much of your biopsy work is actually done
12
under ultrasound guidance, not core, which is an
FNA 13
image-guided biopsy, which is extremely efficient for patient
14
care, because you get the diagnosis in 15 minutes.
15
16 I think that also has to be put into the continuum.
know, we are lucky enough in our department, we have a prone
You 17
table, we have ultrasound guidance, we do FNA, we do core.
18 We
do it all.
19 I think that Dr. Bassett's point that if you are
going to have to say, well, let's see, I have got three of
20
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Category 1, and I have got one of Category 2, so tomorrow I had
1
better do them all this way or all that way, and you are not
2
thinking about what is best for the patient, but you are thinking
3
about getting your numbers.
4 That is extremely dangerous and
counterproductive to what we are trying to do here.
5
6 What we are trying to do here is what is best for the
patient and who is the most qualified to do it.
7
8 DR. MONSEES: Dr. Dowlat.
9 DR. DOWLAT: I wholeheartedly support Dr. Dempsey,
I
but 10 have one question for you. You said 83 percent of your
biopsies are ultrasound guided?
11
12 DR. DEMPSEY: 87.
13 DR. DOWLAT: You mean you do some
microcalcifications with ultrasound, too?
14
15 DR. DEMPSEY: From 1991 until 1996, we very
definitely skewed our population, so that we stayed away from
16
microcalcifications.
17 We did that for a very good reason. We
were on certain protocols and we were trying to prove a certain
18
point.
19
20 We increased the positive predicted value of nodules
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going to surgery from 30 percent positive to, in 1996, 78 percent
1
positive.
2 So, what we were trying to do was to make the
surgeons' work more efficient, that the only thing the surgeon
3
operated on primarily was cancer.
4 So, we have proven that point
with 5nodules, and now we are going into microcalcifications
more.
6
7 So, I suspect, as you allude to, that that number in
the mid to high 80s will come down as we are doing more
8
microcalcifications.
9 That is true, but by the same token, if
have a number of image-guided procedures, you want to be
you 10
guided by what is best for the patient, not how many numbers
11
have in that particular slot.
you 12
13 DR. MONSEES: That is a very important point.
14 Dr. Israel.
15 DR. ISRAEL: Not to belabor this issue -- which is
what I am going to do -- I would like to respond, and to Dr.
16
Bassett, I would like to say that we do a lot of
17
ultrasound-guided biopsies.
18 We do all -- I would say 95 percent
of our nodular densities we do with ultrasound, but all of our
19
microcalcifications -- and 50 percent of your lesions are going
20
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to be microcalcifications -- and when Dr. Dempsey starts doing
1
all the microcalcifications, he is going to do a lot more core
2
biopsies.
3
4 The issue of 12 being enough, I said it wasn't enough.
I believe that.
5 It is not enough to maintain proficiency. If
a surgeon asks me, he says I am going to do one stereotactic
6
breast biopsy a month, my advice to him don't do it at all.
7 I
would say the same thing to a radiologist, if you can only do
8
one a month, don't do them.
9
10 In Dr. Bassett's case, maybe only one of those
radiologists needs to be doing this procedure.
11 One a month is
enough.
not 12 And I don't think that we should compromise that
number to satisfy other situations.
13 If 12 is not enough, it
is not enough.
14
15 DR. MONSEES: Thank you.
16 I would like to move on technologist issues, but I
don't want to cut anybody off if they have any other comments
17
about these numbers and about physician qualifications.
18 Are
there any other pressing issues here?
19 Do people on the panel
have any questions or comments before we move on to technologist
20
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issues?
1
2 We have probably another half-hour, maybe another
hour 3if 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
6
other feelings about the four hours of the CME and medical
7
radiation physics for surgeons practicing independently and
8
whether or not that was felt to be sufficient for supervision
9
of the technologist and medical physicist.
10
11 DR. MONSEES: Let's put that on the table. Would you
like to comment on that?
12
13 MS. HEINLEIN: No.
14 DR. MONSEES: Anybody on this panel like to comment
on that?
15 Dr. Winchester, do you have something to say? You
were headed towards the microphone.
16
17 DR. WINCHESTER: I have had a fair amount of feedback
from the surgical community about that, and they think that
18
number is excessive.
19 I don't know anything about this subject.
I think others, coming from the other perspective, they think
20
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it ought be 12 hours or 10 hours, and I don't know the answer
1
to that.
2
3 After watching the presentation from Bob today, I
think I would need a couple days.
4
5 DR. MONSEES: He only showed one formula, don't
forget.
6
7 Dr. Bassett, you helped to formulate this report.
Can you tell us where you got that number and maybe -- I know
8
you didn't just pull it out of the air, but do you want to give
9
us some more information about this?
10
11 DR. BASSETT: I think there was an attempt to compare
it to what was being required for other things like what the
12
interpreting physician was required to do, and the alternative
13
pathway that was an alternative for doing interpretation.
14 Part
of it came out of the air, I guess, but I think there was some
15
attempt to try to make it a reasonable amount.
16
17 David, do you want to comment on that?
18 DR. DERSHAW: Yes. Let me make a specific comment
a
and 19 general comment. I have kind of mixed them all up. There
I
was 20 think an appreciation that the skills that are involved
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in doing this procedure are the same whatever the postgraduate
1
medical education is that a physician has had, whether he or
2
she is a radiologist or a surgeon or whatever, the same skills
3
are involved in performing these procedures with a high level
4
of competence.
5
6 It is not expected, and it is an inappropriate
expectation, that radiologists will become surgeons in order
7
to perform this and that surgeons will become radiologists in
8
order to perform this, that there are surgeons and radiologists
9
are extremely expert in performing these procedures, and
who 10
there are surgeons and radiologists who are performing these
11
procedures who are not very good at it, and, in fact, probably
12
shouldn't be performing these procedures.
13
14 The numbers that constitute this document are
obviously compromise numbers.
15 Do they guarantee an
extraordinary level of expertise in any physician who is
16
performing these procedures?
17 No, they certainly do not.
18 May they, in fact, end up excluding some physicians
might do this procedure very well?
who 19 Perhaps they might, but
they are an attempt to look at the skills that are required in
20
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order to perform the procedures well, and try and see what kind
1
of training and what kind of experience is necessary for
2
physicians in various specialty groups to perform those
3
procedures well.
4
5 I think that the document is a reasonable document
and I think that the level of skill that a physician has, if
6
he or she has met the criteria spelled out in this document,
7
is reasonably high in terms of performing these procedures.
8
9 We may argue about this number or that number, and
this committee can go through the same kind of arguments that
10
committee went through in terms of this.
our 11 These were not
an attempt to make people happy.
12
13 These were not an attempt to go back to our members
-- and we were very successful in that -- these were not an
14
attempt either to go back to the membership of the individual
15
colleges and say look what we have done for you.
16 These were
an attempt to look at physicians and other personnel involved
17
in these procedures and say what kind of training and experience
18
do you have to have initially and in an ongoing fashion in order
19
to be competent in this.
20
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1 Four hours of CME in physics does not give a surgeon
the same level of competence that a radiologist has in looking
2
at these numbers, but it hopefully gives a non-radiologist some
3
level of sophistication, some level of insight in order to be
4
able 5to have a discussion with the medical physicist and the
technologist involved in the procedures, so there is a level
6
of understanding about what the equipment is and what the
7
problems that arise in the equipment may be.
8
9 I agree with you that three weeks of physics would,
in fact, be better, but it is unrealistic that non-radiologists
10
going to have that kind of experience.
are 11
12 DR. HENDRICK: On the other hand, if you are serious
about having these as the responsible physician, anyone, I don't
13
care who it is, as the responsible physician overseeing all of
14
quality control, overseeing the work of the technologist, the
15
work of the medical physicist, you can't substitute the
16
background of a radiologist who has gone through four years of
17
residency getting physics, training in mammography, getting
18
physics specifically directed at mammography.
19
20 I mean I can't tell you how many hundreds of lectures
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I have given on quality control in mammography to radiologists,
1
you know, how to review a physicist's report, how to work with
2
the technologist and the medical physicist.
3
4 I would like to think that that has had some value
in mammography, and I don't think it is really replaced by four
5
hours, especially for someone who hasn't been involved in the
6
radiology environment the way radiologists have.
7 That's all.
8 DR. MONSEES: Which brings me to ask a question about
the technologist, which is something I would like to get to this
9
afternoon.
10
11 Do you think that as a substitute perhaps that if a
technologist had added qualifications, and were going to take
12
on more responsibility in a type of practice where the surgeons
13
were running the show, that that would suffice, that if there
14
were some additional education for a technologist that was
15
running this practice in conjunction with the surgeon, that that
16
would be an alternative?
17 Would you care to answer that?
18 DR. HENDRICK: Yes. The technologist is not running
practice.
the 19
20 DR. MONSEES: No, in conjunction. If that
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technologist had some additional -- I am not saying that this
1
is what I suggest, I am asking you is this a possibility.
2
3 DR. HENDRICK: No, I think it is a model that doesn't
work, because I think the medical responsibility lies with the
4
physician, the supervision responsibility lies with the
5
physician, and to try to supplant that in the case where the
6
physician isn't really knowledgeable about all the things the
7
tech 8does, or the physicist does, is just complicating the
issue, because they never have the control or the power to
9
exercise that responsibility even if you assign it to them.
10
11 DR. MONSEES: The reason I asked that is that at least
in our community and what I have noticed is that there are some
12
surgeons not of the caliber of these surgeons in the audience
13
today who do a large number of these procedures, but that do
14
occasional case, and I think they rely heavily on a
the 15
technologist that is very facile with the equipment, to set it
16
position the patient, target the lesion, and do everything
up, 17
shoot.
but 18
19 I think that we all know that this exists, and what
I would like to know is do we think that that is satisfactory
20
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or not.
1
2 MR. MOBLEY: Maybe it is because this is my first
meeting, but as I read this in preparing for the meeting, I did
3
not see that there was any -- and it is not intended to address
4
that 5-- but I did not see that there were any basic requirements
there in terms of the technologist or the medical physicist.
6
They 7are just listed radiologic technologist.
8 In looking at it, I would think, well, maybe that is
a technologist that is certified in mammography, maybe that is
9
a medical physicist that meets certain criteria, but that is
10
listed here or elucidated here or anywhere else that I am
not 11
aware of.
12 Now, maybe it is elsewhere.
13 DR. MONSEES: You are correct.
14 MR. MOBLEY: The question is do you just roll over
requirements for technologist from the basic mammography
the 15
standard, or is there something else that I am missing here?
16
17 MS. HEINLEIN: It is in the ACR. It is in this folder
here, this one.
18
19 DR. MONSEES: You are talking about the MQSA
qualifications?
20
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1 MS. HEINLEIN: It's in the ACR stereo.
2 DR. MONSEES: Oh, yes, for the voluntary
accreditation program.
3
4 MS. HEINLEIN: Right.
5 MR. MOBLEY: Can I then assume that this is the basic
that 6we are working from in reference to this?
7 DR. MONSEES: Well, the ACR accreditation program
did not include the collaborative or the surgeon working alone,
8
and therefore this other document was drawn up for the physician
9
component, but I think what they are saying is that the
10
technologist and the physicist qualifications would remain the
11
same regardless of what type of practice.
12 Is that correct?
13 DR. DERSHAW: That is correct. First of all, let me
that what was distributed was the old application form, so
say 14
will get a new one tomorrow morning, and those of you who
you 15
going to apply for certification for your practices, don't
are 16
this form, but it is correct that this document, which is
use 17
College of Surgeons and College of Radiology joint document,
the 18
pertains only to physician qualifications, the physician
19
requirements, the requirements for technologists, for medical
20
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physicists, for quality control, and for practice outcome data
1
are all included in the application document.
2
3 DR. MONSEES: Dr. Winchester.
4 DR. WINCHESTER: Ed Hendrick, I had a question. You
have 5had a lot of experience in teaching surgeons through the
college courses, and I think other courses, you have interfaced
6
with 7them on many occasions. How many hours do you think you
need 8with surgeons to teach them what they need to know to do
this?
9
10 DR. HENDRICK: I have only taught the surgeons course
once.
11 Bob Pizzutiello, I think has taught it a number of other
times.
12 But in that course, I had I believe it was either an
hour or an hour and a half, and it was painfully deficient at
13
that level.
14
15 I discussed with Dr. Dowlat much longer periods, but
this was trying to be fit into a weekend course, and the physics
16
trimmed down to I think it was an hour.
got 17 Is that right, Bob?
18 MR. PIZZUTIELLO: About an hour.
19 DR. HENDRICK: But I think that seeing what the
questions were back and the issues, I think much more than an
20
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hour 1is needed, probably much more than five hours is needed
to really get at -- if you wanted to get a surgeon to the point
2
of being the responsible physician in a breast biopsy practice,
3
that 4is, responsible for the technologist and the medical
physicist and the quality of the images that are coming out of
5
that 6equipment.
7 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,
8
that 9I thought we were talking about these basic requirements
technologists and physicists from this document that is
for 10
entitled, "Basic Requirements for ACR Stereotactic Breast
11
Biopsy Accreditation."
12 Is that correct?
13 MR. PIZZUTIELLO: Yes.
14 DR. HENDRICK: And that is not going to change,
right?
15
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.
19 Yes.
20 DR. DERSHAW: Dr. Hendrick, you have mentioned that
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you have given lots of lectures to radiologists.
1 How did they
perform?
2 What was your evaluation of their understanding of
what 3is needed in order to do a stereotaxic needle biopsy?
4 DR. HENDRICK: Well, unfortunately, they don't have
to perform at all.
5 They just have to stay there in the room.
But we have tried in the context of a number of educational
6
efforts through the ACR to actually test what they get out of
7
the QC components of the coursework like ACR viewbox symposium,
8
things like that, and the QC, I mean Ed Sickles and other people
9
here can address this more, Larry Bassett, but we have tried
10
to embed the QC types of questions into viewing of images at
11
viewbox and assessment of image quality and what do you do
the 12
about -- what is the problem, do you find a problem, and then
13
what do you about it if there is a problem.
14
15 So, it has been addressed. Not all radiologists test
well on QC.
16
17 DR. MONSEES: I will point out also that radiologists
do take written boards on radiation biology and basic radiation
18
physics, so we do have some certain qualifications now.
19 Of
course, many of us were boarded before stereotactic biopsy came
20
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in, so the specifics pertaining to that would be new, but it
1
is taught in training programs.
2
3 Now, I don't know whether or not the written board
questions -- does anybody know whether the written board
4
questions will pertain to this part of physics, do you know,
5
written board questions?
6
7 DR. HENDRICK: Some do.
8 DR. MONSEES: Dr. Sickles?
9 DR. SICKLES: I can answer your question about
radiologists' performance.
10 The American College of Radiology
developed a self-assessment examination for radiologists,
has 11
tests, image interpretation, and embedded in this, as you have
12
heard, are questions that relate to image quality and image
13
quality physics.
14 They are purposely put in there.
15 Radiologists who take this test -- and there have been
hundreds and hundreds of radiologists who have taken the test
16
in various installations -- performed just as well, no better,
17
no worse, on image quality and image quality physics as they
18
do in areas like detection of lesions and analysis of lesions.
19
there is no reason to believe that education of radiologists
So, 20
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in physics is any better or any worse than it is in regular
1
education.
2
3 DR. DOWLAT: Dr. Sickles, I am trying to be
constructive here, and I really want to learn, I want to take
4
a message away as how to incorporate that test or that
5
instruction into the courses that we are giving in the future,
6
so if there is a lesson that I can learn or I can convey, please
7
let me know.
8
9 DR. SICKLES: I could make a suggestion to you that
that particular test is geared more to image interpretation,
10
which is really not what the non-MQSA physician has to do.
11 They
have already been told there is a finding there that needs a
12
biopsy.
13 They need to know how to target it and how to evaluate
that it is an appropriate lesion to be targeted.
14
15 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
16
to direct the physicists who are teaching to concentrate their
17
lectures on what the non-MQSA physician needs to know about
18
working with a physicist as opposed to all of medical physics
19
that has to do with mammography.
20
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1 I think you should direct them to the areas where they
have 2to perform as opposed to all areas where maybe i it is not
so important they perform.
3
4 DR. DOWLAT: Nevertheless, the area at the time when
the surgeon and radiologist are doing the interventional
5
procedure using this stereotaxic, which these days is mostly
6
digital, and the quality of the image is good, is not adequate,
7
at that time they should know what the problem is.
8 I think this
is what Hendrick was alluding to earlier on.
9
10 DR. SICKLES: Exactly, and with digital systems, as
well as with film systems, the quality is not guaranteed to be
11
good, as you may know.
12
13 DR. DOWLAT: Correct.
14 DR. SICKLES: At least at a minimum, whatever the
background of the physician performing a stereotactic biopsy,
15
image quality is not adequate to proceed, they have to know,
the 16
number one, it is not adequate to proceed, and number two, what
17
to do about it.
18
19 If what to do about it is simply not to do the
procedure and call the physicist, that's fine, but they have
20
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to know that much, and I think the education has to be directed
1
to that.
2
3 DR. DOWLAT: I think that is the probably most
important lesson that a surgeon can learn from medical physicist
4
while doing this procedure, because if the machine breaks down
5
and the lights go out, I mean anyone can say that.
6
7 DR. MONSEES: We need to cover a few more things
today.
8 Is it going to be quick?
9 DR. ISRAEL: It has to do with the issue that we were
just discussing.
10 There is no way that Dr. Hendrick can teach
me in probably any amount of time to supervise a medical
11
physicist.
12 There is no way.
13 So, what I would suggest is that my situation, having
a stereotactic unit in a facility where there are no
14
radiologists, if we are talking about the equipment, let's say
15
that I and all surgeons who use equipment will have a radiologist
16
to work with the radiation physicist in making sure the
17
equipment is safe and operative.
18 I certainly will be willing
to do that, and I think all other surgeons would, I think --
19
I
and 20 shouldn't speak so fully -- but I think that those surgeons
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who have equipment and there are no radiologists around, that
1
we get a radiologist to supervise the physicist.
2
3 DR. MONSEES: Shall we tell Dr. Winchester to forward
those letters and E-mails to you?
4
5 DR. ISRAEL: I am not sure, but now, on the other hand
-- you haven't heard the other hand yet -- on the other hand,
6
those surgeons who are working on a stereotactic unit that is
7
radiology department or where there is radiology support,
in a 8
that 9those surgeons not be required to take four hours of
radiation physics.
10
11 DR. MONSEES: They are not in the collaborative
practice.
12 This is only in the setting where they were solely
-- 13
14 DR. ISRAEL: I think we are talking about such a small
number, so even those surgeons that do the procedure
15
independently, I think a lot of them are doing them on
16
stereotactic units that are located in radiology departments
17
or where a radiologist is present.
18 I think it is a very small
number who represent doctors like myself and Dr. Dowlat.
19
20 DR. MONSEES: Thank you.
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1 I think Mr. Pizzutiello wanted to make a comment and
then 2I am going to ask you all about technologists and about
physicists.
3 Start thinking about this because you need to
answer quickly, are the qualifications outlined in the ACR
4
voluntary accreditation program appropriate for technologist
5
and physicists, and before we get to that, did you want to ask
6
a question?
7
8 MR. PIZZUTIELLO: I just wanted to comment on what
I saw as a starting point for the physics portion for the
9
surgeons, which was some basic understandings of what radiation
10
is and the issues of radiosensitivity of the breast and
11
radiation dose, and just the scratching the surface of the
12
equipment.
13
14 I guess I don't want to give opinions, so I will just
that that is what I have done.
say 15 The plan is for that to be
beginning.
the 16 It is in no way -- I want to make it clear that
hour of physics is in no way considered to be adequate, and
one 17
more hours are planned.
18
19 DR. MONSEES: Let's turn to first technologist
issues.
20 Does anybody want to talk about this first? How about
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a technologist?
1 Rita Heinlein.
2 MS. HEINLEIN: I think that what is here is fine, only
I would add "include training in QC procedures related to
3
stereotactic breast biopsy procedures," because there is
4
nothing, nowhere does it say that they have to have any training
5
in QC procedures, so I would add that.
6
7 DR. MONSEES: Any other comments on the
technologist?
8 How much training?
9 MS. HEINLEIN: I wasn't going to touch how much, I
mean because I think many of them will have come with some
10
understanding of basic QC, and that is why I said just training
11
in the QC procedures related to stereo as opposed to putting
12
a number to it, unless, Patricia, you feel that there should
13
be one.
14
15 DR. MONSEES: Dr. Sickles.
16 DR. SICKLES: I have a question for Rita. As with
plain mammography in terms of QC, would you be comfortable with
17
a lead QC technologist during stereo and having the other
18
technologist simply perform the procedures, but having a lead
19
technologist do the stereo QC?
20
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1 MS. HEINLEIN: Yes, I would be very comfortable with
that.
2
3 DR. MONSEES: That would be very parallel to the
current program.
4
5 MS. HEINLEIN: Yes, I think that would be good.
6 DR. MONSEES: Did you have a comment? I am pointing
to you, Dr. Hendrick.
7
8 DR. HENDRICK: I wanted to give an opportunity for
Pat to comment.
9
10 DR. MONSEES: Speak up.
11 MS. WILSON: I think that the qualifications for 12
year is not enough in my opinion for a technologist to stay
per 12
adequate.
13 I would think 12 every six months.
14 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
15
I think we will be going around about.
16
17 Let's just hear opinions. Is there anybody else on
this panel that has an opinion about whether or not it is too
18
high or too low or appropriate?
19 Does anybody want to venture
a comment?
20
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1 MS. HEINLEIN: I think we are back to the same
position that we were in with the physician.
2 I think one a month
is not enough, however, you know, you get back to the same
3
situation, then, do you have just one or two technologists doing
4
it. 5I think you are back at the same situation that you had
the physicians and how do you run your practice and maintain
with 6
proficiency.
7
8 So, I mean I think you are dealing basically with the
same 9situation.
10 DR. MONSEES: Any other comments?
11 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
12
in. 13
14 DR. MONSEES: Go for it.
15 DR. FINDER: I would like some clarification on the
initial qualification for the technologist where they took
16
about five hands-on procedures under the guidance of a qualified
17
physician or technologist.
18
19 I am wondering under what conditions would a
technologist not be under the guidance of a qualified physician
20
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at least.
1
2 DR. MONSEES: Dr. Dershaw, would you like to comment
on that?
3
4 DR. DERSHAW: We weren't sure, but we wanted to make
sure 5that it was under these circumstances.
6 DR. MONSEES: So you just want to stipulate that it
had to be.
7 I see.
8 DR. SICKLES: Perhaps what they were referring to is
if qualified meant MQSA qualified physician, but they were a
9
non-MQSA physician.
10 Maybe that is what they were talking
about.
11
12 DR. FINDER: Well, that is why we are here and that's
what we could use the clarification on.
13
14 DR. DERSHAW: By "qualified," we meant someone who
been accredited by the program is what a qualified physician
had 15
is. 16
17 DR. SICKLES: Stereo qualified.
18 DR. DERSHAW: Stereo qualified. Not an application
specialist.
19
20 DR. MONSEES: Do you need any more clarification on
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that 1or are you okay? Dr. Hendrick.
2 DR. HENDRICK: I would just like to also ask the
technologists here if three hours of category A continuing
3
education in stereotactic breast biopsy is a sufficient initial
4
qualification, and then three hours every three years is
5
sufficient continuing education for a qualified tech in this
6
area.
7
8 DR. MONSEES: Can we hear from our technologist
representatives on the panel?
9
10 MS. HEINLEIN: My first look was the 15 hours, and
I was thinking no, I think 15 hours is more than sufficient,
11
I
but 12 see that is just in mammography. I don't know that three
hours -- three hours would be the didactic training in stereo
13
breast biopsy.
14
15 DR. HENDRICK: It doesn't have to be didactic. It has
to be category A, though.
16
17 MS. HEINLEIN: I see it as didactic and then the
clinical part would be the five hands-on procedures.
18
19 DR. MONSEES: Okay.
20 MS. HEINLEIN: I don't know, how did you come up with
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the number 3?
1
2 DR. DERSHAW: It parallels the physician.
3 DR. MONSEES: Any other comments on that?
4 DR. HOUN: Just for reference sake, I know while we
were 5discussing the MQSA final regs for new modalities, we did
put in training needed prior to new modalities, and that was
6
eight hours that I think the committee had discussion on.
7
8 DR. HENDRICK: I thought we said six.
9 DR. MONSEES: For the technologist?
10 DR. HOUN: I think six hours was related to
continuing education in your new modality.
11
12 DR. MONSEES: That would be significantly higher
than what is in the voluntary accreditation.
13
14 MR. MOBLEY: Under technologist there are two
bullets that seem to be much the same.
15 I am trying to understand
exactly what the intent there is.
16 The third bullet says three
hours of category A, continuing education, et cetera, and then
17
last bullet says three hours of category A, continuing
the 18
education every three years after initial qualifications are
19
met.
20
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1 DR. MONSEES: That is a continuing requirement.
2 MR. MOBLEY: That is an initial requirement. Okay.
It just wasn't really clear that that is what that was.
3 That
is the initial requirement.
4 Okay. I just wondered was there
supposed to be some other difference there, but that first one
5
is initial requirement.
6
7 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
8
for the night -- the medical physicist.
9 I am sorry we are going
to have to do this tonight.
10
11 Did you want to comment on that Dr. Winchester?
12 DR. WINCHESTER: I wasn't done with the physicians.
13 DR. MONSEES: I am sorry. Well, we will be taking
that up again tomorrow.
14 Are you going to be here?
15 DR. WINCHESTER: Yes.
16 DR. MONSEES: We will do that first thing in the
morning.
17
18 Can we move on to the physicist now, and then we will
continue the discussion pertaining to personnel first thing in
19
morning and then we will move on to non-personnel issues.
the 20
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1 MS. HEINLEIN: Can I bring up one other thing about
the technologist?
2
3 DR. MONSEES: Yes.
4 MS. HEINLEIN: I just want to make sure I get
clarification from Dr. Houn.
5 It was eight hours for initial
training in a new modality, right?
6 Then, perhaps it should be
eight hours here then, too.
7 This would be initial training in
stereo.
8
9 DR. HOUN: This is not an FDA program. You can
recommend this to the voluntary folks, but I just wanted to give
10
--
you 11
12 MS. HEINLEIN: What I am wondering is are we bringing
up any of this to make suggestions?
13 I mean is this going to
go under regulation?
14
15 DR. MONSEES: These are suggestions, so that if it
decided that this will be regulated, that they would have a
16
ballpark for the first draft if they wrote a draft for
17
regulations.
18 So, if you would like to suggest that three is
enough, they are listening.
not 19 If it should come to this being
regulated, they want to know what you have to say about it.
20 It
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doesn't matter what the ACR says.
1 It doesn't matter what
somebody else says, what do you think.
2
3 MS. HEINLEIN: Well, since this committee and the FDA
has made a decision that for a new modality, it would be eight
4
hours, then, I would suggest if this becomes regulated that
5
there be consistency and that that number turn into eight hours.
6
7 DR. MONSEES: The hour is late. I would like to know
whether or not we should try and discuss the medical physicist
8
today or should we attack that the first thing in the morning?
9
10 May I see a show of hands who would like to adjourn
and attack that in the morning, and then go on to other
now 11
personnel issues?
12
13 Okay. The physicists. Are you happy about talking
about this in the morning or would you like to talk about this
14
tonight?
15 Let's do it. One more notch on the belt.
16 Would you like to start using perhaps the document
here as a starting point, comment on that, and make any
17
suggestions that you would like to add to it, any disagreements
18
perhaps, how do you feel about it?
19
20 DR. HENDRICK: Like the discussion about
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technologists, I think there does need to be --
1
2 DR. MONSEES: Did he write it? Did you write this?
3 DR. HENDRICK: No. Well, I was involved in writing
this.
4
5 DR. FINDER: If we can get factual information, but
we really can't get your opinion because we assume that you
6
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
10
anything.
say 11
12 DR. MONSEES: Did you write this?
13 MR. PIZZUTIELLO: Yes.
14 DR. MONSEES: Do we have anybody here who didn't
write this?
15 Yes, sir.
16 MR. MOBLEY: I just need some information and maybe
Ed can respond or Ed or Bob.
17 In the hearing discussions today,
we heard the discussions of the digital imaging, and I know that
18
digital imaging has been discussed for years as being the coming
19
thing, but I don't think it has got there except just in very
20
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certain areas, this one area in particular.
1
2 That is different than the normal kinds of imaging
operations that medical physicists usually see, and as I read
3
this, I didn't see anything on here that led me to believe that
4
there was a lot of extra effort necessary and I heard this
5
morning that because of the differences in the digital imaging
6
systems, there is some extra effort and some extra
7
understanding, and I have not heard a lot addressing that in
8
the other areas, the technologist, the physician, and somebody
9
needs to be very cognizant of what these differences are and
10
this equipment needs to perform and then how it needs to
how 11
be modified to perform like it is supposed to once it is
12
installed and put into operation.
13
14 Has that been addressed?
15 DR. MONSEES: I think that is a very important point
and, in fact, as a starting point it is probably most important
16
the physicist, so can you address that, please?
for 17 Should we
-- I know you wrote this -- but would you reconsider and do you
18
think that we should specify in here that there needs to be some
19
pertaining to digital?
CME 20
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1 DR. HENDRICK: In Bob's presentation, he mentioned
that 2six or seven of what used to be 10, now are 11, QC tests
for the medical physicist are changed in stereotactic by the
3
implementation, primarily the implementation of digital and the
4
small field of view that comes with digital.
5
6 So, I think initially there will be need for education
specifically on the QC tests done by the medical physicist in
7
order to be cognizant of all those changes and really know how
8
to do the test correctly, and I don't think this gets at that
9
in its present form.
10
11 DR. MONSEES: As a matter of fact, Rita suggested the
same thing for the technologist, so I think we can be specific,
12
only QC, but QC related to digital technology, which should
not 13
probably be put in there and the wording perhaps should be
14
considered at least to put in there.
15
16 How many hours do you think additional training would
that take, would you like to take that question pertaining to
17
digital, additional hours?
18
19 MR. PIZZUTIELLO: I guess I want to say, first, that
when we came up with these qualifications, it was probably a
20
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year 1and a half before we really coalesced what we felt the 11
tests needed to be, so this was written before we knew exactly
2
what 3the 11 tests are.
4 So, I would say that some training in digital and
digital QC is important, and it is probably on the order of two
5
to three hours to review, as I say, as a minimum, two to three
6
hours to review the actual performance of the digital QC test.
7
8 Does that seem reasonable, Ed?
9 DR. HENDRICK: I would say at least three.
10 MR. PIZZUTIELLO: I would be happy with three.
11 DR. MONSEES: Any other comments from any other
individuals on this panel pertaining to the technologist or the
12
physicist qualifications, initial and ongoing?
13
14 MS. HEINLEIN: I just want to make sure I understand
where we are now.
15 We are adding that for both the technologist
the
and 16 medical physicist, that that would include training and
QC procedures related to stereo and digital?
17
18 DR. MONSEES: Yes.
19 MS. HEINLEIN: A minimum of three hours is what was
discussed, and then as far as the technologist, if this becomes
20
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regulation to be consistent with what is currently in the
1
regulation as far as eight hours of continuing education as part
2
of the initial training, and then six hours as part of the
3
continuing education, and that would make it consistent with
4
what 5is in the regulation.
6 DR. MONSEES: I don't think those numbers are written
in stone.
7 Those were just the numbers that were thrown from
this 8panel previously, talking about new technologies, is that
correct?
9 Okay.
10 MS. HEINLEIN: Just to be consistent with whatever
is written in stone.
11
12 DR. MONSEES: I don't think anybody is writing
anything in stone right now.
13
14 DR. HENDRICK: As far as stereotactic.
15 DR. MONSEES: Correct, as far as stereotactic,
correct.
16
17 Any other comments about physicist and the
technologist qualifications?
18 Yes.
19 MR. MOBLEY: I just want to be sure I understand
exactly what it is that we are suggesting here.
20 The three-hour
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minimum you were talking about, Ed, was initial training for
1
digital systems.
2 What would be additional training for the QC
that 3is necessary for these digital systems?
4 DR. HENDRICK: I think when I was addressing that,
it was three hours of initial training in QC of stereotactic,
5
which would include the digital components, and we talk about
6
what 7you do if it is a film screen system. So, basically, an
overall, at least three hours on QC of stereotactic without
8
specifying specifically digital or film.
9
10 DR. MONSEES: Yes, ma'am.
11 MR. HAWKINS: Pat Hawkins. I just wanted to ask in
regards to looking at qualifications for technologist and
12
medical physicist, especially as it relates to previous
13
requirements that have been set by FDA.
14 Have these created
access problems in rural areas?
15
16 DR. MONSEES: Funny you should ask.
17 DR. HOUN: No, they have not in terms of the
availability of technologists and a physicist.
18 I think we have
a
had 19 couple of studies done, one was a subcommittee of this
committee last year submitted a review on the qualified
20
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physicist and potential shortage areas under MQSA, and I think
1
the one area of the country that seemed vulnerable was Montana.
2
3 But in terms of technologists, we have not
encountered a problem with that.
4 I think initially when the
new regulations on 10-1-94 came down, there was a lot of concern,
5
but a lot of courses and teaching has come around
6 and actually
have 7proliferated to try to get the proper training that was
required.
8
9 I don't know if Rita or Pat would like to comment on
technologists, what they think about access.
10
11 MS. WILSON: We have found that we have, with the
onset of MQSA, had much more access to technologist training.
12
BCCCP program has provided many, many hours, workshops,
The 13
weekends, and working with a local AHECs, like some years our
14
technologists will have 40 hours of training in mammography.
15
We think it has helped our program tremendously having these
16
regulations because people have recognized the fact that a good
17
technologist does not end at their training, that it is an
18
ongoing process.
19
20 DR. MONSEES: Plus the courses are more available
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obviously, because they are needed.
1
2 DR. HENDRICK: I think part of it is having this as
a regulation has enabled technologists to get the time off and
3
to get sometimes the support.
4 Often they pay their own way,
but to get at least the time off and the encouragement to get
5
these hours that are required rather than the way it used to
6
be which was that they were discouraged from taking time away
7
from 8the practice to even get continuing education.
9 So it has recognized the need and it has encouraged
acquisition regardless of whether they are rural or urban.
the 10
11 DR. MONSEES: If there are no other additional
comments on technologist or physicists, I think we are going
12
to adjourn for the evening.
13 We will start up tomorrow morning
at 8:00 a.m., and we will start revisiting personnel issues
14
until we have resolved that, and then we will move on to
15
non-personnel issues.
16
17 [Whereupon, at 5:45 p.m., the hearing was recessed,
to reconvene at 8:00 a.m., Wednesday, October 29, 1997.]
18
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