ucm119843
Document Sample
MQSA Archived Document
Although some of the information in this document has
been modified or no longer applies to MQSA regulatory
requirements, this item is presented here for research and
historical reference.
From FDA/CDRH to help facilities implement MQSA
Summer 1998 Volume 5, Issue 3
Final MQSA Rule, Part 3
ith less than a year before the rule: breast implant imaging, con-
final Mammography Quality sumer complaints, and additional
Standards Act (MQSA) rule mammography review and patient
takes effect on April 28, 1999, facilities notification.
fter serving four and a half should review their personnel opera-
years as Director of FDA’s tions, equipment, and procedures for
Division of Mammography regulatory compliance. Early prepara- MQSA requires that specific atten-
Quality and Radiation Programs tion is critical, especially in areas that tion be given to ensuring that
(DMQRP), Florence Houn, may require weeks or months of lead patients with breast implants receive
M.D., is moving on to become time to correct problems. adequate examinations. This was not
Deputy Director of the Office of A checklist of key areas for facili- addressed in either the ACR accredi-
Drug Evaluation II in FDA’s ties to review is included in this issue tation program or the interim regula-
Center for Drug Evaluation and (see page 6). The two previous issues of tions, but has now been included in
Research. (See “From the Direc- Mammography Matters covered some the final regs. The purpose is to
tor” column in this issue.) John of these major items in more detail. ensure that the estimated 2 million
McCrohan, DMQRP Deputy Areas covered included personnel women with breast implants can
Director, succeeds Dr. Houn as requirements for interpreting physi- benefit from mammography services.
Director. cians, radiologic technologists, and The final rule requires facilities
Trained as a medical physicist medical physicists; some of the new to inquire about the presence of
with a master’s degree in Radio- equipment standards; reporting and implants before the examination, and
logical Sciences from the Univer- recordkeeping; and quality assurance.
sity of Washington, McCrohan Readers should note that back Continued on page 5
has been an officer in the Public issues of Mammography Matters are
Health Service (PHS) since 1974, available on the Internet (see What’s Inside
serving in FDA’s Bureau of Radi- www.fda.gov/cdrh/dmqrp.html). In
ological Health and its successor addition, FDA is preparing draft From the Director 2
organization, the Center for guidance for implementing the final A Big Step Forward on
rule. Expected to be available for Collimation Issue 3
Devices and Radiological Health.
public review and comment July MQSA Advisory
McCrohan currently holds the Committee Update 4
rank of Captain in the PHS. 1998, the first installment of this MQSA Compliance Checklist 6
In the mid-1970s, McCrohan guidance will provide further clarifi- On the Go: Mobile
was involved in the Breast Expo- cation on various questions raised Units and MQSA 8
sure: Nationwide Trends (BENT) since the final rule was published in Q&A 10
program. His involvement in October 1997. FDA Accepts Three
This issue touches on some of More Training Courses 11
Continued on page 5
the new areas covered in the final Address Change Reminder 11
From the Director . . .
Replacing Florence Houn as DMQRP important procedure. As a nation, we
Director offers me the opportunity to have defined a common set of standards
personally acknowledge her years of ser- for providing safe, reliable mammogra-
vice to improving the health of America’s phy. By applying these standards consis-
women and to recall some of the pro- tently through a quality inspection pro-
gram’s accomplishments under her gram, in partnership with the facilities,
tenure. She is a valued and trusted col- we have significantly improved the pro-
league, whose determination to improve portion of facilities delivering quality
the quality of mammography con- mammography services that can provide
tributed to the program’s documented life-saving diagnostic information in
success. I’m proud to continue efforts put combating breast cancer.
in place under Dr. Houn’s leadership There are many challenges before us,
now that she’s moving on to meet new such as developing appropriate guidance,
challenges at FDA’s Center for Drug as we prepare to implement final regula-
Evaluation and Research. tions next year. Facilities should keep alert
As some of you may know, in addi- 28, 1999. The final rule was devel- for notices regarding the availability of
tion to serving as the DMQRP Director oped with the advice of the National proposed guidance sometime this summer.
for the past four and a half years, Dr. Mammography Quality Assurance The public will have a 90-day comment
Houn is an oncology instructor at Johns Advisory Committee, composed of period after guidance is published in the
Hopkins School of Medicine. As Co- consumer and medical representa- Federal Register.
Director of Johns Hopkins’ breast sur- tives, and took into consideration We’re also developing new inspec-
veillance service, she sees women at high public comments from approximately tion procedures tied to the final rule, as
risk for breast and ovarian cancer and 1,900 respondents to FDA’s proposed well as the new States-as-Certifiers
counsels them on early detection and regulations published April 3, 1996. demonstration project as provided for by
prevention as well as risk management • Accreditation and certification of MQSA (see Spring 1998 Mammogra-
options. Dr. Houn is a champion in the 10,161 mammography facilities as of phy Matters, page 3).
fight against breast cancer. December 31, 1997. I look forward to continuing our
During Dr. Houn’s tenure as • Establishment of an outreach pro- strong partnership with facilities, estab-
DMQRP Director, FDA has accom- gram to help facilities meet the regu- lished under Dr. Houn’s leadership, in
plished the following: lations. our mission to further improve the qual-
• Establishment of an inspection pro- ity of mammography in the United
• Publication of interim regulations gram in partnership with the states. States.
on December 21, 1993, to provide a • Establishment of a compliance pro-
mechanism for accreditation and gram to ensure that FDA regulatory
certification of mammography facili- requirements are adhered to, with an
ties by October 1, 1994. emphasis on assisting facilities in
• Publication on October 28, 1997, meeting the regulations.
of more comprehensive final regula- John L. McCrohan, M.S.
tions, which become effective April More important than the program- Director, Division of Mammography
matic accomplishments is the success in Quality and Radiation Programs
enhancing the quality of mammography
without adversely affecting access to this
2 Mammography Matters, Summer 1998
A Big Step Forward on
Summer 1998
Collimation Issue
he Spring 1998 issue of Mam- have x-ray fields that extend beyond
Mammography Matters is a quarterly mography Matters noted that a the edges of the image receptor up to
publication of the Division of Mam- conflict had been discovered a specified limit. To obtain approval
mography Quality and Radiation
Programs (DMQRP), Center for between the final MQSA regulations of this alternative, which was granted
Devices and Radiological Health and the Electronic Product Radiation under section 900.18 of the MQSA
(CDRH), Food and Drug Adminis- Control (EPRC) performance stan- regulations, GE provided data for
tration. Its purpose is to help mam- dards that must be met by mammog- FDA review to show that their alter-
mography facilities comply with the raphy equipment manufacturers. native provides as great or greater
requirements of the Mammography The conflict related to x-ray field and assurance of mammography quality
Quality Standards Act of 1992. It is
distributed to mammography facili- image receptor alignment. FDA is as the original standard.
ties and other interested organiza- pleased to announce an interim mea- The approved alternative applies
tions and individuals. sure that will eliminate this conflict to all GE Senographe mammography
Articles may be reproduced or for many facilities. systems, including those having
adapted for other publications. The final MQSA regulations model names 500, 600T, 800T, and
Comments should be addressed to: require beam limiting devices to DMR, and means that these systems
Mammography Matters allow the x-ray beam to extend to or will not have to be modified to be in
FDA/CDRH (HFZ-240) beyond the non-chest wall edges of compliance with the x-ray field-
1350 Piccard Drive
the image receptor. To be certain to image receptor alignment require-
Rockville, MD 20850
be in compliance with the EPRC ments of the final MQSA regula-
Fax 301-594-3306 requirement, some manufacturers tions. The alternative becomes
Back issues of Mammography Mat- have designed their units so that the effective on April 28, 1999, the effec-
ters may be viewed on the Internet at x-ray field does not extend beyond tive date of the final MQSA regula-
www.fda.gov/cdrh/ dmqrp.html
the edges of the image receptor. Such tions. No time limit has been placed
John L. McCrohan, M.S., Director, units would not be in compliance on the period of approval.
DMQRP, CDRH with the final MQSA requirements. FDA expects to achieve a general
Carole Sierka, Editor; Chief, FDA previously advised facilities resolution of this issue before April
Outreach Staff, DMQRP, CDRH
to not change their equipment’s colli- 28, 1999. In the meantime, facilities
David Heffernan, Managing Editor mation until this issue was resolved with concerns about meeting the
Evelyn Wandell, Production and it was clear what action, if any, final MQSA alignment requirement
Manager would need to be taken. Recently, the and whose units are not covered by
Other contributors: Cathy Akey, agency approved an application from the approved alternative have the
Anne Bowen, Roger Burkhart, the General Electric (GE) Company option of encouraging the manufac-
Mary Cerny, Mike Divine
for an alternative standard to the final turers of their units to apply for simi-
MQSA regulations. This alternative lar alternative standards.
will permit, but not require, units to
Facility Hotline
Call the facility telephone
hotline (1-800-838-7715)
for more information about
FDA certification or
inspections.
Mammography Matters, Summer 1998 3
MQSA Advisory Committee Update
he National Mammography Spring 1998 Mammography Matters, and interventional mammography.
Quality Assurance Advisory page 4.) With respect to interventional mam-
Committee, which advises FDA “Our recommendation was to mography, the committee will be
on a range of issues related to imple- amend both sets of regulations to looking at whether regulation is
menting MQSA, met in early May avoid having many facilities modify needed or whether similar results can
under the leadership of its new chair, their equipment at great expense,” be achieved through non-regulatory
Dr. Barbara Monsees, Chief of the said Monsees. FDA expects to resolve means, including voluntary accredita-
Breast Imaging Section at the this issue before the April 28, 1999, tion.
Mallinckrodt Institute of Radiology. effective date of the final MQSA reg- At any given time, the committee
One of the key issues discussed ulations. In the meantime, FDA has between 13 and 19 members, who
at the May meeting was collimation recently approved an alternative stan- are invited to serve for overlapping
of the x-ray field. The MQSA regu- dard to the final regulations that will terms of up to four years. Members
lations regarding collimation are in eliminate this conflict for many facili- are drawn from among physicians,
conflict with the Electronic Product ties. (See “A Big Step Forward on medical physicists, radiologic technol-
Radiation Control (EPRC) perfor- Collimation Issue,” page 3.) ogists, and other health professionals
mance standards that mammography The committee also reviewed with significant experience in mam-
equipment manufacturers must meet proposed inspection procedures mography. At least four members
under a 1968 law. (See “Facilities under the final regulations and in the come from national breast cancer or
Advised To Delay Collimation future plans to take up further dis- consumer health organizations with
Changes Until Further Work,” cussions on digital mammography expertise in mammography.
Barbara Monsees, M.D. Ellen Mendelson, M.D. Patricia Wilson, R.T. Carolyn Brown-Davis
Chief, Breast Imaging Section Chief, Women’s Imaging Chief Technologist Executive Director
Mallinckrodt Institute of The Western Pennsylvania Biltmore Imaging Center Breast Cancer Resource
Radiology Hospital Committee
Roland Fletcher, M.S.
Department of Radiology Department of Radiology
Manager-Radiological Health Kendra McCarthy, M.A.
Peter Dempsey, M.D. Michael Mobley, M.S., Program-ARMA Director, Administration for
Director of Outpatient M.P.A. Maryland Department of the State of Virginia
Radiology Director-Division of Environment Department of Mental Health
University of Alabama Radiological Health
David Winchester, M.D. Robert Nishikawa, Ph.D.
State of Tennessee
Laura Moore-Farrell, M.D. Professor and Chairman, Dept. Assistant Professor of Radiology
Director of Breast Imaging Sandra Nichols, M.D. of Surgery Department of Radiology
Holt-Crock Clinic Director Arkansas Department Evanston Hospital The University of Chicago
of Health
Patricia Hawkins, M.P.H. Kambiz Dowlat, M.D. Ivis Febus-Sampayo
Eldercare Consultant Robert Pizzutiello, M.S. Associate Professor of Surgery Coordinator-Latina Project of
Oklahoma State President-Upstate Medical Rush-Presbyterian-St. Lukes SHARE
Department of Health Physics, Inc. Medical Center
Eldercare Services Department of Surgery
Edward Sickles, M.D.
Professor of Radiology
UCSF Medical Center
Department of Radiology
4 Mammography Matters, Summer 1998
Final MQSA Rule collecting and resolving consumer
Continued from page 1 complaints. McCrohan
FDA recognizes that facilities can Succeeds Houn
to select views that will maximize effectively address most consumer Continued from page 1
visualization of breast tissue. complaints. In the final rule, only
mammography continued with
Related to this section is an addi- serious complaints (as defined previ-
the Nationwide Evaluation of
tional requirement in the personnel ously) that cannot be resolved by
X-ray Trends (NEXT) program
section specifying that all technolo- facility staff are referred to the accred-
that assessed the practice of mam-
gists who begin performing mam- itation body (and eventually to FDA).
mography in 1985, 1988, and
mography after April 28, 1999, must Facilities should keep consumer
1992. He has also served on
have training in performing mam- complaint records as part of their
numerous committees related to
mography on patients with breast patient recordkeeping and should
mammography under the aus-
implants. handle consumer complaint records
pices of the American College of
with the same care as other records.
Radiology, the Conference of
Radiation Control Program
Another new area of regulation Directors, and the National
requires each facility to establish a Council on Radiation Protection
system for resolving serious consumer The last new requirement in the and Measurements.
complaints related to mammography facility quality standards section In 1997, McCrohan received
services. A “serious complaint” is addresses additional mammography the prestigious Stanley J. Kissel,
defined as a report of a serious review and patient notification. For Jr. Award as PHS’s Health Ser-
adverse event that significantly com- cases in which FDA believes that vice Officer of the Year.
promises clinical outcomes, such as mammography quality has been “Under Dr. Houn’s leader-
poor image quality or a failure to compromised, facilities must provide ship, DMQRP helped improve
communicate results. (Please refer to clinical images and other relevant the quality of mammography in
pages 55977-55978 of the final regu- information for review by an accredi- the United States,” said McCro-
lations for definitions of “adverse tation body. This additional review han. “Her drive and determina-
event,” “consumer,” and “serious will help FDA determine if serious tion in building DMQRP helped
adverse event.”) conditions exist at a facility that set a standard of documented
The complaint system provides would endanger public health such success of which we’re all very
patients and their representatives with that notification of patients and their proud. As Dr. Houn moves on
a mechanism to report what they referring health providers is needed. to new challenges, I look forward
believe to be seriously deficient mam- Facilities should note that FDA to continuing DMQRP’s part-
mography services, and gives them the views patient notification as an infre- nership with facilities in the mis-
opportunity to have their complaints quently used, cooperative action — sion of improving mammogra-
heard, investigated, and resolved. not a first-line step — reserved for phy, particularly as we prepare
The interim regulations required severe public health risks. for implementing final MQSA
facilities to post an address where com- For example, patient notification regulations next year.”
plaints could be registered with the may be warranted in cases where
accreditation body and to maintain diagnoses of possible malignancy
records of all complaints. The final may have been missed due to grossly
rule takes this requirement further to inadequate performance. Patients,
require the development of a com- their designees, health care profes-
plaint mechanism. This means that sionals, or the public may have to be
each facility must establish its own notified so that they may take appro-
written and documented system for priate action.
Mammography Matters, Summer 1998 5
6 Mammography Matters, Summer 1998
Mammography Matters, Summer 1998 7
On the Go:
Mobile Units and MQSA
s facilities become more familiar were owned by other entities such as where the mobile unit “parks,” such
with the final MQSA regula- the government or a corporation. An as a small hospital that has a radiol-
tions, there may be many ques- additional 17 percent of the units ogy department and x-ray machines
tions regarding mobile mammogra- were leased or owned by more than but doesn’t have a mammography
phy units. What’s unique about one group or organization. unit. In this scenario, the mobile unit
operating a mobile unit? How does The day-to-day operation of provides the technologist who per-
the final rule affect the operation of mobile mammography units can forms the mammography examina-
mobile units? Does the rule require vary considerably. In the most com- tions, while the hospital staff does
anything that is specific to mobile mon setting, the mobile unit, which patient intake and film processing
units? If so, do the regulations pro- is based at a central site, travels to and provides the interpreting physi-
vide guidance as to how these one or more satellite sites, where the cian. Thus, both the mobile unit and
requirements should be met? Where technologist takes mammograms. stationary site serve as “partial
can operators of mobile units go for The central site processes the mam- providers” of mammography services.
more information? mographic films, sometimes several
Articles in this and the next issue days later. In this case, all films are Filling a gap: Increasing access
of Mammography Matters focus on put in a “black bag,” which shuts out through mobile units
the operation of mobile units under light; films are kept in the bag until One primary goal of mobile mam-
MQSA, with some specific and processing. This is referred to as mography is to
unique examples. batch processing. In increase access to
this scenario, the cen- screening for breast
Mobile units defined tral site keeps, at the cancer, especially
MQSA defines “facility” as any set- very least, the units’ among underserved,
ting or entity, including a mobile quality assurance/qual- uninsured, and under-
mammography unit, that performs ity control (QA/QC) insured women and
any of the following mammography- records. women in rural loca-
related activities: operates equipment In contrast, a tions. Mobile units
to produce a mammogram, processes mobile unit may func- strive to achieve this
mammograms, provides the initial tion as a self-contained goal through a variety
interpretation of mammograms, operation; that is, the of strategies. For
and/or maintains viewing conditions technologist takes the example, mobile units
for interpretation of mammograms. mammograms, processes the films, usually provide lower cost exams and
An estimated 380 mobile mam- and keeps the records. Thus, process- accept a higher number of self-
mography units operate in the ing is done “on board.” In a third, referred patients than stationary or
United States. A survey conducted by less common scenario, each examina- hospital-based units. Mobile units
the American College of Radiology tion site — whether a central or a also increase availability of screening
(ACR) and the Centers for Disease satellite site — processes all of its by going to places where women are
Control and Prevention (CDC) own films and keeps all of its own — work sites, health clinics, commu-
found that 46 percent of mobile units records. nity centers, health fairs, shopping
were owned by hospitals, 20 percent In more complex settings, mam- malls and centers, places of worship,
were owned by radiologists or radio- mography-related activities are split retirement homes and centers, and
logic technologists, and 17 percent between the mobile unit and the site city streets.
8 Mammography Matters, Summer 1998
The ACR/CDC survey found Perhaps the greatest challenge verify the performance of each unit
that two-thirds of mobile units per- associated with mobile mammogra- to ensure that it produces adequate
formed only screening mammogra- phy, however, is controlling the inter- quality images. The final rule does
phy, with nearly all of the remaining nal environment, especially in the not specify which test or tests to use
units performing both screening and face of extremes and/or changes in to verify performance and leaves this
diagnostic mammography. The climate. Maintaining ambient tem- decision to the unit’s operator. How-
mobile units in this survey operated perature, humidity, and ventilation is ever, FDA will be issuing guidance
at a high volume, performing an critical to producing high-quality describing some acceptable methods.
average of 20 mammograms per day. images consistently. Processing and This change from the interim MQSA
other equipment used in mammogra- rule was made in response to reports
Special challenges phy-related activities are very sensi- from mobile operators that moving
Providing mobile mammography ser- tive to environmental changes. the location of their unit(s) some-
vices is distinct in many ways from Because of this sensitivity, some times caused problems in the quality
that in stationary facilities. Mobile equipment is incompatible with of the mammograms produced.
unit operators and staff face a variety mobile mammography, and equip-
of issues that are of little or no con- ment that is onboard must be moni- Meeting the new requirement:
cern to those running non-mobile tored more frequently (and adjusted Inspection and certification
units. Some of these issues include: accordingly) than units at fixed sites. Mobile units follow the same guid-
following local parking and related Such issues form the basis for the ance as stationary facilities in meeting
regulations, patients follow up, additional equipment checks requirements for inspection and cer-
onboard or batch film processing required of mobile units under the tification, with the additional equip-
(with associated unique quality con- final MQSA regulations. ment QC checks for mobile units, as
trol problems), availability of equip- described above. Inspections of
ment compatible with the mobile set- What’s new under the final mobile units do often require extra
ting, environment and changes in MQSA rule time and effort, however, and usually
seasons and weather, and sometimes Prior to implementation of MQSA, must be scheduled well in advance,
very limited space for record storage. the ACR had a voluntary program requiring a high level of coordination
Processing is a significant issue for accrediting each mammography among staff and inspectors.
for mobile units. For example, with unit. Under MQSA, the FDA con- Most complex are situations
onboard processing, technologists ducts inspections and provides for where mammography activities are
can check the quality of the images certification of all mammography split between the mobile unit and
produced onsite and obtain supple- facilities, including mobile units. another group or facility. Often,
mental views at the time of the initial MQSA states that requirements explains FDA’s Mike Divine, who
exam. Onboard processing also can under the rule are universal to all specializes in MQSA compliance
reduce patient recalls and eliminate units, whether fixed or mobile. Thus, issues, the mobile units are the only
latent image fading, which can occur for all intents and purposes, mobile certified mammography facility and,
with batch processing when films are units must meet the same criteria and as such, are legally responsible for all
not processed for some time. On the same standards as fixed units. In mammography-related functions.
the other hand, units that do addition, after the final regulations Sometimes, the non-mobile site, such
onboard processing have specific become effective on April 28, 1999, as a small hospital without mammog-
space requirements and must accom- equipment checks must be per- raphy radiology equipment, certifies
modate for mixing, spillage, and dis- formed on mobile units every time jointly with the mobile unit. In yet
posal of chemicals. These and other the unit is moved and before any another scenario, both the mobile
factors contribute to the added patient examination is done. Under unit and its “partner” site are certified.
expense of running a unit with this new quality assurance directive, a
onboard processing. mobile unit operator is required to Continued on page 11
Mammography Matters, Summer 1998 9
Q&A
Q & A is a regular column in
Mammography Matters. We wel- Q Does FDA plan to distrib- A Mammographic modality
come your questions and will publish ute a poster or notice for is defined as a technology
answers to any that are of general facilities to display that informs used for radiography of the
interest. Send your questions to patients with serious complaints, breast, which falls under MQSA
Mammography Matters, that cannot be resolved by the authority. Since MQSA authority is
FDA/CDRH (HFZ- 240), 1350 facility, about how to report those limited to imaging with x-rays, MRI
Piccard Drive, Rockville, MD problems? If not, should facilities and ultrasound are not included;
20850, Fax 301-594-3306. provide such notices? therefore personnel who use those
modalities do not have to have
A No. Although the final training with them in order to meet
regulations provide a com- MQSA requirements.
Q I submitted a question to plaint mechanism, there is no
FDA requesting clarification requirement for facilities to post a
of a point under the final regula- sign or notice with instructions Q Since hardly anyone works
tions but have not received an about registering consumer com- with xeromammography any
answer yet. In the past FDA has plaints. However, as a public ser- more and MRI and ultrasound
responded quickly to my ques- vice, facilities may wish to do so. are exempt, doesn’t this really
tions. Why haven’t I heard any- Complaints that cannot be mean that, at present, most per-
thing yet? resolved at the facility should be sonnel only have to have training
forwarded to the facility’s accredi- with screen-film systems?
A Please be patient. Your tation body. Facilities should pro-
A That’s right. This further
question concerns an area in vide consumers with instructions
which guidance is currently being for filing complaints with the facil- means that the specific
developed. Before the guidance is ity accreditation body. Also, the mammographic modality train-
implemented, facilities will have a name and address of the accredita- ing requirement will automatically
90-day period to review and submit tion body is listed on each facility’s be met while meeting the general
comments regarding the proposed certificate, which must be promi- initial training requirement. It will
guidance. The notice of the avail- nently displayed. also be met for the continuing
ability of the proposed guidance will education requirement as long as 6
be published in the Federal Register of 15 hours is with screen-film
this summer, and the document Q The final regulations systems. But should another mam-
itself will be available on the website require training in each mographic modality become
(http://www.fda.gov/cdrh/dmqrp. mammographic modality used accepted in the future (digital
html) and by mail. Submit your by a physician, technologist, or mammography seems the most
request by fax to 301-986-8015 or physicist. Would you please clarify likely candidate), personnel will
by mail to MQSA, c/o SciComm, what is meant by mammographic have to receive additional training
.O.
Inc., P Box 30224, Bethesda, modality? Only screen-film and with that mammographic modal-
MD 20824-9998. xeromammography are mentioned ity before they can lawfully begin
as examples; what about MRI and to use it independently.
ultrasound?
10 Mammography Matters, Summer 1998
Q & A (continued)
request by fax to 301-986-8015 or
Q I am giving a talk on the A Yes. FDA has produced by mail to MQSA, c/o SciComm,
final regulations at an an MQSA Final Regulations Inc., P.O. Box 30224, Bethesda,
upcoming meeting. Does FDA Speaker’s Kit consisting of a MD 20824-9998. Be sure to
have any materials that would help speech, slides, overheads, and include your name, organization,
me prepare my speech? additional background informa- full address, phone and fax num-
tion in slide and overhead formats. bers. A copy of the speech is also
Speakers may borrow these kits available on FDA’s website at
(pending availability) for a 30-day http://www.fda.gov/cdrh/dmqrp.
period at no charge. Submit your html.
Mobile Units
Continued from page 9
At the very least, says Divine, the DA has recently accepted successful completion of three more mammog-
entity providing the technologist and raphy-specific courses as meeting the technologist initial training require-
the mammography unit must be certi- ments, even though they are less than 40 hours in length. The courses are:
fied. These situations present a unique
challenge to inspectors, who must Achieving Quality Images: 3-Day Mammography Seminar, provided by
inspect the entire process. With joint Achieving Quality Images of East Grand Rapids, Michigan at 1-800-522-
certification, the inspection must be 3439.
coordinated, and the two facilities and Mammography, provided by Rose State College of Midwest City, Okla-
their staff and equipment must be homa. Contact Jo Bishop at 405-733-7569.
available at the same time.
Initial Mammography Training, provided by Mammography Accreditation
Consultants, Rock Hall, MD. Contact Judith Hagerty or Gerry Lockwood
at 1-800-570-2511.
Operators of mobile units can turn
to a variety of resources for more For more information on meeting this requirement, as well as other course
information and assistance. Facilities listings, see Mammography Matters, Spring 1996, Fall 1996, and Spring 1997.
and operators may want to access
information on the Internet
(www.fda.gov/cdrh/dmqrp.html) or
call the facility telephone hotline (1-
800-838-7715) for clarification of or
guidance regarding the final regula- Facilities must notify their ACCREDITATION BODY of any changes in
tions. their mailing address information, such as new contact person, change of
address, or change of facility name.
FDA relies on the address information provided by the accreditation
bodies and cannot change or modify a facility’s address.
Failure to notify your ACCREDITATION BODY of any address
changes may result in you’re not receiving important MQSA mailings such
as Federal Register notices or Mammography Matters.
Mammography Matters, Summer 1998 11
Name and Address Changes: Accreditation, Certification,
If your mailing label code includes either: and Commercial Products
ACR, SAR, SCA, or SIA, notify your accreditation
body of any name and/or address changes. FDA neither endorses nor requires the use of any spe-
cific x-ray system component, measuring device, soft-
Otherwise submit your address changes to: ware package, or other commercial product as a condi-
MQSA, c/o SciComm Inc., P Box 30224,
.O. tion for accreditation or certification under MQSA.
Bethesda, MD 20824-9998. Fax 301-986-8015. Any representations, either orally or in sales litera-
ture, or in any other form, that purchase of a particular
product is required in order to be accredited or certi-
fied under MQSA should be reported to FDA imme-
diately so that appropriate action may be taken.
Mammography Matters is a publication of the Food and Drug Administration, Center for Devices and Radiological Health
DEPARTMENT OF HEALTH AND HUMAN SERVICES PRESORTED
Public Health Service
Food and Drug Administration (HFZ-240) FIRST-CLASS MAIL
Center for Devices and Radiological Health POSTAGE AND FEES
1350 Piccard Drive PAID
Rockville, Maryland 20850
PHS/FDA
ATTN: Editor, Mammography Matters
PERMIT NO. G-285
OFFICIAL BUSINESS
PENALTY FOR PRIVATE USE, $300
ADDRESS CORRECTION REQUESTED
See box above if:
s You do NOT wish to receive this material, or
s A change of address is needed
s (indicate change, including ZIP code)
ROUTE THIS ISSUE OF MAMMOGRAPHY
MATTERS TO YOUR FACILITY’S:
s Mammographer
s Mammography Technologist
s Quality Assurance Staff
s Medical Physicist
s Administrator
s Other______________________________
