The Mammography Quality 
Standards Act Final Regulations: 
Preparing for MQSA Inspections; 
Final Guidance for Industry and 
FDA 
 
 
 
 
 
Document issued on November 5, 2001 
 
 
 
This document supersedes Preparing for MQSA Inspections issued on  
May 5, 1999. 
 
 
 
 
 
 
 
 
 
 
 
 
 
U.S. Department Of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
Inspection Support Branch 
Division of Mammography Quality  
and Radiation Programs 
Office of Health and Industry Programs 
                                 Preface 
 
Public Comment 
 
Comments and suggestions may be submitted at any time for Agency consideration to Dockets 
Management Branch, Division of Management Systems and Policy, Office of Human Resources 
and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, 
(HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to the exact title of 
this guidance document.  Comments may not be acted upon by the Agency until the document is 
next revised or updated. 
 
For questions regarding the use or interpretation of this guidance contact Charles Gunzburg at 
301-796-5898 or email charles.gunzburg@fda.hhs.gov. 
 
 
Additional Copies 
 
Additional copies are available from the Internet at: http://www.fda.gov/downloads/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm094441.pdf, You may also send an e-mail 
request to dsmica@fda.hhs.gov to receive an electronic copy of the guidance or send a fax request 
to 301-847-8149 to receive a hard copy.  Please use the document number (6400) to identify the 
guidance you are requesting.(cid:13)
 
 
   
The Mammography Quality Standards Act 
Final Regulations: Preparing for MQSA 
Inspections 
 
This document is intended to provide guidance.  It represents the Agencys current 
thinking on this topic.  It does not create or confer any rights for or on any person and 
does not operate to bind Food and Drug Administration (FDA) or the public.  An 
alternative approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations. 
 
 
 
 
 
 
   
 
TABLE  OF  CONTENTS
 
 
Background ......................................................................................................................1 
 
Introduction ...................................................................................................................... 2 
 
Preparing for MQSA Inspections......................................................................................3 
 
 
 
  Background 
 
The Mammography Quality Standards Act was passed on October 27, 1992, to establish national 
quality standards for mammography.  The MQSA required that to provide mammography 
services legally after October 1, 1994, all facilities, except facilities of the Department of 
Veterans Affairs, must be accredited by an approved accreditation body and certified by the 
Secretary of Health and Human Services (the Secretary).  The authority to approve accreditation 
bodies and to certify facilities was delegated by the Secretary to the FDA.  On October 28, 1997, 
the FDA published the MQSA final regulations in the Federal Register.  The final regulations, 
under which mammography facilities are currently regulated, became effective April 28, 1999.  
The FDA compiled all final guidance referable to MQSA into a computerized searchable Policy 
Guidance Help System in November 1998.  The Policy Guidance Help System is available on 
the Internet at: www.fda.gov/cdrh/mammography/guidance-rev.html 
 
Guidance information is periodically updated.  Individuals wishing to get automatic notification 
of such updates may subscribe to our E-mail ListServ by visiting http://list.nih.gov/cgi-
bin/wa?SUBED1=mammography_cdrh-l&A=1 and following the directions there. 
 
 
 
    1  Introduction 
 
This document is intended to provide guidance to mammography facilities and their personnel.  
It represents the Food and Drug Administrations (FDA) current thinking on the final regulations 
implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539).  The FDA 
uses mandatory language, such as shall, must, and require, when referring to statutory or 
regulatory requirements.  The FDA uses non-mandatory language, such as should, may, can, and 
recommend when referring to guidance.  It is the responsibility of the facility to read, understand, 
and follow the final regulations. 
 
Under its own authority, a State may impose more stringent requirements beyond those specified 
under MQSA and its implementing regulations.  A facility may want to check with the State or 
local authorities regarding their requirements. 
    2  PREPARING FOR MQSA INSPECTIONS 
This document contains an overview of the annual inspection process and is intended to help 
facilities prepare for MQSA inspections under the final regulations. It supersedes guidance 
previously issued on May 5, 1999. This guidance describes facility responsibilities and 
recommends actions that a facility may take, before an inspection, to minimize both facility 
disruption and inspection time. In large part the material has been excerpted from the Policy 
Guidance Help System provided on the internet site mentioned above which you may consult for 
more detailed information regarding the regulations. 
MQSA requires each facility conducting mammography in the United States (except those of the 
Department of Veterans Affairs) to:  
  meet quality standards for personnel, equipment, maximum allowable radiation dose, 
quality assurance, medical audit and outcome analysis, medical recordkeeping and 
reporting requirements;  
  be accredited by a Food and Drug Administration (FDA)-approved accreditation body 
(AB) (currently, the American College of Radiology [ACR] and the States of Arkansas, 
California, Iowa, and Texas);  
  be certified to perform mammography by the FDA, or an FDA approved State 
certification body (each certified facility must prominently display its certificate where it 
can be viewed by mammography patients); and  
  maintain its certified status by:  
-  maintaining its accreditation,  
-  having an annual survey performed by a qualified medical physicist, 
-  undergoing an annual inspection conducted by an MQSA inspector , 
-  paying an inspection fee (and, where applicable, re-inspection fees), and  
-  correcting any deficiencies found during these processes. 
NOTE: The Centers for Medicare and Medicaid Services accepts MQSA certification as 
evidence of compliance with mammography quality standards. Only facilities with a current 
MQSA certificate will be eligible to receive Medicare/Medicaid payment for screening and 
diagnostic mammography. 
 
SCOPE OF THE MQSA FACILITY INSPECTION 
During each inspection, MQSA inspectors assess a facility's compliance with MQSA quality 
standards. Facilities must correct all deficiencies found. Inspections will not cover any new 
regulation before its effective date. To reduce the inspection time, the scope of the standard 
inspection questions has been limited to items that FDA believes have the most direct bearing on 
facility performance and mammographic quality. However, the facility remains responsible for 
meeting all requirements of the regulations, not only those specifically listed in the inspection 
procedures. Concurrent with the MQSA inspection, States may inspect for some items that are 
required by their laws and regulations. However, these items will not affect the facility's 
compliance with MQSA or the associated MQSA inspection fee. 
Under MQSA, each facility location will be inspected at least annually for the following:  
    3    Equipment performance  
  Quality Assurance (QA) records  
  Quality Control (QC) records and tests  
-  Technologist tests 
-  Medical physicist's annual survey report 
-  Mammography equipment evaluations, if any 
  Personnel qualification records  
  Medical records (mammography reports and films) and lay summaries 
  Medical audit and outcome analysis records  
Mobile mammography facilities may provide services at multiple locations under the same 
certificate. Each location is recognized by FDA as a part of that facility. Each such site may be 
inspected. The scope of inspections at sites where mobile mammography activities are conducted 
will vary depending on the type of mammography services provided at each location, with or 
without the mobile x-ray system being at that location. The facility representative may request 
details regarding tests and record requirements for scheduled inspections of such sites from the 
inspector during the prior notification and scheduling process discussed below. 
PRIOR NOTIFICATION 
Normally, the inspector will provide the facility with an advance notice of at least five business 
days, before an inspection. The inspector will work with the facility in scheduling the inspection 
to minimize any inconvenience to the facility.  
INSPECTION DURATION 
Based on our experience, the average on-site inspection of a facility with a single x-ray unit/film 
processor combination takes between five and six hours. Approximately one hour will be 
required to evaluate the equipment with the remainder being spent reviewing facility procedures 
and records. To minimize any interference with patient care, FDA suggests that the facility 
schedule a block of time for the testing of each x-ray unit and film processor combination. To 
help minimize disruption to the facility's activities, as well as to reduce the inspection time, FDA 
recommends that the facility organize and consolidate all records the inspector will need and 
have them readily available on the day of the inspection (such records are described more fully 
below). Facility personnel may conduct their usual duties during the inspection, but should be 
available if the inspector has questions or needs assistance. 
INSPECTION PROCESS 
The inspector will first meet with facility-designated representatives to verify preliminary facility 
information and to briefly outline the proposed inspection agenda. At this time, the facility staff 
should request any special sequencing of the testing and records reviews so that the facility's 
normal schedule is interrupted as little as possible. A standard annual inspection will include the 
tests and records review outlined below. After inspection, the inspector will again meet with 
facility representatives for an exit interview. 
 
 
    4  SPECIFIC INSPECTION ITEMS 
The equipment and QA/QC requirements listed in items 2 and 4 below relate to screen-film 
mammography systems. Systems using other mammographic imaging modalities are required to 
follow a quality assurance program essentially the same as that recommended by the equipment 
manufacturer. During the inspection, the inspector will verify that this requirement is met. 
1.  Certificate Display 
Since October 1, 1994, no facility may legally perform mammography services unless it has a 
valid certificate issued under the MQSA regulations. Additionally, as described above, each such 
facility must prominently display that certificate in the facility. If a facility operates multiple 
locations under one certificate number, it may make copies of the original certificate or obtain 
additional originals from the certification authority for display at each location. 
2.  Equipment Tests 
FDA will inspect each x-ray system used by the facility for regulated mammography activities. 
This inspection includes equipment being leased by, loaned to, or evaluated for purchase, as well 
as equipment owned by the facility. For several of these tests, the inspector will use the facility's 
film and cassettes to ensure the applicability of the results to the facility. The inspector will also 
require assistance from facility personnel in setting up technique factors normally used by the 
facility for an average breast examination and operating the equipment, as well as any other 
preparatory work needed for each of the following elements:  
a)  Determination that the equipment has been designed specifically for mammography.  The 
x-ray unit satisfies this requirement as long as it meets all of the applicable MQSA 
requirements and is designated by the manufacturer and accepted by the FDA as 
appropriate for mammography. Equipment designed specifically for mammography, 
because of its unique characteristics, may also be useful for non-mammography 
procedures and such use is permitted. 
b)  Determination that the system contains image receptors, moving grids, and compression 
paddles for both 18 x 24 cm and 24 x 30 cm image receptors. 
c)  Confirmation that the x-ray system has a functioning post-exposure display of the actual 
x-ray focal spot and the target material used during each exposure. The display must be 
clear, legible, and visible to the operator at the unit or the operator control location. The 
actual mechanism can be achieved in any manner that provides the required information 
in an unambiguous fashion. 
d)  Collimation assessment.  
e)  Exposure reproducibility.  
f)  Beam quality or half-value layer (HVL) measurement.  
g)  Dose calculation for a cranio-caudal view of a standard breast.  
h)  Processor evaluation. The regulations require that the facility set up and maintain the 
processor according to the specifications of the film manufacturer. Conformance with this 
requirement will be evaluated using the FDA's "Sensitometric Technique for Evaluation 
of Processing" (STEP) test to assess the processor performance. 
    5  i)  Darkroom fog.  
j)  Phantom image quality evaluation.  
NOTE: To meet item b, the facility must have at least one of each of the listed items for each 
mammography x-ray unit in the facility. There is no requirement that image receptor sizes other 
than the 18 X 24 and 24 X 30 be available for each unit in the facility. However, if a facility uses 
additional (not required by the regulations) image receptor sizes, the facility must have at least 
one moving grid and compression paddle for each such additional size. It is not necessary to 
have these items for each x-ray unit. 
3.  Records Inspection 
Facilities should maintain specific records regarding each regulated mammography system. 
These records cover:  
  X-ray unit accreditation status  
  Mammography equipment evaluation for new/repaired equipment  
  Annual physics survey reports (both the most recent and the previous one)  
  Evidence of post-move performance testing for mobile units  
  QC test records  
  Evidence of any corrective actions taken and subsequent verification testing 
The facility should have documentation showing that each x-ray unit has been accredited by the 
accreditation body. For a new unit, the facility must show that it has passed a mammography 
equipment evaluation prior to use on patients and that the application for accreditation of the unit 
has been submitted. For very new units (within five working days of installation), simply having 
the mammography equipment evaluation (see discussion below) and demonstrating that the 
application for accreditation is under preparation will be adequate to establish compliance. 
There are three cases where a unit in use may not need to be accredited:  
a)  The unit is a "loaner," while repairs to the facility's unit are taking place, or awaiting 
delivery of a replacement unit (limited to 30 days without extenuating documentation 
from the service or dealer organization showing reasons for delay in replacement or 
repair);  
b)  The unit is installed in the facility for evaluation before purchasing (limited to 90 days 
maximum without accreditation); and  
c)  The unit is an experimental one, installed and used under an FDA investigative device 
exemption or other FDA-authorized research protocol.  
Note: Under both a) and b) above, the unit still must have passed a mammography equipment 
evaluation before use on patients. The above time frames and allowances are permitted under 
MQSA. Under State or local regulations and accreditation body policies, all such use may 
require registration or accreditation. Be sure to verify the requirements with these sources. 
4.  Quality Assurance and Quality Control Programs 
The QA program includes the designation of appropriate, qualified personnel to implement and 
oversee the QA process. These personnel must include a lead interpreting physician, medical 
physicist, and quality control technologist. The inspector will check to establish that qualified 
    6  personnel have been designated for each of these duties and that the facility has established a QA 
program, as required by the regulations, to "ensure the safety, reliability, clarity, and accuracy of 
the mammography services provided at the facility." 
Evaluation of the QA program includes the review of QA procedures and records for all of the 
requirements outlined in 21 CFR 900.12(d) and (e). Facilities are required to retain the written 
QC records for each test specified by the regulations until the next annual MQSA inspection has 
established that the facility is in compliance with the QA requirements, or until the test has been 
performed two additional times at the required frequency, whichever is longer. The time periods 
for retaining sensitometric film strips and other films produced during the tests vary and are 
described below under the individual tests.  Although these records must be maintained and be 
available for review, not all records will always be evaluated during each inspection. However, 
the inspector will always seek the QA/QC information listed below:  
  Daily Processor Quality Control  
-   Including actual sensitometric film strips for the previous 30 days of mammographic 
film processing and charting of the strips for the period specified above 
  Weekly Phantom Images  
-   Including phantom images for the previous 90 days, and records covering the 
remainder of the retention period specified above 
  Quarterly Analysis of Fixer Retention in Film  
  Quarterly Repeat Analysis  
-   Conducted quarterly, regardless of the number of films obtained in the quarter, and 
should include all repeated and rejected clinical films obtained in the quarter. Large 
volume facilities may limit the analysis to those films collected after a minimum of 
250 patient examinations. 
  Semiannual Darkroom Fog  
-   QC records and test strips must be retained for the period specified above 
  Semiannual Screen-Film Contact  
-   QC records and images from screen-film contact for the retention period specified 
above 
  Semiannual Compression  
  Personnel responsibilities and procedures for QA/QC testing. Records must be kept 
indefinitely. 
  Other QA-related written policies, procedures, and records required by the regulations 
such as those relating to infection control, breast implants, and consumer complaints. 
Records must be kept indefinitely.  
  Mammographic technique charts, and information pertinent to optimizing 
mammographic quality should also be available for inspection. Records should be kept 
indefinitely.  
In general, the facility's QC records should show that all MQSA required tests were:  
  conducted at the frequencies specified in the regulations (as a minimum), and  
  followed by timely and effective corrective actions that were shown to be necessary 
(documentation of any corrective action is required).  
Note regarding the Interpretation of Test Frequencies: In the past, some facilities have 
interpreted the words "weekly," "quarterly," and "semi-annually" in ways different from that 
    7  intended by FDA. Since October 1, 1999, FDA has interpreted the regulatory requirements for 
test frequencies as follows:  
  Weekly Phantom Image Test: Must be performed each week in which mammograms are 
performed. However, the test need not be performed on the same day each week.  
   Quarterly Tests: Must be performed 4 times a year or at a minimum once in each 3 month 
period in which mammograms are performed. The 4 months that are chosen must be 
spaced 3 months apart (such as February, May, August, and November.) However, for 
any of the 4 selected months, each test may be performed on any day (not necessarily the 
same day) in the month.  
  Semi-annual Tests: Must be performed 2 times a year or at a minimum once in each 6 
month period in which mammograms are performed. The 2 months that are chosen must 
be spaced 6 months apart (such as January and July). However, for any of the 2 selected 
months, each test may be performed on any day (not necessarily the same day) in the 
month.  
For listing of the required QC test items, required frequencies, and examples of acceptable 
documentation, see Attachments 2 and 3. The items appearing in Attachment 2 must be 
performed more frequently than the annual tests in Attachment 3 and will normally fall under the 
responsibility of the quality control technologist. Although the annual tests may be conducted 
more frequently than annually, they must be conducted by a MQSA-qualified medical physicist 
(or someone in training under his or her direct supervision) when performed as part of the annual 
survey or a mammography equipment evaluation. The results of the annual tests and any 
recommendations for corrective actions must be stated in the medical physicist's survey report. 
5.  Medical Physicist's Survey Report 
Each facility must undergo at least once each year a survey performed by a medical physicist.  
For various reasons it is often impractical for these annual surveys to be conducted exactly on the 
anniversary of the previous survey, therefore FDA will accept a range of 10 to 14 months since 
the previous survey as being adequate to satisfy the at least once each year requirement stated 
in the regulations. The facility must have available for the inspector the two most recent annual 
physicist survey reports. The reports must document the physicist's tests, the results, the 
evaluation of the technologist's QC testing, and include recommendations for any corrective 
actions resulting from the tests or review. The facility should also have evidence of its actions 
concerning each recommendation. 
6.  Mammography Equipment Evaluation 
When a new or an existing mammography facility obtains new mammographic equipment or 
processors, it must pass a mammography equipment evaluation conducted by a qualified medical 
physicist before such equipment is placed into service. In this context, "new" means new to the 
facility and may be previously used equipment. In addition, a medical physicist must perform a 
mammography equipment evaluation whenever such equipment is disassembled and then 
reassembled, either at the same or a new location, or whenever a major component is changed or 
repaired. The inspector will verify that appropriate records are available to document compliance 
with this requirement. 
    8  The medical physicist must provide the facility with sufficient documentation to clarify the 
testing performed and the results of the testing. All problems must be corrected, and the 
corrections documented, before the new or changed equipment is put into clinical service. 
7.  Personnel Qualifications 
The facility is required to maintain records documenting initial and continuing qualifications of 
all personnel who have performed or are performing the duties of interpreting physician, 
radiological technologist, or medical physicist, and all employees assigned to quality assurance 
tasks for the facility. Facilities are to ensure that new mammography personnel meet all 
applicable requirements prior to allowing them to provide mammography services. This 
requirement covers records for individuals who provide or have provided temporary and/or 
contract services for the facility, including personnel who may provide services offsite. Once an 
employee leaves, the facility is not expected to continue tracking their status. If personnel leave, 
the facility is expected to maintain their records until the next annual MQSA inspection has been 
completed and FDA has determined that the facility complies with all MQSA personnel 
requirements. 
Facilities should be aware that their State(s) might have more stringent recordkeeping 
requirements. Check with your State(s) before making any final decisions regarding the 
disposition of any records. 
The required personnel information is listed below and must be available for the inspector's 
review during the inspection. 
Interpreting Physicians 
Interpreting physicians initially qualifying on or after the April 28, 1999 effective date of the 
final regulations, must meet all of the following requirements. Physicians who qualified under 
FDA's interim regulations (prior to April 28,1999) are considered to have met the initial 
requirements listed in items 2 through 4 below. They may continue to interpret mammograms if 
they continue to meet the licensure requirement in item 1, the new modality training requirement 
for item 5 (if applicable), and the continuing experience and continuing education requirements 
for items 6 and 7.  
1.  Licensure: Be licensed to practice medicine in a State.  
AND 
2.  a.  Board Certification: Be certified in radiology or diagnostic radiology by any of the 
following bodies:  
  The American Board of Radiology (ABR) 
  The American Osteopathic Board of Radiology (AOBR) 
  The Royal College of Physicians and Surgeons of Canada (RCPSC)  
OR 
b.  Initial Training: Have had at least 3 months of documented formal training in the 
interpretation of mammograms and in topics related to mammography (to include 
    9  instruction in radiation physics, including radiation physics specific to mammography, 
radiation effects, and radiation protection). 
AND 
3.  Initial Category I Education: Have a minimum of 60 hours of documented category I 
medical education in mammography (including instruction in the interpretation of 
mammograms and education in basic breast anatomy, pathology, physiology, technical 
aspects of mammography, and quality assurance and quality control in mammography). 
At least 15 of the required 60 hours must have been acquired within the 3 years 
immediately before the physician's initial qualification date. These 60 hours may be 
included in the 3 months of training specified in 2.b above. Hours received in residency 
training are considered equivalent to category I.  
AND 
4.  Initial Experience: Have interpreted or multi-read, under direct supervision of a 
qualified interpreting physician, at least 240 mammographic examinations within the 6-
month period immediately before the date that the physician qualifies as an interpreting 
physician (or in any 6-month period during the last 2 years of a diagnostic radiology 
residency for physicians who become appropriately board certified at the first allowable 
time, as defined by the board).  
AND 
5.  New Mammographic Modality: Before an interpreting physician may begin 
independently interpreting mammograms produced by any mammographic modality in 
which the interpreting physician was not previously trained (e.g., xeromammography, 
digital mammography, screen-film mammography), the physician must have at least 8 
hours of training in that mammographic modality.  
AND 
6.  Continuing Experience: Have interpreted or multi-read at least 960 mammographic 
examinations during the 24 months immediately preceding the date of the facility's 
annual MQSA inspection, or the last day of the calendar quarter preceding the inspection, 
or any date in between the two.  
The beginning date for meeting the continuing experience requirement is the later of 
October 1, 1994, or the individual's actual starting date (the date on which an individual 
met all applicable requirement to begin independently providing mammography 
services). Failure to meet the continuing experience requirement will not be considered a 
noncompliance until at least 24 months after the individual's starting date. 
AND 
7.  Continuing Education: Have taught or completed at least 15 category I continuing 
medical education (CME) credits in mammography during the 36 months immediately 
preceding the date of the facility's annual MQSA inspection, or the last day of the 
calendar quarter preceding the inspection, or any date in between the two. CME credits 
earned through teaching a course can be counted only once toward meeting the 15 credits 
required in any 36-month period. Such training shall include at least 6 credits of category 
I CME in each mammographic modality used by the interpreting physician.  
    10  The beginning date for meeting the continuing education requirement is the later of 
October 1, 1994, or the individual's actual starting date (the date on which an individual 
met all applicable requirement to begin independently providing mammography 
services). Failure to meet the continuing education requirement will not be considered a 
noncompliance until at least 36 months after the individual's starting date. 
FDA permits multi-reading/interpreting of mammograms and summing of 
readings/interpretations from different facilities in calculating the total mammographic 
examinations for items 4 and 6 above. Multi-reading is defined as two or more physicians, at 
least one of whom is a fully qualified interpreting physician, interpreting the same mammogram. 
Multi-reading includes reading comparison mammograms not previously read by the physician.  
So that facilities are aware of potential problems, FDA recommends that facilities update 
education and experience records at least quarterly. 
Specific information on acceptable documentation for the interpreting physician's qualifications 
is listed in Attachment 4. 
Radiologic Technologist 
Radiologic technologists initially qualifying on or after the April 28,1999 effective date of the 
final regulations must meet all of the following requirements. Radiologic technologists, who 
qualified under FDA's interim regulations (before April 28,1999) are considered to have met the 
initial training requirements listed in item 2 below. They may continue to perform mammograms 
if they continue to meet the licensure or certification requirements of item 1, any applicable new 
modality training requirement from item 3, and the continuing experience and education 
requirements of items 4 and 5.  
1.  a.  Licensure: Have a general/full license to perform radiographic procedures issued by 
a State.  
OR 
b.  Board Certification: Be certified by either of the following bodies:  
  The American Registry of Radiologic Technologists (ARRT)  
  The American Registry of Clinical Radiography Technologists (ARCRT)  
AND 
2.  Initial Training in Mammography: Have at least 40 contact hours of mammography 
training, including breast anatomy, physiology, positioning, compression, quality 
assurance/quality control techniques, imaging of patients with breast implants, and the 
performance of 25 supervised examinations. The actual time spent performing supervised 
examinations may be included in the 40 hour total. As guidance, however, no more than 
12.5 hours of the required 40 should come from the performance of examinations.  
AND 
3.  New Mammographic Modality: Before a radiologic technologist may independently 
perform mammographic examinations using any mammographic modality in which the 
radiologic technologist was not previously trained (e.g., xeromammography, digital 
    11  mammography, screen-film mammography), the radiologic technologist must have at 
least 8 hours of training in the modality.  
AND 
4.  Continuing Experience: Have performed a minimum of 200 mammography 
examinations during the 24 months immediately preceding the date of the facility's 
annual MQSA inspection, or the last day of the calendar quarter preceding the inspection, 
or any date in between the two.  
The beginning date for meeting this requirement is April 28, 1999, or the individuals 
actual starting date (date on which the individual initially qualifies to work 
independently), whichever is later. Failure to meet the technologist's continuing 
experience requirement will not be considered a noncompliance until the later of July 1, 
2001, or at least 24 months after the technologist's starting date. 
AND 
5.  Continuing Education: Have taught or completed at least 15 continuing education units 
in mammography during the 36 months immediately preceding the date of the facility's 
annual MQSA inspection, or the last day of the calendar quarter preceding the inspection, 
or any date in between the two. At least 6 of these CEUs must be in each of the 
mammographic modalities used by the technologist. CEUs earned through teaching a 
course can be counted only once towards meeting the units required in any 36-month 
period.  
The beginning date for meeting the continuing education requirements is the later of 
October 1, 1994, or the individuals actual starting date (date on which the individual 
initially qualifies to work independently), whichever is later. Failure to meet the 
continuing education requirements will not be considered a noncompliance until at least 
36 months after the technologist's starting date. 
As with the physicians, FDA recommends that the facilities update the education and experience 
records at least quarterly. 
Specific information on acceptable documentation for the technologist's qualifications is listed in 
Attachment 5. 
Medical Physicist 
There are no "grandparenting" provisions in the final MQSA regulations covering the medical 
physicist, and ALL physicists qualified prior to April 28, 1999, have additional criteria for 
qualification under the final regulations. 
The qualifications for the medical physicist are relatively complicated. As an aid to 
understanding them, we have separated the medical physicist section into three parts.  
A.  The requirements for those physicists who are qualifying through the "master's degree or 
higher" route  
B.  The requirements for those who are qualifying through the "alternative initial 
requirements" approach covering education, training, and experience  
C.  The continuing qualification requirements applicable to all physicists  
    12  All qualifying medical physicists must demonstrate compliance with either "A" or "B" below. 
The continuing education and experience requirements covered in "C" are applicable to all 
physicists.  
A.  All medical physicists qualifying under the "master's degree or higher" route must 
demonstrate:  
1.  a. Licensure or approval: Be licensed or approved by a State to perform 
mammography surveys.  
OR 
b. Board Certification: Be certified in diagnostic medical physics or medical 
physics by one of the following:  
i.  The American Board of Radiology (ABR)  
ii.  The American Board of Medical Physics (ABMP)  
AND 
2.  Education, training, and experience:  
a.  Degree: Have at least a master's degree or higher in a physical science with at 
least 20 semester hours (30 quarter hours) of graduate or undergraduate 
physics.  
AND 
b.  Survey Training: Have at least 20 contact hours of mammography facility 
survey training.  
AND 
c.  Initial Experience: Have the experience of conducting surveys of at least 1 
mammography facility and at least 10 mammography units.  
B.  Certain medical physicists may have qualified under the interim regulations before April 28, 
1999, through the State approval or licensing mechanism or through the professional certification 
route without having the appropriate degree to meet the final regulations as described above. 
Such medical physicists may qualify under the "Alternative Initial Qualifications" route. Such 
individuals must demonstrate that, by April 28, 1999, they have achieved compliance with the 
following:  
1.  a.  Licensure or approval: Be licensed or approved by a State to perform 
mammography surveys.  
OR 
b. Board Certification: Be certified in diagnostic medical physics or medical 
physics by one of the following:  
i.  The American Board of Radiology (ABR)  
i.  The American Board of Medical Physics (ABMP)  
AND 
    13  2.  Education, training, and experience:  
a.  Degree: Have a bachelor's degree in a physical science with at least 10 
semester hours (15 quarter hours) of graduate or undergraduate physics. (This 
would include individuals having advanced degrees in non-physical science 
fields.)  
AND 
b.  Survey Training: Have at least 40 contact hours of mammography facility 
survey training. This training must have occurred after fulfilling the degree 
requirement in 2.a.  
AND 
c.  Initial Experience: Have the experience of conducting surveys of at least 1 
mammography facility and at least 20 mammography units. This initial 
experience must have occurred after fulfilling the degree requirement in 2.a.  
C.  All medical physicists must meet the following requirements;  
1.  New Mammographic Modality: Before a physicist may begin independently 
performing surveys or mammography equipment evaluations on any 
mammographic modalities in which the physicist was not previously trained (e.g., 
xeromammography, digital mammography, screen-film mammography), the 
physicist must have at least 8 hours of training in the modality.  
AND 
2.  Continuing Experience: The physicist must have conducted a minimum of two 
mammography facility surveys and a total of six mammography unit surveys (or 
mammography equipment evaluations which cover all of the equipment survey 
items) during the 24 months immediately preceding the date of the facility's 
annual MQSA inspection, or the last day of the calendar quarter preceding the 
inspection, or any date in between the two  
The beginning date for this requirement is April 28, 1999 or the individuals 
actual starting date (date on which the physicist initially qualifies to work 
independently), whichever is later. Failure to meet the physicist's continuing 
experience requirement will not be considered a noncompliance until the later of 
July 1, 2001 or at least 24 months after the physicist's starting date. 
AND 
3.  Continuing Education: Have taught or completed at least 15 continuing 
education units in medical physics or mammography during the 36 months 
immediately preceding the date of the facility's annual MQSA inspection, or the 
last day of the calendar quarter preceding the inspection, or any date in between 
the two. The continuing education must include more than 1 unit in each 
mammographic modality evaluated by the medical physicist. CEUs earned 
through teaching a course can be counted only once toward meeting the 15 units 
required in any 36-month period.  
    14  The beginning date for this requirement is October 1, 1994, or the individuals 
actual starting date (date on which the physicist initially qualifies to work 
independently), whichever is later. Failure to meet the physicist's continuing 
education requirement will not be considered a noncompliance until at least 36 
months after the physicist's starting date. 
NOTE: For meeting the requirements in items A.2.b., A.2.c., B.2.b., B.2.c., and C.2., FDA 
allows multiple testing of the same mammography unit. However, no more than one survey of a 
specific facility within a 10-month period can be counted toward the total requirement, and tests 
of the same unit cannot be counted more than once in any consecutive 60-day period. It is 
important enough to repeat that, for the alternative initial qualifications route, the training and 
experience in items B.2.b. and B.2.c. must have been obtained after the qualifying degree 
requirements are satisfied and before April 28, 1999. 
Specific information on acceptable documentation for the physicist's qualifications is listed in 
Attachment 6. 
All Personnel - Attestation 
FDA allows personnel to attest to certain training, education, or experience earned before 
October 1, 1994. Physician initial 2 or 3 months training and medical physicist degree 
requirements, including the required number of hours in physics, cannot be attested to at any 
time. In general, FDA does not intend to accept attestation for training, education, or experience 
obtained after October 1, 1994. However, FDA will accept a limited form of attestation for 
CME/CEUs earned after October 1, 1994, if a continuing education provider does not 
specifically document the number of hours earned in mammography. Such attestation will be 
acceptable if it includes documentation showing both the total number of CME/CEUs earned in 
the program and the total number of CME/CEUs specific to mammography that were available. 
If the meeting or other educational opportunity is limited to mammography, then only 
documentation from the provider of the number of CME/CEUs earned is needed (no attestation 
is required in this instance).  
In certain situations, attestation will also be accepted for meeting the new mammographic 
modality requirement.  Specifically, personnel who worked with investigational full field digital 
mammography systems prior to April 28, 1999, may attest to that experience. In addition, 
personnel who received mammography modality specific training prior to October 1, 1994 may 
attest to that training. All attestations must be in the proper format. (An attestation form is 
included as Attachment 1.) 
8.  Medical Records 
Patient Permanent Records 
Medical records must contain certain required types of information. To ensure that both the 
mammographic images and reports are being retained as required, and to verify they contain the 
information outlined below, the inspector will randomly select records for review. In general, the 
inspector will request reports from those examinations performed since the last MQSA 
inspection, or since the facility's certification, whichever is the most recent. However, inspectors 
may examine records from other time frames. The inspector will not attempt to assess the 
correctness of these reports, but will determine that the records are being generated, properly 
    15  maintained, and identify the interpreting physician who originally interpreted the mammograms. 
For those mammography medical reports created on or after April 28, 1999, the inspector will 
also verify that one of the following assessment categories appears in each: "Negative," 
"Benign," "Probably Benign," "Suspicious," "Highly suggestive of malignancy," or "Incomplete: 
Need additional imaging evaluation." 
The facility is required to communicate the results, within 30 days of the examination, to the 
referring health care provider and to the patient (lay summary). In the case of self-referred 
patients, if a health care provider (or a responsible designee) is not named or is unavailable, then 
the report must be provided to the patient. Communications to the patient, if there is no health 
care provider, must include 1) the complete report of findings referenced above and 2) the 
summary written in lay terms that is required for all patients. When the assessment is 
"Suspicious" or "Highly suggestive of malignancy," the facility is required to communicate the 
results, as soon as possible, to the referring health care provider and to the patient (lay summary) 
and depending on health care provider availability, may need to send the complete report to the 
patient). Facility personnel should be prepared to explain the facility's procedure for 
communicating results to referring physicians and to patients and their mechanism for providing 
quick response for cases requiring such action.  
FDA's concern is not the details of the communication system but rather:  
  that one has been established by the facility,  
  that it is in place, and  
  that it meets the requirements of the regulations.  
The inspector will verify that the communication system meets these criteria and that lay 
summaries are available. If patient records are stored in an electronic format, the inspector will 
ask the facility to assist in the selection and retrieval of the records to be inspected. 
9.  Mammography Medical Audit and Outcomes Analysis 
Each facility must establish and maintain a system to track positive mammographic findings and 
to correlate such findings with the biopsy results the facility obtains on an annual basis.  
At a minimum, the system must track "positive mammographic findings," which refers to 
mammograms interpreted as "Suspicious" or " Highly suggestive of malignancy." MQSA leaves 
it up to each facility to use a tracking system that works best for it. This system must include a 
set of procedures to track mammograms, determine whether biopsies were done on the patient, 
determine (at a minimum) whether the biopsy specimen was benign or malignant, and report this 
information back to the interpreting physician. The system may be manual or computerized. 
Facilities must also include in their audit any patients that they become aware of who were 
subsequently found to have cancer that was not detected through their mammogram. The audit 
analysis must be initiated within 12 months after the date the facility becomes certified. The 
audit analysis must then be completed within an additional 12 months with subsequent audit 
analyses to be conducted at least once every 12 months. The analyses are to be reviewed by an 
"audit interpreting physician" appointed by the facility. The "audit interpreting physician" has 
multiple responsibilities listed in 900.12(f)(3) that must be covered in the facility's audit 
program. 
    16  The inspector will examine the audit system for the inclusion of the above items, ascertain how 
biopsy results are obtained, and request to see examples of biopsy results that the facility has 
obtained. If biopsies were recommended but no results were obtained, the facility must provide 
documentation of attempts to get this information. 
REPEAT FINDINGS 
If a facility inspection finds "repeat" problems (deficiencies of the same type, either recurring or 
never corrected, found during the previous inspection), the post-inspection report provided to the 
facility will identify which findings have been repeated. Depending on their seriousness, these 
repeat deficiencies could result in the requirement of a written response from the facility, a 
follow-up inspection, and/or sanctions against the facility. 
MOBILE MAMMOGRAPHY 
The QC for x-ray units used for mobile mammographic purposes must meet all of the 
requirements applicable to stationary mammography x-ray units plus the additional requirement 
of post-move, pre-clinical use performance testing. This additional test is to ensure the 
satisfactory performance of the unit after each move and before patients are imaged. The 
following are examples of acceptable tests: 
  A phantom image can be taken in the AEC mode (or the mode used clinically) after the 
move but prior to patient examination.  This image is then either processed and evaluated 
at the mobile unit site (if possible), or processed off-site and evaluated to verify 
performance prior to examining patients.  A passing score for this phantom image verifies 
that the unit is performing adequately after moving and before patient examination. 
  Another example is to (1) for a given kVp, record the mAs resulting from a phantom 
exposure (in the AEC mode under typical clinical conditions or the mode used clinically); 
(2) compare that mAs to a standard mAs value previously established as ensuring output 
consistency; and (3) if the two readings are within +/- 10%, proceed with clinical 
examinations; otherwise take corrective actions to bring the two values within this limit 
before proceeding with clinical examinations.  A crucial follow-up to this test by the 
facility is to process (using a processor in control) and score the phantom image taken in 
step (1) at the earliest time available and before batch processing any of the clinical 
images.  If this phantom fails because of any processing problems, the problems should 
be corrected prior to processing any of the clinical images.  If the phantom image fails 
due to a non-processor problem, the mobile facility should still process all the films.  
Each clinical exam should be evaluated individually to determine whether any of the 
patients have to be recalled to have their images repeated.  The entire imaging chain must 
be checked and adjusted or repaired prior to further clinical use. 
  If the facility takes a phantom image as part of its post-move/pre-examination testing, it 
must document the phantom image score.  The facility must keep the written records of 
post-move/pre-examination tests for the last 12 months or since the last inspection, 
whichever is longer, and the phantom images for the last 30 days. 
  Other tests designed by qualified personnel (the medical physicist should be consulted) 
could be acceptable but may have to be evaluated by the inspector on a case-by-case 
basis. If a facility has any questions regarding the acceptability of such alternative 
    17  measures, they should obtain a ruling from FDA on the alternative before relying on such 
testing. 
EXIT INTERVIEW 
During the exit interview with facility personnel, the inspector will review the results of the 
inspection and either leave a summary of findings or mail this summary to the facility within two 
weeks. 
If major deficiencies are found, the facility will receive a letter, addressed to the facility's 
"Responsible Person," concerning these issues. The facility's "Responsible Person" is a person 
the facility has identified as having the authority to make vital operational and financial decisions 
concerning corrective actions that are required to bring the facility into compliance. All 
deficiencies should be corrected as soon as possible. Depending on the level of the severity of 
the problems, specific regulatory mandated time frames will be included in the letter. The 
facility is required [21 CFR 900.12(e)(8)(ii)(A)] to correct problems found with the 
following areas of the QC program "before any further examinations are performed or any 
films are processed using the component of the mammography system that failed the 
test...."  
  Daily QC tests - 900.12(e)(1),  
-   base plus fog 
-   mid-density 
-   density difference 
  Weekly QC tests - 900.12(e)(2)  
-   phantom image quality 
  Semiannual QC tests - 900.12(e)(4)  
-   Darkroom fog - 900.12(e)(4)(i) 
-   Screen-film contact - 900.12 (e)(4)(ii) 
-   Compression device performance - 900.12 (e)(4)(iii) 
  Annual QC tests - 900.12(e)(5)  
-   Dose - 900.12(e)(5)(vi) 
  Other modalities - 900.12(e)(6)  
  Mobile units - 900.12(e)(7)  
For violations related to the quality control (QC) tests described in paragraph 900.12(e)(8)(ii)(B), 
the facility must complete repairs within 30 days of discovering the problem. Facilities 
continuing to operate under deficient conditions could be subject to sanctions. Such sanctions 
could include a directed plan of correction, civil money penalties, or certificate suspension or 
revocation. Certain findings could also require a follow-up inspection to verify correction. 
FOR MORE INFORMATION 
FDA maintains an MQSA Internet site at http://www.fda.gov/cdrh/mammography. The site 
contains many useful items, including current information about the mammography program. If 
you have questions on how to prepare for inspections, call FDA's Facility Hotline at (800) 838-
7715, or FAX your request to (410) 290-6351. 
    18  Attachment 1 
ATTESTATION FORM 
 
Regarding Requirements of the Mammography Quality Standards Act 
Attestation must include as much of the following information as possible:   
Name of the institution/facility where the applicable training or mammography 
reading/interpreting, or other activity, took place; name of the course(s) or training (where 
applicable); the attendance, reading/interpreting, or other activity dates; and the 
supervising/responsible person (where applicable) for the institution/facility.  
Please provide these details in the space below.  Attach additional sheets if necessary. 
I ________________________ attest that, to the best of my knowledge and my belief, the 
following information provided in this declaration is true and correct. I understand that 
FDA may request additional information to substantiate the statements made in this 
declaration:   
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
______________ 
I understand that knowingly providing false information in a matter within the 
jurisdiction of an agency of the United States could result in criminal liability, punishable 
by up to $10,000 fine and imprisonment of up to five years, or civil liability under the 
MQSA, or both. 
____________________________________________________________________________ 
Attestor's Signature and Title 
_____________________ 
Date signed 
Facility Name and Address (if applicable) (including zip code): 
___________________________________ 
___________________________________ 
___________________________________ 
Facility ID Number (if applicable)    (from the Facility's MQSA certificate) 
    19  Attachment 2 
Quality Control Tests Other than Annual 
 
Test &  Requirements for  Guidance  for Acceptable  Timing of Required 
Frequency  Acceptable Operation  Documentation Retention*  Corrective Action ** 
Processor  Established operating level  QC records (&charts) for the last 12  Before any further clinical 
QC-   for B+F, + up to 0.03 OD.  months or since the last inspection,  films are processed. 
whichever is longer. 
Daily   
QC test films for the last 30 days. 
"  Established operating level  "  " 
for MD,  0.15 OD. 
"  Established operating level  "  " 
for DD,  0.15 OD. 
Phantom QC-   Established operating level  QC records for the last 12 months or  Before any further 
for OD at center of image  since the last inspection, whichever  examinations are performed 
Weekly 
1.2   0.20, but the  is longer. Phantom images for the  using the x-ray machine. 
minimum OD must be  1.2  last 90 days. 
at any time. 
"  Established operating level  "  " 
for contrast,  0.05 OD 
"  Minimum score of 4 fibers, 3  "  " 
speck groups, 3 masses. 
Fixer retention in  < 5 micrograms per square  QC Records since the last  Within 30 days of the date of 
film-   cm of residual fixer.  inspection or for the past three tests,  the test. 
whichever is longer. 
Quarterly 
Repeat Analysis-  Operating level for repeat or  "  " 
reject rate is < 2% change (up 
Quarterly 
or down) from previous rate.  
Darkroom Fog-   OD  0.05.  QC Records since last inspection or  Before any further clinical 
for the past three tests, whichever is  films are processed. 
Semi-annually   
longer.  Fog QC films from the 
  previous three tests. 
Screen-Film  All mammography cassettes  QC records since last inspection or  Before any further 
Contact-  used must be tested with a  for the past three tests, whichever is  examinations are performed 
40-mesh copper screen.  longer.  S-F contact QC films from  using the cassettes. 
Semi-annually 
the previous three tests. 
 
Compression  Compression force  111  QC records since last inspection or  Before examinations are 
Device   newtons (25 pounds).  for the past three tests, whichever is  performed using the 
longer.  compression device. 
Semi-annually  Effective 10/28/2002, initial 
power drive maximum 
 
compression force between 
111 and 200 newtons (25 and 
45 pounds). 
*  Guidance regarding the length of time for which the facility is required to keep QC records was given earlier under 
900.12(d)(2). 
** Refer to 900.12(e)(8)(ii)(A) or (B) as applicable. 
    20  Attachment 3 
Annual Quality Control Tests 
 
Timing of required 
Test  Scope  Regulatory Action Levels  corrective action* 
AEC  All x-ray units.  OD exceeds the mean by more than  Within 30 days after test 
Performance  Thickness tracking (2-6 cm,    0.30 (over 2-6 cm thickness range)  failure. 
Capability  appropriate kVps).  [ 0.15 after 10/28/2002]. 
kVp Tracking (clinic. range).  Phantom image OD at center < 1.20. 
kVp Accuracy &  All x-ray units.  kVp accuracy outside  5% of   
Reproducibility    indicated /selected kVp. 
Reproducibility COV > 0.02. 
Focal  All x-ray units, all clinically used  See focal spot table in the regs.   
spot/System  target materials and   focal spots   11 cycles/mm with bars 
Resolution  1) Spot size measurement until  perpendicular to anode-cathode axis. 
10/28/02 @ the most used SID  13 cycles/mm with bars parallel to 
2) Resolution measurement  anode-cathode axis. 
Same as 1) but if mag mode is 
used, then test at SID w/mag 
value closest to 1.5 obtainable 
(used clinically or not) & for all 
clinically used mag screen-film 
combinations 
HVL  All x-ray units.  See HVL table in regulations.   
All clinically used target/filter 
combinations. 
Air Kerma &  All x-ray units.  Reproducibility COV for each   
AEC    exceeds 0.05. 
Reproducibility 
Dose  All x-ray units.  Exceeds 3.0 mGy (0.3 rad) per  Before any further 
All targets/filter combos used for  exposure (for the Standard Breast).  examinations are 
the Standard Breast.  performed. 
Phantom  All x-ray units  < 4 fibers, 3 speck groups, 3 masses   
Image** 
X-ray field/light  All x-ray units.  X-ray/light field: > 2% SID   Within 30 days of the 
field   All combinations of collimators,  X-ray field/IR: Outside IR: > 2%  date of discovery. 
X-ray field/IR  image receptor sizes, targets &  SID (all sides.) Inside IR: less than 
Compression  focal spots clinically used in full  full coverage at cw. Comp. 
device/IR    field imaging of the breast.  device/IR: Outside IR:>1%SID 
Inside IR: Paddle visible on image 
Screen Speed  All cassettes  sub-grouping  O.D. variation exceeds 0.30 from  " 
Uniformity  allowed.  highest to lowest. 
System Artifacts  All x-ray units and processors,  Determined by physicist.  " 
  all cassette sizes, all clinically 
used focal spots & target/filter 
combinations. 
Radiation Output  All x-ray units.  Output < 4.5 mGy/sec (513 mR/sec),  " 
  and < (7 & 800) after 10/28/2002  
Decompression   All x-ray units (if auto  Failure of override mechanism,  " 
decompression is provided).  manual release, or status indicator. 
Any applicable  All x-ray units.  Depends on test.  Before clinical use. 
annual new 
modality tests 
* Refer to 900.12(e)(8)(ii)(A) or (B) as applicable. 
** This is the same as the weekly phantom image test but it must also be performed annually by the medical physicist. 
    21  Attachment 4 
Acceptable Documents For Interpreting Physicians 
 
Requirement  Obtained Prior to 10/1/94  Obtained 10/1/94-4/28/99  Obtained after 4/28/99 
State License  1.  State license/copy with  1.  State license/copy with  1.  State license/copy with 
expiration date  expiration date  expiration date 
2.  Confirming letter from  2.  Confirming letter from  2.  Confirming letter from State 
State licensing board  State licensing board   licensing board  
3.  Pocket card/copy of license  3.  Pocket card/copy of license 3.  Pocket card/copy of license 
Board Certification  1.  Original/copy of certificate 1.  Original/copy of certificate  1.  Original/copy of certificate 
(ABR, AOBR, or RCPSC)  2.  Confirming letter from  2.  Confirming letter from  2.  Confirming letter from 
certifying board  certifying board  certifying board 
3.  Confirming letter from  3.  Confirming letter from  3.  Confirming letter from 
ACR  ACR  ACR 
4.  Listing in ABMS directory  4.  Listing in ABMS directory  4.  Listing in ABMS directory 
Formal Training  1.  Letters or other documents  1.  Letters or other documents  1.  Letters or other documents 
(2 months-interim regs)  from US or Canadian  from US or Canadian  from US or Canadian 
(3 months-final regs)  residency programs  residency programs  residency programs 
2.  Documentation of formal  2.  Documentation of formal  2.  Documentation of formal 
mammography training  mammography training  mammography training 
courses  courses  courses 
3.  Category I CME certificates 3. Category I CME certificates 3.  Category I CME certificates 
Initial Medical Education  1.  Attestation  1.  Letter from residency  1.  Letter from residency 
(40 hours-interim regs)  2.  Letter from residency  program  program 
(60 hours/15 in last 3 years- program  2.  CME certificates  2.  CME certificates 
final regs)  3.  CME certificates  3.  Letter or other document  3.  Letter or other document 
4.  Letter or other document  confirming in-house or  confirming in-house or 
confirming in-house or  formal training  formal training (Category I) 
formal training 
Initial Experience (240)  1.  Attestation  1.  Letter or other document  1.  Letter or other document 
(any 6 month period-interim  2.  Letter or other document  from residency or training  from residency or training 
regs)  from residency or training  program or mammography  program or mammography 
(last 6 month vs 6 month in last  program or mammography  facility  done under direct  facility  done under direct 
2 years of residency-final  facility  supervision  supervision 
regs) 
Initial Mammographic  1.  Attestation for training or  1.  Attestation for experience  1.  Mammography Modality 
Modality Specific Training- experience with  with investigational units  Specific CME certificates 
8 hours-final regs  investigational units  2.  Mammography Modality  (Category I or II) 
2.  Mammography Modality  Specific CME certificates  2.  CME certificates (Category 
Specific CME certificates  (Category I or II)  I or II) plus agenda, course 
(Category I or II)  3.  CME certificates (Category  outline or syllabus 
3.  CME certificates (Category  I or II) plus agenda, course  3.  Confirming letters from 
I or II) plus agenda, course  outline or syllabus  CME granting 
outline or syllabus  4.  Confirming letters from  organizations 
4.  Confirming letters from  CME granting organizations 4.  Letters, certificates or other 
CME granting  5.  Letters, certificates or other  documents from 
organizations  documents from  manufacturers or other 
5.  Letters, certificates or other  manufacturers or other  formal training courses 
documents from  formal training courses 
manufacturers or other  6.  Letter from facility where 
formal training courses  experience was obtained 
6. Letter from facility where  documenting experience in 
experience was obtained  the new mammographic 
documenting experience in  modality 
the new mammographic 
modality 
    22  Continuing Experience (960/24 N/A  1.  Letter, table, facility logs or 1.  Letter, table, facility logs or 
months)  other documentation from  other documentation from 
residency or training  residency or training 
program or mammography  program or mammography 
facility  facility 
Continuing Education (15  N/A  1.  CME certificates (Category 1.  CME certificates (Category 
CME/36 months-interim  I or II)  I) 
regs)  2.  Confirming letters from  2.  Confirming letters from 
(15 Category I CME/36  CME granting  CME granting 
months-final regs)  organizations  organizations 
3.  Letters, certificates or other 
documents from 
manufacturers training 
courses 
Continuing Mammographic  N/A  1.  Mammography Modality  1.  Mammography Modality 
Modality Specific  Specific CME certificates  Specific CME certificates 
Education-final regs  (Category I or II)  (Category I) 
2.  CME certificates (Category 2.  CME certificates (Category 
I or II) plus agenda, course  I) plus agenda, course 
outline or syllabus  outline or syllabus 
3.  Confirming letters from  3.  Confirming letters from 
CME granting  CME granting 
organizations  organizations 
4.  Letters, certificates or other 
documents from 
manufacturers or other 
formal training courses 
Requalification-Experience N/A  1.  Letter, table, facility logs or 1.  Letter, table, facility logs or 
done under direct  other documentation from  other documentation from 
supervision  residency or training  residency or training 
program or mammography  program or mammography 
facility   facility  
Requalification- Education  N/A  1.  CME certificates (Category 1.  CME certificates (Category 
I or II)  I) 
2.  Confirming letters from  2.  Confirming letters from 
CME granting  CME granting 
organizations  organizations 
 
 
 
 
    23  Attachment 5 
Acceptable Documents For Radiologic Technologists 
 
Requirement  Obtained Prior to 10/1/94  Obtained 10/1/94-4/28/99  Obtained after 4/28/99 
State Licensure  1.  State license/copy with  1.  State license/copy with  1.  State license/copy with 
expiration date  expiration date  expiration date 
2.  Confirming letter from State 2.  Confirming letter from State 2.  Confirming letter from State 
licensing board  licensing board  licensing board  
3.  Pocket card/copy of license  3.  Pocket card/copy of license  3.  Pocket card/copy of license 
Board Certification  1.  Original/copy of current  1.  Original/copy of current  1.  Original/copy of current 
(ARRT or ARCRT)  certificate  certificate  certificate 
2.  Confirming letter from  2.  Confirming letter from  2.  Confirming letter from 
certifying board  certifying board  certifying board 
3.  Pocket card/copy of  3.  Pocket card/copy of  3.  Pocket card/copy of 
certificate  certificate  certificate 
Initial Training   1.  Attestation   1.  Letter or other document  1.  Letter or other document 
(~40 hours-interim regs)  2.  Letter or other document  from training program  from training program 
(40 hours-25 supervised  from training program  2.  CEU certificates  2.  CEU certificates 
exams-final regs)  3.  CEU certificates  3.  Letter or other document  3.  Letter or other document 
4.  Letter or other document  confirming in-house or  confirming in-house or 
confirming in-house or  formal training  formal training 
formal training  4.  Approved RT training 
5.  ARRT(M) Mammography  courses 
certificate  5.  ARRT(M) Mammography 
6.  California Mammography  certificate 
certificate  6.  California Mammography 
7.  Arizona Mammography  certificate 
certificate  7.  Arizona Mammography 
8.  Nevada Mammography  certificate 
certificate  8.  Nevada Mammography 
certificate 
Initial Mammography Modality 1.  Attestation for training or  1.  Attestation for experience  1.  Mammography Modality 
Specific training-8 hours- experience with  with investigational units  Specific CEU certificates  
final regs  investigational units  2.  Mammography Modality  2.  CEU certificates plus 
2.  Mammography Modality  Specific CEU certificates  agenda, course outline or 
Specific CEU certificates   3.  CEU certificates plus  syllabus 
3.  CEU certificates plus  agenda, course outline or  3.  Confirming letters from 
agenda, course outline or  syllabus  CEU granting organizations 
syllabus  4.  Confirming letters from  4.  Letters, certificates or other 
4.  Confirming letters from  CEU granting organizations  documents from 
CEU granting organizations  5.  Letters, certificates or other  manufacturers or other 
5.  Letters, certificates or other  documents from  formal training courses 
documents from  manufacturers or other 
manufacturers or other  formal training courses 
formal training courses  6.  Letter from facility where 
6.  Letter from facility where  experience was obtained 
experience was obtained  documenting experience in 
documenting experience in  the new mammographic 
the new mammographic  modality 
modality 
Continuing Experience  N/A  N/A  1.  Letter, table, facility logs or 
(200/24 months-final regs)  other documentation from 
training program or 
mammography facility 
    24  Continuing Education (15  N/A  1.  CEU certificates   1.  CEU certificates  
CME/36 months)  2.  Confirming letters from  2.  Confirming letters from 
CEU granting organizations  CEU granting organizations 
3.  Formal training courses  3.  Formal training courses 
4.  Letters, certificates or other  4.  Letters, certificates or other 
documents from  documents from 
manufacturers or other  manufacturers or other 
formal training courses  formal training courses 
Continuing Mammographic  N/A  1.  Mammography Modality  1.  Mammography Modality 
Modality Specific  Specific CEU certificates   Specific CEU certificates  
Education-final regs  2.  CEU certificates (plus  2.  CEU certificates (plus 
agenda, course outline or  agenda, course outline or 
syllabus  syllabus 
3.  Confirming letters from  3.  Confirming letters from 
CEU granting organizations  CEU granting organizations 
4.  Letters, certificates or other  4.  Letters, certificates or other 
documents from  documents from 
manufacturers or other  manufacturers or other 
formal training courses  formal training courses 
Requalification-Experience N/A  N/A  1.  Letter, table, facility logs or 
final regsdone under direct  other documentation from 
supervision  training program or 
mammography facility 
(done under direct 
supervision) 
Requalification- Education  N/A  1.  CEU certificates   1.  CEU certificates  
2.  Confirming letters from  2.  Confirming letters from 
CEU granting organizations  CEU granting organizations 
3.  Letter or other document  3.  Letter or other document 
confirming in-house or  confirming in-house or 
formal training  formal training 
4.  Letters, certificates or other  4.  Letters, certificates or other 
documents from  documents from 
manufacturers or other  manufacturers or other 
formal training courses  formal training courses 
 
 
 
    25  Attachment 6 
Acceptable Documents For Medical Physicists 
 
Requirement  Obtained Prior to 10/1/94  Obtained 10/1/94-4/28/99  Obtained after 4/28/99 
State Licensure or Approval  1.  State license or approval/copy  1.  State license or approval/copy  1.  State license or approval/copy 
  with expiration date  with expiration date  with expiration date 
2.  Confirming letter from State  2.  Confirming letter from State  2.  Confirming letter from State 
licensing board  licensing board  licensing board 
3.  FDA Approval Letter  3.  FDA Approval Letter  3.  FDA Approval Letter 
Board Certification  1.  Original/copy of certificate  1.  Original/copy of certificate  1.  Original/copy of certificate 
(ABR or ABMP)  2.  Confirming letter from  2.  Confirming letter from  2.  Confirming letter from 
  certifying board  certifying board  certifying board 
3.  Pocket card/copy of certificate  3.  Pocket card/copy of  3.  Pocket card/copy of 
4.  Confirming letter from ACR  certificate  certificate 
5.  FDA Approval Letter  4.  Confirming letter from ACR  4.  Confirming letter from ACR 
5.  FDA Approval Letter  5.  FDA Approval Letter 
Degree in a physical science- 1.  Original/copy of diploma  1.  Original/copy of diploma  1.  Original/copy of diploma 
final regs  2.  Confirming letter from college  2.  Confirming letter from  2.  Confirming letter from 
(Masters pathway)  or university  college or university  college or university 
(Bachelors pathway)  3.  FDA Approval Letter  3.  FDA Approval Letter  3.  FDA Approval Letter 
Initial physics education-final  1.  College or university transcripts  1.  College or university  1.  College or university 
regs  2.  Confirming letter from college  transcripts  transcripts 
  or university  2.  Confirming letter from  2.  Confirming letter from 
(20 semester hours-Master)  3.  Master or Bachelor degree  college or university  college or university 
  specifically in physics  3.  Master or Bachelor degree   3.  Master or Bachelor degree  
(10 semester hours-Bachelor)  4.  FDA Approval Letter  specifically in physics  specifically in physics 
4.  FDA Approval Letter  4.  FDA Approval Letter 
Survey Training-final regs  1.  Attestation  1.  Letter or other document from  1.  Letter or other document 
  2.  Letter or other document from  training program  from training program 
(20 contact hours-Master)  training program  2.  CME/CEU certificates  2.  CME/CEU certificates 
  3.  CME/CEU certificates  3.  Letter or other document  3.  Letter or other document 
(40 contact hours-Bachelor)  4.  Letter or other document  confirming in-house or formal  confirming in-house or 
  confirming in-house or formal  training  formal training 
training  4.  Training gained performing  4.  Training gained performing 
5.  Training gained performing  surveys  surveys 
surveys  5.  FDA Approval Letter  5.  FDA Approval Letter 
6.  FDA Approval Letter     
Initial Experience-final regs  1.  Attestation  1.  Copy or coversheet of survey  1. Copy or coversheet of survey 
  2.  Copy or coversheet of survey  2.  Letter from facility or listing  done under direct supervision 
(1 facility-10 units-Master)  3.  Letter from facility or listing  from company providing the  2. Letter from facility or listing 
  from company providing the  physics survey services  from company providing the 
(1 facility-20 units-Bachelor)  physics survey services  documenting performance of  physics survey services 
documenting performance of  survey done   documenting performance of 
survey done  3.  FDA Approval Letter  survey done under direct 
4.  FDA Approval Letter    supervision 
  3. FDA Approval Letter 
    26  Initial Mammography  1.  Attestation for training or  1.  Attestation for experience  1.  Mammography Modality 
Modality Specific training- experience with investigational  with investigational units  Specific CME/CEU 
8 hours-final regs  units  2.  Mammography Modality  certificates  
  2.  Mammography Modality  Specific CME/CEU  2.  CME/CEU certificates plus 
Specific CME/CEU certificates   certificates   agenda, course outline or 
3.  CME/CEU certificates plus  3.  CME/CEU certificates plus  syllabus 
agenda, course outline or  agenda, course outline or  3.  Confirming letters from 
syllabus  syllabus  CME/CEU granting 
4.  Confirming letters from  4.  Confirming letters from  organizations 
CME/CEU granting  CME/CEU granting  4.  Letters, certificates or other 
organizations  organizations  documents from 
5.  Letters, certificates or other  5.  Letters, certificates or other  manufacturers or other 
documents from manufacturers  documents from  formal training courses 
or other formal training courses  manufacturers or other   
6. Letter from facility where  formal training courses   
experience was obtained   6.  Letter from facility where 
documenting experience in the  experience was obtained 
new mammographic modality  documenting experience in 
the new mammographic 
modality 
Continuing Experience  N/A  N/A  1.  Copy or coversheet of survey 
(2 facilities-6 units/24      2.   Letter from facility or listing 
months-final regs)  from company providing the 
  physics survey services 
documenting performance of 
survey done 
Continuing Education (15  N/A  1.  CME/CEU certificates   1.  CME/CEU certificates  
CME/36 months)  2.  Confirming letters from  2.  Confirming letters from 
  CME/CEU granting  CME/CEU granting 
organizations  organizations 
3.  Letters, certificates or other  3.  Letters, certificates or other 
documents from  documents from 
manufacturers or other  manufacturers or other 
formal training courses  formal training courses 
Continuing Mammographic  N/A  1.  Mammography Modality  1.  Mammography Modality 
Modality Specific  Specific CME/CEU  Specific CME/CEU 
Education-final regs  certificates   certificates  
  2.  CME/CEU certificates (plus  2.  CME/CEU certificates (plus 
agenda, course outline or  agenda, course outline or 
syllabus  syllabus 
3.  Confirming letters from  3.  Confirming letters from 
CME/CEU granting  CME/CEU granting 
organizations  organizations 
4.  Letters, certificates or other  4.  Letters, certificates or other 
documents from  documents from 
manufacturers or other  manufacturers or other 
formal training courses  formal training courses  
Requalification-Experience N/A  N/A  1.  Copy or coversheet of survey 
final regsdone under  done under direct 
direct supervision  supervision 
  2.  Letter from facility or listing 
from company providing the 
physics survey services 
documenting performance of 
survey done under direct 
supervision 
Requalification- Education  N/A  1.  CME/CEU certificates   1.  CME/CEU certificates  
  2.  Confirming letters from  2.  Confirming letters from 
CME/CEU granting  CME/CEU granting 
organizations  organizations 
3.  Letters, certificates or other  3.  Letters, certificates or other 
documents from  documents from 
manufacturers or other  manufacturers or other 
formal training courses  formal training courses 
 
    27