1. 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.
2. 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.
3. 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.
4. Collimation assessment.
5. Exposure reproducibility.
6. Beam quality or half-value layer (HVL) measurement.
7. Dose calculation for a cranio-caudal view of a standard breast.
8. 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.
9. Darkroom fog.
10. Phantom image quality evaluation.

• 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

There are three cases where a unit in use may not need to be accredited:

1. 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);
2. The unit is installed in the facility for evaluation before purchasing (limited to 90 days maximum without accreditation); and
3. The unit is an experimental one, installed and used under an FDA investigative device exemption or other FDA-authorized research protocol.

• 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 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. The annual tests and their regulatory requirements are summarized in Attachment 3. 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.

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.

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.

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.

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.

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.

1. The requirements for those physicists who are qualifying through the "master's degree or higher" route
2. The requirements for those who are qualifying through the "alternative initial requirements" approach covering education, training, and experience
3. The continuing qualification requirements applicable to all physicists

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.

1. 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:

      1. The American Board of Radiology (ABR)
      2. The American Board of Medical Physics (ABMP)

      AND

   2. Education, training, and experience:

      1. 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

      2. Survey Training: Have at least 20 contact hours of mammography facility survey training.

         AND

      3. Initial Experience: Have the experience of conducting surveys of at least 1 mammography facility and at least 10 mammography units.

2. 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:

      1. The American Board of Radiology (ABR)
      2. The American Board of Medical Physics (ABMP)

      AND

   2. Education, training, and experience:

      1. 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

      2. 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

      3. 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.

3. 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: 1. 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 individual’s 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.

      The beginning date for this requirement is October 1, 1994, or the individual’s 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.)

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 maintained, and identify the interpreting physician who originally interpreted the mammograms. For those records 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.

• 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.

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.

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.