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Attestation - Acceptable Uses for Personnel Requirements

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Applicable Citations:

900.12(a)(1)(ii)(B): All interpreting physicians shall maintain their qualifications by meeting the following requirement: Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(1)(i) of this section were completed, the interpreting physician shall have taught or completed at least 15 category I continuing medical 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. The facility will choose one of these dates to determine the 36-month period. This training shall include at least six category I continuing medical education credits in each mammographic modality used by the interpreting physician in his or her practice.

900.12(a)(1)(ii)(C) Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.

900.12(a)(1)(iv)(B): Interpreting physicians who fail to meet the continuing education requirements of paragraph (a)(1)(ii)(B) of this section shall obtain a sufficient number of additional category I continuing medical education credits in mammography to bring their total up to the required 15 credits in the previous 36 months before resuming independent interpretation.

900.12(a)(2)(iii)(A) and (C): Continuing Education Requirements:

(A) Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section were completed, the radiologic technologist shall 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. The facility will choose one of these dates to determine the 36-month period.

(C) At least six of the continuing education units required in paragraph (a)(2)(iii)(A) of this section shall be related to each mammographic modality used by the technologist.

900.12(a)(2)(iii)(D): Requalification. Radiologic technologists who fail to meet the continuing education requirements of paragraph (a)(2)(iii)(A) of this section shall obtain a sufficient number of continuing education units in mammography to bring their total up to at least 15 in the previous 3 years, at least 6 of which shall be related to each modality used by the technologist in mammography. The technologist may not resume performing unsupervised mammography examinations until the continuing education requirements are completed.

900.12(a)(3)(iii)(A): Continuing education. Following the third anniversary date of the end of the calendar quarter in which the requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section were completed, the medical physicist shall 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 inspection or the last day of the calendar quarter preceding the inspection or any date between the two. The facility shall choose one of these dates to determine the 36-month period. This continuing education shall include hours of training appropriate to each mammographic modality evaluated by the medical physicist during his or her surveys or oversight of quality assurance programs. Units earned through teaching a specific course can be counted only once towards the required 15 units in a 36-month period, even if the course is taught multiple times during the 36 months.

900.12(a)(3)(iii)(C) Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours of training in surveying units of the new mammographic modality.

900.12(a)(3)(iv)(A): Medical physicists who fail to maintain the required continuing qualifications of paragraph (a)(3)(iii) of this section may not perform the MQSA surveys without the supervision of a qualified medical physicist. Before independently surveying another facility, medical physicists must reestablish their qualifications as follows: (A) Medical physicists who fail to meet the continuing educational requirements of paragraph (a)(3)(iii)(A) of this section shall obtain a sufficient number of continuing education units to bring their total units up to the required 15 in the previous 3 years.

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Discussion - Attestation - Table of Use:

Requirement Is Attestation Acceptable?
Interpreting Physician  
State License Never
Board Certification (ABR, AOBR, or RCPSC) Never
Formal Training (2 months-interim regs)(3 months-final regs) Never
Initial Medical Education (40 hours-interim regs) Yes, if education completed before 10/1/94
Initial Experience (240)(any 6 month period-interim regs) Yes, if experience completed before 10/1/94
Initial Mammographic Modality Specific Training (8 hours) Yes, for training in the mammographic modality if completed before 10/1/94 or for experience with investigational units (no time period limitation)
Continuing Experience (960/24 months) Never
Continuing Education (15 Cat I/36 months) Limited*
Continuing Mammographic Modality Specific Education (6 Cat I/36 months) Limited*
Requalification-Experience Never
Requalification-Education Limited*
Radiological Technologist  
State Licensure Never
Board Certification (ARRT or ARCRT) Never
Initial Training (~40 hours-interim regs) Yes, if training completed before 10/1/94
Initial Mammography Modality Specific training (8 hours) Yes, for training in the mammographic modality if completed before 10/1/94 or for experience with investigational units (no time period limitation)
Continuing Experience (200/24 months) Never
Continuing Education (15 CME/36 months) Limited*
Continuing Mammographic Modality Specific Education (6 CME/36 months) Limited*
Requalification-Experience Never
Requalification-Education Limited*
Medical Physicists  
State Licensure or Approval Never
Board Certification (ABR or ABMP) Never
Degree in a physical science (Master’s pathway)(Bachelor’s pathway) Never
Initial physics education (20 semester hours-Master)(10 semester hours-Bachelor) Never
Survey Training (20 contact hours-Master)(40 contact hours-Bachelor) Yes, if training completed before 10/1/94

 
Initial Experience (1 facility-10 units-Master)(1 facility-20 units-Bachelor) Yes, if experience completed before 10/1/94
Initial Mammography Modality Specific training (8 hours) Yes, for training in the mammographic modality if completed before 10/1/94 or for experience with investigational units (no time period limitation)
Continuing Experience (2 facilities-6 units/24 months) Never
Continuing Education (15 CME/36 months) Limited*
Continuing Mammographic Modality Specific Education (>1 CME/36 months) Limited*
Requalification-Experience Never
Requalification-Education Limited*
*Limited Attestation Policy

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FDA will continue to accept a limited form of attestation in certain cases where the following conditions exist:

(1) The documentation (certificate) lacks specific reference that the education was in topics directly related to the regulated areas in mammography or the documentation does not specify the specific mammography modality(ies) credit hours included. Education directly related to achieving quality mammography (e.g., anatomy of the breast, positioning, interpretation of mammographic examinations, quality assurance procedures, stereotactic techniques, breast ultrasound, needle localization) is acceptable toward meeting the continuing education requirement. Education in an area not covered by the regulations (e.g., stereotactic techniques, breast ultrasound, needle localization) shall not be accepted toward meeting the requirements for initial training.

(2) It is possible for conference attendees to earn education credits in topics not directly related to the regulated areas in mammography at that education event (e.g., angiography, pediatric radiography, orthopedic radiography) or in which more than one mammographic modality was included.

In order to attest when these conditions apply, the interpreting physician, radiologic technologist, and medical physicist will need to provide:

(1) A letter, certificate or other documentation from the education provider identifying the total number of credits actually earned at the conference, and

(2) Documentation (for example, conference agendas) showing the total number of hours of education offered at the conference which were in topics directly related to the regulated areas in mammography and/or in a specific mammographic modality.

Facility personnel can then attest to the mammography education and/or mammography modality specific credits earned at the education event. However, the education credits attested to may not exceed the total number of credits identified in items 1 or 2 above.

In most cases, the inspector will only look for the certificate and the attestation form. However, the inspector may make spot checks to verify that an agenda or syllabus is present.

Attestation can also be used by facility personnel who had experience working with an FFDM unit(s) when the unit on which they gained that experience was in its investigational stage (prior to receiving FDA approval for commercial use). Such individuals are considered to have met the 8 hour initial mammographic modality training requirement for FFDM units by virtue of this experience. Personnel may either attest or provide documentation of that experience in order to be recognized as having met the 8 hour requirement. Personnel whose experience was with a non-investigational FFDM unit (one that had previously been approved by FDA for commercial use) must document 8 hours of training and cannot use experience to meet this requirement.

FDA’s “Attestation Regarding Requirements of the Mammography Quality Standards Act” form (ATTESTATION FORM), or a form with similar elements or equivalent, shall be used for these purposes.

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Questions:

  1. My initial mammography training document does not specify whether the training was in screen-film or full field digitial. Will I have to go back to my training program to get additional documentation or will I be able to attest to which mammographic modality I was trained in?
  2. I am qualified to interpret screen-film mammograms independently but I also interpreted some FFDM mammograms while under direct supervision. Can I count those FFDM mammograms toward my continuing experience requirement?
  3. I am a physician who wishes to become initially qualified as an interpreting physician. I completed my three months of initial mammography training in screen-film mammography and read 240 mammograms during the last six months of the residency program under my direct supervision but all the examinations were performed on a full field digital mammographic (FFDM) unit. Does this satisfy the regulatory requirement?
  4. I am the physician in question 3. Once I've completed my intia requirements, can I independently read both screen-film and FFDM examinations?

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Page Last Updated: 06/25/2014
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