[Federal Register Volume 61, Number 65 (Wednesday, April 3, 1996)]
[Proposed Rules]
[Pages 14898-14908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7832]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR PART 900
[Docket No. 95N-0215]
RIN 0910-AA24
Quality Standards and Certification Requirements for Mammography
Facilities; Personnel Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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[[Page 14899]]
SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the mammography facility standards by modifying and adding to the
personnel requirements for interpreting physicians, radiologic
technologists, and medical physicists who perform mammography services.
In addition to the statutory framework and the expertise and research
of FDA personnel, the agency is proposing this rule based on advice
provided by the National Mammography Quality Assurance Advisory
Committee (NMQAAC) and public comments received in response to the
interim regulations. This action is being taken to ensure that all
personnel involved in mammography meet at least the minimum
requirements for providing safe, accurate, and reliable mammography.
This is the fourth of five proposed rules being published concurrently.
DATES: Written comments on this proposed rule by July 2, 1996.
Written comments on the information collection requirements should
be submitted by May 3, 1996. The agency is proposing that any final
rule based on this proposed rule become effective 1 year after its date
of publication in the Federal Register.
ADDRESSES: Submit written comments on this proposed rule to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857. The Regulatory Impact
Study (RIS) is available at the Dockets Management Branch for review
between 9 a.m. and 4 p.m., Monday through Friday. Requests for copies
of the RIS should be submitted to the Freedom of Information Staff
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 12A-16,
Rockville, MD 20857.
Submit written comments on the information collection requirements
to the Office of Information and Regulatory Affairs, OMB, New Executive
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn:
Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Charles K. Showalter, Center for
Devices and Radiological Health (HFZ-240), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-594-3332.
SUPPLEMENTARY INFORMATION:
I. Background
This proposal is the fourth of five related proposed rules
published in this issue of the Federal Register to amend interim
regulations published on December 21, 1993 (58 FR 67558 and 58 FR
67565), implementing the Mammography Quality Standards Act of 1992 (the
MQSA). The first proposed rule entitled ``Quality Mammography
Standards; General Preamble and Proposed Alternative Approaches''
contains background information and a summary of the preliminary
analysis of the costs and benefits of all of these proposed rules, a
description of the information collection requirements, proposed
revisions to Sec. 900.1 Scope and Sec. 900.2 Definitions, and proposed
alternative approaches to mammography quality standards and a request
for comments on the proposed alternatives.
II. Provisions of the Proposed Rule
A. Development of the Proposed Regulation
This proposed rule establishes the personnel qualification
standards that the staff of each mammography facility must meet in
order to comply with requirements under the MQSA. As in the development
of the interim regulations, FDA has been guided by the requirements of
this statute and its stated legislative intent to guarantee access to
safe and effective mammography services for all women in the United
States (Ref. 1).
In addition to the statutory framework and the expertise and
research of FDA personnel, the agency relied upon three major sources
of information in developing this proposed rule. The first source was
the written comments received on the interim regulations. FDA received
103 comments from individuals and organizations on the interim
regulations. Included among the written comments were responses from
professional organizations, medical facilities, State agencies,
consumer groups, manufacturers, and individual physicians, medical
physicists, and radiologic technologists.
Drafts of this proposed rule were also discussed with the NMQAAC,
particularly at the February 1994 and January 1995 public meetings with
the agency. The members of the NMQAAC include interpreting physicians,
medical physicists, radiologic technologists, representatives of State
agencies, and consumer representatives. Consultants to the Committee
and guests invited to attend the meetings in recognition of their
expertise in mammography also participated in these discussions. In the
Federal Register of January 26, 1995 (60 FR 5152), the agency published
a notice of availability of the draft of the proposed rule that was
discussed with the NMQAAC.
Finally, the problems with the interim regulation were discussed
with many of the individuals who currently perform annual inspections
of mammography facilities under the MQSA to determine whether minimum
quality standards are being achieved. Most of these inspectors have
extensive prior experience in the inspection of radiology facilities.
After the MQSA inspections began in January 1995, the agency closely
monitored the process and gathered information that was valuable for
developing the proposed final regulations.
B. Interpreting Physicians
The proposed regulation for interpreting physicians generally
clarifies the requirements issued under the interim regulations and
adds some new requirements. Although neither a national standard nor a
continuing competency test for mammography interpretation currently
exists, the proposed training and experience requirements for
interpreting physicians will provide minimum standards to help ensure
the reliability and accuracy of interpretation of mammograms for women
throughout the country.
As discussed below, the quality standards proposed by FDA for
interpreting physicians are divided into four general sections: Initial
qualifications; continuing experience and education; exceptions; and
reestablishing qualifications.
1. General Comments
Two comments expressed concern that providers in rural areas would
have difficulty meeting the requirements of the interim regulations.
They suggested that allowance should be made for such facilities,
either through lowering the standards for rural facilities or
establishing a longer phase-in period. One of these comments also
stated that it would be helpful if the Department of Health and Human
Services monitored the effect of the rules on rural providers.
Both FDA and NMQAAC are concerned about the impact of the MQSA on
access to mammography in rural areas. However, both the agency and
NMQAAC believe that the standards should not be lower for certain
facilities. One of the primary goals of the MQSA is to ensure that all
women receive at least the same minimum standard of care, no matter
which facility they use. However, one of the specific duties that the
MQSA requires of NMQAAC is to determine whether there exists a shortage
of mammography facilities or health professionals in any areas and to
determine the effects of the quality standards on access to mammography
[[Page 14900]]
services in such areas. This study already has begun and the results
will be published upon completion.
2. Initial Qualifications
The first qualification for an interpreting physician under the
MQSA is a State license to practice medicine (proposed
Sec. 900.12(a)(1)(i)(A)).
One comment stated that Sec. 900.12(a)(1)(i)(A) in the interim
regulations was confusing and would appear to allow a facility to
license a physician. Similarly, another comment stated that the
licensing requirements of physicians practicing in Federal facilities
are unclear.
In response, FDA notes that a facility cannot license a physician
to practice medicine. Licensing of physicians is a State function.
Proposed Sec. 900.12(a)(1)(i) simply requires the interpreting
physician to have a State license to practice medicine. However, if the
State in which the mammography facility is located is different from
the State that issued the license, a physician may have to meet
additional State requirements in order to practice medicine lawfully at
that facility. With respect to physicians practicing in Federal
facilities, a valid State license from any State is sufficient.
However, the Federal employee would be unable to practice outside the
Federal facility unless the physician also fulfilled the requirements
of that State for the practice of medicine.
Proposed Sec. 900.12(a)(1)(i)(B) provides two pathways to establish
the second initial qualification: Board certification or documented
training in interpreting mammograms. The training shall include
radiation physics (including radiation physics specific to
mammography), radiation effects, and radiation protection.
One comment recommended that FDA accept both American and Canadian
boards as certifying bodies.
FDA does accept certification from both American and Canadian
boards. Currently, FDA recognizes certification in Diagnostic Radiology
and Radiology by the American Board of Radiology (ABR), the American
Osteopathic Board of Radiology (AOBR), and the Royal College of
Physicians and Surgeons of Canada.
Another comment asked that two British radiology boards be added to
the list of bodies designated by FDA as eligible to certify
interpreting physicians: Fellow of the Royal College of Radiologists
(FRCR) and, Diploma in Medical Radiodiagnosis (DMRD) from the Royal
College of Physicians and Surgeons of England.
NMQAAC discussed but did not recommend including other bodies to
certify interpreting physicians at this time because there was
insufficient information about the procedures and requirements for
obtaining board certification from other bodies. FDA has not added
additional bodies to its list of certifying bodies because FDA agrees
that it has insufficient information at this time.
One comment stated that certifying bodies for interpreting
physicians should be listed in the regulations. Another comment noted
that the interim regulations do not indicate the particular bodies that
have or will be designated by FDA as eligible to certify interpreting
physicians and noted that approval of inappropriate certifying bodies
could result in poorly qualified physicians reading and interpreting
mammograms. The comment suggested that guidelines are needed regarding
the certification of interpreting physicians.
FDA believes that it is best not to codify the list of eligible
certifying bodies in the regulation in order to be able to make changes
to the list of certifying bodies in a timely manner each time a body
must be added to or deleted from the list. FDA will add or delete names
based upon the agency's determination that the body has in place and
implements procedures and requirements that are adequate to ensure that
interpreting physicians certified by the body are capable of satisfying
the MQSA needs. Whenever possible, FDA intends to consult with the
NMQAAC before making a determination about adding or removing a body
from the list of those eligible to certify physicians. The list of
currently eligible certifying boards is based upon FDA evaluation and
consultation with NMQAAC, as described above. FDA will follow a similar
policy with respect to its determination of eligibility for boards or
organizations that certify radiologic technologists and medical
physicists.
One comment noted that his State's requirements for interpreting
physicians are more stringent than the interim requirements and
suggested that FDA may want to include the following language in the
regulation (sic): ``require A.B.R. or A.O.B.R. certification or has
successfully completed and graduated from an accredited radiology
residency within the past 24 months.'' Another comment stated that FDA
should give careful consideration before approving either the ABR or
the AOBR to certify interpreting physicians. The comment further
explained that if the ABR or AOBR certifies physicians based on ``board
certification,'' many physicians who are not adequately trained in
mammography automatically would be allowed to interpret mammograms.
FDA recognizes that some earlier board examinations may not have
included testing in mammography. FDA also recognizes that board
certification that includes mammography cannot by itself ensure the
accuracy of outcomes in clinical mammography practices. However, board
certification is evidence that the physician is knowledgeable in the
basics of diagnostic radiology and board certification serves as a
foundation for the additional requirements specific to mammography that
interpreting physicians must meet under FDA's interim and proposed
regulations.
Alternatively, proposed Sec. 900.12(a)(1)(i)(B) would permit 3
months of documented formal training in mammography, including the
interpretation of mammograms and other topics related to mammography,
in place of board certification in diagnostic radiology. The other
topics related to mammography include, but are not limited to:
Radiation physics, including radiation physics specific to mammography;
radiation effects; and radiation protection. The interim regulations
require 2 months of documented full-time training. The agency is
proposing an additional month of required training to reflect the
increased emphasis that has been placed on mammography in residency
programs.
During discussions at an NMQAAC meeting, it was recommended that
FDA require training in radiation physics specific to mammography
instead of training in general radiation physics as the training
required by the alternative pathway in proposed
Sec. 900.12(a)(1)(i)(B). FDA agrees that mammography specific training
is necessary, but also believes that general training in radiation
physics is important for basic principles and should be retained as
part of the requirements for the alternative pathway provided by
proposed Sec. 900.12(a)(1)(i)(B). NMQAAC also suggested that all
required training in physics be obtained from a physicist. However, the
agency believes that this suggestion is too restrictive and would limit
the availability of adequate training opportunities.
The agency is proposing that the training in interpretation
required for the alternative pathway be performed under the direct
supervision of an interpreting physician who meets the MQSA
requirements for an interpreting physician. It was recommended during
NMQAAC discussions that there be additional qualifications for the
[[Page 14901]]
supervising physician beyond those required of an interpreting
physician. For example, FDA could require supervising physicians to be
qualified to offer continuing medical education (CME) credits. Again,
the agency believes that this suggestion would be too restrictive and
reduce the availability of effective training opportunities.
One comment suggested having an alternative method for allowing a
physician who is not a radiologist but who is experienced in
interpreting film mammography to be certified and allowed to continue
to interpret mammograms.
The agency agrees and has proposed Sec. 900.12(a)(1)(i)(B) in order
to provide an alternative to board certification for radiologists and
physicians who are not radiologists, but who otherwise qualify.
One comment stated that the alternate pathway to board
certification in the interim regulations, requiring 2 months of
training in the interpretation of mammograms, is not adequate. The
comment stated that some type of board certification is necessary to
ensure that women are receiving high quality interpretation of
mammograms. Another comment advocated the addition of a proficiency
examination, which would require a physician to demonstrate his or her
ability to interpret mammograms, both at the point of the physician's
initial certification and at periodic intervals to maintain that
certification. The latter comment noted that academic achievement,
although important, is not sufficient to ensure high quality
mammography.
The NMQAAC discussed the possibility of requiring that interpreting
physicians undergo proficiency testing in mammography, but did not
recommend such testing at this time. To date, sufficient data have not
been compiled on existing levels of interpretive skills for
interpreting physicians to determine whether there is a general need
for proficiency testing. With respect to the adequacy of the training
required under the alternate pathway, FDA is proposing to increase that
requirement from 2 to 3 months of documented training in the
interpretation of mammograms.
Proposed Sec. 900.12(a)(1)(i)(C) requires 60 hours of documented
continuing medical education credits in mammography for all
interpreting physicians, including instruction in the interpretation of
mammograms and training appropriate to each mammographic modality used
in the interpreting physician's practice. At least 40 of these hours
must be Category I CME credits and, to ensure that the physician has
recent mammography education, at least 15 of these 40 Category I CME
hours must have been acquired within the 3 years immediately preceding
qualifying as an interpreting physician. Hours spent in residency
specifically devoted to mammography will be considered as equivalent to
Category I CME and will be accepted if documented in writing by the
appropriate representative of the training institution.
One comment stated that the interim regulations, which require 40
hours of documented CME in mammography, are quite adequate to ensure
that interpreting physicians have the training, expertise, and
experience necessary to do mammographic interpretations.
The agency believes that an increase to 60 hours is in keeping with
current training trends and the emergence of new technologies.
Proposed Sec. 900.12(a)(1)(i)(C) requires training in each
mammographic modality employed in the interpreting physician's
practice. FDA added this requirement because of the differences among
imaging modalities (e.g., film screen and xeromammography) currently in
use and emerging technologies, such as digital mammography. The agency
believes that, before a physician begins to interpret images produced
by a particular modality, he or she should have specific training in
the interpretation of such images. FDA is proposing that at least 8
hours of Category I CME credit be related to each mammographic modality
used by the interpreting physician.
FDA has also proposed, with the concurrence of NMQAAC, that the
interpreting physician must have education in each of the following:
basic breast anatomy; breast pathology and physiology; technical
aspects of mammography (e.g., exposure factors, compression,
positioning); quality assurance and quality control in mammography.
One comment questioned whether ABR certified physicians are
required to document 40 hours of initial education under the interim
regulations.
The interim regulations require this documentation from physicians
using either of the two pathways and proposed Sec. 900.12(a)(1)(i)(C)
would continue this requirement for the 60 hours of required initial
training.
Two comments asked what FDA will consider to be adequate
documentation of the radiologist's training.
A variety of documentation has and will be accepted (e.g., copy(s)
of the license(s) to practice medicine, copy(s) of the certificate
issued by certifying board(s), CME credit certificates). The agency
previously issued guidance on adequate documentation under the interim
regulations that will be revised, as needed, and made available when
the final regulations are published. Such guidance does not bind the
agency or the facility and facilities may choose to accept
documentation that is not discussed in FDA guidance. However, FDA
encourages facilities that plan to accept alternate documentation to
discuss the matter in advance with FDA in order to avoid potential loss
of time and resources. Upon inspection of the facility, in any
situation in which documentation appears inadequate, the burden will be
upon the employee and the facility to provide additional evidence to
demonstrate the qualifications of personnel employed by the facility.
One comment suggested that time spent in a residency program
devoted to mammography should be documented by the residency program.
FDA agrees and is proposing that the resident's training be
documented in writing by the appropriate representative of the training
institution.
Proposed Sec. 900.12(a)(1)(i)(D) requires the qualifying physician
to interpret at least 240 mammographic examinations under the direct
supervision of a qualified interpreting physician within the 6 months
immediately prior to fulfilling the initial qualifications as an
interpreting physician. The intent of this requirement is to
demonstrate recent supervised experience before the physician begins to
interpret mammograms independently. Proposed Sec. 900.12(a)(1)(iii)(B)
provides an exception from this prior 6-month timeframe for diagnostic
radiology residents who become board certified at the first allowable
time, as defined by the eligible certifying body of their choice. Such
residents must still interpret at least 240 mammographic examinations
in the last 2 years of residency under the direct supervision of a
qualified interpreting physician.
One comment expressed concern that the volume of films that must be
read to achieve and maintain certification may have an unintended,
negative impact on a physician working on a locum tenens basis, that
is, a physician serving as a temporary replacement for another
physician.
In response, FDA notes that proposed Sec. 900.12(a)(1)(i)(D) is an
initial requirement that need only be met once if the interpreting
physician maintains his or her continuing experience requirements under
proposed Sec. 900.12(a)(1)(ii).
[[Page 14902]]
3. Continuing Qualifications
Proposed Sec. 900.12(a)(1)(ii)(A) is the first of the requirements
established to ensure that interpreting physicians maintain their
qualifications. Under this requirement, in order to continue to qualify
under the MQSA, interpreting physicians must have read an average of at
least 40 mammographic examinations a month during the previous 24
months. Although the wording has changed somewhat from the interim
rule, the proposed regulation is not substantially different from the
interim requirement.
There were numerous comments on this requirement in the interim
regulations. Comments expressed concern about the difficulty in meeting
this requirement in rural areas due to lack of volume at the facility.
One comment expressed concern that the requirement may have a negative
impact on physicians serving as temporary replacements for other
physicians (i.e., on a locum tenens basis). Two comments suggested
allowing the substitution of continuing education for this experience
requirement, and one of these comments suggested that the physician be
allowed to submit interpretations on a specified number of test
mammograms in lieu of the 40 per month average and that the
requirements could also be modified slightly to focus on the number of
mammograms read per year, instead of per month. Another comment
requested that rural x-ray departments be exempted from this
requirement.
As previously stated, FDA believes that all women, including those
in rural areas, are entitled to the same quality of care, and the
agency cannot support lower standards for particular facilities. The
agency also believes, as discussed below, that it will not be difficult
for most physicians to meet this continuing qualification, even for
those in rural areas.
The monthly average is to be maintained over a 24-month period. FDA
selected 24 months to allow interpreting physicians a reasonable chance
to maintain the required average. Physicians who are absent for a
period of time, due to sabbaticals or other reasons, or who only read
mammographic images during selected periods, because of their facility
rotation schedule or employment on a locum tenens basis, will have the
opportunity to read enough images during some portions of the 24-month
period to maintain the required average. The agency also wants to
clarify that this is a physician requirement, not a facility
requirement. Interpreting physicians who provide services to low
workload facilities can read films at more than one facility to attain
the required average. Double reading of images (2 or more physicians
interpreting the same mammogram) is also accepted as a way of meeting
this requirement. However, the agency excludes from its definition of
double reading the interpretation of the same mammogram more than once
by a same physician. For all of these reasons, the agency believes
there will not be widespread difficulty in meeting this requirement.
One comment suggested that the agency develop something besides an
artificial number to tell whether or not a radiologist is able to do a
good job.
FDA recognizes that numbers alone cannot guarantee competency, but
believes that the experience a radiologist accumulates through
interpreting a certain minimum number of films is a necessary aspect of
the qualification process. Elsewhere in this issue of the Federal
Register, FDA is proposing requirements for the establishment and
implementation of a medical outcomes' audit for individual physicians.
This type of monitoring can further improve the reliability, clarity,
and accuracy of interpretation of mammograms.
One comment suggested that FDA establish a maximum number of images
that the interpreting physician would be allowed to read in a given
period of time.
FDA does not believe there is any evidence to support a need to
establish such a limit.
Proposed Sec. 900.12(a)(1)(ii)(B) requires interpreting physicians
to further maintain their skills by teaching or completing at least 15
Category I CME credits in mammography in the previous 3 years. Category
I CME credits are generally those that offer more formal training and
provide a solid basis for the ongoing maintenance and growth of the
interpretive skills of the physician.
The interim regulations require interpreting physicians to
participate in education programs, either by teaching or completing an
average of at least five CME credits in mammography per year. There
were numerous comments on this requirement in the interim regulations,
most of which focused on the lack of a specified average period. Some
comments suggested that it should be 15 hours over a 3-year period.
Proposed Sec. 900.12(a)(1)(ii)(B) addresses these concerns by
establishing a 3-year period of time for determining the yearly
average. FDA has proposed that the credits be in category I CME in
order to ensure that continuing education is more formal and
contributes to the development of the physician. The section also
requires that at least 6 of the CME hours be in each mammographic
modality used in the interpreting physician's practice. Therefore, the
CME hours required for an interpreting physician who practices in a
facility that employs more than 2 modalities will be in excess of the
minimum requirement of 15 hours of category I CME.
Proposed Sec. 900.12(a)(1)(ii)(C) requires that, before using a
new mammographic modality in his or her practice, the interpreting
physician must have at least 8 hours of training with that modality.
This education requirement is a logical parallel to the requirement in
proposed Sec. 900.12(a)(1)(i)(C) that the physician must have at least
8 hours of training in each modality used in his or her practice when
the initial qualifications are first met.
4. Exceptions
Proposed Sec. 900.12(a)(1)(iii) would allow exceptions to some of
these requirements in certain specific cases. In order to ensure
continuing and uninterrupted availability of mammography services, FDA
is proposing to permit those interpreting physicians who have qualified
under the interim regulations to continue to interpret mammograms,
provided that they maintain the continuing experience and education
requirements in proposed Sec. 900.12(a)(1)(ii)(A) through
(a)(1)(ii)(C). Proposed Sec. 900.12(a)(1)(iii)(A) would exempt these
physicians from the new and additional initial requirements proposed in
Sec. 900.12(a)(1)(i). The additional month of training in proposed
Sec. 900.12(a)(1)(i)(B) for physicians using the alternative pathway,
the additional 20 hours of CME in proposed Sec. 900.12(a)(1)(i)(C), the
8 Category I CME credits in new modalities in proposed
Sec. 900.12(a)(1)(i)(C), and the requirement that 15 Category I CME
credits must have been acquired in the 3 years immediately before
qualifying as an interpreting physician in proposed
Sec. 900.12(a)(1)(i)(C).
Proposed Sec. 900.12(a)(1)(iii)(B) allows another exception in
response to NMQAAC's concern that the initial experience requirement in
proposed Sec. 900.12(a)(1)(i)(D) may pose a problem in some diagnostic
residency programs that schedule mammography rotations in the first 6
months of the last year. This exception permits a resident to satisfy
the requirement of proposed Sec. 900.12(a)(1)(i)(D) by having
interpreted at least 240 mammographic examinations under the direct
supervision of a qualified interpreting
[[Page 14903]]
physician during the last 2 years of the residency. FDA has included
this exception only for the diagnostic radiology resident who
successfully becomes board certified at the earliest opportunity
provided by an eligible certifying board (``first allowable time'').
For the physician who qualifies for the exception under proposed
Sec. 900.12(a)(1)(iii)(B), the continuing education and experience
requirements of proposed Sec. 900.12(a)(1)(ii)(A) through (a)(1)(ii)(C)
would begin from the date of that physician's board certification in
diagnostic radiology, provided the other initial requirements are
satisfied. If the physician does not become board certified at the
first allowable time by the certifying board, then this physician must
interpret 240 mammographic examinations under the direct supervision of
a qualified interpreting physician within a period of 6 months
immediately prior to initial qualification as an interpreting
physician. The ``first allowable time'' means the earliest time a
physician is eligible to take the diagnostic radiology boards of an
eligible certifying body. Because the ``first allowable time'' a
resident becomes eligible to take the boards may vary with the
certifying body, that term is not defined further in the regulations.
If the physician wishes to use this exemption, it is the physician's
responsibility to ascertain the requirements of the body by which he or
she wishes to become certified and to seek that certification as soon
as he or she becomes eligible to do so.
5. Reestablishment of Qualifications
Proposed Sec. 900.12(a)(1)(iv) provides a method for physicians to
reestablish their qualifications as interpreting physicians in the
event they do not maintain the continuing experience or education
requirements. Proposed Sec. 900.12(a)(1)(iv)(A) requires the physician
who fails to meet the continuing experience requirements to interpret
at least 240 mammographic examinations under the direct supervision of
a qualified interpreting physician within a period of 6 months
immediately before reestablishing qualifications and resuming
independent interpretation.
Proposed Sec. 900.12(a)(1)(iv)(B) requires physicians who do not
maintain the continuing education requirements to obtain a sufficient
number of Category I CME credits in mammography to bring their total up
to the required 15 credits in the previous 3 years. A physician who
fails to maintain continuing experience or education requirements may
not serve as an interpreting physician until he or she reestablishes
those qualifications.
C. Radiologic Technologists
FDA's interim regulations for radiologic technologists performing
mammography sought to ensure that: (1) The technologists possessed
adequate general qualifications for performing radiologic examinations;
(2) the technologists possessed adequate specific qualifications for
performing mammography examinations; and (3) the technologists
maintained these qualifications over time. The proposed regulations are
intended to achieve the same goals. They are primarily clarifications
of the interim regulations with some added requirements to address
concerns that developed as the interim regulations were implemented.
The first clarification is in response to a number of comments
received by FDA asking whether all of the radiologic technologists who
perform mammography at the facility had to meet the requirements or if
it would be sufficient if only some of them did. These questions may
have been generated from experience with a previous voluntary system
for accreditation.
All radiologic technologists who perform mammography must meet the
requirements. The plain language of the statute clearly states that
personnel who perform mammography must meet the minimum training and
experience requirements and either be licensed by a State or certified
to perform radiological procedures by an organization designated by the
Secretary of HHS (42 U.S.C. 263b(f)(1)(C)). The statute does not
provide, nor does the legislative history indicate, that Congress
intended any of the individuals who perform mammography to be exempt
from minimum quality standards. Exempting some radiologic technologists
from compliance with the personnel standards required under the act
would increase, not diminish, the possibility that an incipient cancer
might be misdiagnosed because of a poorly produced mammogram. FDA has
revised Sec. 900.12(a)(2) to read ``All mammographic examinations shall
be performed by radiologic technologists who meet the following general
requirements, mammography requirements, and continuing education and
experience requirements.'' Similar revisions were included in other
paragraphs of Sec. 900.12(a) to clarify the requirement that all
physicians and medical physicists must also meet the personnel
qualifications specific to their areas of practice.
Several comments expressed concern that the interim regulations
would allow technologists with ``partial'' or ``special'' licenses to
perform mammography. States that issue such licenses usually limit
their holders to the performance of certain narrow types of
examinations (e.g., extremities or dental x-rays) or particular medical
practices (e.g., podiatry).
The intent of the licensure requirement under the MQSA is to ensure
that the radiologic technologist has a broad background in radiologic
technology as a basis for his or her specific work in mammography. FDA
does not believe that partial or special licenses demonstrate this
necessary background. The provisions set forth in proposed
Sec. 900.12(a)(2)(i)(A) require the State license to be a general
license to perform radiologic procedures. As an alternative to
obtaining such a State license, proposed Sec. 900.12(a)(2)(i)(B) would
recognize a general certification by one of the bodies designated by
FDA to certify radiologic technologists as adequate evidence that a
technologist satisfies the general radiologic technology requirements.
The license required by proposed Sec. 900.12(a)(2)(i)(A) must be a
State license but need not be from the State in which the technologist
currently practices, as some States do not have a licensing
requirement. For States that do have their own licensing requirements,
the technologists practicing in these States are responsible for
meeting those licensing requirements as well as the requirements under
the MQSA.
One comment suggested that FDA amend the language of the interim
regulations at Sec. 900.12(a)(2)(i)(B) to indicate that certification
by an eligible body is an alternative that is available only when the
State in which the radiologic technologist is practicing has no
licensure procedures or requirements.
Proposed Sec. 900.12(a)(2)(i) requires the technologist to become
licensed or certified to perform general radiological procedures. The
license may be obtained from a State under Sec. 900.12(a)(2)(i)(A) or
the certificate can be obtained from an eligible certification body
under Sec. 900.12(a)(2)(i)(B). If the technologist is certified by an
eligible certifying body and practices in a State that has its own
licensing requirement, the technologist must still become licensed
under State law, unless otherwise exempted by the State.
Although such individuals would be in compliance with Federal
requirements under the MQSA, a technologist that is not licensed in
accordance with the requirements of the
[[Page 14904]]
State in which he or she practices will be in violation of the State
law.
Several comments on the interim regulations stated that FDA should
clarify the initial requirements that a radiological technologist must
satisfy to demonstrate specific mammography training.
After seeking and obtaining the advice of the NMQAAC, the agency
has proposed more specific requirements for this training in
Sec. 900.12(a)(2)(ii). Under the proposed regulation, training specific
to mammography includes the performance of a minimum of 50 examinations
under the direct instruction of a qualified individual. After the
effective date of these regulations, only individuals meeting the
requirements of Sec. 900.12(a)(2) for radiologic technologists will be
considered qualified to provide this supervision.
The NMQAAC has discussed the option of recognizing the American
Registry of Radiologic Technologists' (ARRT) special certification in
mammography as fulfilling, at least in part, the training requirement
under Sec. 900.12(a)(2)(ii). At its February 1994 meeting, the NMQAAC
advised against reducing the training required based on the ARRT
special certification. However, at its subsequent meeting in May 1994,
members reconsidered this possibility and discussed how much credit
might reasonably be allocated for an ARRT special certification and for
which aspects of the training requirements. Suggestions were made by
some NMQAAC committee members that this special certificate be accepted
in lieu of 20 of the required 40 contact hours, but that the
certificate not be a substitute for any part of the required
performance of 50 examinations under the direct supervision of a
qualified radiologic technologist.
After further consideration, FDA has decided not to propose
recognition of the special certificate as a partial fulfillment of the
training requirement. FDA does not want to incorporate into its
regulations a training requirement that specifically relies on a
particular certification program by a private group. If, in the
agency's view, subsequent changes in the certification program
diminished the certificate's value in assuring properly trained
radiologic technologists, the agency might, nevertheless, be bound to
continue to accept the certificate until the regulations could be
amended through notice and comment rulemaking to remove the recognition
of the certificate as a substitute for training. On the other hand, the
agency believes that the training that is required to earn the
certificate can fulfill part of the proposed training requirements,
even if the program is not mentioned explicitly in the regulations. In
fact, when evaluating technologists' training under the interim
regulations, the agency has recognized the value of training hours
required for AART special certification as well as training hours
required by other programs. The agency intends to continue to do so, as
long as it believes such recognition is warranted. Agency guidance on
this subject is available for review. As mentioned earlier, guidance
represents the agency's best thinking at the current time and does not
bind either the facility or FDA.
The NMQAAC did recommend that there be a requirement that all
technologists have the equivalent of at least five continuing education
units (CEU) of initial training in imaging examinees with breast
implants. NMQAAC recognized that many technologists rarely conduct
examinations of individuals with breast implants. However, the
committee recommended that this training be required of all
technologists so that all examinees with breast implants can use any
certified facility with assurance that there will be technologists
trained to perform these examinations.
FDA agrees and has included this requirement in proposed
Sec. 900.12(a)(2)(ii)(C).
The interim regulations permit a technologist to have all of his or
her training in mammography, both initial and continuing, related to
one modality (e.g., film screen, xerography), even if the radiologic
technologist uses other modalities to perform mammography. However, the
agency and the NMQAAC believe that education and training should be
required for each modality performed by the technologist. Proposed
Sec. 900.12(a)(2)(ii)(B) and (a)(2)(iii)(B) would correct this
shortcoming in the interim regulations by requiring both the initial
training and the continuing education requirements to include training
in each modality used by the technologist.
Several comments on the interim regulations objected to the use of
an undefined overall averaging period for the requirement that the
radiologic technologist earn at least five CEU's per year in
mammography.
Although the use of an undefined time period has provided a
flexibility that is advantageous under the interim regulations, FDA
agrees that more specific requirements are desirable. Therefore,
proposed Sec. 900.12(a)(2)(iii) requires that, on any given date, each
technologist must have earned at least 15 CEU's in mammography in the 3
years immediately preceding that date. To be fair to technologists who
have just completed their initial training in mammography, proposed
Sec. 900.12(a)(2)(iii) would not apply this requirement immediately.
Technologists will have up to 3 years after completing their initial
training to earn at least 15 CEU's related to mammography. After the
end of the initial 3-year period, all technologists would have to be
able to demonstrate, on any subsequent date, that they had earned at
least 15 CEU's in mammography in the 3 previous years.
Proposed Sec. 900.12(a)(2)(iii)(C) describes the actions that must
be taken by technologists who fail to meet the continuing education
requirement in order to reestablish their qualifications. Until these
actions are taken, such technologists cannot perform mammographic
examinations without supervision.
In recognition of the fact that unused skills may deteriorate,
proposed Sec. 900.12(a)(2)(iv) establishes a continuing experience
requirement corresponding to the continuing experience requirement for
interpreting physicians found in both the interim and proposed
regulations. This requirement is based upon the advice of NMQAAC that
performance of 100 or more mammography examinations a year represents a
reasonable level of experience. Proposed Sec. 900.12(a)(2)(iv)(B)
permits radiologic technologists who fail to meet this continuing
requirement to reestablish their qualification through performance of
50 examinations (a number suggested by NMQAAC) under the direct
supervision of a qualified radiologic technologist before resuming
independent performance of mammography examinations.
One comment on the interim regulations questioned the use of
October 1, 1996, for changing certain requirements for radiologic
technologists while a date of October 27, 1997, was used for similar
changes for medical physicists. The comment suggested that the dates
should be the same.
FDA notes that the MQSA established these dates and FDA cannot
modify them. It is likely that the differences in these provisions is
the result of congressional concern about the availability of medical
physicists.
Another comment suggested that a training and experience
alternative to the licensure or certification requirement be made
available to radiologic technologists similar to the alternative
available to medical physicists.
[[Page 14905]]
FDA disagrees, Congress specified the alternative route for medical
physicists in the statute. The MQSA did not provide a similar
alternative for technologists.
D. Medical Physicists
Proposed requirements for medical physicists are set forth in
Sec. 900.12(a)(3). FDA recognizes that the medical physicist plays a
pivotal role in assuring the overall quality of mammography and,
therefore, seeks to emphasize, in the proposed regulations, the need
for uniform national minimum requirements for medical physicists
working in mammography facilities.
In developing the proposed qualifications for medical physicists,
the agency has considered: (1) The requisite amount of prior knowledge
and experience to evaluate mammography equipment; (2) the level of
performance of individuals currently providing mammography physics
support; (3) the concern over the supply of qualified medical
physicists; and (4) the recommendations from members of the NMQAAC and
comments from the Conference of Radiation Control Program Director's
Task Force on Medical Physics Criteria. The issue of qualifications for
medical physicists was discussed extensively at several NMQAAC
meetings. Earlier draft regulations on this subject were shared with
the NMQAAC and made available to the public.
The MQSA provides two alternative pathways for medical physicists
to demonstrate minimum qualifications after October 27, 1997. These
alternative pathways, set forth in the statute and codified in proposed
Sec. 900.12(a)(3)(i)(A), are: (1) State licensure or approval or (2)
certification by a board approved by FDA. However, the NMQAAC expressed
concern during the February 1994 meeting that not all States have
adequate minimum qualification standards. Concern has also been
expressed that some board certified physicists do not have adequate
experience with mammography equipment. Therefore, FDA proposes to add
additional requirements for all physicists, regardless of which initial
route they follow to become qualified under the MQSA. After October 27,
1997, or the effective date of the regulation, whichever is later, only
those medical physicists who meet the initial additional education and
experience requirements proposed in Sec. 900.12(a)(3)(i)(B) or
(a)(3)(ii)(B) will be qualified to perform surveys under the MQSA.
FDA believes that ongoing developments in imaging technology,
including the development of new technologies, such as digital
mammography, will require medical physicists to have increased
understanding of science and technology in order to apply these
scientific advances to the practice of mammography. Proposed
Sec. 900.12(a)(3)(i)(B) addresses this need by requiring medical
physicists who enter the field after October 27, 1997, to hold at least
a master's degree in a physical science, including a minimum of 20
semester credit hours or equivalent of college level physics, to have
specialized training in conducting mammography surveys, and to have
actual experience conducting surveys of at least 5 mammography
facilities and a total of at least 10 mammography units. The experience
in conducting surveys must be acquired under the direct supervision of
a medical physicist who has fulfilled all of the requirements of
Sec. 900.12(a)(3)(i) and (a)(3)(iii). This requirement is intended to
ensure that medical physicists who serve as supervisors will have an
adequate educational background to train new physicists in new imaging
technologies.
The advisory committee recommended that FDA require the 20 semester
credit hours of physics be specific to imaging physics.
FDA agrees that courses in imaging physics would be desirable.
However, the agency does not have enough information about the number
of imaging physics courses offered in different curricula to be certain
that these courses would be available nationwide. Therefore, the agency
has not proposed limiting the physics credit hours to imaging physics
at this time. The agency is soliciting public comment on this issue.
Although FDA believes that future changes in technology will
require an enhancement of the educational qualifications of medical
physicists, the agency also recognizes that currently there are a
number of medical physicists with bachelor's degrees and substantial
experience who are performing medical physics surveys of mammography
facilities with care and competence. These physicists provide valuable
physics support to facilities. The agency believes that it would be
unjust to these physicists and potentially detrimental to the
facilities that they serve to bar them from continuing to provide this
physics support to mammography facilities in the absence of any
evidence to show that the services that they currently offer are
inadequate. Accordingly, proposed Sec. 900.12(a)(3)(ii) provides an
opportunity for those individuals who are lawfully practicing medical
physics under the interim regulations (21 CFR 900.12(a)(3)) to continue
their practice after October 27, 1997.
Proposed Sec. 900.12(a)(3)(ii) has been modified from the draft
proposal discussed at the January 1995 meeting with the NMQAAC. During
this meeting, the NMQAAC recommended that the opportunity to continue
services as a mammography physicist because of prior experience should
be open only to physicists with bachelor's degrees and 5 years of
experience in conducting surveys of mammography facilities by October
27, 1997.
However, upon further consideration, FDA believes that the
fundamental requirement of this alternative pathway is the quality and
depth of the survey experience itself, and not the number of years it
has taken the individual to acquire that experience. Therefore,
proposed Sec. 900.12(a)(3)(ii) requires those physicists who intend to
qualify because of prior experience to have performed surveys of at
least 10 facilities and a total of at least 20 units by October 27,
1997, or the effective date of these regulations, whichever date is
later. This change has been made in order to give all medical
physicists who are currently eligible to practice under the interim
rules a reasonable opportunity to acquire the requisite experience
before this alternative pathway closes.
Proposed Sec. 900.12(a)(3)(ii) further requires that the bachelor's
degree and specific training requirements be completed before any
physics survey or unit evaluations may be counted toward satisfying the
experience requirement under this provision. During a presentation at
the January 1995 NMQAAC meeting, a representative of the medical
physics community, speaking on behalf of the professional medical
physicists who are members of the American College of Radiology, the
American College of Medical Physics, and the North American Association
of Physicists in Medicine, expressed the view that any mammography
medical physics experience obtained prior to obtaining a basic
understanding of fundamental principles through education is of little
value. The NMQAAC also strongly recommended that the degree requirement
must be a prerequisite to the experience requirement. The agency's
proposal, therefore, establishes that the initial education and
training qualifications must be met before any experience can be
considered for purposes of satisfying the initial experience
qualifications. The
[[Page 14906]]
agency is soliciting public comment on this requirement.
Under proposed Sec. 900.12(a)(3)(iii), medical physicists will be
required to maintain their education and experience qualifications, as
are radiologic technologists and interpreting physicians.
Proposed Sec. 900.12(3)(iv) establishes the requirements that
medical physicists who fail to maintain their qualifications must meet
to reestablish their eligibility to perform mammography facility
surveys.
At its February 1994 meeting, the NMQAAC members raised the concern
that medical physicists who meet the qualifications requirement may
nevertheless delegate the onsite survey work to less qualified
personnel.
FDA shares this concern and, therefore, is proposing in
Sec. 900.12(e)(9), published elsewhere in this issue of the Federal
Register, that the medical physicist who signs the facility survey
report must be present at the facility during the survey and must meet
the requirements of proposed Sec. 900.12(a)(3).
Physicists in training may perform surveys in order to meet the
experience requirement described in these standards, but they must do
so under the direct supervision of a qualified medical physicist.
``Direct supervision'' is defined in proposed Sec. 900.2(k)(2), also
published elsewhere in this issue of the Federal Register, to mean:
``During the performance of a mammography examination or survey of the
facility's equipment and quality assurance program, the supervisor is
present to observe and correct, as needed, the performance of the
individual being supervised who is performing the examination or
conducting the survey.''
E. Retention of Personnel Records
Under the interim regulations, FDA is often asked how long records
demonstrating personnel qualifications must be kept after an individual
is no longer employed by the facility.
Proposed Sec. 900.12(a)(4) requires that records be retained for
all individuals employed in mammography by the facility from: (1) The
date of the last inspection or (2) the effective date of the final
regulations, whichever is later. Because inspections are required
annually under the MQSA, records of individuals no longer employed by
the facility typically would be retained less than a year after the
individual's employment ends. The agency believes that this requirement
will allow FDA adequately to assess whether personnel requirements are
being met without putting an undue paperwork burden on the facility.
Facilities should also become familiar with any State regulations that
are applicable to personnel records because these State laws may
require retaining the records for a longer period of time.
III. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(3) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
IV. Analysis of Impacts
FDA has examined together the impacts of this proposed rule and the
proposed rules on accreditation bodies, general facility requirements,
and quality standards for mammography equipment and quality assurance,
published elsewhere in this issue of the Federal Register, under
Executive Order 12866, the Regulatory Flexibility Act (Pub. L. 96-354),
and under the Unfunded Mandates Reform Act. The analysis has addressed
the proposed requirements of these four rules as one unit for purposes
of determining their economic impact. The preamble to the proposed rule
``Quality Mammography Standards; General Preamble and Proposed
Alternative Approaches'', published elsewhere in this issue of the
Federal Register, contains a brief summary of the cost and benefit
determination and the Regulatory Impact Study that details the agency's
calculation of these economic impacts and is available at the Dockets
Management Branch (address above) for review. FDA recognized that these
proposed regulations may have a disproportionate effect on small volume
mammography facilities and is currently collecting additional
information on the potential impact on this industry sector. The agency
requests comments that will assist it in accounting for this impact.
V. Paperwork Reduction Act of 1995
This proposed rule contains information collections which are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The title,
description, and respondent description of the information collection
and an estimate of the annual reporting and recordkeeping burden are
contained in the proposed rule entitled ``Quality Mammography
Standards; General Preamble and Proposed Alternative Approaches''
published elsewhere in this issue of the Federal Register.
The agency has submitted a copy of this proposed rule to OMB for
its review of these information collections. Other organizations and
individuals desiring to submit comments regarding this burden estimate
or any aspect of these information collection requirements, including
suggestions for reducing the burden, should direct them to the Office
of Information and Regulatory Affairs, OMB, New Executive Office Bldg.,
725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Desk Officer
for FDA. Written comments on the information collection should be
submitted by May 3, 1996.
VI. Request for Comments
Interested persons may, on or before July 2, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposed rule. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
VII. Reference
The following reference has been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. ``Report on the Mammography Quality Standards Act of 1992,'' S.
Rept. 102-448, October 1, 1992.
List of Subjects in 21 CFR Part 900
Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 900 be
amended as follows:
PART 900--MAMMOGRAPHY
1. The authority citation for 21 CFR part 900 continues to read as
follows:
Authority: Secs. 519, 537, and 704(e) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360i, 360nn, and 374(e)); sec. 354 of
the Public Health Service Act (42 U.S.C. 263b).
2. Section 900.12 is amended by revising paragraph (a) to read as
follows:
Sec. 900.12 Quality standards.
* * * * *
[[Page 14907]]
(a) Personnel. The following requirements apply to all personnel
involved in any aspect of mammography, including the production,
processing, and interpretation of mammograms and related quality
assurance activities.
(1) Interpreting physicians. All physicians interpreting mammograms
shall meet the following qualifications:
(i) Initial qualifications. Before beginning to interpret
mammograms independently, the interpreting physician shall:
(A) Be licensed to practice medicine in a State;
(B)(1) Be certified in an appropriate specialty area by a body
determined by FDA to have procedures and requirements adequate to
ensure that physicians certified by the body are competent to interpret
radiological procedures, including mammography; or
(2) Have had at least 3 months of documented formal training in the
interpretation of mammograms and in topics related to mammography. The
training shall include instruction in radiation physics, including
radiation physics specific to mammography, radiation effects, and
radiation protection. The mammographic interpretation component shall
be under the direct supervision of a physician who meets the
requirements of paragraph (a)(1) of this section;
(C) Have a minimum of 60 hours of documented medical education in
mammography, which must include: Instruction in the interpretation of
mammograms; at least 8 hours of Category I continuing medical education
credits in each mammographic modality used in the interpreting
physician's practice; and education in basic breast anatomy, pathology,
and physiology; technical aspects of mammography, and quality assurance
and quality control in mammography. At least 40 of these hours must be
Category I and at least 15 of the Category I hours must have been
acquired within the 3 years immediately prior to the date that the
physician qualifies as an interpreting physician. Hours spent in
residency specifically devoted to mammography will be considered as
equivalent to Category I continuing medical education credits and will
be accepted if documented in writing by the appropriate representative
of the training institution; and
(D) Have interpreted at least 240 mammographic examinations under
the direct supervision of a qualified interpreting physician within the
6-month period immediately prior to fulfilling the requirements of
paragraph(a)(1)(i) of this section.
(ii) Continuing experience and education. All interpreting
physicians shall maintain their qualifications by meeting the following
requirements:
(A) At all times following the second anniversary date of
completion of the requirements of paragraph (a)(1)(i) of this section,
the interpreting physician shall have interpreted an average of at
least 40 mammographic examinations a month during the previous 24
months;
(B) At all times following the third anniversary date of completion
of the requirements of paragraph (a)(1)(i) of this section, the
interpreting physician shall have taught or completed at least 15
Category I continuing medical education credits in mammography in the
previous 3 years. This training must include at least six Category I
continuing medical education credits in each mammographic modality used
by the interpreting physician in his or her practice; and
(C) Before an interpreting physician may begin independently
interpreting mammograms produced by a new mammographic modality, that
is, a modality in which the physician has not previously been trained,
the interpreting physician shall have at least 8 hours of training in
the new modality.
(iii) Exceptions. (A) Those physicians who previously qualified as
interpreting physicians under FDA's interim regulations at
Sec. 900.12(a)(1) are considered to have met the initial requirements
of paragraph (a)(1)(i) of this section. They may continue to interpret
mammograms provided they continue to meet the continuing experience and
education requirements of paragraph (a)(1)(ii) of this section.
(B) Physicians who have interpreted at least 240 mammographic
examinations under the direct supervision of a qualified interpreting
physician during the last 2 years of a diagnostic radiology residency
and who become appropriately board certified at the first allowable
time, as defined by an eligible certifying body, are otherwise exempt
from paragraph (a)(1)(i)(D) of this section.
(iv) Reestablishing qualifications. Interpreting physicians who
fail to maintain the required continuing experience or continuing
education requirements shall reestablish their qualifications before
resuming the independent interpretation of mammograms, as follows:
(A) Interpreting physicians who fail to meet the continuing
experience requirements of paragraph (a)(1)(ii)(A) of this section
shall interpret at least 240 mammographic examinations under the direct
supervision of a qualified interpreting physician, within a period of 6
months immediately prior to reestablishing their qualifications as an
interpreting physician.
(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 3 years before resuming independent
reading.
(2) Radiologic technologists. All mammographic examinations shall
be performed by radiologic technologists who meet the following general
requirements, mammography requirements, and continuing education and
experience requirements:
(i) General requirements. (A) Be licensed to perform general
radiographic procedures in a State; or
(B) Have general certification from one of the bodies determined by
FDA to have procedures and requirements adequate to ensure that
radiologic technologists certified by the body are competent to perform
radiologic examinations; and
(ii) Mammography requirements. Have undergone 40 contact hours of
documented training specific to mammography under the supervision of a
qualified individual. A qualified individual is one that has met all
the requirements of paragraph (a)(2) of this section. The 40 hours of
documented training shall include:
(A) Training in breast anatomy and physiology, positioning and
compression, quality assurance/quality control techniques;
(B) The performance of a minimum of 50 examinations under the
direct supervision of a qualified individual; and
(C) At least 5 hours of training in imaging examinees with breast
implants and at least 8 hours of training in each imaging modality to
be used by the technologist in performing mammography exams.
(iii) Continuing education requirements. (A) At all times following
the third anniversary date of completion of the requirements of
paragraphs (a)(2)(i) and (a)(2)(ii) of this section or (insert
effective date of the final regulation), whichever date is later, the
radiologic technologist shall have taught or completed at least 15
continuing education units related to mammography in the previous 3
years.
(B) At least six of these continuing education units shall be
related to each
[[Page 14908]]
modality used by the technologist in mammography.
(C) Requalification. Following any 3-year period in which a
radiologic technologist fails to meet the continuing education
requirements under paragraphs (a)(2)(iii)(A) through (a)(2)(iii)(B) of
this section, that technologist shall obtain a sufficient number of
continuing education units in mammography to bring the 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.
(D) Before a radiologic technologist may begin independently
performing mammographic examinations using a modality other than one of
those for which the technologist received training under paragraph
(a)(2)(ii)(C) of this section, the technologist shall have at least 8
hours of continuing education units in the new modality.
(iv) Continuing experience requirements. (A) In each 12-month
period after completion of the requirements of paragraphs (a)(2)(i) and
(a)(2)(ii) of this section or (effective date of the final rule),
whichever date is later, the radiologic technologist shall perform a
minimum of 100 mammography examinations.
(B) Requalification. Following any 12-month period in which a
radiologic technologist fails to perform at least 100 mammography
examinations, that technologist shall perform a minimum of 50
mammography examinations under the direct supervision of a qualified
radiologic technologist, before resuming the performance of
unsupervised mammography examinations.
(3) Medical physicists. All medical physicists conducting surveys
of mammography facilities and providing oversight of the facility
quality assurance program under 42 U.S.C. 263b shall meet the
following:
(i) Initial qualifications. (A) Be State licensed or approved or
have certification in an appropriate specialty area by one of the
bodies determined by FDA to have procedures and requirements to ensure
that medical physicists certified by the body are competent to perform
physics surveys; and
(B)(1) Have a master's degree or higher in a physical science from
an accredited institution, including at least 20 semester hours or
equivalent (e.g., 30 quarter hours) of college (graduate or
undergraduate) level physics;
(2) Have 20 contact hours of documented specialized training in
conducting surveys of mammography facilities; and
(3) Have the experience of conducting surveys of at least 5
mammography facilities and a total of at least 10 mammography units.
After the later date of October 27, 1997, or the effective date of
these regulations, experience conducting surveys must be acquired under
the direct supervision of a medical physicist who meets all the
requirements of paragraphs (a)(3)(i) and (a)(3)(iii) of this section;
or
(ii) Alternative initial qualifications. (A) Have qualified as a
medical physicist under the interim regulations at Sec. 900.12(a)(3)
and maintained the active status of any qualifying licensure, approval,
or certification required under the interim regulations; and
(B) By October 27, 1997, or [Date 1 year after date of publication
of the final rule] regulations, whichever is later, have:
(1) A bachelor's degree or higher in a physical science from an
accredited institution with no less than 10 semester hours or
equivalent of college level physics,
(2) Forty contact hours of documented specialized training in
conducting surveys of mammography facilities and,
(3) The experience of conducting surveys of at least 10 mammography
facilities and a total of at least 20 mammography units. The training
and experience requirements must be met after fulfilling the degree
requirement.
(iii) Continuing qualifications. (A) Continuing education. At all
times after the third anniversary of completion of the initial
requirements of paragraph (a)(3)(i) or (a)(3)(ii) of this section, the
medical physicist shall have taught or completed at least 15 continuing
education units in mammography over the preceding 3 years. This
continuing education shall include training appropriate to each
mammographic modality evaluated by the medical physicist during his or
her surveys or oversight of quality assurance programs.
(B) Continuing experience. At all times after the first anniversary
of completion of the initial requirements of paragraph (a)(3)(i) or
(a)(3)(ii) of this section, the medical physicist shall have surveyed
at least three mammography facilities within the preceding 12 months.
(C) Before a medical physicist may begin independently performing
mammographic examinations using a new modality, that is, a 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 with the
new modality.
(iv) Reestablishing qualifications. 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.
(B) Medical physicists who fail to meet the continuing experience
requirement of paragraph (a)(3)(iii)(B) of this section shall complete
a satisfactory survey of three mammography facilities under the direct
supervision of a medical physicist who meets the qualifications of
paragraphs (a)(3)(i) and (a)(3)(iii) of this section.
(4) Retention of personnel records. Facilities shall maintain
records to document the qualifications of all personnel employed by the
facility in the production, processing, and interpretation of
mammographic images. These records must be available for review by the
MQSA inspectors and should not bediscarded until the next annual
inspection has been completed and FDA has determined that the facility
is in compliance with the MQSA personnel requirements.
* * * * *
Dated: March 22, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-7832 Filed 3-29-96; 8:45 am]
BILLING CODE 4160-01-P