Quality Standards and Certification Requirements for Mammography Facilities; Personnel Requirements

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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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

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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

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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).

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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