Quality Mammography Standards; Correcting Amendment

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 900

[Docket No. 95N-0192]

RIN 0910-AA24

Quality Mammography Standards; Correcting Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correcting amendment.

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SUMMARY: The Food and Drug Administration (FDA) is correcting its

regulations governing mammography, published in a document entitled

``Quality Mammography Standards'' that appeared in the Federal Register

of October 28, 1997. The regulations are effective April 28, 1999;

except Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B), which

become effective October 28, 2002. The October 28, 1997, document was

published with some inadvertent typographical errors. Some of those

errors were corrected in a document entitled ``Quality Mammography

Standards; Correction'' that appeared in the Federal Register of

November 10, 1997, but additional typographical errors occurred in the

publication of this document. In addition, since November 10, 1997,

certain other problems with the text of the regulations have been

identified that, if uncorrected, would lead to unforeseen and

undesirable consequences. This document corrects those errors.

EFFECTIVE DATE: The corrections are effective April 28, 1999, except

corrections to Sec. 900.12(b)(8)(i), (e)(4)(iii)(B), and (e)(5)(i)(B),

which become effective October 28, 2002.

FOR FURTHER INFORMATION CONTACT: Roger L. Burkhart, 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

The Mammography Quality Standards Act (the MQSA) (Pub. L. 102-539)

was signed on October 27, 1992, to establish national quality standards

for mammography. The MQSA required that, to provide mammography

services legally after October 1, 1994, all facilities, except

facilities of the Department of Veterans Affairs, be accredited by an

approved accreditation

[[Page 56556]]

body and certified by the Secretary of Health and Human Services (the

Secretary). The authority to approve accreditation bodies and to

certify facilities was delegated by the Secretary to FDA.

A specific requirement of the MQSA was that quality standards be

established for mammographic equipment and practices, including quality

assurance and quality control programs. Mammography facilities had to

meet these standards to become accredited and certified. The standards

were intended to replace the patchwork of Federal, State, and private

standards existing in 1992 to ensure that all women nationwide receive

high quality mammography services.

On December 14, 1993, the President signed legislation granting

interim rule authority to the Secretary (and by delegation to FDA) to

issue interim quality standards under the MQSA. In the Federal Register

of December 21, 1993 (58 FR 67558 and 67565), FDA issued rules

establishing interim standards for the approval of accreditation bodies

and for the certification of mammography facilities. These standards

were amended by another interim rule published in the Federal Register

of September 30, 1994 (59 FR 49808). Since October 1, 1994, the

effective date of the MQSA requirements, these interim standards have

governed the approval of accreditation bodies and the accreditation and

certification of mammography facilities.

On April 3, 1996, FDA proposed final regulations to replace the

interim regulations (61 FR 14856, 14870, 14884, 14898, and 14908).

Developed with strong congressional encouragement, these proposed final

regulations reflected FDA's belief that more comprehensive quality

standards would further optimize facility performance. After analysis

of the extensive public comments received on the proposed regulations,

revisions were made and a final rule was published on October 28, 1997

(62 FR 55852). The effective date for most of the final rule is April

28, 1999. A few equipment and equipment quality assurance requirements

do not become effective until October 28, 2002.

During the preparation of the final rule for publication, a number

of typographical errors, some with a significant impact, occurred. Some

of these errors were corrected in a republication of November 10, 1997

(62 FR 60614), but in the process additional errors occurred. In the

subsequent months, further errors have been discovered and certain

other problems, with unforeseen significant consequences, have been

identified. The purpose of the amendments is to correct these remaining

problems in part 900 (21 CFR part 900).

II. Need for Amendments

A. Section 900.2(d)--Air Kerma

In the definition of ``air kerma,'' an editorial error in the

November 10, 1997, republication led to the radiation dose unit, the

rad, being identified as an abbreviation for the angular measurement

unit of the radian. The amendment eliminates mention of the radian. The

opportunity to amend this definition was also used to more precisely

state the relationship between the several radiation quantities and

units. The equal sign between 1 Gray and 114 roentgens was replaced

with the statement that ``In air, 1 Gy of absorbed dose is delivered by

114 roentgens (R) of exposure.''

B. Section 900.12(a)(2)(ii)--Mammography Requirements

This paragraph provides alternative ways for the technologist to

meet the requirement to have adequate initial training in the

performance of mammography examinations. The technologist must complete

at least 40 hours of training specific to mammography, including

training and experience in certain identified areas, or ``* * * prior

to April 28, 1999 must have qualified as a radiologic technologist

under paragraph (a)(2) of this section * * *.'' Under the second

option, qualification as a radiologic technologist would have to have

been achieved under the interim regulations, as they are effective

until April 28, 1999. A reader could, however, misinterpret this

reference to paragraph (a)(2) as meaning (a)(2) of the final

regulations. To avoid such a misinterpretation, FDA is clarifying this

requirement by adding the words ``of FDA's interim regulations'' after

the word ``section.'' This would make the wording of this

``grandparenting'' provision identical with that used in defining a

similar grandparenting provision for interpreting physicians.

C. Section 900.12(a)(2)(iv) and (a)(3)(iii)(B)--Continuing Experience

Requirements of the Radiologic Technologist and the Medical Physicist

The present wording of the final rule requires that these

requirements be met ``following the second anniversary date of the end

of the calender quarter'' during which the technologist or physicist's

initial requirements were met ``or of October 28, 1997, whichever is

later.'' For most radiologic technologists and medical physicists, this

wording means that they would be checked during inspections for

compliance with this requirement beginning after January 1, 2000. This

date is well after the effective date of the regulations; however, for

some time after this date, the 24-month averaging period, during which

compliance would be assessed, begins before the effective date of the

final rule. To avoid such a retroactive effect of the regulation, the

date in these two provisions is changed from October 28, 1997 (the date

of publication of the final rule), to April 28, 1999 (the effective

date of the final rule). This means that checking for compliance with

these requirements during inspections will begin after June 30, 2001,

and in all cases, the 24-month averaging period will fall completely

after April 28, 1999.

The phrase ``preceding the inspection,'' which should have modified

the calendar quarter by the end of which a radiologic technologist or

medical physicist must meet certain requirements, was also erroneously

omitted in these two sections. FDA is amending these sections to

include this phrase. The options for the continuing experience

requirement, thus would read ``* * * the 24 months immediately

preceding the date of the facility's annual MQSA inspection or the last

day of the calendar quarter preceding the inspection or any date in

between * * *.'' This will eliminate any confusion over what calendar

quarter is referred to. It will also make the wording of the end point

options identical to those for the continuing experience requirement of

the interpreting physician and to those of the continuing education

requirement for interpreting physicians, radiologic technologists, and

medical physicists, as was intended.

D. Section 900.12(a)(3)(iii)(B)--Continuing Experience of the Medical

Physicist

A typographical error led to the word ``or'' in ``* * * within a

10-month period or a specific unit * * *'' being changed to ``on,''

significantly confusing the meaning of the requirement. Similarly the

phrase ``the total mammography unit survey,'' preceding the word

``requirement,'' was not replaced with ``this'' as intended, again

leading to confusion over the exact requirement. The amendments replace

``on'' with ``or'' and replace ``the total mammography units survey''

with ``this.''

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E. Section 900.12(c)(4)(i)--Maintenance of Records

A typographic error of serious consequences was made in the

citation in this provision to ``paragraph (c)(3)(ii) of this section.''

The citation should be to ``paragraph (c)(4)(ii).''

F. Section 900.12(c)(4)(ii)--Transfer of Records

The editor's note to move the word ``by'' from this requirement

from after to before the words ``on behalf of'' was not accomplished

during the final production of the document. The amendment moves this

word, thus making the requirement clearer.

G. Section 900.12(d)(2)--Quality Assurance Records

As discussed in the preamble to the final regulations (62 FR 55852

at 55936 and 55937), the recordkeeping requirements for the quality

assurance program contained in the proposed final regulations,

published April 3, 1996, were simplified in the final regulations. The

rewording unfortunately created two possible interpretations of the

list of records that must be kept. The intended interpretation is that

the records ``concerning employee qualifications to meet assigned

quality assurance tasks'' would be the first on the list of categories

of required records that continues with the categories of ``mammography

techniques and procedures, quality control * * *.'' However, it is also

possible to interpret this as saying that the required records are of

employee qualifications to meet assigned quality assurance tasks,

employee qualifications for mammography techniques and procedures,

employee qualifications for quality control, and so forth. Two changes

were made in order to leave only the interpretation that the preamble

discussion shows was intended. First, the words ``employee

qualifications to meet assigned quality assurance tasks'' was moved

from first to last in the list of records that must be kept. Second,

the word ``these'' beginning the second sentence of the requirement was

changed to ``the.''

H. Section 900.12(e)(1)--Daily Quality Control Tests

The preamble to the final regulations (62 FR 55852 at 55938) stated

that the agency would replace the word ``examinations'' with ``films''

and the word ``performed'' with ``processed.'' Each word appeared twice

in the paragraph, but only one set of words was replaced. FDA is now

amending the rule to change the remaining set of words.

I. Section 900.12(e)(4)(iii)(B)--Compression Force After October 28,

2002

The proposed final regulations, published April 3, 1996, required

that 5 years after publication, the compression device shall provide a

maximum compression from the power drive of between 111 newtons (25

pounds) and 200 newtons (45 pounds). As pointed out at two places ( 62

FR 55852 at 55942) of the preamble to the final regulations, after a

review of the comments received on this portion of the proposal, it was

decided to retain this requirement in the final rule. In the

regulations themselves, however, the upper limit was mistakenly stated

as 209 newtons (47 pounds). FDA is changing this figure to the intended

value of 200 newtons (45 pounds).

J. Section 900.12(e)(8)(ii)(A)--Tests Whose Failure Means That

Corrective Actions Must be Carried Out Before Use of the Failed

Component in Clinical Examinations

The proposed final regulations of April 3, 1996, in

Sec. 900.12(e)(8)(ii) had required that corrective action be carried

out before further clinical use of the failed component, no matter

which of the quality control tests required in other parts of

Sec. 900.12(e) was failed. As discussed in (62 FR 55852 at 55942 and

55947) the preamble to the final rule, numerous comments were made on

this requirement, which also received significant attention from the

National Mammography Quality Assurance Advisory Committee (NMQAAC).

After consideration of the information provided to it, FDA concluded

that failure of only some tests was serious enough to require

corrective action before further use and that to apply this requirement

to all tests would disrupt facility operations without achieving a

compensating benefit. In the final regulations, the agency divided the

quality control tests into two groups. Section 900.12(e)(8)(ii)(A)

lists those tests whose failure is considered serious enough that the

corrective actions must be carried out before the failed component of

the mammography system is used for further patient examinations.

Section 900.12(e)(8)(ii)(B) lists those tests for which it was believed

the corrective action could be delayed for up to 30 days without

presenting a serious threat to the public health.

Some errors were made in the editing of the regulations, however,

that caused them to depart from the division of the tests into the two

groups described in the preamble. The test required by

Sec. 900.12(e)(4)(i) was mistakingly listed in Sec. 900.12(e)(8)(ii)(A)

as Sec. 900.12(e)(5)(ii) and the tests in Sec. 900.12(e)(5)(iii) and

Sec. 900.12(e)(5)(v) were also mistakenly included in this group. FDA

is amending Sec. 900.12(e)(8)(ii)(A) so that it correctly reflects the

division of the tests into the two groups described in the preamble.

K. Section 900.12(e)(10)--Mammography Equipment Evaluations

A typographical error will be corrected in the first sentence of

this paragraph by changing the word ``dissembled'' to ``disassembled.''

L. Section 900.12(f)(3)--Reviewing Interpreting Physician for the

Medical Outcome Audit

An edit in the sequence of words ``for documenting the results and

for notifying other interpreting physicians'' in this provision was

overlooked in the final preparation of the regulations for publication.

As a result, a comma appeared instead of the words ``and for'' making

the sentence in which these words occur appear to be incomplete. FDA is

amending the regulation to eliminate this error.

III. Environmental Impact

The agency has previously determined under 21 CFR 25.30(i) that

this final rule 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 was

required. The changes in these amendments do not alter this conclusion.

IV. Analysis of Impacts

FDA has examined the impact of this rule under Executive Order

12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as amended

by subtitle D of the Small Business Regulatory Fairness Act of 1996

(Pub. L. 104-121)), and the Unfunded Mandates Reform Act of 1995 (Pub.

L. 104-4). Executive Order 12866 directs agencies to assess all costs

and benefits of available regulatory alternatives and, when regulation

is necessary, to select regulatory approaches that maximize net

benefits (including potential economic, environmental, public health

and safety, and other advantages; distributive impacts; and equity).

The agency believes that this rule is consistent with the regulatory

philosophy and principles identified in the Executive Order. In

addition, this rule is not a significant regulatory action as defined

by the Executive Order and so is not

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subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The agency certifies that this final rule will not

have a significant negative economic impact on a substantial number of

small entities. This rule also does not trigger the requirement for a

written statement under section 202(a) of the Unfunded Mandates Reform

Act because it does not impose a mandate that results in an expenditure

of $100 million or more by State, local, or tribal governments in the

aggregate, or by the private sector, in any 1 year.

FDA had previously estimated (62 FR 55852 at 55968) that the

expected average annual benefits from the final regulations would range

between $181.7 to $262.7 million. Average annual compliance costs were

estimated at $38.2 million.

The amendment to Sec. 900.12(e)(4)(iii)(B) may act to reduce costs

somewhat from the changes estimated as presumably a compression limit

of 200 newtons can be achieved at less cost than the present limit of

209 newtons. However, the change in the requirement is relatively minor

and so the costs savings are not likely to be significant. None of the

other amendments will change the estimates of compliance costs.

In summary, the effect of the amendments, if any, would be to

reduce very slightly the estimated average annual compliance level of

$38.2 million.

V. Paperwork Reduction Act of 1995

FDA has determined that this final rule contains no additional

collections of information. Therefore, clearance by the Office of

Management and Budget under the Paperwork Reduction Act of 1995 is not

required.

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 and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

900 is amended as follows:

PART 900--MAMMOGRAPHY

1. The authority citation for 21 CFR part 900 continues to read as

follows:

Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

2. Section 900.2 is amended by revising paragraph (d) to read as

follows:

Sec. 900.2 Definitions.

* * * * *

(d) Air kerma means kerma in a given mass of air. The unit used to

measure the quantity of air kerma is the Gray (Gy). For X-rays with

energies less than 300 kiloelectron volts (keV), 1 Gy = 100 rad. In

air, 1 Gy of absorbed dose is delivered by 114 roentgens (R) of

exposure.

* * * * *

3. Section 900.12 is amended by revising the first sentence of

paragraph (a)(2)(ii), paragraphs (a)(2)(iv)(A) and (a)(3)(iii)(B); by

removing ``(c)(3)(ii)'' from paragraph (c)(4)(i) and adding in its

place ``(c)(4)(ii)''; by revising paragraphs (c)(4)(ii), the first

sentence of paragraph (d)(2), the introductory text of paragraph

(e)(1), paragraphs (e)(4)(iii)(B), and (e)(8)(ii)(A), the first

sentence of paragraph (e)(10), and paragraph (f)(3) to read as follows:

Sec. 900.12 Quality standards.

(a) * * *

(2) * * *

(ii) Mammography requirements. Have, prior to April 28, 1999,

qualified as a radiologic technologist under paragraph (a)(2) of this

section of FDA's interim regulations of December 21, 1993, or completed

at least 40 contact hours of documented training specific to

mammography under the supervision of a qualified instructor. * * *

* * * * *

(iv) Continuing experience requirements. (A) Following the second

anniversary date of the end of the calendar quarter in which the

requirements of paragraphs (a)(2)(i) and (a)(2)(ii) of this section

were completed or of April 28, 1999, whichever is later, the radiologic

technologist shall have performed a minimum of 200 mammography

examinations during the 24 months immediately preceding the date of the

facility's annual inspection or the last day of the calendar quarter

preceding the inspection or any date in between the two. The facility

will choose one of these dates to determine the 24-month period.

* * * * *

(3) * * *

(iii) * * *

(B) Continuing experience. Following the second anniversary date of

the end of the calendar quarter in which the requirements of paragraphs

(a)(3)(i) and (a)(3)(ii) of this section were completed or of April 28,

1999, whichever is later, the medical physicist shall have surveyed at

least two mammography facilities and a total of at least six

mammography units during the 24 months immediately preceding the date

of the facility's annual MQSA inspection or the last day of the

calender quarter preceding the inspection or any date in between the

two. The facility shall choose one of these dates to determine the 24-

month period. No more than one survey of a specific facility within a

10-month period or a specific unit within a period of 60 days can be

counted towards this requirement.

* * * * *

(c) * * *

(4) * * *

(ii) Shall upon request by, or on behalf of, the patient,

permanently or temporarily transfer the original mammograms and copies

of the patient's reports to a medical institution, or to a physician or

health care provider of the patient, or to the patient directly;

* * * * *

(d) * * *

(2) Quality assurance records. The lead interpreting physician,

quality control technologist, and medical physicist shall ensure that

records concerning mammography technique and procedures, quality

control (including monitoring data, problems detected by analysis of

that data, corrective actions, and the effectiveness of the correction

actions), safety, protection, and employee qualifications to meet

assigned quality assurance tasks are properly maintained and updated. *

* *

* * * * *

(e) Quality assurance--equipment--(1) Daily quality control tests.

Film processors used to develop mammograms shall be adjusted and

maintained to meet the technical development specifications for the

mammography film in use. A processor performance test shall be

performed on each day that clinical films are processed before any

clinical films are processed that day. The test shall include an

assessment of base plus fog density, mid-density, and density

difference, using the mammography film used clinically at the facility.

* * * * *

(4) * * *

(iii) * * *

(B) Effective October 28, 2002, the maximum compression force for

the initial power drive shall be between 111 newtons (25 pounds) and

200 newtons (45 pounds).

* * * * *

(8) * * *

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(ii) * * *

(A) Before any further examinations are performed or any films are

processed using a component of the mammography system that failed any

of the tests described in paragraphs (e)(1), (e)(2), (e)(4)(i),

(e)(4)(ii), (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;

* * * * *

(10) Mammography equipment evaluations. Additional evaluations of

mammography units or image processors shall be conducted whenever a new

unit or processor is installed, a unit or processor is disassembled and

reassembled at the same or a new location, or major components of a

mammography unit or processor equipment are changed or repaired. * * *

* * * * *

(f) * * *

(3) Reviewing interpreting physician. Each facility shall

designate at least one interpreting physician to review the medical

outcomes audit data at least once every 12 months. This individual

shall record the dates of the audit period (s) and shall be responsible

for analyzing results based on this audit. This individual shall also

be responsible for documenting the results and for notifying other

interpreting physicians of their results and the facility aggregate

results. If followup actions are taken the reviewing interpreting

physician shall also be responsible for documenting the nature of the

followup.

* * * * *

Dated: October 6, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-28148 Filed 10-21-98; 8:45 am]

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