Medicare, Medicaid and CLIA Programs; Extension of Certain Effective Dates for Clinical Laboratory Requirements and Personnel Requirements for Cytologists

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

Public Health Service

42 CFR Part 493

[HSQ-217-FC]

RIN 0938-AG86

Medicare, Medicaid and CLIA Programs; Extension of Certain

Effective Dates for Clinical Laboratory Requirements and Personnel

Requirements for Cytologists

AGENCY: Health Care Financing Administration (HCFA) and Public Health

Service (PHS), HHS.

ACTION: Final rule with comment period.

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SUMMARY: This final rule extends certain effective dates for clinical

laboratory requirements in regulations published on February 28, 1992,

which implemented provisions of the Clinical Laboratory Improvement

Amendments of 1988 (CLIA) and announces our approval of a certifying

organization for qualifying cytotechnologists. This rule extends the

date by which an individual must enroll in an HCFA-approved cytology

proficiency testing (PT) program and the date by which an individual

with a doctoral degree must possess board certification to qualify as a

director of a laboratory that performs high complexity testing. In

addition, we are extending the phase-in of the quality control

requirements applicable to unmodified, moderate complexity tests

cleared for commercial distribution by the Food and Drug Administration

(FDA). We are extending the date to meet applicable CLIA QC

requirements for laboratories using commercial, nonmodified tests to

fulfill certain quality control (QC) requirements.

These effective date extensions do not reduce the current

requirements for quality test performance. The date extensions are

necessary due to the limited number and scope of currently operating

cytology PT programs, resource constraints that have prevented

commencement of the substantial number of quality control reviews, and

inability of many laboratory directors to complete certification

requirements within the time period originally specified.

DATES: These regulations are effective on December 6, 1994. Comments

will be considered if we receive them at the appropriate address, as

provided below, no later than 5 p.m. on February 6, 1996.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Health Care Financing Administration, Department of

Health and Human Services, Attention: HSQ-217-FC, P.O. Box 26676,

Baltimore, MD 21207.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to one of the following addresses: Room 309-G, Hubert H.

Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201,

or Room 132, East High Rise Building, 6325 Security Boulevard,

Baltimore, MD 21207.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code HSQ-217-FC. Comments received timely will be available for

public inspection as they are received, generally beginning

approximately 3 weeks after publication of a document, in Room 309-G of

the Department's offices at 200 Independence Avenue, SW., Washington,

DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.

(phone: (202) 690-7890).

FOR FURTHER INFORMATION CONTACT: Josephine A. Simmons (410) 597-5882.

SUPPLEMENTARY INFORMATION:

I. Background

On February 28, 1992, we published in the Federal Register at 57 FR

7002, final regulations with an opportunity for public comment that set

forth requirements for laboratories that are subject to CLIA.

These regulations established uniform requirements for all

laboratories regardless of location, size or type. In developing the

regulations, we included requirements that would ensure the quality of

service and be in the best interest of the public health. We recognized

that a rule of this scope required time for laboratories to understand

and to implement the new requirements. Therefore, certain requirements

were phased-in and given prospective effective dates. We also planned

to address comments on the February 28 rule and make modifications, if

necessary, in a successor final rule.

On January 6, 1994, we published a final regulation in the Federal

Register, at 59 FR 682. This revision to the February 28, 1992 rule

extended the time for individuals to meet the educational

qualifications for a cytotechnologist by either completing a training

program or being certified by an approved organization. These changes

were made to prevent the loss of qualified personnel in the field of

cytotechnology and to allow the Department the time necessary to

recognize organizations that certify cytology personnel.

In the February 28, 1992 regulations, there are three prospectively

set dates that need extensions to prevent disruption in implementation

of the CLIA requirements. At Sec. 493.855, Standard; Cytology:

Gynecologic examinations, we required the laboratory, by January 1,

1994, to enroll each individual engaged in the examination of

gynecologic preparations in a PT program approved by HCFA. At

Sec. 493.1202, Standard; Moderate or high complexity testing, or both:

Effective from September 1, 1992, to September 1, 1994, we established

quality control (QC) requirements for high complexity or moderate

complexity tests including less stringent requirements for unmodified,

moderate complexity testing cleared for commercial distribution by the

FDA. At Sec. 493.1203, Standard; Moderate or high complexity testing,

or both: Effective beginning September 1, 1994, we established a

mechanism for laboratories using commercial, non-modified tests to

fulfill certain QC requirements by following manufacturer's

instructions that have been reviewed and determined by the FDA to meet

applicable CLIA QC requirements. At Sec. 493.1443, Standard; Laboratory

director qualifications, until September 1, 1994, an individual holding

a doctoral degree may qualify with either (1) board certification, or

(2) two years of laboratory training or experience, or both, and two

years of experience directing or supervising high complexity testing.

After September 1, 1994, all individuals qualifying with a doctoral

degree must have board certification.

For each of these requirements, we allowed what we considered as

adequate time for laboratories to enroll personnel in a HCFA-approved

cytology PT program, for manufacturers to obtain a QC review from the

FDA, and for individuals to obtain certifications, given our planned

publication date of the final regulations. However, approximately

16,000 comments were received on the February 28 rule, which required

reevaluation of numerous provisions.

As of January 1994, no cytology PT program had met the requirements

for HCFA approval, we have not yet been able to implement the FDA

review of QC instructions, and we do not anticipate that a final rule

will be issued prior to the September 1994 date affecting the board

certification requirement for an individual with a doctoral degree to

qualify as a laboratory director. Therefore, we need to extend these

prospectively set dates to allow time for laboratories and individuals

to meet the CLIA requirements.

In the regulations published on February 28, 1992, we established a

pathway at Sec. 493.1483 that allows an individual to qualify as a

cytotechnologist if she or he is certified in cytotechnology by an HHS-

approved agency. In the preamble to this rule, we are announcing HHS

approval of an agency to certify cytotechnologists.

In this rule we also address the comments we received in response

to two major areas: Effective dates for implementation of the

requirements mentioned above and approval of an agency to certify

cytotechnologists. The comments on implementation effective dates

focused on the need for phase-in periods, feasibility of achieving

compliance with the requirements by the end of the phase-in periods,

and alternatives to the phase-in periods. The comments on the cytology

qualification requirements included recommendations that HHS approve an

agency that certifies cytotechnologists.

II. Responses to Comments

A. Proficiency Testing of Individuals Who Examine Gynecological

Preparations (Sec. 493.855)

Section 493.855 requires that a laboratory ensure that, as of

January 1, 1994, each individual performing gynecologic cytology

services is enrolled in a gynecologic cytology PT program approved by

HCFA. A Request for Proposal was issued for a contractor to undertake

procurement of glass slides necessary to operate the cytology PT

program nationally. We received no responses. However, we did receive

comments from the cytology societies and individuals indicating that

the program was logistically and financially unworkable. The Centers

for Disease Control and Prevention (CDC) cosponsored a cytology

symposium in November 1993 to establish possible alternatives to

providing a cytology PT program. In December 1993, the Clinical

Laboratory Improvement Advisory Committee (CLIAC) established under

Sec. 493.2001 of our regulations recommended that legislative and

regulatory changes be pursued to provide for an alternative program for

cytology PT, including encouraging private or State-administered

programs to meet current regulations. To date, only two cytology PT

programs have applied for HCFA approval. The two programs are State-

operated and enrollment capacity is limited.

Comment: One group of commenters believed that the PT requirements,

as currently written, are impossible to implement. The commenters noted

the limited availability of PT programs and believed that the timeframe

for implementing cytology PT is unrealistic.

Response: We understand the commenters' concerns. Although a State

program has been approved for calendar year 1995, it has not been

possible to implement a national program within the timeframe specified

in the regulations. Therefore, in this final rule, we are changing the

effective date for individuals to enroll and participate in a HCFA-

approved cytology PT program from January 1, 1994 to January 1, 1995.

Enrollment by this date is required if an approved program is available

in the State in which the individual is employed.

For individuals engaged in the examination of gynecologic

preparations who are employed in a State in which an approved cytology

PT program is available, cytology PT enrollment and participation is

required beginning January 1, 1995. For individuals engaged in the

examination of gynecologic preparations who are employed in a State in

which a HCFA-approved cytology PT program is not available beginning

January 1, 1995, enrollment and participation in cytology PT is

required when a HCFA-approved program becomes available. We recognize

that additional time is needed for development and approval of cytology

PT programs that will apply nationwide. Presently, the major impediment

in making cytology PT available on a national basis is the difficulty

in obtaining a sufficient number of properly referenced glass slides.

It has been suggested, and we agree, that programs using facsimiles of

glass slides (for example, transparencies, computer images, etc.)

should be considered for PT purposes. We plan to revise the regulations

to allow approval of programs that employ testing media other than

glass slides. The CDC is undertaking studies to evaluate alternative

cytology PT programs. If alternative programs are feasible, we will

ensure that such programs are comparable to glass side programs.

Implementation of PT using alternative media will be phased-in to

familiarize cytology personnel and evaluate the programs. During the

phase-in, we will ensure that individuals are not penalized due to

performance in an alternative program. We believe that this approach

will meet the statutory mandate that PT be available nationwide to

evaluate the performance of all cytology personnel.

B. Quality Control Requirements for Unmodified, Moderately Complex

Tests (Secs. 493.1202 and 493.1203)

Sections 493.1202 and 493.1203 provide for a 2-year phase-in period

during which manufacturers could submit QC instructions relevant to

their products to FDA for review and clearance. Under the regulations,

laboratories would be in compliance with the QC provisions of part 493

subpart K by meeting less stringent QC requirements and following the

manufacturer's instructions, as long as the laboratory has not modified

the instrument, kit, or test system's procedure.

Comment: Of the approximately 16,000 letters of comment received in

response to the February 28, 1992 regulations, nearly 300 were in

reference to the general QC requirements of subpart K. Over 25 percent

of these commenters were opposed to allowing a laboratory to meet the

CLIA QC requirements by following the manufacturer's FDA-cleared QC

instructions. The majority of commenters indicated that all

laboratories should be subject to the same QC requirements. Less than

two percent of the commenters agreed with the provision. Approximately

two percent of the commenters expressed concern that a laboratory may

be penalized if the FDA does not complete the assessment of a

manufacturer's QC instructions prior to the end of the phase-in period.

Response: We acknowledge the commenters' concerns. Having

encountered difficulties in commencing the review of manufacturers' QC

instructions, we are extending the effective date of Sec. 493.1203,

which contains the quality control requirements for moderate or high

complexity testing, or both, from September 1, 1994 to September 1,

1996. In addition, we are extending the September 1, 1994 sunset date

until September 1, 1996 of Sec. 493.1202, which contains the quality

control standards for moderate or high complexity testing, or both.

C. Board Certification of a Laboratory Director With Doctoral Degree

(Sec. 493.1443(b)(3))

Section 493.1443(b)(3) provides that a director of a laboratory

performing high complexity testing who has an earned doctoral degree in

a chemical, physical, biological or clinical laboratory science from an

accredited institution must, as of September 1, 1994, be certified by a

board recognized by HHS. The 2-year phase-in was designed to allow HHS

additional time to review requests for approval of certification

programs and to ensure that a laboratory director with a doctoral

degree had sufficient time to successfully complete the requirements

for board certification.

A number of commenters on the final rule suggested that board

certification not be a mandatory requirement for currently employed

individuals. In addition, CLIAC has suggested, and we are considering,

development of alternative provisions to qualify currently employed

individuals with a doctoral degree on the basis of laboratory training

or experience, in lieu of requiring board certification. Furthermore,

in at least one specialty, there is currently no board certification,

but a program is being developed.

Comment: One commenter suggested that doctoral degree training and

education were sufficient without requiring board certification to

qualify as a laboratory director. One commenter agreed with requiring

board certification.

Response: In reply to these comments and to the recommendations of

CLIAC, we are allowing additional time to review the qualifications

required to ensure that they are appropriate. We are extending the

phase-in period in Sec. 493.1443 from September 1, 1994, to September

1, 1996 to allow additional time for this evaluation.

Comment: One commenter suggested that the director be board

certified in the specialty of testing that the laboratory performs.

Response: We recognize that, at this time, not all specialties have

board certification programs. In at least one specialty, certification

programs are being developed. To allow additional time for boards to

request HHS approval, for us to review the requirements for

appropriateness, and to ensure that laboratory directors can continue

to meet the requirements as boards apply, we are extending the time

period in Sec. 493.1443 from September 1, 1994, to September 1, 1996.

D. Agency Approved by HHS To Certify Cytotechnologists

(Sec. 493.1483(b)(2))

In the personnel requirements in Sec. 493.1483(b)(2), an individual

may qualify as a cytotechnologist if he or she is certified in

cytotechnology by a certifying agency approved by HHS. In response to

the regulations published February 28, 1992, numerous commenters

suggested that the American Society of Clinical Pathologists (ASCP) be

recognized by the Department since it is a national certifying agency

for cytotechnologists in the United States. The ASCP applied for

approval and provided materials in support of its request for

recognition as a cytotechnologist certifying agency. The qualifications

used by ASCP to qualify an individual as a cytotechnologist include

both educational and training components that are similar to, or more

stringent than, the current CLIA requirements for cytotechnologists. In

addition, ASCP requires successful completion of a competency

examination to measure skills in cytology. Since the ASCP's

requirements for certifying individuals in cytotechnology meet the CLIA

requirements, we are announcing that, effective on the date of

publication of this rule, we have approved the ASCP as a certifying

agency for cytotechnologists. Cytotechnologists certified by ASCP now

meet the CLIA cytotechnologists personnel qualification requirements.

III. Waiver of Delayed Effective Date

As required by the Administrative Procedure Act, we generally

provide for final rules to be effective 30 days after the date of

publication unless we find good cause to waive the delay. We believe

that these revisions are essential to the effective implementation of

the CLIA program and should be implemented immediately. Delaying the

effective date of this regulation would potentially disrupt public

access to laboratory services and create unnecessary confusion among

laboratories in understanding the standards they must meet.

Accordingly, we find good cause to waive the delayed effective date as

contrary to the public interest.

IV. Regulatory Impact Statement

We generally prepare a regulatory flexibility analysis that is

consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612) unless the Secretary certifies that a final rule will not

have a significant economic impact on a substantial number of small

entities. For purposes of the RFA, all laboratories are considered to

be small entities. Individuals and States are not included in the

definition of a small entity.

Also, section 1102(b) of the Act requires the Secretary to prepare

a regulatory impact analysis if a final rule may have a significant

impact on the operations of a substantial number of small rural

hospitals. This analysis must conform to the provisions of section 604

of the RFA. For purposes of section 1102(b) of the Act, we define a

small rural hospital as a hospital that is located outside of a

Metropolitan Statistical Area and has fewer than 50 beds.

This final rule extends the date by which an individual must enroll

in an approved cytology proficiency testing program, the date by which

an individual with a doctoral degree must obtain board certification to

qualify as a director of a laboratory that performs high complexity

testing, and the expiration date of the phase-in for quality control

requirements for unmodified, moderate complexity testing cleared

through the FDA 510(k) or PMA processes. Because controlling components

of the regulations (for example, approved PT programs and approved

board certification programs) are not yet fully in place, compliance

with these existing regulations is unachievable for most laboratories

and their personnel. Extending the phase-in periods will result in

continuation of previously published requirements and will not result

in changed costs, savings, burden or opportunities to manufacturers,

laboratories, individuals administering tests, or patients receiving

them.

This rule also announces the approval of ASCP as a certifying

agency for cytotechnologists. The February 28, 1992 regulation added

certification by an approved certifying agency as an optional method of

qualifying as a cytotechnologist. The majority of those who commented

on the cytotechnologist qualification requirements specified in the

February 28, 1992 rule identified certification by ASCP as the

preferred alternative method of qualifying and recommended that ASCP be

approved by HHS as a certifying agency. The ASCP's certification

requirements have been shown to meet or exceed CLIA requirements;

therefore, the announcement of ASCP's approval should be well received

by all affected entities.

We are not preparing an analysis for either the RFA or section

1102(b) of the Act since we have determined, and the Secretary

certifies, that this final rule will not result in a significant

economic impact on a substantial number of small entities and will not

have a significant impact on the operations of a substantial number of

small rural hospitals.

In accordance with the provisions of Executive Order 12866, this

regulation was reviewed by the Office of Management and Budget.

IV. Collection of Information Requirements

This document does not impose information collection and

recordkeeping requirements. Consequently, it need not be reviewed by

the Office of Management and Budget under the authority of the

Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).

Lists of Subjects in 42 CFR Part 493

Grant programs--health, Health facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping requirements.

PART 493--LABORATORY REQUIREMENTS

Part 493 is amended as follows:

1. The authority citation for part 493 is revised to read as

follows:

Authority: Sec. 353 of the Public Health Service Act, secs.

1102, 1861(e), the sentence following sections 1861(s)(14),

1861(s)(15), and 1861(s)(16) of the Social Security Act (42 U.S.C.

263a, 1302, 1395x(e), the sentence following 1395x(s)(14),

1395x(s)(15), and 1395x(s)(16).

Sec. 493.855 [Amended]

2. In Sec. 493.855(a), ``January 1, 1994.'' is revised to read

``January 1, 1995, if available in the State in which he or she is

employed.''

3. Section 493.1202 is amended by revising the section heading to

change the expiration date from September 1, 1994 to September 1, 1996

and reads as follows:

Sec. 493.1202 Standard; Moderate or high complexity testing, or both:

Effective from September 1, 1992 to September 1, 1996.

5. In Sec. 493.1203, the section heading is revised to change the

effective date from September 1, 1994 to September 1, 1996 and read as

follows:

Sec. 493.1203 Standard; Moderate or high complexity testing, or both:

Effective beginning September 1, 1996.

Sec. 493.1443 [Amended]

6. Section Sec. 493.1443 is amended as set forth below:

a. In Sec. 493.1443(b)(3)(ii), ``September 1, 1994'' is revised to

read ``September 1, 1996''.

b. In Sec. 493.1443(b)(3)(ii)(C), ``September 1, 1994,'' is revised

to read ``September 1, 1996,''.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical

Assistance Program; Catalog of Federal Domestic Assistance Program

No. 93.773, Medicare--Hospital Insurance; and Program No. 93.774,

Medicare--Supplementary Medical Insurance Program)

Dated: August 24, 1994.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: September 6, 1994.

Philip R. Lee,

Assistant Secretary for Health.

Dated: September 28, 1994.

Donna E. Shalala,

Secretary.

[FR Doc. 94-29914 Filed 12-5-94; 8:45 am]

BILLING CODE 4120-01-P