Medicare, Medicaid and CLIA Programs; Personnel Requirements for Cytotechnologists

DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 493

[HSQ-210-FC]

Medicare, Medicaid and CLIA Programs; Personnel Requirements for

Cytotechnologists

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

Service (PHS), HHS.

ACTION: Final Rule with Comment Period.

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SUMMARY: This rule amends certain personnel requirements for

cytotechnologists that perform testing in laboratories subject to the

requirements of the Clinical Laboratory Improvement Amendments of 1988

(CLIA). We are providing an adequate period of time for individuals to

gain the necessary 2 years experience performing cytology testing which

is currently included in two of the provisions for qualifying as a

cytotechnologist. Also, we are extending the time for individuals to

either meet the educational qualifications by virtue of completing

training in an approved cytotechnology training program or be certified

by an approved organization. We are making these changes to prevent the

loss of qualified personnel in the field of cytotechnology.

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

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

provided below, no later than 5 p.m. on March 7, 1994.

ADDRESSES: Mail an original and 3 copies of comments to the following

address:

Health Care Financing Administration, Department of Health and Human

Services, Attention: HSQ-210-FC, P.O. Box 26676, Baltimore, MD 21207.

If you prefer, you may deliver your written comments 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.

Due to staffing and resource limitations, we cannot accept

facsimile (FAX) transmissions. In commenting, please refer to file code

HSQ-210-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: Cheryl Wiseman, (410) 597-5906.

SUPPLEMENTARY INFORMATION:

I. Background

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

7002, rules that set forth the test performance requirements for

laboratories that are subject to the Clinical Laboratory Improvement

Amendments of 1988 (CLIA). We subsequently published in the Federal

Register a related rule (January 19, 1993 (58 FR 5215)) that made

technical corrections and addressed immediate concerns raised by some

of the approximately 16,000 comments on the publication of the February

28 regulations. This rule responds to concerns raised by some of the

commenters and pertains to limited aspects of the CLIA requirements:

The period of time during which an individual who needs 2 years

experience as a cytotechnologist is allowed to earn that experience,

and the period of time that a person may either obtain appropriate

training in a school approved by the Commission on Allied Health

Education and Accreditation (CAHEA) or be certified by an organization

approved by HHS.

The February 28, 1992 CLIA regulations represented establishment of

uniform personnel standards for cytotechnologists for all laboratories

offering cytology, regardless of location. Prior to these regulations,

individuals working in hospital cytology laboratories that were not

licensed under the Clinical Laboratory Improvement Act of 1967 to test

specimens in interstate commerce were not subject to Federal personnel

qualification requirements for cytotechnologists. In addition,

individuals employed in cytology laboratories that were not approved to

participate in the Medicare or Medicaid program were not subject to

Federal requirements, including personnel requirements.

In the preamble to the February 28, 1992 regulations, we stated

that in developing the personnel standards for cytotechnologists, it

was not our intention to put out of work individuals currently employed

as cytotechnologists. Our aim was to provide qualification standards

that would ensure quality of service and be in the best interest of the

public health. Recognizing the existing shortage of laboratory

personnel, particularly cytotechnologists, we stated that we were

expanding the qualification requirements to allow individuals

additional methods of qualifying. We stated, ``In our opinion, many

individuals currently working in laboratories, as a function of their

employment, have gained valuable experience in testing operations. In

most instances in this rule, we are acknowledging the value of this

experience, by allowing those individuals, who do not meet the

qualification requirements in these regulations, to continue their

laboratory employment while acquiring the education or training

necessary to meet the requirements. The net effect of the personnel

standards will be to permit a preponderance of personnel presently

working in laboratories to continue their employment while they are

updating their credentials to meet the national standards for

laboratory personnel specified in this rule.'' (57 FR 7083)

To Sec. 493.1483, Standard: Cytotechnologist Qualifications, we

added several alternative qualification standards for cytotechnologists

with education or experience requirements that had to be met by the

effective date of the regulations (September 1, 1992) or by a specified

later date. To the previous Federal requirements, we added at

Sec. 493.1483(b)(4) a current work experience requirement that had to

be met by September 1, 1992, which was applicable to those individuals

who received their cytotechnology training and acquired their work

experience prior to January 1, 1969. At Sec. 493.1483(b)(5), we added a

new provision requiring current work experience by September 1, 1993,

in addition to requiring on or before September 1, 1994, that

individuals either complete their cytotechnology training in an

approved school or be certified in cytotechnology by an organization

approved by HHS.

II. Revisions to the Rules

We have now determined that we did not provide sufficient time for

cytotechnologists to meet current standards. Without prior

notification, the February 28, 1992 rule required individuals, who

obtained their education and training prior to January 1, 1969, 6

months to acquire 2 years of current work experience. Also,

individuals, who trained outside of the United States, were given 1

year and 6 months to fulfill the requirement of 2 years for current

work experience in the United States. Therefore, we are revising the

dates originally published in the February 28, 1992 rule at

Sec. 493.1483(b) (4) and (5) concerning personnel requirements for

cytotechnologists who qualified under Federal regulations and for

individuals who trained outside of the United States. Based on public

concern and our analysis of anticipated availability of qualified

individuals, we are revising our regulations to allow all individuals 2

full years from September 1, 1992, the effective date of our personnel

requirements, to gain the necessary experience to qualify under the

regulations.

Accordingly, in Sec. 493.1483(b)(4), we are revising the date from

September 1, 1992 to September 1, 1994, to enable a previously

qualified cytotechnologist to continue working without interruption and

obtain the necessary work experience. In Sec. 493.1483(b)(5)(i), we are

similarly revising the date from September 1, 1993 to September 1, 1994

to allow an individual trained outside the United States and an

individual who does not meet the other qualification standards an

opportunity to obtain the 2 years of slide examination experience

within the United States.

As a technical revision to our rules, we note that

Sec. 493.1483(b)(5)(ii) provides that an individual qualifying as a

cytotechnologist must, on or before September 1, 1994, have either

graduated from a school of cytotechnology approved by the CAHEA or be

certified by an organization approved by the Department. It is possible

that the CAHEA may cease to function as an accrediting organization

before the Department has recognized any alternative certifying

organization. In order to prevent the possibility that individuals will

not have 2 full years to be certified by an approved certifying

organization, we are extending the date from September 1, 1994 to

September 1, 1995. This will allow time for the Department to recognize

organizations that certify cytology personnel and minimize the loss of

currently employed individuals at a time when there is an existing

shortage of qualified cytology personnel.

We are also making a conforming change to Sec. 493.1483(b)(1) to

provide that a school of cytotechnology must be accredited by CAHEA

``or other organization approved by HHS.''

III. Waiver of Proposed Rulemaking and Delay of Effective Date

We ordinarily publish a notice of proposed rulemaking in the

Federal Register and invite public comment on proposed requirements.

The notice of proposed rulemaking includes a reference to the legal

authority under which the rule is proposed, and the terms and

substances of the proposed rule or a description of the subjects and

issues involved. This procedure can be waived, however, if an agency

finds good cause that a notice-and-comment procedure is impracticable,

unnecessary, or contrary to the public interest and incorporates a

statement of the finding and its reasons in the rule issued.

We believe that these revisions are essential to the effective

implementation of the CLIA program, and to delay the effective date

would potentially disrupt public access to laboratory services,

unnecessarily expose laboratories to greater costs than are needed to

help assure quality testing, and create unnecessary confusion among

laboratories in understanding the standards they must meet. Without

immediate revision of the regulations, we believe there may be

shortages of cytotechnologists in some areas resulting in limited

access to cytology services. Therefore, we believe it is contrary to

the public interest to go through a notice-and-comment procedure, and

we find good cause to waive the notice of proposed rulemaking and to

issue this final rule on an interim basis. For these same reasons, we

find there is good cause to dispense with a delayed effective date of

these regulations. Although the regulations are final and effective on

the date of publication, we are providing a 60-day period for public

comment.

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 with comment period revises personnel requirements

for cytotechnologists by extending the dates by which they must meet

the qualification requirements. We are unable to quantify the number of

individuals, laboratories, or rural hospitals affected by this rule. In

the laboratory industry generally, recent surveys indicate that 80

percent of U.S. laboratories have experienced a shortage of technical

personnel. A shortage of cytotechnologists throughout the United States

has been demonstrated through anecdotal studies of wages and vacancy

rates. According to the American Hospital Association's 1991 Survey of

Human Resources, there was a full-time equivalent vacancy rate of 12.2

percent for cytotechnologists in hospital laboratories. The survey also

reported that more than 60 days were required to fill almost two-thirds

of the full-time vacancies. The average length of time required to fill

approximately half of the full-time vacancies was over 90 days. This

scarcity level existed prior to the imposition of Federal personnel

standards that might lead to lesser numbers of qualified

cytotechnologists.

In the absence of a registry that indicates the actual number of

cytotechnologists, their employment and age distribution, the amount

and type of work they do, and the specific number of individuals that

meet all the qualifications except the two years' experience, we cannot

determine the cause of this shortage or predict when the shortage will

end. Based on data projections from the Census Bureau and the National

Health Interview Survey, the demand for Pap smears in women 18 and

older was nearly 79 million in 1992 and is expected to increase. If

there is an existing shortage of personnel and we anticipate the

increased demand for cytology services, the impact of this regulation

would be beneficial to laboratories because it will allow larger

numbers of cytotechnologists to meet Federal personnel requirements.

Although we cannot determine whether this final rule's provisions to

allow a longer period of time for certain individuals to accumulate

required experience will have a significant impact on a substantial

number of small entities or small rural hospitals, because of the lack

of data, we have determined that its impact is beneficial.

As stated previously, one of the new methods of qualifying as a

cytotechnologist includes graduation, by September 1, 1994, from a

CAHEA-approved school. In the event that CAHEA should cease to function

as an accrediting agency prior to September 1, 1994, individuals may

not be able to avail themselves of this method of qualifying as a

cytotechnologist. To accommodate individuals seeking to qualify under

this provision, we are extending the date of graduation to September 1,

1995. This should provide sufficient time for us to formally recognize

another accrediting organization, if that becomes necessary.

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.).

List 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 continues 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.

1302, 1395x(e), the sentence following 1395x(s)(14), 1395x(s)(15),

and 1395x(s)(16)).

Sec. 493.1483 [Amended]

2. Section Sec. 493.1483 is amended as set forth below:

a. In Sec. 493.1483(b)(1), ``Accreditation; or'' is revised to read

``Accreditation or other organization approved by HHS; or'';

b. In Sec. 493.1483(b)(4) introductory text, ``September 1, 1992,''

is revised to read ``September 1, 1994,'';

c. In Sec. 493.1483(b)(5)(i), ``September 1, 1993,'' is revised to

read ``September 1, 1994,''; and

d. In Sec. 493.1483(b)(5)(ii), ``September 1, 1994,'' is revised to

read ``September 1, 1995,''.

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

Assistance Program; Program No. 93.773, Medicare--Hospital

Insurance; and Program No. 93.774, Medicare--Supplementary Medical

Insurance Program)

Dated: October 14, 1993.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: November 12, 1993.

Philip R. Lee.

Assistant Secretary for Health.

Dated: December 20, 1993.

Donna E. Shalala,

Secretary.

[FR Doc. 94-58 Filed 1-5-94; 8:45 am]

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