42 CFR Part 493

[HSQÄ210ÄFC]

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.

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: HSQÄ210ÄFC, P.O. Box 26676, Baltimore, MD 21207.

If you prefer, you may deliver your written comments to one of the following
addresses:

Room 309ÄG, 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 HSQÄ210ÄFC. 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 309ÄG 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) 690Ä7890).

FOR FURTHER INFORMATION CONTACT: Cheryl Wiseman, (410) 597Ä5906.

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  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  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  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  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  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  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  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  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)).

 493.1483 [Amended]

2. Section  493.1483 is amended as set forth below:

a. In  493.1483(b)(1), "Accreditation; or'' is revised to read "Accreditation
or other organization approved by HHS; or'';

b. In  493.1483(b)(4) introductory text, "September 1, 1992,'' is revised to
read "September 1, 1994,'';

c. In  493.1483(b)(5)(i), "September 1, 1993,'' is revised to read "September
1, 1994,''; and

d. In  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. 94Ä58 Filed 1Ä5Ä94; 8:45 am]

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