[Federal Register Volume 59, Number 4 (Thursday, January 6, 1994)]
[Rules and Regulations]
[Pages 682-685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-58]


[[Page Unknown]]

[Federal Register: January 6, 1994]


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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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