[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]
BILLING CODE 4120-01-P
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