[Federal Register: April 24, 1995 (Volume 60, Number 78)]
[Rules and Regulations]
[Page 20035-20051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24ap95-16]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 493
[HSQ-216-FC]
RIN 0938-AG71
CLIA Program; Categorization of Tests and Personnel Modifications
AGENCY: Health Care Financing Administration (HCFA) and Public Health
Service (PHS), HHS.
ACTION: Final rule with comment period.
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SUMMARY: In this rule we are responding to some of the comments on
categorization of tests and personnel requirements received in response
to rules published on February 28, 1992 and January 19, 1993. (In a
future rule, we will be responding to the remaining comments.) We are
revising our regulations to: Allow dentists and midlevel practitioners
to perform tests in the ``physician-performed'' microscopy (PPM)
subcategory of moderate complexity procedures (we now call the
subcategory ``provider-performed''); include three additional tests in
PPM; and expand provisions relating to general supervisor and high
complexity testing personnel.
DATES: Effective date: These regulations are effective April 24, 1995.
Comment date: Comments on the addition of three PPM tests will be
considered if we receive them at the appropriate address, as provided
under ADDRESSES, no later than 5 p.m. on June 23, 1995.
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-216-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-216-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 comments that relate to information collection requirements,
mail a copy of comments to: Office of Information and Regulatory
Affairs, Office of Management and Budget, Room 10235, New Executive
Office Building, Washington, DC 20503, Attn: Allison Herron Eydt, HCFA
Desk Officer.
Copies: To order copies of the Federal Register containing this
document, send your request to: New Orders, Superintendent of
Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date
of the issue requested and enclose a check or money order payable to
the Superintendent of Documents, or enclose your Visa or Master Card
number and expiration date. Credit card orders can also be placed by
calling the order desk at (202) [[Page 20036]] 783-3238 or by faxing to
(202) 275-6802. The cost for each copy is $8.00. As an alternative, you
can view and photocopy the Federal Register document at most libraries
designated as Federal Depository Libraries and at many other public and
academic libraries throughout the country that receive the Federal
Register.
FOR FURTHER INFORMATION CONTACT: Rosemary Bakes-Martin, (404) 488-7655,
for questions regarding the addition of the three PPM tests; Rhonda S.
Whalen, (404) 488-7655, for questions regarding personnel; and Judy
Yost, (410) 597-5907, for certificate, fee, and inspection issues.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 353 of the Public Health Service Act (42 U.S.C.
263a), as amended by the Clinical Laboratory Improvement Amendments of
1988 (CLIA), all laboratories that examine human specimens for the
diagnosis, prevention or treatment of any disease or impairment of, or
the assessment of the health of, human beings must meet certain
requirements to perform the examination. Many of the requirements are
based on the complexity of the tests performed. There are currently
three test categories: Waived, moderate complexity, including the
subcategory of physician-performed microscopy, and high complexity.
Following the publication on February 28, 1992 (57 FR 7002) of the
initial regulations implementing CLIA, HHS established a Clinical
Laboratory Improvement Advisory Committee (CLIAC) to advise and make
recommendations on technical and scientific aspects of the regulations.
The CLIAC is composed of individuals involved in the provision of
laboratory services, use of laboratory services, development of
laboratory testing devices or methodologies, and others as approved by
HHS. In addition, HHS has designated the following four CLIAC
subcommittees: cytology; personnel; proficiency testing, quality
control and quality assurance; and test categorization.
The CLIAC meets as needed, but not less than once a year. So far,
the CLIAC has met in October, 1992, February, May, August, and
December, 1993, and March and September, 1994. The subcommittee on test
categorization has met in January and June, 1993; the subcommittee on
cytology has met in December, 1993; and the subcommittee on proficiency
testing, quality control, and quality assurance has met in March and
September, 1994.
Following publication of the February 28, 1992 regulations, we
received approximately 16,000 letters from professional organizations
and individuals that provided around 71,000 comments. In response to
public comments received concerning certain physician performed
microscopy procedures, we requested the CLIAC to evaluate the
categorization of these tests. As a result, we developed a new
subcategory of moderate complexity testing, called physician-performed
microscopy (PPM) procedures, and published the requirements concerning
the subcategory in a rule on January 19, 1993 (58 FR 5215).
In this rule, we address the comments we received concerning the
application of certain personnel requirements and comments concerning
categorization of PPM tests. One area of commenter concern was that
currently employed supervisors and high complexity testing personnel
continue to be qualified. Another area of concern was that our
requirements would diminish access to services, particularly in rural
and underserved areas, leading to recommendations that we expand the
PPM procedures subcategory to include dentists and midlevel
practitioners.
II. Responses to Comments
A. Categorization: Physician-Performed Microscopy Procedures
As stated earlier, we established a new subcategory of moderate
complexity testing called ``physician-performed microscopy (PPM)
procedures'' in revisions to the CLIA regulations, published in the
Federal Register on January 19, 1993. In response to the regulation
establishing PPM, we received approximately 2,200 comments from
professional organizations and individuals. A significant number of
these comments addressed the tests categorized as PPM procedures,
including requests that some of these tests be waived, or that
additional tests be added to the list of PPM procedures. Some
commenters asked that PPM be expanded to include specific tests related
to a particular medical specialty or practice. Conversely, other
commenters were opposed to adding additional tests or criteria to PPM,
and felt that this subcategory should remain very limited.
Comments and Responses
Comment: A number of commenters stated that PPM is too restrictive,
and that all of the PPM procedures should be categorized as waived
tests. Some commenters specifically stated that wet mounts and urine
sediment examinations should not be in PPM but should be waived tests.
Response: Tests included in PPM are moderate complexity microscopic
examinations that do not meet the criteria for waiver because they are
not simple procedures; they require training and specific skills for
test performance. Personnel performing these tests must be proficient
in the use of a microscope and must be able to detect and identify
cellular elements present in a specimen, both of which require
substantial training, experience, and specific knowledge to be
accurately performed. To differentiate significant elements in a
specimen from debris or artifacts requires a high level of interpretive
skills. In fact, personnel requirements for this subcategory of
moderate complexity testing are more stringent than for other moderate
complexity testing due to the nature of testing in PPM. Examinations of
wet mount preparations and urine sediment were included in PPM because
they meet the PPM criteria. These microscopic examinations are
performed during a patient's physical examination on specimens that are
labile or not appropriate to send to another laboratory for analysis.
In addition, controls are generally not available to monitor the
complete testing process for these procedures. Therefore, only limited
activities are suitable for inspection.
Comment: Several commenters expressed confusion as to which
examinations are considered ``wet mount examinations''.
Response: We are revising the description of ``wet mount
examinations'' at Sec. 493.19(c)(1) (formerly Sec. 493.16(c)(1)), to
clarify what we mean by wet mount preparations. Although we provided
the examples of vaginal, cervical or skin specimens as part of the wet
mount definition, we never intended to limit wet mount examinations to
only these specimens. By revising the definition of this test, we are
not making any changes in what was originally intended for this group
of examinations. They are moderate complexity microscopic examinations
performed on any direct specimen that may be suspended in a drop of
water or saline. They are performed using a microscope, which is
limited to bright-field or phase-contrast, in order to recognize the
presence or absence of bacteria, fungi, parasites, and human cellular
elements (including red and white blood cells, epithelial cells, etc.)
and to differentiate these from artifacts. They are not procedures in
which definitive identification or enumeration is made or any staining
is performed. [[Page 20037]]
Comment: A number of commenters requested that additional tests be
added to PPM. Microscopic tests that were suggested include synovial
fluid analysis, qualitative and quantitative semen analysis, nasal
smears or sputum for eosinophils or basophils, wet mount examination of
prostatic fluid or secretions, stools for leukocytes, scabies
examinations, Gram stain, Tzanck preparations, white blood cell counts
and leukocyte differentials, microscopic examinations of hair
morphology, dark-field examinations and molluscum smears. A number of
non-microscopic procedures were also requested, including microbiology
cultures, serum glucose and BUN levels, qualitative drug screens, a
variety of serologic tests, and miscellaneous tests performed using
hand-held or elementary instrumentation.
Other organizations and professionals were opposed to adding tests
or criteria to PPM. Two organizations suggested explicit language to
limit procedures included in PPM to specific microscopic examinations
and exclude any testing that involves automated instrumentation or
biochemical reactions.
Response: Tests in PPM are limited to specific microscopic
examinations that are moderately complex procedures and meet the
criteria for PPM. Most of the tests named by commenters for addition to
PPM do not meet these established criteria. However, nasal smear
examinations for granulocytes, fecal leukocyte examinations, and
qualitative semen analysis (limited to the presence or absence of sperm
and detection of motility) do meet the criteria for inclusion in PPM.
They are all moderate complexity microscopic examinations that are
performed during the course of a patient examination. They are
performed on labile specimens, require very limited specimen processing
and handling, and controls are not available to monitor the entire
testing process. Fecal leukocyte examinations and qualitative semen
analyses are actually forms of wet mount examinations. The CLIAC
recommended that these three examinations be included in PPM, and HHS
agrees with CLIAC that these procedures meet the PPM criteria. The
other examination that the CLIAC recommended be added to PPM, the wet
mount examination of expressed prostatic secretions, is now included in
PPM because it meets the clarified definition of wet mounts in
Sec. 493.19(c)(1). Tests that the CLIAC reviewed, and recommended not
be included in PPM, are the Gram stain, quantitative semen analysis,
histodermatology slides, white blood cell (WBC) differential, and
polarization of synovial fluid for crystals. These examinations do not
meet the criteria for inclusion in the PPM subcategory. The
quantitative semen analysis, histodermatology slides, and polarization
of synovial fluid for crystals are all high complexity procedures.
Although some Gram stains and WBC differentials are categorized as
moderate complexity, these examinations do not meet the additional
criteria required for inclusion in PPM. They are not performed on
labile specimens, and quality control materials are readily available
for Gram stains and WBC differentials. Both of these examinations are
performed on specimen preparations that must be stained in order to
differentiate and identify cellular elements. These staining procedures
require multiple, critical steps. Therefore, HHS concurs with the CLIAC
recommendations that these tests not be included in the PPM
subcategory, and has not added these tests to the list of PPM
examinations.
Comment: Several organizations requested that tests relevant to
specific medical specialties, including pediatrics, internal medicine,
family practice, rheumatology, and infectious disease, be added to PPM
for physicians with appropriate training.
Response: The CLIAC considered a proposal by HHS to expand PPM to
include additional medical specialty-specific microscopic examinations
when performed by physicians with specialty training. The CLIAC
recommended that PPM not be expanded to include medical specialty-
specific procedures, due to the difficulty in establishing a mechanism
to assure adequate training and competency in performing each of these
specialized procedures. HHS agrees with this recommendation and we have
not added medical specialty-specific procedures to PPM; however,
physicians may continue to perform these procedures in accordance with
the applicable requirements for the level of complexity in which the
test is categorized.
Comment: One organization stated that, in order to contain costs,
physicians should be able to perform essential laboratory tests in
their offices without restrictions and recommended that a free-standing
physician category be established with the range of tests performed in
each laboratory based on the physician's specialty, training and
experience. The organization indicated that there should be no specific
test list; any testing other than cytopathology would be included in
this category. Testing could be performed by the physician, or by other
personnel under the direction and control of the physician. Quality
control and proficiency testing would be required, and laboratories
would be subject to on-site inspections if it was suspected that they
were not in compliance with the regulations.
Response: The CLIA regulations were developed in an effort to
ensure the quality of laboratory services in every testing situation
and assure that accurate and reliable testing is available to all
patients. To do this, minimum requirements were established for
laboratory testing that, in accordance with the law, depend on the
complexity of the procedures being performed and are independent of the
testing location. As test procedures become more complex, more
stringent testing requirements are imposed. PPM contains a unique group
of microscopic procedures that are routinely performed in the course of
a patient examination. They are tests for which it is difficult to
enforce regulatory requirements because biological controls that
monitor the entire testing process are not readily available and
because the inspection process would interfere with a patient
examination. The PPM subcategory was established to exempt physicians
(and, as discussed below, mid-level practitioners and dentists are now
included) from the requirement for routine inspections if the PPM
procedures are the only tests, in addition to waived tests, that they
perform. Physicians, mid-level practitioners, and dentists are not
prohibited from performing other laboratory procedures in their offices
or clinics. However, for procedures that can be regulated through an
inspection process, routine inspections are required, since this is one
mechanism to assure that the quality of testing is maintained.
Changes to the Regulations
In this regulation, we have moved the PPM subcategory, formerly
located at Sec. 493.16, to a new Sec. 493.19.
In the list of PPM procedures now located at Sec. 493.19(c), we are
changing the description of wet mounts at Sec. 493.19 (c)(1) to clarify
the types of examinations that are included in this procedure. Also, to
the list of PPM procedures, we are adding three tests: nasal smears for
granulocytes, fecal leukocyte examinations, and qualitative semen
analysis (limited to the presence or absence of sperm and detection of
motility). [[Page 20038]]
Other Revisions to the Regulations
Currently, PPM procedures are subsumed in the category of moderate
complexity, with changes made to moderate complexity testing
requirements as needed. To aid readers in finding requirements
pertinent to their needs, we have created a discrete subcategory of
requirements for PPM procedures, by breaking out the requirements for
PPM as necessary.
Currently, a laboratory that meets the requirements to perform high
or moderate complexity tests is issued a ``certificate''. We also have
certificates for PPM procedures. For clarity, to distinguish between
the generic use of the word certificate and the type of certificate
issued to a laboratory that performs tests of moderate or high
complexity, or both, we are changing ``certificate'' (for tests of
moderate or high complexity, or both) to ``certificate of compliance.''
This is the certificate that will be issued following the determination
of successful compliance with the CLIA regulations for testing that
includes moderate and/or high complexity. Where necessary, we make
revisions concerning each specific certificate and/or subcategory
(including waived tests). We are changing, as required, references to
specific certificates to refer to ``appropriate'' certificates.
We make these technical changes in the following existing sections
and headings: Secs. 493.2, definition of ``certificate'' under ``CLIA
certificate''; 493.3(a)(1); 493.5(a)(2) and (c) (formerly 493.10);
493.20(a) and (b); 493.25(c) (formerly 493.25(d)); subpart C heading;
493.43 heading and paragraph (a); 493.45 introductory paragraph and
paragraphs (a)(1), (2) and (3) (the last is deleted) and (d) and (f);
493.49; 493.51 heading, introductory paragraph, and paragraphs (b) and
(c); 493.55(a); 493.57 introductory paragraph and subparagraph
(b)(1)(ii); 493.511(h); 493.521(j); 493.602; 493.638; 493.639(b);
493.643(d); 493.645 heading and paragraph (c) (redesignated from
paragraph (a)(2)); 493.646(a); 493.649(a) and (b); subpart H heading;
493.803(a); 493.807 heading; subheading preceding 493.821; subpart I
heading; subpart J heading; 493.1101, including the heading; subpart K
heading; 493.1201 heading; subpart M heading; subpart P heading;
493.1701, including heading; 493.1777 heading, introductory paragraph
and paragraphs (a) and (g); 493.1814(b)(3); 493.1834(b) and
(f)(2)(iii); 493.1836(c)(2) and (3); and 493.2001.
B. Personnel
1. Physician-Performed Microscopy Procedures
Comment: Approximately 68 percent of the 2,200 comments received in
response to the regulation establishing PPM addressed personnel
requirements, especially expansion of the PPM subcategory to include
other health care practitioners. The comments were divided between
individuals who suggested expansion of PPM to include other health care
professionals and those commenters who believed that PPM should be
limited to physicians. While national laboratory organizations and
individual laboratory professionals commented that PPM should be
limited to physicians, professional organizations representing
physicians and midlevel health care practitioners stated that PPM
should be expanded to include other health care providers. We also
received comments requesting that dentists be included in PPM to allow
them to perform wet mount examinations as part of their dental
evaluations.
Several commenters representing physicians and midlevel health care
practitioners included information and responded to questions posed in
the preamble to the January 19, 1993, Federal Register rule creating
the PPM subcategory. In that publication, we specifically asked
commenters to comment on the type of health care professionals who
usually perform the PPM tests as part of a physical examination, how
often the tests are performed, and the quality, access and cost
implications in establishing the PPM subcategory.
The commenters who responded to these questions stated that
depending on the type of health care setting, physicians, or quite
often nurse practitioners, nurse midwives, or physician assistants,
perform physical examinations and the laboratory tests related to these
examinations. In some cases, State laws authorize these midlevel
practitioners to practice independently. These commenters added that,
because of the variety of settings, it is impossible to estimate the
percentage of testing done by each group of health professionals.
However, they did say that many midlevel practitioners perform patient
examinations and certain microscopic tests on a daily basis and in
equal or greater numbers than physicians in some places. They also said
that midlevel practitioners receive the training needed to perform
these tests and the quality of their test results is at least
equivalent to testing performed by physicians. Commenters indicated
that, in addition to the physicians and the midlevel practitioners
listed above, emergency personnel, registered nurses, licensed
practical nurses, and medical assistants perform PPM tests. Commenters
indicated that although the cost of testing might vary, this was not
related to who performed the test.
Lastly, the commenters stressed that the quality, cost and access
implications of not including midlevel practitioners under the
certificate for the PPM subcategory were extensive, especially in rural
areas, among low-income populations, and in other areas where there is
a shortage of physicians. In some of these settings, midlevel
practitioners are the only available health care providers. Excluding
these professionals from obtaining a certificate for the PPM
subcategory has substantial cost implications. Since laboratories that
have a certificate for the PPM subcategory are not subject to fees for
routine inspections, the cost of providing services under the PPM
certificate is lower than under a certificate of compliance. If
facilities cannot afford to provide testing under a certificate of
compliance, patient access to health care would be limited.
Response: In considering these comments, we sought the advice of
the CLIAC. In an effort to provide an opportunity for public discussion
and consideration of these issues, we scheduled two CLIAC meetings on
the PPM subcategory. Presentations were made by HHS, and the public was
invited to comment and provide information. The CLIAC recommended that
individuals and organizations representing practitioners seeking to be
included in the PPM subcategory submit documentation concerning the
specific course work and the amount of training such individuals
receive in the performance of microscopic examinations. Over 100
individuals and organizations responded to the request for information,
with many of the commenters providing documentation of specific
training curricula in microscopic procedures. The CLIAC asked CDC to
evaluate the materials submitted. In reviewing the training programs of
nurse midwives, nurse practitioners and physician assistants, CDC
concluded that these practitioners, like physicians, perform the
procedures currently included in the PPM subcategory in conjunction
with patient evaluations, and the training they receive in microscopic
examinations is comparable to that of physicians. The CLIAC considered
this information and recommended that midlevel practitioners, defined
as nurse [[Page 20039]] practitioners, nurse midwives, and physician
assistants, be included in the PPM subcategory. The CLIAC suggested
that these midlevel practitioners be permitted to perform PPM
procedures under the supervision of a physician or to function
independently in States that authorize individual practice.
In view of the CLIAC recommendation and the CDC evaluation that
nurse midwives, nurse practitioners and physician assistants receive
sufficient training to properly perform and interpret the microscopic
examinations currently included in the PPM subcategory, we are adding
midlevel practitioners to the PPM subcategory. We define them in
Sec. 493.2 as nurse practitioners, nurse midwives and physician
assistants, licensed by a State if such licensing is required.
As a result of the comments received, we also considered the
inclusion of dentists in the PPM subcategory. After evaluating the
education and training that dentists receive in clinical laboratory
procedures, we concluded that dentists, with either a Doctor of Dental
Medicine (DDM) or Doctor of Dental Surgery (DDS) degree, are qualified
to perform the examinations in the PPM subcategory and we are adding
dentists as persons who may perform PPM procedures.
Upon evaluation of the education and training of emergency
personnel, registered nurses, licensed practical nurses, and medical
assistants, we determined that these practitioners do not receive
sufficient training to properly perform and interpret the microscopic
examinations currently included in the PPM subcategory. For this
reason, we are not adding them as persons who may perform PPM
procedures.
Changes to the Regulations
To accommodate the above additions, we are changing the name from
``physician-performed microscopy procedures'' to ``provider-performed
microscopy procedures.''
To be consistent with other personnel requirements, we are moving
the personnel requirements for the PPM subcategory, formerly located at
Sec. 493.16(e)(2) (Sec. 493.16(e)(3) is redesignated as
Sec. 493.19(e)(2)), to subpart M. At Sec. 493.1355, we are specifying
the condition requirements for laboratory director of PPM procedures,
with director qualification requirements located at Sec. 493.1357 and
director responsibilities at Sec. 493.1359. To the director
responsibility requirements, we are adding the requirement limiting the
number of laboratories that an individual can direct to five, which was
inadvertently not included in previous regulations; currently,
directors of laboratories performing other moderate complexity testing
may only direct five. The condition requirements for testing personnel
performing PPM procedures are now located at Sec. 493.1361, while
testing personnel qualifications are located at Sec. 493.1363 and
responsibilities are at Sec. 493.1365.
We are also making numerous conforming changes to part 493 to
accommodate the revision to include midlevel practitioners and
dentists. We are revising the following additional sections and
headings: Secs. 493.2--definition of ``CLIA certificate--certificate
for physician-performed microscopy procedures'' by adding ``dentist''
and ``midlevel practitioner'', and revising ``physician'' (for
consistency to include doctors of osteopathy and to require the
physician to be licensed in the State in which the laboratory is
located); 493.20(b); 493.25(c) (redesignated from 493.25(d)); heading
for subpart C; 493.43 heading; 493.45(a)(2); 493.47; 493.49(a)(3);
493.53 heading and introductory paragraph; 493.638; 493.639(b);
493.643(a); 493.646(a); 493.1776 heading and paragraphs (a) (3) and (4)
and (b); 493.1814(b)(3); 493.1834(b) and (f)(2)(iii); and 493.1836(c)
(2) and (3).
2. General Discussion of General Supervisor and High Complexity Testing
Personnel Comments
In response to the personnel requirements contained in the final
regulations published February 28, 1992, we received approximately
55,000 comments from individuals and organizations. The qualification
requirements for general supervisor and high complexity testing
personnel received the most extensive comments. Approximately 8,000
comments concerned general supervisor, 14,000 comments related to high
complexity testing personnel and more than 10,000 comments pertained to
testing personnel, with the complexity of testing not specified. Some
commenters indicated that the regulations were too stringent, while
others thought the requirements were too lenient. Among the commenters
who thought that the minimum qualifications should be raised, there was
a general consensus that the increase in requirements should be
prospective and that the regulations should include alternative
qualifying pathways to avoid affecting currently employed individuals
adversely. Many commenters were concerned that the regulations would
eliminate the jobs of many laboratory employees who possess extensive
work experience but lack the requisite degree or formal laboratory
training. This would particularly exacerbate the shortage of qualified
laboratory personnel in rural and underserved areas and limit patient
access to testing.
In evaluating the many comments, we sought advice from the CLIAC
concerning whether changes were needed in the regulations pertaining to
general supervisor and high complexity testing personnel. Many
individuals and organizations provided detailed information and
suggestions to CLIAC about the qualifications that should be required
for supervision and performance of high complexity testing. The CLIAC
recommended revising the regulations to recognize currently employed
individuals who do not meet the qualifications contained in the final
regulations but who have clinical laboratory training and extensive
laboratory experience.
We acknowledge that extensive experience can qualify individuals to
competently perform these functions. Therefore, in response to the
comments provided to the regulations published February 28, 1992, and
to the CLIAC advice, and to mitigate the impact of the regulations on
currently employed people, especially those in rural and underserved
areas, we are making in this regulation the changes necessary to
provide alternative qualification pathways.
We are revising the general supervisor (Sec. 493.1461) and high
complexity testing personnel (Sec. 493.1489) requirements to: qualify
individuals currently performing high complexity testing and those
currently employed general supervisors if they have the requisite
laboratory training or experience; recognize 50-week U.S. military
medical laboratory training programs and accredited laboratory training
programs; and establish equivalent requirements for the associate
degree. More specific comments and responses concerning revisions to
the regulations to create alternative qualifications for general
supervisor and high complexity testing personnel follow.
We also are making conforming cross-reference changes to
Secs. 493.1463 and 493.1495.
3. Specific Comments and Responses
General Supervisor Qualifications
Comment: Although many commenters agreed that the minimum
requirement for general supervisor should be an associate degree in
clinical laboratory science or medical laboratory technology, others
indicated that the [[Page 20040]] requirement should be an associate
degree with area of study not specified. Some commenters said that
requirements equivalent to the associate degree should be established.
Several commenters indicated that individuals having a bachelor of arts
or education degree with a specified number of science courses should
be qualified.
Response: We agree with the commenters who suggested the
establishment of requirements equivalent to the associate degree with
appropriate study in the sciences because we believe individuals who
have completed the requisite courses and training are qualified to
supervise high complexity testing. In this regulation, we are defining
the following as equivalent to the academic requirements for an
associate degree: 60 semester hours, which must include either 24
semester hours of medical laboratory technology courses or 24 semester
hours of science courses that include six semester hours of chemistry,
six semester hours of biology, and twelve semester hours of courses in
chemistry, biology or medical laboratory technology, or any
combination. In addition, individuals must have completed either an
accredited clinical laboratory or medical laboratory training program
(which may be included in the 60 semester hours specified above) or
three months of documented training in each specialty in which the
individual performs high complexity testing. We are specifying the
equivalent requirements for the associate degree under high complexity
testing personnel, which are adopted by cross-reference to the general
supervisor requirements. Therefore, individuals who do not have a
degree or who have a bachelor's degree that is not in a science can now
qualify as a general supervisor if they meet the equivalency
requirements for an associate degree and have at least two additional
years of laboratory training or experience in high complexity testing.
Comment: Many commenters recommended qualifying medical laboratory
technicians without an associate degree to serve as general supervisor.
Some commenters recommended qualifying individuals, including certified
laboratory assistants, who received training in an accredited hospital
or approved technical school training program. Other commenters
recommended qualifying individuals with military training.
Response: We agree with the commenters that the regulations should
recognize individuals who were serving as a general supervisor of high
complexity testing on or before September 1, 1992 (the effective date
of the CLIA personnel regulations) but do not have an associate degree,
or equivalent, provided they have completed an accredited clinical
laboratory training program. We believe individuals having this
training and experience have the appropriate qualifications to serve as
a general supervisor. Therefore, we are adding a provision to the
general supervisor qualification requirements to qualify individuals
who, on or before September 1, 1992, were serving as a general
supervisor of high complexity testing. The individual must on or before
April 24, 1995, have completed a 50-week U.S. military medical
laboratory training program or have graduated from a medical laboratory
or clinical laboratory training program accredited by the Accrediting
Bureau of Health Education Schools, Commission on Allied Health
Education Accreditation or other organization approved by HHS. To help
assure equivalency to other qualification pathways, individuals having
this type of training are required to have two additional years of
laboratory training or experience in high complexity testing in order
to qualify as general supervisor. This additional training or
experience may be acquired before or after completing the accredited or
U.S. military medical laboratory training program.
Comment: Several commenters misread the regulations and thought
that individuals qualified under regulations published March 14, 1990
(55 FR 9576) were required to obtain an associate degree.
Response: Individuals who qualified as general supervisors under
the previous Federal regulations are qualified under these regulations
and are not required to obtain an associate degree.
Comment: Some commenters recommended that all laboratory personnel
currently employed as general supervisors be qualified through a
``grandfather'' provision.
Response: We agree with the commenters and the CLIAC recommendation
that regulations should include provisions to allow currently employed
supervisors who have pertinent laboratory experience to continue their
employment. We are adding a provision to the general supervisor
requirements to qualify high school graduates, or equivalent, who, on
or before September 1, 1992, were serving as a general supervisor and
have at least ten years of laboratory training or experience in high
complexity testing, including at least 6 years of supervisory
experience in high complexity testing within the last 10 years because
we believe this amount of experience is appropriate to qualify
individuals as general supervisors and is commensurate with the general
supervisor responsibility requirements.
Comment: A few commenters agreed with the responsibilities for
general supervisor, while a few commenters disagreed. Most of the
commenters who disagreed with the responsibilities were opposed to
requiring the general supervisor to be onsite when high complexity
tests are performed by personnel who do not have at least an associate
degree. Conversely, many commenters indicated that an individual with
an associate degree should be allowed to perform high complexity
testing only when a technologist or supervisor is onsite.
Response: In the revised regulation published in the Federal
Register on January 19, 1993, we changed the requirement for onsite
supervision to require 24-hour review of any high complexity testing
performed by personnel who do not have at a minimum an associate degree
and were performing high complexity testing on or before January 19,
1993. However, in the January 19, 1993 regulation, we retained the
onsite supervision requirement for those high school graduates, or
equivalent, who began performing high complexity testing after January
19, 1993. In this regulation, we are not changing the requirements for
onsite supervision or 24-hour review. However, we believe individuals
who have completed accredited or 50-week U.S. military medical
laboratory training programs or have academic qualifications equivalent
to the associate degree are qualified to perform high complexity
testing. Therefore, we are revising the regulations to qualify as high
complexity testing personnel individuals having these qualifications.
Individuals who qualify under these new provisions may perform high
complexity testing without onsite supervision or 24-hour review.
We do not agree with the commenters that onsite supervision should
be required for high complexity testing performed by individuals having
an associate degree; such a requirement would be unnecessarily
burdensome and could exacerbate personnel shortages and limit patient
access to testing. It should be emphasized that these are minimum
requirements that do not restrict laboratories from establishing their
own policies requiring higher personnel qualifications. In all cases,
the laboratory director is responsible for ensuring that all testing
[[Page 20041]] personnel have the necessary education and training or
experience required for test performance.
Testing Personnel Qualifications (High Complexity)
Comment: Numerous commenters believed an associate degree in
laboratory science or medical laboratory technology should be the
minimum education requirement. Several commenters suggested recognizing
associate degrees in fields other than clinical laboratory science or
medical laboratory technology, with others suggesting equivalent
requirements be established for the associate degree.
Response: Currently, the qualification requirements for high
complexity testing personnel contain provisions that prospectively
require high school graduates to obtain an associate degree. As
mentioned above, in evaluating the comments received concerning high
complexity testing personnel, we sought the advice of the CLIAC about
the appropriateness of the qualifications required. The CLIAC
recommended that the associate degree be established as the minimum
education requirement and, in addition, that equivalent academic
requirements be established for the associate degree. In this
regulation, we are adding a provision to qualify individuals who have
completed specific college courses but do not have an associate degree
or who have an associate degree that is not in medical laboratory
technology or a laboratory science. As previously mentioned, we have
defined requirements equivalent to the associate degree (60 semester
hours that must include 24 semester hours of medical laboratory
technology courses or 24 semester hours of science courses that include
six semester hours of chemistry, six semester hours of biology and
twelve semester hours of courses in chemistry, biology or medical
laboratory technology, or any combination); individuals qualifying
under the equivalency provisions also must have completed either an
accredited clinical laboratory or medical laboratory training program
(which may be included in the 60 semester hours) or three months of
documented training in each specialty in which the individual performs
high complexity testing. The laboratory training may be acquired
before, during or after completing the academic requirements.
Comment: Many commenters recommended recognizing medical laboratory
technicians without an associate degree. Commenters also recommended
qualifying individuals, including certified laboratory assistants, who
received training in an accredited hospital or technical school
training program. A large number of commenters suggested qualifying
individuals with military training.
Response: We agree with the commenters that, in addition to the
revisions made to the general supervisor requirements, revisions are
needed in the qualification requirements for high complexity testing
personnel to recognize individuals who have completed a nondegree
clinical laboratory training program and, therefore, have equivalent
training. Therefore, we are adding to the high complexity testing
personnel requirements, a provision to qualify individuals who, on or
before April 24, 1995 have completed a 50-week U.S. military medical
laboratory training program or have graduated from a medical laboratory
or clinical laboratory training program accredited by the Accrediting
Bureau of Health Education Schools, Commission on Allied Health
Education Accreditation or other organization approved by HHS.
Comment: A number of commenters recommended that the regulations be
revised to qualify all currently employed high complexity testing
personnel. Other commenters said currently employed high school
graduates, who were trained on the job, should be allowed to continue
performing high complexity testing but only under supervision.
Response: We agree with the CLIAC recommendation that the
regulations should be revised to alleviate the impact on currently
employed personnel. We also believe that high school graduates with
appropriate training, who were performing high complexity testing on or
before April 24, 1995 have obtained sufficient work experience to allow
them to continue performing testing with supervisory oversight.
Therefore, we are revising the regulations to allow these individuals
to continue performing high complexity testing even after September 1,
1997 (the current limit) and do not require that they obtain additional
training or education. However, performance of any high complexity
testing by these individuals must be in accordance with the supervision
requirements discussed below.
Comment: A few commenters agreed with the responsibility
requirements for high complexity testing personnel, while numerous
commenters disagreed. The majority of the commenters who disagreed were
opposed to requiring onsite supervision when individuals who do not
have an associate degree perform high complexity testing.
Response: As previously mentioned above under the discussion of
qualifications of the general supervisor, in the regulation published
in the Federal Register on January 19, 1993, we changed the requirement
for onsite supervision to only require 24-hour review of any high
complexity testing performed by personnel who do not have an associate
degree and who were performing high complexity testing on or before
January 19, 1993. The onsite supervision requirement was retained only
for those high school graduates, or equivalent, who began performing
high complexity testing after January 19, 1993. In this regulation, we
are not changing the requirements for onsite supervision or 24-hour
review. However, we believe individuals who have completed accredited
or U.S. military laboratory training programs or have qualifications
equivalent to the associate degree and have appropriate laboratory
training are qualified to perform high complexity testing without
supervision. Therefore, we are revising the qualification requirements
for high complexity testing personnel to allow individuals having these
qualifications to perform high complexity testing without onsite
supervision or 24-hour review.
III. Other Revisions
We are making the following technical changes in addition to those
discussed above:
<bullet> We are making minor editorial changes to improve clarity
and remove redundancies. This includes removing Secs. 493.610, 493.614,
493.618, 493.622, 493.626, 493.629, 493.630, 493.631, 493.632, 493.633
and 493.634.
<bullet> We are revising the definition of ``certificate of
registration'' in Sec. 493.2 to exclude reference to laboratories that
are exempt from CLIA requirements because they are licensed by a HCFA-
approved laboratory licensure program: these laboratories are not
required to obtain a registration certificate.
<bullet> From the definition of ``physician'' in Sec. 493.2 we are
deleting the phrase ``or equivalent degree'' as there are no degrees
equivalent to doctor of medicine, osteopathy or podiatric medicine.
<bullet> To Secs. 493.35(d)(2) and 493.37(b)(2) we are adding a
requirement that a laboratory seeking a certificate of waiver must
permit announced inspections by HHS (as well as unannounced) because it
was inadvertently omitted from the January 19, 1993 rule.
<bullet> In Secs. 493.35(d)(2)(iv), 493.49(b)(2)(iv),
493.1776(a)(4) and 493.1776(b)(4)(iv), we indicate that we will collect
information during [[Page 20042]] inspections to determine the
``appropriateness'' of tests, rather than their ``addition, deletion or
continued inclusion''.
<bullet> In Sec. 493.602 we clarify Federal validation survey
activity to include accredited laboratories and change ``State-exempt''
to ``CLIA exempt'' to agree with references that were changed in
previous regulations.
<bullet> In Secs. 493.638, 493.639, and 493.645(c), we revise the
text so that it more accurately reflects what costs fees do and do not
cover; for example, they do cover the cost of categorizing tests.
<bullet> In the title of Sec. 493.645 and paragraph (a) we are
changing the word ``licensure'' to ``laboratory'' and, in paragraph
(a), ``State-exempt'' to ``CLIA-exempt'' to conform to changes made in
previous regulations.
IV. Waiver of Delay in Effective Date
We find good cause to waive the usual 30-day delay in effective
date for most of the revisions. Those persons who become qualified
under the revised regulations are no less qualified now than they will
be in 30 days. Hence, it serves no purpose to delay our regulations.
Other revisions are very technical in nature and to delay their
effective date is also unnecessary. Also, under the provisions of the
current regulations, revisions of the list of PPM tests may be done
outside of a rulemaking process through publication of a Federal
Register notice that does not require a 30 day delay. As indicated
earlier, we also will consider comments received on the addition of
three new PPM procedures. Therefore, we find good cause to waive the
delay in effective date of this rule.
V. Response to Comments
Because of the large number of items of correspondence we normally
receive on Federal Register documents published for comment, we are not
able to acknowledge or respond to them individually. We will consider
all comments we receive by the date and time specified in the DATES
section of this preamble, and, if we proceed with a subsequent
document, we will respond to the comments in the preamble to that
document.
VI. Collection of Information Requirements
The portions of Secs. 493.7, 493.35, 493.39, 493.43, 493.53,
493.55, and 493.57 of this document that have been revised contain
information collection and recordkeeping requirements that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.). These
reporting and recordkeeping requirements are not effective until a
notice of OMB's approval is published in the Federal Register. The
information collection requirements concern the performance of
recordkeeping. The respondents who will provide the information include
any entity performing laboratory testing used for assessment,
diagnostic or treatment purposes. Public reporting burden for this
collection of information is estimated to be 61 hours per laboratory
per year.
Organizations and individuals desiring to submit comments on the
information collection and recordkeeping requirements should direct
them to the OMB official whose name appears in the ADDRESSES section of
this preamble.
VII. Regulatory Impact Statement
Background
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 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 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.
General
This rule modifies CLIA regulations published February 28, 1992 and
January 19, 1993. There are approximately 157,000 entities enrolled
under CLIA that may be affected by the provisions of this rule. The
significance of the effect will vary depending on the volume and
complexity of tests performed; whether the entity employs midlevel
practitioners to perform provider-performed microscopy (PPM)
procedures; and whether employees meet the personnel requirements
contained in the February 28, 1992 regulations. While we cannot
estimate the number of entities that may make changes in their
laboratory testing practices as a result of this rule, we believe the
modifications to the CLIA program will benefit the affected entities in
several ways. This rule will help to ease implementation of the CLIA
program at no loss to public health and safety by offering alternative
qualification standards for laboratory employees who would be adversely
affected by the original personnel requirements. It also increases
patient access to laboratory services, especially in rural and
underserved areas, by expanding the list of personnel qualified to
conduct certain laboratory tests. In addition, it reduces the
regulatory burden for laboratories by enabling them to provide an
expanded menu of tests under a PPM certificate without incurring the
costs associated with obtaining a certificate of compliance.
Categorization of Tests
Expanding the list of PPM procedures may affect a laboratory's
choice of certificate. Laboratories with certificates for PPM are not
subject to costs associated with the routine inspections required under
a certificate of compliance. Therefore, laboratories holding a
certificate of compliance that change to a certificate for PPM will
have a decrease in compliance costs and the number of inspections.
Certificate of waiver laboratories choosing to expand their test menu
to include PPM procedures and obtain a certificate of PPM will have
increased certificate fees, as well as additional costs inherent in
meeting applicable requirements, such as personnel and proficiency
testing. The current biennial fee for a certificate of waiver is $100,
as compared to $150 for a certificate for PPM. Although the cost of
obtaining a certificate for PPM is more than for a certificate of
waiver, it is less than the cost associated with a certificate of
compliance.
Provider-Performed Microscopy Procedures
All providers performing microscopy examinations in conjunction
with patient evaluations may be affected by the expansion of the
subcategory of microscopy procedures to include midlevel health care
practitioners and dentists. Many midlevel practitioners routinely
perform patient examinations and associated laboratory testing, and in
some States, are authorized to practice independently. Because there is
such a wide variety of settings in which these services are offered, we
cannot quantify the percentage of tests done by each type of health
professional. However, there are no data to indicate that the quality
of their tests results is not at least equivalent to the tests
performed [[Page 20043]] by physicians. As a result of this expansion,
patient access to care and services will increase, particularly in
rural and underserved areas where there are shortages of physicians
and, as many commenters pointed out, midlevel practitioners are the
only health care providers available.
Personnel Requirements
As a result of our evaluation of the 32,000 comments received on
the general supervisor and testing personnel requirements contained in
the February 28, 1992 regulations, and after consultation with the
CLIAC, we are revising the regulations to mitigate the impact of the
regulations on currently employed individuals. Adding alternative
qualification standards to the general supervisor and high complexity
testing personnel requirements enables currently employed individuals
with equivalent training and experience to continue to qualify for
these positions. As stated in the impact analysis that accompanied the
February 28, 1992 regulations, we recognize that flexibility is needed
by the laboratory industry to effectively take advantage of the
personnel resources available to it, and it was not our intention to
disenfranchise anyone currently employed. By providing equivalent
qualification standards, we will increase the available pool of
qualified laboratory personnel which will enable laboratories to meet
the certification requirements without compromising the health and
safety of patients. We expect many laboratories to benefit from this
revision to the regulations, especially those in rural and underserved
areas who are experiencing personnel shortages and the resultant
limited patient access to laboratory services.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 493
Grant programs--health, Health facilities, Laboratories, Medicaid,
Medicare, Reporting and recordkeeping requirements.
42 CFR part 493 is amended as set forth below:
PART 493--LABORATORY PROCEDURES
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 1861(s)(11), 1861(s)(12),
1861(s)(13), 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)(11), 1395x(s)(12), 1395x(s)(13), 1395x(s)(14),
1395x(s)(15), and 1395x(s)(16)).
2. Section 493.2 is amended by revising the definition of ``CLIA
certificate'' and ``physician'' and adding in alphabetical order
definitions of ``Dentist'' and ``Midlevel practitioner'' to read as
follows:
Sec. 493.2 Definitions.
* * * * *
CLIA certificate means any of the following types of certificates
issued by HCFA or its agent:
(1) Certificate of compliance means a certificate issued to a
laboratory after an inspection that finds the laboratory to be in
compliance with all applicable condition level requirements, or
reissued before the expiration date, pending an appeal, in accordance
with Sec. 493.49, when an inspection has found the laboratory to be out
of compliance with one or more condition level requirements.
(2) Certificate for provider-performed microscopy (PPM) procedures
means a certificate issued or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.47, to a laboratory in
which a physician, midlevel practitioner or dentist performs no tests
other than PPM procedures and, if desired, waived tests listed in
Sec. 493.15(c).
(3) Certificate of accreditation means a certificate issued on the
basis of the laboratory's accreditation by an accreditation
organization approved by HCFA (indicating that the laboratory is deemed
to meet applicable CLIA requirements) or reissued before the expiration
date, pending an appeal, in accordance with Sec. 493.61, when a
validation or complaint survey has found the laboratory to be
noncompliant with one or more CLIA conditions.
(4) Certificate of registration or registration certificate means a
certificate issued or reissued before the expiration date, pending an
appeal, in accordance with Sec. 493.45, that enables the entity to
conduct moderate or high complexity laboratory testing or both until
the entity is determined to be in compliance through a survey by HCFA
or its agent; or in accordance with Sec. 493.57 to an entity that is
accredited by an approved accreditation organization.
(5) Certificate of waiver means a certificate issued or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.37, to a laboratory to perform only the waived tests listed at
Sec. 493.15(c).
* * * * *
Dentist means a doctor of dental medicine or doctor of dental
surgery licensed by the State to practice dentistry within the State in
which the laboratory is located.
* * * * *
Midlevel practitioner means a nurse midwife, nurse practitioner, or
physician assistant, licensed by the State within which the individual
practices, if such licensing is required in the State in which the
laboratory is located.
* * * * *
Physician means an individual with a doctor of medicine, doctor of
osteopathy, or doctor of podiatric medicine degree who is licensed by
the State to practice medicine, osteopathy, or podiatry within the
State in which the laboratory is located.
* * * * *
3. In Sec. 493.3, the introductory text of paragraph (a) is
republished and paragraph (a)(1) is revised to read as follows:
Sec. 493.3 Applicability.
(a) Basic rule. Except as specified in paragraph (b) of this
section, a laboratory will be cited as out of compliance with section
353 of the Public Health Service Act unless it--
(1) Has a current, unrevoked or unsuspended certificate of waiver,
registration certificate, certificate of compliance, certificate for
PPM procedures, or certificate of accreditation issued by HHS
applicable to the category of examinations or procedures performed by
the laboratory; or
* * * * *
4. A new Sec. 493.5 is added to read as follows:
Sec. 493.5 Categories of tests by complexity.
(a) Laboratory tests are categorized as one of the following:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategory of PPM
procedures.
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of
moderate complexity, only PPM procedures, only tests of high complexity
or any combination of these tests.
(c) Each laboratory must be either CLIA-exempt or possess one of
the following CLIA certificates, as defined in Sec. 493.2:
(1) Certificate of registration or registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate of compliance. [[Page 20044]]
(5) Certificate of accreditation.
Sec. 493.10 [Removed]
5. Section 493.10 is removed.
Sec. 493.16 [Redesignated as Sec. 493.19]
6. Section 493.16 is redesignated as Sec. 493.19 and is revised to
read as follows:
Sec. 493.19 Provider-performed microscopy (PPM) procedures.
(a) Requirement. To be categorized as a PPM procedure, the
procedure must meet the criteria specified in paragraph (b) of this
section.
(b) Criteria. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the
following practitioners:
(i) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or an employee.
(ii) A midlevel practitioner, under the supervision of a physician
or in independent practice only if authorized by the State, during the
patient's visit on a specimen obtained from his or her own patient or
from a patient of a clinic, group medical practice, or other health
care provider of which the midlevel practitioner is a member or an
employee.
(iii) A dentist during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group dental
practice of which the dentist is a member or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the
microscope, limited to bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could
compromise the accuracy of the test result.
(5) Control materials are not available to monitor the entire
testing process.
(6) Limited specimen handling or processing is required.
(c) Provider-performed microscopy (PPM) examinations. A laboratory
may qualify to perform tests under this section if it restricts PPM
examinations to one or more of the following procedures (or additional
procedures added to this list as provided under paragraph (d) of this
section), waived tests and no others:
(1) All direct wet mount preparations for the presence or absence
of bacteria, fungi, parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations.
(3) Pinworm examinations.
(4) Fern tests.
(5) Post-coital direct, qualitative examinations of vaginal or
cervical mucous.
(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
(8) Fecal leukocyte examinations.
(9) Qualitative semen analysis (limited to the presence or absence
of sperm and detection of motility).
(d) Revisions to criteria and the list of PPM procedures.
(1) The CLIAC conducts reviews upon HHS' request and recommends to
HHS revisions to the criteria for categorization of procedures.
(2) HHS determines whether a laboratory procedure meets the
criteria listed under paragraph (b) of this section for a PPM
procedure. Revisions to the list of PPM procedures proposed by HHS are
published in the Federal Register as a notice with an opportunity for
public comment.
(e) Laboratory requirements. Laboratories eligible to perform PPM
examinations must--
(1) Meet the applicable requirements in subpart C or subpart D, and
subparts F, H, J, K, M, and P of this part.
(2) Be subject to inspection as specified under subpart Q of this
part.
7. Section 493.20 is revised to read as follows:
Sec. 493.20 Laboratories performing tests of moderate complexity.
(a) A laboratory may qualify for a certificate to perform tests of
moderate complexity provided that it restricts its test performance to
waived tests or examinations and one or more tests or examinations
meeting criteria for tests of moderate complexity including the
subcategory of PPM procedures.
(b) A laboratory that performs tests or examinations of moderate
complexity must meet the applicable requirements in subpart C or
subpart D, and subparts F, H, J, K, M, P, and Q of this part. Under a
registration certificate or certificate of compliance, laboratories
also performing PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(c) If the laboratory also performs waived tests, compliance with
subparts H, J, K, M, and P of this part is not applicable to the waived
tests. However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
8. In Sec. 493.25, paragraphs (c) and (d) are redesignated as (d)
and (c), respectively, and paragraphs (b), (c) and (d) are revised to
read as follows:
Sec. 493.25 Laboratories performing tests of high complexity.
* * * * *
(b) A laboratory performing one or more tests of high complexity
must meet the applicable requirements of subpart C or subpart D, and
subparts F, H, J, K, M, P, and Q of this part.
(c) If the laboratory also performs tests of moderate complexity,
the applicable requirements of subparts H, J, K, M, P, and Q of this
part must be met. Under a registration certificate or certificate of
compliance, PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(d) If the laboratory also performs waived tests, the requirements
of subparts H, J, K, M, and P are not applicable to the waived tests.
However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
9. In Sec. 493.35, paragraphs (a) and (d) are revised to read as
follows:
Sec. 493.35 Application for a certificate of waiver.
(a) Filing of application. Except as specified in paragraph (b) of
this section, a laboratory performing only one or more waived tests
listed in Sec. 493.15 must file a separate application for each
laboratory location.
* * * * *
(d) Access requirements. Laboratories that perform one or more
waived tests listed in Sec. 493.15(c) and no other tests must meet the
following conditions:
(1) Make records available and submit reports to HHS as HHS may
reasonably require to determine compliance with this section and
Sec. 493.15(e);
(2) Agree to permit announced and unannounced inspections by HHS in
accordance with subpart Q of this part under the following
circumstances:
(i) When HHS has substantive reason to believe that the laboratory
is being operated in a manner that constitutes an imminent and serious
risk to human health.
(ii) To evaluate complaints from the public.
(iii) On a random basis to determine whether the laboratory is
performing tests not listed in Sec. 493.15.
(iv) To collect information regarding the appropriateness of waiver
of tests listed in Sec. 493.15.
* * * * *
10. In Sec. 493.37, the introductory text of paragraph (b) is
republished and paragraphs (b)(2) and (g) are revised to read as
follows:
Sec. 493.37 Requirements for a certificate of waiver.
* * * * * [[Page 20045]]
(b) Laboratories issued a certificate of waiver--
* * * * *
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part.
* * * * *
(g) A laboratory with a certificate of waiver that wishes to
perform examinations or tests not listed in the waiver test category
must meet the requirements set forth in subpart C or subpart D of this
part, as applicable.
11. In Sec. 493.39, the introductory paragraph is republished and
paragraph (a) is revised to read as follows:
Sec. 493.39 Notification requirements for laboratories issued a
certificate of waiver.
Laboratories performing one or more tests listed in Sec. 493.15 and
no others must notify HHS or its designee--
(a) Before performing and reporting results for any test or
examination that is not specified under Sec. 493.15 for which the
laboratory does not have the appropriate certificate as required in
subpart C or subpart D of this part, as applicable; and
* * * * *
12. The heading of subpart C is revised to read as follows:
Subpart C--Registration Certificate, Certificate for Provider-
performed Microscopy Procedures, and Certificate of Compliance
13. In Sec. 493.43, the heading and paragraph (a) are revised to
read as follows:
Sec. 493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and certificate of
compliance.
(a) Filing of application. Except as specified in paragraph (b) of
this section, all laboratories performing tests of moderate complexity
(including the subcategory) or high complexity, or any combination of
these tests, must file a separate application for each laboratory
location.
* * * * *
14. In Sec. 493.45, a new introductory paragraph is added, the
introductory paragraph (a) is republished, paragraph (a)(3) is removed,
and paragraphs (a)(1), (a)(2), (d), and (f) are revised to read as
follows:
Sec. 493.45 Requirements for a registration certificate.
Laboratories performing only waived tests, PPM procedures, or any
combination of these tests, are not required to obtain a registration
certificate.
(a) A registration certificate is required--(1) Initially for all
laboratories performing test procedures of moderate complexity (other
than the subcategory of PPM procedures) or high complexity, or both;
and
(2) For all laboratories that have been issued a certificate of
waiver or certificate for PPM procedures that intend to perform tests
of moderate or high complexity, or both, in addition to those tests
listed in Sec. 493.15(c) or specified as PPM procedures.
* * * * *
(d) In accordance with subpart R of this part, HHS will initiate
suspension or revocation of a laboratory's registration certificate and
will deny the laboratory's application for a certificate of compliance
for failure to comply with the requirements set forth in this subpart.
HHS may also impose certain alternative sanctions. In addition, failure
to meet the requirements of this subpart will result in suspension of
payments under Medicare and Medicaid as specified in subpart R of this
part.
* * * * *
(f) In the event of a noncompliance determination resulting in an
HHS denial of a laboratory's certificate of compliance application, HHS
will provide the laboratory with a statement of grounds on which the
noncompliance determination is based and offer an opportunity for
appeal as provided in subpart R.
* * * * *
15. In Sec. 493.47, the heading, paragraph (a), the introductory
text of paragraphs (b) and (c), paragraph (c)(2), and paragraphs (d)
and (e) are revised to read as follows:
Sec. 493.47 Requirements for a certificate for provider-performed
microscopy (PPM) procedures.
(a) A certificate for PPM procedures is required--
(1) Initially for all laboratories performing test procedures
specified as PPM procedures; and
(2) For all certificate of waiver laboratories that intend to
perform only test procedures specified as PPM procedures in addition to
those tests listed in Sec. 493.15(c).
(b) HHS will issue a certificate for PPM procedures if the
laboratory--
* * * * *
(c) Laboratories issued a certificate for PPM procedures are
subject to--
* * * * *
(2) The applicable requirements of this subpart and subparts H, J,
K, M, and P of this part; and
* * * * *
(d) In accordance with subpart R of this part, HHS will initiate
suspension, limitation, or revocation of a laboratory's certificate for
PPM procedures for failure to comply with the applicable requirements
set forth in this subpart. HHS may also impose certain alternative
sanctions. In addition, failure to meet the requirements of this
subpart may result in suspension of all or part of payments under
Medicare and Medicaid, as specified in subpart R of this part.
(e) A certificate for PPM procedures is valid for a period of no
more than 2 years.
16. Section 493.49 is revised to read as follows:
Sec. 493.49 Requirements for a certificate of compliance.
A certificate of compliance may include any combination of tests
categorized as high complexity or moderate complexity or listed in
Sec. 493.15(c) as waived tests. Moderate complexity tests may include
those specified as PPM procedures.
(a) HHS will issue a certificate of compliance to a laboratory only
if the laboratory--
(1) Meets the requirements of Secs. 493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part;
and
(3) Meets the applicable requirements of this subpart and subparts
H, J, K, M, P, and Q of this part.
(b) Laboratories issued a certificate of compliance--
(1) Are subject to the notification requirements of Sec. 493.51;
and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part--
(i) To determine compliance with the applicable requirements of
this part;
(ii) To evaluate complaints;
(iii) When HHS has substantive reason to believe that tests are
being performed, or the laboratory is being operated in a manner that
constitutes an imminent and serious risk to human health; and
(iv) To collect information regarding the appropriateness of tests
listed in Sec. 493.15 or tests categorized as moderate complexity
(including the subcategory) or high complexity.
(c) Failure to comply with the requirements of this subpart will
result in--
(1) Suspension, revocation or limitation of a laboratory's
certificate of compliance in accordance with subpart R of this part;
and
(2) Suspension or denial of payments under Medicare and Medicaid in
accordance with subpart R of this part. [[Page 20046]]
(d) A certificate of compliance issued under this subpart is valid
for no more than 2 years.
(e) In the event of a noncompliance determination resulting in an
HHS action to revoke, suspend or limit the laboratory's certificate of
compliance, HHS will--
(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based; and
(2) Offer an opportunity for appeal as provided in subpart R of
this part. If the laboratory requests a hearing within 60 days of the
notice of sanction, it retains its certificate of compliance or
reissued certificate of compliance until a decision is made by an
administrative law judge (ALJ) as provided in subpart R of this part,
except when HHS finds that conditions at the laboratory pose an
imminent and serious risk to human health or when the criteria at
Sec. 493.1840(a) (4) and (5) are met.
(f) For laboratories receiving payment from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory of a noncompliance
determination even if there has been no appeals decision issued.
(g) A laboratory seeking to renew its certificate of compliance
must--
(1) Complete and return the renewal application to HHS 9 to 12
months prior to the expiration of the certificate of compliance; and
(2) Meet the requirements of Sec. 493.43 and paragraphs (a)(2) and
(b)(2) of this section.
(h) If HHS determines that the application for the renewal of a
certificate of compliance must be denied or limited, HHS will notify
the laboratory in writing of the--
(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
(i) If the laboratory requests a hearing within the time period
specified by HHS, the laboratory retains its certificate of compliance
or reissued certificate of compliance until a decision is made by an
ALJ as provided in subpart R, except when HHS finds that conditions at
the laboratory pose an imminent and serious risk to human health.
(j) For laboratories receiving payment from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory of nonrenewal of the
certificate of compliance even if there has been no appeals decision
issued.
17. In Sec. 493.51, the introductory paragraph of paragraph (a) is
republished and the heading, the section's introductory paragraph and
paragraphs (a)(5), (b) and (c) are revised to read as follows:
Sec. 493.51 Notification requirements for laboratories issued a
certificate of compliance.
Laboratories issued a certificate of compliance must meet the
following conditions:
(a) Notify HHS or its designee within 30 days of any change in--
* * * * *
(5) Technical supervisor (laboratories performing high complexity
only).
(b) Notify HHS no later than 6 months after performing any test or
examination within a specialty or subspecialty area that is not
included on the laboratory's certificate of compliance, so that
compliance with requirements can be determined.
(c) Notify HHS no later than 6 months after any deletions or
changes in test methodologies for any test or examination included in a
specialty or subspecialty, or both, for which the laboratory has been
issued a certificate of compliance.
18. In Sec. 493.53, the heading, the introductory paragraph, and
paragraph (a) are revised to read as follows:
Sec. 493.53 Notification requirements for laboratories issued a
certificate for provider-performed microscopy (PPM) procedures.
Laboratories issued a certificate for PPM procedures must notify
HHS or its designee--
(a) Before performing and reporting results for any test of
moderate or high complexity, or both, in addition to tests specified as
PPM procedures or any test or examination that is not specified under
Sec. 493.15(c), for which it does not have a registration certificate
as required in subpart C or subpart D, as applicable, of this part; and
* * * * *
19. The introductory text of Sec. 493.55(a) is revised to read as
follows:
Sec. 493.55 Application for registration certificate and certificate
of accreditation.
(a) Filing of application. A laboratory may be issued a certificate
of accreditation in lieu of the applicable certificate specified in
subpart B or subpart C of this part provided the laboratory--
* * * * *
20. In Sec. 493.57, the introductory paragraph and paragraph (b)
are revised to read as follows:
Sec. 493.57 Requirements for a registration certificate.
A registration certificate is required for all laboratories seeking
a certificate of accreditation, unless the laboratory holds a valid
certificate of compliance issued by HHS.
* * * * *
(b)(1) The laboratory must provide HHS with proof of accreditation
by an approved accreditation program--
(i) Within 11 months of issuance of the registration certificate;
or
(ii) Prior to the expiration of the certificate of compliance.
(2) If such proof of accreditation is not supplied within this
timeframe, the laboratory must meet, or continue to meet, the
requirements of Sec. 493.49.
* * * * *
21. In Sec. 493.511, paragraph (h) is revised to read as follows:
Sec. 493.511 Removal of deeming authority and final determination
review.
* * * * *
(h) After HCFA withdraws approval of an accreditation
organization's deeming authority, the certificates of accreditation of
all affected laboratories continue in effect for 60 days after the
laboratory receives notification of the withdrawal of approval. HCFA
may extend the period for an additional 60 days for a laboratory if it
determines that the laboratory submitted an application for inspection
to another approved accreditation organization or an application for
the appropriate certificate to HCFA, the State agency, or other HCFA
agent before the initial 60-day period ends.
* * * * *
22. Paragraph (j) of Sec. 493.521 is revised to read as follows:
Sec. 493.521 Removal of CLIA exemption and final determination review.
* * * * *
(j) After HCFA withdraws approval of a State laboratory licensure
program, the exempt status of licensed or approved laboratories in the
State continues in effect for 60 days after the laboratory receives
notification from the State of the withdrawal of HCFA's approval of the
program. HCFA may extend this period for an additional 60 days for a
laboratory if it determines that the laboratory submitted an
application for accreditation to an approved accreditation organization
or an application to HCFA for the appropriate certificate before the
initial 60-day period ends.
* * * * *
23. Section 493.602 is revised to read as follows:
[[Page 20047]]
Sec. 493.602 Scope of subpart.
This subpart sets forth the methodology for determining the amount
of the fees for issuing the appropriate certificate, and for
determining compliance with the applicable standards of the Public
Health Service Act (the PHS Act) and the Federal validation of
accredited laboratories and of CLIA-exempt laboratories.
Secs. 493.610, 493.614, 493.618, 493.622, 493.626, 493.629, 493.630,
493.631, 493.632, 493.633 and 493.634 [Removed]
24. Sections 493.610, 493.614, 493.618, 493.622, 493.626, 493.629,
493.630, 493.631, 493.632, 493.633 and 493.634 are removed.
25. Section 493.638 is revised to read as follows:
Sec. 493.638 Certificate fees.
(a) Basic rule. Laboratories must pay a fee for the issuance of a
registration certificate, certificate for PPM procedures, certificate
of waiver, certificate of accreditation, or a certificate of
compliance, as applicable. Laboratories must also pay a fee to reapply
for a certificate for PPM procedures, certificate of waiver,
certificate of accreditation, or a certificate of compliance. The total
of fees collected by HHS under the laboratory program must be
sufficient to cover the general costs of administering the laboratory
certification program under section 353 of the PHS Act.
(1) For registration certificates and certificates of compliance,
the costs include issuing the certificates, collecting the fees,
evaluating and monitoring proficiency testing programs, evaluating
which procedures, tests or examinations meet the criteria for inclusion
in the appropriate complexity category, and implementing section 353 of
the PHS Act.
(2) For a certificate of waiver, the costs include issuing the
certificate, collecting the fees, determining if a certificate of
waiver should be issued, evaluating which tests qualify for inclusion
in the waived category, and other direct administrative costs.
(3) For a certificate for PPM procedures, the costs include issuing
the certificate, collecting the fees, determining if a certificate for
PPM procedures should be issued, evaluating which procedures meet the
criteria for inclusion in the subcategory of PPM procedures, and other
direct administrative costs.
(4) For a certificate of accreditation, the costs include issuing
the certificate, collecting the fees, evaluating the programs of
accrediting bodies, and other direct administrative costs.
(b) Fee amount. The fee amount is set annually by HHS on a calendar
year basis and is based on the category of test complexity, or on the
category of test complexity and schedules or ranges of annual
laboratory test volume (excluding waived tests and tests performed for
quality control, quality assurance, and proficiency testing purposes)
and specialties tested, with the amounts of the fees in each schedule
being a function of the costs for all aspects of general administration
of CLIA as set forth in Sec. 493.649 (b) and (c). This fee is assessed
and payable at least biennially. The methodology used to determine the
amount of the fee is found in Sec. 493.649. The amount of the fee
applicable to the issuance of the registration certificate or the
issuance or renewal of the certificate for PPM procedures, certificate
of waiver, certificate of accreditation, or certificate of compliance
is the amount in effect at the time the application is received. Upon
receipt of an application for a certificate, HHS or its designee
notifies the laboratory of the amount of the required fee for the
requested certificate.
26. Section 493.639(b) is revised to read as follows:
Sec. 493.639 Fee for revised certificate.
* * * * *
(b) A laboratory must pay a fee to cover the cost of issuing a
revised certificate in any of the following circumstances:
(1) The fee for issuing an appropriate revised certificate is based
on the cost to issue the revised certificate to the laboratory as
follows:
(i) If a laboratory with a certificate of waiver wishes to perform
tests in addition to those listed in Sec. 493.15(c) as waived tests, it
must, as set forth in Sec. 493.638, pay an additional fee for the
appropriate certificate to cover the additional testing.
(ii) If a laboratory with a certificate for PPM procedures wishes
to perform tests in addition to those specified as PPM procedures or
listed in Sec. 493.15(c) as waived tests, it must, as set forth in
Sec. 493.638, pay an additional fee for the appropriate certificate to
cover the additional testing.
(2) A laboratory must pay a fee to cover the cost of issuing a
revised certificate when--
(i) A laboratory changes its name, location, or its director; or
(ii) A laboratory deletes services or wishes to add services and
requests that its certificate be changed. (An additional fee is also
required under Sec. 493.643(d) if it is necessary to determine
compliance with additional requirements.)
27. In Sec. 493.643, paragraphs (a) and (d) are revised to read as
follows:
Sec. 493.643 Fee for determination of program compliance.
(a) Fee requirement. In addition to the fee required under
Sec. 493.638, a laboratory subject to routine inspections must pay a
fee to cover the cost of determining program compliance. Laboratories
issued a certificate for PPM procedures, certificate of waiver, or a
certificate of accreditation are not subject to this fee for routine
inspections.
* * * * *
(d) Additional fees. (1) If after a certificate of compliance is
issued, a laboratory adds services and requests that its certificate be
upgraded, the laboratory must pay an additional fee if, in order to
determine compliance with additional requirements, it is necessary to
conduct an inspection, evaluate personnel, or monitor proficiency
testing performance. The additional fee is based on the actual
resources and time necessary to perform the activities. HHS revokes the
laboratory's certificate for failure to pay the compliance
determination fee.
(2) If it is necessary to conduct a complaint investigation, impose
sanctions, or conduct a hearing, HHS assesses the laboratory holding a
certificate of compliance a fee to cover the cost of these activities.
If a complaint investigation results in a complaint being
unsubstantiated, or if an HHS adverse action is overturned at the
conclusion of the administrative appeals process, the government's
costs of these activities are not imposed upon the laboratory. Costs
for these activities are based on the actual resources and time
necessary to perform the activities and are not assessed until after
the laboratory concedes the existence of deficiencies or an ALJ rules
in favor of HHS. HHS revokes the laboratory's certificate of compliance
for failure to pay the assessed costs.
28. Section 493.645 is revised to read as follows:
Sec. 493.645 Additional fee(s) applicable to approved State laboratory
programs and laboratories issued a certificate of accreditation,
certificate of waiver, or certificate for PPM procedures.
(a) Approved State laboratory programs. State laboratory programs
approved by HHS are assessed a fee for the following:
(1) Costs of Federal inspections of laboratories in that State
(that is, CLIA-exempt laboratories) to verify that
[[Page 20048]] standards are being enforced in an appropriate manner.
(2) Costs incurred for investigations of complaints against the
State's CLIA-exempt laboratories if the complaint is substantiated.
(3) Costs of the State's prorata share of general overhead to
develop and implement CLIA.
(b) Accredited laboratories. (1) In addition to the certificate
fee, a laboratory that is issued a certificate of accreditation is also
assessed a fee to cover the cost of evaluating individual laboratories
to determine overall whether an accreditation organization's standards
and inspection policies are equivalent to the Federal program. All
accredited laboratories share in the cost of these inspections. These
costs are the same as those that are incurred when inspecting
nonaccredited laboratories.
(2) If a laboratory issued a certificate of accreditation has been
inspected and followup visits are necessary because of identified
deficiencies, HHS assesses the laboratory a fee to cover the cost of
these visits. The fee is based on the actual resources and time
necessary to perform the followup visits. HHS revokes the laboratory's
certificate of accreditation for failure to pay the assessed fee.
(c) If, in the case of a laboratory that has been issued a
certificate of accreditation, certificate of waiver, or certificate for
PPM procedures, it is necessary to conduct a complaint investigation,
impose sanctions, or conduct a hearing, HHS assesses that laboratory a
fee to cover the cost of these activities. Costs are based on the
actual resources and time necessary to perform the activities and are
not assessed until after the laboratory concedes the existence of
deficiencies or an ALJ rules in favor of HHS. HHS revokes the
laboratory's certificate for failure to pay the assessed costs. If a
complaint investigation results in a complaint being unsubstantiated,
or if an HHS adverse action is overturned at the conclusion of the
administrative appeals process, the costs of these activities are not
imposed upon the laboratory.
29. Section 493.646(a) is revised to read as follows:
Sec. 493.646 Payment of fees.
(a) Except for CLIA-exempt laboratories, all laboratories are
notified in writing by HHS or its designee of the appropriate fee(s)
and instructions for submitting the fee(s), including the due date for
payment and where to make payment. The appropriate certificate is not
issued until the applicable fees have been paid.
* * * * *
30. In Sec. 493.649, paragraph (a) and the introductory paragraph
of paragraph (b) are revised to read as follows:
Sec. 493.649 Methodology for determining fee amount.
(a) General rule. The amount of the fee in each schedule for
compliance determination inspections is based on the average hourly
rate (which includes the costs to perform the required activities and
necessary administration costs) multiplied by the average number of
hours required or, if activities are performed by more than one of the
entities listed in paragraph (b) of this section, the sum of the
products of the applicable hourly rates multiplied by the average
number of hours required by the entity to perform the activity. The fee
for issuance of the registration certificate or certificate of
compliance is based on the laboratory's scope and volume of testing.
(b) Determining average hourly rates used in fee schedules. Three
different entities perform activities related to the issuance or
reissuance of any certificate. HHS determines the average hourly rates
for the activities of each of these entities.
* * * * *
31. The heading of subpart H is revised to read as follows:
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the
Subcategory), High Complexity, or Any Combination of These Tests
32. Section 493.803(a) is revised to read as follows:
Sec. 493.803 Condition: Successful participation.
(a) Each laboratory performing tests of moderate complexity
(including the subcategory) and/or high complexity must successfully
participate in a proficiency testing program approved by HCFA, if
applicable, as described in subpart I of this part for each specialty,
subspecialty, and analyte or test in which the laboratory is certified
under CLIA.
* * * * *
33. The heading of Sec. 493.807 is revised to read as follows:
Sec. 493.807 Condition: Reinstatement of laboratories performing tests
of moderate complexity (including the subcategory), high complexity, or
any combination of these tests, after failure to participate
successfully.
* * * * *
34. The undesignated center heading immediately preceding
Sec. 493.821 is revised to read as follows:
Proficiency Testing by Specialty and Subspecialty for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
35. The heading to subpart I is revised to read as follows:
Subpart I--Proficiency Testing Programs for Tests of Moderate
Complexity (Including the Subcategory), High Complexity, or Any
Combination of These Tests
36. The heading for subpart J is revised to read as follows:
Subpart J--Patient Test Management for Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
37. Section 493.1101 is revised to read as follows:
Sec. 493.1101 Condition: Patient test management; moderate complexity
(including the subcategory), or high complexity testing, or any
combination of these tests.
Each laboratory performing moderate complexity (including the
subcategory) or high complexity testing, or any combination of these
tests, must employ and maintain a system that provides for proper
patient preparation; proper specimen collection, identification,
preservation, transportation, and processing; and accurate result
reporting. This system must assure optimum patient specimen integrity
and positive identification throughout the preanalytic (pre-testing),
analytic (testing), and postanalytic (post-testing) processes and must
meet the standards as they apply to the testing performed.
38. The heading to subpart K is revised to read as follows:
Subpart K--Quality Control for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
39. The heading to Sec. 493.1201 is revised to read as follows:
Sec. 493.1201 Condition: General quality control; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
40. The heading to subpart M is revised to read as follows:
[[Page 20049]]
Subpart M--Personnel for Moderate Complexity (Including the
Subcategory) and High Complexity Testing
41. New Sec. 493.1351 is added to subpart M to read as follows:
Sec. 493.1351 General.
This subpart consists of the personnel requirements that must be
met by laboratories performing moderate complexity testing, PPM
procedures, high complexity testing, or any combination of these tests.
42. Following Sec. 493.1351, a new undesignated center heading and
new Secs. 493.1353, 493.1355, 493.1357, 493.1359, 493.1361, 493.1363,
and 493.1365 are added to subpart M to read as follows:
Laboratories Performing Provider-Performed Microscopy (PPM)
Procedures
Sec. 493.1353 Scope.
In accordance with Sec. 493.19(b), the moderate complexity
procedures specified as PPM procedures are considered such only when
personally performed by a health care provider during a patient visit
in the context of a physical examination. PPM procedures are subject to
the personnel requirements in Secs. 493.1355 through 493.1365.
Sec. 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1357 and provides overall management and
direction in accordance with Sec. 493.1359.
Sec. 493.1357 Standard; laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and the performance of PPM procedures as specified
in Sec. 493.19(c) and must be eligible to be an operator of a
laboratory within the requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if the licensing is required.
(b) The laboratory director must meet one of the following
requirements:
(1) Be a physician, as defined in Sec. 493.2.
(2) Be a midlevel practitioner, as defined in Sec. 493.2,
authorized by a State to practice independently in the State in which
the laboratory is located.
(3) Be a dentist, as defined in Sec. 493.2.
Sec. 493.1359 Standard; PPM laboratory director responsibilities.
The laboratory director is responsible for the overall operation
and administration of the laboratory, including the prompt, accurate,
and proficient reporting of test results. The laboratory director
must--
(a) Direct no more than five laboratories; and
(b) Ensure that any procedure listed under Sec. 493.19(c)--
(1) Is personally performed by an individual who meets the
qualification requirements in Sec. 493.1363; and
(2) Is performed in accordance with applicable requirements in
subparts H, J, K, M, and P of this part.
Sec. 493.1361 Condition: Laboratories performing PPM procedures;
testing personnel.
The laboratory must have a sufficient number of individuals who
meet the qualification requirements of Sec. 493.1363 to perform the
functions specified in Sec. 493.1365 for the volume and complexity of
testing performed.
Sec. 493.1363 Standard: PPM testing personnel qualifications.
Each individual performing PPM procedures must--
(a) Possess a current license issued by the State in which the
laboratory is located if the licensing is required; and
(b) Meet one of the following requirements:
(1) Be a physician, as defined in Sec. 493.2.
(2) Be a midlevel practitioner, as defined in Sec. 493.2, under the
supervision of a physician or in independent practice if authorized by
the State in which the laboratory is located.
(3) Be a dentist as defined in Sec. 493.2 of this part.
Sec. 493.1365 Standard; PPM testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance, and for reporting test results. Any PPM procedure must
be--
(a) Personally performed by one of the following practitioners:
(1) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or employee.
(2) A midlevel practitioner, under the supervision of a physician
or in independent practice if authorized by the State in which the
laboratory is located, during the patient's visit on a specimen
obtained from his or her own patient or from the patient of a clinic,
group medical practice, or other health care provider, in which the
midlevel practitioner is a member or an employee.
(3) A dentist during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group dental
practice of which the dentist is a member or an employee; and
(b) Performed using a microscope limited to a brightfield or a
phase/contrast microscope.
Sec. 493.1401 [Removed]
43. Section 493.1401 is removed.
44. In Sec. 493.1461, the introductory text of paragraph (c) and
paragraph (c)(2) is revised, and new paragraphs (c)(4) and (c)(5) are
added to read as follows:
Sec. 493.1461 Standard; General supervisor qualifications.
* * * * *
(c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of
this section are not met, the individual functioning as the general
supervisor must--
* * * * *
(2)(i) Qualify as testing personnel under Sec. 493.1489(b)(2); and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing; or
* * * * *
(4) On or before September 1, 1992, have served as a general
supervisor of high complexity testing and as of April 24, 1995--
(i) Meet one of the following requirements:
(A) Have graduated from a medical laboratory or clinical laboratory
training program approved or accredited by the Accrediting Bureau of
Health Education Schools (ABHES), the Commission on Allied Health
Education Accreditation (CAHEA), or other organization approved by HHS.
(B) Be a high school graduate or equivalent and have successfully
completed an official U.S. military medical laboratory procedures
course of at least 50 weeks duration and have held the military
enlisted occupational specialty of Medical Laboratory Specialist
(Laboratory Technician).
(ii) Have at least 2 years of clinical laboratory training, or
experience, or both, in high complexity testing; or
(5) On or before September 1, 1992, have served as a general
supervisor of high complexity testing and--
(i) Be a high school graduate or equivalent; and
(ii) Have had at least 10 years of laboratory training or
experience, or both, in high complexity testing, including at least 6
years of supervisory [[Page 20050]] experience between September 1,
1982 and September 1, 1992.
* * * * *
Sec. 493.1463 [Amended]
45. In Sec. 493.1463, all references to ``Sec. 493.1489(b)(4)'' are
amended to read ``Sec. 493.1489(b)(5).''
46. In Sec. 493.1489, the introductory text to the section and to
paragraph (b) are republished, paragraphs (b)(2) and (b)(4) through
(b)(6) are revised, and paragraph (b)(7) is added to read as follows:
Sec. 493.1489 Standard; Testing personnel qualifications.
Each individual performing high complexity testing must--
* * * * *
(b) Meet one of the following requirements:
* * * * *
(2)(i) Have earned an associate degree in a laboratory science, or
medical laboratory technology from an accredited institution or--
(ii) Have education and training equivalent to that specified in
paragraph (b)(2)(i) of this section that includes--
(A) At least 60 semester hours, or equivalent, from an accredited
institution that, at a minimum, include either--
(1) 24 semester hours of medical laboratory technology courses; or
(2) 24 semester hours of science courses that include--
(i) Six semester hours of chemistry;
(ii) Six semester hours of biology; and
(iii) Twelve semester hours of chemistry, biology, or medical
laboratory technology in any combination; and
(B) Have laboratory training that includes either of the following:
(1) Completion of a clinical laboratory training program approved
or accredited by the ABHES, the CAHEA, or other organization approved
by HHS. (This training may be included in the 60 semester hours listed
in paragraph (b)(2)(ii)(A) of this section.)
(2) At least 3 months documented laboratory training in each
specialty in which the individual performs high complexity testing.
* * * * *
(4) On or before April 24, 1995 be a high school graduate or
equivalent and have either--
(i) Graduated from a medical laboratory or clinical laboratory
training program approved or accredited by ABHES, CAHEA, or other
organization approved by HHS; or
(ii) Successfully completed an official U.S. military medical
laboratory procedures training course of at least 50 weeks duration and
have held the military enlisted occupational specialty of Medical
Laboratory Specialist (Laboratory Technician);
(5)(i) Until September 1, 1997--
(A) Have earned a high school diploma or equivalent; and
(B) Have documentation of training appropriate for the testing
performed before analyzing patient specimens. Such training must ensure
that the individual has--
(1) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(2) The skills required for implementing all standard laboratory
procedures;
(3) The skills required for performing each test method and for
proper instrument use;
(4) The skills required for performing preventive maintenance,
troubleshooting, and calibration procedures related to each test
performed;
(5) A working knowledge of reagent stability and storage;
(6) The skills required to implement the quality control policies
and procedures of the laboratory;
(7) An awareness of the factors that influence test results; and
(8) The skills required to assess and verify the validity of
patient test results through the evaluation of quality control values
before reporting patient test results; and
(ii) As of September 1, 1997, be qualified under
Sec. 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals
qualified under paragraph (b)(5)(i) of this section who were performing
high complexity testing on or before April 24, 1995;
(6) For blood gas analysis--
(i) Be qualified under Sec. 493.1489(b)(1), (b)(2), (b)(3), (b)(4),
or (b)(5);
(ii) Have earned a bachelor's degree in respiratory therapy or
cardiovascular technology from an accredited institution; or
(iii) Have earned an associate degree related to pulmonary function
from an accredited institution; or
(7) For histopathology, meet the qualifications of Sec. 493.1449
(b) or (l) to perform tissue examinations.
Sec. 493.1495 [Amended]
47. In Sec. 493.1495, all references to ``Sec. 493.1489(b)(4)'' are
amended to read ``Sec. 493.1489(b)(5).''
48. The heading to subpart P is revised to read as follows:
Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of
These Tests
49. Section 493.1701 is revised to read as follows:
Sec. 493.1701 Condition: Quality assurance; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
Each laboratory performing moderate complexity (including the
subcategory) or high complexity testing, or any combination of these
tests, must establish and follow written policies and procedures for a
comprehensive quality assurance program that is designed to monitor and
evaluate the ongoing and overall quality of the total testing process
(preanalytic, analytic, postanalytic). The laboratory's quality
assurance program must evaluate the effectiveness of its policies and
procedures; identify and correct problems; assure the accurate,
reliable and prompt reporting of test results; and assure the adequacy
and competency of the staff. As necessary, the laboratory must revise
policies and procedures based upon the results of those evaluations.
The laboratory must meet the standards as they apply to the services
offered, complexity of testing performed and test results reported, and
the unique practices of each testing entity. All quality assurance
activities must be documented.
50. In Sec. 493.1776, the introductory text of paragraphs (a), (b),
and (b)(4) are republished and the heading and paragraphs (a)(3),
(a)(4), (b)(1), (b)(4)(iii) and (b)(4)(iv) are revised to read as
follows:
Sec. 493.1776 Condition: Inspection of laboratories issued a
certificate for PPM procedures.
(a) HHS or its designee will conduct announced or unannounced
inspections of any laboratory at any time during its hours of operation
to--
* * * * *
(3) Determine whether the laboratory is performing tests in
addition to procedures specified as PPM procedures; and
(4) Collect information regarding the appropriateness of tests
specified as PPM procedures.
(b) The laboratory may be required, as part of this inspection,
to--(1) Permit HHS or its designee to interview all employees of the
laboratory concerning the laboratory's compliance with the applicable
requirements of part 493. Requirements for the purposes of this section
are located in subpart C or [[Page 20051]] subpart D, if applicable,
and subparts H, J, K, M, and P of this part;
* * * * *
(4) Permit HHS or its designee upon request to review all
information and data necessary to--
* * * * *
(iii) Determine whether the laboratory is performing tests in
addition to procedures specified as PPM procedures; (iv) Collect
information regarding the appropriateness of tests specified as PPM
procedures; and
* * * * *
51. In Sec. 493.1777, introductory text to the section is added and
the heading and paragraphs (a) and (g) are revised to read as follows:
Sec. 493.1777 Condition: Inspection of laboratories requesting or
issued a certificate of compliance.
Laboratories requesting or issued a certificate of compliance must
permit an inspection to assess compliance with part 493 of this
chapter. Testing in the subcategory of PPM procedures, may be included
in the laboratory's routine or complaint inspection. PPM procedures are
assessed for compliance with only the applicable requirements specific
to the subcategory of testing.
(a) HHS or its designee may conduct unannounced or announced
inspections on at least a biennial basis of any laboratory at any time
during its hours of operation. To assess compliance with the
requirements of part 493, HHS will inspect a laboratory possessing a
registration certificate before issuance of a certificate of
compliance.
* * * * *
(g) Failure to permit an inspection under this subsection will
result in the suspension of Medicare and Medicaid payments to the
laboratory, or termination of the laboratory's participation in
Medicare and Medicaid for payment, and suspension of or action to
revoke the laboratory's CLIA certificate of compliance in accordance
with subpart R of this part.
Sec. 493.1804 [Amended]
52. In Sec. 493.1804(b)(2), the word ``ore'' is revised to read
``or''.
53. In Sec. 493.1814, the introductory text of paragraph (b) is
republished and paragraph (b)(3) is revised to read as follows:
Sec. 493.1814 Action when deficiencies are at the condition level but
do not pose immediate jeopardy.
* * * * *
(b) Failure to correct condition level deficiencies. If HCFA
imposes alternative sanctions for condition level deficiencies that do
not pose immediate jeopardy, and the laboratory does not correct the
condition level deficiencies within 12 months after the last day of
inspection, HCFA--
* * * * *
(3) May impose (or continue, if already imposed) any alternative
sanctions that do not pertain to Medicare payments. (Sanctions imposed
under the authority of section 353 of the PHS Act may continue for more
than 12 months from the last date of inspection, while a hearing on the
proposed suspension, limitation, or revocation of the certificate of
compliance, registration certificate, certificate of accreditation, or
certificate for PPM procedures is pending.)
* * * * *
54. In Sec. 493.1834, the heading and introductory text of
paragraph (f)(2) are republished and paragraphs (b) and (f)(2)(iii) are
revised to read as follows:
Sec. 493.1834 Civil money penalty.
* * * * *
(b) Scope. This section sets forth the procedures that HCFA follows
to impose a civil money penalty in lieu of, or in addition to,
suspending, limiting, or revoking the certificate of compliance,
registration certificate, certificate of accreditation, or certificate
for PPM procedures of a laboratory that is found to have condition
level deficiencies.
* * * * *
(f) Accrual and duration of penalty--
* * * * *
(2) Duration of penalty. The civil money penalty continues to
accrue until the earliest of the following occurs:
* * * * *
(iii) HCFA suspends, limits, or revokes the laboratory's
certificate of compliance, registration certificate, certificate of
accreditation, or certificate for PPM procedures.
* * * * *
55. In Sec. 493.1836, the heading of paragraph (c) is republished
and paragraphs (c)(2) and (c)(3) are revised to read as follows:
Sec. 493.1836 State onsite monitoring.
* * * * *
(c) Duration of sanction.
* * * * *
(2) If the laboratory does not correct all deficiencies within 12
months, and a revisit indicates that deficiencies remain, HCFA cancels
the laboratory's approval for Medicare payment for its services and
notifies the laboratory of its intent to suspend, limit, or revoke the
laboratory's certificate of compliance, registration certificate,
certificate of accreditation, or certificate for PPM procedures.
(3) If the laboratory still does not correct its deficiencies, the
Medicare sanction continues until the suspension, limitation, or
revocation of the laboratory's certificate of compliance, registration
certificate, certificate of accreditation, or certificate for PPM
procedures is effective.
56. In Sec. 493.2001, paragraph (e) and paragraph (e)(1) are
revised to read as follows:
Sec. 493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
* * * * *
(e) The Clinical Laboratory Improvement Advisory Committee or
subcommittee, at the request of HHS, will review and make
recommendations concerning:
(1) Criteria for categorizing tests and examinations of moderate
complexity (including the subcategory) and high complexity;
* * * * *
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance; Program No. 93.773, Medicare--Hospital Insurance; and
Program No. 93.774, Medicare--Supplementary Medical Insurance
Program)
Dated: December 23, 1994.
Philip R. Lee,
Assistant Secretary for Health.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: December 27, 1994.
Donna E. Shalala,
Secretary.
[FR Doc. 95-9953 Filed 4-21-95; 8:45 am]
BILLING CODE 4120-01-P