[Federal Register Volume 60, Number 78 (Monday, April 24, 1995)]
[Rules and Regulations]
[Pages 20035-20051]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9953]



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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