CLIA Program; Categorization of Tests and Personnel Modifications

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:

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.

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.

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.

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.

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''.

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.

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.

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