[Federal Register: September 15, 1995 (Volume 60, Number 179)]
[Proposed Rules]
[Page 47981-47998]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se95-29]
[[Page 47981]]
_______________________________________________________________________
Part II
Department of Health and Human Services
_______________________________________________________________________
Health Care Financing Administration
_______________________________________________________________________
42 CFR Part 493
CLIA Program; Categorization and Certification Requirements for a New
Subcategory of Moderate Complexity Testing; Proposed Rule
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 493
[HSQ-222-P]
RIN 0938-AG98
CLIA Program; Categorization and Certification Requirements for a
New Subcategory of Moderate Complexity Testing
AGENCY: Health Care Financing Administration (HCFA) and Public Health
Service (PHS), HHS.
ACTION: Proposed rule.
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SUMMARY: In this proposed rule we are responding to some of the
comments on categories of tests received in response to the rule
published on February 28, 1992. To reduce the regulations burden on
laboratories, we are proposing to revise our regulations to create a
new subcategory of high quality moderate complexity procedures called
accurate and precise technology (APT) tests.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on
November 14, 1995.
ADDRESSES: Mail written comments (1 original and 3 copies) to the
following address: Centers for Disease Control and Prevention, Public
Health Service, Department of Health and Human Services, Attention:
HSQ-222-P, 4770 Buford Highway, N.E., MSF11, Atlanta, Georgia 30341-
3724.
If you prefer, you may deliver your written comments (1 original
and 3 copies) to one of the following addresses: Room 714-B, Hubert H.
Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code HSQ-222-P. 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) 512-1800 or by faxing to (202) 512-
2250. 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 APT requirements and criteria for APT
categorization; and Judy Yost, (410) 786-3531, 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. In accordance with the law,
regulations implementing CLIA that HHS published on February 28, 1992
(57 FR 7002) established laboratory requirements based on the
complexity of the tests performed. There are currently three test
categories: waived, moderate, and high complexity.
Following publication of the February 28, 1992 regulations, 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 primarily 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. The CLIAC has four
subcommittees: cytology; personnel; proficiency testing, quality
control and quality assurance; and test categorization.
In response to publication of the February 28, 1992 regulations, we
received approximately 16,000 letters from professional organizations
and individuals providing around 71,000 comments.
In response to those comments, we have published three rules (in
addition to this proposed rule). One of those rules responds to the
comments received on the waived criteria, tests presently included in
the waived category and those tests that commenters believed should be
added. At our request, the CLIAC evaluated the waived category and
suggested that the Centers for Disease Control and Prevention (CDC)
clarify the criteria and develop a process for review of requests for
waiver. We clarified the criteria for waiver and the process for
requesting waived categorization and published the clarified criteria
and process for requesting waiver in a proposed rule with comment on
September 13, 1995 (60 FR 47534). (The other two rules appeared in the
Federal Register on January 19, 1993 (58 FR 5215) and on April 24,
1995.
In this rule, in response to numerous comments regarding the test
complexity model, we are proposing to establish a new subcategory of
moderate complexity that would include high quality tests that would be
subject to less stringent requirements. Establishment of this
subcategory should encourage manufacturers to produce accurate, easy-
to-use test systems for use by physicians and laboratories to improve
test quality and enhance patient care.
II. Response to Comments Received to Previous CLIA Regulations
In this rule we address additional comments received in response to
the establishment of the three testing categories. Below we have
provided a general overview of the comments and our responses, followed
by some additional specific comments concerning the categories of
testing and our response to these comments, which includes the
rationale used to develop the proposed accurate and precise technology
(APT) subcategory.
Upon review of the comments, we believe that additional revision of
the test categorization model is warranted. The revisions to the
regulations proposed in this rule would address the commenters'
concerns that many high quality tests are less complex than many of the
tests currently categorized as moderate complexity, but they do not
meet the criteria for waiver. The commenters feel and we agree that
these tests should be subject to less stringent
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requirements than those currently associated with moderate complexity
tests.
In addition, we received numerous comments from professional
organizations and individuals expressing concern about the burden
associated with regulating laboratories based on test complexity and
the criteria used to categorize tests as moderate or high complexity.
Many commenters indicated that the special circumstances involved in
physician offices, rural and public health clinics providing laboratory
services should justify minimizing the regulatory burden on them. Some
commenters believed that regulating laboratories on the basis of test
complexity and the requirements applicable to moderate and high
complexity tests would increase the cost of laboratory testing. Several
commenters thought this regulatory burden would cause many laboratories
to discontinue providing services, thereby limiting health care in
underserved and rural areas. Some commenters recommended reducing some
of the regulatory burden by creating a category of tests at a level
between waived and moderate complexity. Other commenters suggested
creating additional categories and provided examples for alternatives
to the current test complexity model.
In response to these comments, the CDC developed a proposal to
create a new subcategory of moderate complexity that would include
simple, easy-to-use tests with proven accuracy and precision and
therefore would require somewhat less stringent requirements than the
requirements currently applicable to other moderate complexity tests.
During the development of the subcategory, we were especially
cognizant of the concerns of the commenters who stated that there are
many high quality, moderate complexity tests that might not qualify for
waiver, but, on the other hand, should not be subject to the full range
of requirements currently applicable to moderate complexity testing. We
agree with the commenters that regulatory relief for high quality tests
is appropriate. In order to justify less stringent application of the
requirements, we are proposing that the tests meet rigid performance
specifications and have demonstrated, through scientifically valid
studies, a high level of accuracy and precision. Through this process,
test systems would be evaluated to ensure they provide quality results
and physicians and laboratories would have access to this
categorization information to employ in test selection and determining
types of laboratory services to provide.
We therefore designed a subcategory of moderate complexity testing
that we proposed to call APT testing that would include high quality,
less complex tests that would be unique in that the test system
instructions would not only contain complete procedures for test
performance, including instructions regarding the preanalytic, analytic
and postanalytic phases of testing, but would also include protocols
that would assist laboratories in meeting the CLIA requirements. We
proposed that, in order to be considered for categorization in the APT
subcategory, the producer or manufacturer of the test system would have
to submit data demonstrating that the test system meets the criteria
for APT categorization. In addition, the test system instructions would
have to specify clearly what laboratories must do to be in compliance
with the CLIA requirements. For APT testing, laboratories could rely on
the manufacturer's or producer's test system instructions to meet the
CLIA requirements. Since, for APT testing, compliance with the CLIA
requirements would be based on laboratories following the test system
instructions, we believe that random, rather than routine, inspections
of laboratories having an APT certificate would be sufficient.
We discussed with the CLIAC the proposed criteria and requirements
to be applicable to the new subcategory. The CLIAC supported the
concept of the APT subcategory. However, the CLIAC expressed the view
that the subcategory (as currently structured) would not provide the
amount of regulatory relief desired by many commenters who requested
revisions to the complexity model. We understand the CLIAC's concerns;
however, we believe that it is essential that we reevaluate the
complexity model to determine whether the regulations are effective in
ensuring public access to quality laboratory services. When we
established the CLIA requirements in 1992, we sought to devise a
regulatory model based on the complexity of testing performed that
would establish the minimum requirements necessary to ensure accurate
testing. At this point, we believe there are many highly accurate,
simple, easy-to-use test systems currently categorized as moderate
complexity that could be eligible for less stringent requirements, and
laboratories performing such testing should be provided financial and
regulatory relief through a reduction in the CLIA requirements.
To obtain broad public review, we are publishing this proposed rule
and encourage commenters to provide suggestions on how we might revise
the CLIA requirements to ensure that they promote access to quality
services and stimulate technological advances in testing. With respect
to the provisions contained in this rule, we are seeking specific
suggestions and recommendations concerning the criteria and process for
categorizing tests in the APT subcategory, as well as comments on the
appropriateness of the proposed requirements for APT testing.
III. Provisions of the Proposed Rule
Criteria for APT Categorization
In this rule, we are proposing to establish at 42 CFR 493.18 a new
subcategory of moderate complexity testing designated as APT, and we
are outlining the proposed criteria for determining which tests would
be categorized as APT. The proposed criteria for inclusion in the APT
subcategory are structurally similar to our proposed clarifications to
the criteria for waived tests published on September 13, 1995.
For quantitative and qualitative tests, the similarities between
the proposed criteria for APT categorization and the proposed
clarifications to the criteria for waiver are as follows:
<bullet> Quantitative APT tests and quantitative waived tests would
have to meet similar test characteristics and performance
specifications by demonstrating, through scientifically valid studies,
a high level of accuracy and precision.
<bullet> Qualitative APT tests would have to meet the same
requirements for allowable error as we have proposed for qualitative
waived tests.
The proposed criteria for inclusion in the APT subcategory would
differ from the proposed criteria for waiver in that:
<bullet> Waived tests must be fail-safe with no operator
intervention, whereas APT test protocols could allow some operator
intervention to investigate questionable results and to resolve test
system failures.
<bullet> Waived qualitative tests are limited to reagent
impregnated devices (such as dipsticks), whereas qualitative APT tests
would not be limited to any specific type of technology. [It is
important to clarify what is meant by qualitative tests in this
regulation. Qualitative tests are test methods that provide two
categorical responses (e.g., positive/negative or presence/absence).
For these types of tests, the concentration of the analyte is defined
as being above or below a certain discrimination zone that
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defines negativity or positivity.] On the other hand, test methods that
give results by defining specific absorbance values at which tests will
be considered positive are essentially quantitative tests in that they
directly depend on defined concentrations of the analyte producing the
discrete absorbance value. In this regulation, we are proposing to
consider the latter as quantitative tests.
<bullet> Waived tests may use only direct unprocessed specimens,
have direct readout of results and require no invasive troubleshooting
or electronic or mechanical maintenance. However, APT tests could have
simple noncalculated conversions and some troubleshooting and
maintenance performed by the analyst.
<bullet> Instructions for performance of waived tests must be
written at no higher than a seventh grade reading level and include a
description of the analytic skills required to perform the test. APT
test instructions would have no such requirements, since personnel
performing APT testing would, at a minimum, have to have a high school
diploma, or equivalent, and relevant training.
<bullet> Quantitative waived tests may have a certain amount of
random error but they must be shown to be essentially free of
systematic error, whereas quantitative APT tests would be allowed a
minimal amount of error that may be either random or systematic, or
both.
Review Process
Also at Sec. 493.18, we are proposing the process for approving
tests for the APT subcategory. We are proposing that requests for
placement of tests in this subcategory be in conformance with the
proposed submission process outlined in this regulation. The data
submitted for evaluation would have to meet specific criteria related
to operational characteristics, ease of use, and test performance. The
test system's instructions will be reviewed by PHS to ensure that
laboratories can rely on these instructions to assist them in meeting
the regulations in subparts J, K and P when performing APT testing.
Submission Requirements
Under the proposed rule, the manufacturer or test system producer
would have to determine which procedures in the preanalytic, analytic
and postanalytic phases of testing are essential to ensure accurate
test results. These procedures would be identified in the submission to
PHS as mandatory procedures for the laboratory to follow. In addition,
the manufacturer or test system producer would have to include
protocols to assist laboratories in meeting the CLIA requirements. The
test system instructions should remind laboratories to enroll in an
HHS-approved proficiency testing program, if applicable.
Since many manufacturers are currently providing this type of
assistance to laboratories, often in the form of complete protocols
containing instructional materials that cover all aspects of the
regulations and, in addition, examples of suggested forms to use to
document monitoring activities, we believe that the APT subcategory
merely strengthens and confirms that interaction between the producer
of the test system and the laboratory user. Formalizing this
relationship and making it uniform for all manufacturers and producers
of these test systems should reduce the regulatory burden on
laboratories, while providing an effective mechanism for laboratories
to achieve regulatory compliance with the CLIA requirements.
We encourage individuals to submit their comments and suggestions
on how we might improve the APT categorization criteria or process and
revise the regulations to incorporate these changes. Following review
of comments received in response to this notice, we will make the
necessary revisions to the APT requirements, including the criteria for
APT categorization and the process for reviewing requests for APT
categorization of test systems.
After a final rule responding to the comments received to this
proposed rule is published establishing the APT subcategory, requests
for APT categorization may be submitted for review. Once a test system
review has been completed, the manufacturer or producer would be
notified of the APT categorization decision, whether denied or granted.
APT categorization would be effective on the date of notification to
the applicant. Any test categorized as APT also would be published in
the Federal Register as a notice with an opportunity for public
comment. (As with all comments received on test categorization, our
responses to the comments received on APT categorization will be
included in a subsequent Federal Register notice.) Once we receive
comments on the Federal Register notice, we reserve the right to
reevaluate and recategorize the test based upon those comments.
Administration
We are proposing to make conforming changes to subpart F (General
Administration) to accommodate the addition of the new certificate for
APT tests. Laboratories that qualify for a certificate of APT tests
would have to pay a fee for the issuance of a certificate. Each
laboratory would be assessed a fee representing the certificate fee and
a fee for the costs of the random inspections. The certificate fee
would be based on the fee schedule (which is based on the test volume
and scope of specialties tested) in effect. This fee would represent
the APT laboratory's share of the general cost to HHS of administering
the laboratory certification program. This would include, but would not
be limited to, the cost of issuing the certificate, the cost of
collecting fees, the administrative costs of determining which tests
would qualify for inclusion in the APT test category, and the
administrative costs associated with processing and evaluating
laboratory applications. The fee for random inspection would represent
the cost to HHS of conducting random inspections of approximately five
percent of the laboratories issued a certificate for APT tests to
assess compliance with the applicable requirements of 42 CFR part 493.
Random inspection costs would be shared by all laboratories issued a
certificate for APT tests.
If, in the case of a laboratory subject to a random inspection, it
is determined that a follow-up survey is necessary because of
identified deficiencies, HHS would assess that laboratory an additional
fee to cover the cost of the follow-up survey activities. The fee would
be based on the actual resources and time necessary to perform the
follow-up visits. Failure of a laboratory to pay any assessed costs
would result in HHS revoking the laboratory's certificate.
Patient Test Management
We are proposing to add a new Sec. 493.1102 to subpart J (patient
test management) to include the new patient test management
requirements that would be applicable to APT testing. These
requirements would be less burdensome to the laboratory than the
requirements currently applicable to other moderate complexity testing
because the manufacturer's or producer's PHS-approved test system
instructions would specify what laboratories must do to comply with the
CLIA patient test management requirements. There would be two
requirements in this new standard. The two requirements would be that
the laboratory must: (a) have available and follow the patient test
management procedures specified in the PHS-approved instructions; and
(b) maintain records documenting compliance with
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the patient test management requirements for two years.
Quality Control
In subpart K (quality control), we propose to recodify the current
Sec. 493.1204 as Sec. 493.1206 and add a new Sec. 493.1204 to
accommodate the quality control provisions resulting from the proposed
addition of the new subcategory of APT tests. Since the PHS-approved
test system instructions for APT procedures would include instructions
for meeting the CLIA requirements, the laboratory quality control
requirements for APT testing would be less stringent than for other
moderate complexity tests. We are proposing that, before reporting
patient test results, laboratories, at a minimum, use the PHS-approved
test system instructions for verifying the test system's performance
specifications. The laboratory may include, as appropriate, expanded or
additional protocols for verifying the test system's performance
specifications. As with other procedures of moderate complexity,
quality control activities for APT tests would have to be documented
and the records retained for two years, except immunohematology
records, which must be maintained for a period of no less than five
years. We would stress that laboratories must not modify the test
system's PHS-approved test performance instructions, since any
modification would result in the test no longer being categorized as
APT. Any modified procedure would become an uncategorized test and
would be considered high complexity until categorized by PHS.
Personnel
The personnel requirements for APT testing would be located at
Sec. 493.1371 through Sec. 493.1387. APT personnel requirements would
be somewhat less stringent than for other moderate complexity testing
because APT tests would have been reviewed to ensure that they meet the
criteria for simple, reliable, accurate and precise tests. The
personnel requirements for this subcategory would not include a
technical consultant because manufacturers or producers of APT tests
would develop maintenance protocols, calibration and control
procedures, remedial action policies and criteria for reporting and
interpreting test results, which would fulfill most of the technical
consultant's responsibilities. The remaining technical consultant
responsibilities (e.g., employee evaluations) would be performed by the
laboratory director.
For APT tests, we would require laboratories to have a qualified
director, clinical consultant and testing personnel. The qualifications
required for director and clinical consultant would be the same as for
moderate complexity testing, while the testing personnel training
requirements would be modified slightly from the training required for
other moderate complexity testing because the test system manufacturer
or producer would be providing specific instructions on test system
performance, including reagent stability and storage and quality
control. The responsibility requirements for each level of personnel
within the APT subcategory would be somewhat less stringent in
accordance with the laboratory's reliance on the manufacturer or
producer of the test system to provide detailed test instructions,
protocols for meeting the regulatory requirements, performance
specifications and information regarding test results and
interpretation.
Quality Assurance
We are proposing to add a new Sec. 493.1702 to the quality
assurance requirements located in subpart P to include the proposed
requirements applicable to APT testing. These requirements would be
less burdensome than the requirements currently applicable to other
moderate complexity testing, since the PHS-approved test system
instructions would assist the laboratory in meeting the quality
assurance requirements. Like Sec. 493.1102 in subpart J (patient test
management), there would be two requirements in Sec. 493.1702. To meet
the quality assurance requirements in subpart P, we are proposing that:
(a) laboratories must have available and follow procedures specified in
the test system's PHS-approved instructions to meet the quality
assurance requirements; and (b) laboratories must document and maintain
records of quality assurance activities for two years.
Inspections
We are proposing to establish a new Sec. 493.1778 specifying that
laboratories with a certificate for APT tests are subject to announced
or unannounced inspections on a random basis to assess compliance with
the applicable requirements of part 493, to evaluate compliance when
indicated by unsuccessful participation in proficiency testing and
complaints, and to collect information for determining the
appropriateness of tests categorized as APT. We are proposing to
require random, rather than routine, inspections for a laboratory
having an APT certificate since the laboratory would be required only
to follow the PHS-approved instructions to meet the CLIA requirements
for APT testing. During a random inspection, as with any inspection of
other test complexity categories, not all test systems would be
reviewed. A few test systems would be randomly selected and assessed
for compliance. We would also clarify in this section that if the same
laboratory is performing provider-performed microscopy procedures,
those tests may also be assessed for compliance with all applicable
requirements specific to that subcategory of testing during the random
inspection.
Additionally, we would revise the introductory paragraph to
Sec. 493.1777, which currently contains the condition concerning
inspection of laboratories requesting or issued a certificate of
compliance, to clarify the inspection requirements for a laboratory
with a certificate of compliance when the laboratory also performs APT
procedures. Specifically, for laboratories that perform APT procedures
and have a certificate of compliance, APT procedures may be included in
the sample of moderate complexity tests inspected during the
laboratory's routine, biennial inspections.
Summary of Changes to the Regulations
We are proposing to add or change the following sections to
incorporate requirements applicable to APT tests:
<bullet> Section 493.18, Accurate and precise technology (APT)
tests.
<bullet> Section 493.21, Laboratories performing accurate and
precise technology (APT) tests.
<bullet> Section 493.48, Requirements for a certificate for
accurate and precise technology (APT) tests.
<bullet> Section 493.1102, Patient test management requirements for
accurate and precise technology (APT) tests.
<bullet> In subpart K, we are proposing to add the new quality
control requirements applicable to APT testing at Sec. 493.1204 and
move the facilities requirements (without change) currently located at
Sec. 493.1204 to a new Sec. 493.1206.
<bullet> To subpart M, we are proposing to add nine new sections to
include the personnel requirements for laboratories performing APT
testing. At Sec. 493.1371, we are proposing to add the condition
requirements for director, and at Secs. 493.1373 and 493.1375,
respectively, we plan to include the qualification and responsibility
requirements for director. The condition level requirements for
clinical consultant would be located at Sec. 493.1377, with clinical
consultant qualifications to be specified under
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Sec. 493.1379 and responsibilities to be included under Sec. 493.1381.
The testing personnel condition requirements would be at Sec. 493.1383,
with testing personnel qualifications at Sec. 493.1385 and
responsibilities to be included at Sec. 493.1387.
<bullet> Section 493.1702, Quality assurance requirements for
accurate and precise technology (APT) tests.
<bullet> Section 493.1778, Inspection of laboratories issued a
certificate for accurate and precise technology (APT) tests.
We are proposing to make conforming technical changes to the
following sections and headings: Secs. 493.2; 493.3(a)(1); 493.5
(a)(2), (b) and (c)(4); 493.20 (a) and (b); 493.25(c); the headings for
subpart C and 493.43; 493.43(a); 493.45 introductory paragraph and (a);
493.49; 493.51 heading, introductory paragraph and paragraphs (b) and
(c) and new (d); 493.53(a); 493.602; 493.638 (a) and (b); 493.639(b);
493.643(a); 493.645 heading and new paragraph (c) and paragraph (d)
(redesignated from paragraph (c)); subpart H; 493.803(a); 493.807
heading; subheading preceding 493.821; subpart I heading; subpart J
heading; 493.1101 heading and introductory paragraph; subpart K
heading; 493.1201 heading, revision to paragraph (a) and (b) and
addition of new paragraph (c); 493.1202(c); 493.1203; part M heading;
493.1351; subpart P heading; 493.1777 introductory paragraph;
493.1814(b)(3); 493.1834 (b) and (f)(2)(iii); and 493.1836 (c)(2) and
(c)(3); and 493.2001.
In addition, we are deleting the words ``of this part'' wherever
they follow a specific section number in regulations text appearing in
this Federal Register document to conform with rules of the Office of
the Federal Register.
IV. 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.
V. Collection of Information Requirements
The proposed rule contains information collections that are subject
to review by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1980. The title, description, and respondent
description of the information collection requirements are shown below
with an estimate of the annual reporting and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Sec. 493.18: This section outlines the criteria a manufacturer must
follow in order to have its moderate complexity test categorized as an
``Accuracy and Precise Technology'' (APT) test. These include but are
not limited to test system characteristics, instructions, field studies
and evaluation of data.
Secs. 493.43, 493.45, 493.48, 493.49, 493.51, 493.53: Sections
493.43 through 493.53 are currently approved under OMB approval number
0938-0612 with an expiration date of February 28, 1998. The information
is gathered on form number HCFA-R-26. These sections outline the
requirements for a laboratory to follow to submit application forms for
CLIA certification. The requirements include laboratory notification to
HHS of changes to the types of tests performed or changes in ownership,
name location or director.
Section 493.48 is a new section added to reflect the addition of
the new certificate category for laboratories performing tests
categorized as accurate and precise technology testing (APT).
Secs. 493.1101 and 493.1102: Sections 493.1101 through 493.1111 are
currently approved under OMB approval number 0938-0612 with an
expiration date of February 28, 1998. This section concerns patient
test management for laboratories performing tests of moderate and high
complexity that implement the CLIA statutory mandate for laboratories
to meet requirements relating to the proper collection, transportation,
and storage of specimens and the reporting of results. Section 493.1102
is a new section added to reflect the addition of the new subcategory
for tests categorized as accurate and precise technology testing (APT).
Secs. 493.1201, 493.1202 and 493.1204: Sections 493.1201 and
493.1202 are currently approved under OMB approval number 0938-0612
with an expiration date of February 28, 1998. These sections set forth
the general quality control standards for monitoring and evaluating the
quality of the testing process to assure accurate and reliable patient
test results and reports as required under CLIA. Section 493.1204 is a
new section required to reflect the addition of the new subcategory for
accurate and precise technology testing (APT).
Sec. 493.1702: Sections 493.1701 through 493.1721 are currently
approved under OMB approval number 0938-0612 with an expiration date of
February 28, 1998. Section 493.1702 is a new section developed to
address specific requirements that relate to quality assurance for a
laboratory performing APT testing. Specifically it requires a
laboratory to have available and follow the PHS-approved instructions
and supplements (where appropriate) and maintain records documenting
compliance for a 2-year period.
Secs. 493.1777 and 493.1778: Sections 493.1725 through 493.1780 are
currently approved under OMB approval number 0938-0612 with an
expiration date of February 28, 1998. Section 493.1777 concerns the
inspections of laboratories. The burden associated with inspections
consists of retrieving the records and documentation requested by the
inspector, participating in the entrance and exit interviews,
responding to the statement of deficiencies that may result from the
inspection and documenting any corrective actions taken that are
appropriate to the plan of correction for the deficiencies cited.
Section 493.1778 is a new section developed to address the inspection
requirements as they apply to laboratories with an APT certificate.
This section sets forth the policy of random inspections for
laboratories with an APT certificate.
When OMB approves those provisions not currently approved we will
publish a notice in the Federal Register to that affect.
Description of Respondents
Sec. 493.18: Small businesses or organizations, businesses or other
for profit, non-profit institutions, who manufacture laboratory tests.
Secs. 493.43, 493.45, 493.48, 493.49, 493.51, 493.53; 493.1101 and
493.1102; 493.1201, 493.1202 and 493.1204; 493.1702; 493.1777 and
493.1778: Small businesses or organizations, businesses or other for
profit, non-profit institutions, state and local governments, federal
agencies.
[[Page 47987]]
Estimated Annual Reporting and Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
Average
Annual number of Annual burden per Annual
CFR sections responses frequency response burden
(hours) hours
----------------------------------------------------------------------------------------------------------------
493.18................................................. 50 1 336 16,800
493.43, 493.45, 493.48, 493.49, 493.51, 493.53......... 28,700 1 .25 7,175
493.1101, 493.1102..................................... 82,000 1 .5 41,000
493.1201, 493.1202 and 493.1204........................ 82,000 1 12 984,000
493.1702............................................... 24,600(a) 1 42 1,033,200
493.1777 and 493.1778.................................. 1,230(a) 1 4 4,920
----------------------------------------------------------------------------------------------------------------
(a) Assuming 30% of 82,000 non-waived laboratories become APT.
The agency has submitted a copy of the proposed rule to OMB for its
review of these information collections. Interested persons are invited
to send comments regarding this burden estimate or any other aspect of
these collections of information, including any of the following
subjects: (1) The necessity and utility of the proposed information
collection for the proper performance of the agency's functions; (2)
the accuracy of the estimated burden; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) the
use of automated collection techniques or other forms of information
technology to minimize the information collection burden. Comments
should be sent to HCFA, OFHR, MPAS, C2-26-17, 7500 Security Boulevard,
Baltimore, Maryland 21244-1850 and to the OMB official whose name
appears in the ADDRESSES section of this preamble.
VI. Regulatory Impact Statement
We generally prepare a regulatory flexibility analysis that is
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
through 612) unless the Secretary certifies that a rule would not have
a significant economic impact on a substantial number of small
entities. For purposes of the RFA, all laboratories and manufacturers
of laboratory test systems 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 603 of the RFA. For
purposes of section 1102(b) of the Act, we define a small rural
hospital as a hospital that is located outside of a Metropolitan
Statistical Area and has fewer than 50 beds.
This proposed rule would modify CLIA regulations published February
28, 1992 by establishing a new subcategory of moderate complexity
testing, accurate and precise technology (APT) tests. There are
approximately 157,000 entities enrolled under CLIA that could be
affected by this rule; however, the significance of the effect would
vary depending on the volume and complexity of tests performed. While
we cannot estimate the number of entities that may make changes in
their laboratory testing practices, we believe the modifications to the
CLIA program would be beneficial to the affected entities and would be
well received, since they are being proposed in response to comments
requesting revisions to the test complexity categories.
In proposing this new subcategory, we acknowledge the unique
aspects of the many tests with proven accuracy and precision that may
not qualify for waiver, but should not be subject to all of the
requirements applicable to moderate complexity testing, including
routine inspection. To this end, this proposed rule would establish
less stringent requirements, including less frequent (random)
inspections and fewer personnel requirements, for laboratories
providing tests categorized as APT. We expect no clinically meaningful
decrease in test accuracy, or patient health, from this proposal.
Furthermore, to the extent that it encourages cost-effective testing
more than the present CLIA rules, and increases the amount of such
testing in settings that might otherwise eschew testing, it is likely
to improve patient health. In addition, this proposed rule would reduce
the financial burden for some laboratories by enabling them to provide
an expanded test menu without incurring the higher costs associated
with a certificate of compliance.
The changes proposed in this regulation may affect a laboratory's
test menu and choice of certificate. Laboratories holding a certificate
of compliance that change to a certificate for APT would experience a
decrease in compliance costs and the number of surveys, since APT
laboratories would not be subject to routine inspections and the
associated fees. The laboratories that would realize the greatest
benefit from these savings would most likely be physician office
laboratories and public health laboratories. Laboratories, specifically
many physician offices and other limited service laboratories,
expanding from a certificate of waiver or PPM to a certificate for APT
would be able to enhance the range of laboratory services available to
patients, while their costs (including certification fees and costs
inherent in meeting applicable requirements such as personnel and
quality control), would remain less than the costs of obtaining a
certificate of compliance. The availability of a CLIA certificate that
allows an expanded test menu at less cost also may encourage new
entities to begin providing services, thereby increasing physician and
patient access to health care, particularly in underserved and rural
areas.
This proposed rule may affect some manufacturers of laboratory
tests who would be required to submit specific information and data
demonstrating that their test meets the criteria for APT
categorization. We estimate that approximately 500 test systems may
qualify for this subcategory. These test systems are predominantly
small automated instruments or ``desktop'' analyzers. Manufacturers of
any test system approved by PHS in the APT subcategory also must
provide laboratories with complete instructions, which include
protocols to assist laboratories in meeting the CLIA requirements.
However, many manufacturers are currently providing this type of
information and assistance to laboratories in the form of instructional
materials and protocols. Because laboratories would not be required to
develop their own operational policies and quality control protocols, a
wider variety of laboratories might decide to offer APT testing.
[[Page 47988]]
Therefore, we anticipate that categorization as an APT test would
result in increased sales and distribution for the manufacturers.
As indicated above, we believe that the creation of the subcategory
of APT and subsequent decrease in the regulatory and financial burden
for laboratories performing APT tests would benefit patients,
laboratories, and manufacturers. However, we are unable to quantify
these likely long run effects because they depend on market decisions,
research results, and technological change that cannot be predicted.
Regardless, we believe that for the most part these effects would
involve relatively small savings of a few hundred or a few thousand
dollars a year for each laboratory, mainly due to reduced inspection
fees or QC costs. In the aggregate these savings would be substantial,
because they are shared by thousands of laboratories. However, few if
any entities are likely to achieve very substantial savings.
This proposed rule would establish the process for categorizing
moderate complexity tests into a new subcategory of moderate complexity
testing and would also establish a new type of certificate. Proper
realignment of the fee schedule, if necessary, would follow
implementation of this rule.
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined, and the
Secretary certifies, that this proposed rule would not have a
significant economic impact on a substantial number of small entities
or a significant impact on the operations of a substantial number of
small rural hospitals. We do request comments, however, on possible
improvements in these proposed regulations to achieve even greater
savings to affected entities and will consider them carefully in
formulating the final rule.
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 would be amended as set forth below:
PART 493--LABORATORY REQUIREMENTS
1. The authority citation continues 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. In Section 493.2, in the definition of ``CLIA certificate'' the
introductory text is republished and paragraph (6) is added to read as
follows:
Sec. 493.2 Definitions.
* * * * *
CLIA certificate means any of the following types of certificates
issued by HCFA or its agent:
* * * * *
(6) Certificate for accurate and precise technology (APT) tests
means a certificate issued or reissued before the expiration date,
pending an appeal in accordance with Sec. 493.48, to a laboratory that
only performs tests approved by PHS as APT tests and, if desired, tests
specified as PPM procedures, tests approved by PHS as waived tests, or
both.
* * * * *
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,
a registration certificate, a certificate of compliance, certificate
for PPM procedures, certificate for APT tests, or a certificate of
accreditation issued by HHS applicable to the category of examinations
or procedures performed by the laboratory; or
* * * * *
4. Section 493.5 is revised to read as follows:
Sec. 493.5 Categories of tests by complexity.
(a) Laboratory tests are categorized as one of the following types
of tests:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategories of
moderate complexity, which are limited to the following tests and
procedures:
(i) PPM procedures.
(ii) APT tests.
(3) Tests of high complexity.
(b) A laboratory has the option of performing only waived tests,
only tests of moderate complexity, only PPM procedures, only APT tests,
only tests of high complexity, or any combination.
(c) Each laboratory must be either CLIA-exempt or possess one of
the following certificates, as defined in this part:
(1) Registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate for APT tests.
(5) Certificate of compliance.
(6) Certificate of accreditation.
5. A new Sec. 493.18 is added to read as follows:
Sec. 493.18 Accurate and precise technology (APT) tests.
(a) Requirement. To be included in the APT subcategory, the test
system must be categorized as moderate complexity using the criteria in
Sec. 493.17 and it must meet the descriptive criteria specified in
paragraph (b) of this section.
(b) Criteria. (1) For quantitative tests, methods must be easy to
use, accurate, and precise as evidenced by the following items:
(i) Test systems that have the following characteristics:
(A) Are fully automated (no operator intervention during the
analytic phase).
(B) Provide direct readout of results or simple noncalculated
conversions.
(ii) Test system instructions that address the following items:
(A) Requirements for specimen collection, handling, storage and
preservation.
(B) Reportable range for patient results.
(C) Reference range (normal values) and suggested panic values
(values requiring immediate medical intervention).
(D) Units of measurement used for reporting patient results.
(E) Step-by-step protocols that include, as appropriate, the
following items:
(1) Instrument or test system operation and test performance
instructions.
(2) Test system maintenance procedures.
(3) Preparation and storage of reagents, calibrators, controls, or
other materials used in testing.
(4) Control procedures including the type of materials, suggested
concentrations, and frequency of assay.
(5) Calibration procedures including the number and type of
materials and frequency of assay.
(6) Acceptable ranges for any control or calibration material
included with the test system.
(7) Action to be taken when calibration or control results do not
meet the acceptable range of values.
[[Page 47989]]
(8) Methods for converting test system values to reportable
results.
(9) Description of course of action to be taken when the test
system becomes inoperable.
(10) Any limitations to methodologies such as interfering
substances.
(11) A written protocol for reporting patient test results.
(iii) Field studies that meet the following requirements:
(A) Demonstrate that the manufacturer's or producer's written
instructions are the only protocols required to perform the test
accurately and reliably.
(B) Demonstrate that individuals with no formal laboratory training
can correctly perform the test.
(iv) Data from field studies that meet the following requirements:
(A) Are generated from protocols that address the points described
in paragraph (b)(1)(iii) of this section.
(B) Are adequate to produce measures of performance that are both
statistically valid and defensible (estimates must support valid
confidence limits for all statistical parameters).
(C) Evaluate performance at all medical decision points and
relevant upper and lower limits of the reportable range using at least
three concentrations of the analyte being tested.
(D) Evaluate among-operator imprecision using test results of all
study participants.
(E) Evaluate within-site imprecision using test results generated
at each site by an adequate number of participants to produce measures
of performance that are statistically valid and defensible. Testing
must be performed at a minimum of three independent study sites.
(F) Evaluate among-site imprecision at an adequate number of sites
to produce measures of performance that are statistically valid and
defensible using results generated by study participants on aliquots of
a single testing material.
(v) Method accuracy studies demonstrating little or no systematic
error when--
(A) Using reference materials assayed by study participants that
produce data that show there is little or no statistically significant
difference between the test results and the value of the reference
materials.
(B) Using patient samples instead of reference materials,
demonstrating there is little or no introduction of error in patient
test results due to the effects of the sample matrix.
(C) Adding or simulating common interfering substances known to
affect the analyte in patient samples, demonstrating that there is
little or no introduction of error due to the presence of these
substances.
(vi) Demonstration that the total amount of error, which includes
all components contributing to imprecision and inaccuracy as defined by
studies described in paragraphs (b)(1)(iv)(D) through (b)(1)(iv)(F) and
(b)(1)(v)(A) through (b)(1)(v)(C) of this section, is less than one
fourth of the reference range for the analyte divided by the mean of
the reference interval.
(2) For qualitative tests, methods must be easy to use, accurate,
and precise as evidenced by the following items:
(i) Test systems that meet the following requirements:
(A) Contain steps that are limited in number and complexity, are
self-contained and are packaged as a complete system.
(B) Have a qualitative endpoint that requires no interpretation
beyond discerning agglutination patterns, color comparisons, or other
easily interpreted reactions.
(ii) Test system instructions that address the following items:
(A) Requirements for specimen collection, handling, storage and
preservation.
(B) Reportable range for patient results.
(C) Reference range (normal values).
(D) Step-by-step protocols that include, as appropriate, the
following items:
(1) Test performance instructions.
(2) Preparation and storage of reagents, calibrators, controls, or
other materials used in testing.
(3) Control procedures including the type of materials and
frequency of assay.
(4) Calibration procedures including the number and type of
materials and frequency of assay.
(5) Acceptable ranges for any control or calibration material
included with the test system.
(6) Action to be taken when calibration or control results do not
meet acceptable range of values.
(7) The correct interpretation of test reactions or endpoints.
(8) Description of course of action to be taken when test reactions
or endpoints cannot be determined.
(9) Any limitations to methodologies.
(iii) Field studies that meet the following requirements:
(A) Demonstrate that the manufacturer's or producer's written
instructions are the only protocols required to perform the test
accurately and reliably.
(B) Demonstrate that individuals with no formal laboratory training
can correctly perform the test.
(iv) Data from field studies that meet the following requirements:
(A) Are generated from protocols that address the points described
in paragraph (b)(2)(iii) of this section.
(B) Are adequate to produce measures of performance that are both
statistically valid and defensible.
(C) Confirm that study participants are able to read and interpret
test endpoints with the same precision as laboratory professionals.
(D) Confirm that the performance of study participants is
essentially the same as laboratory professionals when testing samples
at or near the cutoff and at sufficient distance above and below the
cutoff to confirm precision at all analytical decision points.
(E) Demonstrate minimal among-operator imprecision using results of
all study participants.
(F) Demonstrate minimal within-site imprecision using test results
generated at each site by an adequate number of participants to produce
measures of performance that are statistically valid and defensible.
Testing must be performed at a minimum of three independent study
sites.
(G) Using results generated by study participants, demonstrate
minimal among-site imprecision at an adequate number of sites to
produce measures of performance that are statistically valid and
defensible.
(v) Method accuracy studies demonstrating that there is no
statistically significant difference between observed values and
expected values at the cutoff point when--
(A) The test values are compared to a quantitative result such as
the value of a reference material or the presence or absence of a
particular biologic component;
(B) Confirming that there are no significant equivocal test results
on either side of the cutoff;
(C) Comparing results between study participants and laboratory
professionals on samples with values at the cutoff;
(D) The test is performed on patient samples instead of reference
materials, confirming there is no introduction of error due to sample
matrix; and
(E) Samples contain substances that commonly cause interference
confirming there is no introduction of error because of these
substances.
(c) Provisions for inclusion of tests in the APT subcategory--(1)
Process for requesting APT categorization.
(i) Requests for APT categorization must be submitted to PHS.
(ii) PHS reviews requests for APT categorization that meet the
criteria specified in paragraph (b) of this section and the submission
requirements under paragraph (c)(2) of this section.
[[Page 47990]]
(iii) The CLIAC, as specified in subpart T of this part, conducts
reviews upon the request of HHS and makes recommendations to HHS
concerning APT test categorization.
(iv) Any change or modification to an APT test system by the
manufacturer or producer that could affect the accuracy or reliability
of that test must be resubmitted to PHS for evaluation and review.
Until this review is completed and categorization status is determined,
the modified test is considered uncategorized and, in accordance with
Sec. 493.17(c)(4), is considered high complexity.
(v) A request for reconsideration of a test denied APT
categorization is accepted for review if the request is based on
information not previously submitted.
(2) Submission requirements.
(i) Requests for APT categorization must meet the criteria
described in paragraph (b) of this section. In the event that a request
does not include complete information, the request is not reviewed and
the manufacturer or producer of the test system is notified.
(ii) Data collection protocols and data submitted must be complete
and data submitted must be statistically valid and meet the criteria
described under paragraph (b) of this section.
(iii) Test system instructions must be complete and must include,
as applicable, the items defined in paragraph (b)(1)(ii) of this
section for quantitative tests and under paragraph (b)(2)(ii) of this
section for qualitative tests. In addition, test system instructions
must include the following statements:
(A) ``Any modification by the laboratory to the PHS-approved test
system instructions will result in the test no longer meeting the
requirements for APT categorization. Modified tests are considered high
complexity and are subject to all applicable CLIA requirements
contained in 42 CFR part 493.''
(B) ``The laboratory must notify the producer of this test system
of any performance, perceived or validated, that does not meet the
performance specifications as outlined in these instructions.'' The
name, address and phone number(s) of the producer's contact person(s)
must follow this statement.
(C) If applicable: ``Laboratories performing accurate and precise
technology (APT) tests are subject to the proficiency testing (PT)
requirements under 42 CFR part 493, subpart H of this part. The
laboratory must enroll and successfully participate in an HHS-approved
PT program.''
(iv) Patient test management protocols must be complete and include
sufficient information to assist laboratories in meeting each of the
requirements in subpart J of this part. These protocols must meet the
following requirements:
(A) Clearly specify the instructions that must be followed by the
laboratory to ensure proper specimen handling and accurate test result
reporting and assist laboratories in meeting the requirements of
subpart J of this part, including the following requirements listed in
paragraphs (c)(2)(iv)(A)(1) through (c)(2)(iv)(A)(4) and (c)(2)(iv)(B)
of this section, as applicable:
(1) Section 493.1103(a), procedures for specimen submission and
handling, including protocols for preparation of patients, specimen
collection, preservation, and conditions for specimen transport.
(2) Section 493.1105(f), any test requisition information that is
relevant and necessary to a specific test to assure accurate testing
and reporting of results.
(3) Sections 493.1107(c) and 493.1109(c), test records and test
report information related to the criteria for specimen acceptability.
(4) Section 493.1109, test report information including the
following information:
(i) Section 493.1109(d), pertinent ``reference'' or ``normal''
ranges.
(ii) Section 493.1109(f), any imminent life-threatening laboratory
results or panic values.
(iii) Section 493.1109(g), the test methodology employed and any
information that may affect the interpretation of test results.
(B) Provide information (for example, written instructions,
instructional materials or samples of forms for documentation of
activities performed) that laboratories may follow or supplement, in
accordance with the test system's PHS-approved instructions, in meeting
the requirements in subpart J of this part.
(v) Quality control instructions must include the following items:
(A) Protocols for documentation of all control and calibration
results, any remedial action to be taken, and the appropriate record
retention requirements as described at Sec. 493.1221.
(B) Protocols for documentation of equipment maintenance
performance and the appropriate record retention requirements as
described at Sec. 493.1221.
(C) Safety precaution instructions that cover any physical hazard
or biohazardous material, including the proper handling and disposal of
testing materials.
(D) Protocols for developing written procedures for the following
activities:
(1) Determining specimen acceptability.
(2) Reporting patient test results, including suggested panic
values, if applicable.
(3) The course of action to be taken in the event that a test
system becomes inoperable.
(4) Referral of samples, as specified in Sec. 493.1111, including
procedures for specimen submission and handling as described in
Sec. 493.1103.
(E) Verification of method performance specifications and
verification that the reference range is appropriate for the
laboratory's patient population.
(vi) Quality assurance protocols must be complete and include
sufficient information to assist laboratories in meeting each of the
requirements in subpart P of this part. These protocols must meet the
following requirements:
(A) Clearly specify the instructions that must be followed by the
laboratory in establishing a comprehensive quality assurance program
for monitoring and evaluating the overall quality of the total testing
process (preanalytic, analytic, and postanalytic) and identifying and
correcting problems based on the results of the evaluation to assure
the accurate, reliable and prompt reporting of patient results and
assist laboratories in meeting the requirements of subpart P of this
part listed in paragraphs (c)(2)(vi)(A)(1) through (c)(2)(vi)(A)(4) and
(c)(2)(vi)(B) of this section, and, as applicable, meet the
requirements of the following sections:
(1) Section 493.1703, Patient test management assessment, including
the following requirements:
(i) The criteria established for patient preparation, specimen
collection, preservation and transportation.
(ii) The completeness and relevance of the information solicited on
the laboratory's test requisition.
(iii) The use and appropriateness of the criteria established for
specimen rejection.
(iv) The completeness, usefulness and accuracy of the test report
information necessary for the interpretation or utilization of test
results.
(2) Section 493.1705, Quality control assessment, including a
mechanism to assess the effectiveness of the corrective actions taken
in the following situations:
(i) Problems identified during the evaluation of calibration and
control data for the test method.
(ii) Problems identified during the evaluation of patient test
values for the purpose of ensuring the appropriateness of the reference
range of the test method.
[[Page 47991]]
(3) Section 493.1709, Comparison of test results, including
procedures for evaluating and defining the relationship between test
results using different methodologies, instruments, or testing sites.
(4) Section 493.1711, Relationship of patient information to
patient results, including procedures for identifying and evaluating
patient test results that appear inconsistent with any relevant
criteria specified in Sec. 493.1711.
(B) Provide information (for example, written instructions,
instructional materials, or samples of forms for documentation of
activities performed) that laboratories may follow or supplement, in
accordance with the test system's PHS-approved instructions, in meeting
the requirements in subpart P of this part.
(3) Notification of decision.
(i) PHS determines whether a laboratory test meets the criteria
listed under paragraph (b) of this section for an APT test.
(ii) PHS notifies the applicant of APT categorization, whether
denied or granted.
(iii) APT categorization is effective as of the date of
notification to the applicant.
(iv) PHS publishes additions and revisions periodically to tests
categorized as APT in the Federal Register in a notice with opportunity
for public comment. PHS reserves the right to reevaluate and
recategorize a test based upon the comments it receives in response to
the Federal Register notice.
6. In Sec. 493.20, paragraphs (a) and (b) are 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 if 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 subcategories
of PPM and APT tests.
(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 and APT tests must meet the inspection
requirements at Sec. 493.1777.
* * * * *
7. A new Sec. 493.21 is added to read as follows:
Sec. 493.21 Laboratories performing accurate and precise technology
(APT) tests.
(a) A laboratory may qualify for a certificate to perform APT tests
if it performs tests categorized by PHS as APT tests and no other
procedures, except those specified as PPM procedures or those approved
by PHS as waived tests.
(b) Laboratories performing APT tests must meet the following
requirements:
(1) Follow each test system's PHS-approved instructions for
performing the test; and
(2) Meet the applicable requirements in subpart C or subpart D of
this part and subparts F, H, J, K, M, P, and Q of this part.
(c) If the laboratory also performs PPM procedures, the laboratory
must meet the applicable requirements in subparts H, J, K, M, P, and Q
of this part.
(d) If the laboratory also performs waived tests, the requirements
of subparts H, J, K, M, and P of this part are not applicable for the
waived tests. However, the laboratory must comply with the requirements
in Secs. 493.15(e) and 493.1775.
8. In Sec. 493.25, paragraph (c) is revised to read as follows:
Sec. 493.25 Laboratories performing tests of high complexity.
* * * * *
(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 and APT tests must meet the inspection
requirements at Sec. 493.1777.
* * * * *
9. The heading of subpart C is revised to read as follows:
Subpart C--Registration Certificate, Certificate for Provider-
Performed Microscopy Procedures, Certificate for Accurate and
Precise Technology Tests, and Certificate of Compliance
10. In Sec. 493.43, the section heading and paragraph (a) are
revised to read as follows:
Sec. 493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, certificate for
accurate and precise technology (APT) tests, 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 subcategories) or high complexity, or any combination of
these tests, must file a separate application for each laboratory
location.
* * * * *
11. In Sec. 493.45, the introductory paragraph is revised, the
introductory text of paragraph (a) is republished, and paragraphs
(a)(1) and (a)(2) are revised to read as follows:
Sec. 493.45 Requirements for a registration certificate.
Laboratories performing only waived tests, PPM procedures, APT
tests, 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 subcategories of APT tests and PPM procedures) or high
complexity, or both;
(2) For all laboratories that have been issued a certificate of
waiver, certificate for PPM procedures, or certificate for APT tests
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, or categorized as APT tests; and
* * * * *
12. A new Sec. 493.48 is added to read as follows:
Sec. 493.48 Requirements for a certificate for accurate and precise
technology (APT) tests.
(a) A certificate for APT tests is required for all laboratories
that intend to perform only the following tests:
(1) Tests that have been categorized by PHS as APT tests.
(2) APT tests in addition to waived tests or PPM procedures.
(3) APT tests, waived tests and PPM procedures.
(b) HHS issues a certificate for APT tests if the laboratory meets
the following requirements:
(1) Complies with the requirements of Sec. 493.43 for applying for
a certificate.
(2) Agrees to treat proficiency testing samples in the same manner
as it treats patient specimens.
(3) Agrees to be inspected by HHS as specified in Sec. 493.1778.
(4) Remits the fee for the certificate as specified in subpart F of
this part.
(c) A laboratory issued a certificate for APT tests is subject to
the following requirements:
(1) The notification requirements of Sec. 493.51.
(2) The applicable requirements of this subpart and subparts H, J,
K, M, P and Q of this part.
(d) A laboratory requesting a certificate for APT tests that also
[[Page 47992]]
performs PPM procedures is subject to the following requirements:
(1) Ensuring that PPM procedures are performed only by individuals
meeting the personnel requirements of subpart M of this part.
(2) Undergoing random inspections as specified in Sec. 493.1778.
(e) In accordance with subpart R of this part, HHS initiates
suspension, limitation, or revocation of a laboratory's certificate for
APT tests 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.
(f) A certificate for APT tests is valid for a period of no more
than 2 years. A laboratory must follow the procedures established by
HHS for renewal of this certificate.
13. Section 493.49 is amended by revising the introductory text and
paragraphs (a) and (b) 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 or categorized as APT tests.
(a) HHS issues a certificate of compliance to a laboratory only if
the laboratory meets the following requirements:
(1) Meets the requirements of Secs. 493.43 and 493.45.
(2) Remits the certificate fee specified in subpart F of this part.
(3) Meets the applicable requirements of this subpart and subparts
H, J, K, M, P, and Q of this part.
(b) A laboratory issued a certificate of compliance must meet the
following requirements:
(1) Meets the notification requirements of Sec. 493.51.
(2) Permits announced or unannounced inspections by HHS in
accordance with subpart Q of this part for the following reasons:
(i) Routine determination of compliance with the applicable
requirements of this part.
(ii) Evaluation of complaints.
(iii) Nonroutine survey of the laboratory 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.
(iv) Collection of information regarding the appropriateness of
tests listed in Sec. 493.15 or tests categorized as moderate complexity
(including the subcategories) or high complexity.
* * * * *
14. Section 493.51 is revised to read as follows:
Sec. 493.51 Notification requirements for laboratories issued a
certificate for accurate and precise technology (APT) tests or a
certificate of compliance.
Laboratories issued a certificate for APT tests or a certificate of
compliance must meet the following requirements:
(a) Notify HHS or its designee within 30 days of any change in any
of the following items:
(1) Ownership.
(2) Name.
(3) Location.
(4) Director.
(5) Technical supervisor (laboratories performing high complexity
testing 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 for APT tests or a 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 for APT tests or a certificate of compliance.
(d) Notify HHS before performing and reporting results for tests
not included under the certificate for APT tests (which are tests other
than waived tests, PPM procedures, and APT tests) unless the laboratory
has been issued a registration certificate as required in subpart C or
subpart D of this part, as applicable.
15. Section 493.53 is amended by revising the introductory text and
paragraph (a) 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 in the following situations:
(a) Before performing and reporting results for any test of
moderate complexity (including the subcategory of APT tests) 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 or certificate
for APT technology tests as required in subpart C or subpart D, as
applicable, of this part.
* * * * *
16. In Sec. 493.638, introductory paragraph (a) is revised,
paragraph (a)(4) is redesignated as (a)(5), new paragraph (a)(4) is
added, and paragraph (b) 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 for APT tests, 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 for APT tests, 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.
* * * * *
(4) For a certificate for APT tests, the costs include issuing the
certificate, collecting the fees, determining if a certificate for APT
tests should be issued, evaluating which test systems qualify for
inclusion in the subcategory of APT tests, and other direct
administrative costs.
(5) 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 for APT tests, certificate of accreditation, or
certificate of compliance is the amount in effect at
[[Page 47993]]
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.
17. In Sec. 493.639, paragraphs (b) introductory text and (b)(1)
are 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 circumstances specified in paragraphs
(b)(1) and (b)(2) of this section.
(1) The fee for issuing an appropriate revised certificate is based
on the cost of issuing 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
(registration or certificate for APT tests) to cover the additional
testing.
(iii) If a laboratory with a certificate for APT tests wishes to
perform tests in addition to those categorized as APT tests, 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 a
registration certificate to cover the additional testing.
* * * * *
18. In Sec. 493.643, paragraph (a) is 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,
certificate for APT tests, or a certificate of accreditation are not
subject to this fee for routine inspections.
* * * * *
19. In section 493.645, the heading is revised, paragraph (c) is
redesignated as (d) and revised, and a new paragraph (c) is added:
Sec. 493.645 Additional fee(s) applicable to approved State laboratory
programs and laboratories issued certain certificates.
* * * * *
(c) Laboratories with a certificate for APT tests.
(1) In addition to the certificate fee, a laboratory requesting a
certificate for APT tests is also assessed a fee representing the cost
to HHS of random inspections to determine compliance with CLIA
requirements. All laboratories issued a certificate for APT tests will
share in the cost of these inspections.
(2) If a laboratory issued a certificate for APT tests 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 follow up visits. HHS revokes the laboratory's
certificate for APT tests for failure to pay the assessed fee.
(d) Other fees. If, in the case of a laboratory that has been
issued a certificate of accreditation, certificate of waiver,
certificate for PPM procedures, or certificate for APT tests, 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 the
determination that a complaint is 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.
20. 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
Subcategories), High Complexity, or any Combination of These Tests
21. 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 subcategories) 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.
* * * * *
22. 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 subcategories), high complexity,
or any combination of these tests, after failure to participate
successfully.
* * * * *
23. 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 Subcategories),
High Complexity, or Any Combination of These Tests
24. The heading to subpart I is revised to read as follows:
Subpart I--Proficiency Testing Programs for Tests of Moderate
Complexity (Including the Subcategories), High Complexity, or any
Combination of These Tests
25. The heading to subpart J is revised to read as follows:
Subpart J--Patient Test Management for Moderate Complexity
(Including the Subcategories), High Complexity, or any Combination
of These Tests
26. Section 493.1101 is revised to read as follows:
Sec. 493.1101 Condition: Patient test management; moderate complexity
(including the subcategories), high complexity testing, or any
combination of these tests.
Each laboratory performing moderate complexity (including the
subcategories) 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.
27. A new Sec. 493.1102 is added to read as follows:
[[Page 47994]]
Sec. 493.1102 Standard; Patient test management requirements for
accurate and precise technology (APT) tests.
For each APT test performed, the laboratory must meet all
applicable patient test management requirements specified in
Secs. 493.1103 through 493.1111. The laboratory meets these
requirements by doing both of the following activities:
(a) Having available and following the test system's PHS-approved
instructions and, as appropriate, any supplements to the procedures
established by the laboratory in accordance with the test system's PHS-
approved instructions.
(b) Maintaining all records documenting compliance with paragraph
(a) of this section for 2 years.
28. The heading to subpart K is revised to read as follows:
Subpart K--Quality Control for Tests of Moderate Complexity
(Including the Subcategories), High Complexity, or any Combination
of These Tests
29. Section 493.1201 is amended by revising paragraph (a)
introductory text and paragraph (b) and by adding paragraph (c) to read
as follows:
Sec. 493.1201 Condition: General quality control; Moderate complexity
(including the subcategories) or high complexity testing, or any
combination of these tests.
(a) General. Subpart K of this part is divided into two sections,
general quality control and quality control for specialties and
subspecialties. The quality control requirements are specified in
Secs. 493.1201 through 493.1285 unless--
* * * * *
(b) Applicability of subpart K to moderate complexity (excluding
APT tests) and high complexity tests. The laboratory must establish and
follow written quality control procedures for monitoring and evaluating
the quality of the analytical testing process of each method to assure
the accuracy and reliability of patient test results and reports. The
laboratory must meet the applicable general quality control standards
in Secs. 493.1202 through 493.1221, unless an alternative procedure
specified in the manufacturer's protocol has been cleared by the Food
and Drug Administration (FDA) as meeting certain CLIA requirements for
quality control or HHS approves an equivalent procedure specified in
appendix C of the State Operations Manual (HCFA Pub. 7). HCFA Pub. 7 is
available from the National Technical Information Service, U.S.
Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161,
telephone number (703) 487-4630.
(c) Applicability of subpart K to APT testing. The laboratory must
follow each test system's PHS-approved written instructions for
monitoring and evaluating the quality of the analytical testing process
to assure the accuracy and reliability of patient test results and
reports. For each APT test, the laboratory must meet the quality
control requirements of Sec. 493.1204.
30. In Sec. 493.1202, the introductory text of paragraph (c) is
revised to read as follows:
Sec. 493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to September 1, 1996.
* * * * *
(c) For all other tests of moderate complexity, excluding the
subcategory of APT testing, performed using an instrument, kit, or test
system cleared by the FDA through premarket notification (510(k)) or
the premarket approval (PMA) process for in-vitro diagnostic use, the
laboratory must--
* * * * *
31. Section 493.1203 is amended by revising the introductory text
to read as follows:
Sec. 493.1203 Standard; Moderate complexity (excluding accurate and
precise technology (APT) tests) or high complexity testing or both:
Effective September 1, 1996.
For each moderate complexity (excluding APT tests) or high
complexity test performed, the laboratory is in compliance with this
section if it--
* * * * *
Sec. 493.1204 [Redesignated as Sec. 493.1206]
32. Section 493.1204 is redesignated as Sec. 493.1206.
33. New Sec. 493.1204 is added to read as follows:
Sec. 493.1204 Standard; Quality control requirements for accurate and
precise technology (APT) tests.
For each APT test performed, the laboratory is in compliance with
this subpart if it meets all applicable quality control requirements in
this section. The laboratory must meet the following requirements:
(a) Have available and follow each test system's PHS-approved
written instructions, which include the following protocols:
(1) Safety precautions.
(2) Protocols for instrument or test system operation and test
performance, including maintenance and function checks.
(3) Calibration procedures.
(4) Quality control procedures defined by the manufacturer or
producer of the test system, which include running at least two levels
of control each day of testing to monitor all steps in the testing
process, including the extraction phase if applicable, unless one of
the following circumstances applies:
(i) The test system's PHS-approved instructions specify other than
two levels of control.
(ii) The procedure cannot be controlled by conventional procedures
and an alternative means of controlling the system has been approved by
PHS.
(5) Remedial action procedures.
(b) Ensure that it meets the following requirements:
(1) It has available and follows written procedures, based on each
test system's PHS-approved instructions, as applicable, for the
following procedures:
(i) Determining specimen acceptability.
(ii) Reporting patient test results, including panic values (values
requiring immediate medical intervention).
(iii) Course of action to be taken in the event that a test system
becomes inoperable.
(iv) Referral of samples as specified in Sec. 493.1111, including
procedures for specimen submission and handling, as described in
Sec. 493.1103.
(2) The written procedures, whether provided by the manufacturer,
the test system producer, or the laboratory, are approved, signed and
dated by the current director of the laboratory.
(3) Any change to a procedure by the manufacturer or producer of a
test system is approved by PHS and signed and dated by the laboratory
director for use by laboratory personnel.
(4) Any change to a laboratory's protocol designed to meet the
requirements is approved, signed and dated by the laboratory director.
[[Page 47995]]
(5) A copy of each procedure with the dates of initial use and
discontinuance is retained for 2 years after a procedure has been
discontinued.
(c) Before reporting patient results, using at least the test
system's PHS-approved written instructions, verify that it can obtain
performance specifications for accuracy, precision and reportable range
of patient results that meet those established by the manufacturer or
producer of the test system. The laboratory must also ensure that the
laboratory's patient population is included in the reference range
specified in the PHS-approved instructions.
(d) Document all remedial actions taken--
(1) In accordance with the test system's PHS-approved written
instructions; and
(2) When errors in the reported patient test results are detected.
In such a case, the laboratory must perform the following procedures:
(i) Promptly notify the authorized person ordering the test or
individual using the test results of report errors.
(ii) Issue corrected reports promptly to the authorized person
ordering the test or the individual using the test results.
(iii) Maintain exact duplicates of the original erroneous report as
well as the corrected report for 2 years.
(e) Document and maintain records of all quality control activities
specified in this section and retain records for at least 2 years or
longer as specified by the manufacturer or producer of the test system
in accordance with Sec. 493.1221.
(f) Promptly report any inaccurate or imprecise method performance,
whether perceived or validated, to the manufacturer or producer of the
test system and, if the problem is not rectified, to PHS.
(g) Ensure that no modification is made in the test system's PHS-
approved written instructions. Any changes made to the test system will
result in the test system no longer meeting the requirements for
categorization in the APT category. Modified tests are considered high
complexity and are subject to the applicable CLIA quality control
requirements contained in subpart K of this part, as well as all other
applicable requirements for high complexity testing.
34. The heading to subpart M is revised to read as follows:
Subpart M--Personnel for Moderate Complexity (Including the
Subcategories) and High Complexity Testing
35. Section 493.1351 is revised 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, APT tests, high complexity testing, or any combination of
these tests.
36. Following Sec. 493.1365, a new undesignated center heading and
new Secs. 493.1371 through 493.1387 are added to read as follows:
Laboratories Performing Accurate and Precise Technology (APT) Tests
Sec.
493.1371 Condition: Laboratories performing APT tests; Laboratory
director.
493.1373 Standard; Laboratory director qualifications.
493.1375 Standard; Laboratory director responsibilities.
493.1377 Condition: Laboratories performing APT testing; clinical
consultant.
493.1379 Standard; Clinical consultant qualifications.
493.1381 Standard: Clinical consultant responsibilities.
493.1383 Condition: Laboratories performing APT testing; testing
personnel.
493.1385 Standard; Testing personnel qualifications.
493.1387 Standard; Testing personnel responsibilities.
Laboratories Performing Accurate and Precise Technology (APT) Tests
Sec. 493.1371 Condition: Laboratories performing APT tests; Laboratory
director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1373 and provides overall management and
direction in accordance with Sec. 493.1375.
Sec. 493.1373 Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and the performance of APT tests and must be
eligible to be an operator of a laboratory within the requirements of
subpart R of this part and meet the requirements of Sec. 493.1405,
which contain laboratory director qualifications for moderate
complexity testing.
Sec. 493.1375 Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation
and administration of the laboratory, including the employment of
personnel who are competent to perform APT tests in accordance with
each test system's PHS-approved instructions, and record and report
test results promptly, accurately, and proficiently, and for assuring
compliance with applicable regulations.
(a) The laboratory director, if qualified, may perform the duties
of the clinical consultant and testing personnel or may delegate these
responsibilities to personnel meeting the qualification requirements of
Secs. 493.1379 and 493.1385, respectively.
(b) The laboratory director must be accessible to the laboratory to
provide onsite, telephone or electronic consultation as needed.
(c) No individual may direct more than five laboratories.
(d) The laboratory director must meet the following requirements:
(1) Ensure that testing systems selected for each of the tests
performed in the laboratory are appropriate for the clinical use of the
test results.
(2) Ensure that the physical plant and environmental conditions of
the laboratory are appropriate for the testing performed and provide a
safe environment in which employees are protected from physical,
chemical, and biological hazards.
(3) Ensure that the following requirements are met:
(i) Before reporting patient results, using at least the test
system's PHS-approved verification procedure, the laboratory can obtain
or verify performance specifications for accuracy, precision and
reportable range of patient results that meet those established by the
manufacturer or producer of the test system and can ensure that the
reference range specified by the manufacturer or producer of the test
system is appropriate for the laboratory's patient populations.
(ii) Testing personnel are following test analyses and quality
control procedures in accordance with each test system's PHS-approved
instructions.
(4) Ensure that the laboratory is enrolled in an HHS-approved
proficiency testing program for the
[[Page 47996]]
testing performed and that the laboratory meets the following
requirements:
(i) The proficiency testing samples are tested as required under
subpart H of this part.
(ii) The results are returned within the time frames established by
the proficiency testing program.
(iii) All proficiency testing reports received are reviewed to
evaluate the laboratory's performance and to identify any problems that
require corrective action.
(iv) An approved corrective action plan is followed and documented
when any proficiency testing results are found to be unacceptable or
unsatisfactory.
(5) Ensure that a quality assurance program is established and
maintained to assure the quality of laboratory services provided.
(6) Ensure that all necessary remedial actions are taken and
documented and that patient results are reported only when the test
system is functioning properly.
(7) Ensure that the producer or manufacturer of the test system is
notified when the test system does not meet the performance
specifications as outlined in the test system's PHS-approved
instructions and, if the problem is not rectified, notify PHS.
(8) Ensure that reports of test results include pertinent
information required for interpretation.
(9) Ensure that consultation is available to the laboratory's
clients on matters relating to the results of APT tests reported and
their interpretation concerning specific patient conditions, including
any relevant information provided in the test system's PHS-approved
instructions.
(10) Employ a sufficient number of testing personnel with the
appropriate education and either experience or training to perform
tests and report test results in accordance with the personnel
responsibilities described in this subpart.
(11) Ensure that, before they test patient samples, testing
personnel receive the appropriate training for the services offered and
have demonstrated that they can perform all testing operations, in
accordance with each test system's PHS-approved instructions, to
provide and report accurate results.
(12) Ensure that policies and procedures are established for
evaluating and documenting the performance of testing personnel
responsible for APT testing to ensure that they are competent and
maintain their competency to handle specimens, perform test procedures,
report test results promptly and proficiently, and, whenever necessary,
identify needs for remedial training or continuing education to improve
testing skills. The director must ensure that evaluations are conducted
at least semiannually during the first year the individual tests
patient specimens and that, thereafter, the evaluations are performed
at least annually unless test methodology or instrumentation changes,
in which case, before reporting patient test results, the individual's
performance must be reevaluated to include the use of the new test
methodology or instrumentation. The evaluation of the competency of
testing personnel must include at least one or more of the following,
but is not limited to the following procedures:
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling, and
testing.
(ii) Monitoring the recording and reporting of test results.
(iii) Review of work sheets, quality control records, proficiency
testing results, and preventive maintenance records.
(iv) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples, or external
proficiency testing samples.
(13) Ensure that an approved procedure manual is available to all
testing personnel.
(14) Specify, in writing, the responsibilities and duties of each
person engaged in the performance of APT testing that identifies which
examinations and procedures each individual is authorized to perform.
Sec. 493.1377 Condition: Laboratories performing APT testing; clinical
consultant.
The laboratory must have a clinical consultant who meets the
qualification requirements of Sec. 493.1379 and provides clinical
consultation in accordance with Sec. 493.1381.
Sec. 493.1379 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and
furnish opinions to the laboratory's clients concerning the diagnosis,
treatment and management of patient care. The clinical consultant must
meet the requirements of Sec. 493.1417, Clinical consultant
qualifications for moderate complexity testing.
Sec. 493.1381 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must meet the following requirements:
(a) Be available to provide clinical consultation to the
laboratory's clients.
(b) Be available to assist the laboratory's clients in ensuring
that appropriate tests are ordered to meet the clinical expectations.
(c) Ensure that reports of test results include pertinent
information required for specific patient interpretation.
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the results of APT tests
reported and their interpretation concerning specific patient
conditions, including any relevant information provided in the test
system's PHS-approved instructions.
Sec. 493.1383 Condition: Laboratories performing APT testing; testing
personnel.
The laboratory must have a sufficient number of individuals who
meet the qualification requirements of Sec. 493.1385 to perform the
functions specified in Sec. 493.1387 for the volume of tests performed.
Sec. 493.1385 Standard; Testing personnel qualifications.
Each individual performing APT testing must meet the following
requirements:
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required.
(b) Meet one of the following requirements:
(1) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located or have earned
a doctoral, master's, or bachelor's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution.
(2) Have earned an associate degree in a chemical, physical, or
biological science, or in medical laboratory technology from an
accredited institution.
(3) 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).
(4) (i) Have earned a high school diploma or equivalent; and
(ii) Have documentation of training appropriate for the APT testing
performed before analyzing patient
[[Page 47997]]
specimens. This training must ensure that the individual has the
following skills and knowledge:
(A) The skills required for proper specimen collection, including
patient preparation (if applicable), labeling, handling, preservation,
transportation and storage of specimens.
(B) The skills required for performing each test method and control
procedure and for proper instrument use.
(C) The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each test
performed.
(D) An awareness of the factors that influence test results.
Sec. 493.1387 Standard; Testing personnel responsibilities.
The testing personnel performing APT tests are responsible for
specimen processing, test performance, and for reporting test results.
(a) Each individual performs only those APT tests that they are
authorized by the laboratory director to perform.
(b) Each individual performing APT testing must meet the following
requirements:
(1) Follow each test system's PHS-approved written instructions
and, as applicable, the laboratory's written policies and procedures
for specimen submission and handling and for reporting and maintaining
records of patient test results.
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient samples.
(3) Adhere to each test system's PHS-approved written instructions
for quality control procedures, including the documentation of all
quality control activities, remedial actions, instrument and procedural
calibrations, and maintenance performed.
(4) Be capable of identifying problems that may adversely affect
test performance or reporting of test results and either must correct
the problems or immediately notify the director.
(5) Notify the director of any test system performance that does
not meet the performance specifications as outlined in the test
system's PHS-approved instructions.
37. The heading to subpart P is revised to read as follows:
Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategories), High Complexity Testing, or any Combination of
These Tests
Sec. 493.1701 [Amended]
38. Section 493.1701 is amended by revising the word
``subcategory'' to read ``subcategories'' wherever it appears in the
heading and text.
39. A new Sec. 493.1702 is added to read as follows:
Sec. 493.1702 Standard; Quality Assurance for accurate and precise
technology (APT) tests.
For each APT test performed, the laboratory must meet all
applicable quality assurance requirements specified in Secs. 493.1703
through 493.1721. The laboratory meets these requirements by doing both
of the following activities:
(a) Having available and following the test system's PHS-approved
instructions and, as appropriate, any supplements to the procedures
established by the laboratory in accordance with the test system's PHS-
approved instructions.
(b) Maintaining all records documenting compliance with paragraph
(a) of this section for 2 years.
40. In Sec. 493.1777 the introductory text is revised to read as
follows:
Sec. 493.1777 Condition: Inspection of laboratories requesting or
issued a certificate of compliance.
Laboratories requesting a certificate of compliance must permit an
inspection to assess compliance with part 493 of this chapter. All
testing conducted, including testing in the subcategories of APT tests
or PPM procedures, may be included in the laboratory's routine or
complaint inspection. APT tests and PPM procedures are assessed for
compliance with only the applicable requirements specific to those
subcategories of testing.
* * * * *
41. A new Sec. 493.1778 is added to read as follows:
Sec. 493.1778 Condition: Inspection of laboratories issued a
certificate for accurate and precise technology (APT) tests.
(a) HHS or its designee may conduct announced or unannounced
inspections of any laboratory issued a certificate for APT tests at any
time during its hours of operation for the following purposes:
(1) Assess compliance with the following circumstances, as
applicable:
(i) On a random basis.
(ii) Following a laboratory's demonstration of unsuccessful
participation in proficiency testing for analytes specified in subpart
I of this part.
(iii) To evaluate complaints from the public.
(2) Determine whether testing is being performed or the laboratory
is being operated in a manner that does not constitute an imminent and
serious risk to public health.
(3) Collect information to determine the appropriateness of tests
categorized as APT tests according to the criteria listed at
Sec. 493.18.
(4) Determine whether the laboratory is performing tests in
addition to tests categorized as APT tests according to the criteria
listed at Sec. 493.18, specified as PPM procedures, or tests approved
by PHS as waived tests that are not included on the laboratory's
certificate.
(b) The laboratory may be required as part of this inspection to
perform or authorize the following activities:
(1) Test samples (including proficiency testing samples) or perform
procedures as HHS or its designee requires.
(2) Allow HHS or its designee to interview all employees of the
laboratory concerning the laboratory's compliance with the applicable
requirements as noted in paragraph (d) of this section.
(3) Permit employees to be observed performing tests (including
proficiency testing specimens), data analysis and reporting.
(4) Permit HHS or its designee access to all areas of the facility,
including the following areas:
(i) Specimen procurement and processing areas.
(ii) Storage facilities for specimens, reagents, supplies, records,
and reports.
(iii) Testing and reporting areas.
(5) Provide copies to HHS or its designee of all records and data
required under this part.
(c) The laboratory must have all records and data accessible and
retrievable within a reasonable time frame during the inspection.
(d) Applicable requirements for the purpose of this section are
located in subparts C, H, J, K, M, and P of this part and Sec. 493.21.
(e) The laboratory must provide upon reasonable request all
information and data needed by HHS or its designee to make a
determination of compliance with the applicable requirements.
(f) HHS or its designee may reinspect a laboratory at any time
necessary to assess the laboratory's compliance with the applicable
requirements.
(g) Failure to permit an inspection under this section will result
in the suspension of Medicare and Medicaid payments to the laboratory
or
[[Page 47998]]
termination of the laboratory's participation in Medicare and Medicaid
for payment, and suspension of, or action to revoke, the laboratory's
CLIA certificate in accordance with subpart R of this part.
42. In Sec. 493.1814, the text of 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,
certificate for APT tests, or certificate for PPM procedures is
pending.)
* * * * *
43. 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, certificate for
APT tests, 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, certificate for APT tests, or certificate for PPM
procedures.
* * * * *
44. 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 and 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, certificate for APT tests, 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, certificate for APT tests,
or certificate for PPM procedures is effective.
45. In Sec. 493.2001, the introductory text of paragraph (e) is
republished and paragraph (e)(1) is 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 subcategories) and high complexity;
* * * * *
Authority: Sec. 353 of the Public Health Service Act (42 U.S.C.
263a)
Dated: May 25, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
Dated: May 26, 1995.
Philip R. Lee,
Assistant Secretary for Health.
Dated: June 5, 1995.
Donna E. Shalala,
Secretary.
[FR Doc. 95-22861 Filed 9-14-95; 8:45 am]
BILLING CODE 4120-01-P
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