September 15, 1995
Health and Human
Health Care Financing Administration
42 CFR Part 493
CLIA Program; Categorization and
Certification Requirements for a New
Subcategory of Moderate Complexity
Testing; Proposed Rule
47982 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
DEPARTMENT OF HEALTH AND Allison Herron Eydt, HCFA Desk In response to publication of the
HUMAN SERVICES Officer. February 28, 1992 regulations, we
Copies: To order copies of the Federal received approximately 16,000 letters
Health Care Financing Administration Register containing this document, send from professional organizations and
your request to: New Orders, individuals providing around 71,000
42 CFR Part 493 Superintendent of Documents, P.O. Box comments.
[HSQ–222–P] 371954, Pittsburgh, PA 15250–7954. In response to those comments, we
Specify the date of the issue requested have published three rules (in addition
RIN 0938–AG98 and enclose a check or money order to this proposed rule). One of those
payable to the Superintendent of rules responds to the comments
CLIA Program; Categorization and received on the waived criteria, tests
Documents, or enclose your Visa or
Certification Requirements for a New presently included in the waived
Master Card number and expiration
Subcategory of Moderate Complexity category and those tests that
date. Credit card orders can also be
Testing commenters believed should be added.
placed by calling the order desk at (202)
AGENCY: Health Care Financing 512–1800 or by faxing to (202) 512– At our request, the CLIAC evaluated the
Administration (HCFA) and Public 2250. The cost for each copy is $8.00. waived category and suggested that the
Health Service (PHS), HHS. As an alternative, you can view and Centers for Disease Control and
ACTION: Proposed rule. photocopy the Federal Register Prevention (CDC) clarify the criteria and
document at most libraries designated develop a process for review of requests
SUMMARY: In this proposed rule we are as Federal Depository Libraries and at for waiver. We clarified the criteria for
responding to some of the comments on many other public and academic waiver and the process for requesting
categories of tests received in response libraries throughout the country that waived categorization and published the
to the rule published on February 28, receive the Federal Register. clarified criteria and process for
1992. To reduce the regulations burden FOR FURTHER INFORMATION CONTACT: requesting waiver in a proposed rule
on laboratories, we are proposing to Rosemary Bakes-Martin (404) 488–7655, with comment on September 13, 1995
revise our regulations to create a new for questions regarding the APT (60 FR 47534). (The other two rules
subcategory of high quality moderate requirements and criteria for APT appeared in the Federal Register on
complexity procedures called accurate categorization; and Judy Yost, (410) January 19, 1993 (58 FR 5215) and on
and precise technology (APT) tests. 786–3531, for certificate, fee, and April 24, 1995.
In this rule, in response to numerous
DATES: Comments will be considered if inspection issues.
comments regarding the test complexity
we receive them at the appropriate
SUPPLEMENTARY INFORMATION: model, we are proposing to establish a
address, as provided below, no later
I. Background new subcategory of moderate
than 5 p.m. on November 14, 1995.
complexity that would include high
ADDRESSES: Mail written comments (1 Under section 353 of the Public quality tests that would be subject to
original and 3 copies) to the following Health Service Act (42 U.S.C. 263a), as less stringent requirements.
address: Centers for Disease Control and amended by the Clinical Laboratory Establishment of this subcategory
Prevention, Public Health Service, Improvement Amendments of 1988 should encourage manufacturers to
Department of Health and Human (CLIA), all laboratories that examine produce accurate, easy-to-use test
Services, Attention: HSQ–222–P, 4770 human specimens for the diagnosis, systems for use by physicians and
Buford Highway, N.E., MSF11, Atlanta, prevention or treatment of any disease laboratories to improve test quality and
Georgia 30341–3724. or impairment of, or the assessment of enhance patient care.
If you prefer, you may deliver your the health of, human beings, must meet
written comments (1 original and 3 certain requirements to perform the II. Response to Comments Received to
copies) to one of the following examination. In accordance with the Previous CLIA Regulations
addresses: Room 714–B, Hubert H. law, regulations implementing CLIA In this rule we address additional
Humphrey Building, 200 Independence that HHS published on February 28, comments received in response to the
Avenue, SW., Washington, DC 20201. 1992 (57 FR 7002) established establishment of the three testing
Because of staffing and resource laboratory requirements based on the categories. Below we have provided a
limitations, we cannot accept comments complexity of the tests performed. There general overview of the comments and
by facsimile (FAX) transmission. In are currently three test categories: our responses, followed by some
commenting, please refer to file code waived, moderate, and high complexity. additional specific comments
HSQ–222–P. Comments received timely Following publication of the February concerning the categories of testing and
will be available for public inspection as 28, 1992 regulations, HHS established a our response to these comments, which
they are received, generally beginning Clinical Laboratory Improvement includes the rationale used to develop
approximately 3 weeks after publication Advisory Committee (CLIAC) to advise the proposed accurate and precise
of a document, in Room 309–G of the and make recommendations on technology (APT) subcategory.
Department’s offices at 200 technical and scientific aspects of the Upon review of the comments, we
Independence Avenue, SW., regulations. The CLIAC is composed believe that additional revision of the
Washington, DC, on Monday through primarily of individuals involved in the test categorization model is warranted.
Friday of each week from 8:30 a.m. to provision of laboratory services, use of The revisions to the regulations
5 p.m. (phone: (202) 690–7890). laboratory services, development of proposed in this rule would address the
For comments that relate to laboratory testing devices or commenters’ concerns that many high
information collection requirements, methodologies, and others as approved quality tests are less complex than many
mail a copy of comments to: Office of by HHS. The CLIAC has four of the tests currently categorized as
Information and Regulatory Affairs, subcommittees: cytology; personnel; moderate complexity, but they do not
Office of Management and Budget, proficiency testing, quality control and meet the criteria for waiver. The
Room 10235, New Executive Office quality assurance; and test commenters feel and we agree that these
Building, Washington, DC 20503, Attn: categorization. tests should be subject to less stringent
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47983
requirements than those currently determining types of laboratory services To obtain broad public review, we are
associated with moderate complexity to provide. publishing this proposed rule and
tests. We therefore designed a subcategory encourage commenters to provide
In addition, we received numerous of moderate complexity testing that we suggestions on how we might revise the
comments from professional proposed to call APT testing that would CLIA requirements to ensure that they
organizations and individuals include high quality, less complex tests promote access to quality services and
expressing concern about the burden that would be unique in that the test stimulate technological advances in
associated with regulating laboratories system instructions would not only testing. With respect to the provisions
based on test complexity and the criteria contain complete procedures for test contained in this rule, we are seeking
used to categorize tests as moderate or performance, including instructions specific suggestions and
high complexity. Many commenters regarding the preanalytic, analytic and recommendations concerning the
indicated that the special circumstances postanalytic phases of testing, but criteria and process for categorizing
involved in physician offices, rural and would also include protocols that would tests in the APT subcategory, as well as
public health clinics providing assist laboratories in meeting the CLIA comments on the appropriateness of the
laboratory services should justify requirements. We proposed that, in proposed requirements for APT testing.
minimizing the regulatory burden on order to be considered for categorization
them. Some commenters believed that III. Provisions of the Proposed Rule
in the APT subcategory, the producer or
regulating laboratories on the basis of manufacturer of the test system would Criteria for APT Categorization
test complexity and the requirements have to submit data demonstrating that
applicable to moderate and high In this rule, we are proposing to
the test system meets the criteria for establish at 42 CFR 493.18 a new
complexity tests would increase the cost APT categorization. In addition, the test
of laboratory testing. Several subcategory of moderate complexity
system instructions would have to testing designated as APT, and we are
commenters thought this regulatory specify clearly what laboratories must
burden would cause many laboratories outlining the proposed criteria for
do to be in compliance with the CLIA determining which tests would be
to discontinue providing services, requirements. For APT testing,
thereby limiting health care in categorized as APT. The proposed
laboratories could rely on the criteria for inclusion in the APT
underserved and rural areas. Some manufacturer’s or producer’s test system
commenters recommended reducing subcategory are structurally similar to
instructions to meet the CLIA our proposed clarifications to the
some of the regulatory burden by requirements. Since, for APT testing,
creating a category of tests at a level criteria for waived tests published on
compliance with the CLIA requirements September 13, 1995.
between waived and moderate
would be based on laboratories For quantitative and qualitative tests,
complexity. Other commenters
following the test system instructions, the similarities between the proposed
suggested creating additional categories
we believe that random, rather than criteria for APT categorization and the
and provided examples for alternatives
routine, inspections of laboratories proposed clarifications to the criteria for
to the current test complexity model.
In response to these comments, the having an APT certificate would be waiver are as follows:
CDC developed a proposal to create a sufficient. • Quantitative APT tests and
new subcategory of moderate We discussed with the CLIAC the quantitative waived tests would have to
complexity that would include simple, proposed criteria and requirements to be meet similar test characteristics and
easy-to-use tests with proven accuracy applicable to the new subcategory. The performance specifications by
and precision and therefore would CLIAC supported the concept of the demonstrating, through scientifically
require somewhat less stringent APT subcategory. However, the CLIAC valid studies, a high level of accuracy
requirements than the requirements expressed the view that the subcategory and precision.
currently applicable to other moderate (as currently structured) would not • Qualitative APT tests would have to
complexity tests. provide the amount of regulatory relief meet the same requirements for
During the development of the desired by many commenters who allowable error as we have proposed for
subcategory, we were especially requested revisions to the complexity qualitative waived tests.
cognizant of the concerns of the model. We understand the CLIAC’s The proposed criteria for inclusion in
commenters who stated that there are concerns; however, we believe that it is the APT subcategory would differ from
many high quality, moderate complexity essential that we reevaluate the the proposed criteria for waiver in that:
tests that might not qualify for waiver, complexity model to determine whether • Waived tests must be fail-safe with
but, on the other hand, should not be the regulations are effective in ensuring no operator intervention, whereas APT
subject to the full range of requirements public access to quality laboratory test protocols could allow some operator
currently applicable to moderate services. When we established the CLIA intervention to investigate questionable
complexity testing. We agree with the requirements in 1992, we sought to results and to resolve test system
commenters that regulatory relief for devise a regulatory model based on the failures.
high quality tests is appropriate. In complexity of testing performed that • Waived qualitative tests are limited
order to justify less stringent application would establish the minimum to reagent impregnated devices (such as
of the requirements, we are proposing requirements necessary to ensure dipsticks), whereas qualitative APT tests
that the tests meet rigid performance accurate testing. At this point, we would not be limited to any specific
specifications and have demonstrated, believe there are many highly accurate, type of technology. [It is important to
through scientifically valid studies, a simple, easy-to-use test systems clarify what is meant by qualitative tests
high level of accuracy and precision. currently categorized as moderate in this regulation. Qualitative tests are
Through this process, test systems complexity that could be eligible for less test methods that provide two
would be evaluated to ensure they stringent requirements, and laboratories categorical responses (e.g., positive/
provide quality results and physicians performing such testing should be negative or presence/absence). For these
and laboratories would have access to provided financial and regulatory relief types of tests, the concentration of the
this categorization information to through a reduction in the CLIA analyte is defined as being above or
employ in test selection and requirements. below a certain discrimination zone that
47984 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
defines negativity or positivity.] On the meeting the CLIA requirements. The test tests. Laboratories that qualify for a
other hand, test methods that give system instructions should remind certificate of APT tests would have to
results by defining specific absorbance laboratories to enroll in an HHS- pay a fee for the issuance of a certificate.
values at which tests will be considered approved proficiency testing program, if Each laboratory would be assessed a fee
positive are essentially quantitative tests applicable. representing the certificate fee and a fee
in that they directly depend on defined Since many manufacturers are for the costs of the random inspections.
concentrations of the analyte producing currently providing this type of The certificate fee would be based on
the discrete absorbance value. In this assistance to laboratories, often in the the fee schedule (which is based on the
regulation, we are proposing to consider form of complete protocols containing test volume and scope of specialties
the latter as quantitative tests. instructional materials that cover all tested) in effect. This fee would
• Waived tests may use only direct aspects of the regulations and, in represent the APT laboratory’s share of
unprocessed specimens, have direct addition, examples of suggested forms the general cost to HHS of administering
readout of results and require no to use to document monitoring the laboratory certification program.
invasive troubleshooting or electronic or activities, we believe that the APT This would include, but would not be
mechanical maintenance. However, subcategory merely strengthens and limited to, the cost of issuing the
APT tests could have simple confirms that interaction between the certificate, the cost of collecting fees, the
noncalculated conversions and some producer of the test system and the administrative costs of determining
troubleshooting and maintenance laboratory user. Formalizing this which tests would qualify for inclusion
performed by the analyst. relationship and making it uniform for in the APT test category, and the
• Instructions for performance of all manufacturers and producers of administrative costs associated with
waived tests must be written at no these test systems should reduce the processing and evaluating laboratory
higher than a seventh grade reading regulatory burden on laboratories, while applications. The fee for random
level and include a description of the providing an effective mechanism for inspection would represent the cost to
analytic skills required to perform the laboratories to achieve regulatory HHS of conducting random inspections
test. APT test instructions would have compliance with the CLIA of approximately five percent of the
no such requirements, since personnel requirements. laboratories issued a certificate for APT
performing APT testing would, at a We encourage individuals to submit tests to assess compliance with the
minimum, have to have a high school their comments and suggestions on how applicable requirements of 42 CFR part
diploma, or equivalent, and relevant we might improve the APT 493. Random inspection costs would be
training. categorization criteria or process and shared by all laboratories issued a
• Quantitative waived tests may have revise the regulations to incorporate certificate for APT tests.
a certain amount of random error but these changes. Following review of
comments received in response to this If, in the case of a laboratory subject
they must be shown to be essentially
notice, we will make the necessary to a random inspection, it is determined
free of systematic error, whereas
revisions to the APT requirements, that a follow-up survey is necessary
quantitative APT tests would be allowed
including the criteria for APT because of identified deficiencies, HHS
a minimal amount of error that may be
categorization and the process for would assess that laboratory an
either random or systematic, or both.
reviewing requests for APT additional fee to cover the cost of the
Review Process categorization of test systems. follow-up survey activities. The fee
Also at § 493.18, we are proposing the After a final rule responding to the would be based on the actual resources
process for approving tests for the APT comments received to this proposed and time necessary to perform the
subcategory. We are proposing that rule is published establishing the APT follow-up visits. Failure of a laboratory
requests for placement of tests in this subcategory, requests for APT to pay any assessed costs would result
subcategory be in conformance with the categorization may be submitted for in HHS revoking the laboratory’s
proposed submission process outlined review. Once a test system review has certificate.
in this regulation. The data submitted been completed, the manufacturer or Patient Test Management
for evaluation would have to meet producer would be notified of the APT
specific criteria related to operational categorization decision, whether denied We are proposing to add a new
characteristics, ease of use, and test or granted. APT categorization would be § 493.1102 to subpart J (patient test
performance. The test system’s effective on the date of notification to management) to include the new patient
instructions will be reviewed by PHS to the applicant. Any test categorized as test management requirements that
ensure that laboratories can rely on APT also would be published in the would be applicable to APT testing.
these instructions to assist them in Federal Register as a notice with an These requirements would be less
meeting the regulations in subparts J, K opportunity for public comment. (As burdensome to the laboratory than the
and P when performing APT testing. with all comments received on test requirements currently applicable to
categorization, our responses to the other moderate complexity testing
Submission Requirements because the manufacturer’s or
comments received on APT
Under the proposed rule, the categorization will be included in a producer’s PHS-approved test system
manufacturer or test system producer subsequent Federal Register notice.) instructions would specify what
would have to determine which Once we receive comments on the laboratories must do to comply with the
procedures in the preanalytic, analytic Federal Register notice, we reserve the CLIA patient test management
and postanalytic phases of testing are right to reevaluate and recategorize the requirements. There would be two
essential to ensure accurate test results. test based upon those comments. requirements in this new standard. The
These procedures would be identified in two requirements would be that the
the submission to PHS as mandatory Administration laboratory must: (a) have available and
procedures for the laboratory to follow. We are proposing to make conforming follow the patient test management
In addition, the manufacturer or test changes to subpart F (General procedures specified in the PHS-
system producer would have to include Administration) to accommodate the approved instructions; and (b) maintain
protocols to assist laboratories in addition of the new certificate for APT records documenting compliance with
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47985
the patient test management For APT tests, we would require certificate since the laboratory would be
requirements for two years. laboratories to have a qualified director, required only to follow the PHS-
clinical consultant and testing approved instructions to meet the CLIA
personnel. The qualifications required requirements for APT testing. During a
In subpart K (quality control), we for director and clinical consultant random inspection, as with any
propose to recodify the current would be the same as for moderate inspection of other test complexity
§ 493.1204 as § 493.1206 and add a new complexity testing, while the testing categories, not all test systems would be
§ 493.1204 to accommodate the quality personnel training requirements would reviewed. A few test systems would be
control provisions resulting from the be modified slightly from the training randomly selected and assessed for
proposed addition of the new required for other moderate complexity compliance. We would also clarify in
subcategory of APT tests. Since the testing because the test system this section that if the same laboratory
PHS-approved test system instructions manufacturer or producer would be is performing provider-performed
for APT procedures would include providing specific instructions on test microscopy procedures, those tests may
instructions for meeting the CLIA system performance, including reagent also be assessed for compliance with all
requirements, the laboratory quality stability and storage and quality control. applicable requirements specific to that
control requirements for APT testing The responsibility requirements for each subcategory of testing during the
would be less stringent than for other level of personnel within the APT random inspection.
moderate complexity tests. We are subcategory would be somewhat less Additionally, we would revise the
proposing that, before reporting patient stringent in accordance with the introductory paragraph to § 493.1777,
test results, laboratories, at a minimum, laboratory’s reliance on the which currently contains the condition
use the PHS-approved test system manufacturer or producer of the test concerning inspection of laboratories
instructions for verifying the test system to provide detailed test requesting or issued a certificate of
system’s performance specifications. instructions, protocols for meeting the compliance, to clarify the inspection
The laboratory may include, as regulatory requirements, performance requirements for a laboratory with a
appropriate, expanded or additional specifications and information regarding certificate of compliance when the
protocols for verifying the test system’s test results and interpretation. laboratory also performs APT
performance specifications. As with Quality Assurance procedures. Specifically, for laboratories
other procedures of moderate that perform APT procedures and have
We are proposing to add a new a certificate of compliance, APT
complexity, quality control activities for § 493.1702 to the quality assurance
APT tests would have to be documented procedures may be included in the
requirements located in subpart P to sample of moderate complexity tests
and the records retained for two years, include the proposed requirements
except immunohematology records, inspected during the laboratory’s
applicable to APT testing. These routine, biennial inspections.
which must be maintained for a period requirements would be less burdensome
of no less than five years. We would than the requirements currently Summary of Changes to the Regulations
stress that laboratories must not modify applicable to other moderate complexity
the test system’s PHS-approved test We are proposing to add or change the
testing, since the PHS-approved test following sections to incorporate
performance instructions, since any system instructions would assist the
modification would result in the test no requirements applicable to APT tests:
laboratory in meeting the quality • Section 493.18, Accurate and
longer being categorized as APT. Any assurance requirements. Like § 493.1102 precise technology (APT) tests.
modified procedure would become an in subpart J (patient test management), • Section 493.21, Laboratories
uncategorized test and would be there would be two requirements in performing accurate and precise
considered high complexity until § 493.1702. To meet the quality technology (APT) tests.
categorized by PHS. assurance requirements in subpart P, we • Section 493.48, Requirements for a
Personnel are proposing that: (a) laboratories must certificate for accurate and precise
have available and follow procedures technology (APT) tests.
The personnel requirements for APT specified in the test system’s PHS- • Section 493.1102, Patient test
testing would be located at § 493.1371 approved instructions to meet the management requirements for accurate
through § 493.1387. APT personnel quality assurance requirements; and (b) and precise technology (APT) tests.
requirements would be somewhat less laboratories must document and • In subpart K, we are proposing to
stringent than for other moderate maintain records of quality assurance add the new quality control
complexity testing because APT tests activities for two years. requirements applicable to APT testing
would have been reviewed to ensure at § 493.1204 and move the facilities
that they meet the criteria for simple, Inspections requirements (without change) currently
reliable, accurate and precise tests. The We are proposing to establish a new located at § 493.1204 to a new
personnel requirements for this § 493.1778 specifying that laboratories § 493.1206.
subcategory would not include a with a certificate for APT tests are • To subpart M, we are proposing to
technical consultant because subject to announced or unannounced add nine new sections to include the
manufacturers or producers of APT tests inspections on a random basis to assess personnel requirements for laboratories
would develop maintenance protocols, compliance with the applicable performing APT testing. At § 493.1371,
calibration and control procedures, requirements of part 493, to evaluate we are proposing to add the condition
remedial action policies and criteria for compliance when indicated by requirements for director, and at
reporting and interpreting test results, unsuccessful participation in §§ 493.1373 and 493.1375, respectively,
which would fulfill most of the proficiency testing and complaints, and we plan to include the qualification and
technical consultant’s responsibilities. to collect information for determining responsibility requirements for director.
The remaining technical consultant the appropriateness of tests categorized The condition level requirements for
responsibilities (e.g., employee as APT. We are proposing to require clinical consultant would be located at
evaluations) would be performed by the random, rather than routine, inspections § 493.1377, with clinical consultant
laboratory director. for a laboratory having an APT qualifications to be specified under
47986 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
§ 493.1379 and responsibilities to be to review by the Office of Management quality control standards for monitoring
included under § 493.1381. The testing and Budget (OMB) under the Paperwork and evaluating the quality of the testing
personnel condition requirements Reduction Act of 1980. The title, process to assure accurate and reliable
would be at § 493.1383, with testing description, and respondent description patient test results and reports as
personnel qualifications at § 493.1385 of the information collection required under CLIA. Section 493.1204
and responsibilities to be included at requirements are shown below with an is a new section required to reflect the
§ 493.1387. estimate of the annual reporting and addition of the new subcategory for
• Section 493.1702, Quality assurance recordkeeping burden. Included in the accurate and precise technology testing
requirements for accurate and precise estimate is the time for reviewing (APT).
technology (APT) tests. instructions, searching existing data § 493.1702: Sections 493.1701 through
• Section 493.1778, Inspection of sources, gathering and maintaining the 493.1721 are currently approved under
laboratories issued a certificate for data needed, and completing and OMB approval number 0938–0612 with
accurate and precise technology (APT) reviewing the collection of information. an expiration date of February 28, 1998.
tests. § 493.18: This section outlines the Section 493.1702 is a new section
We are proposing to make conforming criteria a manufacturer must follow in
technical changes to the following developed to address specific
order to have its moderate complexity requirements that relate to quality
sections and headings: §§ 493.2; test categorized as an ‘‘Accuracy and
493.3(a)(1); 493.5 (a)(2), (b) and (c)(4); assurance for a laboratory performing
Precise Technology’’ (APT) test. These APT testing. Specifically it requires a
493.20 (a) and (b); 493.25(c); the include but are not limited to test
headings for subpart C and 493.43; laboratory to have available and follow
system characteristics, instructions, the PHS-approved instructions and
493.43(a); 493.45 introductory field studies and evaluation of data.
paragraph and (a); 493.49; 493.51 supplements (where appropriate) and
§§ 493.43, 493.45, 493.48, 493.49, maintain records documenting
heading, introductory paragraph and 493.51, 493.53: Sections 493.43 through
paragraphs (b) and (c) and new (d); compliance for a 2-year period.
493.53 are currently approved under §§ 493.1777 and 493.1778: Sections
493.53(a); 493.602; 493.638 (a) and (b); OMB approval number 0938–0612 with
493.639(b); 493.643(a); 493.645 heading 493.1725 through 493.1780 are currently
an expiration date of February 28, 1998. approved under OMB approval number
and new paragraph (c) and paragraph The information is gathered on form
(d) (redesignated from paragraph (c)); 0938–0612 with an expiration date of
number HCFA-R–26. These sections February 28, 1998. Section 493.1777
subpart H; 493.803(a); 493.807 heading; outline the requirements for a laboratory
subheading preceding 493.821; subpart I concerns the inspections of laboratories.
to follow to submit application forms for The burden associated with inspections
heading; subpart J heading; 493.1101
CLIA certification. The requirements consists of retrieving the records and
heading and introductory paragraph;
include laboratory notification to HHS documentation requested by the
subpart K heading; 493.1201 heading,
of changes to the types of tests inspector, participating in the entrance
revision to paragraph (a) and (b) and
performed or changes in ownership, and exit interviews, responding to the
addition of new paragraph (c);
name location or director. statement of deficiencies that may result
493.1202(c); 493.1203; part M heading;
Section 493.48 is a new section added
493.1351; subpart P heading; 493.1777 from the inspection and documenting
to reflect the addition of the new
introductory paragraph; 493.1814(b)(3); any corrective actions taken that are
certificate category for laboratories
493.1834 (b) and (f)(2)(iii); and 493.1836 appropriate to the plan of correction for
performing tests categorized as accurate
(c)(2) and (c)(3); and 493.2001. the deficiencies cited. Section 493.1778
In addition, we are deleting the words and precise technology testing (APT).
is a new section developed to address
‘‘of this part’’ wherever they follow a §§ 493.1101 and 493.1102: Sections
the inspection requirements as they
specific section number in regulations 493.1101 through 493.1111 are currently
apply to laboratories with an APT
text appearing in this Federal Register approved under OMB approval number
certificate. This section sets forth the
document to conform with rules of the 0938–0612 with an expiration date of
policy of random inspections for
Office of the Federal Register. February 28, 1998. This section
laboratories with an APT certificate.
concerns patient test management for
IV. Response to Comments laboratories performing tests of When OMB approves those provisions
moderate and high complexity that not currently approved we will publish
Because of the large number of items
implement the CLIA statutory mandate a notice in the Federal Register to that
of correspondence we normally receive
for laboratories to meet requirements affect.
on Federal Register documents
published for comment, we are not able relating to the proper collection, Description of Respondents
to acknowledge or respond to them transportation, and storage of specimens
individually. We will consider all and the reporting of results. Section § 493.18: Small businesses or
comments we receive by the date and 493.1102 is a new section added to organizations, businesses or other for
time specified in the DATES section of reflect the addition of the new profit, non-profit institutions, who
this preamble, and, if we proceed with subcategory for tests categorized as manufacture laboratory tests.
a subsequent document, we will accurate and precise technology testing §§ 493.43, 493.45, 493.48, 493.49,
respond to the comments in the (APT). 493.51, 493.53; 493.1101 and 493.1102;
preamble to that document. §§ 493.1201, 493.1202 and 493.1204: 493.1201, 493.1202 and 493.1204;
Sections 493.1201 and 493.1202 are 493.1702; 493.1777 and 493.1778: Small
V. Collection of Information currently approved under OMB businesses or organizations, businesses
Requirements approval number 0938–0612 with an or other for profit, non-profit
The proposed rule contains expiration date of February 28, 1998. institutions, state and local
information collections that are subject These sections set forth the general governments, federal agencies.
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47987
ESTIMATED ANNUAL REPORTING AND RECORDKEEPING BURDEN
Annual num- Annual fre- burden per Annual bur-
CFR sections ber of re- quency response den 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- This proposed rule would modify for APT would experience a decrease in
waived laboratories become APT. CLIA regulations published February compliance costs and the number of
The agency has submitted a copy of 28, 1992 by establishing a new surveys, since APT laboratories would
the proposed rule to OMB for its review subcategory of moderate complexity not be subject to routine inspections and
of these information collections. testing, accurate and precise technology the associated fees. The laboratories that
Interested persons are invited to send (APT) tests. There are approximately would realize the greatest benefit from
comments regarding this burden 157,000 entities enrolled under CLIA these savings would most likely be
estimate or any other aspect of these that could be affected by this rule; physician office laboratories and public
collections of information, including however, the significance of the effect health laboratories. Laboratories,
any of the following subjects: (1) The would vary depending on the volume specifically many physician offices and
necessity and utility of the proposed and complexity of tests performed. other limited service laboratories,
information collection for the proper While we cannot estimate the number of expanding from a certificate of waiver or
performance of the agency’s functions; entities that may make changes in their PPM to a certificate for APT would be
(2) the accuracy of the estimated laboratory testing practices, we believe able to enhance the range of laboratory
burden; (3) ways to enhance the quality, the modifications to the CLIA program services available to patients, while
utility, and clarity of the information to would be beneficial to the affected their costs (including certification fees
be collected; and (4) the use of entities and would be well received, and costs inherent in meeting applicable
automated collection techniques or since they are being proposed in requirements such as personnel and
other forms of information technology to response to comments requesting quality control), would remain less than
minimize the information collection revisions to the test complexity the costs of obtaining a certificate of
burden. Comments should be sent to categories. compliance. The availability of a CLIA
HCFA, OFHR, MPAS, C2–26–17, 7500 In proposing this new subcategory, we certificate that allows an expanded test
Security Boulevard, Baltimore, acknowledge the unique aspects of the menu at less cost also may encourage
Maryland 21244–1850 and to the OMB many tests with proven accuracy and new entities to begin providing services,
official whose name appears in the precision that may not qualify for thereby increasing physician and
ADDRESSES section of this preamble. waiver, but should not be subject to all patient access to health care,
of the requirements applicable to particularly in underserved and rural
VI. Regulatory Impact Statement areas.
moderate complexity testing, including
We generally prepare a regulatory routine inspection. To this end, this This proposed rule may affect some
flexibility analysis that is consistent proposed rule would establish less manufacturers of laboratory tests who
with the Regulatory Flexibility Act stringent requirements, including less would be required to submit specific
(RFA) (5 U.S.C. 601 through 612) unless frequent (random) inspections and information and data demonstrating that
the Secretary certifies that a rule would fewer personnel requirements, for their test meets the criteria for APT
not have a significant economic impact laboratories providing tests categorized categorization. We estimate that
on a substantial number of small as APT. We expect no clinically approximately 500 test systems may
entities. For purposes of the RFA, all meaningful decrease in test accuracy, or qualify for this subcategory. These test
laboratories and manufacturers of patient health, from this proposal. systems are predominantly small
laboratory test systems are considered to Furthermore, to the extent that it automated instruments or ‘‘desktop’’
be small entities. Individuals and States encourages cost-effective testing more analyzers. Manufacturers of any test
are not included in the definition of a than the present CLIA rules, and system approved by PHS in the APT
small entity. increases the amount of such testing in subcategory also must provide
Also, section 1102(b) of the Act settings that might otherwise eschew laboratories with complete instructions,
requires the Secretary to prepare a testing, it is likely to improve patient which include protocols to assist
regulatory impact analysis if a rule may health. In addition, this proposed rule laboratories in meeting the CLIA
have a significant impact on the would reduce the financial burden for requirements. However, many
operations of a substantial number of some laboratories by enabling them to manufacturers are currently providing
small rural hospitals. This analysis must provide an expanded test menu without this type of information and assistance
conform to the provisions of section 603 incurring the higher costs associated to laboratories in the form of
of the RFA. For purposes of section with a certificate of compliance. instructional materials and protocols.
1102(b) of the Act, we define a small The changes proposed in this Because laboratories would not be
rural hospital as a hospital that is regulation may affect a laboratory’s test required to develop their own
located outside of a Metropolitan menu and choice of certificate. operational policies and quality control
Statistical Area and has fewer than 50 Laboratories holding a certificate of protocols, a wider variety of laboratories
beds. compliance that change to a certificate might decide to offer APT testing.
47988 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
Therefore, we anticipate that Authority: Sec. 353 of the Public Health procedures, only APT tests, only tests of
categorization as an APT test would Service Act, secs. 1102, 1861(e), the sentence high complexity, or any combination.
result in increased sales and following 1861(s)(11), 1861(s)(12), (c) Each laboratory must be either
distribution for the manufacturers. 1861(s)(13), 1861(s)(14), 1861(s)(15), and CLIA-exempt or possess one of the
1861(s)(16) of the Social Security Act (42
As indicated above, we believe that following certificates, as defined in this
U.S.C. 263a, 1302, 1395x(e), the sentence
the creation of the subcategory of APT following 1395x(s)(11), 1395x(s)(12), part:
and subsequent decrease in the 1395x(s)(13), 1395x(s)(14), 1395x(s)(15), and (1) Registration certificate.
regulatory and financial burden for 1395x(s)(16)). (2) Certificate of waiver.
laboratories performing APT tests would (3) Certificate for PPM procedures.
2. In Section 493.2, in the definition (4) Certificate for APT tests.
benefit patients, laboratories, and of ‘‘CLIA certificate’’ the introductory (5) Certificate of compliance.
manufacturers. However, we are unable text is republished and paragraph (6) is (6) Certificate of accreditation.
to quantify these likely long run effects added to read as follows: 5. A new § 493.18 is added to read as
because they depend on market follows:
decisions, research results, and § 493.2 Definitions.
technological change that cannot be * * * * * § 493.18 Accurate and precise technology
predicted. CLIA certificate means any of the (APT) tests.
Regardless, we believe that for the following types of certificates issued by (a) Requirement. To be included in
most part these effects would involve HCFA or its agent: the APT subcategory, the test system
relatively small savings of a few * * * * * must be categorized as moderate
hundred or a few thousand dollars a (6) Certificate for accurate and precise complexity using the criteria in § 493.17
year for each laboratory, mainly due to technology (APT) tests means a and it must meet the descriptive criteria
reduced inspection fees or QC costs. In certificate issued or reissued before the specified in paragraph (b) of this
the aggregate these savings would be expiration date, pending an appeal in section.
substantial, because they are shared by accordance with § 493.48, to a (b) Criteria. (1) For quantitative tests,
thousands of laboratories. However, few laboratory that only performs tests methods must be easy to use, accurate,
if any entities are likely to achieve very approved by PHS as APT tests and, if and precise as evidenced by the
substantial savings. desired, tests specified as PPM following items:
This proposed rule would establish procedures, tests approved by PHS as (i) Test systems that have the
the process for categorizing moderate waived tests, or both. following characteristics:
complexity tests into a new subcategory (A) Are fully automated (no operator
* * * * * intervention during the analytic phase).
of moderate complexity testing and 3. In § 493.3, the introductory text of
would also establish a new type of (B) Provide direct readout of results or
paragraph (a) is republished and simple noncalculated conversions.
certificate. Proper realignment of the fee paragraph (a)(1) is revised to read as
schedule, if necessary, would follow (ii) Test system instructions that
follows: address the following items:
implementation of this rule.
§ 493.3 Applicability.
(A) Requirements for specimen
For these reasons, we are not collection, handling, storage and
preparing analyses for either the RFA or (a) Basic rule. Except as specified in preservation.
section 1102(b) of the Act because we paragraph (b) of this section, a (B) Reportable range for patient
have determined, and the Secretary laboratory will be cited as out of results.
certifies, that this proposed rule would compliance with section 353 of the (C) Reference range (normal values)
not have a significant economic impact Public Health Service Act unless it— and suggested panic values (values
on a substantial number of small entities (1) Has a current, unrevoked or requiring immediate medical
or a significant impact on the operations unsuspended certificate of waiver, a intervention).
of a substantial number of small rural registration certificate, a certificate of (D) Units of measurement used for
hospitals. We do request comments, compliance, certificate for PPM reporting patient results.
however, on possible improvements in procedures, certificate for APT tests, or (E) Step-by-step protocols that
these proposed regulations to achieve a certificate of accreditation issued by include, as appropriate, the following
even greater savings to affected entities HHS applicable to the category of items:
and will consider them carefully in examinations or procedures performed (1) Instrument or test system
formulating the final rule. by the laboratory; or operation and test performance
In accordance with the provisions of * * * * * instructions.
Executive Order 12866, this regulation 4. Section 493.5 is revised to read as (2) Test system maintenance
was reviewed by the Office of follows: procedures.
Management and Budget. (3) Preparation and storage of
§ 493.5 Categories of tests by complexity. reagents, calibrators, controls, or other
List of Subjects in 42 CFR Part 493 (a) Laboratory tests are categorized as materials used in testing.
Grant programs-health, Health one of the following types of tests: (4) Control procedures including the
facilities, Laboratories, Medicaid, (1) Waived tests. type of materials, suggested
Medicare, Reporting and recordkeeping (2) Tests of moderate complexity, concentrations, and frequency of assay.
requirements. including the subcategories of moderate (5) Calibration procedures including
42 CFR part 493 would be amended complexity, which are limited to the the number and type of materials and
as set forth below: following tests and procedures: frequency of assay.
(i) PPM procedures. (6) Acceptable ranges for any control
PART 493—LABORATORY (ii) APT tests. or calibration material included with
REQUIREMENTS (3) Tests of high complexity. the test system.
(b) A laboratory has the option of (7) Action to be taken when
1. The authority citation continues to performing only waived tests, only tests calibration or control results do not
read as follows: of moderate complexity, only PPM meet the acceptable range of values.
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47989
(8) Methods for converting test system introduction of error due to the presence (A) Are generated from protocols that
values to reportable results. of these substances. address the points described in
(9) Description of course of action to (vi) Demonstration that the total paragraph (b)(2)(iii) of this section.
be taken when the test system becomes amount of error, which includes all (B) Are adequate to produce measures
inoperable. components contributing to imprecision of performance that are both statistically
(10) Any limitations to methodologies and inaccuracy as defined by studies valid and defensible.
such as interfering substances. described in paragraphs (b)(1)(iv)(D) (C) Confirm that study participants
(11) A written protocol for reporting through (b)(1)(iv)(F) and (b)(1)(v)(A) are able to read and interpret test
patient test results. through (b)(1)(v)(C) of this section, is endpoints with the same precision as
(iii) Field studies that meet the less than one fourth of the reference laboratory professionals.
following requirements: range for the analyte divided by the (D) Confirm that the performance of
(A) Demonstrate that the mean of the reference interval. study participants is essentially the
manufacturer’s or producer’s written (2) For qualitative tests, methods must same as laboratory professionals when
instructions are the only protocols be easy to use, accurate, and precise as testing samples at or near the cutoff and
required to perform the test accurately evidenced by the following items: at sufficient distance above and below
and reliably. (i) Test systems that meet the the cutoff to confirm precision at all
(B) Demonstrate that individuals with following requirements: analytical decision points.
no formal laboratory training can (A) Contain steps that are limited in (E) Demonstrate minimal among-
correctly perform the test. number and complexity, are self- operator imprecision using results of all
(iv) Data from field studies that meet contained and are packaged as a study participants.
the following requirements: complete system. (F) Demonstrate minimal within-site
(A) Are generated from protocols that (B) Have a qualitative endpoint that imprecision using test results generated
address the points described in requires no interpretation beyond at each site by an adequate number of
paragraph (b)(1)(iii) of this section. discerning agglutination patterns, color participants to produce measures of
(B) Are adequate to produce measures comparisons, or other easily interpreted performance that are statistically valid
of performance that are both statistically reactions. and defensible. Testing must be
valid and defensible (estimates must (ii) Test system instructions that performed at a minimum of three
support valid confidence limits for all address the following items: independent study sites.
statistical parameters). (A) Requirements for specimen (G) Using results generated by study
(C) Evaluate performance at all collection, handling, storage and participants, demonstrate minimal
medical decision points and relevant preservation. among-site imprecision at an adequate
upper and lower limits of the reportable (B) Reportable range for patient number of sites to produce measures of
range using at least three concentrations results. performance that are statistically valid
of the analyte being tested. (C) Reference range (normal values). and defensible.
(D) Evaluate among-operator (D) Step-by-step protocols that (v) Method accuracy studies
imprecision using test results of all include, as appropriate, the following demonstrating that there is no
study participants. items: statistically significant difference
(E) Evaluate within-site imprecision (1) Test performance instructions.
(2) Preparation and storage of between observed values and expected
using test results generated at each site values at the cutoff point when—
by an adequate number of participants reagents, calibrators, controls, or other
(A) The test values are compared to a
to produce measures of performance materials used in testing.
(3) Control procedures including the quantitative result such as the value of
that are statistically valid and a reference material or the presence or
defensible. Testing must be performed type of materials and frequency of assay.
(4) Calibration procedures including absence of a particular biologic
at a minimum of three independent component;
the number and type of materials and
study sites. (B) Confirming that there are no
frequency of assay.
(F) Evaluate among-site imprecision at (5) Acceptable ranges for any control significant equivocal test results on
an adequate number of sites to produce or calibration material included with either side of the cutoff;
measures of performance that are the test system. (C) Comparing results between study
statistically valid and defensible using (6) Action to be taken when participants and laboratory
results generated by study participants calibration or control results do not professionals on samples with values at
on aliquots of a single testing material. meet acceptable range of values. the cutoff;
(v) Method accuracy studies (7) The correct interpretation of test (D) The test is performed on patient
demonstrating little or no systematic reactions or endpoints. samples instead of reference materials,
error when— (8) Description of course of action to confirming there is no introduction of
(A) Using reference materials assayed be taken when test reactions or error due to sample matrix; and
by study participants that produce data endpoints cannot be determined. (E) Samples contain substances that
that show there is little or no (9) Any limitations to methodologies. commonly cause interference
statistically significant difference (iii) Field studies that meet the confirming there is no introduction of
between the test results and the value of following requirements: error because of these substances.
the reference materials. (A) Demonstrate that the (c) Provisions for inclusion of tests in
(B) Using patient samples instead of manufacturer’s or producer’s written the APT subcategory—(1) Process for
reference materials, demonstrating there instructions are the only protocols requesting APT categorization.
is little or no introduction of error in required to perform the test accurately (i) Requests for APT categorization
patient test results due to the effects of and reliably. must be submitted to PHS.
the sample matrix. (B) Demonstrate that individuals with (ii) PHS reviews requests for APT
(C) Adding or simulating common no formal laboratory training can categorization that meet the criteria
interfering substances known to affect correctly perform the test. specified in paragraph (b) of this section
the analyte in patient samples, (iv) Data from field studies that meet and the submission requirements under
demonstrating that there is little or no the following requirements: paragraph (c)(2) of this section.
47990 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
(iii) The CLIAC, as specified in (iv) Patient test management protocols (1) Determining specimen
subpart T of this part, conducts reviews must be complete and include sufficient acceptability.
upon the request of HHS and makes information to assist laboratories in (2) Reporting patient test results,
recommendations to HHS concerning meeting each of the requirements in including suggested panic values, if
APT test categorization. subpart J of this part. These protocols applicable.
(iv) Any change or modification to an must meet the following requirements: (3) The course of action to be taken in
APT test system by the manufacturer or (A) Clearly specify the instructions the event that a test system becomes
producer that could affect the accuracy that must be followed by the laboratory inoperable.
or reliability of that test must be to ensure proper specimen handling and (4) Referral of samples, as specified in
resubmitted to PHS for evaluation and accurate test result reporting and assist § 493.1111, including procedures for
review. Until this review is completed laboratories in meeting the requirements specimen submission and handling as
and categorization status is determined, of subpart J of this part, including the described in § 493.1103.
the modified test is considered following requirements listed in (E) Verification of method
uncategorized and, in accordance with paragraphs (c)(2)(iv)(A)(1) through performance specifications and
§ 493.17(c)(4), is considered high (c)(2)(iv)(A)(4) and (c)(2)(iv)(B) of this verification that the reference range is
complexity. section, as applicable: appropriate for the laboratory’s patient
(v) A request for reconsideration of a (1) Section 493.1103(a), procedures population.
test denied APT categorization is for specimen submission and handling, (vi) Quality assurance protocols must
accepted for review if the request is including protocols for preparation of be complete and include sufficient
based on information not previously patients, specimen collection, information to assist laboratories in
submitted. preservation, and conditions for meeting each of the requirements in
(2) Submission requirements. specimen transport. subpart P of this part. These protocols
(i) Requests for APT categorization (2) Section 493.1105(f), any test must meet the following requirements:
must meet the criteria described in requisition information that is relevant (A) Clearly specify the instructions
paragraph (b) of this section. In the and necessary to a specific test to assure that must be followed by the laboratory
event that a request does not include accurate testing and reporting of results. in establishing a comprehensive quality
complete information, the request is not (3) Sections 493.1107(c) and assurance program for monitoring and
reviewed and the manufacturer or 493.1109(c), test records and test report evaluating the overall quality of the total
producer of the test system is notified. information related to the criteria for testing process (preanalytic, analytic,
(ii) Data collection protocols and data specimen acceptability. and postanalytic) and identifying and
submitted must be complete and data (4) Section 493.1109, test report correcting problems based on the results
submitted must be statistically valid and information including the following of the evaluation to assure the accurate,
meet the criteria described under information: reliable and prompt reporting of patient
paragraph (b) of this section. (i) Section 493.1109(d), pertinent results and assist laboratories in meeting
(iii) Test system instructions must be ‘‘reference’’ or ‘‘normal’’ ranges. the requirements of subpart P of this
complete and must include, as (ii) Section 493.1109(f), any imminent part listed in paragraphs (c)(2)(vi)(A)(1)
applicable, the items defined in life-threatening laboratory results or through (c)(2)(vi)(A)(4) and (c)(2)(vi)(B)
paragraph (b)(1)(ii) of this section for panic values. of this section, and, as applicable, meet
quantitative tests and under paragraph (iii) Section 493.1109(g), the test the requirements of the following
(b)(2)(ii) of this section for qualitative methodology employed and any sections:
tests. In addition, test system information that may affect the (1) Section 493.1703, Patient test
instructions must include the following interpretation of test results. management assessment, including the
statements: (B) Provide information (for example, following requirements:
(A) ‘‘Any modification by the written instructions, instructional (i) The criteria established for patient
laboratory to the PHS-approved test materials or samples of forms for preparation, specimen collection,
system instructions will result in the documentation of activities performed) preservation and transportation.
test no longer meeting the requirements that laboratories may follow or (ii) The completeness and relevance of
for APT categorization. Modified tests supplement, in accordance with the test the information solicited on the
are considered high complexity and are system’s PHS-approved instructions, in laboratory’s test requisition.
subject to all applicable CLIA meeting the requirements in subpart J of (iii) The use and appropriateness of
requirements contained in 42 CFR part this part. the criteria established for specimen
493.’’ (v) Quality control instructions must rejection.
(B) ‘‘The laboratory must notify the include the following items: (iv) The completeness, usefulness and
producer of this test system of any (A) Protocols for documentation of all accuracy of the test report information
performance, perceived or validated, control and calibration results, any necessary for the interpretation or
that does not meet the performance remedial action to be taken, and the utilization of test results.
specifications as outlined in these appropriate record retention (2) Section 493.1705, Quality control
instructions.’’ The name, address and requirements as described at § 493.1221. assessment, including a mechanism to
phone number(s) of the producer’s (B) Protocols for documentation of assess the effectiveness of the corrective
contact person(s) must follow this equipment maintenance performance actions taken in the following
statement. and the appropriate record retention situations:
(C) If applicable: ‘‘Laboratories requirements as described at § 493.1221. (i) Problems identified during the
performing accurate and precise (C) Safety precaution instructions that evaluation of calibration and control
technology (APT) tests are subject to the cover any physical hazard or data for the test method.
proficiency testing (PT) requirements biohazardous material, including the (ii) Problems identified during the
under 42 CFR part 493, subpart H of this proper handling and disposal of testing evaluation of patient test values for the
part. The laboratory must enroll and materials. purpose of ensuring the appropriateness
successfully participate in an HHS- (D) Protocols for developing written of the reference range of the test
approved PT program.’’ procedures for the following activities: method.
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47991
(3) Section 493.1709, Comparison of § 493.21 Laboratories performing accurate a separate application for each
test results, including procedures for and precise technology (APT) tests. laboratory location.
evaluating and defining the relationship (a) A laboratory may qualify for a * * * * *
between test results using different certificate to perform APT tests if it 11. In § 493.45, the introductory
methodologies, instruments, or testing performs tests categorized by PHS as paragraph is revised, the introductory
sites. APT tests and no other procedures, text of paragraph (a) is republished, and
(4) Section 493.1711, Relationship of except those specified as PPM paragraphs (a)(1) and (a)(2) are revised
patient information to patient results, procedures or those approved by PHS as to read as follows:
including procedures for identifying waived tests.
(b) Laboratories performing APT tests § 493.45 Requirements for a registration
and evaluating patient test results that
appear inconsistent with any relevant must meet the following requirements:
criteria specified in § 493.1711. (1) Follow each test system’s PHS- Laboratories performing only waived
approved instructions for performing tests, PPM procedures, APT tests, or any
(B) Provide information (for example, combination of these tests, are not
written instructions, instructional the test; and
(2) Meet the applicable requirements required to obtain a registration
materials, or samples of forms for certificate.
documentation of activities performed) in subpart C or subpart D of this part
and subparts F, H, J, K, M, P, and Q of (a) A registration certificate is
that laboratories may follow or required—(1) Initially for all
supplement, in accordance with the test this part.
laboratories performing test procedures
system’s PHS-approved instructions, in (c) If the laboratory also performs
of moderate complexity (other than the
meeting the requirements in subpart P PPM procedures, the laboratory must
subcategories of APT tests and PPM
of this part. meet the applicable requirements in
procedures) or high complexity, or both;
(3) Notification of decision. subparts H, J, K, M, P, and Q of this part.
(2) For all laboratories that have been
(d) If the laboratory also performs issued a certificate of waiver, certificate
(i) PHS determines whether a
waived tests, the requirements of for PPM procedures, or certificate for
laboratory test meets the criteria listed
subparts H, J, K, M, and P of this part APT tests that intend to perform tests of
under paragraph (b) of this section for
are not applicable for the waived tests. moderate or high complexity, or both in
an APT test.
However, the laboratory must comply addition to those tests listed in
(ii) PHS notifies the applicant of APT with the requirements in §§ 493.15(e)
categorization, whether denied or § 493.15(c) or specified as PPM
and 493.1775. procedures, or categorized as APT tests;
granted. 8. In § 493.25, paragraph (c) is revised and
(iii) APT categorization is effective as to read as follows:
of the date of notification to the * * * * *
applicant. § 493.25 Laboratories performing tests of 12. A new § 493.48 is added to read
high complexity. as follows:
(iv) PHS publishes additions and
revisions periodically to tests * * * * * § 493.48 Requirements for a certificate for
categorized as APT in the Federal (c) If the laboratory also performs tests accurate and precise technology (APT)
Register in a notice with opportunity for of moderate complexity, the applicable tests.
public comment. PHS reserves the right requirements of subparts H, J, K, M, P (a) A certificate for APT tests is
to reevaluate and recategorize a test and Q of this part must be met. Under required for all laboratories that intend
based upon the comments it receives in a registration certificate or certificate of to perform only the following tests:
response to the Federal Register notice. compliance, PPM procedures and APT (1) Tests that have been categorized
tests must meet the inspection by PHS as APT tests.
6. In § 493.20, paragraphs (a) and (b)
requirements at § 493.1777. (2) APT tests in addition to waived
are revised to read as follows:
* * * * * tests or PPM procedures.
§ 493.20 Laboratories performing tests of 9. The heading of subpart C is revised (3) APT tests, waived tests and PPM
moderate complexity. to read as follows: procedures.
(a) A laboratory may qualify for a (b) HHS issues a certificate for APT
certificate to perform tests of moderate Subpart C—Registration Certificate, tests if the laboratory meets the
complexity if it restricts its test Certificate for Provider-Performed following requirements:
performance to waived tests or Microscopy Procedures, Certificate for (1) Complies with the requirements of
examinations and one or more tests or Accurate and Precise Technology § 493.43 for applying for a certificate.
examinations meeting criteria for tests Tests, and Certificate of Compliance (2) Agrees to treat proficiency testing
of moderate complexity including the samples in the same manner as it treats
10. In § 493.43, the section heading
subcategories of PPM and APT tests. patient specimens.
and paragraph (a) are revised to read as
(3) Agrees to be inspected by HHS as
(b) A laboratory that performs tests or follows:
specified in § 493.1778.
examinations of moderate complexity
§ 493.43 Application for registration (4) Remits the fee for the certificate as
must meet the applicable requirements
certificate, certificate for provider- specified in subpart F of this part.
in subpart C or subpart D, and subparts
performed microscopy (PPM) procedures, (c) A laboratory issued a certificate for
F, H, J, K, M, P, and Q of this part. certificate for accurate and precise APT tests is subject to the following
Under a registration certificate or technology (APT) tests, and certificate of requirements:
certificate of compliance, laboratories compliance. (1) The notification requirements of
also performing PPM procedures and (a) Filing of application. Except as § 493.51.
APT tests must meet the inspection specified in paragraph (b) of this (2) The applicable requirements of
requirements at § 493.1777. section, all laboratories performing tests this subpart and subparts H, J, K, M, P
* * * * * of moderate complexity (including the and Q of this part.
7. A new § 493.21 is added to read as subcategories) or high complexity, or (d) A laboratory requesting a
follows: any combination of these tests, must file certificate for APT tests that also
47992 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
performs PPM procedures is subject to (iv) Collection of information registration certificate or certificate for
the following requirements: regarding the appropriateness of tests APT technology tests as required in
(1) Ensuring that PPM procedures are listed in § 493.15 or tests categorized as subpart C or subpart D, as applicable, of
performed only by individuals meeting moderate complexity (including the this part.
the personnel requirements of subpart subcategories) or high complexity. * * * * *
M of this part. * * * * * 16. In § 493.638, introductory
(2) Undergoing random inspections as 14. Section 493.51 is revised to read paragraph (a) is revised, paragraph (a)(4)
specified in § 493.1778. as follows: is redesignated as (a)(5), new paragraph
(e) In accordance with subpart R of
(a)(4) is added, and paragraph (b) is
this part, HHS initiates suspension, § 493.51 Notification requirements for revised to read as follows:
limitation, or revocation of a laboratories issued a certificate for accurate
laboratory’s certificate for APT tests for and precise technology (APT) tests or a § 493.638 Certificate fees.
failure to comply with the applicable certificate of compliance.
(a) Basic rule. Laboratories must pay
requirements set forth in this subpart. Laboratories issued a certificate for a fee for the issuance of a registration
HHS may also impose certain APT tests or a certificate of compliance certificate, certificate for PPM
alternative sanctions. In addition, must meet the following requirements: procedures, certificate of waiver,
failure to meet the requirements of this (a) Notify HHS or its designee within certificate for APT tests, certificate of
subpart may result in suspension of all 30 days of any change in any of the accreditation, or a certificate of
or part of payments under Medicare and following items: compliance, as applicable. Laboratories
Medicaid. (1) Ownership. must also pay a fee to reapply for a
(f) A certificate for APT tests is valid (2) Name. certificate for PPM procedures,
for a period of no more than 2 years. A (3) Location. certificate of waiver, certificate for APT
laboratory must follow the procedures (4) Director. tests, certificate of accreditation, or a
established by HHS for renewal of this (5) Technical supervisor (laboratories certificate of compliance. The total of
certificate. performing high complexity testing
13. Section 493.49 is amended by fees collected by HHS under the
only). laboratory program must be sufficient to
revising the introductory text and (b) Notify HHS no later than 6 months
paragraphs (a) and (b) to read as follows: cover the general costs of administering
after performing any test or examination the laboratory certification program
§ 493.49 Requirements for a certificate of within a specialty or subspecialty area under section 353 of the PHS Act.
compliance. that is not included on the laboratory’s
* * * * *
A certificate of compliance may certificate for APT tests or a certificate
(4) For a certificate for APT tests, the
include any combination of tests of compliance, so that compliance with
costs include issuing the certificate,
categorized as high complexity or requirements can be determined.
collecting the fees, determining if a
moderate complexity or listed in (c) Notify HHS no later than 6 months
certificate for APT tests should be
§ 493.15(c) as waived tests. Moderate after any deletions or changes in test
issued, evaluating which test systems
complexity tests may include those methodologies for any test or
qualify for inclusion in the subcategory
specified as PPM procedures or examination included in a specialty or
of APT tests, and other direct
categorized as APT tests. subspecialty, or both, for which the
(a) HHS issues a certificate of laboratory has been issued a certificate
(5) For a certificate of accreditation,
compliance to a laboratory only if the for APT tests or a certificate of
the costs include issuing the certificate,
laboratory meets the following compliance.
collecting the fees, evaluating the
requirements: (d) Notify HHS before performing and
programs of accrediting bodies, and
(1) Meets the requirements of reporting results for tests not included
other direct administrative costs.
§§ 493.43 and 493.45. under the certificate for APT tests
(b) Fee amount. The fee amount is set
(2) Remits the certificate fee specified (which are tests other than waived tests,
annually by HHS on a calendar year
in subpart F of this part. PPM procedures, and APT tests) unless
basis and is based on the category of test
(3) Meets the applicable requirements the laboratory has been issued a
complexity, or on the category of test
of this subpart and subparts H, J, K, M, registration certificate as required in
complexity and schedules or ranges of
P, and Q of this part. subpart C or subpart D of this part, as
(b) A laboratory issued a certificate of annual laboratory test volume
compliance must meet the following (excluding waived tests and tests
15. Section 493.53 is amended by
requirements: performed for quality control, quality
revising the introductory text and
(1) Meets the notification assurance, and proficiency testing
paragraph (a) to read as follows:
requirements of § 493.51. purposes) and specialties tested, with
(2) Permits announced or § 493.53 Notification requirements for the amounts of the fees in each schedule
unannounced inspections by HHS in laboratories issued a certificate for being a function of the costs for all
accordance with subpart Q of this part provider-performed microscopy (PPM) aspects of general administration of
procedures. CLIA as set forth in § 493.649 (b) and
for the following reasons:
(i) Routine determination of Laboratories issued a certificate for (c). This fee is assessed and payable at
compliance with the applicable PPM procedures must notify HHS or its least biennially. The methodology used
requirements of this part. designee in the following situations: to determine the amount of the fee is
(ii) Evaluation of complaints. (a) Before performing and reporting found in § 493.649. The amount of the
(iii) Nonroutine survey of the results for any test of moderate fee applicable to the issuance of the
laboratory when HHS has substantive complexity (including the subcategory registration certificate or the issuance or
reason to believe that tests are being of APT tests) or high complexity, or renewal of the certificate for PPM
performed, or the laboratory is being both, in addition to tests specified as procedures, certificate of waiver,
operated in a manner that constitutes an PPM procedures, or any test or certificate for APT tests, certificate of
imminent and serious risk to human examination that is not specified under accreditation, or certificate of
health. § 493.15(c) for which it does not have a compliance is the amount in effect at
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47993
the time the application is received. § 493.645 Additional fee(s) applicable to HCFA, if applicable, as described in
Upon receipt of an application for a approved State laboratory programs and subpart I of this part for each specialty,
certificate, HHS or its designee notifies laboratories issued certain certificates. subspecialty, and analyte or test in
the laboratory of the amount of the * * * * * which the laboratory is certified under
required fee for the requested certificate. (c) Laboratories with a certificate for CLIA.
APT tests. * * * * *
17. In § 493.639, paragraphs (b) (1) In addition to the certificate fee, a
introductory text and (b)(1) are revised laboratory requesting a certificate for 22. The heading of § 493.807 is
to read as follows: APT tests is also assessed a fee revised to read as follows:
§ 493.639 Fee for revised certificate. representing the cost to HHS of random § 493.807 Condition: Reinstatement of
* * * * * inspections to determine compliance laboratories performing tests of moderate
with CLIA requirements. All complexity (including the subcategories),
(b) A laboratory must pay a fee to laboratories issued a certificate for APT high complexity, or any combination of
cover the cost of issuing a revised tests will share in the cost of these these tests, after failure to participate
certificate in any of the circumstances inspections. successfully.
specified in paragraphs (b)(1) and (b)(2) (2) If a laboratory issued a certificate * * * * *
of this section. for APT tests has been inspected and 23. The undesignated center heading
(1) The fee for issuing an appropriate followup visits are necessary because of immediately preceding § 493.821 is
revised certificate is based on the cost identified deficiencies, HHS assesses revised to read as follows:
of issuing the revised certificate to the the laboratory a fee to cover the cost of
laboratory as follows: these visits. The fee is based on the Proficiency Testing by Specialty and
actual resources and time necessary to Subspecialty for Laboratories
(i) If a laboratory with a certificate of Performing Tests of Moderate
waiver wishes to perform tests in perform the follow up visits. HHS
revokes the laboratory’s certificate for Complexity (Including the
addition to those listed in § 493.15(c) as Subcategories), High Complexity, or
waived tests, it must, as set forth in APT tests for failure to pay the assessed
fee. Any Combination of These Tests
§ 493.638, pay an additional fee for the
(d) Other fees. If, in the case of a 24. The heading to subpart I is revised
appropriate certificate to cover the
laboratory that has been issued a to read as follows:
certificate of accreditation, certificate of
(ii) If a laboratory with a certificate for waiver, certificate for PPM procedures, Subpart I—Proficiency Testing
PPM procedures wishes to perform tests or certificate for APT tests, it is Programs for Tests of Moderate
in addition to those specified as PPM necessary to conduct a complaint Complexity (Including the
procedures or listed in § 493.15(c) as investigation, impose sanctions, or Subcategories), High Complexity, or
waived tests, it must, as set forth in conduct a hearing, HHS assesses that any Combination of These Tests
§ 493.638, pay an additional fee for the laboratory a fee to cover the cost of these
appropriate certificate (registration or activities. Costs are based on the actual 25. The heading to subpart J is revised
certificate for APT tests) to cover the resources and time necessary to perform to read as follows:
additional testing. the activities and are not assessed until
(iii) If a laboratory with a certificate after the laboratory concedes the Subpart J—Patient Test Management
for APT tests wishes to perform tests in existence of deficiencies or an ALJ rules for Moderate Complexity (Including the
addition to those categorized as APT in favor of HHS. HHS revokes the Subcategories), High Complexity, or
tests, specified as PPM procedures, or laboratory’s certificate for failure to pay any Combination of These Tests
listed in § 493.15(c) as waived tests, it the assessed costs. If a complaint 26. Section 493.1101 is revised to read
must, as set forth in § 493.638, pay an investigation results in the as follows:
additional fee for a registration determination that a complaint is
certificate to cover the additional unsubstantiated, or if an HHS adverse § 493.1101 Condition: Patient test
testing. action is overturned at the conclusion of management; moderate complexity
the administrative appeals process, the (including the subcategories), high
* * * * * complexity testing, or any combination of
18. In § 493.643, paragraph (a) is costs of these activities are not imposed
revised to read as follows: upon the laboratory.
20. The heading of subpart H is Each laboratory performing moderate
§ 493.643 Fee for determination of revised to read as follows: complexity (including the
program compliance. subcategories) or high complexity
Subpart H—Participation in Proficiency testing, or any combination of these
(a) Fee requirement. In addition to the Testing for Laboratories Performing tests, must employ and maintain a
fee required under § 493.638, a Tests of Moderate Complexity system that provides for proper patient
laboratory subject to routine inspections (Including the Subcategories), High preparation; proper specimen
must pay a fee to cover the cost of Complexity, or any Combination of collection, identification, preservation,
determining program compliance. These Tests transportation, and processing; and
Laboratories issued a certificate for PPM accurate result reporting. This system
procedures, certificate of waiver, 21. Section 493.803(a) is revised to
must assure optimum patient specimen
certificate for APT tests, or a certificate read as follows:
integrity and positive identification
of accreditation are not subject to this § 493.803 Condition: Successful throughout the preanalytic (pre-testing),
fee for routine inspections. participation. analytic (testing), and postanalytic
* * * * * (a) Each laboratory performing tests of (post-testing) processes and must meet
19. In section 493.645, the heading is moderate complexity (including the the standards as they apply to the
revised, paragraph (c) is redesignated as subcategories) and/or high complexity testing performed.
(d) and revised, and a new paragraph (c) must successfully participate in a 27. A new § 493.1102 is added to read
is added: proficiency testing program approved by as follows:
47994 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
§ 493.1102 Standard; Patient test procedure specified in appendix C of The laboratory must meet the following
management requirements for accurate and the State Operations Manual (HCFA requirements:
precise technology (APT) tests. Pub. 7). HCFA Pub. 7 is available from (a) Have available and follow each test
For each APT test performed, the the National Technical Information system’s PHS-approved written
laboratory must meet all applicable Service, U.S. Department of Commerce, instructions, which include the
patient test management requirements 5825 Port Royal Road, Springfield, VA following protocols:
specified in §§ 493.1103 through 22161, telephone number (703) 487– (1) Safety precautions.
493.1111. The laboratory meets these 4630. (2) Protocols for instrument or test
requirements by doing both of the (c) Applicability of subpart K to APT system operation and test performance,
following activities: testing. The laboratory must follow each
(a) Having available and following the including maintenance and function
test system’s PHS-approved written checks.
test system’s PHS-approved instructions instructions for monitoring and
and, as appropriate, any supplements to (3) Calibration procedures.
evaluating the quality of the analytical
the procedures established by the (4) Quality control procedures defined
testing process to assure the accuracy
laboratory in accordance with the test by the manufacturer or producer of the
and reliability of patient test results and
system’s PHS-approved instructions. test system, which include running at
reports. For each APT test, the
(b) Maintaining all records least two levels of control each day of
laboratory must meet the quality control
documenting compliance with testing to monitor all steps in the testing
requirements of § 493.1204.
paragraph (a) of this section for 2 years. 30. In § 493.1202, the introductory process, including the extraction phase
28. The heading to subpart K is text of paragraph (c) is revised to read if applicable, unless one of the
revised to read as follows: as follows: following circumstances applies:
(i) The test system’s PHS-approved
Subpart K—Quality Control for Tests § 493.1202 Standard; Moderate or high instructions specify other than two
of Moderate Complexity (Including the complexity testing, or both: Effective from levels of control.
Subcategories), High Complexity, or September 1, 1992 to September 1, 1996. (ii) The procedure cannot be
any Combination of These Tests * * * * * controlled by conventional procedures
29. Section 493.1201 is amended by (c) For all other tests of moderate and an alternative means of controlling
revising paragraph (a) introductory text complexity, excluding the subcategory the system has been approved by PHS.
and paragraph (b) and by adding of APT testing, performed using an (5) Remedial action procedures.
paragraph (c) to read as follows: instrument, kit, or test system cleared by (b) Ensure that it meets the following
the FDA through premarket notification requirements:
§ 493.1201 Condition: General quality (510(k)) or the premarket approval (1) It has available and follows written
control; Moderate complexity (including the (PMA) process for in-vitro diagnostic procedures, based on each test system’s
subcategories) or high complexity testing, use, the laboratory must—
or any combination of these tests. PHS-approved instructions, as
* * * * * applicable, for the following procedures:
(a) General. Subpart K of this part is 31. Section 493.1203 is amended by
divided into two sections, general (i) Determining specimen
revising the introductory text to read as acceptability.
quality control and quality control for follows:
specialties and subspecialties. The (ii) Reporting patient test results,
quality control requirements are § 493.1203 Standard; Moderate complexity including panic values (values requiring
specified in §§ 493.1201 through (excluding accurate and precise technology immediate medical intervention).
493.1285 unless— (APT) tests) or high complexity testing or (iii) Course of action to be taken in the
both: Effective September 1, 1996. event that a test system becomes
* * * * *
(b) Applicability of subpart K to For each moderate complexity inoperable.
moderate complexity (excluding APT (excluding APT tests) or high (iv) Referral of samples as specified in
tests) and high complexity tests. The complexity test performed, the § 493.1111, including procedures for
laboratory must establish and follow laboratory is in compliance with this specimen submission and handling, as
written quality control procedures for section if it— described in § 493.1103.
monitoring and evaluating the quality of * * * * * (2) The written procedures, whether
the analytical testing process of each provided by the manufacturer, the test
§ 493.1204 [Redesignated as § 493.1206]
method to assure the accuracy and system producer, or the laboratory, are
32. Section 493.1204 is redesignated approved, signed and dated by the
reliability of patient test results and
as § 493.1206. current director of the laboratory.
reports. The laboratory must meet the
33. New § 493.1204 is added to read
applicable general quality control (3) Any change to a procedure by the
standards in §§ 493.1202 through manufacturer or producer of a test
493.1221, unless an alternative § 493.1204 Standard; Quality control system is approved by PHS and signed
procedure specified in the requirements for accurate and precise and dated by the laboratory director for
manufacturer’s protocol has been technology (APT) tests. use by laboratory personnel.
cleared by the Food and Drug For each APT test performed, the (4) Any change to a laboratory’s
Administration (FDA) as meeting laboratory is in compliance with this protocol designed to meet the
certain CLIA requirements for quality subpart if it meets all applicable quality requirements is approved, signed and
control or HHS approves an equivalent control requirements in this section. dated by the laboratory director.
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47995
(5) A copy of each procedure with the Subpart M—Personnel for Moderate § 493.1375 Standard; Laboratory director
dates of initial use and discontinuance Complexity (Including the responsibilities.
is retained for 2 years after a procedure Subcategories) and High Complexity The laboratory director is responsible
has been discontinued. Testing for the overall operation and
(c) Before reporting patient results, administration of the laboratory,
using at least the test system’s PHS- 35. Section 493.1351 is revised to read
including the employment of personnel
approved written instructions, verify as follows:
who are competent to perform APT tests
that it can obtain performance § 493.1351 General. in accordance with each test system’s
specifications for accuracy, precision This subpart consists of the personnel PHS-approved instructions, and record
and reportable range of patient results requirements that must be met by and report test results promptly,
that meet those established by the laboratories performing moderate accurately, and proficiently, and for
manufacturer or producer of the test complexity testing, PPM procedures, assuring compliance with applicable
system. The laboratory must also ensure APT tests, high complexity testing, or regulations.
that the laboratory’s patient population any combination of these tests. (a) The laboratory director, if
is included in the reference range 36. Following § 493.1365, a new qualified, may perform the duties of the
specified in the PHS-approved undesignated center heading and new clinical consultant and testing
instructions. §§ 493.1371 through 493.1387 are added personnel or may delegate these
(d) Document all remedial actions to read as follows: responsibilities to personnel meeting
taken— the qualification requirements of
Laboratories Performing Accurate and
(1) In accordance with the test Precise Technology (APT) Tests §§ 493.1379 and 493.1385, respectively.
system’s PHS-approved written
instructions; and Sec. (b) The laboratory director must be
493.1371 Condition: Laboratories accessible to the laboratory to provide
(2) When errors in the reported performing APT tests; Laboratory
patient test results are detected. In such onsite, telephone or electronic
director. consultation as needed.
a case, the laboratory must perform the 493.1373 Standard; Laboratory director
following procedures: qualifications. (c) No individual may direct more
(i) Promptly notify the authorized 493.1375 Standard; Laboratory director than five laboratories.
person ordering the test or individual responsibilities. (d) The laboratory director must meet
using the test results of report errors. 493.1377 Condition: Laboratories the following requirements:
(ii) Issue corrected reports promptly performing APT testing; clinical
(1) Ensure that testing systems
to the authorized person ordering the consultant.
493.1379 Standard; Clinical consultant selected for each of the tests performed
test or the individual using the test qualifications. in the laboratory are appropriate for the
results. 493.1381 Standard: Clinical consultant clinical use of the test results.
(iii) Maintain exact duplicates of the responsibilities. (2) Ensure that the physical plant and
original erroneous report as well as the 493.1383 Condition: Laboratories environmental conditions of the
corrected report for 2 years. performing APT testing; testing laboratory are appropriate for the testing
(e) Document and maintain records of personnel.
493.1385 Standard; Testing personnel
performed and provide a safe
all quality control activities specified in environment in which employees are
this section and retain records for at qualifications.
493.1387 Standard; Testing personnel protected from physical, chemical, and
least 2 years or longer as specified by biological hazards.
the manufacturer or producer of the test
Laboratories Performing Accurate and (3) Ensure that the following
system in accordance with § 493.1221.
Precise Technology (APT) Tests requirements are met:
(f) Promptly report any inaccurate or
imprecise method performance, whether (i) Before reporting patient results,
§ 493.1371 Condition: Laboratories using at least the test system’s PHS-
perceived or validated, to the performing APT tests; Laboratory director.
manufacturer or producer of the test approved verification procedure, the
The laboratory must have a director laboratory can obtain or verify
system and, if the problem is not who meets the qualification
rectified, to PHS. performance specifications for accuracy,
requirements of § 493.1373 and provides precision and reportable range of patient
(g) Ensure that no modification is overall management and direction in
made in the test system’s PHS-approved results that meet those established by
accordance with § 493.1375. the manufacturer or producer of the test
written instructions. Any changes made
to the test system will result in the test § 493.1373 Standard; Laboratory director system and can ensure that the reference
system no longer meeting the qualifications. range specified by the manufacturer or
requirements for categorization in the The laboratory director must be producer of the test system is
APT category. Modified tests are qualified to manage and direct the appropriate for the laboratory’s patient
considered high complexity and are laboratory personnel and the populations.
subject to the applicable CLIA quality performance of APT tests and must be (ii) Testing personnel are following
control requirements contained in eligible to be an operator of a laboratory test analyses and quality control
subpart K of this part, as well as all within the requirements of subpart R of procedures in accordance with each test
other applicable requirements for high this part and meet the requirements of system’s PHS-approved instructions.
complexity testing. § 493.1405, which contain laboratory (4) Ensure that the laboratory is
34. The heading to subpart M is director qualifications for moderate enrolled in an HHS-approved
revised to read as follows: complexity testing. proficiency testing program for the
47996 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
testing performed and that the whenever necessary, identify needs for clinical consultant must meet the
laboratory meets the following remedial training or continuing following requirements:
requirements: education to improve testing skills. The (a) Be available to provide clinical
(i) The proficiency testing samples are director must ensure that evaluations consultation to the laboratory’s clients.
tested as required under subpart H of are conducted at least semiannually (b) Be available to assist the
this part. during the first year the individual tests laboratory’s clients in ensuring that
(ii) The results are returned within the patient specimens and that, thereafter, appropriate tests are ordered to meet the
time frames established by the the evaluations are performed at least clinical expectations.
proficiency testing program. annually unless test methodology or (c) Ensure that reports of test results
(iii) All proficiency testing reports instrumentation changes, in which case, include pertinent information required
received are reviewed to evaluate the before reporting patient test results, the for specific patient interpretation.
laboratory’s performance and to identify individual’s performance must be (d) Ensure that consultation is
any problems that require corrective reevaluated to include the use of the available and communicated to the
action. new test methodology or laboratory’s clients on matters related to
(iv) An approved corrective action instrumentation. The evaluation of the the results of APT tests reported and
plan is followed and documented when competency of testing personnel must their interpretation concerning specific
any proficiency testing results are found include at least one or more of the patient conditions, including any
to be unacceptable or unsatisfactory. following, but is not limited to the relevant information provided in the
(5) Ensure that a quality assurance following procedures: test system’s PHS-approved
program is established and maintained (i) Direct observations of routine instructions.
to assure the quality of laboratory patient test performance, including
services provided. patient preparation, if applicable, § 493.1383 Condition: Laboratories
(6) Ensure that all necessary remedial specimen handling, and testing. performing APT testing; testing personnel.
actions are taken and documented and (ii) Monitoring the recording and The laboratory must have a sufficient
that patient results are reported only reporting of test results. number of individuals who meet the
when the test system is functioning (iii) Review of work sheets, quality qualification requirements of § 493.1385
properly. control records, proficiency testing to perform the functions specified in
(7) Ensure that the producer or results, and preventive maintenance § 493.1387 for the volume of tests
manufacturer of the test system is records. performed.
notified when the test system does not (iv) Assessment of test performance
meet the performance specifications as through testing previously analyzed § 493.1385 Standard; Testing personnel
outlined in the test system’s PHS- specimens, internal blind testing
approved instructions and, if the samples, or external proficiency testing Each individual performing APT
problem is not rectified, notify PHS. samples. testing must meet the following
(8) Ensure that reports of test results (13) Ensure that an approved requirements:
include pertinent information required procedure manual is available to all (a) Possess a current license issued by
for interpretation. testing personnel. the State in which the laboratory is
(9) Ensure that consultation is (14) Specify, in writing, the located, if such licensing is required.
available to the laboratory’s clients on responsibilities and duties of each (b) Meet one of the following
matters relating to the results of APT person engaged in the performance of requirements:
tests reported and their interpretation APT testing that identifies which (1) Be a doctor of medicine, doctor of
concerning specific patient conditions, examinations and procedures each osteopathy, or doctor of podiatric
including any relevant information individual is authorized to perform. medicine licensed to practice medicine,
provided in the test system’s PHS- osteopathy, or podiatry in the State in
approved instructions. § 493.1377 Condition: Laboratories which the laboratory is located or have
performing APT testing; clinical consultant. earned a doctoral, master’s, or
(10) Employ a sufficient number of
testing personnel with the appropriate The laboratory must have a clinical bachelor’s degree in a chemical,
education and either experience or consultant who meets the qualification physical, biological or clinical
training to perform tests and report test requirements of § 493.1379 and provides laboratory science or medical
results in accordance with the personnel clinical consultation in accordance with technology from an accredited
responsibilities described in this § 493.1381. institution.
subpart. § 493.1379 Standard; Clinical consultant (2) Have earned an associate degree in
(11) Ensure that, before they test qualifications. a chemical, physical, or biological
patient samples, testing personnel The clinical consultant must be science, or in medical laboratory
receive the appropriate training for the qualified to consult with and furnish technology from an accredited
services offered and have demonstrated opinions to the laboratory’s clients institution.
that they can perform all testing concerning the diagnosis, treatment and (3) Be a high school graduate or
operations, in accordance with each test management of patient care. The equivalent and have successfully
system’s PHS-approved instructions, to clinical consultant must meet the completed an official U.S. military
provide and report accurate results. requirements of § 493.1417, Clinical medical laboratory procedures course of
(12) Ensure that policies and consultant qualifications for moderate at least 50 weeks duration and have
procedures are established for complexity testing. held the military enlisted occupational
evaluating and documenting the specialty of Medical Laboratory
performance of testing personnel § 493.1381 Standard; Clinical consultant Specialist (Laboratory Technician).
responsible for APT testing to ensure responsibilities. (4) (i) Have earned a high school
that they are competent and maintain The clinical consultant provides diploma or equivalent; and
their competency to handle specimens, consultation regarding the (ii) Have documentation of training
perform test procedures, report test appropriateness of the testing ordered appropriate for the APT testing
results promptly and proficiently, and, and interpretation of test results. The performed before analyzing patient
Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules 47997
specimens. This training must ensure Subpart P—Quality Assurance for analytes specified in subpart I of this
that the individual has the following Moderate Complexity (Including the part.
skills and knowledge: Subcategories), High Complexity (iii) To evaluate complaints from the
Testing, or any Combination of These public.
(A) The skills required for proper
Tests (2) Determine whether testing is being
specimen collection, including patient
performed or the laboratory is being
preparation (if applicable), labeling, § 493.1701 [Amended] operated in a manner that does not
handling, preservation, transportation 38. Section 493.1701 is amended by constitute an imminent and serious risk
and storage of specimens. revising the word ‘‘subcategory’’ to read to public health.
(B) The skills required for performing ‘‘subcategories’’ wherever it appears in (3) Collect information to determine
each test method and control procedure the heading and text. the appropriateness of tests categorized
and for proper instrument use. 39. A new § 493.1702 is added to read as APT tests according to the criteria
(C) The skills required for performing as follows: listed at § 493.18.
(4) Determine whether the laboratory
preventive maintenance, § 493.1702 Standard; Quality Assurance is performing tests in addition to tests
troubleshooting and calibration for accurate and precise technology (APT) categorized as APT tests according to
procedures related to each test tests.
the criteria listed at § 493.18, specified
performed. For each APT test performed, the as PPM procedures, or tests approved by
(D) An awareness of the factors that laboratory must meet all applicable PHS as waived tests that are not
influence test results. quality assurance requirements included on the laboratory’s certificate.
specified in §§ 493.1703 through (b) The laboratory may be required as
§ 493.1387 Standard; Testing personnel 493.1721. The laboratory meets these part of this inspection to perform or
responsibilities. requirements by doing both of the authorize the following activities:
The testing personnel performing APT following activities: (1) Test samples (including
tests are responsible for specimen (a) Having available and following the proficiency testing samples) or perform
test system’s PHS-approved instructions procedures as HHS or its designee
processing, test performance, and for
and, as appropriate, any supplements to requires.
reporting test results.
the procedures established by the (2) Allow HHS or its designee to
(a) Each individual performs only laboratory in accordance with the test interview all employees of the
those APT tests that they are authorized system’s PHS-approved instructions. laboratory concerning the laboratory’s
by the laboratory director to perform. (b) Maintaining all records compliance with the applicable
(b) Each individual performing APT documenting compliance with requirements as noted in paragraph (d)
testing must meet the following paragraph (a) of this section for 2 years. of this section.
requirements: 40. In § 493.1777 the introductory text (3) Permit employees to be observed
is revised to read as follows: performing tests (including proficiency
(1) Follow each test system’s PHS- testing specimens), data analysis and
approved written instructions and, as § 493.1777 Condition: Inspection of reporting.
applicable, the laboratory’s written laboratories requesting or issued a (4) Permit HHS or its designee access
policies and procedures for specimen certificate of compliance. to all areas of the facility, including the
submission and handling and for Laboratories requesting a certificate of following areas:
reporting and maintaining records of compliance must permit an inspection (i) Specimen procurement and
patient test results. to assess compliance with part 493 of processing areas.
(2) Maintain records that demonstrate this chapter. All testing conducted, (ii) Storage facilities for specimens,
that proficiency testing samples are including testing in the subcategories of reagents, supplies, records, and reports.
APT tests or PPM procedures, may be (iii) Testing and reporting areas.
tested in the same manner as patient
included in the laboratory’s routine or (5) Provide copies to HHS or its
complaint inspection. APT tests and designee of all records and data required
(3) Adhere to each test system’s PHS- PPM procedures are assessed for under this part.
approved written instructions for compliance with only the applicable (c) The laboratory must have all
quality control procedures, including requirements specific to those records and data accessible and
the documentation of all quality control subcategories of testing. retrievable within a reasonable time
activities, remedial actions, instrument * * * * * frame during the inspection.
and procedural calibrations, and 41. A new § 493.1778 is added to read (d) Applicable requirements for the
maintenance performed. as follows: purpose of this section are located in
(4) Be capable of identifying problems subparts C, H, J, K, M, and P of this part
§ 493.1778 Condition: Inspection of and § 493.21.
that may adversely affect test laboratories issued a certificate for accurate (e) The laboratory must provide upon
performance or reporting of test results and precise technology (APT) tests. reasonable request all information and
and either must correct the problems or (a) HHS or its designee may conduct data needed by HHS or its designee to
immediately notify the director. announced or unannounced inspections make a determination of compliance
(5) Notify the director of any test of any laboratory issued a certificate for with the applicable requirements.
system performance that does not meet APT tests at any time during its hours (f) HHS or its designee may reinspect
the performance specifications as of operation for the following purposes: a laboratory at any time necessary to
outlined in the test system’s PHS- (1) Assess compliance with the assess the laboratory’s compliance with
approved instructions. following circumstances, as applicable: the applicable requirements.
(i) On a random basis. (g) Failure to permit an inspection
37. The heading to subpart P is (ii) Following a laboratory’s under this section will result in the
revised to read as follows: demonstration of unsuccessful suspension of Medicare and Medicaid
participation in proficiency testing for payments to the laboratory or
47998 Federal Register / Vol. 60, No. 179 / Friday, September 15, 1995 / Proposed Rules
termination of the laboratory’s § 493.1834 Civil money penalty. (3) If the laboratory still does not
participation in Medicare and Medicaid * * * * * correct its deficiencies, the Medicare
for payment, and suspension of, or (b) Scope. This section sets forth the sanction continues until the suspension,
action to revoke, the laboratory’s CLIA procedures that HCFA follows to limitation, or revocation of the
certificate in accordance with subpart R impose a civil money penalty in lieu of, laboratory’s certificate of compliance,
of this part. or in addition to, suspending, limiting, registration certificate, certificate of
42. In § 493.1814, the text of the or revoking the certificate of accreditation, certificate for APT tests,
introductory text of paragraph (b) is compliance, registration certificate, or certificate for PPM procedures is
republished and paragraph (b)(3) is certificate of accreditation, certificate for effective.
revised to read as follows: APT tests, or certificate for PPM 45. In § 493.2001, the introductory
procedures of a laboratory that is found text of paragraph (e) is republished and
§ 493.1814 Action when deficiencies are at to have condition level deficiencies. paragraph (e)(1) is revised to read as
the condition level but do not pose * * * * * follows:
immediate jeopardy. (f) Accrual and duration of penalty.
* * * * * * * * § 493.2001 Establishment and function of
(2) Duration of penalty. The civil the Clinical Laboratory Improvement
(b) Failure to correct condition level Advisory Committee.
money penalty continues to accrue until
deficiencies. If HCFA imposes
the earliest of the following occurs: * * * * *
alternative sanctions for condition level
deficiencies that do not pose immediate * * * * * (e) The Clinical Laboratory
jeopardy and the laboratory does not (iii) HCFA suspends, limits, or Improvement Advisory Committee or
correct the condition level deficiencies revokes the laboratory’s certificate of subcommittee at the request of HHS will
within 12 months after the last day of compliance, registration certificate, review and make recommendations
inspection, HCFA— certificate of accreditation, certificate for concerning—
APT tests, or certificate for PPM
* * * * * procedures. (1) Criteria for categorizing tests and
(3) May impose (or continue, if examinations of moderate complexity
* * * * *
already imposed) any alternative 44. In § 493.1836, the heading of (including the subcategories) and high
sanctions that do not pertain to paragraph (c) is republished and complexity;
Medicare payments. (Sanctions imposed paragraphs (c)(2) and (c)(3) are revised * * * * *
under the authority of section 353 of the to read as follows: Authority: Sec. 353 of the Public Health
PHS Act may continue for more than 12 Service Act (42 U.S.C. 263a)
months from the last date of inspection, § 493.1836 State onsite monitoring. Dated: May 25, 1995.
while a hearing on the proposed * * * * * Bruce C. Vladeck,
suspension, limitation, or revocation of (c) Duration and sanction. * * *
(2) If the laboratory does not correct Administrator, Health Care Financing
the certificate of compliance, Administration.
registration certificate, certificate of all deficiencies within 12 months, and
a revisit indicates that deficiencies Dated: May 26, 1995.
accreditation, certificate for APT tests,
or certificate for PPM procedures is remain, HCFA cancels the laboratory’s Philip R. Lee,
pending.) approval for Medicare payment for its Assistant Secretary for Health.
services and notifies the laboratory of its
* * * * * Dated: June 5, 1995.
intent to suspend, limit, or revoke the
43. In § 493.1834, the heading and laboratory’s certificate of compliance, Donna E. Shalala,
introductory text of paragraph (f)(2) are registration certificate, certificate of Secretary.
republished and paragraphs (b) and accreditation, certificate for APT tests, [FR Doc. 95–22861 Filed 9–14–95; 8:45 am]
(f)(2)(iii) are revised to read as follows: or certificate for PPM procedures. BILLING CODE 4120–01–P