CLIA Program; Categorization and Certification Requirements for a New Subcategory of Moderate Complexity Testing

[[Page 47982]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 493

[HSQ-222-P]

RIN 0938-AG98

CLIA Program; Categorization and Certification Requirements for a

New Subcategory of Moderate Complexity Testing

AGENCY: Health Care Financing Administration (HCFA) and Public Health

Service (PHS), HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: In this proposed rule we are responding to some of the

comments on categories of tests received in response to the rule

published on February 28, 1992. To reduce the regulations burden on

laboratories, we are proposing to revise our regulations to create a

new subcategory of high quality moderate complexity procedures called

accurate and precise technology (APT) tests.

DATES: Comments will be considered if we receive them at the

appropriate address, as provided below, no later than 5 p.m. on

November 14, 1995.

ADDRESSES: Mail written comments (1 original and 3 copies) to the

following address: Centers for Disease Control and Prevention, Public

Health Service, Department of Health and Human Services, Attention:

HSQ-222-P, 4770 Buford Highway, N.E., MSF11, Atlanta, Georgia 30341-

3724.

If you prefer, you may deliver your written comments (1 original

and 3 copies) to one of the following addresses: Room 714-B, Hubert H.

Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201.

Because of staffing and resource limitations, we cannot accept

comments by facsimile (FAX) transmission. In commenting, please refer

to file code HSQ-222-P. Comments received timely will be available for

public inspection as they are received, generally beginning

approximately 3 weeks after publication of a document, in Room 309-G of

the Department's offices at 200 Independence Avenue, SW., Washington,

DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.

(phone: (202) 690-7890).

For comments that relate to information collection requirements,

mail a copy of comments to: Office of Information and Regulatory

Affairs, Office of Management and Budget, Room 10235, New Executive

Office Building, Washington, DC 20503, Attn: Allison Herron Eydt, HCFA

Desk Officer.

Copies: To order copies of the Federal Register containing this

document, send your request to: New Orders, Superintendent of

Documents, P.O. Box 371954, Pittsburgh, PA 15250-7954. Specify the date

of the issue requested and enclose a check or money order payable to

the Superintendent of Documents, or enclose your Visa or Master Card

number and expiration date. Credit card orders can also be placed by

calling the order desk at (202) 512-1800 or by faxing to (202) 512-

2250. The cost for each copy is $8.00. As an alternative, you can view

and photocopy the Federal Register document at most libraries

designated as Federal Depository Libraries and at many other public and

academic libraries throughout the country that receive the Federal

Register.

FOR FURTHER INFORMATION CONTACT: Rosemary Bakes-Martin (404) 488-7655,

for questions regarding the APT requirements and criteria for APT

categorization; and Judy Yost, (410) 786-3531, for certificate, fee,

and inspection issues.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 353 of the Public Health Service Act (42 U.S.C.

263a), as amended by the Clinical Laboratory Improvement Amendments of

1988 (CLIA), all laboratories that examine human specimens for the

diagnosis, prevention or treatment of any disease or impairment of, or

the assessment of the health of, human beings, must meet certain

requirements to perform the examination. In accordance with the law,

regulations implementing CLIA that HHS published on February 28, 1992

(57 FR 7002) established laboratory requirements based on the

complexity of the tests performed. There are currently three test

categories: waived, moderate, and high complexity.

Following publication of the February 28, 1992 regulations, HHS

established a Clinical Laboratory Improvement Advisory Committee

(CLIAC) to advise and make recommendations on technical and scientific

aspects of the regulations. The CLIAC is composed primarily of

individuals involved in the provision of laboratory services, use of

laboratory services, development of laboratory testing devices or

methodologies, and others as approved by HHS. The CLIAC has four

subcommittees: cytology; personnel; proficiency testing, quality

control and quality assurance; and test categorization.

In response to publication of the February 28, 1992 regulations, we

received approximately 16,000 letters from professional organizations

and individuals providing around 71,000 comments.

In response to those comments, we have published three rules (in

addition to this proposed rule). One of those rules responds to the

comments received on the waived criteria, tests presently included in

the waived category and those tests that commenters believed should be

added. At our request, the CLIAC evaluated the waived category and

suggested that the Centers for Disease Control and Prevention (CDC)

clarify the criteria and develop a process for review of requests for

waiver. We clarified the criteria for waiver and the process for

requesting waived categorization and published the clarified criteria

and process for requesting waiver in a proposed rule with comment on

September 13, 1995 (60 FR 47534). (The other two rules appeared in the

Federal Register on January 19, 1993 (58 FR 5215) and on April 24,

1995.

In this rule, in response to numerous comments regarding the test

complexity model, we are proposing to establish a new subcategory of

moderate complexity that would include high quality tests that would be

subject to less stringent requirements. Establishment of this

subcategory should encourage manufacturers to produce accurate, easy-

to-use test systems for use by physicians and laboratories to improve

test quality and enhance patient care.

II. Response to Comments Received to Previous CLIA Regulations

In this rule we address additional comments received in response to

the establishment of the three testing categories. Below we have

provided a general overview of the comments and our responses, followed

by some additional specific comments concerning the categories of

testing and our response to these comments, which includes the

rationale used to develop the proposed accurate and precise technology

(APT) subcategory.

Upon review of the comments, we believe that additional revision of

the test categorization model is warranted. The revisions to the

regulations proposed in this rule would address the commenters'

concerns that many high quality tests are less complex than many of the

tests currently categorized as moderate complexity, but they do not

meet the criteria for waiver. The commenters feel and we agree that

these tests should be subject to less stringent

[[Page 47983]]

requirements than those currently associated with moderate complexity

tests.

In addition, we received numerous comments from professional

organizations and individuals expressing concern about the burden

associated with regulating laboratories based on test complexity and

the criteria used to categorize tests as moderate or high complexity.

Many commenters indicated that the special circumstances involved in

physician offices, rural and public health clinics providing laboratory

services should justify minimizing the regulatory burden on them. Some

commenters believed that regulating laboratories on the basis of test

complexity and the requirements applicable to moderate and high

complexity tests would increase the cost of laboratory testing. Several

commenters thought this regulatory burden would cause many laboratories

to discontinue providing services, thereby limiting health care in

underserved and rural areas. Some commenters recommended reducing some

of the regulatory burden by creating a category of tests at a level

between waived and moderate complexity. Other commenters suggested

creating additional categories and provided examples for alternatives

to the current test complexity model.

In response to these comments, the CDC developed a proposal to

create a new subcategory of moderate complexity that would include

simple, easy-to-use tests with proven accuracy and precision and

therefore would require somewhat less stringent requirements than the

requirements currently applicable to other moderate complexity tests.

During the development of the subcategory, we were especially

cognizant of the concerns of the commenters who stated that there are

many high quality, moderate complexity tests that might not qualify for

waiver, but, on the other hand, should not be subject to the full range

of requirements currently applicable to moderate complexity testing. We

agree with the commenters that regulatory relief for high quality tests

is appropriate. In order to justify less stringent application of the

requirements, we are proposing that the tests meet rigid performance

specifications and have demonstrated, through scientifically valid

studies, a high level of accuracy and precision. Through this process,

test systems would be evaluated to ensure they provide quality results

and physicians and laboratories would have access to this

categorization information to employ in test selection and determining

types of laboratory services to provide.

We therefore designed a subcategory of moderate complexity testing

that we proposed to call APT testing that would include high quality,

less complex tests that would be unique in that the test system

instructions would not only contain complete procedures for test

performance, including instructions regarding the preanalytic, analytic

and postanalytic phases of testing, but would also include protocols

that would assist laboratories in meeting the CLIA requirements. We

proposed that, in order to be considered for categorization in the APT

subcategory, the producer or manufacturer of the test system would have

to submit data demonstrating that the test system meets the criteria

for APT categorization. In addition, the test system instructions would

have to specify clearly what laboratories must do to be in compliance

with the CLIA requirements. For APT testing, laboratories could rely on

the manufacturer's or producer's test system instructions to meet the

CLIA requirements. Since, for APT testing, compliance with the CLIA

requirements would be based on laboratories following the test system

instructions, we believe that random, rather than routine, inspections

of laboratories having an APT certificate would be sufficient.

We discussed with the CLIAC the proposed criteria and requirements

to be applicable to the new subcategory. The CLIAC supported the

concept of the APT subcategory. However, the CLIAC expressed the view

that the subcategory (as currently structured) would not provide the

amount of regulatory relief desired by many commenters who requested

revisions to the complexity model. We understand the CLIAC's concerns;

however, we believe that it is essential that we reevaluate the

complexity model to determine whether the regulations are effective in

ensuring public access to quality laboratory services. When we

established the CLIA requirements in 1992, we sought to devise a

regulatory model based on the complexity of testing performed that

would establish the minimum requirements necessary to ensure accurate

testing. At this point, we believe there are many highly accurate,

simple, easy-to-use test systems currently categorized as moderate

complexity that could be eligible for less stringent requirements, and

laboratories performing such testing should be provided financial and

regulatory relief through a reduction in the CLIA requirements.

To obtain broad public review, we are publishing this proposed rule

and encourage commenters to provide suggestions on how we might revise

the CLIA requirements to ensure that they promote access to quality

services and stimulate technological advances in testing. With respect

to the provisions contained in this rule, we are seeking specific

suggestions and recommendations concerning the criteria and process for

categorizing tests in the APT subcategory, as well as comments on the

appropriateness of the proposed requirements for APT testing.

III. Provisions of the Proposed Rule

Criteria for APT Categorization

In this rule, we are proposing to establish at 42 CFR 493.18 a new

subcategory of moderate complexity testing designated as APT, and we

are outlining the proposed criteria for determining which tests would

be categorized as APT. The proposed criteria for inclusion in the APT

subcategory are structurally similar to our proposed clarifications to

the criteria for waived tests published on September 13, 1995.

For quantitative and qualitative tests, the similarities between

the proposed criteria for APT categorization and the proposed

clarifications to the criteria for waiver are as follows:

Quantitative APT tests and quantitative waived tests would

have to meet similar test characteristics and performance

specifications by demonstrating, through scientifically valid studies,

a high level of accuracy and precision.

Qualitative APT tests would have to meet the same

requirements for allowable error as we have proposed for qualitative

waived tests.

The proposed criteria for inclusion in the APT subcategory would

differ from the proposed criteria for waiver in that:

Waived tests must be fail-safe with no operator

intervention, whereas APT test protocols could allow some operator

intervention to investigate questionable results and to resolve test

system failures.

Waived qualitative tests are limited to reagent

impregnated devices (such as dipsticks), whereas qualitative APT tests

would not be limited to any specific type of technology. [It is

important to clarify what is meant by qualitative tests in this

regulation. Qualitative tests are test methods that provide two

categorical responses (e.g., positive/negative or presence/absence).

For these types of tests, the concentration of the analyte is defined

as being above or below a certain discrimination zone that

[[Page 47984]]

defines negativity or positivity.] On the other hand, test methods that

give results by defining specific absorbance values at which tests will

be considered positive are essentially quantitative tests in that they

directly depend on defined concentrations of the analyte producing the

discrete absorbance value. In this regulation, we are proposing to

consider the latter as quantitative tests.

Waived tests may use only direct unprocessed specimens,

have direct readout of results and require no invasive troubleshooting

or electronic or mechanical maintenance. However, APT tests could have

simple noncalculated conversions and some troubleshooting and

maintenance performed by the analyst.

Instructions for performance of waived tests must be

written at no higher than a seventh grade reading level and include a

description of the analytic skills required to perform the test. APT

test instructions would have no such requirements, since personnel

performing APT testing would, at a minimum, have to have a high school

diploma, or equivalent, and relevant training.

Quantitative waived tests may have a certain amount of

random error but they must be shown to be essentially free of

systematic error, whereas quantitative APT tests would be allowed a

minimal amount of error that may be either random or systematic, or

both.

Review Process

Also at Sec. 493.18, we are proposing the process for approving

tests for the APT subcategory. We are proposing that requests for

placement of tests in this subcategory be in conformance with the

proposed submission process outlined in this regulation. The data

submitted for evaluation would have to meet specific criteria related

to operational characteristics, ease of use, and test performance. The

test system's instructions will be reviewed by PHS to ensure that

laboratories can rely on these instructions to assist them in meeting

the regulations in subparts J, K and P when performing APT testing.

Submission Requirements

Under the proposed rule, the manufacturer or test system producer

would have to determine which procedures in the preanalytic, analytic

and postanalytic phases of testing are essential to ensure accurate

test results. These procedures would be identified in the submission to

PHS as mandatory procedures for the laboratory to follow. In addition,

the manufacturer or test system producer would have to include

protocols to assist laboratories in meeting the CLIA requirements. The

test system instructions should remind laboratories to enroll in an

HHS-approved proficiency testing program, if applicable.

Since many manufacturers are currently providing this type of

assistance to laboratories, often in the form of complete protocols

containing instructional materials that cover all aspects of the

regulations and, in addition, examples of suggested forms to use to

document monitoring activities, we believe that the APT subcategory

merely strengthens and confirms that interaction between the producer

of the test system and the laboratory user. Formalizing this

relationship and making it uniform for all manufacturers and producers

of these test systems should reduce the regulatory burden on

laboratories, while providing an effective mechanism for laboratories

to achieve regulatory compliance with the CLIA requirements.

We encourage individuals to submit their comments and suggestions

on how we might improve the APT categorization criteria or process and

revise the regulations to incorporate these changes. Following review

of comments received in response to this notice, we will make the

necessary revisions to the APT requirements, including the criteria for

APT categorization and the process for reviewing requests for APT

categorization of test systems.

After a final rule responding to the comments received to this

proposed rule is published establishing the APT subcategory, requests

for APT categorization may be submitted for review. Once a test system

review has been completed, the manufacturer or producer would be

notified of the APT categorization decision, whether denied or granted.

APT categorization would be effective on the date of notification to

the applicant. Any test categorized as APT also would be published in

the Federal Register as a notice with an opportunity for public

comment. (As with all comments received on test categorization, our

responses to the comments received on APT categorization will be

included in a subsequent Federal Register notice.) Once we receive

comments on the Federal Register notice, we reserve the right to

reevaluate and recategorize the test based upon those comments.

Administration

We are proposing to make conforming changes to subpart F (General

Administration) to accommodate the addition of the new certificate for

APT tests. Laboratories that qualify for a certificate of APT tests

would have to pay a fee for the issuance of a certificate. Each

laboratory would be assessed a fee representing the certificate fee and

a fee for the costs of the random inspections. The certificate fee

would be based on the fee schedule (which is based on the test volume

and scope of specialties tested) in effect. This fee would represent

the APT laboratory's share of the general cost to HHS of administering

the laboratory certification program. This would include, but would not

be limited to, the cost of issuing the certificate, the cost of

collecting fees, the administrative costs of determining which tests

would qualify for inclusion in the APT test category, and the

administrative costs associated with processing and evaluating

laboratory applications. The fee for random inspection would represent

the cost to HHS of conducting random inspections of approximately five

percent of the laboratories issued a certificate for APT tests to

assess compliance with the applicable requirements of 42 CFR part 493.

Random inspection costs would be shared by all laboratories issued a

certificate for APT tests.

If, in the case of a laboratory subject to a random inspection, it

is determined that a follow-up survey is necessary because of

identified deficiencies, HHS would assess that laboratory an additional

fee to cover the cost of the follow-up survey activities. The fee would

be based on the actual resources and time necessary to perform the

follow-up visits. Failure of a laboratory to pay any assessed costs

would result in HHS revoking the laboratory's certificate.

Patient Test Management

We are proposing to add a new Sec. 493.1102 to subpart J (patient

test management) to include the new patient test management

requirements that would be applicable to APT testing. These

requirements would be less burdensome to the laboratory than the

requirements currently applicable to other moderate complexity testing

because the manufacturer's or producer's PHS-approved test system

instructions would specify what laboratories must do to comply with the

CLIA patient test management requirements. There would be two

requirements in this new standard. The two requirements would be that

the laboratory must: (a) have available and follow the patient test

management procedures specified in the PHS-approved instructions; and

(b) maintain records documenting compliance with

[[Page 47985]]

the patient test management requirements for two years.

Quality Control

In subpart K (quality control), we propose to recodify the current

Sec. 493.1204 as Sec. 493.1206 and add a new Sec. 493.1204 to

accommodate the quality control provisions resulting from the proposed

addition of the new subcategory of APT tests. Since the PHS-approved

test system instructions for APT procedures would include instructions

for meeting the CLIA requirements, the laboratory quality control

requirements for APT testing would be less stringent than for other

moderate complexity tests. We are proposing that, before reporting

patient test results, laboratories, at a minimum, use the PHS-approved

test system instructions for verifying the test system's performance

specifications. The laboratory may include, as appropriate, expanded or

additional protocols for verifying the test system's performance

specifications. As with other procedures of moderate complexity,

quality control activities for APT tests would have to be documented

and the records retained for two years, except immunohematology

records, which must be maintained for a period of no less than five

years. We would stress that laboratories must not modify the test

system's PHS-approved test performance instructions, since any

modification would result in the test no longer being categorized as

APT. Any modified procedure would become an uncategorized test and

would be considered high complexity until categorized by PHS.

Personnel

The personnel requirements for APT testing would be located at

Sec. 493.1371 through Sec. 493.1387. APT personnel requirements would

be somewhat less stringent than for other moderate complexity testing

because APT tests would have been reviewed to ensure that they meet the

criteria for simple, reliable, accurate and precise tests. The

personnel requirements for this subcategory would not include a

technical consultant because manufacturers or producers of APT tests

would develop maintenance protocols, calibration and control

procedures, remedial action policies and criteria for reporting and

interpreting test results, which would fulfill most of the technical

consultant's responsibilities. The remaining technical consultant

responsibilities (e.g., employee evaluations) would be performed by the

laboratory director.

For APT tests, we would require laboratories to have a qualified

director, clinical consultant and testing personnel. The qualifications

required for director and clinical consultant would be the same as for

moderate complexity testing, while the testing personnel training

requirements would be modified slightly from the training required for

other moderate complexity testing because the test system manufacturer

or producer would be providing specific instructions on test system

performance, including reagent stability and storage and quality

control. The responsibility requirements for each level of personnel

within the APT subcategory would be somewhat less stringent in

accordance with the laboratory's reliance on the manufacturer or

producer of the test system to provide detailed test instructions,

protocols for meeting the regulatory requirements, performance

specifications and information regarding test results and

interpretation.

Quality Assurance

We are proposing to add a new Sec. 493.1702 to the quality

assurance requirements located in subpart P to include the proposed

requirements applicable to APT testing. These requirements would be

less burdensome than the requirements currently applicable to other

moderate complexity testing, since the PHS-approved test system

instructions would assist the laboratory in meeting the quality

assurance requirements. Like Sec. 493.1102 in subpart J (patient test

management), there would be two requirements in Sec. 493.1702. To meet

the quality assurance requirements in subpart P, we are proposing that:

(a) laboratories must have available and follow procedures specified in

the test system's PHS-approved instructions to meet the quality

assurance requirements; and (b) laboratories must document and maintain

records of quality assurance activities for two years.

Inspections

We are proposing to establish a new Sec. 493.1778 specifying that

laboratories with a certificate for APT tests are subject to announced

or unannounced inspections on a random basis to assess compliance with

the applicable requirements of part 493, to evaluate compliance when

indicated by unsuccessful participation in proficiency testing and

complaints, and to collect information for determining the

appropriateness of tests categorized as APT. We are proposing to

require random, rather than routine, inspections for a laboratory

having an APT certificate since the laboratory would be required only

to follow the PHS-approved instructions to meet the CLIA requirements

for APT testing. During a random inspection, as with any inspection of

other test complexity categories, not all test systems would be

reviewed. A few test systems would be randomly selected and assessed

for compliance. We would also clarify in this section that if the same

laboratory is performing provider-performed microscopy procedures,

those tests may also be assessed for compliance with all applicable

requirements specific to that subcategory of testing during the random

inspection.

Additionally, we would revise the introductory paragraph to

Sec. 493.1777, which currently contains the condition concerning

inspection of laboratories requesting or issued a certificate of

compliance, to clarify the inspection requirements for a laboratory

with a certificate of compliance when the laboratory also performs APT

procedures. Specifically, for laboratories that perform APT procedures

and have a certificate of compliance, APT procedures may be included in

the sample of moderate complexity tests inspected during the

laboratory's routine, biennial inspections.

Summary of Changes to the Regulations

We are proposing to add or change the following sections to

incorporate requirements applicable to APT tests:

Section 493.18, Accurate and precise technology (APT)

tests.

Section 493.21, Laboratories performing accurate and

precise technology (APT) tests.

Section 493.48, Requirements for a certificate for

accurate and precise technology (APT) tests.

Section 493.1102, Patient test management requirements for

accurate and precise technology (APT) tests.

In subpart K, we are proposing to add the new quality

control requirements applicable to APT testing at Sec. 493.1204 and

move the facilities requirements (without change) currently located at

Sec. 493.1204 to a new Sec. 493.1206.

To subpart M, we are proposing to add nine new sections to

include the personnel requirements for laboratories performing APT

testing. At Sec. 493.1371, we are proposing to add the condition

requirements for director, and at Secs. 493.1373 and 493.1375,

respectively, we plan to include the qualification and responsibility

requirements for director. The condition level requirements for

clinical consultant would be located at Sec. 493.1377, with clinical

consultant qualifications to be specified under

[[Page 47986]]

Sec. 493.1379 and responsibilities to be included under Sec. 493.1381.

The testing personnel condition requirements would be at Sec. 493.1383,

with testing personnel qualifications at Sec. 493.1385 and

responsibilities to be included at Sec. 493.1387.

Section 493.1702, Quality assurance requirements for

accurate and precise technology (APT) tests.

Section 493.1778, Inspection of laboratories issued a

certificate for accurate and precise technology (APT) tests.

We are proposing to make conforming technical changes to the

following sections and headings: Secs. 493.2; 493.3(a)(1); 493.5

(a)(2), (b) and (c)(4); 493.20 (a) and (b); 493.25(c); the headings for

subpart C and 493.43; 493.43(a); 493.45 introductory paragraph and (a);

493.49; 493.51 heading, introductory paragraph and paragraphs (b) and

(c) and new (d); 493.53(a); 493.602; 493.638 (a) and (b); 493.639(b);

493.643(a); 493.645 heading and new paragraph (c) and paragraph (d)

(redesignated from paragraph (c)); subpart H; 493.803(a); 493.807

heading; subheading preceding 493.821; subpart I heading; subpart J

heading; 493.1101 heading and introductory paragraph; subpart K

heading; 493.1201 heading, revision to paragraph (a) and (b) and

addition of new paragraph (c); 493.1202(c); 493.1203; part M heading;

493.1351; subpart P heading; 493.1777 introductory paragraph;

493.1814(b)(3); 493.1834 (b) and (f)(2)(iii); and 493.1836 (c)(2) and

(c)(3); and 493.2001.

In addition, we are deleting the words ``of this part'' wherever

they follow a specific section number in regulations text appearing in

this Federal Register document to conform with rules of the Office of

the Federal Register.

IV. Response to Comments

Because of the large number of items of correspondence we normally

receive on Federal Register documents published for comment, we are not

able to acknowledge or respond to them individually. We will consider

all comments we receive by the date and time specified in the DATES

section of this preamble, and, if we proceed with a subsequent

document, we will respond to the comments in the preamble to that

document.

V. Collection of Information Requirements

The proposed rule contains information collections that are subject

to review by the Office of Management and Budget (OMB) under the

Paperwork Reduction Act of 1980. The title, description, and respondent

description of the information collection requirements are shown below

with an estimate of the annual reporting and recordkeeping burden.

Included in the estimate is the time for reviewing instructions,

searching existing data sources, gathering and maintaining the data

needed, and completing and reviewing the collection of information.

Sec. 493.18: This section outlines the criteria a manufacturer must

follow in order to have its moderate complexity test categorized as an

``Accuracy and Precise Technology'' (APT) test. These include but are

not limited to test system characteristics, instructions, field studies

and evaluation of data.

Secs. 493.43, 493.45, 493.48, 493.49, 493.51, 493.53: Sections

493.43 through 493.53 are currently approved under OMB approval number

0938-0612 with an expiration date of February 28, 1998. The information

is gathered on form number HCFA-R-26. These sections outline the

requirements for a laboratory to follow to submit application forms for

CLIA certification. The requirements include laboratory notification to

HHS of changes to the types of tests performed or changes in ownership,

name location or director.

Section 493.48 is a new section added to reflect the addition of

the new certificate category for laboratories performing tests

categorized as accurate and precise technology testing (APT).

Secs. 493.1101 and 493.1102: Sections 493.1101 through 493.1111 are

currently approved under OMB approval number 0938-0612 with an

expiration date of February 28, 1998. This section concerns patient

test management for laboratories performing tests of moderate and high

complexity that implement the CLIA statutory mandate for laboratories

to meet requirements relating to the proper collection, transportation,

and storage of specimens and the reporting of results. Section 493.1102

is a new section added to reflect the addition of the new subcategory

for tests categorized as accurate and precise technology testing (APT).

Secs. 493.1201, 493.1202 and 493.1204: Sections 493.1201 and

493.1202 are currently approved under OMB approval number 0938-0612

with an expiration date of February 28, 1998. These sections set forth

the general quality control standards for monitoring and evaluating the

quality of the testing process to assure accurate and reliable patient

test results and reports as required under CLIA. Section 493.1204 is a

new section required to reflect the addition of the new subcategory for

accurate and precise technology testing (APT).

Sec. 493.1702: Sections 493.1701 through 493.1721 are currently

approved under OMB approval number 0938-0612 with an expiration date of

February 28, 1998. Section 493.1702 is a new section developed to

address specific requirements that relate to quality assurance for a

laboratory performing APT testing. Specifically it requires a

laboratory to have available and follow the PHS-approved instructions

and supplements (where appropriate) and maintain records documenting

compliance for a 2-year period.

Secs. 493.1777 and 493.1778: Sections 493.1725 through 493.1780 are

currently approved under OMB approval number 0938-0612 with an

expiration date of February 28, 1998. Section 493.1777 concerns the

inspections of laboratories. The burden associated with inspections

consists of retrieving the records and documentation requested by the

inspector, participating in the entrance and exit interviews,

responding to the statement of deficiencies that may result from the

inspection and documenting any corrective actions taken that are

appropriate to the plan of correction for the deficiencies cited.

Section 493.1778 is a new section developed to address the inspection

requirements as they apply to laboratories with an APT certificate.

This section sets forth the policy of random inspections for

laboratories with an APT certificate.

When OMB approves those provisions not currently approved we will

publish a notice in the Federal Register to that affect.

Description of Respondents

Sec. 493.18: Small businesses or organizations, businesses or other

for profit, non-profit institutions, who manufacture laboratory tests.

Secs. 493.43, 493.45, 493.48, 493.49, 493.51, 493.53; 493.1101 and

493.1102; 493.1201, 493.1202 and 493.1204; 493.1702; 493.1777 and

493.1778: Small businesses or organizations, businesses or other for

profit, non-profit institutions, state and local governments, federal

agencies.

[[Page 47987]]

Estimated Annual Reporting and Recordkeeping Burden

----------------------------------------------------------------------------------------------------------------

Average

Annual number of Annual burden per Annual

CFR sections responses frequency response burden

(hours) hours

----------------------------------------------------------------------------------------------------------------

493.18................................................. 50 1 336 16,800

493.43, 493.45, 493.48, 493.49, 493.51, 493.53......... 28,700 1 .25 7,175

493.1101, 493.1102..................................... 82,000 1 .5 41,000

493.1201, 493.1202 and 493.1204........................ 82,000 1 12 984,000

493.1702............................................... 24,600(a) 1 42 1,033,200

493.1777 and 493.1778.................................. 1,230(a) 1 4 4,920

----------------------------------------------------------------------------------------------------------------

(a) Assuming 30% of 82,000 non-waived laboratories become APT.

The agency has submitted a copy of the proposed rule to OMB for its

review of these information collections. Interested persons are invited

to send comments regarding this burden estimate or any other aspect of

these collections of information, including any of the following

subjects: (1) The necessity and utility of the proposed information

collection for the proper performance of the agency's functions; (2)

the accuracy of the estimated burden; (3) ways to enhance the quality,

utility, and clarity of the information to be collected; and (4) the

use of automated collection techniques or other forms of information

technology to minimize the information collection burden. Comments

should be sent to HCFA, OFHR, MPAS, C2-26-17, 7500 Security Boulevard,

Baltimore, Maryland 21244-1850 and to the OMB official whose name

appears in the ADDRESSES section of this preamble.

VI. Regulatory Impact Statement

We generally prepare a regulatory flexibility analysis that is

consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601

through 612) unless the Secretary certifies that a rule would not have

a significant economic impact on a substantial number of small

entities. For purposes of the RFA, all laboratories and manufacturers

of laboratory test systems are considered to be small entities.

Individuals and States are not included in the definition of a small

entity.

Also, section 1102(b) of the Act requires the Secretary to prepare

a regulatory impact analysis if a rule may have a significant impact on

the operations of a substantial number of small rural hospitals. This

analysis must conform to the provisions of section 603 of the RFA. For

purposes of section 1102(b) of the Act, we define a small rural

hospital as a hospital that is located outside of a Metropolitan

Statistical Area and has fewer than 50 beds.

This proposed rule would modify CLIA regulations published February

28, 1992 by establishing a new subcategory of moderate complexity

testing, accurate and precise technology (APT) tests. There are

approximately 157,000 entities enrolled under CLIA that could be

affected by this rule; however, the significance of the effect would

vary depending on the volume and complexity of tests performed. While

we cannot estimate the number of entities that may make changes in

their laboratory testing practices, we believe the modifications to the

CLIA program would be beneficial to the affected entities and would be

well received, since they are being proposed in response to comments

requesting revisions to the test complexity categories.

In proposing this new subcategory, we acknowledge the unique

aspects of the many tests with proven accuracy and precision that may

not qualify for waiver, but should not be subject to all of the

requirements applicable to moderate complexity testing, including

routine inspection. To this end, this proposed rule would establish

less stringent requirements, including less frequent (random)

inspections and fewer personnel requirements, for laboratories

providing tests categorized as APT. We expect no clinically meaningful

decrease in test accuracy, or patient health, from this proposal.

Furthermore, to the extent that it encourages cost-effective testing

more than the present CLIA rules, and increases the amount of such

testing in settings that might otherwise eschew testing, it is likely

to improve patient health. In addition, this proposed rule would reduce

the financial burden for some laboratories by enabling them to provide

an expanded test menu without incurring the higher costs associated

with a certificate of compliance.

The changes proposed in this regulation may affect a laboratory's

test menu and choice of certificate. Laboratories holding a certificate

of compliance that change to a certificate for APT would experience a

decrease in compliance costs and the number of surveys, since APT

laboratories would not be subject to routine inspections and the

associated fees. The laboratories that would realize the greatest

benefit from these savings would most likely be physician office

laboratories and public health laboratories. Laboratories, specifically

many physician offices and other limited service laboratories,

expanding from a certificate of waiver or PPM to a certificate for APT

would be able to enhance the range of laboratory services available to

patients, while their costs (including certification fees and costs

inherent in meeting applicable requirements such as personnel and

quality control), would remain less than the costs of obtaining a

certificate of compliance. The availability of a CLIA certificate that

allows an expanded test menu at less cost also may encourage new

entities to begin providing services, thereby increasing physician and

patient access to health care, particularly in underserved and rural

areas.

This proposed rule may affect some manufacturers of laboratory

tests who would be required to submit specific information and data

demonstrating that their test meets the criteria for APT

categorization. We estimate that approximately 500 test systems may

qualify for this subcategory. These test systems are predominantly

small automated instruments or ``desktop'' analyzers. Manufacturers of

any test system approved by PHS in the APT subcategory also must

provide laboratories with complete instructions, which include

protocols to assist laboratories in meeting the CLIA requirements.

However, many manufacturers are currently providing this type of

information and assistance to laboratories in the form of instructional

materials and protocols. Because laboratories would not be required to

develop their own operational policies and quality control protocols, a

wider variety of laboratories might decide to offer APT testing.

[[Page 47988]]

Therefore, we anticipate that categorization as an APT test would

result in increased sales and distribution for the manufacturers.

As indicated above, we believe that the creation of the subcategory

of APT and subsequent decrease in the regulatory and financial burden

for laboratories performing APT tests would benefit patients,

laboratories, and manufacturers. However, we are unable to quantify

these likely long run effects because they depend on market decisions,

research results, and technological change that cannot be predicted.

Regardless, we believe that for the most part these effects would

involve relatively small savings of a few hundred or a few thousand

dollars a year for each laboratory, mainly due to reduced inspection

fees or QC costs. In the aggregate these savings would be substantial,

because they are shared by thousands of laboratories. However, few if

any entities are likely to achieve very substantial savings.

This proposed rule would establish the process for categorizing

moderate complexity tests into a new subcategory of moderate complexity

testing and would also establish a new type of certificate. Proper

realignment of the fee schedule, if necessary, would follow

implementation of this rule.

For these reasons, we are not preparing analyses for either the RFA

or section 1102(b) of the Act because we have determined, and the

Secretary certifies, that this proposed rule would not have a

significant economic impact on a substantial number of small entities

or a significant impact on the operations of a substantial number of

small rural hospitals. We do request comments, however, on possible

improvements in these proposed regulations to achieve even greater

savings to affected entities and will consider them carefully in

formulating the final rule.

In accordance with the provisions of Executive Order 12866, this

regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 493

Grant programs-health, Health facilities, Laboratories, Medicaid,

Medicare, Reporting and recordkeeping requirements.

42 CFR part 493 would be amended as set forth below:

PART 493--LABORATORY REQUIREMENTS

1. The authority citation continues to read as follows:

Authority: Sec. 353 of the Public Health Service Act, secs.

1102, 1861(e), the sentence following 1861(s)(11), 1861(s)(12),

1861(s)(13), 1861(s)(14), 1861(s)(15), and 1861(s)(16) of the Social

Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following

1395x(s)(11), 1395x(s)(12), 1395x(s)(13), 1395x(s)(14),

1395x(s)(15), and 1395x(s)(16)).

2. In Section 493.2, in the definition of ``CLIA certificate'' the

introductory text is republished and paragraph (6) is added to read as

follows:

Sec. 493.2 Definitions.

* * * * *

CLIA certificate means any of the following types of certificates

issued by HCFA or its agent:

* * * * *

(6) Certificate for accurate and precise technology (APT) tests

means a certificate issued or reissued before the expiration date,

pending an appeal in accordance with Sec. 493.48, to a laboratory that

only performs tests approved by PHS as APT tests and, if desired, tests

specified as PPM procedures, tests approved by PHS as waived tests, or

both.

* * * * *

3. In Sec. 493.3, the introductory text of paragraph (a) is

republished and paragraph (a)(1) is revised to read as follows:

Sec. 493.3 Applicability.

(a) Basic rule. Except as specified in paragraph (b) of this

section, a laboratory will be cited as out of compliance with section

353 of the Public Health Service Act unless it--

(1) Has a current, unrevoked or unsuspended certificate of waiver,

a registration certificate, a certificate of compliance, certificate

for PPM procedures, certificate for APT tests, or a certificate of

accreditation issued by HHS applicable to the category of examinations

or procedures performed by the laboratory; or

* * * * *

4. Section 493.5 is revised to read as follows:

Sec. 493.5 Categories of tests by complexity.

(a) Laboratory tests are categorized as one of the following types

of tests:

(1) Waived tests.

(2) Tests of moderate complexity, including the subcategories of

moderate complexity, which are limited to the following tests and

procedures:

(i) PPM procedures.

(ii) APT tests.

(3) Tests of high complexity.

(b) A laboratory has the option of performing only waived tests,

only tests of moderate complexity, only PPM procedures, only APT tests,

only tests of high complexity, or any combination.

(c) Each laboratory must be either CLIA-exempt or possess one of

the following certificates, as defined in this part:

(1) Registration certificate.

(2) Certificate of waiver.

(3) Certificate for PPM procedures.

(4) Certificate for APT tests.

(5) Certificate of compliance.

(6) Certificate of accreditation.

5. A new Sec. 493.18 is added to read as follows:

Sec. 493.18 Accurate and precise technology (APT) tests.

(a) Requirement. To be included in the APT subcategory, the test

system must be categorized as moderate complexity using the criteria in

Sec. 493.17 and it must meet the descriptive criteria specified in

paragraph (b) of this section.

(b) Criteria. (1) For quantitative tests, methods must be easy to

use, accurate, and precise as evidenced by the following items:

(i) Test systems that have the following characteristics:

(A) Are fully automated (no operator intervention during the

analytic phase).

(B) Provide direct readout of results or simple noncalculated

conversions.

(ii) Test system instructions that address the following items:

(A) Requirements for specimen collection, handling, storage and

preservation.

(B) Reportable range for patient results.

(C) Reference range (normal values) and suggested panic values

(values requiring immediate medical intervention).

(D) Units of measurement used for reporting patient results.

(E) Step-by-step protocols that include, as appropriate, the

following items:

(1) Instrument or test system operation and test performance

instructions.

(2) Test system maintenance procedures.

(3) Preparation and storage of reagents, calibrators, controls, or

other materials used in testing.

(4) Control procedures including the type of materials, suggested

concentrations, and frequency of assay.

(5) Calibration procedures including the number and type of

materials and frequency of assay.

(6) Acceptable ranges for any control or calibration material

included with the test system.

(7) Action to be taken when calibration or control results do not

meet the acceptable range of values.

[[Page 47989]]

(8) Methods for converting test system values to reportable

results.

(9) Description of course of action to be taken when the test

system becomes inoperable.

(10) Any limitations to methodologies such as interfering

substances.

(11) A written protocol for reporting patient test results.

(iii) Field studies that meet the following requirements:

(A) Demonstrate that the manufacturer's or producer's written

instructions are the only protocols required to perform the test

accurately and reliably.

(B) Demonstrate that individuals with no formal laboratory training

can correctly perform the test.

(iv) Data from field studies that meet the following requirements:

(A) Are generated from protocols that address the points described

in paragraph (b)(1)(iii) of this section.

(B) Are adequate to produce measures of performance that are both

statistically valid and defensible (estimates must support valid

confidence limits for all statistical parameters).

(C) Evaluate performance at all medical decision points and

relevant upper and lower limits of the reportable range using at least

three concentrations of the analyte being tested.

(D) Evaluate among-operator imprecision using test results of all

study participants.

(E) Evaluate within-site imprecision using test results generated

at each site by an adequate number of participants to produce measures

of performance that are statistically valid and defensible. Testing

must be performed at a minimum of three independent study sites.

(F) Evaluate among-site imprecision at an adequate number of sites

to produce measures of performance that are statistically valid and

defensible using results generated by study participants on aliquots of

a single testing material.

(v) Method accuracy studies demonstrating little or no systematic

error when--

(A) Using reference materials assayed by study participants that

produce data that show there is little or no statistically significant

difference between the test results and the value of the reference

materials.

(B) Using patient samples instead of reference materials,

demonstrating there is little or no introduction of error in patient

test results due to the effects of the sample matrix.

(C) Adding or simulating common interfering substances known to

affect the analyte in patient samples, demonstrating that there is

little or no introduction of error due to the presence of these

substances.

(vi) Demonstration that the total amount of error, which includes

all components contributing to imprecision and inaccuracy as defined by

studies described in paragraphs (b)(1)(iv)(D) through (b)(1)(iv)(F) and

(b)(1)(v)(A) through (b)(1)(v)(C) of this section, is less than one

fourth of the reference range for the analyte divided by the mean of

the reference interval.

(2) For qualitative tests, methods must be easy to use, accurate,

and precise as evidenced by the following items:

(i) Test systems that meet the following requirements:

(A) Contain steps that are limited in number and complexity, are

self-contained and are packaged as a complete system.

(B) Have a qualitative endpoint that requires no interpretation

beyond discerning agglutination patterns, color comparisons, or other

easily interpreted reactions.

(ii) Test system instructions that address the following items:

(A) Requirements for specimen collection, handling, storage and

preservation.

(B) Reportable range for patient results.

(C) Reference range (normal values).

(D) Step-by-step protocols that include, as appropriate, the

following items:

(1) Test performance instructions.

(2) Preparation and storage of reagents, calibrators, controls, or

other materials used in testing.

(3) Control procedures including the type of materials and

frequency of assay.

(4) Calibration procedures including the number and type of

materials and frequency of assay.

(5) Acceptable ranges for any control or calibration material

included with the test system.

(6) Action to be taken when calibration or control results do not

meet acceptable range of values.

(7) The correct interpretation of test reactions or endpoints.

(8) Description of course of action to be taken when test reactions

or endpoints cannot be determined.

(9) Any limitations to methodologies.

(iii) Field studies that meet the following requirements:

(A) Demonstrate that the manufacturer's or producer's written

instructions are the only protocols required to perform the test

accurately and reliably.

(B) Demonstrate that individuals with no formal laboratory training

can correctly perform the test.

(iv) Data from field studies that meet the following requirements:

(A) Are generated from protocols that address the points described

in paragraph (b)(2)(iii) of this section.

(B) Are adequate to produce measures of performance that are both

statistically valid and defensible.

(C) Confirm that study participants are able to read and interpret

test endpoints with the same precision as laboratory professionals.

(D) Confirm that the performance of study participants is

essentially the same as laboratory professionals when testing samples

at or near the cutoff and at sufficient distance above and below the

cutoff to confirm precision at all analytical decision points.

(E) Demonstrate minimal among-operator imprecision using results of

all study participants.

(F) Demonstrate minimal within-site imprecision using test results

generated at each site by an adequate number of participants to produce

measures of performance that are statistically valid and defensible.

Testing must be performed at a minimum of three independent study

sites.

(G) Using results generated by study participants, demonstrate

minimal among-site imprecision at an adequate number of sites to

produce measures of performance that are statistically valid and

defensible.

(v) Method accuracy studies demonstrating that there is no

statistically significant difference between observed values and

expected values at the cutoff point when--

(A) The test values are compared to a quantitative result such as

the value of a reference material or the presence or absence of a

particular biologic component;

(B) Confirming that there are no significant equivocal test results

on either side of the cutoff;

(C) Comparing results between study participants and laboratory

professionals on samples with values at the cutoff;

(D) The test is performed on patient samples instead of reference

materials, confirming there is no introduction of error due to sample

matrix; and

(E) Samples contain substances that commonly cause interference

confirming there is no introduction of error because of these

substances.

(c) Provisions for inclusion of tests in the APT subcategory--(1)

Process for requesting APT categorization.

(i) Requests for APT categorization must be submitted to PHS.

(ii) PHS reviews requests for APT categorization that meet the

criteria specified in paragraph (b) of this section and the submission

requirements under paragraph (c)(2) of this section.

[[Page 47990]]

(iii) The CLIAC, as specified in subpart T of this part, conducts

reviews upon the request of HHS and makes recommendations to HHS

concerning APT test categorization.

(iv) Any change or modification to an APT test system by the

manufacturer or producer that could affect the accuracy or reliability

of that test must be resubmitted to PHS for evaluation and review.

Until this review is completed and categorization status is determined,

the modified test is considered uncategorized and, in accordance with

Sec. 493.17(c)(4), is considered high complexity.

(v) A request for reconsideration of a test denied APT

categorization is accepted for review if the request is based on

information not previously submitted.

(2) Submission requirements.

(i) Requests for APT categorization must meet the criteria

described in paragraph (b) of this section. In the event that a request

does not include complete information, the request is not reviewed and

the manufacturer or producer of the test system is notified.

(ii) Data collection protocols and data submitted must be complete

and data submitted must be statistically valid and meet the criteria

described under paragraph (b) of this section.

(iii) Test system instructions must be complete and must include,

as applicable, the items defined in paragraph (b)(1)(ii) of this

section for quantitative tests and under paragraph (b)(2)(ii) of this

section for qualitative tests. In addition, test system instructions

must include the following statements:

(A) ``Any modification by the laboratory to the PHS-approved test

system instructions will result in the test no longer meeting the

requirements for APT categorization. Modified tests are considered high

complexity and are subject to all applicable CLIA requirements

contained in 42 CFR part 493.''

(B) ``The laboratory must notify the producer of this test system

of any performance, perceived or validated, that does not meet the

performance specifications as outlined in these instructions.'' The

name, address and phone number(s) of the producer's contact person(s)

must follow this statement.

(C) If applicable: ``Laboratories performing accurate and precise

technology (APT) tests are subject to the proficiency testing (PT)

requirements under 42 CFR part 493, subpart H of this part. The

laboratory must enroll and successfully participate in an HHS-approved

PT program.''

(iv) Patient test management protocols must be complete and include

sufficient information to assist laboratories in meeting each of the

requirements in subpart J of this part. These protocols must meet the

following requirements:

(A) Clearly specify the instructions that must be followed by the

laboratory to ensure proper specimen handling and accurate test result

reporting and assist laboratories in meeting the requirements of

subpart J of this part, including the following requirements listed in

paragraphs (c)(2)(iv)(A)(1) through (c)(2)(iv)(A)(4) and (c)(2)(iv)(B)

of this section, as applicable:

(1) Section 493.1103(a), procedures for specimen submission and

handling, including protocols for preparation of patients, specimen

collection, preservation, and conditions for specimen transport.

(2) Section 493.1105(f), any test requisition information that is

relevant and necessary to a specific test to assure accurate testing

and reporting of results.

(3) Sections 493.1107(c) and 493.1109(c), test records and test

report information related to the criteria for specimen acceptability.

(4) Section 493.1109, test report information including the

following information:

(i) Section 493.1109(d), pertinent ``reference'' or ``normal''

ranges.

(ii) Section 493.1109(f), any imminent life-threatening laboratory

results or panic values.

(iii) Section 493.1109(g), the test methodology employed and any

information that may affect the interpretation of test results.

(B) Provide information (for example, written instructions,

instructional materials or samples of forms for documentation of

activities performed) that laboratories may follow or supplement, in

accordance with the test system's PHS-approved instructions, in meeting

the requirements in subpart J of this part.

(v) Quality control instructions must include the following items:

(A) Protocols for documentation of all control and calibration

results, any remedial action to be taken, and the appropriate record

retention requirements as described at Sec. 493.1221.

(B) Protocols for documentation of equipment maintenance

performance and the appropriate record retention requirements as

described at Sec. 493.1221.

(C) Safety precaution instructions that cover any physical hazard

or biohazardous material, including the proper handling and disposal of

testing materials.

(D) Protocols for developing written procedures for the following

activities:

(1) Determining specimen acceptability.

(2) Reporting patient test results, including suggested panic

values, if applicable.

(3) The course of action to be taken in the event that a test

system becomes inoperable.

(4) Referral of samples, as specified in Sec. 493.1111, including

procedures for specimen submission and handling as described in

Sec. 493.1103.

(E) Verification of method performance specifications and

verification that the reference range is appropriate for the

laboratory's patient population.

(vi) Quality assurance protocols must be complete and include

sufficient information to assist laboratories in meeting each of the

requirements in subpart P of this part. These protocols must meet the

following requirements:

(A) Clearly specify the instructions that must be followed by the

laboratory in establishing a comprehensive quality assurance program

for monitoring and evaluating the overall quality of the total testing

process (preanalytic, analytic, and postanalytic) and identifying and

correcting problems based on the results of the evaluation to assure

the accurate, reliable and prompt reporting of patient results and

assist laboratories in meeting the requirements of subpart P of this

part listed in paragraphs (c)(2)(vi)(A)(1) through (c)(2)(vi)(A)(4) and

(c)(2)(vi)(B) of this section, and, as applicable, meet the

requirements of the following sections:

(1) Section 493.1703, Patient test management assessment, including

the following requirements:

(i) The criteria established for patient preparation, specimen

collection, preservation and transportation.

(ii) The completeness and relevance of the information solicited on

the laboratory's test requisition.

(iii) The use and appropriateness of the criteria established for

specimen rejection.

(iv) The completeness, usefulness and accuracy of the test report

information necessary for the interpretation or utilization of test

results.

(2) Section 493.1705, Quality control assessment, including a

mechanism to assess the effectiveness of the corrective actions taken

in the following situations:

(i) Problems identified during the evaluation of calibration and

control data for the test method.

(ii) Problems identified during the evaluation of patient test

values for the purpose of ensuring the appropriateness of the reference

range of the test method.

[[Page 47991]]

(3) Section 493.1709, Comparison of test results, including

procedures for evaluating and defining the relationship between test

results using different methodologies, instruments, or testing sites.

(4) Section 493.1711, Relationship of patient information to

patient results, including procedures for identifying and evaluating

patient test results that appear inconsistent with any relevant

criteria specified in Sec. 493.1711.

(B) Provide information (for example, written instructions,

instructional materials, or samples of forms for documentation of

activities performed) that laboratories may follow or supplement, in

accordance with the test system's PHS-approved instructions, in meeting

the requirements in subpart P of this part.

(3) Notification of decision.

(i) PHS determines whether a laboratory test meets the criteria

listed under paragraph (b) of this section for an APT test.

(ii) PHS notifies the applicant of APT categorization, whether

denied or granted.

(iii) APT categorization is effective as of the date of

notification to the applicant.

(iv) PHS publishes additions and revisions periodically to tests

categorized as APT in the Federal Register in a notice with opportunity

for public comment. PHS reserves the right to reevaluate and

recategorize a test based upon the comments it receives in response to

the Federal Register notice.

6. In Sec. 493.20, paragraphs (a) and (b) are revised to read as

follows:

Sec. 493.20 Laboratories performing tests of moderate complexity.

(a) A laboratory may qualify for a certificate to perform tests of

moderate complexity if it restricts its test performance to waived

tests or examinations and one or more tests or examinations meeting

criteria for tests of moderate complexity including the subcategories

of PPM and APT tests.

(b) A laboratory that performs tests or examinations of moderate

complexity must meet the applicable requirements in subpart C or

subpart D, and subparts F, H, J, K, M, P, and Q of this part. Under a

registration certificate or certificate of compliance, laboratories

also performing PPM procedures and APT tests must meet the inspection

requirements at Sec. 493.1777.

* * * * *

7. A new Sec. 493.21 is added to read as follows:

Sec. 493.21 Laboratories performing accurate and precise technology

(APT) tests.

(a) A laboratory may qualify for a certificate to perform APT tests

if it performs tests categorized by PHS as APT tests and no other

procedures, except those specified as PPM procedures or those approved

by PHS as waived tests.

(b) Laboratories performing APT tests must meet the following

requirements:

(1) Follow each test system's PHS-approved instructions for

performing the test; and

(2) Meet the applicable requirements in subpart C or subpart D of

this part and subparts F, H, J, K, M, P, and Q of this part.

(c) If the laboratory also performs PPM procedures, the laboratory

must meet the applicable requirements in subparts H, J, K, M, P, and Q

of this part.

(d) If the laboratory also performs waived tests, the requirements

of subparts H, J, K, M, and P of this part are not applicable for the

waived tests. However, the laboratory must comply with the requirements

in Secs. 493.15(e) and 493.1775.

8. In Sec. 493.25, paragraph (c) is revised to read as follows:

Sec. 493.25 Laboratories performing tests of high complexity.

* * * * *

(c) If the laboratory also performs tests of moderate complexity,

the applicable requirements of subparts H, J, K, M, P and Q of this

part must be met. Under a registration certificate or certificate of

compliance, PPM procedures and APT tests must meet the inspection

requirements at Sec. 493.1777.

* * * * *

9. The heading of subpart C is revised to read as follows:

Subpart C--Registration Certificate, Certificate for Provider-

Performed Microscopy Procedures, Certificate for Accurate and

Precise Technology Tests, and Certificate of Compliance

10. In Sec. 493.43, the section heading and paragraph (a) are

revised to read as follows:

Sec. 493.43 Application for registration certificate, certificate for

provider-performed microscopy (PPM) procedures, certificate for

accurate and precise technology (APT) tests, and certificate of

compliance.

(a) Filing of application. Except as specified in paragraph (b) of

this section, all laboratories performing tests of moderate complexity

(including the subcategories) or high complexity, or any combination of

these tests, must file a separate application for each laboratory

location.

* * * * *

11. In Sec. 493.45, the introductory paragraph is revised, the

introductory text of paragraph (a) is republished, and paragraphs

(a)(1) and (a)(2) are revised to read as follows:

Sec. 493.45 Requirements for a registration certificate.

Laboratories performing only waived tests, PPM procedures, APT

tests, or any combination of these tests, are not required to obtain a

registration certificate.

(a) A registration certificate is required--(1) Initially for all

laboratories performing test procedures of moderate complexity (other

than the subcategories of APT tests and PPM procedures) or high

complexity, or both;

(2) For all laboratories that have been issued a certificate of

waiver, certificate for PPM procedures, or certificate for APT tests

that intend to perform tests of moderate or high complexity, or both in

addition to those tests listed in Sec. 493.15(c) or specified as PPM

procedures, or categorized as APT tests; and

* * * * *

12. A new Sec. 493.48 is added to read as follows:

Sec. 493.48 Requirements for a certificate for accurate and precise

technology (APT) tests.

(a) A certificate for APT tests is required for all laboratories

that intend to perform only the following tests:

(1) Tests that have been categorized by PHS as APT tests.

(2) APT tests in addition to waived tests or PPM procedures.

(3) APT tests, waived tests and PPM procedures.

(b) HHS issues a certificate for APT tests if the laboratory meets

the following requirements:

(1) Complies with the requirements of Sec. 493.43 for applying for

a certificate.

(2) Agrees to treat proficiency testing samples in the same manner

as it treats patient specimens.

(3) Agrees to be inspected by HHS as specified in Sec. 493.1778.

(4) Remits the fee for the certificate as specified in subpart F of

this part.

(c) A laboratory issued a certificate for APT tests is subject to

the following requirements:

(1) The notification requirements of Sec. 493.51.

(2) The applicable requirements of this subpart and subparts H, J,

K, M, P and Q of this part.

(d) A laboratory requesting a certificate for APT tests that also

[[Page 47992]]

performs PPM procedures is subject to the following requirements:

(1) Ensuring that PPM procedures are performed only by individuals

meeting the personnel requirements of subpart M of this part.

(2) Undergoing random inspections as specified in Sec. 493.1778.

(e) In accordance with subpart R of this part, HHS initiates

suspension, limitation, or revocation of a laboratory's certificate for

APT tests for failure to comply with the applicable requirements set

forth in this subpart. HHS may also impose certain alternative

sanctions. In addition, failure to meet the requirements of this

subpart may result in suspension of all or part of payments under

Medicare and Medicaid.

(f) A certificate for APT tests is valid for a period of no more

than 2 years. A laboratory must follow the procedures established by

HHS for renewal of this certificate.

13. Section 493.49 is amended by revising the introductory text and

paragraphs (a) and (b) to read as follows:

Sec. 493.49 Requirements for a certificate of compliance.

A certificate of compliance may include any combination of tests

categorized as high complexity or moderate complexity or listed in

Sec. 493.15(c) as waived tests. Moderate complexity tests may include

those specified as PPM procedures or categorized as APT tests.

(a) HHS issues a certificate of compliance to a laboratory only if

the laboratory meets the following requirements:

(1) Meets the requirements of Secs. 493.43 and 493.45.

(2) Remits the certificate fee specified in subpart F of this part.

(3) Meets the applicable requirements of this subpart and subparts

H, J, K, M, P, and Q of this part.

(b) A laboratory issued a certificate of compliance must meet the

following requirements:

(1) Meets the notification requirements of Sec. 493.51.

(2) Permits announced or unannounced inspections by HHS in

accordance with subpart Q of this part for the following reasons:

(i) Routine determination of compliance with the applicable

requirements of this part.

(ii) Evaluation of complaints.

(iii) Nonroutine survey of the laboratory when HHS has substantive

reason to believe that tests are being performed, or the laboratory is

being operated in a manner that constitutes an imminent and serious

risk to human health.

(iv) Collection of information regarding the appropriateness of

tests listed in Sec. 493.15 or tests categorized as moderate complexity

(including the subcategories) or high complexity.

* * * * *

14. Section 493.51 is revised to read as follows:

Sec. 493.51 Notification requirements for laboratories issued a

certificate for accurate and precise technology (APT) tests or a

certificate of compliance.

Laboratories issued a certificate for APT tests or a certificate of

compliance must meet the following requirements:

(a) Notify HHS or its designee within 30 days of any change in any

of the following items:

(1) Ownership.

(2) Name.

(3) Location.

(4) Director.

(5) Technical supervisor (laboratories performing high complexity

testing only).

(b) Notify HHS no later than 6 months after performing any test or

examination within a specialty or subspecialty area that is not

included on the laboratory's certificate for APT tests or a certificate

of compliance, so that compliance with requirements can be determined.

(c) Notify HHS no later than 6 months after any deletions or

changes in test methodologies for any test or examination included in a

specialty or subspecialty, or both, for which the laboratory has been

issued a certificate for APT tests or a certificate of compliance.

(d) Notify HHS before performing and reporting results for tests

not included under the certificate for APT tests (which are tests other

than waived tests, PPM procedures, and APT tests) unless the laboratory

has been issued a registration certificate as required in subpart C or

subpart D of this part, as applicable.

15. Section 493.53 is amended by revising the introductory text and

paragraph (a) to read as follows:

Sec. 493.53 Notification requirements for laboratories issued a

certificate for provider-performed microscopy (PPM) procedures.

Laboratories issued a certificate for PPM procedures must notify

HHS or its designee in the following situations:

(a) Before performing and reporting results for any test of

moderate complexity (including the subcategory of APT tests) or high

complexity, or both, in addition to tests specified as PPM procedures,

or any test or examination that is not specified under Sec. 493.15(c)

for which it does not have a registration certificate or certificate

for APT technology tests as required in subpart C or subpart D, as

applicable, of this part.

* * * * *

16. In Sec. 493.638, introductory paragraph (a) is revised,

paragraph (a)(4) is redesignated as (a)(5), new paragraph (a)(4) is

added, and paragraph (b) is revised to read as follows:

Sec. 493.638 Certificate fees.

(a) Basic rule. Laboratories must pay a fee for the issuance of a

registration certificate, certificate for PPM procedures, certificate

of waiver, certificate for APT tests, certificate of accreditation, or

a certificate of compliance, as applicable. Laboratories must also pay

a fee to reapply for a certificate for PPM procedures, certificate of

waiver, certificate for APT tests, certificate of accreditation, or a

certificate of compliance. The total of fees collected by HHS under the

laboratory program must be sufficient to cover the general costs of

administering the laboratory certification program under section 353 of

the PHS Act.

* * * * *

(4) For a certificate for APT tests, the costs include issuing the

certificate, collecting the fees, determining if a certificate for APT

tests should be issued, evaluating which test systems qualify for

inclusion in the subcategory of APT tests, and other direct

administrative costs.

(5) For a certificate of accreditation, the costs include issuing

the certificate, collecting the fees, evaluating the programs of

accrediting bodies, and other direct administrative costs.

(b) Fee amount. The fee amount is set annually by HHS on a calendar

year basis and is based on the category of test complexity, or on the

category of test complexity and schedules or ranges of annual

laboratory test volume (excluding waived tests and tests performed for

quality control, quality assurance, and proficiency testing purposes)

and specialties tested, with the amounts of the fees in each schedule

being a function of the costs for all aspects of general administration

of CLIA as set forth in Sec. 493.649 (b) and (c). This fee is assessed

and payable at least biennially. The methodology used to determine the

amount of the fee is found in Sec. 493.649. The amount of the fee

applicable to the issuance of the registration certificate or the

issuance or renewal of the certificate for PPM procedures, certificate

of waiver, certificate for APT tests, certificate of accreditation, or

certificate of compliance is the amount in effect at

[[Page 47993]]

the time the application is received. Upon receipt of an application

for a certificate, HHS or its designee notifies the laboratory of the

amount of the required fee for the requested certificate.

17. In Sec. 493.639, paragraphs (b) introductory text and (b)(1)

are revised to read as follows:

Sec. 493.639 Fee for revised certificate.

* * * * *

(b) A laboratory must pay a fee to cover the cost of issuing a

revised certificate in any of the circumstances specified in paragraphs

(b)(1) and (b)(2) of this section.

(1) The fee for issuing an appropriate revised certificate is based

on the cost of issuing the revised certificate to the laboratory as

follows:

(i) If a laboratory with a certificate of waiver wishes to perform

tests in addition to those listed in Sec. 493.15(c) as waived tests, it

must, as set forth in Sec. 493.638, pay an additional fee for the

appropriate certificate to cover the additional testing.

(ii) If a laboratory with a certificate for PPM procedures wishes

to perform tests in addition to those specified as PPM procedures or

listed in Sec. 493.15(c) as waived tests, it must, as set forth in

Sec. 493.638, pay an additional fee for the appropriate certificate

(registration or certificate for APT tests) to cover the additional

testing.

(iii) If a laboratory with a certificate for APT tests wishes to

perform tests in addition to those categorized as APT tests, specified

as PPM procedures, or listed in Sec. 493.15(c) as waived tests, it

must, as set forth in Sec. 493.638, pay an additional fee for a

registration certificate to cover the additional testing.

* * * * *

18. In Sec. 493.643, paragraph (a) is revised to read as follows:

Sec. 493.643 Fee for determination of program compliance.

(a) Fee requirement. In addition to the fee required under

Sec. 493.638, a laboratory subject to routine inspections must pay a

fee to cover the cost of determining program compliance. Laboratories

issued a certificate for PPM procedures, certificate of waiver,

certificate for APT tests, or a certificate of accreditation are not

subject to this fee for routine inspections.

* * * * *

19. In section 493.645, the heading is revised, paragraph (c) is

redesignated as (d) and revised, and a new paragraph (c) is added:

Sec. 493.645 Additional fee(s) applicable to approved State laboratory

programs and laboratories issued certain certificates.

* * * * *

(c) Laboratories with a certificate for APT tests.

(1) In addition to the certificate fee, a laboratory requesting a

certificate for APT tests is also assessed a fee representing the cost

to HHS of random inspections to determine compliance with CLIA

requirements. All laboratories issued a certificate for APT tests will

share in the cost of these inspections.

(2) If a laboratory issued a certificate for APT tests has been

inspected and followup visits are necessary because of identified

deficiencies, HHS assesses the laboratory a fee to cover the cost of

these visits. The fee is based on the actual resources and time

necessary to perform the follow up visits. HHS revokes the laboratory's

certificate for APT tests for failure to pay the assessed fee.

(d) Other fees. If, in the case of a laboratory that has been

issued a certificate of accreditation, certificate of waiver,

certificate for PPM procedures, or certificate for APT tests, it is

necessary to conduct a complaint investigation, impose sanctions, or

conduct a hearing, HHS assesses that laboratory a fee to cover the cost

of these activities. Costs are based on the actual resources and time

necessary to perform the activities and are not assessed until after

the laboratory concedes the existence of deficiencies or an ALJ rules

in favor of HHS. HHS revokes the laboratory's certificate for failure

to pay the assessed costs. If a complaint investigation results in the

determination that a complaint is unsubstantiated, or if an HHS adverse

action is overturned at the conclusion of the administrative appeals

process, the costs of these activities are not imposed upon the

laboratory.

20. The heading of subpart H is revised to read as follows:

Subpart H--Participation in Proficiency Testing for Laboratories

Performing Tests of Moderate Complexity (Including the

Subcategories), High Complexity, or any Combination of These Tests

21. Section 493.803(a) is revised to read as follows:

Sec. 493.803 Condition: Successful participation.

(a) Each laboratory performing tests of moderate complexity

(including the subcategories) and/or high complexity must successfully

participate in a proficiency testing program approved by HCFA, if

applicable, as described in subpart I of this part for each specialty,

subspecialty, and analyte or test in which the laboratory is certified

under CLIA.

* * * * *

22. The heading of Sec. 493.807 is revised to read as follows:

Sec. 493.807 Condition: Reinstatement of laboratories performing tests

of moderate complexity (including the subcategories), high complexity,

or any combination of these tests, after failure to participate

successfully.

* * * * *

23. The undesignated center heading immediately preceding

Sec. 493.821 is revised to read as follows:

Proficiency Testing by Specialty and Subspecialty for Laboratories

Performing Tests of Moderate Complexity (Including the Subcategories),

High Complexity, or Any Combination of These Tests

24. The heading to subpart I is revised to read as follows:

Subpart I--Proficiency Testing Programs for Tests of Moderate

Complexity (Including the Subcategories), High Complexity, or any

Combination of These Tests

25. The heading to subpart J is revised to read as follows:

Subpart J--Patient Test Management for Moderate Complexity

(Including the Subcategories), High Complexity, or any Combination

of These Tests

26. Section 493.1101 is revised to read as follows:

Sec. 493.1101 Condition: Patient test management; moderate complexity

(including the subcategories), high complexity testing, or any

combination of these tests.

Each laboratory performing moderate complexity (including the

subcategories) or high complexity testing, or any combination of these

tests, must employ and maintain a system that provides for proper

patient preparation; proper specimen collection, identification,

preservation, transportation, and processing; and accurate result

reporting. This system must assure optimum patient specimen integrity

and positive identification throughout the preanalytic (pre-testing),

analytic (testing), and postanalytic (post-testing) processes and must

meet the standards as they apply to the testing performed.

27. A new Sec. 493.1102 is added to read as follows:

[[Page 47994]]

Sec. 493.1102 Standard; Patient test management requirements for

accurate and precise technology (APT) tests.

For each APT test performed, the laboratory must meet all

applicable patient test management requirements specified in

Secs. 493.1103 through 493.1111. The laboratory meets these

requirements by doing both of the following activities:

(a) Having available and following the test system's PHS-approved

instructions and, as appropriate, any supplements to the procedures

established by the laboratory in accordance with the test system's PHS-

approved instructions.

(b) Maintaining all records documenting compliance with paragraph

(a) of this section for 2 years.

28. The heading to subpart K is revised to read as follows:

Subpart K--Quality Control for Tests of Moderate Complexity

(Including the Subcategories), High Complexity, or any Combination

of These Tests

29. Section 493.1201 is amended by revising paragraph (a)

introductory text and paragraph (b) and by adding paragraph (c) to read

as follows:

Sec. 493.1201 Condition: General quality control; Moderate complexity

(including the subcategories) or high complexity testing, or any

combination of these tests.

(a) General. Subpart K of this part is divided into two sections,

general quality control and quality control for specialties and

subspecialties. The quality control requirements are specified in

Secs. 493.1201 through 493.1285 unless--

* * * * *

(b) Applicability of subpart K to moderate complexity (excluding

APT tests) and high complexity tests. The laboratory must establish and

follow written quality control procedures for monitoring and evaluating

the quality of the analytical testing process of each method to assure

the accuracy and reliability of patient test results and reports. The

laboratory must meet the applicable general quality control standards

in Secs. 493.1202 through 493.1221, unless an alternative procedure

specified in the manufacturer's protocol has been cleared by the Food

and Drug Administration (FDA) as meeting certain CLIA requirements for

quality control or HHS approves an equivalent procedure specified in

appendix C of the State Operations Manual (HCFA Pub. 7). HCFA Pub. 7 is

available from the National Technical Information Service, U.S.

Department of Commerce, 5825 Port Royal Road, Springfield, VA 22161,

telephone number (703) 487-4630.

(c) Applicability of subpart K to APT testing. The laboratory must

follow each test system's PHS-approved written instructions for

monitoring and evaluating the quality of the analytical testing process

to assure the accuracy and reliability of patient test results and

reports. For each APT test, the laboratory must meet the quality

control requirements of Sec. 493.1204.

30. In Sec. 493.1202, the introductory text of paragraph (c) is

revised to read as follows:

Sec. 493.1202 Standard; Moderate or high complexity testing, or both:

Effective from September 1, 1992 to September 1, 1996.

* * * * *

(c) For all other tests of moderate complexity, excluding the

subcategory of APT testing, performed using an instrument, kit, or test

system cleared by the FDA through premarket notification (510(k)) or

the premarket approval (PMA) process for in-vitro diagnostic use, the

laboratory must--

* * * * *

31. Section 493.1203 is amended by revising the introductory text

to read as follows:

Sec. 493.1203 Standard; Moderate complexity (excluding accurate and

precise technology (APT) tests) or high complexity testing or both:

Effective September 1, 1996.

For each moderate complexity (excluding APT tests) or high

complexity test performed, the laboratory is in compliance with this

section if it--

* * * * *

Sec. 493.1204 [Redesignated as Sec. 493.1206]

32. Section 493.1204 is redesignated as Sec. 493.1206.

33. New Sec. 493.1204 is added to read as follows:

Sec. 493.1204 Standard; Quality control requirements for accurate and

precise technology (APT) tests.

For each APT test performed, the laboratory is in compliance with

this subpart if it meets all applicable quality control requirements in

this section. The laboratory must meet the following requirements:

(a) Have available and follow each test system's PHS-approved

written instructions, which include the following protocols:

(1) Safety precautions.

(2) Protocols for instrument or test system operation and test

performance, including maintenance and function checks.

(3) Calibration procedures.

(4) Quality control procedures defined by the manufacturer or

producer of the test system, which include running at least two levels

of control each day of testing to monitor all steps in the testing

process, including the extraction phase if applicable, unless one of

the following circumstances applies:

(i) The test system's PHS-approved instructions specify other than

two levels of control.

(ii) The procedure cannot be controlled by conventional procedures

and an alternative means of controlling the system has been approved by

PHS.

(5) Remedial action procedures.

(b) Ensure that it meets the following requirements:

(1) It has available and follows written procedures, based on each

test system's PHS-approved instructions, as applicable, for the

following procedures:

(i) Determining specimen acceptability.

(ii) Reporting patient test results, including panic values (values

requiring immediate medical intervention).

(iii) Course of action to be taken in the event that a test system

becomes inoperable.

(iv) Referral of samples as specified in Sec. 493.1111, including

procedures for specimen submission and handling, as described in

Sec. 493.1103.

(2) The written procedures, whether provided by the manufacturer,

the test system producer, or the laboratory, are approved, signed and

dated by the current director of the laboratory.

(3) Any change to a procedure by the manufacturer or producer of a

test system is approved by PHS and signed and dated by the laboratory

director for use by laboratory personnel.

(4) Any change to a laboratory's protocol designed to meet the

requirements is approved, signed and dated by the laboratory director.

[[Page 47995]]

(5) A copy of each procedure with the dates of initial use and

discontinuance is retained for 2 years after a procedure has been

discontinued.

(c) Before reporting patient results, using at least the test

system's PHS-approved written instructions, verify that it can obtain

performance specifications for accuracy, precision and reportable range

of patient results that meet those established by the manufacturer or

producer of the test system. The laboratory must also ensure that the

laboratory's patient population is included in the reference range

specified in the PHS-approved instructions.

(d) Document all remedial actions taken--

(1) In accordance with the test system's PHS-approved written

instructions; and

(2) When errors in the reported patient test results are detected.

In such a case, the laboratory must perform the following procedures:

(i) Promptly notify the authorized person ordering the test or

individual using the test results of report errors.

(ii) Issue corrected reports promptly to the authorized person

ordering the test or the individual using the test results.

(iii) Maintain exact duplicates of the original erroneous report as

well as the corrected report for 2 years.

(e) Document and maintain records of all quality control activities

specified in this section and retain records for at least 2 years or

longer as specified by the manufacturer or producer of the test system

in accordance with Sec. 493.1221.

(f) Promptly report any inaccurate or imprecise method performance,

whether perceived or validated, to the manufacturer or producer of the

test system and, if the problem is not rectified, to PHS.

(g) Ensure that no modification is made in the test system's PHS-

approved written instructions. Any changes made to the test system will

result in the test system no longer meeting the requirements for

categorization in the APT category. Modified tests are considered high

complexity and are subject to the applicable CLIA quality control

requirements contained in subpart K of this part, as well as all other

applicable requirements for high complexity testing.

34. The heading to subpart M is revised to read as follows:

Subpart M--Personnel for Moderate Complexity (Including the

Subcategories) and High Complexity Testing

35. Section 493.1351 is revised to read as follows:

Sec. 493.1351 General.

This subpart consists of the personnel requirements that must be

met by laboratories performing moderate complexity testing, PPM

procedures, APT tests, high complexity testing, or any combination of

these tests.

36. Following Sec. 493.1365, a new undesignated center heading and

new Secs. 493.1371 through 493.1387 are added to read as follows:

Laboratories Performing Accurate and Precise Technology (APT) Tests

Sec.

493.1371 Condition: Laboratories performing APT tests; Laboratory

director.

493.1373 Standard; Laboratory director qualifications.

493.1375 Standard; Laboratory director responsibilities.

493.1377 Condition: Laboratories performing APT testing; clinical

consultant.

493.1379 Standard; Clinical consultant qualifications.

493.1381 Standard: Clinical consultant responsibilities.

493.1383 Condition: Laboratories performing APT testing; testing

personnel.

493.1385 Standard; Testing personnel qualifications.

493.1387 Standard; Testing personnel responsibilities.

Laboratories Performing Accurate and Precise Technology (APT) Tests

Sec. 493.1371 Condition: Laboratories performing APT tests; Laboratory

director.

The laboratory must have a director who meets the qualification

requirements of Sec. 493.1373 and provides overall management and

direction in accordance with Sec. 493.1375.

Sec. 493.1373 Standard; Laboratory director qualifications.

The laboratory director must be qualified to manage and direct the

laboratory personnel and the performance of APT tests and must be

eligible to be an operator of a laboratory within the requirements of

subpart R of this part and meet the requirements of Sec. 493.1405,

which contain laboratory director qualifications for moderate

complexity testing.

Sec. 493.1375 Standard; Laboratory director responsibilities.

The laboratory director is responsible for the overall operation

and administration of the laboratory, including the employment of

personnel who are competent to perform APT tests in accordance with

each test system's PHS-approved instructions, and record and report

test results promptly, accurately, and proficiently, and for assuring

compliance with applicable regulations.

(a) The laboratory director, if qualified, may perform the duties

of the clinical consultant and testing personnel or may delegate these

responsibilities to personnel meeting the qualification requirements of

Secs. 493.1379 and 493.1385, respectively.

(b) The laboratory director must be accessible to the laboratory to

provide onsite, telephone or electronic consultation as needed.

(c) No individual may direct more than five laboratories.

(d) The laboratory director must meet the following requirements:

(1) Ensure that testing systems selected for each of the tests

performed in the laboratory are appropriate for the clinical use of the

test results.

(2) Ensure that the physical plant and environmental conditions of

the laboratory are appropriate for the testing performed and provide a

safe environment in which employees are protected from physical,

chemical, and biological hazards.

(3) Ensure that the following requirements are met:

(i) Before reporting patient results, using at least the test

system's PHS-approved verification procedure, the laboratory can obtain

or verify performance specifications for accuracy, precision and

reportable range of patient results that meet those established by the

manufacturer or producer of the test system and can ensure that the

reference range specified by the manufacturer or producer of the test

system is appropriate for the laboratory's patient populations.

(ii) Testing personnel are following test analyses and quality

control procedures in accordance with each test system's PHS-approved

instructions.

(4) Ensure that the laboratory is enrolled in an HHS-approved

proficiency testing program for the

[[Page 47996]]

testing performed and that the laboratory meets the following

requirements:

(i) The proficiency testing samples are tested as required under

subpart H of this part.

(ii) The results are returned within the time frames established by

the proficiency testing program.

(iii) All proficiency testing reports received are reviewed to

evaluate the laboratory's performance and to identify any problems that

require corrective action.

(iv) An approved corrective action plan is followed and documented

when any proficiency testing results are found to be unacceptable or

unsatisfactory.

(5) Ensure that a quality assurance program is established and

maintained to assure the quality of laboratory services provided.

(6) Ensure that all necessary remedial actions are taken and

documented and that patient results are reported only when the test

system is functioning properly.

(7) Ensure that the producer or manufacturer of the test system is

notified when the test system does not meet the performance

specifications as outlined in the test system's PHS-approved

instructions and, if the problem is not rectified, notify PHS.

(8) Ensure that reports of test results include pertinent

information required for interpretation.

(9) Ensure that consultation is available to the laboratory's

clients on matters relating to the results of APT tests reported and

their interpretation concerning specific patient conditions, including

any relevant information provided in the test system's PHS-approved

instructions.

(10) Employ a sufficient number of testing personnel with the

appropriate education and either experience or training to perform

tests and report test results in accordance with the personnel

responsibilities described in this subpart.

(11) Ensure that, before they test patient samples, testing

personnel receive the appropriate training for the services offered and

have demonstrated that they can perform all testing operations, in

accordance with each test system's PHS-approved instructions, to

provide and report accurate results.

(12) Ensure that policies and procedures are established for

evaluating and documenting the performance of testing personnel

responsible for APT testing to ensure that they are competent and

maintain their competency to handle specimens, perform test procedures,

report test results promptly and proficiently, and, whenever necessary,

identify needs for remedial training or continuing education to improve

testing skills. The director must ensure that evaluations are conducted

at least semiannually during the first year the individual tests

patient specimens and that, thereafter, the evaluations are performed

at least annually unless test methodology or instrumentation changes,

in which case, before reporting patient test results, the individual's

performance must be reevaluated to include the use of the new test

methodology or instrumentation. The evaluation of the competency of

testing personnel must include at least one or more of the following,

but is not limited to the following procedures:

(i) Direct observations of routine patient test performance,

including patient preparation, if applicable, specimen handling, and

testing.

(ii) Monitoring the recording and reporting of test results.

(iii) Review of work sheets, quality control records, proficiency

testing results, and preventive maintenance records.

(iv) Assessment of test performance through testing previously

analyzed specimens, internal blind testing samples, or external

proficiency testing samples.

(13) Ensure that an approved procedure manual is available to all

testing personnel.

(14) Specify, in writing, the responsibilities and duties of each

person engaged in the performance of APT testing that identifies which

examinations and procedures each individual is authorized to perform.

Sec. 493.1377 Condition: Laboratories performing APT testing; clinical

consultant.

The laboratory must have a clinical consultant who meets the

qualification requirements of Sec. 493.1379 and provides clinical

consultation in accordance with Sec. 493.1381.

Sec. 493.1379 Standard; Clinical consultant qualifications.

The clinical consultant must be qualified to consult with and

furnish opinions to the laboratory's clients concerning the diagnosis,

treatment and management of patient care. The clinical consultant must

meet the requirements of Sec. 493.1417, Clinical consultant

qualifications for moderate complexity testing.

Sec. 493.1381 Standard; Clinical consultant responsibilities.

The clinical consultant provides consultation regarding the

appropriateness of the testing ordered and interpretation of test

results. The clinical consultant must meet the following requirements:

(a) Be available to provide clinical consultation to the

laboratory's clients.

(b) Be available to assist the laboratory's clients in ensuring

that appropriate tests are ordered to meet the clinical expectations.

(c) Ensure that reports of test results include pertinent

information required for specific patient interpretation.

(d) Ensure that consultation is available and communicated to the

laboratory's clients on matters related to the results of APT tests

reported and their interpretation concerning specific patient

conditions, including any relevant information provided in the test

system's PHS-approved instructions.

Sec. 493.1383 Condition: Laboratories performing APT testing; testing

personnel.

The laboratory must have a sufficient number of individuals who

meet the qualification requirements of Sec. 493.1385 to perform the

functions specified in Sec. 493.1387 for the volume of tests performed.

Sec. 493.1385 Standard; Testing personnel qualifications.

Each individual performing APT testing must meet the following

requirements:

(a) Possess a current license issued by the State in which the

laboratory is located, if such licensing is required.

(b) Meet one of the following requirements:

(1) Be a doctor of medicine, doctor of osteopathy, or doctor of

podiatric medicine licensed to practice medicine, osteopathy, or

podiatry in the State in which the laboratory is located or have earned

a doctoral, master's, or bachelor's degree in a chemical, physical,

biological or clinical laboratory science or medical technology from an

accredited institution.

(2) Have earned an associate degree in a chemical, physical, or

biological science, or in medical laboratory technology from an

accredited institution.

(3) Be a high school graduate or equivalent and have successfully

completed an official U.S. military medical laboratory procedures

course of at least 50 weeks duration and have held the military

enlisted occupational specialty of Medical Laboratory Specialist

(Laboratory Technician).

(4) (i) Have earned a high school diploma or equivalent; and

(ii) Have documentation of training appropriate for the APT testing

performed before analyzing patient

[[Page 47997]]

specimens. This training must ensure that the individual has the

following skills and knowledge:

(A) The skills required for proper specimen collection, including

patient preparation (if applicable), labeling, handling, preservation,

transportation and storage of specimens.

(B) The skills required for performing each test method and control

procedure and for proper instrument use.

(C) The skills required for performing preventive maintenance,

troubleshooting and calibration procedures related to each test

performed.

(D) An awareness of the factors that influence test results.

Sec. 493.1387 Standard; Testing personnel responsibilities.

The testing personnel performing APT tests are responsible for

specimen processing, test performance, and for reporting test results.

(a) Each individual performs only those APT tests that they are

authorized by the laboratory director to perform.

(b) Each individual performing APT testing must meet the following

requirements:

(1) Follow each test system's PHS-approved written instructions

and, as applicable, the laboratory's written policies and procedures

for specimen submission and handling and for reporting and maintaining

records of patient test results.

(2) Maintain records that demonstrate that proficiency testing

samples are tested in the same manner as patient samples.

(3) Adhere to each test system's PHS-approved written instructions

for quality control procedures, including the documentation of all

quality control activities, remedial actions, instrument and procedural

calibrations, and maintenance performed.

(4) Be capable of identifying problems that may adversely affect

test performance or reporting of test results and either must correct

the problems or immediately notify the director.

(5) Notify the director of any test system performance that does

not meet the performance specifications as outlined in the test

system's PHS-approved instructions.

37. The heading to subpart P is revised to read as follows:

Subpart P--Quality Assurance for Moderate Complexity (Including the

Subcategories), High Complexity Testing, or any Combination of

These Tests

Sec. 493.1701 [Amended]

38. Section 493.1701 is amended by revising the word

``subcategory'' to read ``subcategories'' wherever it appears in the

heading and text.

39. A new Sec. 493.1702 is added to read as follows:

Sec. 493.1702 Standard; Quality Assurance for accurate and precise

technology (APT) tests.

For each APT test performed, the laboratory must meet all

applicable quality assurance requirements specified in Secs. 493.1703

through 493.1721. The laboratory meets these requirements by doing both

of the following activities:

(a) Having available and following the test system's PHS-approved

instructions and, as appropriate, any supplements to the procedures

established by the laboratory in accordance with the test system's PHS-

approved instructions.

(b) Maintaining all records documenting compliance with paragraph

(a) of this section for 2 years.

40. In Sec. 493.1777 the introductory text is revised to read as

follows:

Sec. 493.1777 Condition: Inspection of laboratories requesting or

issued a certificate of compliance.

Laboratories requesting a certificate of compliance must permit an

inspection to assess compliance with part 493 of this chapter. All

testing conducted, including testing in the subcategories of APT tests

or PPM procedures, may be included in the laboratory's routine or

complaint inspection. APT tests and PPM procedures are assessed for

compliance with only the applicable requirements specific to those

subcategories of testing.

* * * * *

41. A new Sec. 493.1778 is added to read as follows:

Sec. 493.1778 Condition: Inspection of laboratories issued a

certificate for accurate and precise technology (APT) tests.

(a) HHS or its designee may conduct announced or unannounced

inspections of any laboratory issued a certificate for APT tests at any

time during its hours of operation for the following purposes:

(1) Assess compliance with the following circumstances, as

applicable:

(i) On a random basis.

(ii) Following a laboratory's demonstration of unsuccessful

participation in proficiency testing for analytes specified in subpart

I of this part.

(iii) To evaluate complaints from the public.

(2) Determine whether testing is being performed or the laboratory

is being operated in a manner that does not constitute an imminent and

serious risk to public health.

(3) Collect information to determine the appropriateness of tests

categorized as APT tests according to the criteria listed at

Sec. 493.18.

(4) Determine whether the laboratory is performing tests in

addition to tests categorized as APT tests according to the criteria

listed at Sec. 493.18, specified as PPM procedures, or tests approved

by PHS as waived tests that are not included on the laboratory's

certificate.

(b) The laboratory may be required as part of this inspection to

perform or authorize the following activities:

(1) Test samples (including proficiency testing samples) or perform

procedures as HHS or its designee requires.

(2) Allow HHS or its designee to interview all employees of the

laboratory concerning the laboratory's compliance with the applicable

requirements as noted in paragraph (d) of this section.

(3) Permit employees to be observed performing tests (including

proficiency testing specimens), data analysis and reporting.

(4) Permit HHS or its designee access to all areas of the facility,

including the following areas:

(i) Specimen procurement and processing areas.

(ii) Storage facilities for specimens, reagents, supplies, records,

and reports.

(iii) Testing and reporting areas.

(5) Provide copies to HHS or its designee of all records and data

required under this part.

(c) The laboratory must have all records and data accessible and

retrievable within a reasonable time frame during the inspection.

(d) Applicable requirements for the purpose of this section are

located in subparts C, H, J, K, M, and P of this part and Sec. 493.21.

(e) The laboratory must provide upon reasonable request all

information and data needed by HHS or its designee to make a

determination of compliance with the applicable requirements.

(f) HHS or its designee may reinspect a laboratory at any time

necessary to assess the laboratory's compliance with the applicable

requirements.

(g) Failure to permit an inspection under this section will result

in the suspension of Medicare and Medicaid payments to the laboratory

or

[[Page 47998]]

termination of the laboratory's participation in Medicare and Medicaid

for payment, and suspension of, or action to revoke, the laboratory's

CLIA certificate in accordance with subpart R of this part.

42. In Sec. 493.1814, the text of the introductory text of

paragraph (b) is republished and paragraph (b)(3) is revised to read as

follows:

Sec. 493.1814 Action when deficiencies are at the condition level but

do not pose immediate jeopardy.

* * * * *

(b) Failure to correct condition level deficiencies. If HCFA

imposes alternative sanctions for condition level deficiencies that do

not pose immediate jeopardy and the laboratory does not correct the

condition level deficiencies within 12 months after the last day of

inspection, HCFA--

* * * * *

(3) May impose (or continue, if already imposed) any alternative

sanctions that do not pertain to Medicare payments. (Sanctions imposed

under the authority of section 353 of the PHS Act may continue for more

than 12 months from the last date of inspection, while a hearing on the

proposed suspension, limitation, or revocation of the certificate of

compliance, registration certificate, certificate of accreditation,

certificate for APT tests, or certificate for PPM procedures is

pending.)

* * * * *

43. In Sec. 493.1834, the heading and introductory text of

paragraph (f)(2) are republished and paragraphs (b) and (f)(2)(iii) are

revised to read as follows:

Sec. 493.1834 Civil money penalty.

* * * * *

(b) Scope. This section sets forth the procedures that HCFA follows

to impose a civil money penalty in lieu of, or in addition to,

suspending, limiting, or revoking the certificate of compliance,

registration certificate, certificate of accreditation, certificate for

APT tests, or certificate for PPM procedures of a laboratory that is

found to have condition level deficiencies.

* * * * *

(f) Accrual and duration of penalty. * * *

(2) Duration of penalty. The civil money penalty continues to

accrue until the earliest of the following occurs:

* * * * *

(iii) HCFA suspends, limits, or revokes the laboratory's

certificate of compliance, registration certificate, certificate of

accreditation, certificate for APT tests, or certificate for PPM

procedures.

* * * * *

44. In Sec. 493.1836, the heading of paragraph (c) is republished

and paragraphs (c)(2) and (c)(3) are revised to read as follows:

Sec. 493.1836 State onsite monitoring.

* * * * *

(c) Duration and sanction. * * *

(2) If the laboratory does not correct all deficiencies within 12

months, and a revisit indicates that deficiencies remain, HCFA cancels

the laboratory's approval for Medicare payment for its services and

notifies the laboratory of its intent to suspend, limit, or revoke the

laboratory's certificate of compliance, registration certificate,

certificate of accreditation, certificate for APT tests, or certificate

for PPM procedures.

(3) If the laboratory still does not correct its deficiencies, the

Medicare sanction continues until the suspension, limitation, or

revocation of the laboratory's certificate of compliance, registration

certificate, certificate of accreditation, certificate for APT tests,

or certificate for PPM procedures is effective.

45. In Sec. 493.2001, the introductory text of paragraph (e) is

republished and paragraph (e)(1) is revised to read as follows:

Sec. 493.2001 Establishment and function of the Clinical Laboratory

Improvement Advisory Committee.

* * * * *

(e) The Clinical Laboratory Improvement Advisory Committee or

subcommittee at the request of HHS will review and make recommendations

concerning--

(1) Criteria for categorizing tests and examinations of moderate

complexity (including the subcategories) and high complexity;

* * * * *

Authority: Sec. 353 of the Public Health Service Act (42 U.S.C.

263a)

Dated: May 25, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing Administration.

Dated: May 26, 1995.

Philip R. Lee,

Assistant Secretary for Health.

Dated: June 5, 1995.

Donna E. Shalala,

Secretary.

[FR Doc. 95-22861 Filed 9-14-95; 8:45 am]

BILLING CODE 4120-01-P