64966 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

FOR FURTHER INFORMATION CONTACT:

Donna M. Combs, Committee

Management Office (HFA–306), Food

and Drug Administration, 5600 Fishers

Lane, Rockville MD 20857, 301–827–

5496.

Dated: October 23, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–27835 Filed 10–30–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2118–N]

Medicare, Medicaid, and CLIA

Programs; Continuance of the

Approval of COLA as a CLIA

Accreditation Organization

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

continued approval of COLA (formerly

the Commission on Office Laboratory

Accreditation) as an accreditation

organization for laboratories under the

Clinical Laboratory Improvement

Amendments of 1988 (CLIA) program.

We have found that the accreditation

process of this organization provides

reasonable assurance that the

laboratories accredited by it meet the

conditions required by CLIA law and

regulations. Consequently, laboratories

that voluntarily become accredited by

COLA in lieu of direct Federal oversight

and continue to meet COLA

requirements would meet the CLIA

condition level requirements for

laboratories and, therefore, are not

subject to routine inspection by State

survey agencies to determine their

compliance with CLIA requirements.

They are, however, subject to Federal

validation and complaint investigation

surveys.

EFFECTIVE DATE: This notice is effective

for the period October 31, 2000, through

December 31, 2002.

FOR FURTHER INFORMATION CONTACT: Val

Coppola, (410) 786–3531.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative

Authority

On July 31, 1992, HCFA issued a final

rule (57 FR 33992). Under section

353(e)(2) of the Public Health Service

Act (PHSA), HCFA may approve a

private, nonprofit organization to

accredit clinical laboratories (an

‘‘approved accreditation organization’’)

under the Clinical Laboratory

Improvement Amendments of 1988

(CLIA) program if the organization

meets certain requirements. An

organization’s requirements for

accredited laboratories must be equal to,

or more stringent than, the applicable

CLIA program requirements in 42 Code

of Federal Regulations (CFR), part 493

(Laboratory Requirements). Therefore, a

laboratory accredited by an approved

accreditation organization that meets

and continues to meet all of the

accreditation organization’s

requirements would be considered to

meet CLIA condition level requirements

if it were inspected against CLIA

regulations. The regulations listed in

subpart E (Accreditation by a Private,

Nonprofit Accreditation Organization or

Exemption Under an Approved State

Laboratory Program) of part 493 specify

the requirements an accreditation

organization must meet to be an

approved accreditation organization.

HCFA approves an accreditation

organization for a period not to exceed

6 years.

In general, the approved accreditation

organization must among other

conditions and requirements:

• Use inspectors qualified to evaluate

laboratory performance and agree to

inspect laboratories with the frequency

determined by HCFA.

• Apply standards and criteria that

are equal to or more stringent than those

condition level requirements

established by HCFA when taken as a

whole.

• Provide reasonable assurance that

these standards and criteria are

continually met by its accredited

laboratories;

• Provide HCFA with the name of any

laboratory that has had its accreditation

denied, suspended, withdrawn, limited,

or revoked within 30 days of the action

taken.

• Notify HCFA in writing at least 30

days before the effective date of any

proposed changes in its standards.

• If HCFA withdraws its approval,

notify the accredited laboratories of the

withdrawal within 10 days of the

withdrawal. A laboratory can be

accredited if, among other things, it

meets the standards of an approved

accreditation organization and

authorizes the accreditation body to

submit to HCFA records and other

information HCFA may require.

Along with requiring the

promulgation of criteria for approving

the accreditation body and for

withdrawing this approval, CLIA

requires HCFA to perform an annual

evaluation by inspecting a sufficient

number of laboratories accredited by an

approved accreditation organization as

well as by any other means that HCFA

determines appropriate.

II. Notice of Continued Approval of

COLA as an Accreditation Organization

In this notice, we approve COLA as an

organization that may continue to

accredit laboratories for purposes of

establishing their compliance with CLIA

requirements. HCFA and Centers for

Disease Control and Prevention (CDC)

have examined the COLA application

and all subsequent submissions to

determine equivalency with HCFA

requirements under subpart E of part

493 that an accreditation organization

must meet to be granted approved status

under CLIA. We have determined that

COLA has complied with the applicable

CLIA requirements as of October 31,

2000, and grant COLA approval as an

accreditation organization under

subpart E, through August 31, 2002, for

the following specialty/subspecialty

areas:

• Bacteriology.

• Mycobacteriology.

• Mycology.

• Parasitology.

• Virology.

• Syphilis Serology.

• General Immunology.

• Routine Chemistry.

• Endocrinology.

• Toxicology.

• Urinalysis.

• Hematology.

• Immunohematology.

As a result of this determination, any

laboratory that is accredited by COLA

during this time period for an approved

specialty/subspecialty (listed above) is

deemed to meet the applicable CLIA

condition level requirements for the

laboratories found in part 493 and,

therefore, is not subject to routine

inspection by a State survey agency to

determine its compliance with CLIA

requirements. The accredited laboratory,

however, is subject to validation and

complaint investigation surveys

performed by HCFA, or by any other

Federal or State or local public agency

or nonprofit private organization under

an agreement with the Secretary.

III. Evaluation of COLA

The following describes the process

used to determine that COLA, as a

private, nonprofit organization, provides

reasonable assurance that laboratories it

accredits will meet the applicable

requirements of the CLIA and applicable

regulations.

Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices 64967

A. Requirements for Approving an

Accreditation Organization Under CLIA

To determine whether we should

grant approved status to COLA as a

private, nonprofit organization for

accrediting laboratories under CLIA for

the specific specialty or subspecialty

areas of human specimen testing it

requested, we conducted a detailed and

in-depth comparison of COLA’s

requirements for its laboratories to those

of CLIA. In summary, we evaluated

whether COLA meets the following

requirements:

• Provides reasonable assurance to us

that it requires the laboratories it

accredits to meet requirements that are

equal to or more stringent than the CLIA

condition level requirements (for the

requested specialties/subspecialties)

and would, therefore, meet the

condition level requirements of CLIA if

those laboratories had not been granted

deemed status and had been inspected

against condition level requirements.

• Meets the applicable requirements

of Subpart E.

As specified in the regulations of

subpart E, HCFA review of a private,

nonprofit accreditation organization

seeking approved status under CLIA

includes, but is not limited to, an

evaluation of the following:

• Whether the organization’s

requirements for its accredited

laboratories are equal to or more

stringent than the condition level

requirements of the CLIA regulations.

• The organization’s inspection

process to determine:

—The composition of the inspection

teams, qualifications of the inspectors,

and the ability of the organization to

provide continuing education and

training to all of its inspectors;

—The comparability of the

organization’s full inspection and

complaint inspection requirements to

the Federal requirements including

but not limited to inspection

frequency, and the ability to

investigate and respond to complaints

against its accredited laboratories.

—The organization’s procedures for

monitoring laboratories that it has

found to be out of compliance with its

requirements.

—The ability of the organization to

provide HCFA with electronic data

and reports that are necessary for

effective validation and assessment of

the organization’s inspection process.

—The ability of the organization to

provide HCFA with electronic data,

related to the adverse actions

resulting from unsuccessful

proficiency testing (PT) participation

in HCFA approved PT programs, as

well as data related to the PT failures,

within 30 days of the initiation of the

action.

—The ability of the organization to

provide HCFA with electronic data for

all its accredited laboratories and the

areas of specialty and subspecialty

testing.

—The adequacy of the numbers of staff

and other resources.

—The organization’s ability to provide

adequate funding for performing the

required inspections.

• The organization’s agreement with

HCFA that requires it, among other

things, to meet the following

requirements:

—Notify HCFA of any laboratory that

has had its accreditation denied,

limited, suspended, withdrawn, or

revoked by the accreditation

organization, or that has had any

other adverse action taken against it

by the accreditation organization

within 30 days of the action taken.

—Notify HCFA within 10 days of a

deficiency identified in an accredited

laboratory if the deficiency poses an

immediate jeopardy to the

laboratory’s patients or a hazard to the

general public.

—Notify HCFA of all newly accredited

laboratories, or laboratories whose

areas of specialty or subspecialty are

revised, within 30 days.

—Notify each laboratory accredited by

the organization within 10 days of

HCFA’s withdrawal of approval of the

organization.

—Provide HCFA with inspection

schedules, as requested, for the

purpose of conducting onsite

validation inspections.

—Provide HCFA or our agent, or the

State survey agency with any facilityspecific data that includes, but is not

limited to, PT results that constitute

unsuccessful participation in an

approved PT program and notification

of the adverse actions or corrective

actions imposed by the accreditation

organization as a result of

unsuccessful PT participation.

—Provide HCFA with written

notification at least 30 days in

advance of the effective date of any

proposed changes in its requirements.

—Provide upon the request by any

person, on a reasonable basis (under

State confidentiality and disclosure

requirements, if applicable), any

laboratory’s PT results with the

explanatory information needed to

assist in the interpretation of the

results.

Laboratories that are accredited by an

approved accreditation organization

must, among other things, meet the

following requirements:

• Authorize the organization to

release to HCFA all records and

information required.

• Permit inspections as required by

the CLIA regulations in part 493,

subpart Q (Inspection).

• Obtain a certificate of accreditation

as required by § 493.55 (Application for

registration certificate and certificate of

accreditation).

B. Evaluation of the COLA Request for

Continued Approval as an Accreditation

Organization under CLIA

HCFA has verified COLA’s assurance

that it requires the laboratories it

accredits to be, and that the organization

is, in compliance with the following

subparts of part 493 as explained below:

Subpart E—Accreditation by a Private,

Nonprofit Accreditation Organization or

Exemption Under an Approved State

Laboratory Program

COLA has submitted a list of the

specialties and subspecialties that it

would continue to accredit, a

description of its inspection process and

guidelines, PT monitoring process, and

its data management and analysis

system, a listing of the size,

composition, education and experience

of its inspection teams, its investigative

and complaint response procedures, its

notification agreements with HCFA, its

removal or withdrawal of laboratory

accreditation procedures, its current list

of accredited laboratories, and its

announced or unannounced inspection

process. We have determined that COLA

has complied with the requirements

under CLIA for approval as an

accreditation organization under this

subpart.

Subpart H—Participation in Proficiency

Testing for Laboratories Performing

Tests of Moderate or High Complexity,

or Both

COLA’s requirements for PT are

equivalent to those of CLIA.

Subpart J—Patient Test Management for

Moderate or High Complexity Testing,

or Both

COLA has revised its requirements to

equal the CLIA requirements at

§§ 493.1101 through 493.1111 on an

overall basis.

Subpart K—Quality Control for Tests of

Moderate or High Complexity, or Both

The quality control (QC) requirements

of COLA have been evaluated against

the applicable requirements of CLIA and

its implementing regulations. We have

determined that COLA’s requirements,

when taken as a whole, are equal to or

64968 Federal Register / Vol. 65, No. 211 / Tuesday, October 31, 2000 / Notices

more stringent than the CLIA

requirements.

Subpart M—Personnel for Moderate and

High Complexity Testing

We have found the COLA personnel

requirements to be equal to the CLIA

personnel requirements.

Subpart P—Quality Assurance for

Moderate or High Complexity Testing or

Both

We have determined that COLA’s

requirements are equal to the CLIA

requirements of this subpart.

Subpart Q—Inspections

We have determined that COLA’s

inspection requirements are equal to the

requirements of this subpart.

Subpart R—Enforcement Procedures for

Laboratories

COLA meets the requirements of

subpart R to the extent it applies to

accreditation organizations. COLA

policy stipulates the action it takes

when laboratories it accredits do not

comply with its requirements. COLA

shall suspend, withdraw, revoke, or

limit accreditation of a laboratory as

appropriate and report the action to

HCFA within 30 days. COLA also

provides an appeals process for

laboratories that have had accreditation

denied.

We have determined that COLA’s

laboratory enforcement and appeal

policies are essentially equivalent to the

requirements of this subpart as they

apply to accreditation organizations.

IV. Federal Validation Inspections and

Continuing Oversight

The Federal validation inspections of

COLA accredited laboratories may be

conducted on a representative sample

basis or in response to substantial

allegations of noncompliance

(complaint inspections). The outcome of

those validation inspections, performed

by HCFA or our agent, or the State

survey agency, will be HCFA’s principal

means for verifying that the laboratories

accredited by COLA remain in

compliance with CLIA requirements.

This Federal monitoring is an ongoing

process.

V. Removal of Approval as an

Accrediting Organization

Our regulations provide that we may

remove the approval of an accreditation

organization, such as that of COLA, for

cause, before the end of the effective

date of approval. If validation

inspection outcomes and the

comparability or validation review

produce findings as described in

§ 493.573 (Continuing Federal oversight

of private nonprofit accreditation

organizations and approved State

licensure program), HCFA will conduct

a review of an approved accreditation

organization’s program. We also

conduct a review when the validation

review findings, irrespective of the rate

of disparity (as defined in § 493.2),

indicate systemic problems in the

organization’s processes that provide

evidence that the organization’s

requirements, taken as a whole, are no

longer equivalent to the CLIA

requirements, taken as a whole.

If HCFA determines that COLA has

failed to adopt or maintain requirements

that are equal to or more stringent than

the CLIA requirements, or systemic

problems exist in its inspection process,

a probationary period, not to exceed 1

year, may be given to COLA to adopt

equal or more stringent requirements.

HCFA will make a determination as to

whether or not COLA retains its

approved status as an accreditation

organization under CLIA. If approved

status is withdrawn, an accreditation

organization such as COLA may

resubmit its application if it revises its

program to address the rationale for the

denial, demonstrates that it can

reasonably assure that its accredited

laboratories meet CLIA condition level

requirements, and resubmits its

application for approval as an

accreditation organization in its

entirety. If, however, an approved

accreditation organization requests

reconsideration of an adverse

determination in accordance with

subpart D (Reconsideration of Adverse

Determinations—Deeming Authority for

Accreditation Organizations and CLIA

Exemption of Laboratories Under State

Programs) of part 488 (Survey,

Certification, and Enforcement

Procedures) of our regulations, it may

not submit a new application until

HCFA issues a final reconsideration

determination.

Should circumstances result in COLA

having its approval withdrawn, HCFA

will publish a notice in the Federal

Register explaining the basis for

removing its approval.

Authority: Section 353 of the Public Health

Service Act (42 U.S.C. 263a).

Dated: September 18, 2000.

Nancy-Ann Min-DeParle,

Administrator, Health Care Financing

Administration.

[FR Doc. 00–27956 Filed 10–30–00; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–4010–GNC]

RIN 0938–AK26

Medicare Program; Criteria and

Standards for Evaluating Intermediary

and Carrier Performance During Fiscal

Year 2001

AGENCY: Health Care Financing

Administration (HCFA), Health and

Human Services (HHS).

ACTION: General notice with comment

period.

SUMMARY: This notice describes the

criteria and standards to be used for

evaluating the performance of fiscal

intermediaries and carriers in the

administration of the Medicare program

beginning October 1, 2000. The results

of these evaluations are considered

whenever we enter into, renew, or

terminate an intermediary agreement or

carrier contract or take other contract

actions, for example, assigning or

reassigning providers or services to an

intermediary or designating regional or

national intermediaries. We are

requesting public comment on these

criteria and standards.

EFFECTIVE DATE: The criteria and

standards are effective October 1, 2000.

COMMENTS: Comments will be

considered if we receive them at the

appropriate address as provided below

no later than 5 p.m. (EDT) on November

30, 2000.

ADDRESSES: Mail written comments (1

original and 3 copies) to the following

address: Health Care Financing,

Administration, Department of Health

and Human Services, Attention: HCFA–

4010–GNC, P.O. Box 8016, Baltimore,

MD 21244–8016.

If you prefer, you may deliver your

written comments (1 original and 3

copies) to one of the following

addresses:

Room 443–G, Hubert H. Humphrey

Building, 200 Independence Avenue,

SW., Washington, DC, or

Room C5–16–03, 7500 Security

Boulevard, Baltimore, Maryland.

Because of staffing and resource

limitations, we cannot accept comments

by facsimile (FAX) transmission. When

commenting, please refer to file code

HCFA–4010–GNC. 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 443–G of the Department’s

office at 200 Independence Avenue,