13328 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Criteria for

Medicare Coverage of Liver Transplants;

Form No.: HCFA–R–108 (OMB# 0938–

0580); Use: Medicare participating

hospitals must file an application to be

approved for coverage and payment of

liver transplants performed on Medicare

beneficiaries; Frequency: Monthly;

Affected Public: Business or other forprofit; Number of Respondents: 12;

Total Annual Responses: 12; Total

Annual Hours: 2,110.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Wendy Taylor, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: February 14, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Security and

Standards Group, Division of HCFA

Enterprise Standards.

[FR Doc. 01–5182 Filed 3–2–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–170]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection 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.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: Criteria for

Medicare Coverage of Lung Transplants;

Form No.: HCFA–R–170 (OMB# 0938–

0670); Use: Medicare participating

hospitals must file an application to be

approved for coverage and payment of

lung transplants performed on Medicare

beneficiaries; Frequency: Annually;

Affected Public: Business or other forprofit; Number of Respondents: 6; Total

Annual Responses: 6; Total Annual

Hours: 900.

To obtain copies of the supporting

statement and any related forms for the

proposed paperwork collections

referenced above, access HCFA’s Web

Site address at http://www.hcfa.gov/

regs/prdact95.htm, or E-mail your

request, including your address, phone

number, OMB number, and HCFA

document identifier, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB desk officer: OMB Human

Resources and Housing Branch,

Attention: Wendy Taylor, New

Executive Office Building, Room 10235,

Washington, DC 20503.

Dated: February 14, 2001.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA Office

of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 01–5183 Filed 3–2–01; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[HCFA–2068–N]

Medicare, Medicaid, and CLIA

Programs; Continuance of the

Approval of the American Society for

Histocompatibility and

Immunogenetics as a CLIA

Accreditation Organization

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

continued approval of the American

Society for Histocompatibility and

Immunogenetics (ASHI) as an

accreditation organization for clinical

laboratories under the Clinical

Laboratory Improvement Amendments

of 1988 (CLIA) program. We have

determined that the accreditation

process of this organization provides

reasonable assurance that the

laboratories accredited by ASHI meet

the conditions required by CLIA and its

implementing regulations.

Consequently, laboratories that

voluntarily become accredited by ASHI

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. These laboratories are,

however, subject to Federal validation

and complaint investigation surveys.

EFFECTIVE DATE: This notice is effective

for the period March 5, 2001 through

October 31, 2006.

FOR FURTHER INFORMATION CONTACT:

Minnie Christian, (410) 786–3339.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative

Authority

On October 31, 1988, the Congress

enacted the Clinical Laboratory

Improvement Amendments of 1988

(CLIA), Pub. L. 100–578. CLIA replaced

in its entirety section 353(e)(2) of the

Public Health Service Act, as enacted by

Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13329

the Clinical Laboratories Improvement

Act of 1967. HCFA issued a final rule

(57 FR 33992) implementing the

accreditation provisions of CLIA on July

31, 1992. HCFA may approve a private,

nonprofit organization as an approved

accreditation organization to accredit

clinical laboratories under the 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 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 at least 30 days before

implementing 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

organization to submit to HCFA records

and other information HCFA may

require.

Along with requiring the

promulgation of criteria for approving

an accreditation organization and for

withdrawing this approval, CLIA

regulations require 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

ASHI as an Accreditation Organization

In this notice, we approve ASHI as an

organization that may continue to

accredit laboratories for purposes of

establishing their compliance with CLIA

requirements. HCFA and the Centers for

Disease Control and Prevention (CDC)

have examined the ASHI 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

ASHI complied with the applicable

CLIA requirements as of March 5, 2001

and grant ASHI approval as an

accreditation organization under

subpart E, through October 31, 2006, for

the following specialty and subspecialty

areas:

• Histocompatibility.

• ABO/Rh typing.

As a result of this determination, any

laboratory that is accredited by ASHI

during this time period for an approved

specialty or subspecialty (listed above)

is deemed to meet the applicable CLIA

condition level requirements for the

laboratories found in part 493 of HCFA

regulations 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 validly authorized agent.

III. Evaluation of ASHI

The following describes the process

used to determine that ASHI, as a

private, nonprofit organization, provides

reasonable assurance that laboratories it

accredits will meet the applicable

requirements of CLIA and applicable

regulations.

A. Requirements for Approving an

Accreditation Organization Under CLIA

To determine whether we should

grant approved status to ASHI 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 ASHI’s

requirements for its laboratories to those

of CLIA. In summary, we evaluated

whether ASHI 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 specialty and subspecialty)

and would, therefore, meet the

condition level requirements of CLIA if

those laboratories had been inspected

against condition level requirements.

• Meets the applicable requirements

of part 493, subpart E.

As specified in the regulations of

subpart E, the 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 following:

—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

area of specialty and subspecialty

testing.

—The adequacy of the numbers of staff

and other resources.

13330 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices

—The organization’s ability to provide

adequate funding for performing the

required inspections.

• Whether the organization has an

agreement with HCFA that requires it,

among other things, to meet the

following:

—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 date the action

is 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, on request, for the purpose

of conducting onsite validation

inspections.

—Provide HCFA or our agent, or the

State survey agency, with any facilityspecific data that HCFA requires,

including, but 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

under§ 493.61 (Requirements for a

certificate of accreditation).

B. Evaluation of the ASHI Request for

Continued Approval as an Accreditation

Organization Under CLIA 

HCFA made the following

determinations concerning ASHI’s

standards for accreditation of

laboratories in relation to the CLIA

requirements contained in part 493 as

explained below:

Subpart E—Accreditation by a Private,

Nonprofit Accreditation Organization or

Exemption Under an Approved State

Laboratory Program

ASHI has submitted and requested reapproval for the specialty of

Histocompatibility that it would

continue to accredit and new approval

for the subspecialty of ABO/Rh typing

that it would also accredit. ASHI has

submitted a description of its PT

monitoring process; inspection process

and guidelines; a listing of the size,

composition, education, and experience

of its inspection teams; its investigative

and complaint response procedures; its

data management and analysis system;

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 ASHI

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

ASHI’s requirements for PT are

equivalent to those of CLIA for ABO/Rh

typing.

For the specialty of

Histocompatibility, ASHI’s

requirements exceed those of HCFA.

ASHI requires participation in at least

one external PT program, if available, in

each category of histocompatibility

testing with an 80 percent score

required for successful participation and

enhanced PT for laboratories that fail an

event.

Subpart J—Patient Test Management for

Moderate or High Complexity Testing,

or Both

ASHI exceeds CLIA retention

requirements for Test Requisitions,

requiring 5 years, whereas CLIA

requires § 493.1105 only 2 years. In

addition, ASHI requires laboratories to

obtain written authorization for all

testing performed by the laboratory,

which exceeds the CLIA requirements.

All other requirements in Patient Test

Management are equivalent to those of

CLIA on an overall basis.

Subpart K—Quality Control for Tests of

Moderate or High Complexity, or Both

The quality control (QC) requirements

of ASHI have been evaluated against the

applicable requirements of CLIA and its

implementing regulations. We have

determined that ASHI’s requirements,

when taken as a whole, are more

stringent than the CLIA requirements.

For instance, ASHI’s Nucleic Acid

Analysis addresses DNA extraction and

digestion, amplification, contamination,

physical containment, and multiple

quality controls for the test systems.

HCFA regulations do not include this

requirement.

Subpart M—Personnel for Moderate and

High Complexity Testing

We have found that ASHI personnel

requirements, when taken as a whole,

are equal to or more stringent than the

CLIA requirements for

Histocompatibility. Experience

requirements for Director, Technical

Supervisor, and General Supervisor

exceed CLIA’s personnel experience

requirements in the specialty of

Histocompatibility.

Subpart P—Quality Assurance for

Moderate or High Complexity Testing or

Both

We have determined that ASHI’s

requirements are equal to the CLIA

requirements of this subpart. ASHI has

adopted the CLIA quality assurance

requirements in their entirety and

included them in ASHI’s checklist.

Subpart Q—Inspections

We have determined that ASHI’s

inspections are more frequent than CLIA

requires. ASHI performs an onsite

inspection every 2 years and requires

submission of a self-evaluation

inspection in the intervening years. If

the self-evaluation inspection indicates

that an onsite inspection is warranted,

ASHI conducts an additional onsite

review. In addition, ASHI inspectors

provide onsite proficiency testing

samples to be processed during the

inspection.

Subpart R—Enforcement Procedures for

Laboratories

ASHI meets the requirements of

subpart R to the extent that it applies to

accreditation organizations. ASHI policy

stipulates the action it takes when

laboratories it accredits do not comply

with its requirements. ASHI shall

Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Notices 13331

withdraw, revoke, or limit accreditation

of a laboratory as appropriate and report

the action to HCFA within 30 days.

ASHI also provides an appeal process

for laboratories that have had

accreditation denied, revoked,

suspended, or limited.

We have determined that ASHI’s

laboratory enforcement and appeal

policies are 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

ASHI 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 ASHI remain in

compliance with CLIA requirements.

This Federal monitoring is an ongoing

process.

V. Removal of Approval as an

Accrediting Organization

Our regulations provide, in part, that

we may remove the approval of an

accreditation organization, such as that

of ASHI, 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 programs), 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

(Definitions)), indicate widespread or

systemic problems in the organization’s

accreditation 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

validation inspection results over a 1-

year period indicate a rate of disparity

of 20 percent or more between the

findings of the organization and those of

HCFA, HCFA will conduct a review

under § 493.575(a)(4).

If HCFA determines that ASHI has

failed to adopt or maintain requirements

that are equal to or more stringent than

the CLIA requirements, or systematic

problems exist in its inspection process,

a probationary period as determined by

HCFA, not to exceed 1 year, may be

given to ASHI to adopt equal or more

stringent requirements. HCFA will make

a final determination as to whether or

not ASHI retains its approved status as

an accreditation organization under

CLIA. If approved status is withdrawn,

an accreditation organization such as

ASHI may resubmit its application if it

revises its program to address the

rationale for the withdrawal,

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 ASHI

having its approval withdrawn, HCFA

will publish a notice in the Federal

Register explaining the basis for

removing its approval.

In accordance with the provisions of

Executive Order 12866, this notice was

not reviewed by the Office of

Management of Budget.

Authority: Section 353 of the Public Health

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

Dated: February 2, 2001.

Michael McMullan,

Acting Deputy Administrator, Health Care

Financing Administration.

[FR Doc. 01–4928 Filed 3–2–01; 8:45 am]

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Proposed Collection:

Comment Request

In compliance with the requirement

for opportunity for public comment on

proposed data collection projects

(section 3506(c)(2)(A) of Title 44, United

States Code, as amended by the

Paperwork Reduction Act of 1995,

Public Law 104–13), the Health

Resources and Services Administration

(HRSA) publishes periodic summaries

of proposed projects being developed

for submission to OMB under the

Paperwork Reduction Act of 1995. To

request more information on the

proposed project or to obtain a copy of

the data collection plans and draft

instruments, call the HRSA Reports

Clearance Officer on (301) 443–1129.

Comments are invited on: (a) Whether

the proposed collection of information

is necessary for the proper performance

of the functions of the agency, including

whether the information shall have

practical utility; (b) the accuracy of the

agency’s estimate of the burden of the

proposed collection of information; (c)

ways to enhance the quality, utility, and

clarity of the information to be

collected; and (d) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques

or other forms of information

technology.

Proposed Project

Clinical Pharmacy Demonstration

Project Evaluation: NEW

The Clinical Pharmacy Demonstration

Projects, a supplemental grant

opportunity for health center networks,

were established to evaluate the impact

of comprehensive pharmacy services on

the patients served by Health Resources

and Services Administration (HRSA)

supported programs. The overarching

mission is to demonstrate the effect of

implementing comprehensive pharmacy

services in underserved populations. By

collecting data regarding health

outcomes and the level of pharmacy

services provided, the Office of

Pharmacy Affairs hopes to establish the

provision of comprehensive pharmacy

services as a key to improving access

and eliminating health disparities.

The grantee networks will provide

valuable pharmacy services to patients,

and in the process generate data that

will demonstrate the effect of the

projects on health outcomes. Patient

encounter data will be collected

(baseline and semi-annual) for diabetic

patients who receive clinical pharmacy

services. In addition, each participating

pharmacy will complete survey

instruments (baseline, annual) for

utilization, financial, and process data

which describe the program. These data

will result in the following: the creation

of a database to document the

nationwide impact of implementing

comprehensive pharmacy services

through the Clinical Pharmacy

Demonstration Projects in underserved

areas; and, information sources for the

sharing of best practices, with the

ultimate goal of aiding other health