7774 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices

(receipts from a person’s own

unincorporated business, professional

enterprise, or partnership, after

deductions for business expenses); net

receipts from farm self employment

(receipts from a farm which one

operates as an owner, renter, or

sharecropper, after deductions for farm

operating expenses); regular payments

from social security, railroad retirement,

unemployment compensation, strike

benefits from union funds, workers’

compensation, veterans’ payments,

public assistance (including Aid to

Families with Dependent Children,

Supplemental Security Income,

Emergency Assistance money payments,

and non-Federally-funded General

Assistance or General Relief money

payments), and training stipends;

alimony, child support, and military

family allotments or other regular

support from an absent family member

or someone not living in the household;

private pensions, government employee

pensions (including military retirement

pay), and regular insurance or annuity

payments; college or university

scholarships, grants, fellowships, and

assistantships; and dividends, interest,

net rental income, net royalties, periodic

receipts from estates or trusts, and net

gambling or lottery winnings.

For official statistical purposes,

income does not include the following

types of money received: capital gains;

any assets drawn down as withdrawals

from a bank, the sale of property, a

house, or a car; or tax refunds, gifts,

loans, lump-sum inheritances, one-time

insurance payments, or compensation

for injury. Also excluded are noncash

benefits, such as the employer-paid or

union-paid portion of health insurance

or other employee fringe benefits, food

or housing received in lieu of wages, the

value of food and fuel produced and

consumed on farms, the imputed value

of rent from owner-occupied nonfarm or

farm housing, and such Federal noncash

benefit programs as Medicare, Medicaid,

food stamps, school lunches, and

housing assistance.

Dated: February 6, 1995.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 95–3285 Filed 2–6–95; 8:45 am]

BILLING CODE 4150–04–P

Food and Drug Administration

[Docket No. 91F–0324]

Goodyear Tire & Rubber Co.; Filing of

Food Additive Petition; Amendment;

Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice that appeared in the Federal

Register of January 26, 1995 (60 FR

5184). The document amended the

filing notice for a food additive petition

filed by the Goodyear Tire & Rubber Co.

to indicate that the petitioned additive,

alkylthiophenolics, acid-catalyzed

condensation reaction products of pnonylphenol, formaldehyde, and 1-

dodecanethiol, is also intended for use

in pressure-sensitive adhesives. The

document was published with some

editorial errors. This document corrects

those errors.

FOR FURTHER INFORMATION CONTACT:

Andrew Zajac, Center for Food Safety

and Applied Nutrition (HFS–216), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

In FR Doc. 95–2007, appearing on

page 5184 in the Federal Register of

Thursday, January 26, 1995, the

following corrections are made:

On page 5184, in the second column,

in the first full paragraph, in line 6, and

in the third column, in line 13, the word

‘‘alkylthiophendics’’ is corrected to read

‘‘alkylthiophenolics’’.

Dated: February 3, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–3300 Filed 2–8–95; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

Public Information Collection

Requirements Submitted to the Office

of Management and Budget (OMB) for

Clearance

AGENCY: Health Care Financing

Administration, HHS.

The Health Care Financing

Administration (HCFA), Department of

Health and Human Services, has

submitted to OMB the following

proposals for the collection of

information in compliance with the

Paperwork Reduction Act (Public Law

96–511).

1. Type of Information Collection:

Reinstatement; Type of Review

Requested: Regular submission; Title of

Information Collection: Provider

Reimbursement Manual Sections 2721,

2722, and 2725; Form No.: HCFA–9044;

Use: The requirements in the Manual

describe justification for submitting an

exception request to ESRD composite

rates for outpatient dialysis services;

Respondents: Business or other for

profit, Federal agencies or employees/

Non-profit institutions and Small

businesses or organizations; Obligation

to Respond: Required to obtain or retain

benefit; Number of Respondents: 400;

Total Annual Responses: 400; Total

Annual Hours Requested: 19,200.

2. Type of Information Collection:

Reinstatement, with change, of a

previously approved collection; Type of

Review Requested: Regular submission;

Title of Information Collection:

Medicare Home Health Agency

Conditions of Participation; Form No.:

HCFA–R–39; Use: Home Health

Agencies to participate in Medicare are

required to maintain this information to

show compliance with published health

and safety; Respondents: State or local

governments and Business or other forprofit; Obligation to Respond: Required

to obtain or retain benefit; Number of

Respondents: 8,039; Total Annual

Responses: 8,039; Total Annual Hours

Requested: 69.498.

Additional Information or Comments:

Call the Reports Clearance Office on

(410) 966–5536 for copies of the

clearance request packages. Written

comments and recommendations for the

proposed information collections

should be sent within 30 days of this

notice directly to the OMB Desk Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: February 3, 1995.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 95–3286 Filed 2–8–95; 8:45 am]

BILLING CODE 4120–03–M

[HSQ–223–N]

CLIA Program; Approval of the College

of American Pathologists

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice announces the

approval of the College of American

Pathologists (CAP) as an accrediting
Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices 7775

organization for clinical 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 Federal law and regulations.

Consequently, laboratories that

voluntarily become accredited by CAP

in lieu of receiving direct Federal

oversight and continue to meet CAP

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 Federal requirements.

They are, however, subject to validation

and complaint investigation surveys.

EFFECTIVE DATE: This notice is effective

for the period February 9, 1995 through

December 31, 1998.

FOR FURTHER INFORMATION CONTACT: Val

Coppola (410) 597–5906.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative

Authority

On October 31, 1988, the Congress

enacted the Clinical Laboratory

Improvement Amendments of 1988

(CLIA), Public Law 100–578. CLIA

replaced in its entirety section 353 of

the Public Health Service Act (PHSA),

as enacted by the Clinical Laboratories

Improvement Act of 1967, and made

every laboratory in the United States

and its territories that tests human

specimens for health reasons subject to

the requirements established by HHS

and Federal regulation whether or not it

participates in the Medicare or

Medicaid program and whether or not it

tests specimens in interstate commerce.

New section 353 requires HHS to

establish certification requirements for

any laboratory that performs tests on

human specimens and certify through

issuance of a certificate that those

laboratories meet the certificate

requirements established by HHS.

Section 6141 of the Omnibus Budget

Reconciliation Act of 1989, Public Law

101–239, amended the Social Security

Act (the Act) to require that laboratories

participating in the Medicare program

meet the certificate requirements of

section 353 of the PHSA. Subject to

specified exceptions, laboratories must

have a current unrevoked and

unsuspended certificate to be eligible

for reimbursement in the Medicare or

Medicaid programs or both. Laboratories

that are accredited by a private nonprofit organization approved under

section 353 of the PHSA will

automatically be eligible for Medicare

and Medicaid participation as long as

they meet applicable State

requirements.

On February 28, 1992, we published

several final rules in the Federal

Register (57 FR 7002–7243) that

implemented the amendments to

section 353 of the PHSA. The technical

and scientific portions of these rules

were crafted by The Centers for Disease

Control and Prevention (CDC) of the

Public Health Service (PHS).

Specifically, regulations were

established at 42 CFR part 493 that:

• Require laboratories to pay fees for

issuance of registration certificates,

certificates of waiver, certificates of

accreditation, or other applicable

certificates (in a subsequent rule

published January 19, 1993, 58 FR 5215,

we added ‘‘certificate for physicianperformed microscopy procedures’’) and

to fund activities to determine

compliance with our performance

requirements;

• Specify the performance

requirements that apply to laboratories

subject to CLIA (some of which were

amended by the January 19, 1993 rule)

and list requirements for laboratories

performing certain limited testing to be

eligible for a certificate of waiver; and

• Set forth the rules for the

enforcement of CLIA requirements on

laboratories that are found not to meet

Federal requirements.

On July 31, 1992, HCFA issued

additional final rules (57 FR 33992),

under authority found in section

353(e)(2) of the PHSA, that establish

that we may approve a private,

nonprofit organization as an

accreditation organization for clinical

laboratories under the CLIA program if

that organization’s requirements for its

accredited laboratories are equal to or

more stringent than the applicable CLIA

program requirements of part 493 of our

regulations. Therefore, a laboratory

accredited by an approved organization

that meets and continues to meet all of

the accreditation organization’s

requirements would meet CLIA

condition level requirements if it were

inspected against CLIA regulations. The

regulations listed in subpart E of part

493 specify the requirements an

accreditation organization must meet in

order to be approved. We may approve

an accreditation organization under

§ 493.501(d) of our regulations for a

period not to exceed six years.

In general, the accreditation

organization must:

• 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 HHS when taken as a

whole;

• Provide reasonable assurance that

these standards and criteria are

continually met by its accredited

laboratories;

• Provide HCFA, within 30 days,

with the name of any laboratory that has

had its accreditation denied, suspended,

withdrawn, limited, or revoked;

• Notify HCFA at least 30 days prior

to changing its standards; and

• If HCFA withdraws its approval,

notify its accredited laboratories of the

withdrawal within 10 days of the

withdrawal. A laboratory can be

accredited if it meets the standards of an

approved accreditation body 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

an accreditation body and for

withdrawing such 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. Under section 353(o) of the

PHSA, the Secretary may, by agreement,

use the services or facilities of any other

Federal, State or local public agency, or

any private, nonprofit organization to

conduct inspections of laboratories

performing clinical testing on human

specimens in the United States and its

territories for the purpose of

determining compliance with CLIA

requirements.

II. Notice of Approval of CAP as an

Accrediting Organization

In this notice, we approve CAP as an

organization that may accredit

laboratories for purposes of establishing

their compliance with CLIA

requirements. HCFA has examined the

CAP application, in which it requested

deemed status for all specialties and

subspecialties, and all subsequent

submissions against the requirements

under subpart E of part 493 that an

accreditation organization must meet in

order to be granted approved status

under CLIA. We have determined that

CAP has complied with the applicable

CLIA requirements as of February 9,

1995 and grant CAP approval as an

accreditation organization under this

Subpart through December 31, 1998 for

all specialty/subspecialty areas.

As a result of this determination, any

laboratory that is accredited by CAP
7776 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices

during this time period meets the CLIA

requirements for laboratories found in

part 493 of our 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

Federal or State or local public agency

or nonprofit private organization which

acts in comformance to an agreement

with the Secretary.

III. Evaluation of CAP

The following describes the process

used to determine that CAP, as a

private, nonprofit organization, provides

reasonable assurance that those

laboratories it accredits will meet the

applicable requirements of the Federal

law and regulations.

A. Requirements for Approving an

Accreditation Organization Under CLIA

To determine whether HCFA should

grant approval to CAP as a private,

nonprofit organization for accrediting

laboratories under CLIA, HCFA and

CDC conducted a detailed and in-depth

comparison of CAP’s requirements for

its laboratories to those of CLIA and

evaluated whether CAP’s standards are

at least as stringent as the requirements

of 42 CFR part 493 when taken as a

whole. In summary, we evaluated

whether CAP:

• 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 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;

and

• Meets the requirements of

§ 493.506, which specify the Federal

review and approval requirements of

private, nonprofit accreditation

organizations.

As specified in the regulations at

§ 493.506, our review of a private,

nonprofit accreditation organization

seeking deemed status under CLIA

includes, but is not limited to, an

evaluation of:

• 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 processes to

those of HCFA, 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 of

testing;

—The adequacy of numbers of staff and

other resources; and

—The organization’s ability to provide

adequate funding for performing the

required inspections.

• The organization’s agreement with

HCFA that requires it to:

—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 where 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 recognition of

the organization’s approval as an

accrediting organization under CLIA;

—Provide HCFA with inspection

schedules, as requested, for the

purpose of conducting onsite

validation inspections;

—Provide HCFA, the State survey

agency or other HCFA agent with any

facility-specific data that includes, but

is not limited to, PT results that

constitute unsuccessful participation

in HCFA approved PT programs 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;

and

—Make available, on a reasonable basis,

any laboratory’s PT results upon the

request by any person, with such

explanatory information needed to

assist in the interpretation of the

results.

Laboratories that are accredited by a

HCFA approved accreditation

organization must:

• Authorize the organization to

release to HCFA all records and

information required by HCFA as

required at § 493.501;

• Permit inspections as required by

the CLIA regulations at 42 CFR part 493,

subpart Q;

• Obtain a certificate of accreditation

as required by § 493.632; and

• Pay the applicable fees as required

by §§ 493.638 and 493.645.

B. Evaluation of the CAP Request for

Approval as an Accreditation

Organization Under CLIA

CAP has formally applied to HCFA for

approval as an accreditation

organization under CLIA for all

specialties and subspecialties. We have

evaluated the CAP application to

determine equivalency with our

implementing and enforcement

regulations, and the deeming/exemption

requirements of the CLIA rules. We also

verified the organization’s assurance

that it requires the laboratories it

accredits to be, and that the organization

is, in compliance with the following

subparts of 42 CFR part 493 as

explained below:

Subpart E—Accreditation by a Private,

Nonprofit Accreditation Organization

or Exemption Under an Approved State

Laboratory Program

CAP has submitted a list of all

specialties and subspecialties that it

would accredit, a comparison of

individual accreditation and condition

level requirements, a description of its

inspection process, 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
Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices 7777

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 CAP

has complied with the general

requirements under § 493.501, the

applicable parts of § 493.506, and the

CLIA requirements for approval as an

accreditation organization under various

subparts of part 493.

Our evaluation identified areas of the

CAP requirements that are more

stringent than the CLIA requirements

and apply to the laboratory as a whole.

Rather than include them in the

appropriate subparts multiple times, we

list them here:

• CAP requires its accredited

laboratories to possess documentation of

all State laws and to follow them.

• CAP lists extensive requirements

for the Laboratory Information System

(LIS), which cover but are not limited

to:

+ The preservation, storage, and

retrieval of laboratory and patient data;

+ The review of LIS programs for

appropriate content and testing before

use when a new program is to be put in

place or when changes are made to

existing programming;

+ The maintenance of the LIS facility,

which must be clean, well ventilated,

and at proper temperature and

humidity;

+ The protection of LIS against power

interruptions and surges;

+ The protection of the LIS, its data,

patient information, and programs from

unauthorized use;

+ The entry of data and result

reporting;

+ The verification and maintenance of

LIS hardware and software;

+ The routine and emergency service

and maintenance of the LIS; and

+ An evaluation from the laboratory

director of the LIS performance as it

pertains to patient and clinician needs.

+ In addition, the LIS operators must

have procedure manuals readily

available, be adequately trained in LIS

operation, and know what must be done

to preserve data and equipment in

emergency situations such as software

or hardware failure or in the event of

fire;

• CAP accredits laboratories that

perform testing for any of the following

areas and sets specific standards with

which their accredited laboratories must

comply:

+ Athletic drug testing (for anabolic

steroids, beta-blockers, cannabinoids,

narcotics, and stimulants);

+ Forensic urine drug testing;

+ Parentage testing; and

+ Reproductive laboratory testing

(embryology and andrology).

Subpart H—Participation in Proficiency

Testing for Laboratories Performing

Tests of Moderate or High Complexity,

or Both

The CAP requirements for proficiency

testing (PT) are in comformance with

the CLIA law, which states that

standards shall require all laboratories

be tested by PT for each examination for

which PT is available. The CAP PT

requirements are more stringent than

the CLIA regulations at subpart I, which

list specific tests for which the

laboratory must participate in a HCFA

approved PT program. CLIA exempts

waived testing from PT, whereas CAP

requires its accredited laboratories to

participate in its HCFA approved PT

program for all testing, including

procedures waived under CLIA.

We have determined that the actions

taken by CAP to correct unsatisfactory

(one failure) and unsuccessful (2 in a

row or 2 out of 3 failures) PT

performance of its laboratories is

equivalent to those of CLIA; in the cases

of unsatisfactory performance and the

CLIA phase-in allowances, CAP is more

stringent. CAP has initiated an on-going

electronic monitoring process that flags

both unsatisfactory and unsuccessful

results for all PT performance, both

CLIA required analytes and all other

testing for which PT is available and is

required by CAP. CAP accredited

laboratories are allowed 15 days to

respond in writing to each

unsatisfactory result, indicating how the

problem was investigated, the cause of

the problem, the specific corrective

action that was taken to prevent

recurrence, and evidence that the

problem was successfully corrected.

CLIA regulations state that the

laboratory must undertake appropriate

training and employ the technical

assistance necessary to correct problems

associated with an unsatisfactory score,

take remedial action and document it.

Unsuccessful PT performance, when

identified by CAP, initiates immediate

communication with the laboratory

director. A written response must be

submitted to CAP, explaining why the

adverse results occurred, a description

of the investigation of the problem and

the actions taken to correct the problem.

The laboratory must submit this

information within ten working days. If,

after review by CAP, it is determined

that the laboratory’s approach is

scientifically valid and PT performance

is within acceptable limits, no further

action is taken. If the laboratory does

not respond, fails to address the

problem seriously, or cannot bring

performance into acceptable limits, the

CAP would evaluate the situation and

either request that the laboratory cease

testing for the analyte or specialty or

subspecialty in question, or, if

warranted, revoke accreditation.

CLIA regulations allow a phase-in

period for unsuccessful PT performance,

which, for previously regulated

laboratories (which includes most CAP

accredited laboratories), impose no

sanctions under § 493.803 (Condition:

Successful Participation) until the end

of 1994. As the phase-in period ends,

the sanctions under CLIA and the

actions taken by CAP become

equivalent.

CAP also offers a voluntary

continuing education and external

quality assurance program for PAP

smear cytology. The Interlaboratory

Comparison Program in Cervicovaginal

Cytopathology currently enrolls

approximately 1,800 CAP accredited

laboratories that perform cytology

testing. The number of laboratories this

program can enroll is dependent upon

the availability of the referenced glass

slide material (cervicovaginal smears).

When CAP has sufficient quantities to

accommodate all of its 2,600 accredited

laboratories that perform gynecologic

(GYN) cytology, it intends to offer this

program as a cervicovaginal

cytopathology pathology proficiency

testing survey in which its accredited

laboratories will be required to

participate. Currently there is no HCFA

approved cytology PT program capable

of enrolling all CLIA certified

laboratories that perform GYN cytology

testing.

Subpart J—Patient Test Management

for Moderate or High Complexity

Testing, or Both

The CAP has expanded and in some

cases revised its requirements to be

equivalent to the CLIA requirements at

§§ 493.1101 through 493.1111, on an

overall basis. We have determined that

CAP’s requirements for an accredited

laboratory to include on report forms

the dates and times of specimen

collection (when appropriate) and the

release of the report are more stringent

than the requirements under CLIA as

well as their requirement that reports

must be legible. The CAP also requires

its accreditated laboratories to use

referral laboratories that are

appropriately CLIA certified.

Subpart K—Quality Control for Tests of

Moderate or High Complexity, or Both

The quality control (QC) requirements

of CAP have been evaluated against the

phased-in, complexity based
7778 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices

requirements of the CLIA regulations.

We have determined that after the

additions and revisions made by CAP,

the QC requirements of CAP are more

stringent than the CLIA requirements,

when taken as a whole. Some specific

requirements of QC that are more

stringent are:

• The CAP does not allow a two year

phase-in for QC requirements and

requirements are effective without

delay;

• The CAP imposes QC requirements

equally upon all testing performed by

their accredited laboratories, including

CLIA’s waived procedures. All testing is

considered high complexity by CLIA

definition;

• The CAP laboratory safety

requirements are specific and detailed.

Environmental safety requirements

address electrical voltage, facility

ventilation, lighting, temperature,

humidity, and emergency power source

and require remedial actions to be taken

when necessary. CAP also has

requirements in place for handling and

disposal of biohazardous materials, fire

safety and prevention of fire hazards, as

well as all OSHA regulations as they

pertain to the laboratory;

• The CAP requires procedure

manuals to include the principle and

clinical significance for each test, and

the procedure manuals must also

include documentation of initial and

annual reviews;

• CAP accredited laboratories that

rely on manufacturers’ quality control of

microbiological media must have a copy

of the National Committee for Clinical

Laboratory Standards Document M–22–

A (Quality Assurance for Commercially

Prepared Microbiological Culture

Media) and provide documentation that

its media supplier carries out the quality

assurance guidelines enumerated in

Document M–22–A;

• CLIA regulations allow cytology

slide preparations made using

automated, semi-automated, or other

liquid-based slide preparations that

cover half or less of a slide to be

counted as one half slide for cytology

workload purposes. This allows a

maximum of 200 such preparations to

be examined by an individual in a 24

hour period. The CAP does not

recognize these preparations as half

slides, but rather as full slides to be

included in an individuals’s 100 slide,

24 hour maximum allowable workload;

• CAP requires its accredited

laboratories to use the appropriate

reagent grade water for the testing

performed, stating which type of water

(from type I through Type III) must be

used in specific tests. Source water must

also be evaluated for silicone levels;

• CAP accredited laboratories must

verify all volumetric glassware and

pipettes for accuracy and

reproductability prior to use and

recheck them periodically. These

activities must be documented;

• CAP accredited laboratories that

perform maternal serum alphafetoprotein and amniotic fluid alphafetoprotein have specific requirements

that must be met. These include a

qualitative specimen evaluation,

requesting and reporting information

necessary for interpretation of results;

i.e., gestational age, maternal birth date,

race, maternal weight, insulindependent diabetes mellitus, multiple

gestations, median ranges calculated

and recalculated yearly, results reported

in multiples of the mean, etc;

• The CAP lists specific requirements

for newer methodologies. Molecular

pathology and flow cytometry standards

are presented in separate checklists and

immunohistochemistry has specific

requirements within histology; and

• CAP record retention requirements

are the same or longer than those of

CLIA.

The CAP has made additions and

revisions to its requirements to make

them equivalent to the CLIA regulations.

Some examples of these changes are:

• All reagents must be used within

their indicated expiration date;

• The laboratory must use

components of reagent kits only with

other kits of the same lot number, unless

otherwise specified by the

manufacturer;

• Conforming revisions were made to

the CAP standards for calibration and

calibration;

• Qualitative and quantitative test

control procedure requirements were

revised to specify the following more

clearly:

+ Control specimens must be tested in

the same manner as patient specimens;

+ Reagent performance and adequacy

must be verified before placing the

material in service. The results of the

verification checks must be recorded;

and

+ Stains are checked for intended

reactivity each day of use;

• CAP has imposed a 100 slide

maximum number of cytology slides

that an individual may evaluate in a 24

hour period;

• Records must be maintained of the

number of cytology slides evaluated by

each individual;

• The technical supervisor in

cytology (pathologist) must establish

each individual’s slide limit and reassess this limit every six months;

• Also, in cytology, CAP requires a

minimum of ten percent of negative

(GYN) cases be re-screened by a

qualified individual and the results of

these slides not be released until the

rescreens are complete; and

• All previous negative cytology

smears available within the past five

years must be reviewed on a patient

having a current positive smear.

Subpart M—Personnel for Moderate

and High Complexity Testing

The Standards for Laboratory

Accreditation of the CAP states at

Standard I, Director and Personnel

Requirements, under item D, Personnel,

that all laboratory personnel must be in

compliance with applicable federal,

state, and local laws and regulations.

This standard is implemented in the

general laboratory requirement that

there must be evidence in personnel

records that all testing personnel have

been evaluated against CLIA regulatory

requirements for high complexity

testing and that all individuals qualify.

CAP has added requirements to all

levels of laboratory personnel, most of

which refer to the CLIA regulatory

requirements. We have determined that

the personnel requirements of the CAP

are equal to or more stringent than the

personnel requirements of CLIA.

Subpart P—Quality Assurance for

Moderate or High Complexity Testing

or Both

We have determined that CAP’s

requirements are equal to or more

stringent than the CLIA requirements of

this subpart. CAP has made revisions to

its checklist requirements for quality

assurance to equate to the CLIA

requirements. CAP also offers an

educational program, Q-Probes, to its

accredited laboratories, which provides

further information on quality assurance

to the large, full service laboratories;

this program allows peer review and

comparisons between facilities.

Subpart Q—Inspections

We have determined that the CAP

inspection requirements, taken as a

whole, are equivalent to the CLIA

inspection requirements. CAP has made

some program modifications pertinent

to its overall inspection process,

specifically involving the training of all

inspectors. CAP has initiated a

Laboratory Accreditation Programs

Inspector Training Seminars program.

Two seminars in each of the 13 CAP

regions are presented currently, with 60

such seminars to be presented

nationally per year beginning in 1995.

Training seminar participants include

inspection team leaders and team

members.
Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices 7779

Another program modification

addresses the gathering of information

needed to investigate complaints. CAP

has discontinued its practice of

notifying the laboratory director of the

specific reason for contact or inspection

when a complaint investigation is in

process.

The CAP will continue its policy of

conducting announced biennial on-site

inspections. An unannounced

inspection would be performed when a

complaint, lodged against a CAP

accredited laboratory, indicates that

severe and major problems exist within

that laboratory that are likely to have

serious and immediate effects on patient

care.

Some areas of the CAP inspection

process are more stringent that those of

CLIA:

• CAP requires a mid-cycle selfinspection of all accredited laboratories.

All requirements must be responded to

in writing and the responses submitted

to CAP within a specified timeframe;

and

• A written evaluation of the

inspection process and the inspectors

must be completed after each on-site

inspection of an accredited laboratory.

The director of the inspected laboratory

must submit this evaluation to the CAP

within a specified timeframe.

Subpart R—Enforcement Procedures

for Laboratories

CAP meets the requirements of

subpart R to the extent that it applies to

accreditation organizations. CAP policy

stipulates the actions it takes when

laboratories it accredits do not comply

with its requirements and standards for

accreditation. CAP will deny

accreditation to a laboratory when

appropriate and report the denial to

HCFA within 30 days. CAP also

provides an appeals process for

laboratories that have had accreditation

denied.

Some specific actions CAP takes in

response to non-compliance or violation

of its requirements or standards for

accreditation include:

• When an accredited laboratory has

been identified as having intentionally

referred a PT specimen to another

laboratory for analysis prior to the PT

program end-date for receipt of results,

the CAP laboratory will be denied

accreditation and be ineligible for CAP

accreditation for one year. This action is

similar to the HCFA action of denial of

certification for 1 year.

• When a CAP accredited laboratory

participates unsuccessfully in PT for an

analyte, subspecialty, and/or specialty,

the laboratory must initiate corrective

actions. It must submit to CAP

documentation of a detailed

investigation of the problem causing the

unsuccessful performance with a

corrective action plan within ten

working days. Specific educational

activity or the retention of the services

of a consultant may also be imposed.

Failure to bring PT performance into

acceptable limits or failure to address

the PT problem seriously would cause

CAP to request the laboratory to cease

testing for the procedure(s) in question

or, if warranted, revoke the laboratory’s

accreditation. This action is equal to the

actions that HCFA may take under this

subsection.

• When CAP becomes aware of a

problem that is severe and extensive

enough that it could cause a serious risk

of harm (immediate jeopardy) situation

in an accredited laboratory, an

expedited evaluation is immediately

undertaken by the Chair and Vice Chair

of the Accreditation Committee, the

regional Commissioner and the Director

of the Laboratory Accreditation

Program. If it is determined that an

immediate jeopardy situation exists, the

laboratory is required to remove the

jeopardy situation immediately or

accreditation would be revoked. An onsite focused re-inspection may be

performed to verify that the immediate

jeopardy no longer exists. These actions

are similar to HCFA actions for

immediate jeopardy.

• The CAP requires its accredited

laboratories to correct all deficiencies

within 30 days. CLIA deficiencies that

are not condition level must be

corrected in a timeframe that is

acceptable to HCFA, but no longer than

12 months. CLIA deficiencies that are

condition level but are not instances of

immediate jeopardy must be corrected

in an acceptable timeframe; however,

HCFA may impose one or more

alternate sanctions or a principal

sanction to motivate laboratories to

correct these deficiencies. The CAP

timeframe for correction of deficiencies,

when taken as a whole, is more

stringent than CLIA.

We have determined that CAP’s

laboratory enforcement and 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

CAP accredited laboratories, as

specified in § 493.507, may be

conducted on a representative sample

basis or in response to substantial

allegations of noncompliance (called

complaint inspections). The outcome of

those validation inspections, performed

by HCFA, the State survey agency, or a

HCFA agent, will be HCFA’s principal

means for verifying that the laboratories

accredited by CAP remain in

compliance with CLIA requirements.

This Federal monitoring is an on-going

process.

V. Removal of Approval as an

Accrediting Organization

Our regulations at § 493.511 provide

that the approval of an accreditation

organization, such as that of CAP, may

be removed by HCFA for cause, prior to

the end of the effective date of approval.

If validation inspection outcomes and

the comparability or validation review

produce findings as described at

§ 493.509(a), HCFA will conduct a

review of an accreditation organization’s

program. A review is also conducted

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 it is determined that CAP has failed

to adopt 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 one

year, may be given to allow CAP to

adopt comparable requirements. Based

on an evaluation of any of the items

stipulated at § 493.511(d), we will

determine whether or not CAP retains

its approved status as an accreditation

organization under CLIA. If we deny

approved status, an accreditation

organization such as CAP may resubmit

its application when it has revised its

program to address the rationale for the

denial, demonstrated 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 accrediting

organization requests reconsideration of

an adverse determination in accordance

with Subpart D of part 488 of our

regulations, it may not submit a new

application until a final reconsideration

determination is issued.

Should circumstances result in CAP

having its approval withdrawn, we 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 and Budget.
7780 Federal Register / Vol. 60, No. 27 / Thursday, February 9, 1995 / Notices

Authority: Section 353 of the Public Health

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

Dated: January 17, 1995.

Bruce C. Vladeck,

Administrator, Health Care Financing

Administration.

[FR Doc. 95–3165 Filed 2–8–95; 8:45 am]

BILLING CODE 4120–03–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of Inspector General

Program Exclusions: January 1995

AGENCY: Office of Inspector General,

HHS.

ACTION: Notice of program exclusions.

During the month of January 1995, the

HHS Office of Inspector General

imposed exclusions in the cases set

forth below. When an exclusion is

imposed, no program payment is made

to anyone for any items or services

(other than an emergency item or

service not provided in a hospital

emergency room) furnished, ordered or

prescribed by an excluded party under

the Medicare, Medicaid, Maternal and

Child Health Services Block Grant and

Block Grants to States for Social

Services programs. In addition, no

program payment is made to any

business or facility, e.g., a hospital, that

submits bills for payment for items or

services provided by an excluded party.

Program beneficiaries remain free to

decide for themselves whether they will

continue to use the services of an

excluded party even though no program

payments will be made for items and

services provided by that excluded

party. The exclusions have national

effect and also apply to all other Federal

non-procurement programs.

Subject, city, State Effective

date

Program-Related Convictions

Alexis, Peter, Dallas, TX ............... 02/16/95

Alfonso, Leonard, Fairhaven, MA . 02/13/95

B and L Transport, Inc., Milwaukee, WI ...................................... 02/13/95

Battle, Robert Wayne, Dillard, GA 02/16/95

Becker, Donna C., Spokane, WA . 02/16/95

Bhatt, Harshad, Manhassat, NY ... 02/13/95

Bronshteyn, Boris, Lido Beach,

NY ............................................. 02/13/95

Brown, Ervin L., Spokane, WA ..... 02/16/95

Brown, Eric P, Spokane, WA ....... 02/16/95

Center Green Rest Home, Inc,

Fairhaven, MA ........................... 02/13/95

Champion, Mackie, Blytheville, AR 02/16/95

Cole, Carl Edward, Granville, NY . 02/16/95

Dunigan, James, Steele, MS ........ 02/16/95

Fesler, Michael, Melbourne, AR ... 02/16/95

Subject, city, State Effective

date

Gardners Grove Nursing Home,

Fairhaven, MA ........................... 02/13/95

Hadley, Arthur R, Richmond, CA . 02/16/95

Hamilton, Richard J, Woburn, MA 02/13/95

Hinton, Joseph L, Raymond, MS . 02/16/95

Kelly, Michael, Brooklyn, NY ........ 02/16/95

Melendez, Maria, M, Bronx, NY ... 02/13/95

Murray, April B, Winthrop, ME ...... 02/13/95

Newman, Donald Mark, Grady,

AR ............................................. 02/16/95

Ortiz, Twila G, Hart, TX ................ 02/08/95

Pelusi, Joseph F, Lynnfield, MA ... 02/13/95

Pomonis, Nick S, Orange, TX ...... 02/08/95

Ruyle, David, Dania, FL ............... 02/08/95

Schonbrun, David, Woodbridge,

NY ............................................. 02/16/95

Spielman, Michael, Hauppauge,

NY ............................................. 02/13/95

Strogov, Emilia, Scotch Plains, NJ 02/16/95

Thompson, Beverly K, Milwaukee,

WI .............................................. 02/13/95

Weeks, Edward H, Bonney Lake,

WA ............................................. 02/16/95

Yellow Cab of Woburn, Inc,

Woburn, MA .............................. 02/13/95

Patient Abuse/Neglect Convictions

Anyakora, Peter, Baltimore, MD ... 02/13/95

Bartholomew, Daryl, Denver, CO . 02/15/95

Brewer, Sherry Denise, Birmingham, AL ............................. 02/12/95

Brown, Herman Jr, DeQueen, AR 02/08/95

Cadiz, Pat, Danbury, TX ............... 02/16/95

Dickerson, Yulander, Talladega,

AL .............................................. 02/12/95

Gravdal, Georgene, Annandale,

MN ............................................. 02/13/95

Jasinski, Jeffrey R, West Seneca,

NY ............................................. 02/16/95

Paul, Joyce Jean, Greenbrier, AR 02/08/95

Ross, Darryl, Donaldsonville, LA .. 02/08/95

Siggers, Artedra, L, Ellisville, MS . 02/08/95

Thatcher, James R, Chillcothe,

OH ............................................. 02/15/95

Controlled Substance Convictions

Ekinci, Fevzi, Brooklyn, NY .......... 02/13/95

Oliva, Phillip B, Boulder, CO ........ 02/15/95

Straw, Michael F, Denver, CO ..... 02/15/95

License Revocation/Suspension

Altman, James Lloyd, Walterboro,

SC ............................................. 02/12/95

Amini, Mike, Jordan, UT ............... 02/13/95

Baggett, Lynn D, Hugo, OK .......... 02/08/95

Bottles, Kurt D, Yukon, OK ........... 02/08/95

Boyd, Debra K, Belton, TX ........... 02/16/95

Buckner, John W, San Diego, CA 02/12/95

Busby, Theresa P, West Memphis, AR ..................................... 02/08/95

Cash, Barbara Lynn, Fayetteville,

AR ............................................. 02/08/95

Chastan, Pamela S, Denison, TX 02/08/95

Cranford, Vanessa Lynne, Perryville, AR ..................................... 02/08/95

Daywood, Michael K, San Antonio, TX ....................................... 02/08/95

Deming, Robin, Southbury, CT .... 02/13/95

DeVries, Edward J, Muskegon, MI 02/13/95

Edwards, Jerrie Dean, Little Rock,

AR ............................................. 02/08/95

Subject, city, State Effective

date

Egbuchunam, Maureen I, Irving,

TX .............................................. 02/16/95

Evans, Billie Jean, Reyno, AR ..... 02/08/95

Ewing, Jon R, Quitman, AR ......... 02/08/95

Forbes, Janyce L, Saginaw, TX ... 02/08/95

Grace, Shirlee J, Belton, TX ......... 02/16/95

Griffis, Michael S, Green Forest,

AR ............................................. 02/08/95

Hall, Gayla S, Mount Pleasant, TX 02/08/95

Hanus, Larry J, Waterloo, IA ........ 02/13/95

Henningsgaard, Wayne, Stillwater,

MN ............................................. 02/13/95

Hobbs, William D, Frederick, OK . 02/08/95

Jones, Z Joyce, Ft Worth, TX ...... 02/16/95

Klein, Cathy Marie, Columbia, CT 02/13/95

Lanphere, Margaret Eleese,

Krum, TX ................................... 02/08/95

Loutfi, Yaser Hasan, Panama

City, FL ...................................... 02/12/95

Marang, Boitshoko, Detroit, MI ..... 02/15/95

Miller, Lynn J, Conway, AR .......... 02/08/95

Mills, Judy Y, Lexington, OK ........ 02/08/95

Morris, Sharon Ann, Springdale,

AR ............................................. 02/08/95

Muhammad, Taalib-Din Iqbal,

New York, NY ........................... 02/16/95

Nyman, David W, Colorado

Springs, CO ............................... 02/15/95

Oakley, Diane, Redbird, OK ......... 02/08/95

Parker, Linda M, Hartford, CT ...... 02/13/95

Raskiewicz, Edward B, Bridgeport, PA ..................................... 02/13/95

Reed, Guy D, Tulsa, OK .............. 02/08/95

Robinson, Taylor, Lexington, MA . 02/13/95

Samitier-Cardet, Richard, Miami,

FL .............................................. 02/12/95

Sands, Abel J, Oklahoma City,

OK ............................................. 02/08/95

Satterwhite, Linda L, Overton, TX 02/16/95

Sears, Phyllis Lana, Little Rock,

AR ............................................. 02/16/95

Sheehan, Timothy, Grand Rapids,

MI .............................................. 02/15/95

Soss, Burton Jay, Melbourne, FL . 02/12/95

Thompson, Lewis E III, Little

Rock, AR ................................... 02/08/95

Vaughans, Betty Jennell, Moss

Point, MS ................................... 02/08/95

Welch, Susan E, Toronto, Ontario,

CN ............................................. 02/16/95

Willoughby, Deloris A, Crockett,

TX .............................................. 02/16/95

Young, Henry A, Baltimore, MD ... 02/13/95

Zatkowski, John R, Fairfield, CT .. 02/13/95

Federal/State Exclusion/Suspension

Anthony, Shirelle, New Orleans,

LA .............................................. 02/16/95

Filoreto, Anthony R, West

Hazelton, PA ............................. 02/13/95

Torres, Pedro Luis, New Rochelle,

NY ............................................. 02/16/95

Owned/Controlled by Convicted/Excluded

Arora Clinics, Ltd, Grundy, VA ..... 12/05/94

Hinton Pharmacy, Raymond, MS . 02/16/95

Medcare City Pharmacy, Clover,

SC ............................................. 02/12/95

Medical Assistance SVC, Grady,

AR ............................................. 02/16/95

Northeast Arkansas Ambulance,

Blytheville, AR ........................... 02/16/95