Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 8173 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–2218–N] 

RIN 0938–ZA99 

Medicare, Medicaid, and CLIA 

Programs; Approval of the Joint 

Commission (Formerly the Joint 

Commission on Accreditation of 

Healthcare Organizations) as a CLIA 

Accreditation Organization 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces CMS’

grant of deeming authority to the Joint 

Commission (formerly the Joint 

Commission on Accreditation of 

Healthcare Organizations) under the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) program. 

We have determined that the 

requirements of the Joint Commission 

accreditation process are equal to or 

more stringent than the CLIA condition 

level requirements, and that the Joint 

Commission has met the requirements 

of subpart E of 42 CFR part 493. 

Consequently, laboratories that are 

voluntarily accredited by the Joint 

Commission and continue to meet the 

Joint Commission requirements will be 

deemed to 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 Federal validation 

and complaint investigation surveys 

conducted by us or our designee. 

DATES: Effective Date: This notice is 

effective from February 23, 2007 to 

February 23, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Kathleen Todd, (410) 786–3385. 

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(e)(2) 

of the Public Health Service Act, as 

enacted by the Clinical Laboratories 

Improvement Act of 1967. We issued a 

final rule implementing the 

accreditation provisions of CLIA on July 

31, 1992, (57 FR 33992). Under the CLIA 

program, CMS approves a grant of 

deeming authority to an accreditation 

organization to accredit clinical 

laboratories 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). The 

regulations in subpart E (Accreditation 

by a Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program) 

specify the requirements an 

accreditation organization must meet to 

be an approved accreditation 

organization. We approve an 

accreditation organization for a period 

not to exceed 6 years. 

In general, the approved accreditation 

organization must: 

• Use inspectors qualified to evaluate 

laboratory performance and agree to 

inspect laboratories with the frequency 

determined by us. 

• Apply standards and criteria that 

are equal to, or more stringent than 

those condition level requirements 

established by us. 

• Assure that laboratories accredited 

by the accreditation organization 

continually meet these standards and 

criteria. 

• Provide us 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 us at least 30 days before 

implementing any proposed changes in 

its standards. 

• If we withdraw our approval, notify 

the accredited laboratories of the 

withdrawal within 10 days of the 

withdrawal. 

CLIA requires that we 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 we determine to be 

appropriate. 

II. Notice of Approval of the Joint 

Commission as an Accreditation 

Organization 

In this notice, we approve the Joint 

Commission as an organization that may 

accredit laboratories for purposes of 

establishing their compliance with CLIA 

requirements. We have examined the 

Joint Commission application and all 

subsequent submissions to determine 

equivalency with our requirements 

under subpart E of part 493 that an 

accreditation organization must meet to 

be approved under CLIA. We have 

determined that the Joint Commission 

complied with the applicable CLIA 

requirements and grant the Joint 

Commission deeming authority as an 

accreditation organization under 

subpart E, for the period stated in the 

‘‘Effective Date’’ section of this notice 

for all specialty and subspecialty areas 

under CLIA. 

As a result of this determination, any 

laboratory that is accredited by the Joint 

Commission during the effective time 

period for an approved specialty or 

subspecialty is deemed to meet the 

CLIA requirements for the 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 us, or by any other validly 

authorized agent. 

III. Evaluation of the Joint Commission 

Request for Approval as an 

Accreditation Organization Under 

CLIA 

The following describes the process 

used to determine that requirements of 

the Joint Commission accreditation 

program are equal to or more stringent 

than the CLIA condition level 

requirements, and that the Joint 

Commission has met requirements of 

subpart E of 42 CFR part 493. 

The Joint Commission formally 

reapplied to us for approval as an 

accreditation organization under CLIA 

for all specialties and subspecialties. We 

evaluated the Joint Commission 

application to determine compliance 

with our implementing and enforcement 

regulations, and the deeming/exemption 

requirements of the CLIA rules. 

We verified that the Joint Commission 

accreditation program requirements and 

methods require the laboratories it 

accredits to be, and that the organization 

meets or exceeds 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 

The Joint Commission submitted the 

specialties and subspecialties that it 

would accredit; a comparison of 

individual accreditation and condition 

level requirements; a description of its 

inspection process; proficiency testing 

(PT) monitoring process; 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 us; its 

removal or withdrawal of laboratory 

accreditation procedures; its current list 


cprice-sewell on PROD1PC61 with NOTICES
8174 Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices 

of accredited laboratories; and its 

announced or unannounced inspection 

process. 

Our evaluation identified Joint 

Commission requirements pertaining to 

waived testing that are more stringent 

than the CLIA requirements. The Joint 

Commission waived testing 

requirements include the following: 

• Defining the extent that waived test 

results are used in patient care. 

• Identifying the personnel 

responsible for performing and 

supervising waived testing. 

• Assuring that personnel performing 

waived testing have adequate, specific 

training and orientation to perform the 

testing and can demonstrate satisfactory 

levels of performance. 

• Making certain that policies and 

procedures governing waived testingrelated processes are current and readily 

available. 

• Conducting defined quality control 

checks. 

• Maintaining quality control and test 

records. 

The CLIA requirements at § 493.15 

only require that a laboratory follow 

manufacturer’s instructions and obtain a 

certificate of waiver. 

Subpart H—Participation in Proficiency 

Testing for Laboratories Performing 

Nonwaived Testing 

The Joint Commission’s requirements 

are equal to the CLIA requirements at 

§ 493.801 through § 493.865. 

Subpart J—Facility Administration for 

Nonwaived Testing 

The Joint Commission requirements 

are equal to the CLIA requirements at 

§ 493.1100 through § 493.1105. 

Subpart K—Quality System for 

Nonwaived Testing 

The Joint Commission requirements 

are equal to or more stringent than the 

CLIA requirements at § 493.1200 

through § 493.1299. We have 

determined that Joint Commission’s 

requirements, when taken as a whole, 

are more stringent than the CLIA 

requirements. For instance, the Joint 

Commission has control procedure 

requirements for all waived complexity 

testing performed. 

Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the Joint 

Commission requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.1403 through 

§ 493.1495 for laboratories that perform 

moderate and high complexity testing. 

Subpart Q—Inspections 

We have determined that the Joint 

Commission requirements are equal to 

or more stringent than the CLIA 

requirements at § 493.1771 through 

§ 493.1780. The Joint Commission will 

continue to perform onsite inspections 

every 2 years. 

Subpart R—Enforcement Procedures 

The Joint Commssion meets the 

requirements of subpart R to the extent 

that it applies to accreditation 

organizations. The Joint Commission 

policy sets forth the actions the 

organization takes when laboratories it 

accredits do not comply with its 

requirements and standards for 

accreditation. When appropriate, the 

Joint Commission will deny, suspend, 

or, revoke accreditation in a laboratory 

accredited by the Joint Commission and 

report that action to us within 30 days. 

The Joint Commission also provides an 

appeal process for laboratories that have 

had accreditation denied, suspended, or 

revoked. 

We have determined that the Joint 

Commission’s laboratory enforcement 

and appeal policies are equal to or more 

stringent than the requirements of part 

493 subpart R as they apply to 

accreditation organizations. 

IV. Federal Validation Inspections and 

Continuing Oversight 

The Federal validation inspections of 

Joint Commission accredited 

laboratories may be conducted on a 

representative sample basis or in 

response to substantial allegations of 

noncompliance (that is, complaint 

inspections). The outcome of those 

validation inspections, performed by us 

or our agents, or the State survey 

agencies, will be our principal means 

for verifying that the laboratories 

accredited by the Joint Commission 

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 

rescind the approval of an accreditation 

organization, such as that of the Joint 

Commission, for cause, before the end of 

the effective date of approval. If we 

determine that the Joint Commission 

failed to adopt requirements that are 

equal to, or more stringent than, the 

CLIA requirements, or that systemic 

problems exist in its inspection process, 

we may give it a probationary period, 

not to exceed 1 year to allow the Joint 

Commission to adopt comparable 

requirements. 

Should circumstances result in our 

withdrawal of the Joint Commission’s 

approval, we will publish a notice in the 

Federal Register explaining the basis for 

removing its approval. 

VI. Collection of Information 

Requirements 

This notice does not impose any 

information collection and record 

keeping requirements subject to the 

Paperwork Reduction Act (PRA). 

Consequently, it does not need to be 

reviewed by the Office of Management 

and Budget (OMB) under the authority 

of the PRA. The requirements associated 

with the accreditation process for 

clinical laboratories under the Clinical 

Laboratory Improvement Amendments 

of 1988 (CLIA) program, codified in 42 

CFR part 493 subpart E, are currently 

approved by OMB under OMB approval 

number 0938–0686. 

VII. Executive Order 12866 Statement 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

Authority: Section 353 of the Public Health 

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

Dated: December 7, 2006. 

Leslie V. Norwalk, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. E7–3030 Filed 2–22–07; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1391–NC] 

Medicare and Medicaid Programs; 

Announcement of an Application From 

a Hospital Requesting Waiver for 

Organ Procurement Service Area 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice with comment period. 

SUMMARY: This notice announces a 

hospital’s request for a waiver from 

entering into an agreement with its 

designated organ procurement 

organization (OPO), in accordance with 

section 1138(a)(2) of the Social Security 

Act (the Act). This notice requests 

comments from OPOs and the general 

public for our consideration in 

determining whether we should grant 

the requested waiver. 

DATES: Comment Date: To be assured 

consideration, comments must be 


cprice-sewell on PROD1PC61 with NOTICES