Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices 31359 

Research Centers Network, SIP12–056, and 

Managing Epilepsy Well (MEW) 

Collaborating Center for Epilepsy SelfManagement Intervention Research, SIP12– 

057, Panel E, initial review.’’ 

Contact Person for More Information: M. 

Chris Langub, Ph.D., Scientific Review 

Officer, CDC, 4770 Buford Highway NE., 

Mailstop F–46, Atlanta, Georgia 30341, 

Telephone: (770) 488–3585, EEO6@cdc.gov. 

The Director, Management Analysis and 

Services Office, has been delegated the 

authority to sign Federal Register notices 

pertaining to announcements of meetings and 

other committee management activities, for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 17, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–12730 Filed 5–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Board of Scientific Counselors, 

National Center for Health Statistics 

(BSC, NCHS) 

Notice of Cancellation: This notice 

was published in the Federal Register 

on April 13, 2012, Volume 77, Number 

72, page 22326. This meeting scheduled 

to convene on May 17 and May 18, 

2012, is cancelled due to lack of a 

quorum. Notice will be provided when 

the meeting is rescheduled in 

accordance with section 10(a)(2) of the 

Federal Advisory Committee Act (Pub. 

L. 92–463). 

Contact Person for More Information: 

Virginia S. Cain, Ph.D., Director of 

Extramural Research, NCHS/CDC, 3311 

Toledo Road, Room 7208, Hyattsville, 

Maryland 20782, Telephone (301) 458– 

4500, Fax (301) 458–4020, Email: 

vcain@cdc.gov. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dated: May 15, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–12295 Filed 5–24–12; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3257–N] 

Medicare and Medicaid Programs; 

Announcement of the Re-Approval of 

the Joint Commission as an 

Accreditation Organization Under the 

Clinical Laboratory Improvement 

Amendments of 1988 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

application of the Joint Commission for 

re-approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program for all specialty and 

subspecialty areas under CLIA. We have 

determined that the Joint Commission 

meets or exceeds the applicable CLIA 

requirements. We are announcing the 

re-approval and granting the Joint 

Commission deeming authority for a 

period of 6 years. 

DATES: This notice is effective from May 

25, 2012 to May 25, 2018. 

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) (Pub. L. 100–578). CLIA 

amended section 353 of the Public 

Health Service Act. We issued a final 

rule implementing the accreditation 

provisions of CLIA on July 31, 1992 (57 

FR 33992). Under those provisions, we 

may grant deeming authority to an 

accreditation organization if its 

requirements for laboratories accredited 

under its program are equal to or more 

stringent than the applicable CLIA 

program requirements in 42 CFR part 

493 (Laboratory Requirements). Subpart 

E of part 493 (Accreditation by a Private, 

Nonprofit Accreditation Organization or 

Exemption Under an Approved State 

Laboratory Program) specifies the 

requirements an accreditation 

organization must meet to be approved 

by CMS as an accreditation organization 

under CLIA. 

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 its compliance with CLIA 

requirements for all specialty and 

subspecialty areas under CLIA. We have 

examined the initial Joint Commission 

application and all subsequent 

submissions to determine its 

accreditation program’s equivalency 

with the requirements for approval of an 

accreditation organization under 

subpart E of part 493. We have 

determined that the Joint Commission 

meets or exceeds the applicable CLIA 

requirements. We have also determined 

that the Joint Commission will ensure 

that its accredited laboratories will meet 

or exceed the applicable requirements 

in subparts H, I, J, K, M, Q, and the 

applicable sections of R. Therefore, we 

grant the Joint Commission approval as 

an accreditation organization under 

subpart E of part 493, for the period 

stated in the DATES 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 time period stated in the 

DATES section of this notice will be 

deemed to meet the CLIA requirements 

for the listed subspecialties and 

specialties, and therefore, will generally 

not be subject to routine inspections 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 

CMS, or its agent(s). 

III. Evaluation of the Joint Commission 

Request for Approval as an 

Accreditation Organization Under 

CLIA 

The following describes the process 

used to determine that the Joint 

Commission accreditation program 

meets the necessary requirements to be 

approved by CMS and that, as such, 

CMS may approve the Joint Commission 

as an accreditation program with 

deeming authority under the CLIA 

program. The Joint Commission 

formally applied to CMS for approval as 

an accreditation organization under 

CLIA for all specialties and 

subspecialties under CLIA. In reviewing 

these materials, we reached the 

following determinations for each 

applicable part of the CLIA regulations: 

mstockstill on DSK4VPTVN1PROD with NOTICES

31360 Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

The Joint Commission submitted its 

mechanism for monitoring compliance 

with all requirements equivalent to 

condition-level requirements, a list of 

all its current laboratories and the 

expiration date of their accreditation, 

and a detailed comparison of the 

individual accreditation requirements 

with the comparable condition-level 

requirements. The Joint Commission 

policies and procedures for oversight of 

laboratories performing laboratory 

testing for all CLIA specialties and 

subspecialties are equivalent to those of 

CLIA in the matters of inspection, 

monitoring proficiency testing (PT) 

performance, investigating complaints, 

and making PT information available. 

The Joint Commission’s submitted 

requirements for monitoring and 

inspecting laboratories in the areas of 

accreditation organization, data 

management, the inspection process, 

procedures for removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. The requirements of the 

accreditation programs submitted for 

approval are equal to or more stringent 

than the requirements of the CLIA 

regulations. 

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 procedures 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 

performing waived testing follow the 

manufacturer’s instructions and obtain a 

certificate of waiver. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

The Joint Commission requirements 

are equal to the CLIA requirements at 

§ 493.801 through § 493.865. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

The Joint Commission requirements 

are equal to the CLIA requirements at 

§ 493.1100 through § 493.1105. 

D. 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. For instance, the 

Joint Commission has control procedure 

requirements for all waived complexity 

testing performed. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that Joint 

Commission requirements are equal to 

the CLIA requirements at § 493.1403 

through § 493.1495 for laboratories that 

perform moderate and high complexity 

testing. 

F. Subpart Q—Inspections 

We have determined that the Joint 

Commission requirements are equal to 

the CLIA requirements at § 493.1771 

through § 493.1780. 

G. Subpart R—Enforcement Procedures 

The Joint Commission 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 CMS within 30 

days. The Joint Commission also 

provides an appeals process for 

laboratories that have had accreditation 

denied, suspended, or revoked. 

We have determined that the Joint 

Commission 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 

laboratories accredited by the Joint 

Commission 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 

CMS 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 

has failed to adopt, maintain and 

enforce requirements that are equal to, 

or more stringent than, the CLIA 

requirements, or that systemic problems 

exist in its monitoring, inspection or 

enforcement processes, we may impose 

a probationary period, not to exceed 1 

year, in which the Joint Commission 

would be allowed to address any 

identified issues. Should the Joint 

Commission be unable to address the 

identified issues within that timeframe, 

we may, in accordance with the 

applicable regulations, revoke the Joint 

Commission’s deeming authority under 

CLIA. 

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 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). 

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Federal Register / Vol. 77, No. 102 / Friday, May 25, 2012 / Notices 31361 

Dated: May 18, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2012–12639 Filed 5–24–12; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3264–PN] 

Medicare and Medicaid Programs; 

Application by American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (AOA/HFAP) for 

Continuing CMS-Approval of its 

Ambulatory Surgery Center (ASC) 

Accreditation Program 

AGENCY: Centers for Medicare and 

Medicaid Services (CMS), HHS. 

ACTION: Proposed notice. 

SUMMARY: This proposed notice 

acknowledges the receipt of an 

application from American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (AOA/HFAP) for 

continued recognition as a national 

accrediting organization for ambulatory 

surgery centers (ASCs) that wish to 

participate in the Medicare or Medicaid 

programs. 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on June 25, 2012. 

ADDRESSES: In commenting, refer to file 

code CMS–3264–PN. Because of staff 

and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

four ways (choose only one of the ways 

listed): 

1. Electronically. You may submit 

electronic comments on this regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

2. By regular mail. You may mail 

written comments (one original and two 

copies) to the following address only: 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, Attention: CMS–3264– 

PN, P.O. Box 8016, Baltimore, MD 

21244–8010. Please allow sufficient 

time for mailed comments to be 

received before the close of the 

comment period. 

3. By express or overnight mail. You 

may send written comments (one 

original and two copies) to the following 

address only: Centers for Medicare & 

Medicaid Services, Department of 

Health and Human Services, Attention: 

CMS–3264–PN, Mail Stop C4–26–05, 

7500 Security Boulevard, Baltimore, MD 

21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments before only to 

the following addresses: a. For delivery 

in Washington, DC—Centers for 

Medicare & Medicaid Services, 

Department of Health and Human 

Services, Room 445–G, Hubert H. 

Humphrey Building, 200 Independence 

Avenue SW., Washington, DC 20201. 

(Because access to the interior of the 

Hubert H. Humphrey Building is not 

readily available to persons without 

Federal government identification, 

commenters are encouraged to leave 

their comments in the CMS drop slots 

located in the main lobby of the 

building. A stamp-in clock is available 

for persons wishing to retain a proof of 

filing by stamping in and retaining an 

extra copy of the comments being filed.) 

b. For delivery in Baltimore, MD— 

Centers for Medicare & Medicaid 

Services, Department of Health and 

Human Services, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

If you intend to deliver your comments 

to the Baltimore address, call telephone 

number (410) 786–9994 in advance to 

schedule your arrival with one of our 

staff members. 

Comments erroneously mailed to the 

addresses indicated as appropriate for 

hand or courier delivery may be delayed 

and received after the comment period. 

For information on viewing public 

comments, see the beginning of the 

section entitled SUPPLEMENTARY

INFORMATION section. 

FOR FURTHER INFORMATION CONTACT: 

Barbara Easterling, (410) 786–0416, 

Patricia Chmielewski, (410) 786–6899 or 

Cindy Melanson, (410) 786–0310. 

SUPPLEMENTARY INFORMATION: Inspection 

of Public Comments: All comments 

received before the close of the 

comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. We post all comments 

received before the close of the 

comment period on the following Web 

site as soon as possible after they have 

been received: http:// 

www.regulations.gov. Follow the search 

instructions on that Web site to view 

public comments. 

Comments received timely will also 

be available for public inspection as 

they are received, generally beginning 

approximately 3 weeks after publication 

of a document, at the headquarters of 

the Centers for Medicare & Medicaid 

Services, 7500 Security Boulevard, 

Baltimore, Maryland 21244, Monday 

through Friday of each week from 8:30 

a.m. to 4 p.m. To schedule an 

appointment to view public comments, 

phone 1–800–743–3951. 

I. Background 

Section 1865(a)(3)(A) of the Social 

Security Act (the Act), requires that 

within 60 days of receipt of an 

organization’s complete application, we 

publish a notice that identifies the 

national accrediting body making the 

request, describes the nature of the 

request, and provides at least a 30-day 

public comment period. Under the 

Medicare program, eligible beneficiaries 

may receive covered services in an 

ambulatory surgical center (ASC) 

provided certain requirements are met. 

Section 1832(a)(2)(F)(i) of the Act 

establishes distinct criteria for facilities 

seeking designation as an ASC. 

Regulations concerning provider 

agreements are at 42 CFR part 489 and 

those pertaining to activities relating to 

the survey and certification of facilities 

are at 42 CFR part 488. The regulations 

at 42 CFR part 416 specify the 

conditions that an ASC must meet in 

order to participate in the Medicare 

program, the scope of covered services, 

and the conditions for Medicare 

payment for ASCs. 

Generally, in order to enter into an 

agreement, an ASC must first be 

certified by a State survey agency as 

complying with the conditions or 

requirements set forth in part 416. 

Thereafter, the ASC is subject to regular 

surveys by a State survey agency to 

determine whether it continues to meet 

these requirements. There is an 

alternative, however, to surveys by State 

agencies. 

Section 1865(a)(1) of the Act provides 

that, if a provider entity demonstrates 

through accreditation by an approved 

national accrediting organization that all 

applicable Medicare conditions are met 

or exceeded, we will deem those 

provider entities as having met the 

requirements. Accreditation by an 

accrediting organization is voluntary 

and is not required for Medicare 

participation. 

If an accrediting organization is 

recognized by the Secretary as having 

standards for accreditation that meet or 

exceed Medicare requirements, any 

provider entity accredited by the 

national accrediting body’s approved 

program would be deemed to meet the 

Medicare conditions. A national 

accrediting organization applying for 

approval of its accreditation program 

under part 488, subpart A, must provide 

us with reasonable assurance that the 

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