16408 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

C—‘‘NATIONAL DISEASE SURVEILLANCE PROGRAM III—CDC SUPPORT FOR CASE INVESTIGATION, CONTACT TRACING, 

AND CASE REPORTS’’—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State, Territorial, and 

Local Public Health 

Authorities and Their 

Delegates.

C8—Daily and Weekly Report ............................ 15 42 10/60 105 

Total ........................ .............................................................................. ........................ ........................ ........................ 14,721 

D—‘‘CDC EMERGENCY OPERATIONS CENTER CLINICAL INQUIRIES’’ 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

State and Local Health 

Departments.

D1—Clinical Inquiries Database .......................... 420 1 15/60 105 

Clinicians and Other 

Providers.

D1—Clinical Inquiries Database .......................... 800 1 15/60 200 

Total ........................ .............................................................................. ........................ ........................ ........................ 305 

Leroy A. Richardson 

Chief, Information Collection Review Office, 

Office of Scientific Integrity, Office of the 

Associate Director for Science, Office of the 

Director, Centers for Disease Control and 

Prevention. 

[FR Doc. 2015–07037 Filed 3–26–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3314–N] 

Medicare, Medicaid, and CLIA 

Programs; Announcement of the ReApproval of the American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (Formerly 

Known as the American Osteopathic 

Association) 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 American Osteopathic 

Association/Healthcare Facilities 

Accreditation Program (AOA/HFAP) for 

approval as an accreditation 

organization for clinical laboratories 

under the Clinical Laboratory 

Improvement Amendments of 1988 

(CLIA) program. We have determined 

that AOA/HFAP meets or exceeds the 

applicable CLIA requirements. In this 

notice, we announce the approval and 

grant AOA/HFAP deeming authority for 

a period of 6 years. 

DATES: Effective Date: This notice is 

effective from March 27, 2015 to March 

29, 2021. 

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), which 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 American 

Osteopathic Association/Healthcare 

Facilities Accreditation Program (AOA/ 

HFAP) as an Accreditation 

Organization 

In this notice, we approve the 

American Osteopathic Association/

Healthcare Facilities Accreditation 

Program (AOA/HFAP) as an 

organization that may accredit 

laboratories for purposes of establishing 

their compliance with CLIA 

requirements for all specialty and 

subspecialty areas under CLIA. We have 

examined the initial AOA/HFAP 

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 AOA/HFAP meets or 

exceeds the applicable CLIA 

requirements. We have also determined 

that AOA/HFAP 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 subpart R. 

Therefore, we grant AOA/HFAP 

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 AOA/

HFAP during the time period stated in 

the DATES section of this notice will be 

deemed to meet the CLIA requirements 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16409 

for all 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. 

However, the accredited laboratory is 

subject to validation and complaint 

investigation surveys performed by 

CMS, or its agent(s). 

III. Evaluation of the AOA/HFAP 

Request for Approval as an 

Accreditation Organization Under 

CLIA 

The following describes the process 

used to determine that the AOA/HFAP 

accreditation program meets the 

necessary requirements to be approved 

by CMS as an accreditation program 

with deeming authority under the CLIA 

program. AOA/HFAP formally applied 

to CMS for approval as an accreditation 

organization under CLIA for all 

specialty and subspecialty areas under 

CLIA. In reviewing these materials, we 

reached the following determinations 

for each applicable part of the CLIA 

regulations: 

A. Subpart E—Accreditation by a 

Private, Nonprofit Accreditation 

Organization or Exemption Under an 

Approved State Laboratory Program 

AOA/HFAP submitted its mechanism 

for monitoring compliance with all 

requirements equivalent to conditionlevel 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. We have determined that 

AOA/HFAP policies and procedures for 

oversight of laboratories performing 

laboratory testing for all CLIA 

specialties and subspecialties are 

equivalent to those required by our 

CLIA regulations in the matters of 

inspection, monitoring proficiency 

testing (PT) performance, investigating 

complaints, and making PT information 

available. AOA/HFAP submitted 

documentation regarding its 

requirements for monitoring and 

inspecting laboratories, and describing 

its own standards regarding 

accreditation organization data 

management, inspection processes, 

procedures for removal or withdrawal of 

accreditation, notification requirements, 

and accreditation organization 

resources. We have determined that the 

requirements of the accreditation 

program submitted for approval are 

equal to or more stringent than the 

requirements of the CLIA regulations. 

B. Subpart H—Participation in 

Proficiency Testing for Laboratories 

Performing Nonwaived Testing 

We have determined that the AOA/

HFAP’s requirements are equal to the 

CLIA requirements at § 493.801 through 

§ 493.865. Like CLIA, all of AOA/

HFAP’s accredited laboratories are 

required to participate in an HHSapproved PT program for tests listed in 

subpart I. 

C. Subpart J—Facility Administration 

for Nonwaived Testing 

We have determined that the AOA/

HFAP’s requirements are equal to the 

CLIA requirements at § 493.1100 

through § 493.1105. 

D. Subpart K—Quality System for 

Nonwaived Testing 

We have determined that the AOA/

HFAP requirements are equal to or more 

stringent than the CLIA requirements at 

§ 493.1200 through § 493.1299. 

E. Subpart M—Personnel for Nonwaived 

Testing 

We have determined that the AOA/

HFAP 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 AOA/

HFAP requirements are equal to the 

CLIA requirements at § 493.1771 

through § 493.1780. AOA/HFAP will 

continue to conduct biennial onsite 

inspections. 

G. Subpart R—Enforcement Procedures 

We have determined that the AOA/

HFAP meets the requirements of subpart 

R to the extent that such requirements 

are utilized by accreditation 

organizations. AOA/HFAP policy sets 

forth the actions the organization takes 

when laboratories it accredits do not 

comply with its requirements and 

standards for accreditation. When 

appropriate, AOA/HFAP will deny, 

suspend, or revoke accreditation in a 

laboratory accredited by AOA/HFAP 

and report that action to us within 30 

days. AOA/HFAP also provides an 

appeals process for laboratories that 

have had accreditation denied, 

suspended, or revoked. 

We have determined that AOA/

HFAP’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 

laboratories accredited by AOA/HFAP 

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 AOA/HFAP 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 AOA/

HFAP, for cause, before the end of the 

effective date of approval. If we 

determine that AOA/HFAP 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 one 

year, in which AOA/HFAP would be 

allowed to address any identified issues. 

Should AOA/HFAP be unable to 

address the identified issues within that 

timeframe, CMS may, in accordance 

with the applicable regulations, revoke 

AOA/HFAP’s deeming authority under 

CLIA. 

Should circumstances result in our 

withdrawal of AOA/HFAP’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. 

mstockstill on DSK4VPTVN1PROD with NOTICES

16410 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 

Dated: March 6, 2015. 

Andrew M. Slavitt, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

[FR Doc. 2015–07115 Filed 3–26–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–3308–N] 

Medicare, Medicaid, and CLIA 

Programs; Clinical Laboratory 

Improvement Amendments of 1988 

Exemption of Permit-Holding 

Laboratories in the State of New York 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces that 

laboratories located in and licensed by 

the State of New York that possess a 

valid permit under New York State 

Public Health Law Article 5, Title V, are 

exempt from the requirements of the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) for a 

period of 6 years. 

DATES: The exemption granted by this 

notice is effective from March 27, 2015 

to March 27, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Singer, (410) 786–3531. 

SUPPLEMENTARY INFORMATION: 

I. Background and Legislative 

Authority 

Section 353 of the Public Health 

Service Act (PHSA), as amended by the 

Clinical Laboratory Improvement 

Amendments of 1988 (CLIA) (Pub. L. 

100–578, enacted on October 31, 1988), 

generally provides that no laboratory 

may perform tests on human specimens 

for the diagnosis, prevention or 

treatment of any disease or impairment 

of, or assessment of the health of, 

human beings unless it has a certificate 

to perform that category of tests issued 

by the Secretary of the Department of 

Health and Human Services (HHS). 

Under section 1861(s)(17)(A) of the 

Social Security Act (the Act), the 

Medicare program will only pay for 

laboratory services if the laboratory has 

a CLIA certificate. Under section 

1902(a)(9)(C) of the Act, state Medicaid 

plans generally pay only for laboratory 

services furnished by CLIA-certified 

laboratories. Thus, although subject to 

specified exemptions and exceptions, 

laboratories generally must have a 

current and valid CLIA certificate to test 

human specimens for the purposes 

noted above to be eligible for payment 

for those tests from the Medicare or 

Medicaid programs. Regulations 

implementing section 353 of the PHSA 

are contained in 42 CFR part 493. 

Section 353(p) of the PHSA provides 

for the exemption of laboratories from 

CLIA requirements in states that enact 

legal requirements that are equal to or 

more stringent than CLIA’s statutory 

and regulatory requirements. Section 

353(p) of the PHSA is implemented in 

subpart E of our regulations at 42 CFR 

part 493. Sections 493.551(b) and 

493.553 provide that we may exempt 

from CLIA requirements, for a period 

not to exceed 6 years, all state-licensed 

or state-approved laboratories in a state 

if the state licensure program meets the 

specified conditions. Section 493.559 

provides that we will publish a notice 

in the Federal Register when we grant 

an exemption to an approved state 

licensure program. It also provides that 

the notice will include the following: 

• The basis for granting the 

exemption. 

• A description of how the state’s 

laboratory requirements are equal to or 

more stringent than those of CLIA. 

• The term of approval, not to exceed 

6 years. 

A. State of New York’s Application for 

CLIA Exemption of Its Laboratories 

The State of New York has applied for 

exemption of its Clinical Laboratory 

Evaluation Program (CLEP) permitholding laboratories from CLIA program 

requirements. New York State law is 

applicable to all clinical laboratories 

operating within the State of New York 

except those operated by the federal 

government and those operated by a 

licensed physician, osteopath, dentist, 

midwife, nurse practitioner or podiatrist 

who performs laboratory tests or 

procedures, personally or through his or 

her employees, solely as an adjunct to 

the treatment of his or her own patients. 

The State of New York submitted all of 

the applicable information and 

attestations required by § 493.551(a), 

§ 493.553, and § 493.557(b) for state 

licensure programs seeking exemption 

of their licensed laboratories from CLIA 

program requirements. (Please note that 

although the CLEP issues ‘‘permits’’ 

rather than ‘‘licenses’’ or ‘‘certificates,’’ 

for the purposes of this notice, we will 

hereinafter refer to the CLEP as a ‘‘state 

licensure program.’’) Examples of 

documents and information submitted 

include a comparison of its laboratory 

licensure requirements with comparable 

CLIA condition-level requirements (that 

is, a crosswalk); and a description of the 

following: Its inspection process; its 

proficiency testing (PT) monitoring 

process; its data management and 

analysis system; its investigative and 

response procedures for complaints 

received against laboratories; and its 

policy regarding announced and 

unannounced inspections. 

B. CMS Analysis of New York’s 

Application and Supporting 

Documentation 

To determine whether we should 

grant a CLIA exemption to laboratories 

licensed by a state, we review the 

application and additional 

documentation that the state submits to 

us and conduct a detailed and in-depth 

comparison of the state licensure 

program and CLIA’s statutory and 

regulatory requirements to determine 

whether the state program meets the 

requirements at subpart E of part 493. 

In summary, the state generally must 

demonstrate that: 

• It has state laws in effect that 

provide for a state licensure program 

that has requirements that are equal to 

or more stringent than CLIA conditionlevel requirements for laboratories. 

• It has implemented a state licensure 

program with requirements that are 

equal to or more stringent than the CLIA 

condition-level requirements such that a 

laboratory licensed by the state program 

would meet the CLIA condition-level 

requirements if it were inspected against 

those requirements. 

• The requirements under that state 

licensure program meet or exceed the 

requirements of § 493.553, § 493.555, 

and § 493.557(b) and is suitable for 

approval by us under § 493.551(a). For 

example, among other things, the 

program would need to: 

++ Demonstrate that it has 

enforcement authority and 

administrative structures and resources 

adequate to enforce its laboratory 

requirements. 

++ Permit us or our agents to inspect 

laboratories within the state. 

++ Require laboratories within the 

state to submit to inspections by us or 

our agents as a condition of state 

licensure. 

++ Agree to pay any costs associated 

with our activities to validate its state 

licensure program, as well as the state’s 

pro rata share of the general overhead to 

develop and implement CLIA as 

specified in § 493.645(a), § 493.646(b), 

and § 493.557(b). 

++ Take appropriate enforcement 

action against laboratories found by us 

or our agents to be out of compliance 

with requirements comparable to CLIA 

condition-level requirements, as 

specified in § 493.557(b). 

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