80 FR 16408 - Medicare, Medicaid, and CLIA Programs; Announcement of the Re-Approval 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 80, Issue 59 (March 27, 2015)
Centers for Medicare & Medicaid Services
Federal Register Volume 80, Issue 59 (March 27, 2015)
| Page Range | 16408-16410 | |
| FR Document | 2015-07115 |
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)] [Notices] [Pages 16408-16410] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-07115] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-3314-N] Medicare, Medicaid, and CLIA Programs; Announcement of the Re- Approval 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 [[Page 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 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. 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 Sec. 493.801 through Sec. 493.865. Like CLIA, all of AOA/HFAP's accredited laboratories are required to participate in an HHS-approved 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 Sec. 493.1100 through Sec. 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 Sec. 493.1200 through Sec. 493.1299. E. Subpart M--Personnel for Nonwaived Testing We have determined that the AOA/HFAP requirements are equal to the CLIA requirements at Sec. 493.1403 through Sec. 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 Sec. 493.1771 through Sec. 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. [[Page 16410]] 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
![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
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
State, Territorial, and C8—Daily and Weekly Report ............................ 15 42 10/60 105
Local Public Health
Authorities and Their
Delegates.
Total ........................ .............................................................................. ........................ ........................ ........................ 14,721
D—‘‘CDC EMERGENCY OPERATIONS CENTER CLINICAL INQUIRIES’’
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hours)
respondent (in hours)
State and Local Health D1—Clinical Inquiries Database .......................... 420 1 15/60 105
Departments.
Clinicians and Other D1—Clinical Inquiries Database .......................... 800 1 15/60 200
Providers.
Total ........................ .............................................................................. ........................ ........................ ........................ 305
Leroy A. Richardson that AOA/HFAP meets or exceeds the II. Notice of Approval of the American
Chief, Information Collection Review Office, applicable CLIA requirements. In this Osteopathic Association/Healthcare
Office of Scientific Integrity, Office of the notice, we announce the approval and Facilities Accreditation Program (AOA/
Associate Director for Science, Office of the grant AOA/HFAP deeming authority for HFAP) as an Accreditation
Director, Centers for Disease Control and a period of 6 years. Organization
Prevention.
[FR Doc. 2015–07037 Filed 3–26–15; 8:45 am] DATES: Effective Date: This notice is In this notice, we approve the
effective from March 27, 2015 to March American Osteopathic Association/
BILLING CODE 4163–18–P
29, 2021. Healthcare Facilities Accreditation
Program (AOA/HFAP) as an
FOR FURTHER INFORMATION CONTACT: organization that may accredit
DEPARTMENT OF HEALTH AND
Kathleen Todd, 410–786–3385. laboratories for purposes of establishing
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
their compliance with CLIA
Centers for Medicare & Medicaid requirements for all specialty and
Services I. Background and Legislative subspecialty areas under CLIA. We have
Authority examined the initial AOA/HFAP
[CMS–3314–N] application and all subsequent
On October 31, 1988, the Congress submissions to determine its
Medicare, Medicaid, and CLIA enacted the Clinical Laboratory accreditation program’s equivalency
Programs; Announcement of the Re- Improvement Amendments of 1988 with the requirements for approval of an
Approval of the American Osteopathic (CLIA) (Pub. L. 100–578). CLIA accreditation organization under
Association/Healthcare Facilities amended section 353 of the Public subpart E of part 493. We have
Accreditation Program (Formerly Health Service Act. We issued a final determined that AOA/HFAP meets or
Known as the American Osteopathic rule implementing the accreditation exceeds the applicable CLIA
Association) as an Accreditation provisions of CLIA on July 31, 1992 (57 requirements. We have also determined
Organization Under the Clinical FR 33992). Under those provisions, we that AOA/HFAP will ensure that its
Laboratory Improvement Amendments may grant deeming authority to an accredited laboratories will meet or
of 1988 accreditation organization if its exceed the applicable requirements in
AGENCY: Centers for Medicare & requirements for laboratories accredited subparts H, I, J, K, M, Q, and the
Medicaid Services (CMS), HHS. under its program are equal to or more applicable sections of subpart R.
ACTION: Notice.
stringent than the applicable CLIA Therefore, we grant AOA/HFAP
program requirements in 42 CFR part approval as an accreditation
SUMMARY: This notice announces the 493 (Laboratory Requirements), subpart organization under subpart E of part
E of part 493 (Accreditation by a Private,
mstockstill on DSK4VPTVN1PROD with NOTICES
application of the American Osteopathic 493, for the period stated in the DATES
Association/Healthcare Facilities Nonprofit Accreditation Organization or section of this notice for all specialty
Accreditation Program (AOA/HFAP) for Exemption under an Approved State and subspecialty areas under CLIA. As
approval as an accreditation Laboratory Program), which specifies a result of this determination, any
organization for clinical laboratories the requirements an accreditation laboratory that is accredited by AOA/
under the Clinical Laboratory organization must meet to be approved HFAP during the time period stated in
Improvement Amendments of 1988 by CMS as an accreditation organization the DATES section of this notice will be
(CLIA) program. We have determined under CLIA. deemed to meet the CLIA requirements
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![16410 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
Dated: March 6, 2015. current and valid CLIA certificate to test following: Its inspection process; its
Andrew M. Slavitt, human specimens for the purposes proficiency testing (PT) monitoring
Acting Administrator, Centers for Medicare noted above to be eligible for payment process; its data management and
& Medicaid Services. for those tests from the Medicare or analysis system; its investigative and
[FR Doc. 2015–07115 Filed 3–26–15; 8:45 am] Medicaid programs. Regulations response procedures for complaints
BILLING CODE 4120–01–P implementing section 353 of the PHSA received against laboratories; and its
are contained in 42 CFR part 493. policy regarding announced and
Section 353(p) of the PHSA provides unannounced inspections.
DEPARTMENT OF HEALTH AND for the exemption of laboratories from
CLIA requirements in states that enact B. CMS Analysis of New York’s
HUMAN SERVICES
legal requirements that are equal to or Application and Supporting
Centers for Medicare & Medicaid more stringent than CLIA’s statutory Documentation
Services and regulatory requirements. Section To determine whether we should
353(p) of the PHSA is implemented in grant a CLIA exemption to laboratories
[CMS–3308–N]
subpart E of our regulations at 42 CFR licensed by a state, we review the
Medicare, Medicaid, and CLIA part 493. Sections 493.551(b) and application and additional
Programs; Clinical Laboratory 493.553 provide that we may exempt documentation that the state submits to
Improvement Amendments of 1988 from CLIA requirements, for a period us and conduct a detailed and in-depth
Exemption of Permit-Holding not to exceed 6 years, all state-licensed comparison of the state licensure
Laboratories in the State of New York or state-approved laboratories in a state program and CLIA’s statutory and
if the state licensure program meets the regulatory requirements to determine
AGENCY: Centers for Medicare & specified conditions. Section 493.559 whether the state program meets the
Medicaid Services (CMS), HHS. provides that we will publish a notice requirements at subpart E of part 493.
ACTION: Notice. in the Federal Register when we grant In summary, the state generally must
an exemption to an approved state demonstrate that:
SUMMARY: This notice announces that licensure program. It also provides that • It has state laws in effect that
laboratories located in and licensed by the notice will include the following: provide for a state licensure program
the State of New York that possess a • The basis for granting the that has requirements that are equal to
valid permit under New York State exemption. or more stringent than CLIA condition-
Public Health Law Article 5, Title V, are • A description of how the state’s level requirements for laboratories.
exempt from the requirements of the laboratory requirements are equal to or • It has implemented a state licensure
Clinical Laboratory Improvement more stringent than those of CLIA. program with requirements that are
Amendments of 1988 (CLIA) for a • The term of approval, not to exceed equal to or more stringent than the CLIA
period of 6 years. 6 years. condition-level requirements such that a
DATES: The exemption granted by this A. State of New York’s Application for laboratory licensed by the state program
notice is effective from March 27, 2015 CLIA Exemption of Its Laboratories would meet the CLIA condition-level
to March 27, 2021. requirements if it were inspected against
The State of New York has applied for those requirements.
FOR FURTHER INFORMATION CONTACT: exemption of its Clinical Laboratory • The requirements under that state
Melissa Singer, (410) 786–3531. Evaluation Program (CLEP) permit- licensure program meet or exceed the
SUPPLEMENTARY INFORMATION: holding laboratories from CLIA program requirements of § 493.553, § 493.555,
requirements. New York State law is and § 493.557(b) and is suitable for
I. Background and Legislative applicable to all clinical laboratories
Authority approval by us under § 493.551(a). For
operating within the State of New York example, among other things, the
Section 353 of the Public Health except those operated by the federal program would need to:
Service Act (PHSA), as amended by the government and those operated by a ++ Demonstrate that it has
Clinical Laboratory Improvement licensed physician, osteopath, dentist, enforcement authority and
Amendments of 1988 (CLIA) (Pub. L. midwife, nurse practitioner or podiatrist administrative structures and resources
100–578, enacted on October 31, 1988), who performs laboratory tests or adequate to enforce its laboratory
generally provides that no laboratory procedures, personally or through his or requirements.
may perform tests on human specimens her employees, solely as an adjunct to ++ Permit us or our agents to inspect
for the diagnosis, prevention or the treatment of his or her own patients. laboratories within the state.
treatment of any disease or impairment The State of New York submitted all of ++ Require laboratories within the
of, or assessment of the health of, the applicable information and state to submit to inspections by us or
human beings unless it has a certificate attestations required by § 493.551(a), our agents as a condition of state
to perform that category of tests issued § 493.553, and § 493.557(b) for state licensure.
by the Secretary of the Department of licensure programs seeking exemption ++ Agree to pay any costs associated
Health and Human Services (HHS). of their licensed laboratories from CLIA with our activities to validate its state
Under section 1861(s)(17)(A) of the program requirements. (Please note that licensure program, as well as the state’s
Social Security Act (the Act), the although the CLEP issues ‘‘permits’’ pro rata share of the general overhead to
Medicare program will only pay for rather than ‘‘licenses’’ or ‘‘certificates,’’ develop and implement CLIA as
mstockstill on DSK4VPTVN1PROD with NOTICES
laboratory services if the laboratory has for the purposes of this notice, we will specified in § 493.645(a), § 493.646(b),
a CLIA certificate. Under section hereinafter refer to the CLEP as a ‘‘state and § 493.557(b).
1902(a)(9)(C) of the Act, state Medicaid licensure program.’’) Examples of ++ Take appropriate enforcement
plans generally pay only for laboratory documents and information submitted action against laboratories found by us
services furnished by CLIA-certified include a comparison of its laboratory or our agents to be out of compliance
laboratories. Thus, although subject to licensure requirements with comparable with requirements comparable to CLIA
specified exemptions and exceptions, CLIA condition-level requirements (that condition-level requirements, as
laboratories generally must have a is, a crosswalk); and a description of the specified in § 493.557(b).
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Document Created: 2015-12-18 11:35:49
Document Modified: 2015-12-18 11:35:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Kathleen Todd, 410-786-3385. | |
| FR Citation | 80 FR 16408 |
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