2014-11918. Announcement of the Re-Approval of AABB (Foremerly Known as the American Association of Blood Banks) 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 AABB for approval as an accreditation organization for clinical laboratories under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) program. We have determined that AABB meets or exceeds the applicable CLIA requirements. In this notice, we announce the approval and grant AABB deeming authority for a period of 6 years. This deeming authority is granted to AABB for the Blood Bank and Transfusion Service (BB/TS) program, the Immunohematology Reference Laboratory (IRL) program, the Molecular Testing (MT) program, and the Cellular Therapy (CT) program.

DATES:

Effective Date: This notice is effective from May 23, 2014 to May 25, 2020.

FOR FURTHER INFORMATION CONTACT:

Daralyn Hassan, 410-786-9360.

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 AABB as an Accreditation Organization

In this notice, we approve AABB as an organization that may accredit laboratories for purposes of establishing their compliance with CLIA requirements for the following specialty and subspecialty areas under CLIA:

• Microbiology, including Bacteriology, Mycology, and Virology.
• Diagnostic Immunology, including Syphilis Serology, General Immunology.
• Chemistry, including Routine Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including ABO Group & Rh Group, Antibody Detection, Antibody Identification, Compatibility Testing.

We have examined the initial AABB 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 AABB meets or exceeds the applicable CLIA requirements. We have also determined that AABB 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 AABB approval as an accreditation organization under subpart E of part 493, for the period stated in the DATES section of this notice for the submitted specialty and subspecialty areas under CLIA. As a result of this determination, any laboratory that is accredited by AABB 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. However, the accredited laboratory is subject to validation and complaint investigation surveys performed by CMS, or its agent(s).

III. Evaluation of the AABB Request for Approval as an Accreditation Organization Under CLIA

The following describes the process used to determine that the AABB accreditation program meets the necessary requirements to be approved by CMS as an accreditation program with deeming authority under the CLIA program. AABB formally applied to CMS for approval as an accreditation organization under CLIA for the following specialties and subspecialties:

• Microbiology, including Bacteriology, Mycology, Virology.
• Diagnostic Immunology, including Syphilis Serology, General Immunology.
• Chemistry, including Routine Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including ABO Group & Rh Group, Antibody Detection, Antibody Identification, Compatibility Testing.

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

AABB 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 AABB policies and procedures for oversight of laboratories performing laboratory testing for the submitted 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. AABB 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 programs 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 AABB's requirements are equal to the CLIA requirements at § 493.801 through § 493.865. Like CLIA, all of AABB's accredited laboratories are required to participate in an HHS-approved PT program for tests listed in subpart I. Additionally, AABB administers a non-regulated PT program to challenge the ability of the laboratories in the IRL program to resolve complex serological problems. Laboratories in the MT program are required to participate in a graded PT program or a sample exchange program.

C. Subpart J—Facility Administration for Nonwaived Testing

We have determined that the AABB'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 AABB 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 AABB 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 AABB requirements are equal to the CLIA requirements at § 493.1771 through § 493.1780. AABB will continue to conduct biennial onsite inspections.

G. Subpart R—Enforcement Procedures

We have determined that the AABB meets the requirements of subpart R to the extent that such requirements are utilized by accreditation organizations. AABB policy sets forth the actions the organization takes when laboratories it accredits do not comply with its requirements and standards for accreditation. When appropriate, AABB will deny, suspend, or revoke accreditation in a laboratory accredited by AABB and report that action to us within 30 days. AABB also provides an appeals process for laboratories that have had accreditation denied, suspended, or revoked.

We have determined that AABB'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 AABB 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 AABB 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 AABB, for cause, before the end of the effective date of approval. If we determine that AABB 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 AABB would be allowed to address any identified issues. Should AABB be unable to address the identified issues within that timeframe, CMS may, in accordance with the applicable regulations, revoke AABB's deeming authority under CLIA.

Should circumstances result in our withdrawal of AABB'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.

Dated: May 12, 2014.

Marilyn Tavenner,

Administrator, Centers for Medicare & Medicaid Services.