Source: https://www.federalregister.gov/documents/2014/03/25/2014-06512/medicare-program-announcement-of-the-approval-of-the-american-association-for-laboratory
Timestamp: 2017-08-21 02:29:28
Document Index: 428032362

Matched Legal Cases: ['art 493', 'art 493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493', '§\u2009493']

16342-16344 (3 pages)
https://www.federalregister.gov/d/2014-06512 https://www.federalregister.gov/d/2014-06512
This notice announces the application of the American Association for Laboratory Accreditation (A2LA) for 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 A2LA meets or Start Printed Page 16343exceeds the applicable CLIA requirements. We are announcing the approval and granting the A2LA deeming authority for a period of 4 years.
Effective Date: This notice is effective from March 25, 2014 to March 26, 2018.
In this notice, we approve the American Association for Laboratory Accreditation (A2LA) 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 A2LA 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 A2LA meets or exceeds the applicable CLIA requirements. We have also determined that the A2LA 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 A2LA 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 A2LA 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).
Our evaluation identified the A2LA's requirements pertaining to waived testing, provider performed microscopy procedures, and moderate complexity testing that are more stringent than the CLIA requirements. The A2LA's requirements for high complexity testing are equivalent to the CLIA requirements. The A2LA will only accredit for waived tests or provider performed microscopy procedures if the laboratory is also applying for high or moderate complexity testing accreditation. Under the A2LA's requirements, laboratories performing any of these levels of testing will be held to the high complexity personnel requirements for all testing that the A2LA will accredit (high, moderate, waived or provider performed microscopy), as well as the requirements for nonwaived testing located in Subparts H, J, K, M, Q, and applicable parts of R.
In contrast, 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. The CLIA requirements at § 493.19 require that a laboratory performing provider performed microscopy procedures meet personnel requirements located at § 493.1355 through § 493.1365. The CLIA requirements at § 493.20 require that a laboratory performing moderate complexity testing meet the personnel requirements located at § 493.1403 through § 493.1425.
The A2LA's requirements are equal to or more stringent than the CLIA requirements at § 493.801 through § 493.865. For instance, the A2LA requires that laboratories conduct proficiency testing activities for both primary and secondary test systems for waived and non-waived testing. The CLIA requirement at § 493.801(b)(6) requires proficiency testing activities for the primary test system and for non-waived testing only.
The A2LA requirements for the submitted subspecialties and specialties are equal to the CLIA requirements at § 493.1100 through § 493.1105.
The A2LA requirements are equal to or more stringent than the CLIA requirements at § 493.1200 through § 493.1299. For instance, laboratories Start Printed Page 16344that are performing waived testing in addition to moderate or high complexity testing will need to meet all requirements in subpart K, Quality System for Nonwaived Testing. The A2LA has more specific requirements for laboratory information systems than CLIA. In addition, prior to adding a new test to the laboratory's accreditation, the A2LA requires the laboratory to submit performance specifications for review and approval.
We have determined that the A2LA's 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. Under the A2LA's requirements, laboratories that perform moderate complexity testing must meet the personnel requirements for high complexity testing located at § 493.1441 through § 493.1495.
We have determined that the A2LA requirements for the submitted subspecialties and specialties are equal to or more stringent than the CLIA requirements at § 493.1771 through § 493.1780. The A2LA requires a two day onsite surveillance visit one year after the initial accreditation is granted. The A2LA requires annual review of all accredited laboratories. The laboratory is required to submit any updates on information about its organization, facilities, key personnel and results of any proficiency testing. Laboratories may be required to undergo an onsite surveillance visit if they do not submit their annual review documentation to the A2LA by the established 30 day deadline, if significant changes to the facility or organization have occurred, or if proficiency testing results have been consistently poor. The CLIA regulations do not have this requirement.
[FR Doc. 2014-06512 Filed 3-24-14; 8:45 am]