Justification for Non-substantive Change
Clinical Laboratory Improvement Amendments (CLIA) Application for Certification
(CMS-116) OCN# 0938-0581
We are requesting that a Non-substantive change be made to the CLIA Application for Certification form (CMS-116). A new accreditation organization called the American Association for Laboratory Accreditation and known as A2LA, has been approved by CMS for deeming authority under the CLIA program. This means that any qualified laboratory seeking CLIA accreditation may elect to be accredited by A2LA; unfortunately, because of these timing issues, A2LA was not included on the form for laboratories to select. Therefore, the new accreditation organization has formally requested that CMS revise the form . This minor revision will not change the burden hours.
Attachments
CMS-116: form with highlighted change to Part II on page 1 showing where A2LA will be added; and
CMS-116: clean copy with A2LA printed on page 1.
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| Author | Carol Zeller |
| File Modified | 0000-00-00 |
| File Created | 2021-01-25 |