In order to participate in the Program, the provider shall:

1. A. Meet all requirements as set forth in COMAR 10.09.36.02; and

2. B. Ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed and if located:

   1. (1) In Maryland, comply with requirements of Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland, and COMAR 10.10.06; or
   2. (2) Out-of-State, comply with other applicable standards established by the state or locality in which the service is provided.

Authority: Health-General Article, §§2-104, 15-103, and 15-105, Annotated Code of Maryland

Effective date: September 17, 2012 (39:18 Md. R. 1196)

Regulation .06B amended effective July 4, 2016 (43:13 Md. R. 712)