1. A. In order to participate in the Program, a provider shall:

   1. (1) Be licensed as a hospital by the Department pursuant to Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland; and
   2. (2) Obtain other licenses, as set forth in COMAR 10.07.01.

2. B. The provider shall ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed, and:

   1. (1) If located in Maryland, comply with requirements of:

      1. (a) Health-General Article, Title 17, Subtitles 2 and 3, Annotated Code of Maryland; and
      2. (b) COMAR 10.10.01; or

   2. (2) If located out-of-State, comply with:

      1. (a) All applicable standards established by the state or locality in which the service is provided; and
      2. (b) The requirements of COMAR 10.09.09.02.

Authority: Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland

Effective date: April 10, 2017 (44:7 Md. R. 354)

Regulation .04B amended effective June 24, 2024 (51:12 Md. R. 619)

Regulation .05P, Q amended effective June 24, 2024 (51:12 Md. R. 619)

Regulation .05 R adopted effective June 24, 2024 (51:12 Md. R. 619)

Regulation .07A amended effective November 18, 2019 (46:23 Md. R. 1065)