Md. Code Regs. 10.09.09.02

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.09.09.02 - License Requirements

A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02D.

B. Medical laboratories are required to ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed.

C. Medical laboratories located in Maryland shall be in compliance with COMAR 10.10.01.

D. Out-of-State Laboratories.

(1) Laboratories with representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed, and that requirements of applicable sections of COMAR 10.10.01 are met.

(2) Laboratories without representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed.

Md. Code Regs. 10.09.09.02

Regulation .02 amended effective February 6, 1989 (16:2 Md. R. 159)
Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)