Md. Code Regs. 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.
Notes
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)
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