1. A. Approval Required. A private, nonprofit, or commercial organization or government agency may not provide a PT program in this State without first obtaining program approval from CMS or the OHCQ.
2. B. Approval Granted Automatically. Except in the discipline of job-related alcohol and controlled dangerous substances, or other disciplines, subdisciplines, or specialties not covered by federal PT requirements, a PT program is approved when it is based on written evidence issued by CMS showing the program meets CMS's criteria for approval of PT programs as set forth in 42 CFR §§493.901—493.959.

3. C. Approval Granted by the Secretary. The OHCQ may approve a PT program for a laboratory discipline, subdiscipline, or specialty not approved by CMS, if the program:

   1. (1) Provides reliable, documented evidence that the program is technically and administratively able to meet the applicable requirements of this chapter; and
   2. (2) Uniformly and routinely prepares and submits directly to the OHCQ evaluations of all PT results from all laboratories enrolled in the program and holding a Maryland permit.

Authority: Health-General Article, §§17-202 and 17-211, Annotated Code of Maryland

Effective date: October 5, 1998 (25:20 Md. R. 1529)

Chapter, Job-Related Alcohol and Controlled Dangerous Substances Testing, repealed and new chapter, Medical Laboratories — Proficiency Testing, adopted effective December 13, 1999 (26:25 Md. R. 1897)

Regulation .01 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .02B amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .03 amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .04 amended effective June 1, 2009 (36:11 Md. R. 787); March 1, 2026 (52:24 Md. R. 1198)

Regulation .04D amended effective November 29, 2010 (37:24 Md. R. 1658)

Regulation .05A, B amended effective March 1, 2026 (52:24 Md. R. 1198)

Regulation .05B, C amended effective June 1, 2009 (36:11 Md. R. 787)

Regulation .05C amended effective November 29, 2010 (37:24 Md. R. 1658)