1. A. General.

   1. (1) A licensee operating a permitted POL or POCL who does not employ or otherwise engage technical personnel who qualify as a general supervisor shall arrange with a qualified consulting supervisor to provide technical and general supervisory consultation services in laboratory practice.

   2. (2) The licensee operating a POL or POCL under a permit shall use a consulting supervisor who:

      1. (a) Makes and documents on-site visits to each laboratory facility at least twice each calendar year;
      2. (b) Is available by telephone during the laboratory's regular operating hours; and
      3. (c) Completes a laboratory inspection checklist, provided by the OHCQ, to be submitted to the OHCQ not more than once every 2 years.

2. B. Additional Visits. The OHCQ may require more than two on-site visits per year by a consulting supervisor when:

   1. (1) A laboratory exhibits unsatisfactory proficiency testing performance;

   2. (2) An on-site survey by the OHCQ shows that:

      1. (a) A laboratory is not in substantial compliance with the applicable standards and requirements of this chapter;
      2. (b) A laboratory's written plan of correction in response to a Department survey does not ensure substantial compliance with the applicable standards and requirements of this chapter; or
      3. (c) A laboratory's testing personnel require additional supervisory consultations to obtain or maintain proficiency in quality assurance, performing or reporting test results, or meeting other applicable standards of this chapter;
   3. (3) An inspection checklist submitted by the laboratory shows that the laboratory is operating in a manner that is not in compliance with applicable standards of this chapter; or
   4. (4) The laboratory's general supervisor or consulting supervisor has been unable to perform the duties and responsibilities set forth in Regulation .02B(4) of this chapter.

Authority: Health-General Article, §§17-202, 17-203, 17-206, Annotated Code of Maryland

Effective date: December 13, 1999 (26:25 Md. R. 1897)

Regulation .01B amended effective July 24, 2000 (27:14 Md. R. 1340); June 1, 2009 (36:11 Md. R. 787)

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

Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340)

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

Regulation .07B amended effective March 1, 2026 (52:24 Md. R. 1198)