Md. Code Regs. 10.10.07.03

Current through Register Vol. 51, No. 26, December 27, 2024

Section 10.10.07.03 - Permitted POL and POCL - Consulting Supervisor Services

A. General.

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

(a) Makes and documents on-site visits to each laboratory facility at least twice each calendar year;

(b) Is available by telephone during the laboratory's regular operating hours; and

(c) Completes a laboratory inspection checklist, provided by the OHCQ, to be submitted to the OHCQ not more than once every 2 years.

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

(1) A laboratory exhibits unsatisfactory proficiency testing performance;

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

(a) A laboratory is not in substantial compliance with the applicable standards and requirements of this chapter,

(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

(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) 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) 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.

Md. Code Regs. 10.10.07.03

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