Sec. 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.