Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.07 - Medical Laboratories-Personnel
Section 10.10.07.03 - Permitted POL and POCL - Consulting Supervisor Services
Universal Citation: MD Code Reg 10.10.07.03
Current through Register Vol. 51, No. 19, September 20, 2024
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.
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