Current through Register Vol. 51, No. 19, September 20, 2024
A. General.
(1) A licensee shall allow an on-site survey
by the OHCQ or, when applicable, by the laboratory's approved accrediting
organization, at any time during the laboratory's normal hours of operation, to
evaluate the laboratory's compliance with the applicable requirements,
conditions, and standards of this subtitle.
(2) A survey may include but is not limited
to:
(a) Observation and examination of
laboratory facilities;
(b)
Equipment;
(c) Quality assurance
and quality control program records;
(d) Operating procedures;
(e) Personnel;
(f) Personnel records;
(g) Proficiency testing;
(h) Patient reports; and
(i) Other records and files pertinent to this
subtitle.
(3) Laboratory
employees shall make data and records accessible within a reasonable time
during the on-site survey.
B. Excepted Laboratory. A licensee operating
a laboratory under a letter of exception, other than a mobile or temporary
laboratory, is:
(1) Not subject to routine,
on-site surveys;
(2) Subject to
surveys resulting from complaints or periodic validations, or both, conducted
by the Secretary or CMS, or both, to determine regulatory compliance;
and
(3) Required to make available,
pursuant to a survey, records the Secretary may reasonably require to determine
regulatory compliance.
C. Permitted Laboratory. A licensee operating
a laboratory under a permit shall:
(1) Be
subject to routine surveys conducted by OHCQ;
(2) Undergo a routine annual survey for 2
consecutive years after the laboratory:
(a)
Begins operating,
(b) Undergoes a
change in ownership,
(c) Fails to
complete or submit to the Department an acceptable quality assurance
self-assessment on forms provided by the OHCQ; or
(d) Has imposed on it a principal or
alternative sanction; and
(3) Undergo a routine biennial survey when
the laboratory:
(a) Does not fall under one
of the categories set forth in §C(2) of this regulation, and
(b) Completes and submits to the OHCQ an
acceptable quality assurance self-assessment on forms provided by the OHCQ on
the years when the OHCQ does not conduct an on-site survey, except as provided
in §D of this regulation.
D. Accredited Laboratory. An accredited
laboratory:
(1) Undergoing routine on-site
surveys conducted by an accrediting organization approved by the Secretary,
except as provided in §D(2) and (3) of this regulation, is not subject to
routine surveys conducted by the OHCQ;
(2) Is subject to surveys conducted by the
OHCQ to investigate a complaint or to determine regulatory compliance;
and
(3) Holding a permit in the
discipline of forensic toxicology, subdiscipline of job-related testing, is
subject to routine surveys of the laboratory's alcohol and controlled dangerous
substances testing areas conducted by the OHCQ.
E. Temporary or Mobile Laboratory. The OHCQ
may survey each testing event site when a temporary or mobile laboratory
licensee offers to perform or performs testing services.
F. Excepted Laboratory-Limited Testing for
Rare Diseases. A licensee operating a laboratory under a letter of
exception-limited testing for rare diseases is subject to the survey
requirements stated in §B of this regulation.
