Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.06 - Medical Laboratories-Quality Assurance
Section 10.10.06.12 - Quality Control - Temporary and Mobile Laboratories: General
Universal Citation: MD Code Reg 10.10.06.12
Current through Register Vol. 51, No. 19, September 20, 2024
A. Primary Standard. The licensee shall ensure that a health awareness test or a job-related screening test for alcohol or controlled dangerous substances at a temporary or mobile laboratory is performed:
(1) Under effective supervision, quality
control, and safety procedures;
(2)
Using a previously evaluated analytical system; and
(3) For a job-related screening test for
alcohol or controlled dangerous substances, only at the request of an
individual authorized in COMAR
10.10.06.02B.
B. Standards.
(1) Limited Tests. A person may perform at a
temporary or mobile laboratory only the health awareness tests defined in COMAR
10.10.01.03BB and
job-related screening tests for alcohol or controlled dangerous
substances.
(2) Health awareness
and cholesterol testing may be performed at the request of the examinee. Staff
who perform the tests shall have training and experience to perform testing
that includes:
(a) Operation of the analyzers
per manufacturer's recommendations;
(b) Evaluation of the results of the quality
controls;
(c) Interpretation of the
test results; and
(d) Counseling to
the individual whose specimen is tested.
(3) Supervision. A designated supervisor,
knowledgeable in all aspects of the health awareness testing, shall be present
at a temporary or mobile laboratory throughout a testing event to oversee
testing, including compliance with all applicable requirements set forth in
this chapter.
(4) Testing Sites.
(a) A person may not perform a health
awareness test in a restaurant where food or drink is prepared, served, or
consumed.
(b) A licensee shall
ensure that a temporary laboratory:
(i)
Provides space, when applicable, for counseling examinees regarding test
results;
(ii) Provides space
appropriate for the number of staff, analytical systems, and
examinees;
(iii) Provides work
space adequate to minimize problems of transportation, communication, and
safety;
(iv) Provides electricity
of the type and in the amount needed to operate analytical systems
properly;
(v) Includes access to
water and disinfectant supplies for routine cleaning and disinfection of the
work area, equipment, and personnel;
(vi) Contains or is within 1 minute of a
telephone with access to emergency assistance by calling 911;
(vii) Maintains levels of temperature,
humidity, and ventilation to comply with manufacturer's specifications for
effective operation of analytical systems;
(viii) Is situated a minimum of 12 feet from
any produce, meat, or dairy department in a food market;
(ix) Maintains partitions, such as ropes, on
at least three sides of an area where blood is drawn or processed, to prevent
unsupervised access to a blood-drawing or testing area;
(x) Employs separate receptacles for routine
laboratory and special medical wastes within partitioned testing
areas;
(xi) Provides for the
storage of reagents and other testing materials within temperatures recommended
by the manufacturer; and
(xii)
Complies with all pertinent State laws and local ordinances.
(5) Pre-Field
Evaluation of Analytical Systems. A licensee may not employ an analytical
system in a mobile or temporary laboratory until the laboratory has documented
the analytical system's levels of accuracy and precision in a permanent
laboratory facility.
(6) In-Field
Quality Control. A licensee operating a mobile or temporary laboratory shall
establish and maintain a continuous quality control program for an analytical
system operated in that mobile or temporary laboratory.
(7) Phlebotomy Quality Control and Safety.
(a) A licensee employing a phlebotomist at a
temporary or mobile laboratory shall ensure that the phlebotomist is trained in
proper techniques for:
(i) Specimen
collection; and
(ii) Infection
control.
(b) A licensee
shall provide appropriate protective clothing and disposable gloves and ensure
that they are used appropriately by all personnel involved in drawing or
handling blood.
(c) A phlebotomist
shall wear new gloves for each examinee.
(d) A laboratory employee shall use and clean
phlebotomy devices as prescribed by the manufacturer.
(8) Testing Logs. A licensee shall maintain
for 2 years a log identifying all:
(a)
Persons tested;
(b) Test results;
and
(c) Test dates.
(9) Results Reporting. The
licensee of a temporary or mobile laboratory:
(a) May give results of a health awareness
test immediately following the testing directly to the individual who underwent
the test; and
(b) Shall give the
test results in writing stating the:
(i) Name
of the individual tested,
(ii) Name
of the laboratory performing the test,
(iii) Name of the test,
(iv) Date of the test, and
(v) Test result with appropriate
interpretation or reference range consistent with current nationally recognized
standards.
(10) Disposal of Special Medical Waste. A
licensee operating a temporary or mobile laboratory shall dispose of special
medical waste as required in COMAR 10.06.06.
Disclaimer: These regulations may not be the most recent version. Maryland may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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