Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.06 - Medical Laboratories-Quality Assurance
Section 10.10.06.13 - Quality Control - Temporary and Mobile Laboratories: Personnel Training
Universal Citation: MD Code Reg 10.10.06.13
Current through Register Vol. 51, No. 19, September 20, 2024
A. Primary Standard. In addition to meeting other applicable requirements in this chapter, a licensee shall ensure that all laboratory personnel performing a health awareness test at a temporary or mobile laboratory are trained to perform all assigned duties.
B. Standards.
(1) All Personnel. A licensee shall ensure
that all personnel are trained to:
(a) Keep
examinees' health information confidential;
(b) Deal with emergency situations such as
fainting and anxiety reactions;
(c)
Report and document information on testing services and activities;
and
(d) Dispose of special medical
waste as set forth in COMAR 10.06.06.
(2) Phlebotomist. A licensee shall ensure
that an individual who collects blood specimens is trained in:
(a) Specimen collection methods;
and
(b) Infection control and
prevention techniques, including CDC recommendations for preventing the
transmission of bloodborne pathogens in health care settings.
(3) Operator of an Analytical
System: General. A licensee shall ensure that an operator of an analytical
system is trained in:
(a) Infection control
and prevention techniques, including CDC recommendations concerning the
transmission of bloodborne pathogens in health care settings; and
(b) Proper use of the analytical system,
including:
(i) Analytical system
operation,
(ii) System methods used
to process the specimen, and
(iii)
Quality control techniques, procedures, and requirements.
(4) Operator of an Analytical
System: Competency.
(a) Obtaining Personal
Competency. Before an individual may operate an analytical system without
direct supervision, the individual operator shall demonstrate competency in
operating the analytical system by completing:
(i) Pre-field supervised practice that
includes performing under direct supervision a minimum of ten tests of each
applicable type of health awareness test, and
(ii) Field testing experience that includes
individual performance of directly supervised testing in the field.
(b) Documenting Training and
Competency. The licensee shall document in writing that each analytical system
operator has demonstrated competency as required under this
regulation.
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