Code of Maryland Regulations
Title 10 - MARYLAND DEPARTMENT OF HEALTH
Part 3
Subtitle 10 - LABORATORIES
Chapter 10.10.07 - Medical Laboratories-Personnel
Section 10.10.07.05 - Permitted Laboratories - Technical Supervisors
Universal Citation: MD Code Reg 10.10.07.05
Current through Register Vol. 51, No. 19, September 20, 2024
A. Primary Standards.
(1) A laboratory director certified, or
eligible for certification, in anatomic and clinical pathology by the American
Board of Pathology qualifies as a technical supervisor in all disciplines and
subdisciplines set forth in COMAR
10.10.01.03B,
except:
(a) Genetics; and
(b) Forensic toxicology.
(2) A licensee who does not employ or
otherwise engage a director certified in anatomic and clinical pathology by the
American Board of Pathology, or a licensee operating a laboratory that performs
testing in the discipline of genetics or forensic toxicology shall employ the
services of a technical supervisor for each discipline set forth in COMAR
10.10.01.03BB
except the discipline of health awareness testing.
(3) A technical supervisor shall carry out
the applicable responsibilities set forth in
42 CFR § 493.1451.
B. Standards.
(1) Requirement. A licensee operating a
laboratory that performs testing in one or more disciplines shall employ a
director or technical supervisor who meets the qualifications for a technical
supervisor in the applicable disciplines or subdisciplines set forth in
§B(2)-(13) of this regulation.
(2) Chemistry. A technical supervisor shall
possess a bachelor's or higher degree including significant studies in
chemistry and have at least 4 years post-baccalaureate or 2 years post-master's
medical laboratory experience in clinical chemistry.
(3) Gynecologic Cytology. A technical
supervisor shall meet the requirements set forth in
42 CFR § 493.1449.
(4) Dermatopathology. A technical supervisor
shall be:
(a) A physician licensed by the
Board of Physicians to practice medicine in the State; and
(b) Either certified or eligible for
certification in dermatopathology or anatomic pathology by the:
(i) American Board of Dermatology,
(ii) American Osteopathic Board of
Dermatology,
(iii) American Board
of Pathology, or
(iv) American
Osteopathic Board of Pathology.
(5) Forensic Toxicology-General
Qualifications. A technical supervisor shall:
(a) Be certified in toxicological chemistry
by the American Board of Clinical Chemistry;
(b) Be certified in forensic toxicology by
the American Board of Forensic Toxicology;
(c) Be certified in clinical pathology and
chemistry by the American Board of Pathology; or
(d) Possess education and experience in
toxicology equivalent to that required by one of these boards.
(6) Forensic
Toxicology-Alternative Qualifications. An individual who does not qualify as a
technical supervisor under §B(5) of this regulation may qualify as a
technical supervisor if the individual:
(a)
Can document training or experience, or both, in the:
(i) Analysis of biological material for
alcohol or controlled dangerous substances, or both; and
(ii) Forensic applications of analytical
toxicology, such as court testimony, use of chain of custody, and specimen
security; and
(b)
Possesses:
(i) A degree in medicine or
osteopathy acceptable for licensure as a physician by the Maryland State Board
of Physicians, with certification in clinical pathology or forensic pathology,
and have at least 2 years of laboratory experience in analytical
toxicology;
(ii) A doctoral degree
in a biological, chemical, pharmacological, or toxicological discipline and
have at least 2 years of laboratory experience in analytical toxicology;
or
(iii) A master's degree in a
biological, chemical, pharmacological, or toxicological discipline with at
least 6 years of experience in analytical toxicology.
(7) Genetics. A technical
supervisor of biochemical genetics, cytogenetics, or molecular genetics shall
possess:
(a) A degree in medicine or
osteopathy acceptable for licensure as a physician by the Maryland State Board
of Physicians; or
(b) An earned
doctorate in one of the biological or chemical sciences from an accredited
institution with:
(i) 4 years of laboratory
experience in genetics, or
(ii)
Eligibility for certification by the American Board of Medical
Genetics.
(8)
Hematology. A technical supervisor shall possess a baccalaureate or higher
degree including studies in biology or general cytology and have at least 4
years post-baccalaureate or 2 years post-master's medical laboratory experience
in hematology.
(9) Immunology. A
technical supervisor shall possess a baccalaureate or higher degree including
studies in immunology, microbiology, or chemistry and have at least 4 years
post-baccalaureate or 2 years post-master's experience in
immunology-serology.
(10)
Microbiology. A technical supervisor shall possess a baccalaureate or higher
degree including studies in microbiology or immunology and have at least 4
years post-baccalaureate or 2 years post-master's medical laboratory experience
in clinical microbiology.
(11)
Molecular Biology. A technical supervisor shall possess a baccalaureate or
higher degree including studies in molecular biology and have at least 4 years
post-baccalaureate or 2 years post-master's experience in molecular biology,
microbiology, immunology, or clinical chemistry.
(12) Oral Pathology, Including Oral
Cytopathology. A technical supervisor shall be a dentist or physician licensed
to practice in Maryland and be certified or eligible for certification by the
American Board of Oral Pathology, American Board of Pathology, or the American
Osteopathic Board of Pathology.
(13) Tissue Pathology. A technical supervisor
shall be a physician licensed to practice medicine in Maryland and be certified
or eligible for certification in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology.
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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