Md. Code Regs. 10.10.07.05

Current through Register Vol. 51, No. 25, December 13, 2024

Section 10.10.07.05 - Permitted Laboratories - Technical Supervisors

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.

Md. Code Regs. 10.10.07.05

Regulation .05 amended effective July 24, 2000 (27:14 Md. R. 1340)
Regulation .05B amended effective June 1, 2009 (36:11 Md. R. 787)