The laboratory must employ one or more individuals who are qualified by education and either training or experience to provide technical supervision for each of the specialties and subspecialties of service in which the laboratory performs high complexity tests or procedures. The director of a laboratory performing high complexity testing may function as the technical supervisor provided he or she meets the qualifications specified in this section.

(a) The technical supervisor must possess a current license issued by the State in which the laboratory is located, if such licensing is required; and

(b) The laboratory may perform anatomic and clinical laboratory procedures and tests in all specialties and subspecialties of services except histocompatibility and clinical cytogenetics services provided the individual functioning as the technical supervisor—

(1) Is a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(2) Is certified in both anatomic and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology.

(c) Bacteriology, Mycobacteriology, Mycology, Parasitology or Virology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of bacteriology, mycobacteriology, mycology, parasitology, or virology, the individual functioning as the technical supervisor must—

(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and

(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable microbiology subspecialty; or

(3)(i)(A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or

(B) Meet the requirements in § 493.1443(b)(3)(i)(B); and

(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or

(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or

(B)(1) Meet bachelor's degree equivalency; and

(2) Have at least 16 semester hours of additional graduate level coursework in chemical, biological, clinical or medical laboratory science, or medical technology; or

(C)(1) Meet bachelor's degree equivalency; and

(2) Have at least 16 semester hours in a combination of graduate level coursework in biology, chemistry, medical technology, or clinical or medical laboratory science and an approved thesis or research project related to laboratory testing for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings; and

(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty; or

(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or

(B) Have at least 120 semester hours, or equivalent, from an accredited institution that, at a minimum, includes either—

(1) Forty-eight (48) semester hours of medical laboratory technology courses; or

(2) Forty-eight (48) semester hours of science courses that include—

(i) Twelve (12) semester hours of chemistry, which must include general chemistry and biochemistry or organic chemistry;

(ii) Twelve (12) semester hours of biology, which must include general biology and molecular biology, cell biology or genetics; and

(iii) Twenty-four (24) semester hours of chemistry, biology, or medical laboratory science or technology in any combination; and

(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing within the specialty of microbiology with a minimum of 6 months of experience in high complexity testing within the applicable subspecialty.

(d) Diagnostic Immunology, Chemistry, Hematology, Radiobioassay, or Immunohematology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the specialty of diagnostic immunology, chemistry, hematology, radiobioassay, or immunohematology, the individual functioning as the technical supervisor must—

(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and

(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or

(3)(i)(A) Have an earned doctoral degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or

(B) Meet the education requirement at § 493.1443(b)(3)(i)(B); and

(ii) Have at least 1 year of laboratory training or experience, or both, in high complexity testing within the applicable specialty; or

(4)(i)(A) Have earned a master's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or

(B) Meet the education requirement at paragraph (c)(4)(i)(B) or (C) of this section; and

(ii) Have at least 2 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty; or

(5)(i)(A) Have earned a bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology from an accredited institution; or

(B) Meet the education requirement at paragraph (c)(5)(i)(B) of this section; and

(ii) Have at least 4 years of laboratory training or experience, or both, in high complexity testing for the applicable specialty.

(e) Cytology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of cytology, the individual functioning as the technical supervisor must—

(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2) An individual qualified under paragraph (b) or (e)(1) of this section may delegate some of the cytology technical supervisor responsibilities to an individual who is in the final year of full-time training leading to certification specified in paragraph (b) or (e)(1)(ii) of this section provided the technical supervisor qualified under paragraph (b) or (e)(1) of this section remains ultimately responsible for ensuring that all of the responsibilities of the cytology technical supervisor are met.

(f) Histopathology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of histopathology, the individual functioning as the technical supervisor must—

(1) Meet one of the following requirements:

(i)(A) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(B) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(ii) An individual qualified under paragraph (b) of this section or this paragraph (f)(1) may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(1)(i)(B) of this section, the responsibility for examination and interpretation of histopathology specimens.

(2) For tests in dermatopathology, meet one of the following requirements:

(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(B) Meet one of the following requirements:

(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2) Be certified in dermatopathology by the American Board of Dermatology and the American Board of Pathology; or

(3) Be certified in dermatology by the American Board of Dermatology; or

(ii) An individual qualified under paragraph (b) or (f)(2)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(2)(i)(B) of this section, the responsibility for examination and interpretation of dermatopathology specimens.

(3) For tests in ophthalmic pathology, meet one of the following requirements:

(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(B) Must meet one of the following requirements:

(1) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2) Be certified by the American Board of Ophthalmology and have successfully completed at least 1 year of formal post-residency fellowship training in ophthalmic pathology; or

(ii) An individual qualified under paragraph (b) or (f)(3)(i) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (f)(3)(i)(B) of this section, the responsibility for examination and interpretation of ophthalmic specimens; or

(g) Oral Pathology. If the requirements of paragraph (b) of this section are not met and the laboratory performs tests in the subspecialty of oral pathology, the individual functioning as the technical supervisor must meet one of the following requirements:

(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located; and

(ii) Be certified in anatomic pathology by the American Board of Pathology or the American Osteopathic Board of Pathology; or

(2) Be certified in oral pathology by the American Board of Oral Pathology; or

(3) An individual qualified under paragraph (b) or (g)(1) or (2) of this section may delegate to an individual who is a resident in a training program leading to certification specified in paragraph (b) or (g)(1) or (2) of this section, the responsibility for examination and interpretation of oral pathology specimens.

(h) Histocompatibility. If the laboratory performs tests in the specialty of histocompatibility, the individual functioning as the technical supervisor must either—

(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and

(ii) Have training or experience that meets one of the following requirements:

(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or

(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and

(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility; or

(2)(i) Have an earned doctoral degree in a biological, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at § 493.1443(b)(3)(i)(B); and

(ii) Have training or experience that meets one of the following requirements:

(A) Have 4 years of laboratory training or experience, or both, within the specialty of histocompatibility; or

(B)(1) Have 2 years of laboratory training or experience, or both, in the specialty of general immunology; and

(2) Have 2 years of laboratory training or experience, or both, in the specialty of histocompatibility.

(i) Clinical cytogenetics. If the laboratory performs tests in the specialty of clinical cytogenetics, the individual functioning as the technical supervisor must—

(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located; and

(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics; or

(2)(i) Hold an earned doctoral degree in a biological science, including biochemistry, clinical or medical laboratory science, or medical technology from an accredited institution; or meet the education requirement at § 493.1443(b)(3)(i)(B); and

(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of which have been in clinical cytogenetics.

Note 1 to paragraphs (b) through (i):

The technical supervisor requirements for “laboratory training or experience, or both” in each specialty or subspecialty may be acquired concurrently in more than one of the specialties or subspecialties of service. For example, an individual, who has a doctoral degree in chemistry and additionally has documentation of 1 year of laboratory experience working concurrently in high complexity testing in the specialties of microbiology and chemistry and 6 months of that work experience included high complexity testing in bacteriology, mycology, and mycobacteriology, would qualify as the technical supervisor for the specialty of chemistry and the subspecialties of bacteriology, mycology, and mycobacteriology.

(j) Notwithstanding any other provision of this section, an individual is considered qualified as a technical supervisor under this section if they were qualified and serving as a technical supervisor for high complexity testing in a CLIA-certified laboratory as of December 28, 2024, and have done so continuously since December 28, 2024.

[88 FR 90041, Dec. 28, 2023]