CMS SOM App. C, Tag D6111

(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--

(b)(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

(b)(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—

(c)(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

(c)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or

the American Osteopathic Board of Pathology; or

(c)(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

(c)(2)(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

(c)(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

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

Interpretive Guidelines §493.1449(c)(3)(i)

NOTE: See §493.2 for the definition of an accredited institution, doctoral degree, and

laboratory training or experience.

(c)(3)(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

(c)(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

(c)(4)(i)(B)(1) Meet bachelor’s degree equivalency; and

(c)(4)(i)(B)(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)(4)(i)(C)(1) Meet bachelor’s degree equivalency; and

(c)(4)(i)(C)(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 coursework and an approved or research project related to

laboratory testing for the diagnosis, prevention, or treatment of any disease or

impairment of, or the or the assessment of the health of, human beings; and

(c)(4)(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

(c)(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

(c)(5)(i)(B) Have at least 120 semester hours, or equivalent, from an accredited

institution that, at a minimum, includes either—

(c)(5)(i)(B)(1) Forty-eight (48) semester hours of medical laboratory technology

courses; or

(c)(5)(i)(B)(2) Forty-eight (48) semester hours of science courses that include

(c)(5)(i)(B)(2)(i) Twelve (12) semester hours of chemistry, which must include

general chemistry and biochemistry or organic chemistry;

(c)(5)(i)(B)(2)(ii) Twelve (12) semester hours of biology, which must include general

biology and molecular biology, cell biology or genetics; and

(c)(5)(i)(B)(2)(iii) Twenty-four (24) semester hours of chemistry, biology, or

medical laboratory science or technology in any combination; and

(c)(5)(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—

(d)(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

(d)(1)(ii) Be certified in clinical pathology by the American Board of Pathology or

the American Osteopathic Board of Pathology; or

(d)(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

(d)(2)(ii) Have at least 1 year of laboratory training or experience, or both, in high

complexity testing for the applicable specialty; or

(d)(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

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

(d)(3)(ii) Have at least 1 year of laboratory training or experience, or both, in high

complexity testing within the applicable specialty; or

(d)(4)(i)(A) Have an earned master’s degree in a chemical, biological, clinical or

medical laboratory science, or medical technology from an accredited institution; or

(d)(4)(i)(B) Meet the education requirement at paragraphs (c)(4)(i)(B) or (C) of this

section; and

(d)(4)(ii) Have at least 2 years of laboratory training or experience, or both, in high

complexity testing for the applicable specialty; or

(d)(5)(i)(A) Have an earned bachelor’s degree in a chemical, biological, clinical or

medical laboratory science, or medical technology from an accredited institution; or

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

and

(d)(5)(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—

(e)(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

(e)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or

the American Osteopathic Board of Pathology; or

(e)(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.

Interpretive guidelines 493.1449(e)(2):

NOTE: Delegation of cytology technical supervisor responsibilities to an individual in

the final year of full-time training leading to certification may not include interpretation

of cytology specimens.

CMS considers those individuals who have completed their training and are waiting to

obtain their board certification to qualify under this regulation.

(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—

(f)(1) Meet one of the following requirements:

(f)(1)(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

(f)(1)(i)(B) Be certified in anatomic pathology by the American Board of Pathology

or the American Osteopathic Board of Pathology; or

Interpretive Guidelines 493.1449(f)(1)(i)(B):

An individual who has successfully completed a training program in neuromuscular

pathology approved by HHS may examine and provide reports for neuromuscular

pathology. In July 2003, HHS approved The American Academy of Neurology

Committee for Neuromuscular Pathology Training Program.

(f)(1)(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.

Interpretive Guidelines 493.1449(f)(1)(ii):

CMS considers those individuals who have completed their residency and are waiting to

obtain their board certification to qualify under this regulation.

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

(f)(2)(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

(f)(2)(i)(B) Meet one of the following requirements:

(f)(2)(i)(B)(1) Be certified in anatomic pathology by the American Board of

Pathology or the American Osteopathic Board of Pathology; or

(f)(2)(i)(B)(2) Be certified in dermatopathology by the American Board of

Dermatology and the American Board of Pathology; or

(f)(2)(i)(B)(3) Be certified in dermatology by the American Board of Dermatology;

or

Interpretive Guidelines 493.1449(f)(2)(i)(B)(3):

Certification in dermatology by the American Osteopathic Board of Dermatology is

equivalent to board certification by the American Board of Dermatology.

(f)(2)(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.

Interpretive Guidelines 493.1449(f)(2)(ii):

CMS considers those individuals who have completed their residency and are waiting to

obtain their board certification to qualify under this regulation.

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

(f)(3)(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

(f)(3)(i)(B) Must meet one of the following requirements:

(f)(3)(i)(B)(1) Be certified in anatomic pathology by the American Board of

Pathology or the American Osteopathic Board of Pathology; or

(f)(3)(i)(B)(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

(f)(3)(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

Interpretive guidelines 493.1449(f)(3)(ii):

CMS considers those individuals who have completed their residency and are waiting to

obtain their board certification to qualify under this regulation.

(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:

(g)(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

(g)(1)(ii) Be certified in anatomic pathology by the American Board of Pathology or

the American Osteopathic Board of Pathology; or

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

(g)(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.

Interpretive Guidelines 493.1449(g)(3):

CMS considers those individuals who have completed their residency and are waiting to

obtain their board certification to qualify under this regulation.

(h) Histocompatibility - If the laboratory performs tests in the specialty of

histocompatibility, the individual functioning as the technical supervisor must

either—

(h)(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

(h)(1)(ii) Have training or experience that meets one of the following requirements:

(h)(1)(ii)(A) Have 4 years of laboratory training or experience, or both, within the

specialty of histocompatibility; or

(h)(1)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the

specialty of general immunology; and

(h)(1)(ii)(B)(2) Have 2 years of laboratory training or experience, or both, in the

specialty of histocompatibility; or

(h)(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

(h)(2)(ii) Have training or experience that meets one of the following requirements:

(h)(2)(ii)(A) Have 4 years of laboratory training or experience, or both, within the

specialty of histocompatibility; or

(h)(2)(ii)(B)(1) Have 2 years of laboratory training or experience, or both, in the

specialty of general immunology; and

(h)(2)(ii)(B)(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—

(i)(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

(i)(1)(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of

which have been in clinical cytogenetics; or

(i)(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

(i)(2)(ii) Have 4 years of laboratory training or experience, or both, in genetics, 2 of

which have been in clinical cytogenetics.

(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.

Interpretive Guidelines §493.1449(j)

The grandfathering provision will allow individuals already qualified and employed as a

technical supervisor of high complexity testing as of the effective date of the final rule

December 28, 2024, to continue to be qualified under the new provisions provided the

individuals remain continuously employed in their position after the effective date of

December 28, 2024. To be considered “continuously employed,” in their position, the

individual may have no more than 6 months of break in employment in their position in a

two-year period.

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.