Title 7 . Health and Social Services

Chapter 12 . Assistance for Community Health Facilities

Section 840. Supervision and direction of laboratory service

7 AAC 12.840. Supervision and direction of laboratory service

(a) A laboratory must be under the supervision and direction of one of the following:

(1) a physician who meets the requirements of (e) of this section and who is employed by the laboratory or who is a consulting physician under contract to the laboratory;

(2) a laboratory specialist who meets the requirements of (g) of this section and who is employed by the laboratory or who is under contract to the laboratory; or

(3) a medical technologist employed by the laboratory who meets the requirements of (f) of this section.

(b) If a medical technologist described in (a)(3) of this section is supervising the laboratory under contract, then a consulting physician supervising the laboratory or a laboratory specialist supervising the laboratory under contract must make quarterly visits to the laboratory, and prepare a written evaluation with recommendations to the administrator and medical staff of the facility following each visit. For a consulting physician, up to two of the required visits and evaluations may be made by his or her representative who is a medical technologist competent in one or more laboratory specialties. If a medical technologist described in (a)(3) of this section supervises a laboratory, then either a consulting physician under (a)(1) of this section or a contracted laboratory specialist under (a)(2) of this section must make at least biannual visits to the laboratory and prepare a written evaluation and recommendations following the visits.

(c) A person who exercises supervisory responsibility must have at least the level of training of a medical technologist described in (i) of this section.

(d) A medical technologist must provide direct supervision to technicians.

(e) A physician described in (a)(1) of this section must

(1) be certified in anatomical and clinical pathology by the American Board of Pathology or the American Osteopathic Board of Pathology or be eligible for board certification, as determined by the department;

(2) be certified by the American Board of Pathology or the American Osteopathic Board of Pathology in at least one of the laboratory specialties, or be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to the department in one of the laboratory specialties; or

(3) after graduation, have had four or more years of full-time general laboratory training and experience, of which at least two years were spent acquiring proficiency in one of the laboratory specialties in an approved laboratory.

(f) A medical technologist who supervises a laboratory under (a)(3) must meet the following requirements:

(1) have at least six years of full-time laboratory experience working with human body fluids, after the date of qualifying as a medical technologist, of which not less than two years was spent working in a particular laboratory specialty in an approved laboratory; and

(2) participate in continuing education in laboratory supervisory and management skills and laboratory testing skills in at least one testing service as described in 7 AAC 12.850, offered by the laboratory.

(g) A laboratory specialist who supervises a laboratory under (a)(2) of this section must have a doctoral degree from an accredited institution with a chemical, physical, or biological science as a major subject, and

(1) be certified by the American Board of Medical Microbiology, the American Board of Clinical Chemistry, the American Board of Bioanalysis, or other national accrediting board acceptable to the department in one of the laboratory specialties, or

(2) after graduation, have had four or more years of full-time general clinical laboratory training and experience, of which at least two years were spent acquiring proficiency in one of the laboratory specialties in an approved laboratory.

(h) In this section, "laboratory specialties" include microbiology, serology, chemistry, hematology, and immunohematology.

(i) In this section, "medical technologist" means a person who is a graduate of a medical technology program approved by a nationally recognized body acceptable to the department or who has documented equivalent education, training, or experience, as determined by the department, or has achieved a satisfactory grade in a proficiency examination given by the former United States Department of Health, Education and Welfare or the United States Department of Health and Human Services.

(j) In this section, "technician" means a person who has received academic and on-the-job training in basic laboratory techniques.

(k) In this section,"direct supervision" means that the supervisor is present during and closely supervises the performance of testing.

History: Eff. 11/19/83, Register 88

Authority: AS 18.05.040

AS 18.20.010

AS 18.20.060