Definition of the practice of clinical laboratory technology and clinical laboratory technology practitioner

§ 8601. Definition of the practice of clinical laboratory technology and clinical laboratory technology practitioner. 1. "Clinical laboratory technology" means the performance of microbiological, virological, serological, chemical, immunohematological, hematological, biophysical, cytogenetical, cytological or histological procedures and examinations and any other test or procedure conducted by a laboratory as defined by title five of article five of the public health law, on material derived from the human body which provides information for the diagnosis, prevention or treatment of a disease or assessment of a human medical condition.

2. A "clinical laboratory practitioner" means clinical laboratory technologists, cytotechnologists, histotechnologists, clinical laboratory technicians, and histotechnicians as such terms are defined in this subdivision, who practice clinical laboratory technology in a licensed clinical laboratory. For the purposes of this article, a licensed clinical laboratory does not include a laboratory operated by any licensed physician, dentist, podiatrist, midwife or certified nurse practitioner who performs laboratory tests or procedures, personally or through his or her employees, solely as an adjunct to the treatment of his or her own patients.

(a) "Clinical laboratory technologist" means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department of health, performs clinical laboratory procedures and examinations and any other tests or procedures conducted by a clinical laboratory, including maintaining equipment and records, and performing quality assurance activities related to examination performance, and which require the exercise of independent judgment and responsibility, as determined by the department.

(b) "Cytotechnologist" means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department of health, performs cytological procedures and examinations and any other such tests including maintaining equipment and records and performing quality assurance activities related to examination performance, and which require the exercise of independent judgment and responsibility, as determined by the department.

(c) "Histotechnologist" means a clinical laboratory practitioner who pursuant to established and approved protocols of the department of health performs slide based histological assays, tests, and procedures and any other such tests conducted by a clinical histology laboratory, including maintaining equipment and records and performing quality assurance activities relating to procedure performance on histological testing of human tissues, and which requires the exercise of independent judgment and responsibility as determined by the department.

(d) "Clinical laboratory technician" means a clinical laboratory practitioner who performs clinical laboratory procedures and examinations pursuant to established and approved protocols of the department of health, which require limited exercise of independent judgment and which are performed under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory.

(e) "Histotechnician" means a clinical laboratory practitioner who pursuant to established and approved protocols of the department of health performs slide based histological assays, tests, and procedures and any other such tests conducted by a clinical histology laboratory, including maintaining equipment and records and performing quality assurance activities relating to procedure performance on histological testing of human tissues and which requires limited exercise of independent judgment and is performed under the supervision of a laboratory supervisor, designated by the director of a clinical laboratory or under the supervision of the director of the clinical laboratory.

(f) "Director of a clinical laboratory" means a director as that term is defined in section five hundred seventy-one of the public health law.

(g) "Laboratory supervisor" means an individual who, under the general direction of the laboratory director, supervises technical personnel and reporting of findings, performs tests requiring special scientific skills, and, in the absence of the director, is responsible for the proper performance of all laboratory procedures.