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Title: Section 19.1 - Definitions

Effective Date


19.1 Definitions. (a) Clinical laboratory director means the individual responsible for administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of test procedures, the reporting of results, and the duties and responsibilities specified in section 19.3 of this Part.

(b) Acceptable laboratory means a clinical laboratory or blood bank of a hospital, health department, university, medical research institution, independent clinical laboratory or blood bank, or other facility providing equivalent training and/or experience in patient specimen testing, which has a director who meets or would meet the requirements of this Part and which meets or would meet the commissioner's standards as outlined in Part 58 of this Title.

(c) Accredited means having the approval (accreditation) conferred on schools, institutions or programs by an accrediting agency or agency or association recognized by the United States Secretary of Education and verified as such by the commissioner.

(d) Physician means a physician who is licensed and currently registered to practice medicine in New York State or in the state in which he or she practices.

(e) Dentist means a dentist who is licensed and currently registered to practice dentistry in New York State or in the state in which he or she practices.

(f) Certificate of qualification means a credential issued by the department to applicants meeting the requirements set forth in this Part.

(g) Grandfathered laboratory director means a laboratory director who qualified for and received a certificate of qualification in one or more categories of testing prior to the amendment of this regulation which became effective January 25, 1988.

(h) Category means an area, procedure, or specialty of laboratory medicine specified in section 19.3(d) of this Part.

(i) Blood banking-collection means collection of blood or blood components, or processing of blood or blood components.

(j) Referring physician means a physician or other person authorized by law to order laboratory tests and receive reports, as specified in Subpart 58-1 of this Title.

(k) Virology means isolation and other characterization of virus.

(l) Diagnostic immunology means application of immunologic techniques to detect the presence of antigens in biologic fluids and determine host-antibody responses.

(m) Transfusion service means a service which issues blood or blood components for administration into a person, but does not include a limited transfusion service, as defined in section 58-2.1(k) of this Title.

(n) Genetic testing means enzyme, substrate, and DNA-based analyses, or qualitative and/or quantitative measurement of other body analytes, undertaken to determine the genetic status (carrier or disease) of a person.


VOLUME A (Title 10)