§ 571 — Definitions

New York § 571

• Jurisdiction: New York
• Law PBH: Public Health
• Title 5: Clinical Laboratory and Blood Banking Services
• Art. 5: Laboratories

Text

§ 571. Definitions. As used in this title:\n 1. "Clinical laboratory" means a facility for the microbiological,\nimmunological, chemical, hematological, biophysical, cytological,\npathological, genetic, or other examination of materials derived from\nthe human body, for the purpose of obtaining information for the\ndiagnosis, prevention, or treatment of disease or the assessment of a\nhealth condition or for identification purposes. Such examinations shall\ninclude procedures to determine, measure or otherwise describe the\npresence or absence of various substances, components or organisms in\nthe human body. The term clinical laboratory shall not include any\nfacility or activity specifically excluded by section five hundred\nseventy-nine of this title.\n 2. "Blood bank" means a facility for the collection, processing,\nstorage and/or distribution of human blood, blood components or blood\nderivatives, but shall not mean a source plasma donation center.\n 2-a. "Source plasma donation center" means a facility where source\nplasma is collected by plasmapheresis. "Source plasma" means the fluid\nportion of human blood collected by plasmapheresis and intended as\nsource material for plasma protein therapies. "Source plasma donation\ncenter" shall not include single donor plasma products intended for\nintravenous use.\n 2-b. "Plasmapheresis" means a procedure by which, during a single\nvisit to the facility, blood is removed from an individual, the source\nplasma separated from the formed elements, and at least the red blood\ncells are returned to the donor.\n 3. "Reference system" means a system of assessment of methods,\nprocedures and materials of clinical laboratories and blood banks,\nincluding, but not limited to, ongoing validation which may include\ndirect testing and experimentation by the department of such methods,\nprocedures and materials, the distribution of standards and guidelines,\ninspection of facilities, periodic submission of test specimens for\nexamination, and research conducted by the department that involves the\nstudy of new or existing methods, procedures and materials related to\nthe quality of clinical laboratory medicine.\n 4. "Director" means the person who is responsible for administration\nof the technical and scientific operation of a clinical laboratory or\nblood bank, including supervision of procedures and reporting of\nfindings of tests.\n 5. "Waived test" means a clinical laboratory test that has been\ndesignated as a waived test or is otherwise subject to certificate of\nwaiver requirements pursuant to the federal clinical laboratory\nimprovement act of nineteen hundred eighty-eight, as amended.\n * 6. "Qualified health care professional" means a physician, dentist,\npodiatrist, optometrist performing a clinical laboratory test that does\nnot use an invasive modality as defined in section seventy-one hundred\none of the education law, pharmacist administering COVID-19 and\ninfluenza tests pursuant to subdivision seven of section sixty-eight\nhundred one of the education law, physician assistant, specialist\nassistant, nurse practitioner, or midwife, who is licensed and\nregistered with the state education department.\n * NB Effective until July 1, 2026\n * 6. "Qualified health care professional" means a physician, dentist,\npodiatrist, optometrist performing a clinical laboratory test that does\nnot use an invasive modality as defined in section seventy-one hundred\none of the education law, physician assistant, specialist assistant,\nnurse practitioner, or midwife, who is licensed and registered with the\nstate education department.\n * NB Effective July 1, 2026\n 7. "Provider-performed microscopy procedure" means a procedure\nperformed by a qualified health care professional acting within the\nscope of his or her licensed profession, which has been designated as a\nprovider-performed microscopy procedure pursuant to the federal clinical\nlaboratory improvement act of nineteen hundred eighty-eight, as amended.\n 8. "Laboratory test registrant" means a person, partnership,\ncorporation, or other entity holding a valid certificate of registration\nto perform one or more waived tests or provider-performed microscopy\nprocedures pursuant to section five hundred seventy-nine of this title.\n