N.Y. Public Health Law § 571: Definitions

§ 571. Definitions. As used in this title:

1. "Clinical laboratory" means a facility for the microbiological,

immunological, chemical, hematological, biophysical, cytological,

pathological, genetic, or other examination of materials derived from

the human body, for the purpose of obtaining information for the

diagnosis, prevention, or treatment of disease or the assessment of a

health condition or for identification purposes. Such examinations shall

include procedures to determine, measure or otherwise describe the

presence or absence of various substances, components or organisms in

the human body. The term clinical laboratory shall not include any

facility or activity specifically excluded by section five hundred

seventy-nine of this title.

2. "Blood bank" means a facility for the collection, processing,

storage and/or distribution of human blood, blood components or blood

derivatives, but shall not mean a source plasma donation center.

2-a. "Source plasma donation center" means a facility where source

plasma is collected by plasmapheresis. "Source plasma" means the fluid

portion of human blood collected by plasmapheresis and intended as

source material for plasma protein therapies. "Source plasma donation

center" shall not include single donor plasma products intended for

intravenous use.

2-b. "Plasmapheresis" means a procedure by which, during a single

visit to the facility, blood is removed from an individual, the source

plasma separated from the formed elements, and at least the red blood

cells are returned to the donor.

3. "Reference system" means a system of assessment of methods,

procedures and materials of clinical laboratories and blood banks,

including, but not limited to, ongoing validation which may include

direct testing and experimentation by the department of such methods,

procedures and materials, the distribution of standards and guidelines,

inspection of facilities, periodic submission of test specimens for

examination, and research conducted by the department that involves the

study of new or existing methods, procedures and materials related to

the quality of clinical laboratory medicine.

4. "Director" means the person who is responsible for administration

of the technical and scientific operation of a clinical laboratory or

blood bank, including supervision of procedures and reporting of

findings of tests.

5. "Waived test" means a clinical laboratory test that has been

designated as a waived test or is otherwise subject to certificate of

waiver requirements pursuant to the federal clinical laboratory

improvement act of nineteen hundred eighty-eight, as amended.

* 6. "Qualified health care professional" means a physician, dentist,

podiatrist, optometrist performing a clinical laboratory test that does

not use an invasive modality as defined in section seventy-one hundred

one of the education law, pharmacist administering COVID-19 and

influenza tests pursuant to subdivision seven of section sixty-eight

hundred one of the education law, physician assistant, specialist

assistant, nurse practitioner, or midwife, who is licensed and

registered with the state education department.

* NB Effective until July 1, 2030

* 6. "Qualified health care professional" means a physician, dentist,

podiatrist, optometrist performing a clinical laboratory test that does

not use an invasive modality as defined in section seventy-one hundred

one of the education law, physician assistant, specialist assistant,

nurse practitioner, or midwife, who is licensed and registered with the

state education department.

* NB Effective July 1, 2030

7. "Provider-performed microscopy procedure" means a procedure

performed by a qualified health care professional acting within the

scope of his or her licensed profession, which has been designated as a

provider-performed microscopy procedure pursuant to the federal clinical

laboratory improvement act of nineteen hundred eighty-eight, as amended.

8. "Laboratory test registrant" means a person, partnership,

corporation, or other entity holding a valid certificate of registration

to perform one or more waived tests or provider-performed microscopy

procedures pursuant to section five hundred seventy-nine of this title.