§ 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, 2026

* 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, 2026

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.