2022 New York Laws
PBH - Public Health
Article 5 - Laboratories
Title 5 - Clinical Laboratory and Blood Banking Services
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 April 9, 2024
* 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 April 9, 2024

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.