2023 New York Laws › PBH - Public Health › Article 5 - Laboratories › Title 5 - Clinical Laboratory and Blood Banking Services › 579 - Scope and Exceptions.

§  579.  Scope  and  exceptions.  1.  This  title is applicable to all
clinical laboratories and blood banks operating within the state, except
clinical laboratories and blood banks operated by the federal government
and clinical laboratories operated by a licensed  physician,  osteopath,
dentist,  midwife, nurse practitioner, 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 or podiatrist who
performs laboratory tests or procedures, personally or  through  his  or
her  employees,  solely as an adjunct to the treatment of his or her own
patients; to the extent authorized by federal and state  law,  including
the education law.
2.  This title shall not be applicable to and the department shall not
have the power to regulate pursuant to this title: (a)  any  examination
performed  by  a state or local government of materials derived from the
human body for use in  criminal  identification  or  as  evidence  in  a
criminal   proceeding  or  for  investigative  purposes;  (b)  any  test
conducted pursuant to paragraph  (c)  of  subdivision  four  of  section
eleven  hundred ninety-four of the vehicle and traffic law and paragraph
(c) of subdivision eight of section 25.24 of the parks,  recreation  and
historic  preservation  law; (c) any examination performed by a state or
local agency of materials derived  from  the  body  of  an  incarcerated
individual,   pretrial   releasee,   parolee,  conditional  releasee  or
probationer to (i) determine, measure or otherwise describe the presence
or absence of any  substance  whose  possession,  ingestion  or  use  is
prohibited  by  law,  the  rules  of  the  department of corrections and
community supervision, the conditions  of  release  established  by  the
board  of  parole, the conditions of release established by a court or a
local conditional release commission or the conditions of any program to
which such individuals are referred and (ii) to determine whether  there
has  been  a  violation  thereof;  or (d) any examination performed by a
coroner or medical examiner for the  medical-legal  investigation  of  a
death.  Nothing herein shall prevent the department from consulting with
the division of criminal justice services, the department of corrections
and community supervision, the state police, or any other  state  agency
or  commission,  at  the  request  of  the  division of criminal justice
services, the department of corrections and community  supervision,  the
state police, or such other agency or commission, concerning examination
of materials for purposes other than public health.
3.  (a) This title shall not be applicable to any person, partnership,
corporation  or   other   entity   performing   any   waived   test   or
provider-performed   microscopy   procedure,   provided   such   person,
partnership, corporation or  other  legal  entity:  (i)  holds  a  valid
certificate  of  registration  issued  by the department authorizing the
performance of one or more waived tests or provider-performed microscopy
procedures; and (ii) only performs tests authorized by  the  certificate
of  registration;  and  (iii)  otherwise  complies  with  all applicable
requirements of this subdivision.
(b) The department may issue a certificate of registration authorizing
the performance of  one  or  more  waived  tests  or  provider-performed
microscopy  procedures for a period of up to two years if the applicant:
(i) files a completed application with the department on such  forms  as
the  commissioner  may prescribe; (ii) provides documentation acceptable
to  the  department  demonstrating  the  ability  to  comply  with   the
requirements  of  this  subdivision; and (iii) pays a two hundred dollar
biennial registration fee for each location where services are rendered;
except that a voluntary ambulance service as defined in  article  thirty
of  the  public health law and operated under section two hundred nine-b
of the general municipal law shall be exempt from the requirement to pay

a fee to obtain this certificate of registration; and  except  that  the
following may operate multiple locations under a single registration and
pay  a  single  registration  fee:  (A)  not-for-profit,  state or local
government  laboratories  or  programs  engaged in limited public health
testing not exceeding fifteen types of tests per  registration;  or  (B)
applicants  that maintain a fixed location in the state and are approved
by the department to move from testing site to testing site.
(c) Laboratory test registrants shall: (i) provide only the tests  and
services  listed on the registration issued by the department hereunder;
(ii) advise the department of  any  change  in  the  registrant's  name,
ownership,  location or qualified health care professional or laboratory
director designated to supervise testing  within  thirty  days  of  such
change;  (iii)  provide  the  department  with  immediate  access to all
facilities,  equipment,  records,  and  personnel  as  required  by  the
department  to  determine  compliance with this subdivision; (iv) comply
with all public  health  law  and  federal  requirements  for  reporting
reportable  diseases  and  conditions to the same extent and in the same
manner as a clinical laboratory;  (v)  perform  one  or  more  tests  as
required  by  the department to determine the proficiency of the persons
performing such tests;  and  (vi)  designate  a  qualified  health  care
professional   or   qualified   individual   holding  a  certificate  of
qualification pursuant to section five  hundred  seventy-three  of  this
title,   who  shall  be  jointly  and  severally  responsible  for:  (A)
establishing, approving and continuously updating  policies,  procedures
and  personnel qualifications for each test employed; (B) establishing a
comprehensive quality  assurance  system  which  includes,  but  is  not
limited  to,  test  selection,  test quality, laboratory proficiency and
personnel competency; (C) ensuring all tests are performed in accordance
with the  manufacturers'  instructions  and  standards  of  practice  in
laboratory  medicine;  (D)  maintaining complete and accurate records of
the tests performed, including but not limited to, the  patient's  name,
results,  person  performing  the  test,  and  quality control data; (E)
ensuring that persons do not  participate  in  diagnostic  or  treatment
decisions  using such test results unless such persons are authorized by
law to do so; (F) ensuring that provider-performed microscopy procedures
are performed only by a qualified  health  care  professional  operating
within  the  scope  of practice for his or her profession and as part of
the  physical  examination  performed  by  such  professional;  and  (G)
complying with other applicable laws, rules and regulations.
(d) A certificate of registration shall become void by a change in the
owner of the laboratory test registrant or location of testing.
(e) Notwithstanding the foregoing, if the commissioner determines that
the  performance  of  a  particular  waived  test  or provider-performed
microscopy procedure in a facility or location which does not possess  a
New  York state clinical laboratory permit creates a risk of harm to the
subjects of such test, the commissioner may issue an  order  prohibiting
such  test  from  being performed in any location other than a permitted
clinical laboratory, physician's office or other  location  exempted  by
subdivision one or two of this section.
(f)  Registration  under  this  subdivision  may  be  denied, limited,
suspended, revoked or annulled by the department  upon  a  determination
that  a  laboratory  services  registrant: (i) failed to comply with the
requirements of this subdivision; (ii) provided services that constitute
an unwarranted risk to human health; (iii)  intentionally  provided  any
false   or   misleading   information  to  the  department  relating  to
registration or performing laboratory services; or (iv) has demonstrated
incompetence  or  shown  consistent  errors  in   the   performance   of
examinations  or  procedures.  A  registration  shall  not  be  limited,

suspended, revoked or annulled without a hearing conducted in accordance
with subdivision four of section  five  hundred  seventy-seven  of  this
title.  However,  a  registration may be temporarily limited, suspended,
revoked  or annulled without a hearing for a period not to exceed thirty
days upon notice to the registrant following a finding by the department
that the public health, safety or welfare is in imminent danger.
(g) The commissioner may adopt such rules and regulations  as  may  be
necessary to effectuate the purposes of this subdivision.
(h)  Any  person,  partnership, corporation or other entity performing
waived tests or provider-performed microscopy procedures  without  being
authorized  to  do so pursuant to this title shall be subject to a civil
penalty of up to five hundred dollars for each test  performed,  not  to
exceed two thousand dollars per day for each day tests are performed, in
violation of this subdivision.
(i)   All   fees  and  civil  penalties  collected  pursuant  to  this
subdivision  shall  be  deposited  in  the   special   revenue   account
established  for  the receipt of inspection and reference fees collected
pursuant to section five hundred seventy-six of this title and shall  be
subtracted  from  the  operating  expenses  of  the  department prior to
calculation of such inspection and reference fees.