Assembly Bill A10125

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   10125
 
                           I N  A S S E M B L Y
 
                             February 2, 2026
                                ___________
 
 Introduced  by M. of A. WOERNER -- read once and referred to the Commit-
   tee on Health
 
 AN ACT to amend the public health law, in relation to  exempting  waived
   tests from clinical laboratory requirements
 
   THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
 BLY, DO ENACT AS FOLLOWS:

   Section 1. Paragraphs (a), (b),  (e)  and  (h)  of  subdivision  3  of
 section  579  of  the  public health law, paragraphs (a), (e) and (h) as
 added by chapter 204 of the laws of 2008, paragraph (b)  as  amended  by
 chapter  479 of the laws of 2013, are amended and a new paragraph (j) is
 added to read as follows:
   (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 require-
 ments 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] THIS CHAPTER 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
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
              

                                                            LBD14653-01-6
 A. 10125                            2
 
 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.
   (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.
   (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.
   (J) NOTWITHSTANDING ANY OTHER PROVISION OF LAW TO THE  CONTRARY,  THIS
 TITLE SHALL NOT APPLY TO ANY WAIVED TEST.
   § 2. This act shall take effect on the one hundred twentieth day after
 it shall have become a law.