Assembly Bill A8818

                             
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   8818
 
                        2025-2026 Regular Sessions
 
                           I N  A S S E M B L Y
 
                               June 9, 2025
                                ___________
 
 Introduced by M. of A. JENSEN -- read once and referred to the Committee
   on Health
 
 AN ACT to amend the public health law, in relation to permitting certain
   out-of-state  clinical  laboratories to accept specimens from New York
   when there are no proper labs within the state

   THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND  ASSEM-
 BLY, DO ENACT AS FOLLOWS:
 
   Section 1. Section 572 of the public health law, as amended by chapter
 562 of the laws of 2024, is amended to read as follows:
   §  572.  Certificates  of  qualification.  1. No person shall act as a
 director in a clinical laboratory located in or accepting specimens from
 New York state or in a blood bank located in or collecting,  processing,
 storing  or distributing blood products in New York state unless a valid
 certificate of qualification has been issued as provided in section five
 hundred seventy-three of this title.
    2. (A) THE PROVISIONS OF SUBDIVISION ONE OF THIS  SECTION  SHALL  NOT
 APPLY  TO AN OUT-OF-STATE CLINICAL LABORATORY, LOCATED WITHIN THE UNITED
 STATES, THAT ACCEPTS SPECIMENS FROM NEW YORK STATE FOR THE  PURPOSES  OF
 CONDUCTING  A  CLINICAL  LABORATORY TEST THAT HAS BEEN RECOGNIZED BY THE
 DEPARTMENT AS UNAVAILABLE WITHIN NEW YORK STATE.
   (B) FOR THE PURPOSES OF THIS SECTION, A CLINICAL LABORATORY TEST SHALL
 BE CONSIDERED UNAVAILABLE WITHIN NEW YORK STATE IF  IT  APPEARS  ON  THE
 LIST  OF  UNAVAILABLE  TESTS PUBLISHED ON THE DEPARTMENT'S WEBSITE AS OF
 THE DATE THAT THE SPECIMEN WAS COLLECTED. SUCH LIST SHALL BE CREATED  BY
 THE COMMISSIONER OR THEIR DESIGNEE AND UPDATED AT LEAST BIANNUALLY.
   §  2.  Section 574 of the public health law, as amended by chapter 436
 of the laws of 1993, is amended to read as follows:
   § 574. Permits. 1. No person shall own or operate a clinical laborato-
 ry located in or accepting specimens from New York state or own or oper-
 ate a blood bank which collects, processes, stores  and/or  distributes,
 human  blood,  blood  derivatives or blood components, in New York state
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00480-01-5
              

 A. 8818                             2
 
 unless a valid permit has  been  issued  as  provided  in  section  five
 hundred seventy-five of this title. A permit shall be issued authorizing
 the performance of one or more procedures or services within one or more
 categories.  A  separate  permit  shall be required for each facility at
 which clinical laboratory tests are to be performed or at which a  blood
 bank  is to be operated, provided, however that the department may adopt
 regulations  not  inconsistent  with  the  federal  clinical  laboratory
 improvement act of nineteen hundred eighty-eight authorizing an owner to
 operate more than one facility under a single permit.
   2.  (A)  THE  PROVISIONS  OF SUBDIVISION ONE OF THIS SECTION SHALL NOT
 APPLY TO AN OUT-OF-STATE CLINICAL LABORATORY, LOCATED WITHIN THE  UNITED
 STATES,  THAT  ACCEPTS SPECIMENS FROM NEW YORK STATE FOR THE PURPOSES OF
 CONDUCTING A CLINICAL LABORATORY TEST THAT HAS BEEN  RECOGNIZED  BY  THE
 DEPARTMENT AS UNAVAILABLE WITHIN NEW YORK STATE.
   (B) FOR THE PURPOSES OF THIS SECTION, A CLINICAL LABORATORY TEST SHALL
 BE  CONSIDERED  UNAVAILABLE  WITHIN  NEW YORK STATE IF IT APPEARS ON THE
 LIST OF UNAVAILABLE TESTS PUBLISHED ON THE DEPARTMENT'S  WEBSITE  AS  OF
 THE  DATE THAT THE SPECIMEN WAS COLLECTED. SUCH LIST SHALL BE CREATED BY
 THE COMMISSIONER OR THEIR DESIGNEE AND UPDATED AT LEAST BIANNUALLY.
   § 3. This act shall take effect on the one hundred eightieth day after
 it shall have become a law.