A 8818: Permits out-of-state clinical laboratories located within the United States to accept specimens from New York when there are no proper labs within the state recognized by the department of health.

  
  STATE OF NEW YORK ________________________________________________________________________ 8818 2025-2026 Regular Sessions  IN ASSEMBLY 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: 1 Section 1. Section 572 of the public health law, as amended by chapter 2 562 of the laws of 2024, is amended to read as follows: 3 § 572. Certificates of qualification. 1. No person shall act as a 4 director in a clinical laboratory located in or accepting specimens from 5 New York state or in a blood bank located in or collecting, processing, 6 storing or distributing blood products in New York state unless a valid 7 certificate of qualification has been issued as provided in section five 8 hundred seventy-three of this title. 9 2. (a) The provisions of subdivision one of this section shall not 10 apply to an out-of-state clinical laboratory, located within the United 11 States, that accepts specimens from New York state for the purposes of 12 conducting a clinical laboratory test that has been recognized by the 13 department as unavailable within New York state. 14 (b) For the purposes of this section, a clinical laboratory test shall 15 be considered unavailable within New York state if it appears on the 16 list of unavailable tests published on the department's website as of 17 the date that the specimen was collected. Such list shall be created by 18 the commissioner or their designee and updated at least biannually. 19 § 2. Section 574 of the public health law, as amended by chapter 436 20 of the laws of 1993, is amended to read as follows: 21 § 574. Permits. 1. No person shall own or operate a clinical laborato- 22 ry located in or accepting specimens from New York state or own or oper- 23 ate a blood bank which collects, processes, stores and/or distributes, 24 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 1 unless a valid permit has been issued as provided in section five 2 hundred seventy-five of this title. A permit shall be issued authorizing 3 the performance of one or more procedures or services within one or more 4 categories. A separate permit shall be required for each facility at 5 which clinical laboratory tests are to be performed or at which a blood 6 bank is to be operated, provided, however that the department may adopt 7 regulations not inconsistent with the federal clinical laboratory 8 improvement act of nineteen hundred eighty-eight authorizing an owner to 9 operate more than one facility under a single permit. 10 2. (a) The provisions of subdivision one of this section shall not 11 apply to an out-of-state clinical laboratory, located within the United 12 States, that accepts specimens from New York state for the purposes of 13 conducting a clinical laboratory test that has been recognized by the 14 department as unavailable within New York state. 15 (b) For the purposes of this section, a clinical laboratory test shall 16 be considered unavailable within New York state if it appears on the 17 list of unavailable tests published on the department's website as of 18 the date that the specimen was collected. Such list shall be created by 19 the commissioner or their designee and updated at least biannually. 20 § 3. This act shall take effect on the one hundred eightieth day after 21 it shall have become a law.