NY Pub Health L § 576 (2021)
2021 New York Laws PBH - Public Health Article 5 - Laboratories Title 5 - Clinical Laboratory and Blood Banking Services 576 - Duties and Powers of the Department.

§  576.  Duties  and  powers  of the department. 1. The department may inquire into the operation of clinical laboratories and blood banks  and may  conduct  periodic  inspections  and/or  evaluations  of facilities, methods, procedures, materials, staff and equipment to assess compliance with requirements set forth in this title, the  regulations  promulgated hereunder   and  local  laws,  codes  or  regulations  as  specified  in subdivision three of section five hundred eighty of this title.   2. The department may require clinical laboratories and blood banks to submit, in a form prescribed by  the  department,  periodic  reports  of tests performed and such other information as the department may require to  carry  out  the  provisions  of this title. The department may adopt regulations to require clinical laboratories and blood banks  to  report all  serious  adverse  incidents  which may be connected to the clinical laboratory or blood bank services provided. Such incident reports  shall be  deemed  confidential  in  the  same manner as such reports submitted pursuant to section twenty-eight hundred five-m  of  this  chapter.  The department  may  also  require  clinical laboratories and blood banks to submit lists  of  personnel  who  are  employed  to  perform  laboratory procedures  and to notify the department promptly of any changes in such personnel.   3. The department shall operate a reference system and shall prescribe standards for the proper operation of clinical  laboratories  and  blood banks  and  for  the examination of specimens. As part of such reference system, the department may review and approve testing methods  developed or  modified  by  clinical  laboratories  and  blood  banks prior to the testing methods being offered in this state, and  may  require  clinical laboratories  and  blood  banks to analyze test samples submitted by the department and to report on the results of such analyses. The rules  and regulations  of  the department shall prescribe the requirements for the proper operation of  a  clinical  laboratory  or  blood  bank,  for  the approval  of  methods  and  the  manner  in which proficiency testing or analyses of samples shall be performed and reports submitted. Failure to meet department  standards  for  the  proper  operation  of  a  clinical laboratory  or  blood  bank,  including  the  criteria  for  approval of methods, or failure to maintain satisfactory performance in  proficiency testing  shall  result  in  termination of the permit in the category or categories of testing established by the department in regulation  until remediation  is  achieved. Such standards shall be at least as stringent as federal standards promulgated under the federal  clinical  laboratory improvement  amendments  of  nineteen hundred eighty-eight. Such failure and  termination  shall  be  subject  to  review  in   accordance   with regulations adopted by the department.   4.  (a)  The  department  may adopt and amend rules and regulations to effectuate the provisions and purposes of this  title.  Such  rules  and regulations  shall  establish  fees  for clinical laboratories and blood banks in amounts not exceeding the cost  of  the  reference  system  for clinical  laboratories  and  blood  banks  and  shall  be subject to the approval of the director  of  the  budget.  For  the  purposes  of  this subdivision, standard federally established governmental cost allocation practices shall be used by the commissioner to determine the cost of the reference   system.   The   department  shall  make  available,  on  the department's website, information on the costs included  in  determining the permitted laboratories' fees. The department shall not deem as costs of  the  reference  system,  costs  associated  with  federal grants and patents which are not related to the reference system. The fee  paid  by the  department  to  maintain an exemption for clinical laboratories and blood banks from the requirements of  the  federal  clinical  laboratory  improvement  amendments of nineteen hundred eighty-eight shall be deemed a cost of the reference system.  (b)  In  determining  the  fee  charges to be assessed, the department shall, on or before May first of each year, compute the  costs  for  the preceding   state  fiscal  year  which  were  expended  to  operate  and administer the duties of the department  pursuant  to  this  title.  The department  shall,  at such time or times and pursuant to such procedure as it shall determine by regulation, bill and collect from each clinical laboratory and blood bank an amount computed by multiplying  such  total computed  operating  expenses  of  the  department  by  a  fraction  the numerator of which  is  the  gross  annual  receipts  of  such  clinical laboratory  or  blood bank during such twelve month period preceding the date of computation as the department shall designate by regulation, and the denominator of which is the  total  gross  annual  receipts  of  all clinical  laboratories or blood banks operating in the state during such period.  (c) Each such clinical laboratory and blood bank shall submit  to  the department,  in  such  form  and  at  such  times  as the department may require, a report containing  information  regarding  its  gross  annual receipts for all activities performed pursuant to a permit issued by the department  in  accordance  with  the provisions of section five hundred seventy-five of  this  title.  The  department  may  require  additional information  and  audit  and  review  such  information  to  verify  its accuracy.  (d) Partial payments equal to one-quarter of the total amount  billed, may  be  made on or before June thirtieth, September thirtieth, December thirty-first and March tenth of the fiscal year  to  which  the  billing relates.  (e)  On  or  before  September  fifteenth of each year, the department shall reconcile its costs and expenses for the reference system for  the preceding  state  fiscal  year and shall, on or before October fifteenth send to each clinical laboratory and blood  bank,  a  statement  setting forth  the  amount  due  and  payable  by, or the amount computed to the credit of, such clinical laboratory or blood bank, computed on the basis of the above stated formula,  except  that  for  the  purposes  of  such computation   the   fraction  shall  be  multiplied  against  the  total recomputed expenses of the department for such fiscal year.  Any  amount due  shall  be  payable not later than thirty days following the date of such statement. Any credit  shall  be  applied  against  any  succeeding payment due.  (f) The commissioner may waive all or any part of such fee charges for clinical  laboratories  or blood banks operated by local governments and for  nonprofit  clinical  laboratories   or   blood   banks   performing examinations  and analyses or providing services under contract with the state or its local governments.  (g) Subject to the  approval  of  the  director  of  the  budget,  the commissioner  shall charge adequate and reasonable fees for the periodic inspection of out-of-state clinical laboratories and  blood  banks,  not exceeding  the  estimated  additional  costs  incurred  for out-of-state inspections under this title.   5.  The  department,  within  the  amounts  appropriated,  may  employ inspectors,   investigators,  assistants  and  other  employees  or  may contract with the city of New York to carry out the provisions  of  this title, set the compensation of such employees, within limits provided by law, and prescribe the duties of such employees.   6.  The  commissioner  may  appoint one or more advisory committees of persons expert in the major categories of clinical laboratory procedures to advise the commissioner in  connection  with  the  qualifications  of  technical personnel employed and the use of appropriate procedures. Each such  advisory  committee  shall  include  at  least one designee of the commissioner of the department of health of the city of New York.   7. The department may adopt rules or regulations applicable only to or in  the  city of New York which are designed to address special needs or circumstances existing in such city. The department shall  consider  the recommendations  of  the city of New York, or the department or board of health of such city, concerning the adoption or amendment  of  any  such rules or regulations.   8.  The  department  may  enter  into agreements with the secretary of health  and  human  services  as  authorized  by  the  federal  clinical laboratory  improvement  act  of nineteen hundred eighty-eight and title XVIII of the social  security  act  to  perform  such  acts  as  may  be necessary to assure conformance with such laws by laboratories operating in the state.