2023 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.