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This entry was published on 2014-09-22
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SECTION 576
Duties and powers of the department
Public Health (PBH) CHAPTER 45, ARTICLE 5, TITLE 5
§ 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.