N.Y. Public Health Law § 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.