§ 576 — Duties and powers of the department

§ 576. Duties and powers of the department. 1. The department may\ninquire into the operation of clinical laboratories and blood banks and\nmay conduct periodic inspections and/or evaluations of facilities,\nmethods, procedures, materials, staff and equipment to assess compliance\nwith requirements set forth in this title, the regulations promulgated\nhereunder and local laws, codes or regulations as specified in\nsubdivision three of section five hundred eighty of this title.\n 2. The department may require clinical laboratories and blood banks to\nsubmit, in a form prescribed by the department, periodic reports of\ntests performed and such other information as the department may require\nto carry out the provisions of this title. The department may adopt\nregulations to require clinical laboratories and blood banks to report\nall serious adverse incidents which may be connected to the clinical\nlaboratory or blood bank services provided. Such incident reports shall\nbe deemed confidential in the same manner as such reports submitted\npursuant to section twenty-eight hundred five-m of this chapter. The\ndepartment may also require clinical laboratories and blood banks to\nsubmit lists of personnel who are employed to perform laboratory\nprocedures and to notify the department promptly of any changes in such\npersonnel.\n 3. The department shall operate a reference system and shall prescribe\nstandards for the proper operation of clinical laboratories and blood\nbanks and for the examination of specimens. As part of such reference\nsystem, the department may review and approve testing methods developed\nor modified by clinical laboratories and blood banks prior to the\ntesting methods being offered in this state, and may require clinical\nlaboratories and blood banks to analyze test samples submitted by the\ndepartment and to report on the results of such analyses. The rules and\nregulations of the department shall prescribe the requirements for the\nproper operation of a clinical laboratory or blood bank, for the\napproval of methods and the manner in which proficiency testing or\nanalyses of samples shall be performed and reports submitted. Failure to\nmeet department standards for the proper operation of a clinical\nlaboratory or blood bank, including the criteria for approval of\nmethods, or failure to maintain satisfactory performance in proficiency\ntesting shall result in termination of the permit in the category or\ncategories of testing established by the department in regulation until\nremediation is achieved. Such standards shall be at least as stringent\nas federal standards promulgated under the federal clinical laboratory\nimprovement amendments of nineteen hundred eighty-eight. Such failure\nand termination shall be subject to review in accordance with\nregulations adopted by the department.\n 4. (a) The department may adopt and amend rules and regulations to\neffectuate the provisions and purposes of this title. Such rules and\nregulations shall establish fees for clinical laboratories and blood\nbanks in amounts not exceeding the cost of the reference system for\nclinical laboratories and blood banks and shall be subject to the\napproval of the director of the budget. For the purposes of this\nsubdivision, standard federally established governmental cost allocation\npractices shall be used by the commissioner to determine the cost of the\nreference system. The department shall make available, on the\ndepartment's website, information on the costs included in determining\nthe permitted laboratories' fees. The department shall not deem as costs\nof the reference system, costs associated with federal grants and\npatents which are not related to the reference system. The fee paid by\nthe department to maintain an exemption for clinical laboratories and\nblood banks from the requirements of the federal clinical laboratory\nimprovement amendments of nineteen hundred eighty-eight shall be deemed\na cost of the reference system.\n (b) In determining the fee charges to be assessed, the department\nshall, on or before May first of each year, compute the costs for the\npreceding state fiscal year which were expended to operate and\nadminister the duties of the department pursuant to this title. The\ndepartment shall, at such time or times and pursuant to such procedure\nas it shall determine by regulation, bill and collect from each clinical\nlaboratory and blood bank an amount computed by multiplying such total\ncomputed operating expenses of the department by a fraction the\nnumerator of which is the gross annual receipts of such clinical\nlaboratory or blood bank during such twelve month period preceding the\ndate of computation as the department shall designate by regulation, and\nthe denominator of which is the total gross annual receipts of all\nclinical laboratories or blood banks operating in the state during such\nperiod.\n (c) Each such clinical laboratory and blood bank shall submit to the\ndepartment, in such form and at such times as the department may\nrequire, a report containing information regarding its gross annual\nreceipts for all activities performed pursuant to a permit issued by the\ndepartment in accordance with the provisions of section five hundred\nseventy-five of this title. The department may require additional\ninformation and audit and review such information to verify its\naccuracy.\n (d) Partial payments equal to one-quarter of the total amount billed,\nmay be made on or before June thirtieth, September thirtieth, December\nthirty-first and March tenth of the fiscal year to which the billing\nrelates.\n (e) On or before September fifteenth of each year, the department\nshall reconcile its costs and expenses for the reference system for the\npreceding state fiscal year and shall, on or before October fifteenth\nsend to each clinical laboratory and blood bank, a statement setting\nforth the amount due and payable by, or the amount computed to the\ncredit of, such clinical laboratory or blood bank, computed on the basis\nof the above stated formula, except that for the purposes of such\ncomputation the fraction shall be multiplied against the total\nrecomputed expenses of the department for such fiscal year. Any amount\ndue shall be payable not later than thirty days following the date of\nsuch statement. Any credit shall be applied against any succeeding\npayment due.\n (f) The commissioner may waive all or any part of such fee charges for\nclinical laboratories or blood banks operated by local governments and\nfor nonprofit clinical laboratories or blood banks performing\nexaminations and analyses or providing services under contract with the\nstate or its local governments.\n (g) Subject to the approval of the director of the budget, the\ncommissioner shall charge adequate and reasonable fees for the periodic\ninspection of out-of-state clinical laboratories and blood banks, not\nexceeding the estimated additional costs incurred for out-of-state\ninspections under this title.\n 5. The department, within the amounts appropriated, may employ\ninspectors, investigators, assistants and other employees or may\ncontract with the city of New York to carry out the provisions of this\ntitle, set the compensation of such employees, within limits provided by\nlaw, and prescribe the duties of such employees.\n 6. The commissioner may appoint one or more advisory committees of\npersons expert in the major categories of clinical laboratory procedures\nto advise the commissioner in connection with the qualifications of\ntechnical personnel employed and the use of appropriate procedures. Each\nsuch advisory committee shall include at least one designee of the\ncommissioner of the department of health of the city of New York.\n 7. The department may adopt rules or regulations applicable only to or\nin the city of New York which are designed to address special needs or\ncircumstances existing in such city. The department shall consider the\nrecommendations of the city of New York, or the department or board of\nhealth of such city, concerning the adoption or amendment of any such\nrules or regulations.\n 8. The department may enter into agreements with the secretary of\nhealth and human services as authorized by the federal clinical\nlaboratory improvement act of nineteen hundred eighty-eight and title\nXVIII of the social security act to perform such acts as may be\nnecessary to assure conformance with such laws by laboratories operating\nin the state.\n