§ 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 ref
‹ Prev All New York sections Next ›
Lexace provides legal information, not legal advice, and no attorney–client relationship is created. Statute text is provided for general information and may not reflect the most recent amendments; verify against the official state code.