§ 579 — Scope and exceptions

§ 579. Scope and exceptions. 1. This title is applicable to all\nclinical laboratories and blood banks operating within the state, except\nclinical laboratories and blood banks operated by the federal government\nand clinical laboratories operated by a licensed physician, osteopath,\ndentist, midwife, nurse practitioner, optometrist performing a clinical\nlaboratory test that does not use an invasive modality as defined in\nsection seventy-one hundred one of the education law or podiatrist who\nperforms laboratory tests or procedures, personally or through his or\nher employees, solely as an adjunct to the treatment of his or her own\npatients; to the extent authorized by federal and state law, including\nthe education law.\n 2. This title shall not be applicable to and the department shall not\nhave the power to regulate pursuant to this title: (a) any examination\nperformed by a state or local government of materials derived from the\nhuman body for use in criminal identification or as evidence in a\ncriminal proceeding or for investigative purposes; (b) any test\nconducted pursuant to paragraph (c) of subdivision four of section\neleven hundred ninety-four of the vehicle and traffic law and paragraph\n(c) of subdivision eight of section 25.24 of the parks, recreation and\nhistoric preservation law; (c) any examination performed by a state or\nlocal agency of materials derived from the body of an incarcerated\nindividual, pretrial releasee, parolee, conditional releasee or\nprobationer to (i) determine, measure or otherwise describe the presence\nor absence of any substance whose possession, ingestion or use is\nprohibited by law, the rules of the department of corrections and\ncommunity supervision, the conditions of release established by the\nboard of parole, the conditions of release established by a court or a\nlocal conditional release commission or the conditions of any program to\nwhich such individuals are referred and (ii) to determine whether there\nhas been a violation thereof; or (d) any examination performed by a\ncoroner or medical examiner for the medical-legal investigation of a\ndeath. Nothing herein shall prevent the department from consulting with\nthe division of criminal justice services, the department of corrections\nand community supervision, the state police, or any other state agency\nor commission, at the request of the division of criminal justice\nservices, the department of corrections and community supervision, the\nstate police, or such other agency or commission, concerning examination\nof materials for purposes other than public health.\n 3. (a) This title shall not be applicable to any person, partnership,\ncorporation or other entity performing any waived test or\nprovider-performed microscopy procedure, provided such person,\npartnership, corporation or other legal entity: (i) holds a valid\ncertificate of registration issued by the department authorizing the\nperformance of one or more waived tests or provider-performed microscopy\nprocedures; and (ii) only performs tests authorized by the certificate\nof registration; and (iii) otherwise complies with all applicable\nrequirements of this subdivision.\n (b) The department may issue a certificate of registration authorizing\nthe performance of one or more waived tests or provider-performed\nmicroscopy procedures for a period of up to two years if the applicant:\n(i) files a completed application with the department on such forms as\nthe commissioner may prescribe; (ii) provides documentation acceptable\nto the department demonstrating the ability to comply with the\nrequirements of this subdivision; and (iii) pays a two hundred dollar\nbiennial registration fee for each location where services are rendered;\nexcept that a voluntary ambulance service as defined in article thirty\nof the public health law and operated under section two hundred nine-b\nof the general municipal law shall be exempt from the requirement to pay\na fee to obtain this certificate of registration; and except that the\nfollowing may operate multiple locations under a single registration and\npay a single registration fee: (A) not-for-profit, state or local\ngovernment laboratories or programs engaged in limited public health\ntesting not exceeding fifteen types of tests per registration; or (B)\napplicants that maintain a fixed location in the state and are approved\nby the department to move from testing site to testing site.\n (c) Laboratory test registrants shall: (i) provide only the tests and\nservices listed on the registration issued by the department hereunder;\n(ii) advise the department of any change in the registrant's name,\nownership, location or qualified health care professional or laboratory\ndirector designated to supervise testing within thirty days of such\nchange; (iii) provide the department with immediate access to all\nfacilities, equipment, records, and personnel as required by the\ndepartment to determine compliance with this subdivision; (iv) comply\nwith all public health law and federal requirements for reporting\nreportable diseases and conditions to the same extent and in the same\nmanner as a clinical laboratory; (v) perform one or more tests as\nrequired by the department to determine the proficiency of the persons\nperforming such tests; and (vi) designate a qualified health care\nprofessional or qualified individual holding a certificate of\nqualification pursuant to section five hundred seventy-three of this\ntitle, who shall be jointly and severally responsible for: (A)\nestablishing, approving and continuously updating policies, procedures\nand personnel qualifications for each test employed; (B) establishing a\ncomprehensive quality assurance system which includes, but is not\nlimited to, test selection, test quality, laboratory proficiency and\npersonnel competency; (C) ensuring all tests are performed in accordance\nwith the manufacturers' instructions and standards of practice in\nlaboratory medicine; (D) maintaining complete and accurate records of\nthe tests performed, including but not limited to, the patient's name,\nresults, person performing the test, and quality control data; (E)\nensuring that persons do not participate in diagnostic or treatment\ndecisions using such test results unless such persons are authorized by\nlaw to do so; (F) ensuring that provider-performed microscopy procedures\nare performed only by a qualified health care professional operating\nwithin the scope of practice for his or her profession and as part of\nthe physical examination performed by such professional; and (G)\ncomplying with other applicable laws, rules and regulations.\n (d) A certificate of registration shall become void by a change in the\nowner of the laboratory test registrant or location of testing.\n (e) Notwithstanding the foregoing, if the commissioner determines that\nthe performance of a particular waived test or provider-performed\nmicroscopy procedure in a facility or location which does not possess a\nNew York state clinical laboratory permit creates a risk of harm to the\nsubjects of such test, the commissioner may issue an order prohibiting\nsuch test from being performed in any location other than a permitted\nclinical laboratory, physician's office or other location exempted by\nsubdivision one or two of this section.\n (f) Registration under this subdivision may be denied, limited,\nsuspended, revoked or annulled by the department upon a determination\nthat a laboratory services registrant: (i) failed to comply with the\nrequirements of this subdivision; (ii) provided services that constitute\nan unwarranted risk to human health; (iii) intentionally provided any\nfalse or misleading information to the department relating to\nregistration or performing laboratory services; or (iv) has demonstrated\nincompetence or shown consistent errors in the performance of\nexaminations or procedures. A registration shall not be limited,\nsuspended, revoked or annulled without a hearing conducted in accordance\nwith subdivision four of section five hundred seventy-seven of this\ntitle. However, a registration may be temporarily limited, suspended,\nrevoked or annulled without a hearing for a period not to exceed thirty\ndays upon notice to the registrant following a finding by the department\nthat the public health, safety or welfare is in imminent danger.\n (g) The commissioner may adopt such rules and regulations as may be\nnecessary to effectuate the purposes of this subdivision.\n (h) Any person, partnership, corporation or other entity performing\nwaived tests or provider-performed microscopy procedures without being\nauthorized to do so pursuant to this title shall be subject to a civil\npenalty of up to five hundred dollars for each test performed, not to\nexceed two thousand dollars per day for each day tests are performed, in\nviolation of this subdivision.\n (i) All fees and civil penalties collected pursuant to this\nsubdivision shall be deposited in the special revenue account\nestablished for the receipt of inspection and reference fees collected\npursuant to section five hundred seventy-six of this title and shall be\nsubtracted from the operating expenses of the department prior to\ncalculation of such inspection and reference fees.\n