577. Enforcement. 1. A permit or certificate of qualification may be revoked, suspended, limited or annulled, or the holder thereof censured, reprimanded or otherwise disciplined by the department on proof that the certificate holder, owner or director, or one or more persons in his or her employ:
(a) has been guilty of misrepresentation in obtaining the permit or certificate or in the operation of the clinical laboratory or blood bank, including the submission to the department of proficiency test results obtained from another clinical laboratory;
(b) has knowingly accepted or permitted to be accepted a specimen or assignment for clinical laboratory examination from or rendered a report thereon to a person or persons not authorized by law to submit such assignment or specimen or receive such report;
(c) has engaged or attempted to engage or represented himself or herself as entitled to perform any procedure or category or procedures or services he or she is not authorized to perform;
(d) has rendered a report on work actually performed in another clinical laboratory or blood bank without designating the fact that the examination or procedure was performed in another clinical laboratory or blood bank;
(e) has demonstrated incompetence or shown consistent errors in performance of examinations or procedures;
(f) has failed to file any report required by the provisions of this title or the rules and regulations promulgated thereunder;
(g) has violated or aided and abetted in the violation of any provision of this chapter, including this title, title six of this article, or the rules and regulations promulgated pursuant to this chapter or a violation of title eleven of article five of the social services law or the rules and regulations promulgated thereunder related to laboratory services; or
(h) has violated or aided and abetted in the violation of local laws, codes or regulations as specified in subdivision three of section five hundred eighty of this title.
(i) has been found upon inspection by the department to be in noncompliance with a provision or provisions of this title or the rules and regulations promulgated hereunder, and has failed to address such findings as required by the department.
2. Proceedings under this section may be initiated by any person, corporation, association or public officer, or by the department, by filing written charges with the department.
3. No permit or certificate shall be revoked, suspended, limited or annulled without a hearing, except as provided in subdivision three of section five hundred seventy-six of this title. However, a permit or certificate may be temporarily suspended without a hearing for a period not to exceed thirty days upon notice to the permit or certificate holder following a finding by the department that the public health, safety or welfare is in imminent danger.
4. The commissioner shall set a time and place for the hearing. A copy of the charges, together with the notice of the time and place of the hearing, shall be mailed to the permit or certificate holder, at the address specified on the permit at least fifteen days before the date set for the hearing. The permit or certificate holder shall file with the department, not less than five days prior to the hearing, a written answer to the charges.
5. Any person or entity which owns or operates a clinical laboratory and who does not hold a valid laboratory permit shall be liable to the people of the state for a civil penalty not to exceed two thousand dollars for each day for the unauthorized operation of the clinical laboratory.
Last modified: February 3, 2019