New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter I - State Sanitary Code › Part 19 - Clinical Laboratory Directors › Section 19.4 - Denial of an application for a certificate of qualification

Current through Register Vol. 46, No. 28, July 10, 2024
(a) In determining
				whether to deny an application for a certificate of qualification in whole or
				in part, the department shall consider: the applicant's education, experience,
				and licensure as required in sections
				19.2
				and
				19.3 
				of this Part; the applicant's demonstrated ability to discharge the
				responsibilities set forth in section
				19.3(c) 
				of this Part; the character and competence of the applicant and the laboratory
				or laboratories directed; and any other factors the department considers
				relevant, including, but not limited to:
(1)
				prior sustained charges of administrative violations of state or federal laws,
				rules and regulations related to the provision of health care services or
				reimbursement for such services, against the applicant individually or any
				laboratory directed by the applicant;
(2) conviction of any crime, including, but
				not limited to, any offense relating to the furnishing of, or billing for,
				laboratory services and medical care, services, or supplies, or which is
				considered an offense involving theft or fraud;
(3) false representation or omission of any
				material fact in making an application in any state or city of the United
				States for any license, permit, certificate, or registration related to a
				profession or business, or in making an application for a certificate of
				qualification or laboratory permit to New York State;
(4) submission of a laboratory permit
				application which conceals an ownership or controlling interest by any person
				who otherwise would be ineligible for a permit;
(5) failure to supply additional
				documentation of training and/or experience, pursuant to a written request for
				such documentation, in the course of applying for a certificate of
				qualification;
(6) on the part of
				any laboratory, category, or subcategory directed by the applicant, a pattern
				of repetitive failures of required proficiency testing performance in one or
				more proficiency testing categories, excluding failure for administrative
				reasons such as late result submission;
(7) on the part of any laboratory, category,
				or subcategory directed by the applicant, a pattern of deficiencies on onsite
				inspection, especially in areas of quality control, quality assurance,
				laboratory management, and handling of regulated medical waste and radioactive
				materials, including refusal or inability to produce records as requested by
				department employees, which deficiencies are not corrected from inspection to
				inspection or which recur at each inspection despite written notice of
				violations by a state or Federal licensing or auditing agency and which
				jeopardize the quality of test results and resulting patient care, even if
				interim corrections have occurred;
(8) on the part of any laboratory, category,
				or subcategory directed by the applicant, performance of any laboratory
				procedures not authorized by the laboratory permit issued pursuant to article
				5, Title V of the Public Health Law; or operation or direction of a laboratory
				without a permit; or continuing operation or failure to notify the department
				after a change in director, ownership, or location has voided the
				permit;
(9) on the part of any
				laboratory, category, or subcategory directed by the applicant, referral of
				specimens collected in New York State to laboratories which do not possess a
				New York State permit;
(10) on the
				part of any laboratory, category, or subcategory directed by the applicant,
				knowing acceptance of specimens or requisitions for laboratory examination
				from, or issuance of reports to, a person or persons not authorized by law to
				submit such specimens or requisitions, or receive such reports;
(11) on the part of any laboratory, category,
				or subcategory directed by the applicant, issuance of reports on laboratory
				work, including both patient samples and proficiency testing, actually
				performed in another laboratory, without designating the fact that the
				examinations or procedures were performed in another laboratory; and/or testing
				and reporting results on unsatisfactory specimens as defined by the department,
				including unlabeled specimens or specimens of insufficient quantity to conduct
				the analyses requested;
(12) on
				the part of any laboratory, category, or subcategory directed by the applicant,
				failure to establish and ensure that employees follow procedures for disposal
				or handling of specimens or infectious or radioactive medical waste, in
				violation of applicable state and Federal laws, rules and regulations, or in a
				manner which endangers the public, the laboratory's employees, or the
				environment;
(13) employment of
				unqualified or unlicensed technical personnel or an insufficient number of such
				personnel;
(14) failure of the
				applicant to be responsible for adequately supervising laboratory personnel to
				ensure the proper performance of all tests conducted in the laboratory;
				and
(15) any other factor having a
				direct bearing on the applicant's ability to provide or supervise the provision
				of high quality laboratory services, or to ensure compliance with statutory and
				regulatory requirements.