Title: Section 19.4 - Denial of an application for a certificate of qualification

19.4 Denial of an application for a certificate of qualification. (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 or 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.

(b) If an application for a certificate of qualification is denied, the applicant shall be given written notice of the proposed denial, stating the reason or reasons for the denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice, unless a hearing is requested pursuant to subdivision (c) below.

(c) If the department gives notice of the proposed denial of an application for a certificate of qualification, the applicant may request a hearing on the proposed denial by submitting a written request for a hearing to the department within ten (10) days of the date of the notice. Submission of a request for a hearing within ten (1) days shall stay any action to deny the application for a certificate of qualification, pending the department's decision following the hearing on such proposed denial.