Sec. 58-1.1. Permit

(a) Permit means a clinical laboratory or blood bank issued by the Commissioner of Health. No clinical laboratory or blood bank shall be issued a permit in a category unless:

(1) its director or assistant director holds a certificate of qualification in the category for which the permit is sought;

(2) the laboratory has been inspected and has corrected any deficiencies found; and

(3) the laboratory has successfully participated in all required proficiency examinations or remedial activities in the categories sought.

(b) A clinical laboratory or blood bank shall perform only those tests that are within the categories stated on its permit. Specimens for all other tests shall be referred to a clinical laboratory with a permit in the appropriate category. Categories of tests shall be designated according to the following procedures or specialties:

(1) one or more of the following subspecialities of microbiology: bacteriology, virology, mycology, parasitology and mycobacteriology;

(2) hematology;

(3) blood services—diagnostic immunohematology collection and/or transfusion;

(4) one or more of the following subspecialties of clinical biochemistry: clinical chemistry, blood pH and gases, endocrinology and therapeutic substance monitoring/quantitative toxicology;

(5) histopathology or one or more of the following subspecialties: dermatopathology and oral pathology;

(6) cytopathology;

(7) urinalysis;

(8) one or more of the following subspecialities of toxicology: drug analysis-qualitative, blood lead and erythrocyte protoporphyrin, forensic toxicology, and chlorinated hydrocarbons;

(9) cytogenetics;

(10) human immunodeficiency virus (HIV) testing;

(11) histocompatibility;

(12) diagnostic immunology;

(13) cellular immunology;

(14) oncofetal antigens; and

(15) other specific tests or procedures as designated by the department.

(c) In performance of laboratory procedures stated on its permit, a blood bank shall meet the appropriate requirements in Subpart 58-2 and sections 58-1.2 through 58-1.6, 58-1.9, 58-1.10 and 58-1.11 of this Subpart.

(d) A provisional permit shall be available which shall be valid for a period determined by the department to be sufficient to enable the department to assess the proficiency or lack of proficiency of the laboratory in the categories sought. The provisional permit may be renewed pending issuance or denial of a permit if initial proficiency test results are inconclusive.

(1) A clinical laboratory or blood bank initially applying for a permit may be issued a provisional permit when the laboratory meets the following conditions:

(i) a valid and complete permit application has been filed; and

(ii) application and reference fees have been paid; and

(iii) the director or assistant director holds a Certificate of Qualification in all categories sought; and

(iv) the laboratory has been inspected by the department and has provided satisfactory evidence of correction of any deficiencies found.

(2) Provisional permits shall not be available in the categories of cytogenetics-general, mycology, mycobacteriology, human immunodeficiency virus screening and/or confirmatory testing or virology.

(3) A clinical laboratory or blood bank which has failed to demonstrate its proficiency in testing specimens in a category may, after successful participation in a remediation program, including proficiency testing, be granted a provisional permit.

(4) If the director or any owner of the laboratory applying for a provisional permit has ever directed or owned a laboratory which has had its permit revoked, suspended, limited or annulled, or which has an enforcement proceeding against it pending at the time of application for a provisional permit, a provisional permit shall not be issued. Owner shall include any individual, corporation, partner or other person holding a 10 percent or more interest in the laboratory.

(5) Provisional permits may be revoked, suspended, limited or annulled, or the holder thereof may be censured, reprimanded or otherwise disciplined in accordance with the Public Health Law, including section 577 thereof.

(6) A provisional permit in a category may be converted to a permit when the laboratory has demonstrated to the satisfaction of the department its proficiency in testing specimens in that category.