New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter I - State Sanitary Code › Part 19 - Clinical Laboratory Directors › Section 19.3 - Director of a clinical laboratory or blood bank; certificate of qualification issuance, duties and responsibilities

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Certificate required. An individual
				serving as a director or assistant director of a clinical laboratory or blood
				bank must hold a certificate of qualification issued after the department has
				determined that the applicant meets the requirements specified in sections
				19.2
				and 19.3  of this Part, and has demonstrated, in accordance with subdivision (c)
				of this section and section
				19.4(a) 
				of this Part, that he or she possesses the character, competence, training, and
				ability to direct the technical and scientific operation of a clinical
				laboratory or blood bank, and ensure the proper supervision or performance of
				test procedures, adherence to the department's quality control standards, and
				accurate reporting of findings of tests.
(b) An applicant for a certificate of
				qualification must submit a complete, original, signed, and sworn application
				in such form and manner as may be required by the department, and must supply
				such additional information as may be required by the department. An individual
				seeking renewal of a certificate of qualification must submit an application no
				later than 90 days prior to expiration of the current certificate.
(c) To qualify for, and maintain, a
				certificate of qualification, a laboratory director and any assistant director
				shall demonstrate that he or she possesses knowledge of basic clinical
				laboratory sciences and operations, and shall have the training and/or
				experience and physical capability to discharge the following responsibilities:
(1) provide advice to referring health care
				providers regarding the significance of laboratory findings and ensure that
				reports of test results include pertinent information required for the
				interpretation of laboratory data;
(2) maintain an effective working
				relationship with applicable accrediting and regulatory agencies,
				administrative officials, and the medical community;
(3) define, implement, and monitor standards
				of performance for the laboratory and for other ancillary laboratory testing
				programs in conformance with the department's clinical laboratory standards of
				practice;
(4) monitor all work
				performed in the laboratory to ensure that medically reliable data are
				generated;
(5) assure that the
				laboratory participates in monitoring and evaluating the quality and
				appropriateness of services rendered, within the context of a quality
				management system, regardless of where the testing is performed;
(6) ensure that sufficient qualified
				personnel are employed with documented training and/or experience to supervise
				and perform the work of the laboratory;
(7) ensure that policies and procedures are
				established for monitoring staff to assess competency and, whenever necessary,
				to provide remedial training to improve skills;
(8) specify in writing the responsibilities
				and duties of all laboratory personnel;
(9) provide continuing education to
				laboratory staff;
(10) ensure that
				a current and complete procedure manual is available to all
				personnel;
(11) set goals, develop
				and allocate resources within the laboratory;
(12) provide effective administrative
				direction of the laboratory, in conjunction with the individual(s) responsible
				for financial management of the laboratory, to ensure adequate resources are
				available to operate the laboratory in a manner consistent with all state and
				federal requirements;
(13) select
				all reference laboratories for services not offered by the
				laboratory;
(14) promote a safe
				laboratory environment for personnel and the public; and
(15) ensure that the laboratory, when
				applicable, is enrolled in a proficiency testing program acceptable to the
				department for the testing performed and that the laboratory adheres to the
				proficiency testing program's administrative and technical
				requirements.