Title: Section 19.3 - Director of a clinical laboratory or blood bank; certificate of qualification

19.3 Director of a clinical laboratory or blood bank; certificate of qualification issuance, duties and responsibilities.

(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; and

(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.

(d) Required qualifications. (1) Applicants for a certificate of qualification in bacteriology, mycobacteriology, mycology and/or parasitology must qualify under section 19.2(a)(1)(i), (a)(2)(i), (d)(1)(i), (d)(1)(viii), (d)(1)(x) or (d)(2) of this Part.

(2) Applicants for a certificate of qualification in virology must qualify under section 19.2(d)(1)(viii), (d)(1)(x) or (d)(2) of this Part.  Applicants for a certificate of qualification in virology limited to antigen detection and molecular methods must qualify under section 19.2(a)(1)(i), (a)(2)(i) or (d)(1)(i) of this Part.

(3) Applicants for a certificate of qualification in diagnostic immunology must qualify under section 19.2(a)(1)(i), (a)(2)(i), (d)(1)(i), (d)(1)(vii), (d)(1)(viii), (d)(1)(x) or (d)(2) of this Part.

(4) Applicants for certificate of qualification in hematology must qualify under section 19.2(a)(1)(i), (a)(2)(i), (d)(1)(vi) or (d)(2) of this Part. Applicants qualifying under section 19.2(d)(1)(vi) of this Part must document that the required training and/or experience includes or is supplemented by six months' training and/or experience in an acceptable laboratory.

(5) Applicants for a certificate of qualification in immunohematology must qualify under section 19.2(a)(1)(i), (a)(2)(i), or (d)(2) of this Part.

(6) Applicants for a certificate of qualification in clinical chemistry, blood pH and gases, endocrinology, or therapeutic substance monitoring - quantitative toxicology must qualify under section 19.2(a)(1)(i), (a)(2)(i), (d)(1)(i), (d)(1)(ii), (d)(1)(xi) or (d)(2) of this Part.

(7) Applicants for a certificate of qualification in histopathology and/or cytopathology must qualify under section 19.2(a)(1)(ii) or (a)(2)(ii) of this Part.

(8) Applicants for a certificate of qualification in oral pathology must qualify under section 19.2(a)(1)(ii), (a)(2)(ii), or (c) of this Part.

(9) Applicants for a certificate of qualification in dermatopathology must qualify under section 19.2(a)(1)(ii), (a)(1)(iii), (a)(2)(ii), (a)(2)(iii) or (d)(1)(iv) of this Part.

(10) Applicants for a certificate of qualification in cytogenetics, histocompatibility, cellular immunology, genetic testing, fetal defect markers, forensic identity, oncology, parentage/identity testing, trace elements, and/or transplant monitoring must qualify under section 19.2(d)(2) of this Part.

(11) Applicants for a certificate of qualification in transfusion services must be physicians and must qualify under section 19.2(b)(1), (b)(2) or (b)(3) of this Part.

(12) Applicants for a certificate of qualification in blood banking collection-comprehensive must qualify under section 19.2(d)(2) of this Part. Required experience in blood services must include at least one year's training and/or experience in collection and testing of blood for allogeneic transfusion.

(13) Applicants for a certificate of qualification in blood banking collection-limited must qualify under section 19.2(a)(1)(i), (b)(1)(i), or (d)(1)(vi) of this Part.

(14) Applicants for a certificate of qualification in clinical toxicology must qualify under section 19.2(a)(1)(i), (b)(1)(i), (d)(1)(i), (d)(1)(ii), (d)(1)(iii), (d)(1)(xi), or (d)(2) of this Part.

(15) Applicants for a certificate of qualification in forensic toxicology must qualify under section 19.2(d)(1)(iii), (d)(1)(v) or (d)(2) of this Part.

(16) Applicants for a certificate of qualification in andrology must qualify under section 19.2(d)(1)(i) or (d)(2) of this Part; or under section 19.2(a)(1)(i) or (b)(1)(i) of this Part including or supplemented by at least six months' training and/or experience in andrology.

(17) Applicants for a certificate of qualification in blood lead must qualify under section 19.2(a)(1)(i), (b)(1)(i), (d)(1)(i), (d)(1)(iii), (d)(1)(v), (d)(1)(xi), or (d)(2) of this Part.

(e) Scope and limitations. (1) The requirements for qualification set forth in section 19.2 of this Part shall apply to all laboratory directors, regardless of prior grandfathered status, upon expiration of current certificates of qualification if the laboratory director is no longer employed in a laboratory or in the field of laboratory medicine.

(2) Additional categories of testing may not be added to a certificate of qualification issued on a grandfathered basis. Such a certificate will not be renewed if allowed to lapse.