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

Effective Date

03/11/1992

19.3 Director of a clinical laboratory or blood bank; certificate of qualification. (a) Certificate required. A director of a clinical laboratory or blood bank must hold a certificate of qualification issued after the commissioner has determined that the applicant meets the requirements specified in sections 19.2 and 19.3(e) of this Part, and has demonstrated, in accordance with subdivision (c) below 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 function effectively in fulfilling his or her duties and responsibilities, a laboratory director should possess a knowledge of basic clinical laboratory sciences and operations, and should have the training and/or experience and physical capability to discharge the following responsibilities:

(1) provide advice to referring physicians regarding the significance of laboratory findings and 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 in quality control and quality assurance for the laboratory and for other ancillary laboratory testing programs;

(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 the quality assurance program, 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) set goals and develop and allocate resources within the laboratory;

(8) provide effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory;

(9) provide educational direction to laboratory staff;

(10) select all reference laboratories; and

(11) promote a safe laboratory environment for personnel and the public.

(d) Certification. Certificates of qualification are issued in one or more of the following categories, procedures or specialties:

(1) one or more of the subspecialties of microbiology: bacteriology, virology, mycology, mycobacteriology, diagnostic immunology and parasitology;

(2) hematology;

(3) immunohematology, excluding testing performed solely for transfusion purposes;

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

(5) histopathology, and/or the subspecialties: oral pathology and dermatopathology;

(6) cytopathology;

(7) cytogenetics;

(8) histocompatibility;

(9) cellular immunology;

(10) oncofetal antigens, and/or the subspecialties: tumor markers, maternal serum and amniotic fluids;

(11) genetic testing;

(12) transfusion services, including all pre-transfusion testing;

(13) blood banking collection-comprehensive, including all tests required in Subpart 58-2 of this Title;

(14) blood banking collection-limited, including collection of autologous blood for transfusion and excluding testing for transmissible disease markers;

(15) one or more of the subspecialties of clinical toxicology; drug analysis, blood lead, erythrocyte protoporphyrin and chlorinated hydrocarbons;

(16) forensic toxicology; or

(17) other specific categories, procedures or specialties designated by the department.

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

(2) Applicants for a certificate of qualification in virology must qualify under section 19.2(c)(1)(i) or (c)(2) of this Part.

(3) Applicants for a certificate of qualification in diagnostic immunology must qualify under section 19.2(a)(1), (c)(1)(i), (c)(1)(v) or (c)(2) of this Part. (4) Applicants for certificate of qualification in hematology must qualify under section 19.2(a)(1), (c)(1)(vi) or (c)(2) of this Part. Applicants qualifying under section 19.2(c)(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) or (c)(2) of this Part.

(6) Applicants for a certificate of qualification in one or more of the subspecialties of clinical biochemistry must qualify under section 19.2(a)(1), (c)(1)(ii) or (c)(2) of this Part.

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

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

(9) Applicants for a certificate of qualification in dermatopathology must qualify under section 19.2(a)(2) or (a)(3) of this Part.

(10) Applicants for a certificate of qualification in cytogenetics, histocompatibility, cellular immunology, oncofetal antigens and/or genetic testing must qualify under section 19.2(c)(2) of this Part.

(11) Applicants for a certificate of qualification in transfusion services must be physicians and must qualify under section 19.2(a)(3) or (c)(2) of this Part, or under section 19.2(a)(1) or (c)(1)(vi) of this Part including or supplemented by at least six months' training and/or experience in transfusion services.

(12) Applicants for a certificate of qualification in blood banking collection-comprehensive must qualify under section 19.2(c)(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 homologous transfusion.

(13) Applicants for a certificate of qualification in blood banking collection-limited must qualify under section 19.2(a)(1), (c)(1)(vi) or (c)(2) of this Part.

(14) Applicants for a certificate of qualification in one or more of the subspecialties of clinical toxicology must qualify under section 19.2(a)(1), (c)(1)(iii), (c)(1)(iv) or (c)(2) of this Part.

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

(f) 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 may not be renewed if allowed to lapse, unless extenuating circumstances prevent timely reapplication and specific departmental approval is obtained.
 

Volume

VOLUME A (Title 10)

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