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
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 19.3
Current through Register Vol. 46, No. 39, September 25, 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.
(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.
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