Part 19 - Clinical Laboratory Directors

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Section 573(1)

Section 19.1 - Definitions

19.1 Definitions. (a) Director means the individual responsible for administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of test procedures, the reporting of results, and the duties and responsibilities specified in section 19.3 of this Part.  If a clinical laboratory or blood bank employs more than one director, the laboratory owner(s) shall designate in writing one such individual as the director of record for the laboratory.

(b) Assistant director means a director who has been designated by the owner(s) of the laboratory as having shared responsibility with a director for the technical and scientific operation of the clinical laboratory or blood bank in one or more categories and/or subcategories. 

(c) Acceptable laboratory means a facility, operating lawfully, that meets the definition of a clinical laboratory or blood bank as defined in Section 571 of the Public Health Law and which has a director who meets or would meet the requirements of this Part, including the anatomic and clinical pathology facilities of a hospital or health department, a clinical testing unit of a university or medical research institution, an independent clinical laboratory or blood bank, a privately operated forensic testing laboratory, or a facility providing training and/or experience in the testing of human specimens.

(d) Accredited means having the approval (accreditation) conferred on schools, institutions or programs by an accrediting agency or agency or association recognized by the United States Secretary of Education and verified as such by the department.

(e) Physician means a physician who is licensed and currently registered to practice medicine in New York State or in the state or the country in which he or she practices and is not subject to any disciplinary or non-disciplinary order by the applicable state or country except as otherwise allowed by the department.

(f) Dentist means a dentist who is licensed and currently registered to practice dentistry in New York State or in the state or the country in which he or she practices and is not subject to any disciplinary or non-disciplinary order by the applicable state or country except as otherwise allowed by the department.

(g) Certificate of qualification means a credential issued by the department to applicants determined by the department to meet the requirements set forth in this Part.

(h) Grandfathered laboratory director means a laboratory director who qualified for and received a certificate of qualification in one or more categories of testing prior to the amendment of this regulation which became effective January 25, 1988.

(i) Category means an area, field, or discipline of laboratory medicine or laboratory science in which a certificate of qualification is issued.  The department may issue certificates of qualification in a specified subpart of a category, including, but not limited to, a subcategory,  technology, method, or specific procedure, based on the applicant’s education, training, and experience and the applicant’s ability to demonstrate that tests performed under their direction generate reliable results. The department shall make available a list of: categories and subcategories in which certificates of qualification are issued; minimum qualifications for each category; and the corresponding categories of testing authorized by a laboratory permit.

(j) Department means the New York State Department of Health.

(k) Board certified means having completed all requirements set forth by an accrediting board acceptable to the department, including a passing score on any qualifying examination and completion of all the requirements for recertification whenever the certifying board mandates recertification, provided such requirements are determined by the department to provide the applicant with the ability to effectively discharge the responsibilities described in Parts 10 and 58 of this title. 

(l) Earned doctoral degree means a doctor of philosophy, doctor of science, or equivalent degree as determined by the department.

(m) Training includes participation in a residency, fellowship, or post-doctoral position, or participation in a training course approved by a board acceptable to the department.

(n) Experience includes post-doctoral employment or voluntary participation in an acceptable laboratory where the applicant performed, supervised or directed testing of human clinical specimens.  Teaching experience directly related to a medical technology program, clinical laboratory sciences program, or a clinical laboratory section of a residency program is also considered acceptable experience.

 

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete

Section 19.2 - Clinical laboratory or blood bank; qualifications of laboratory director

19.2 Clinical laboratory or blood bank; qualifications of laboratory director. A director and any assistant director of a clinical laboratory or blood bank shall possess training and/or experience acceptable to the department, obtained within the previous six years, in one or more categories.  Additionally, the applicant must meet one of the following requirements:

(a) be a physician who is currently certified by:

(1) the American Board of Pathology in:

(i) clinical pathology; or

(ii) anatomic pathology; or

(iii) dermatopathology; or

(2) the American Osteopathic Board of Pathology in:

(i) laboratory medicine; or

(ii) anatomic pathology; or

(iii) dermatopathology; or

(b) be a physician in the State of New York who: 

(1) is currently certified by the American Board of Pathology in Blood Banking and Transfusion Medicine; or

(2) is currently certified by the American Board of Pathology in Clinical Pathology or the American Board of Internal Medicine in Hematology, and possesses six months of training and/or experience in transfusion services; or

(3) possesses four years of training and/or experience in an acceptable laboratory including two or more years of training and/or experience in transfusion services and in general laboratory management.

(c) be a dentist who is currently certified by the American Board of Oral and Maxillofacial Pathology; or

(d) be a physician, or hold an earned doctoral degree from an accredited institution with a relevant chemical, physical or biological science major, and:

(1) is currently certified by one of the following boards and meets any supplemental requirements for experience as specified by the department:

(i) the American Board of Bioanalysis as a High Complexity Laboratory Director, provided the applicant has obtained a minimum of four years of post-doctoral experience equivalent to paragraph (2) of this subdivision; or

(ii) the American Board of Clinical Chemistry in clinical chemistry; or

(iii) the American Board of Clinical Chemistry in toxicological chemistry; or

(iv) the American Board of Dermatology; or

(v) the American Board of Forensic Toxicology, provided the applicant has an earned doctoral degree; or

(vi) the American Board of Internal Medicine in hematology or hematology and medical oncology; or

(vii) the American Board of Medical Laboratory Immunology; or

(viii) the American Board of Medical Microbiology; or

(ix) dual certification by the American Board of Pathology in either Anatomic Pathology or Clinical Pathology, and Molecular Genetic Pathology; or

(x) the American Board of Pathology in Medical Microbiology; or

(xi) the National Registry for Certified Chemists, provided the applicant has obtained a minimum of four years of post-doctoral experience equivalent to paragraph (2) of this subdivision; or

(2) subsequent to receiving a doctor of medicine, doctor of osteopathic medicine or earned doctoral degree has had, and has documented to the department, four years of training and/or experience in an acceptable laboratory, including two or more years of training and/or experience in methods and techniques currently in use in the certificate category or categories sought and in general laboratory management, or an equivalent combination of training and/or experience as verified by the department.

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete

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.

 

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete

Section 19.4 - Denial of an application for a certificate of qualification

19.4 Denial of an application for a certificate of qualification. (a) In determining whether to deny an application for a certificate of qualification in whole or in part, the department shall consider: the applicant's education, experience and licensure as required in sections 19.2 and 19.3 of this Part; the applicant's demonstrated ability to discharge the responsibilities set forth in section 19.3(c) of this Part; the character and competence of the applicant and the laboratory or laboratories directed; and any other factors the department considers relevant, including, but not limited to:

(1) prior sustained charges of administrative violations of state or federal laws, rules and regulations related to the provision of health care services or reimbursement for such services, against the applicant individually or any laboratory directed by the applicant;

(2) conviction of any crime, including, but not limited to, any offense relating to the furnishing of, or billing for, laboratory services and medical care, services, or supplies, or which is considered an offense involving theft or fraud;

(3) false representation or omission of any material fact in making an application in any state or city of the United States for any license, permit, certificate, or registration related to a profession or business, or in making an application for a certificate of qualification or laboratory permit to New York State;

(4) submission of a laboratory permit application which conceals an ownership or controlling interest by any person who otherwise would be ineligible for a permit;

(5) failure to supply additional documentation of training and/or experience, pursuant to a written request for such documentation, in the course of applying for a certificate of qualification;

(6) on the part of any laboratory, category, or subcategory directed by the applicant, a pattern of repetitive failures of required proficiency testing performance in one or more proficiency testing categories, excluding failure for administrative reasons such as late result submission;

(7) on the part of any laboratory, category, or subcategory directed by the applicant, a pattern of deficiencies on onsite inspection, especially in areas of quality control, quality assurance, laboratory management, and handling of regulated medical waste and radioactive materials, including refusal or inability to produce records as requested by department employees, which deficiencies are not corrected from inspection to inspection or which recur at each inspection despite written notice of violations by a state or federal licensing or auditing agency and which jeopardize the quality of test results and resulting patient care, even if interim corrections have occurred;

(8) on the part of any laboratory, category, or subcategory directed by the applicant, performance of any laboratory procedures not authorized by the laboratory permit issued pursuant to Article 5, Title V of the Public Health Law; or operation or direction of a laboratory without a permit; or continuing operation or failure to notify the department after a change in director, ownership or location has voided the permit;

(9) on the part of any laboratory, category, or subcategory directed by the applicant, referral of specimens collected in New York State to laboratories which do not possess a New York State permit;

(10) on the part of any laboratory, category, or subcategory directed by the applicant, knowing acceptance of specimens or requisitions for laboratory examination from, or issuance of reports to, a person or persons not authorized by law to submit such specimens or requisitions, or receive such reports;

(11) on the part of any laboratory, category, or subcategory directed by the applicant, issuance of reports on laboratory work, including both patient samples and proficiency testing, actually performed in another laboratory, without designating the fact that the examinations or procedures were performed in another laboratory; and/or testing and reporting results on unsatisfactory specimens as defined by the department, including unlabeled specimens or specimens of insufficient quantity to conduct the analyses requested;

(12) on the part of any laboratory, category, or subcategory directed by the applicant, failure to establish and ensure that employees follow procedures for disposal or handling of specimens or infectious or radioactive medical waste, in violation of applicable state or federal laws, rules and regulations, or in a manner which endangers the public, the laboratory's employees, or the environment;

(13) employment of unqualified or unlicensed technical personnel or an insufficient number of such personnel;

(14) failure of the applicant to be responsible for adequately supervising laboratory personnel to ensure the proper performance of all tests conducted in the laboratory; and

(15) any other factor having a direct bearing on the applicant's ability to provide or supervise the provision of high quality laboratory services, or to ensure compliance with statutory and regulatory requirements.

(b) If an application for a certificate of qualification is denied, the applicant shall be given written notice of the proposed denial, stating the reason or reasons for the denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice, unless a hearing is requested pursuant to subdivision (c) below.

(c) If the department gives notice of the proposed denial of an application for a certificate of qualification, the applicant may request a hearing on the proposed denial by submitting a written request for a hearing to the department within ten (10) days of the date of the notice. Submission of a request for a hearing within ten (1) days shall stay any action to deny the application for a certificate of qualification, pending the department's decision following the hearing on such proposed denial.

Effective Date: 
Wednesday, June 12, 2019
Doc Status: 
Complete