Clinical Laboratory Technology

Regulations of the Commissioner

Part 79 - Regulation of Individual Professions
Subpart 79-13 Clinical Laboratory Technologist

Effective September 23, 2008

79-13.1 Professional study of clinical laboratory technology.

1. Applicability. For purposes of this section, applicants applying for licensure as a clinical laboratory technologist prior to September 1, 2013, shall meet the professional education requirements for admission to the licensing examination set forth in either subdivision (b) or (c) of this section. Applicants applying for licensure as a clinical laboratory technologist on or after September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in subdivision (b) of this section.
2. General professional education requirements for applicants applying for licensure as a clinical laboratory technologist.
   1. As used in this subdivision, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accrediting clinical laboratory technology programs, having accreditation standards that are substantially equivalent to the requirements for programs registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.38 of this Title, and applying its criteria for granting accreditation of programs in a fair, consistent, and nondiscriminatory manner.
   2. To meet the professional education requirement for admission to the licensing examination for clinical laboratory technologists, the applicant shall present satisfactory evidence of:
      1. holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.38 of this Title; or
      2. holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology that is substantially equivalent to a program registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.38 of this Title as determined by the department, which program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist, and must be designed and conducted by the degree-granting institution to prepare graduates to practice as clinical laboratory technologists using independent judgment and responsibility; or
      3. both:
         1. holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences registered pursuant to Part 52 of this Title or its substantial equivalent as determined by the department; and
         2. completing a credit bearing program in clinical laboratory technology in addition to such baccalaureate or higher degree study that is registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.38 of this Title or substantially equivalent to such a registered program as determined by the department. Such equivalent program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist, and must be designed and conducted by the degree-granting institution to prepare graduates to practice as a clinical laboratory technologist using independent judgment and responsibility.
3. Time-limited professional education requirements for applicants applying for licensure as a clinical laboratory technologist prior to September 1, 2013.
   1. As used in this subdivision, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accrediting clinical laboratory technology programs on a national or regional basis, as having reasonable accreditation standards, and as an organization that applies its criteria for granting accreditation of programs in a fair, consistent, and nondiscriminatory manner.
   2. To meet the professional education requirement for admission to the licensing examination for clinical laboratory technologists, applicants who apply for licensure prior to September 1, 2013 may, as an alternative to satisfying the requirements of subdivision (b) of this section, present satisfactory evidence of meeting the requirements of one of the following subparagraphs:
      1. holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology or a related title which:
         1. prepares graduates for employment as a clinical laboratory technologist, as defined in Education Law section 8601(2)(a);
         2. contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/quality improvement, and which is designed and conducted to prepare graduates to practice clinical laboratory technology using independent judgment and responsibility; and
         3. is registered by the department for general educational purposes but need not be specifically registered for licensure purposes, or is accredited by an acceptable accrediting agency, or is recognized by appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist; or
      2. both:
         1. holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences registered pursuant to Part 52 of this Title or its substantial equivalent as determined by the department; and
         2. completing a program which:
            1. prepares graduates for employment as a clinical laboratory technologist, as defined in Education Law section 8601(2)(a);
            2. contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/quality improvement, and which is designed and conducted to prepare graduates to practice clinical laboratory technology using independent judgment and responsibility; and
            3. is registered by the department for general educational purposes but need not be specifically registered for licensure purposes, or is accredited by an acceptable accrediting agency, or is recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist.
4. To meet the professional education requirement for admission to the licensing examination for clinical laboratory technologists, the applicant must also certify to the department that he or she has reviewed the rules and regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a clinical laboratory technologist in New York State, in accordance with written guidance from the department.

79-13.2 Licensing examination.

1. Content. To meet the examination requirement for licensure as a clinical laboratory technologist, the candidate shall pass a general examination for clinical laboratory technologists that is determined by the department to measure the applicant's knowledge, judgment, and skills concerning practice as a clinical laboratory technologist, as defined in section 8601(2)(a) of the Education Law, and to be offered by an organization that has satisfactory administrative and psychometric procedures in place to offer the examination.
2. Passing score. The department shall accept scores on the examination satisfactory to the State Board for Clinical Laboratory Technology, as meeting the requirement for passing the licensing examination. The applicant shall pass the examination with a converted score of at least 75, as determined by the State Board for Clinical Laboratory Technology.

79-13.3 Limited permits.

1. As authorized by section 8608 of the Education Law, upon recommendation of the State Board for Clinical Laboratory Technology, the department may issue a limited permit to practice as a clinical laboratory technologist to an applicant for licensure who meets the requirements of this section.
2. The applicant for a limited permit to practice as a clinical laboratory technologist shall:
   1. file an application for a limited permit with the department and pay the initial licensure and registration fee, as prescribed in section 8605(1) of the Education Law, and a limited permit fee of fifty dollars;
   2. have met all requirements for licensure as a clinical laboratory technologist, except the examination requirement;
   3. submit adequate documentation that the applicant will be under the general supervision of the director of a clinical laboratory, as defined in section 571 of the Public Health Law, in accordance with the requirements of this paragraph.
      1. Such documentation shall identify the director of the clinical laboratory who has responsibility for providing general supervision of the applicant's work while under the limited permit, and include a signed statement by the director of the clinical laboratory certifying that he or she will provide general supervision of the applicant's experience. If a director cannot carry out his or her duties, or is replaced by a new or interim director, the limited permit holder shall submit to the department on a form prescribed by the department the name of the new director who has assumed supervisory responsibility of the permit holder.
      2. For purposes of this section, under the general supervision of the director of a clinical laboratory shall mean that the permit holder shall be supervised by a director of a clinical laboratory who shall:
         1. serve the laboratory full-time, or on a regular part-time basis;
         2. ensure the supervision of the technical performance of the permit holder, and be readily available for consultation with the permit holder, as needed; and
         3. be responsible for the performance and findings of all tests carried out by the limited permit holder, either by directly overseeing such testing, or by delegating this responsibility to authorized qualified supervisors who are on site within the laboratory.
3. The limited permit issued pursuant to this section shall be valid for a period of not more than one year from the date of issuance. Such limited permit may be renewed at the discretion of the department for one additional one-year period, provided that the applicant documents good cause, such as, a specific physical or mental disability certified by an appropriate health care professional or other good cause which in the judgment of the department made it impossible for the applicant to complete requirements for licensure as a clinical laboratory technologist while under the original limited permit.

79-13.4 Special provisions.

1. In accordance with section 8607(1)(a) of the Education Law, an applicant may be licensed by the department as a clinical laboratory technologist by meeting the requirements of this section. The applicant must apply for licensure under this section by January 1, 2009, except as otherwise provided in subparagraph (vii) of paragraph (4) of subdivision (b) of this section, and shall meet the requirements for licensure under this section by July 1, 2009, unless the particular requirement prescribes an earlier date for completion, in which case the requirement must be completed by that earlier date.
2. The applicant shall:
   1. file the application for licensure with the department and pay the fee for the initial license and the fee for the first registration period, as prescribed in section 8605(1) of the Education Law, all by January 1, 2009, except as otherwise provided in subparagraph (vii) of paragraph (4) of this subdivision;
   2. be of good moral character as determined by the department;
   3. be at least 18 years of age; and
   4. meet one of the following requirements:
      1. the applicant shall meet the professional education requirement for licensure, as prescribed in section 79-13.1 of this Subpart by July 1, 2009, and shall have successfully performed the duties of a clinical laboratory technologists for two years, meaning 2,880 clock hours, over the five years immediately preceding December 31, 2007; or
      2. the applicant shall have successfully completed by July 1, 2009 a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences offered by an institution that is accredited by an acceptable accrediting agency, meaning an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent and nondiscriminatory manor, such as an agency recognized for these purposes by the U.S. Department of Education or that is recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as an institution authorized to offer postsecondary degree study, and shall have successfully performed the duties of a clinical laboratory technologist for two years, meaning 2,880 clock hours, over the five years immediately preceding December 31, 2007; or
      3. the applicant has been engaged full-time as a faculty member or managing administrator involved directly in the development or planning of curricula or the provision of instruction for education programs in clinical laboratory technology for clinical laboratory practitioners, at an organized entity that provides postsecondary education, for the equivalent of two years, meaning 2,700 clock hours, over the five years immediately preceding December 31, 2007; or
      4. the applicant shall have successfully performed the duties of a clinical laboratory technologist for five years, meaning 7,200 clock hours, prior to December 31, 2007, as verified in writing by a director of a clinical laboratory, as defined in section 571 of the Public Health Law ; or
      5. the applicant, at the time of application, shall have been previously qualified for a license or its equivalent to practice as a clinical laboratory technologist in New York State through other regulatory requirements of a governmental unit of New York State authorized by law to qualify individuals for such licensure or its equivalent; or
      6. the applicant, at the time of application, shall be currently certified as a clinical laboratory technician, and by July 1, 2009 shall hold a baccalaureate or higher degree based upon successful completion of a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences offered by an institution that is accredited by an acceptable accrediting agency, meaning an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent and nondiscriminatory manor, such as an agency recognized for these purposes by the U.S. Department of Education or that is recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as an institution authorized to offer postsecondary degree study, and by July 1, 2009 shall have successfully performed the duties of a clinical laboratory technician for four years, meaning 5,760 clock hours; or
      7. the applicant shall have competently performed the duties of a clinical laboratory technologist in a clinical laboratory operated in accordance with Title V of Article 5 of the Public Health law and the regulations promulgated thereunder for a period of not less than six months, meaning 720 clock hours, over the three years immediately preceding December 31, 2007 as verified by a director of the clinical laboratory, and the applicant shall have applied for licensure and have paid the fee for the initial license and the fee for the first registration period on or before September 1, 2013.
3. In accordance with subdivision (2) of section 8607 of the Education Law, an individual who on or before January 1, 2009 files with the department an application for licensure as a clinical laboratory technologist under this section and certifies to a good faith belief that he or she has or will have met the requirements for licensure under this section by the prescribed completion dates which shall in no case be later than July 1, 2009, shall be deemed qualified to practice as a clinical laboratory technologist from the date of filing the application with the department until such time as the department has acted upon such application.

79-13.5 Restricted license.

1. In accordance with section 8610(1) of the Education Law, the department may issue a restricted clinical laboratory license to perform certain examinations and procedures within the definition of clinical laboratory technology as set forth 8601(1) of the Education Law, provided that such a restricted licensee may only perform examinations and procedures in those of the following areas which are specifically listed in his or her certificate: histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology and molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology.
2. Notwithstanding subdivision (a) of this section, restricted licensees employed at the National Cancer Institute designated cancer centers or at teaching hospitals that are eligible for distributions pursuant to 2807-m(3)(c) of the Public Health Law may receive a certificate that also includes the practice of molecular diagnosis including but not limited to genetic testing-molecular and molecular oncology, provided that such certificate holders may practice in such additional areas only at such centers, teaching hospitals or other sites as may be designated by the Commissioner.
3. In addition to the requirements set forth in Section 8610(1) of the Education Law, to qualify for a restricted license, an applicant shall satisfy the following requirements:
   1. Professional study. The applicant shall have successfully completed a baccalaureate or higher degree program in the major of biology, chemistry, the physical sciences, or mathematics from a program registered by the department or determined by the department to be the substantial equivalent.
   2. Training program. In accordance with section 8610(1)(c)(iii) of the Education Law, the applicant shall have completed a training program that meets the following requirements:
      1. The training program shall have a planned sequence of supervised employment or engagement in activities appropriate for the area of certification, which training program is satisfactory to the department in quality, breadth, scope and nature and is provided by an entity that shall be responsible for the services provided.
      2. The training program shall be described and attested to by the clinical director of the laboratory in which it is located prior to the beginning of the program.
      3. The training program shall consist of not less than one year of full-time training in the specific areas in which the applicant is seeking certification, which shall consist of no less than 1750 hours in a calendar year, in the specific area in which the applicant is seeking certification, or the part-time equivalent thereof, as determined by the department.
      4. Successful completion of the program shall be certified by a laboratory director who is responsible for overseeing such program.
      5. The training program such include the following curricula for certificates issued in each of the following areas:
         1. For a certificate in the area of histocompatibility, the training program shall include knowledge of clinical immunology, immunogenetics, basic molecular biology, and laboratory mathematics. The training program shall also include, but need not be limited to, general laboratory principles and skills, including infection control and aseptic technique; the practice of HLA typing and HLA antibody testing; specimen collection, processing and handling; instrumentation and equipment; reagent preparation and quality control; quality assurance, principles and techniques of histocompatibility assays, and crossmatching; antibody screening and identification; and determination of degree of HLA matching.
         2. For a certificate in the area of cytogenetics, the training program shall include knowledge of chromosome structure/behavior and its correlation with phenotype and recognition and interpretation of chromosomal abnormalities. It shall also include, but need not be limited to, general laboratory principles and skills; clinical cytogenetics; general knowledge of human genetics; infection control and aseptic technique, quality control, and quality assurance; laboratory mathematics; the collection, handling, preparation and processing of pertinent specimens; the use of appropriate cell culture techniques; the principles and techniques for harvesting specimens or cell cultures; and the principles and techniques of chromosome banding, staining, analysis, and instrumentation.
         3. For a certificate in the area of stem cell process, the training program shall include knowledge of stem cell biology. It shall also include, but need not be limited to, general laboratory principles and skills; infection control and aseptic technique methods; instrumentation and equipment; quality control and quality assurance; laboratory mathematics; the process of handling stem cell specimens in the laboratory; enumeration and characterization of stem cells; ABO/Rh confirmatory typing; and reagent preparation.
         4. For a certificate in the area of flow cytometry/cellular immunology, the training program shall include knowledge of the technique for counting, sorting, and characterization of cells suspended in a fluid stream based on their physical properties and expression of cell surface molecules. The training program shall also include, but need not be limited to, general laboratory principles and skills; infection control and aseptic technique; instrumentation and equipment; quality control and quality assurance; the basic principles of flow cytometry, including specimen preparation, fluidics and electronics; fluorochrome selection; antibody selection; the design of flow cytometry procedures, including routine standardization and quality management; and specific clinical applications.
         5. For a certificate in the area of molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology, the training program shall include knowledge of the role of molecular genetics in tumor diagnosis and individualized tumor therapies that are being defined and implemented. The training program shall also include, but need not be limited to, general laboratory principles; general principles of molecular biology, clinical molecular genetics, and molecular diagnosis; infection control and aseptic technique; applicable laboratory skills; quality control and quality assurance; laboratory mathematics; basic principles of nucleic acid extraction, modification, amplification, identification, and unidirectional workflow techniques to avoid cross contamination; electrophoresis and other separation techniques; and transfer and hybridization techniques and specific techniques of nucleic acid amplification and identification.
         6. For a certificate in the area of molecular diagnosis that is not limited to genetic testing-molecular and molecular oncology as provided in Education Law section 8610(1)(b), an applicant shall:
            1. be employed at a National Cancer Institute designated cancer center or at a teaching hospital that is eligible for distributions pursuant to Public Health Law section 2807-m(3)(c);
            2. have completed the training requirements for the restricted license in molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology; and
            3. have completed additional training in molecular diagnosis acceptable to the department that would enable the applicant to practice competently.
   3. In order to receive a restricted license under this section, the applicant must also certify to the department that he or she has reviewed the rules and regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a clinical laboratory technologist in New York State, in accordance with written guidance from the department.

79-13.6 Limited license.

1. In accordance with section 8610(2) of the Education Law, the department may issue a limited license and registration pursuant to which the limited licensee may perform examinations and procedures within the definition of clinical laboratory technology set forth in 8601(1) of the Education Law, subject to the requirements set forth in section 8610(2) of the Education Law and this section. In addition to the requirements for a limited license established in Education Law section 8610(2), to qualify for a limited license as a clinical laboratory technologist, an applicant shall satisfy one of the following requirements:
   1. An applicant shall be licensed as a clinical laboratory technologist, or the equivalent as determined by the department, in another jurisdiction; or
   2. An applicant shall have received a bachelor’s or higher degree in the biological, chemical, or physical sciences, and training in a clinical laboratory, provided such education and training are acceptable to the department. Such training shall include, but need not be limited to, training as a specialist; clinical experience in the practice of clinical laboratory technology, which provides supervised clinical experience that includes hematology, hemostasis, immunohematology, immunology, clinical chemistry, urinalysis/body fluids, and clinical microbiology or the substantial equivalent of such training or clinical experience, as determined by the department; or
   3. An applicant shall have received a bachelor’s or higher degree in the biological, chemical, or physical sciences or in mathematics, and have served as a research assistant in a research laboratory, under the direction of the director or the principal researcher of such research laboratory, working on the research and development of any procedures and examinations to be conducted by a laboratory, as defined in Title V of Article 5 of the Public Health Law, on material derived from the human body which provides information for the diagnosis, prevention or treatment of a disease or assessment of a human medical condition.
2. In order to receive a limited license as a clinical laboratory technologist under section 8610(2) of the Education Law, the applicant must also certify to the department that he or she has reviewed the rules and regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a clinical laboratory technologist in New York State, in accordance with written guidance from the department.