Clinical Laboratory Technology

Regulations of the Commissioner

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

Effective February 10, 2007

79-13.1 Professional study of clinical laboratory technology.

1. As used in this section, 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, the applicant shall present satisfactory evidence of meeting the requirements of one of the following paragraphs:
   1. applicants who apply for licensure prior to September 1, 2011 may meet the following requirement: 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. applicants who apply for licensure prior to September 1, 2011 may alternatively meet the requirement by 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.
3. 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 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 subdivision. The applicant must apply for licensure under this section by September 1, 2007, and meet the requirements for licensure under this section by September 1, 2008, 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 September 1, 2007;
   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 September 1, 2008, 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 September 1, 2006; or
      2. the applicant shall have successfully completed by September 1, 2008 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 September 1, 2006; 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 September 1, 2006; or
      4. the applicant shall have successfully performed the duties of a clinical laboratory technologists for five years, meaning 7,200 clock hours, prior to September 1, 2006, as verified in writing by the director of the 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 September 1, 2008 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 September 1, 2008 shall have successfully performed the duties of a clinical laboratory technician for four years, meaning 5,760 clock hours.
3. In accordance with subdivision (2) of section 8607 of the Education Law, an individual who on or before September 1, 2007 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 September 1, 2008, 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.