Article 165, Clinical Laboratory Technology Practice Act

This article defines the practice of clinical laboratory technology and provides for the licensing of clinical laboratory technologists, cytotechnologists, and histotechnologists and for the certification of clinical laboratory technicians and histotechnicians. The general provisions for all professions contained in article one hundred thirty of this title shall apply to this article.

1. "Clinical laboratory technology" means the performance of microbiological, virological, serological, chemical, immunohematological, hematological, biophysical, cytogenetical, cytological or histological procedures and examinations and any other test or procedure conducted by a laboratory as defined by title five of article five 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. A "clinical laboratory practitioner" means clinical laboratory technologists, cytotechnologists, histotechnologists, clinical laboratory technicians, and histotechnicians as such terms are defined in this subdivision, who practice clinical laboratory technology in a licensed clinical laboratory. For the purposes of this article, a licensed clinical laboratory does not include a laboratory operated by any licensed physician, dentist, podiatrist, midwife or certified nurse practitioner who performs laboratory tests or procedures, personally or through his or her employees, solely as an adjunct to the treatment of his or her own patients.
   1. "Clinical laboratory technologist" means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department of health, performs clinical laboratory procedures and examinations and any other tests or procedures conducted by a clinical laboratory, including maintaining equipment and records, and performing quality assurance activities related to examination performance, and which require the exercise of independent judgment and responsibility, as determined by the department.
   2. "Cytotechnologist" means a clinical laboratory practitioner who, pursuant to established and approved protocols of the department of health, performs cytological procedures and examinations and any other such tests including maintaining equipment and records and performing quality assurance activities related to examination performance, and which require the exercise of independent judgment and responsibility, as determined by the department.
   3. "Histotechnologist" means a clinical laboratory practitioner who pursuant to established and approved protocols of the department of health performs slide based histological assays, tests, and procedures and any other such tests conducted by a clinical histology laboratory, including maintaining equipment and records and performing quality assurance activities relating to procedure performance on histological testing of human tissues, and which requires the exercise of independent judgment and responsibility as determined by the department.
   4. "Clinical laboratory technician" means a clinical laboratory practitioner who performs clinical laboratory procedures and examinations pursuant to established and approved protocols of the department of health, which require limited exercise of independent judgment and which are performed under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory.
   5. "Histotechnician" means a clinical laboratory practitioner who pursuant to established and approved protocols of the department of health performs slide based histological assays, tests, and procedures and any other such tests conducted by a clinical histology laboratory, including maintaining equipment and records and performing quality assurance activities relating to procedure performance on histological testing of human tissues and which requires limited exercise of independent judgment and is performed under the supervision of a laboratory supervisor, designated by the director of a clinical laboratory or under the supervision of the director of the clinical laboratory.
   6. "Director of a clinical laboratory" means a director as that term is defined in section five hundred seventy-one of the public health law.
   7. "Laboratory supervisor" means an individual who, under the general direction of the laboratory director, supervises technical personnel and reporting of findings, performs tests requiring special scientific skills, and, in the absence of the director, is responsible for the proper performance of all laboratory procedures.

No person shall practice as a clinical laboratory technologist, cytotechnologist or histotechnologist, or hold himself or herself out as a clinical laboratory technologist, or a cytotechnologist, or a histotechnologist in this state unless he or she is licensed or exempt pursuant to this article.

No person shall practice as a clinical laboratory technician or as a histotechnician or hold himself or herself out as a clinical laboratory technician or a histotechnician in this state unless he or she is certified or exempt pursuant to this article, provided that an individual licensed as a clinical laboratory technologist, cytotechnologist, histotechnologist, or clinical laboratory technician may practice the profession of histotechnician.

A state board for clinical laboratory technology shall be appointed by the board of regents upon the recommendation of the commissioner for the purpose of assisting the board of regents and the department on matters of professional licensing and professional conduct in accordance with section sixty-five hundred eight of this title. The board shall be composed of twelve members, four of whom shall be licensed clinical laboratory technologists, two of whom shall be licensed cytotechnologists, one of whom shall be a certified clinical laboratory technician, one of whom shall be a licensed histotechnologist or certified histotechnician, two members of the public, one representative of the diagnostic/manufacturing industry, and one director of a clinical laboratory who shall be a physician. An executive secretary to the board shall be appointed by the board of regents upon the recommendation of the commissioner. The clinical laboratory practitioner members of the initial board need not be licensed prior to their appointment but shall have met all other requirements of licensing except the filing of an application, the passing of a satisfactory exam and paying a fee.

To qualify for a license as a clinical laboratory technology practitioner under one of the titles defined in subdivision two of section eighty-six hundred one of this article, an applicant shall fulfill the particular requirements of a subdivision of this section applicable to the license and title sought by the applicant:

1. Licensure as a clinical laboratory technologist.
   1. a. Application: file an application with the department;
   2. b. Education: have received an education, including a bachelor's degree in clinical laboratory technology from a program registered by the department or determined by the department to be the substantial equivalent or a clinical laboratory technology program accredited by a national accrediting organization acceptable to the department, or have received a bachelor's degree that includes a minimum number of credit hours in the sciences and received appropriate clinical education in an accredited clinical laboratory technology program or a program to be determined by the department to be the substantial equivalent;
   3. b-1. Alternatives to education:
      1. In lieu of requirements specified in paragraph (b) of this subdivision the department may accept:
         1. current clinical laboratory technology certification by a national certification organization acceptable to the department; or
         2. clinical laboratory technology licensure in a jurisdiction acceptable to the department;
      2. In lieu of requirements specified in paragraph (b) of this subdivision the department may accept, a bachelor's degree in a natural science or a clinical laboratory science and coursework acceptable to the department and:
         1. two years' experience in a clinical laboratory while licensed as a clinical laboratory technician in New York or another jurisdiction acceptable to the department; or
         2. two years' experience in a clinical laboratory while certified as a clinical laboratory technician by a national certification organization acceptable to the department.
   4. c. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
   5. d. Age: be at least eighteen years of age;
   6. e. Character: be of good moral character as determined by the department; and
   7. f. Fees: pay a fee of one hundred seventy-five dollars for an initial license and a fee of one hundred seventy dollars for each triennial registration period.
2. Licensure as a cytotechnologist.
   1. a. Application: file an application with the department;
   2. b. Education: have received an education, including a bachelor's degree in cytotechnology from a program registered by the department or determined by the department to be the substantial equivalent, or have received a bachelor's degree that includes a minimum number of credit hours in the sciences and received appropriate clinical education in an accredited cytotechnology program or a program determined by the department to be the substantial equivalent;
   3. b-1. Alternatives to education: in lieu of requirements specified in paragraph (b) of this subdivision the department may accept:
      1. current cytotechnology certification by a national certification organization acceptable to the department; or
      2. cytotechnology licensure in a jurisdiction acceptable to the department.
   4. c. Examination: pass an examination acceptable to the board and in accordance with the commissioner's regulations;
   5. d. Age: be at least eighteen years of age;
   6. e. Character: be of good moral character as determined by the department; and
   7. f. Fees: pay a fee of one hundred seventy-five dollars for an initial license and a fee of one hundred seventy dollars for each triennial registration period.

For certification as a clinical laboratory technician under this article, an applicant shall fulfill the following requirements:

1. 1. Application: file an application with the department;
2. 2. Education: have received an education, including an associate's degree from an approved clinical laboratory technician program registered by the department or determined by the department to be the substantial equivalent, or an associate's degree clinical laboratory technician program accredited by a national accrediting organization acceptable to the department, or an associate's degree program in a natural science or a clinical laboratory science and coursework acceptable to the department and a clinical laboratory technician program accredited by a national accrediting organization acceptable to the department;
3. 2-a. Alternatives to education: in lieu of requirements specified in subdivision two of this section the department may accept:
   1. current clinical laboratory technician certification by a national certification organization acceptable to the department; or
   2. clinical laboratory technician licensure in a jurisdiction acceptable to the department.
4. 3. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
5. 4. Age: be at least eighteen years of age;
6. 5. Character: be of good moral character as determined by the department; and
7. 6. Fees: pay a fee of one hundred twenty-five dollars for an initial certification and a fee of one hundred twenty dollars for each triennial registration period.

For certification as a histotechnician under this article, an applicant shall fulfill the following requirements:

1. 1. Application: file an application with the department;
2. 2. Education: have received an education, including an associate's degree from an approved histotechnician program registered by the department or determined by the department to be the substantial equivalent, or have received an associate's degree that includes a minimum number of credit hours in the sciences and received appropriate clinical education in a histotechnician program approved by the department or a program to be determined by the department to be the substantial equivalent or a histotechnician program accredited by a national accrediting organization acceptable to the department;
3. 2-a. Alternatives to education: in lieu of requirements specified in subdivision two of this section the department may accept:
   1. current histotechnician certification by a national certification organization acceptable to the department; or
   2. histotechnician licensure in a jurisdiction acceptable to the department.
4. 3. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
5. 4. Age: be at least eighteen years of age;
6. 5. Character: be of good moral character as determined by the department; and
7. 6. Fees: pay a fee of one hundred twenty-five dollars for an initial certification and a fee of one hundred twenty dollars for each triennial registration period.

For certification as a histotechnologist under this article, an applicant shall fulfill the following requirements:

1. Application: file an application with the department;
2. Education: have completed one of following requirements:
   1. a bachelor's degree program in histotechnology registered by the department or determined by the department to be the substantial equivalent, or a histotechnology program accredited by a national accrediting organization acceptable to the department; or
   2. a bachelor's degree program in a natural science or a laboratory science and a minimum number of credit hours acceptable to the department, and appropriate clinical education in a histotechnologist program accredited by a national accrediting organization acceptable to the department or a program registered by the department or determined by the department to be the substantial equivalent; or
   3. current histotechnologist certification by a national certification organization acceptable to the department; or
   4. histotechnologist licensure in a jurisdiction acceptable to the department;
3. Alternatives to education: in lieu of requirements specified in subdivision two of this section the department may accept, a bachelor's degree in a natural science or a clinical laboratory science and coursework acceptable to the department and:
   1. two years' experience in a clinical laboratory while licensed as a histotechnician in New York or another jurisdiction acceptable to the department; or
   2. two years' experience in a clinical laboratory while certified as a histotechnician by a national certification organization acceptable to the department.
4. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
5. Age: be at least eighteen years of age;
6. Character: be of good moral character as determined by the department; and
7. Fees: pay a fee of one hundred seventy-five dollars for an initial license and a fee of one hundred seventy dollars for each triennial registration period.

Effective 1/21/2024

1. Notwithstanding the requirements of section eighty-six hundred five and eighty-six hundred six of this article, and until July first, two thousand nine, an individual may be licensed as a clinical laboratory technology practitioner, as defined in section eighty-six hundred one of this article, provided that an individual may be licensed pursuant to subparagraph (vi) of paragraph (a) or subparagraph (iii) of paragraph (b) of this subdivision until December thirty-first, two thousand thirteen provided such person:
   1. In the case of clinical laboratory technologist, has either:
      1. met the educational requirements for clinical laboratory technologist as defined in section eighty-six hundred five of this article and has been performing the duties of a clinical laboratory technologist for two of the past five years prior to December thirty-first, two thousand seven; or completed an approved baccalaureate degree program in biological, chemical or physical sciences from an accredited college or university and has been performing the duties of a clinical laboratory technologist for two of the past five years prior to December thirty-first, two thousand seven;
      2. been engaged full-time in the education of clinical laboratory practitioners for the equivalent of two of the past five years prior to December thirty-first, two thousand seven;
      3. performed the duties of a clinical laboratory technologist for at least five years prior to December thirty-first, two thousand seven as verified by a director of a clinical laboratory;
      4. become previously qualified under other regulatory requirements for that license or its equivalent;
      5. become a currently certified clinical laboratory technician with a bachelor's degree from an accredited college that includes a minimum number of credit hours in the sciences and four years of documented work experience as a clinical laboratory technician, acceptable to the department; or
      6. become qualified to perform the duties of a clinical laboratory technologist in a clinical laboratory operated in accordance with title five of article five of the public health law and the regulations promulgated thereunder, and competently performed the duties of a clinical laboratory technologist in a clinical laboratory for a period of not less than six months in the three years immediately preceding December thirty-first, two thousand seven as verified by a director of the clinical laboratory.
   2. In the case of a clinical laboratory technician, has either:
      1. met the educational requirements of a clinical laboratory technician as defined in section eighty-six hundred six of this article and performed the duties of a clinical laboratory technician for two of the past five years prior to December thirty-first, two thousand seven;
      2. performed the duties of a clinical laboratory technician for at least five years prior to December thirty-first, two thousand seven or has previously qualified under other regulatory requirements for such a certification or such certification's equivalent; or
      3. become qualified to perform the duties of a clinical laboratory technician in a clinical laboratory operated in accordance with title five of article five of the public health law and the regulations promulgated thereunder, and competently performed the duties of a clinical laboratory technician in a clinical laboratory for a period of not less than six months in the three years immediately preceding December thirty-first, two thousand seven as verified by a director of the clinical laboratory.
   3. In the case of cytotechnologist, has either:
      1. met the educational requirements of a cytotechnologist as defined in section eighty-six hundred five of this article and performed the duties of a cytotechnologist for two of the previous five years prior to December thirty-first, two thousand seven;
      2. performed the duties of a cytotechnologist for at least five years prior to December thirty-first, two thousand seven as verified by a director of a clinical laboratory; or
      3. has previously qualified under other regulatory requirements for such a license or such license's equivalent.
   4. In the case of a histological technician, has either:
      1. met the educational requirements of a histological technician as defined in section eighty-six hundred six-a of this article and performed the duties of a histological technician for two of the past five years prior to December thirty-first, two thousand seven;
      2. performed the duties of a histological technician for at least five years prior to December thirty-first, two thousand seven or has previously qualified under other regulatory requirements for such a certification or such certification's equivalent; or
      3. become qualified to perform the duties of a histological technician in a clinical laboratory operated in accordance with title five of article five of the public health law and the regulations promulgated thereunder, and competently performed the duties of a histological technician in a clinical laboratory for a period of not less than six months in the three years immediately preceding December thirty-first, two thousand seven as verified by a director of the clinical laboratory.
2. For the purposes of subdivision one of this section, it shall be determined that the filing of an application with the department on or before January first, two thousand nine shall qualify for purposes of such subdivision, regardless of the time period required for processing such application, provided that an application for licensure pursuant to subparagraph (vi) of paragraph (a), subparagraph (iii) of paragraph (b), or subparagraph (iii) or paragraph (d) of subdivision one of this section shall be submitted on or before September first, two thousand thirteen.
3. The commissioner may adopt such regulations as appropriate to license or certify individuals who hold valid licenses, certifications or their equivalent in another state or country, provided the standards for granting licenses or certifications to such individuals are not less than the standards required of persons otherwise licensed or certified pursuant to this article.

1. Limited permit. On the recommendation of the board, the department may issue a limited permit to practice as a clinical laboratory practitioner to an applicant who has met all requirements for licensure as a clinical laboratory technologist or cytotechnologist, histotechnologist, or certification as a clinical laboratory technician or histotechnician, except those relating to the examination and provided that the individual is under the general supervision of the director of a clinical laboratory, as determined by the department. This limited permit shall be valid for a period of not more than two years and shall not be renewable.
2. Provisional permit.
   1. On the recommendation of the board, the department may issue a provisional permit to practice as a clinical laboratory practitioner to an applicant who is employed in a clinical laboratory for the purpose of enabling the applicant to complete the education requirements and/or to pass the exam required for licensure as a clinical laboratory technologist or histotechnician and provided that the individual is under the general supervision of the director of a clinical laboratory, as determined by the department, and provided further that the applicant meets the requirements outlined in paragraph (b) of this subdivision. This provisional permit shall be valid for a period of not more than two years and shall not be renewable.
   2. To qualify for a provisional permit, the applicant shall:
      1. file a provisional permit application with the department;
      2. have at least one of the following enumerated qualifications:
         1. be licensed as a clinical laboratory technologist, or the equivalent as determined by the department, in another jurisdiction or possess a current certification in clinical laboratory technology from a national certification organization acceptable to the department; or
         2. have received both an education, including a bachelor's degree in the biological, chemical, or physical sciences, and training in a clinical laboratory, provided that such education and training are acceptable to the department; or
         3. have received a bachelor's 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 five of article five 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; or
         4. for those seeking a provisional permit as a histotechnician, have received an education, including an associate's degree that includes a minimum number of credit hours in the sciences, provided that such education is acceptable to the department;
      3. be at least eighteen years of age;
      4. be of good moral character as determined by the department;
      5. pay a fee of fifty dollars for a provisional permit;
      6. file a licensure application with the department; and
      7. pay the licensure fee as outlined in section eighty-six hundred six of this article.
   3. Each provisional permit shall be subject to the disciplinary provisions applicable to licensees pursuant to subarticle three of article one hundred thirty of this title.
3. The board of regents and the department are authorized to adopt such rules and regulations as may be necessary to implement the provisions of this section.

This article shall not be construed to apply to:

1. the practice, conduct, activities, or services by any person licensed or otherwise authorized to practice medicine within the state pursuant to article one hundred thirty-one-B of this title, or by any person registered to perform services as a physician assistant or specialist assistant within the state pursuant to article one hundred thirty-one-B of this title, or by any person licensed to practice dentistry within the state pursuant to article one hundred thirty-three of this title, or by any person licensed to practice podiatry within the state pursuant to article one hundred forty-one of this title, or by any person certified as a nurse practitioner within the state pursuant to article one hundred thirty-nine of this title, or by any person licensed to perform services as a respiratory therapist or respiratory therapy technician under article one hundred sixty-four of this title, or any person licensed to practice midwifery within the state pursuant to article one hundred forty of this title, or a person licensed to practice nursing pursuant to article one hundred thirty-nine of this title, or a person licensed to practice pursuant to article thirty-five of the public health law; provided, however, that no such person shall use the titles licensed clinical laboratory technologist, licensed cytotechnologist, licensed histotechnologist, certified clinical laboratory technician, or certified histotechnician, unless licensed or certified under this article; or
2. clinical laboratory technology practitioners employed by the United States government or any bureau, division, or agency thereof, while in the discharge of the employee's official duties; or
3. clinical laboratory technology practitioners employed by the New York State Department of Health Wadsworth Center Laboratory or the New York City Department of Health and Mental Hygiene Public Health Laboratory, while in the discharge of the employee's official duties; or 4. clinical laboratory technology practitioners engaged in teaching or research, provided that the results of any examination performed are not used in health maintenance, diagnosis or treatment of disease and are not added to the patient's permanent record; or
4. students or trainees enrolled in approved clinical laboratory science or technology education programs or training programs described in subparagraph (iii) of paragraph (c) of subdivision one of section eighty-six hundred ten of this article provided that these activities constitute a part of a planned course in the program, that the persons are designated by a title such as intern, trainee, fellow or student, and the persons work directly under the supervision of an individual licensed or exempt pursuant to subdivision one, two, four or eight of this section; or
5. persons employed by a clinical laboratory to perform supportive functions not related to the direct performance of laboratory procedures or examinations; or
6. persons who are working in facilities registered pursuant to section five hundred seventy-nine of the public health law and only perform waived tests as defined in section five hundred seventy-one of the public health law pursuant to such registration; or
7. a director of a clinical laboratory holding a valid certificate of qualification pursuant to section five hundred seventy-three of the public health law.

1. Restricted clinical laboratory license.
   1. a. The department may issue a restricted license pursuant to which the restricted licensee may receive a certificate to perform certain examinations and procedures within the definition of clinical laboratory technology set forth in subdivision one of section eighty-six hundred one of this article, provided that such a restricted licensee may perform examinations and procedures only 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, and toxicology (under paragraph (b-1) of this subdivision).
   2. b. Notwithstanding paragraph (a) of this subdivision, restricted licensees employed at National Cancer Institute designated cancer centers or at teaching hospitals that are eligible for distributions pursuant to paragraph (c) of subdivision three of section twenty-eight hundred seven-m 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, and restricted licensees employed at national cancer institute designated cancer centers may receive a certificate that includes the use of mass spectrometry or any tests and procedures acceptable to the commissioner of health, in consultation with the commissioner, in the field of proteomics, 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. b-1. Only individuals employed in a New York state department of health authorized toxicology laboratory, operating under the direction of a clinical laboratory director, may obtain a certificate in toxicology.
   4. c. To qualify for a restricted license, an applicant shall:
      1. file an application with the department;
      2. have received an education, including a bachelor's degree in the biological, chemical, or physical sciences or in mathematics from a program registered by the department or determined by the department to be the substantial equivalent;
      3. have completed a training program with 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. 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. The duration of the training program shall be one year of full-time training in the specific areas in which the applicant is seeking certification or the part-time equivalent thereof, as determined by the department, and the successful completion of such program shall be certified by a laboratory director who is responsible for overseeing such program;
      4. be at least eighteen years of age;
      5. be of good moral character as determined by the department; and
      6. pay a fee of one hundred seventy-five dollars for an initial restricted license and a fee of one hundred seventy dollars for each triennial registration period.
   5. d. Each restricted licensee shall register with the department as required of licensees pursuant to section sixty-five hundred two of this title and shall be subject to the disciplinary provisions applicable to licensees pursuant to subarticle three of article one hundred thirty of this title.
2. The board of regents and the department are authorized to adopt such rules and regulations as may be necessary to implement the provisions of this section.
3. Nothing in this section shall restrict a clinical laboratory practitioner, as defined in subdivision two of section eighty-six hundred one of this article, from performing any of the examinations or procedures which restricted clinical laboratory licensees are permitted to perform under this section and which such clinical laboratory practitioner is otherwise authorized to perform.