Clinical Laboratory Technology

Education Law

Chapter 755, Laws of 2004

AN ACT to amend the education law, in relation to the practice of clinical laboratory technology and the licensing or certification of individuals who engage in such practice

Became a law January 30, 2005, with the approval of the Governor.
Passed by a majority vote, three-fifths being present.

The People of the State of New York, represented in Senate and Assembly, do enact as follows:

ARTICLE 165
CLINICAL LABORATORY TECHNOLOGY PRACTICE ACT

§ 8600. Introduction.

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

§ 8601. Definition of the practice of clinical laboratory technology and clinical laboratory technology practitioner.

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, and clinical laboratory technicians, as such terms are defined in this subdivision, who work in licensed clinical laboratories and practice clinical laboratory technology. For the purposes of this article, a licensed clinical laboratory does not include a laboratory operated by any licensed physician, registered physician assistant, dentist, podiatrist 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. "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.
   4. "Director of a clinical laboratory" means a director as that term is defined in section five hundred seventy-one of the public health law.
   5. "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.

§ 8602. Practice of clinical laboratory technology and cytotechnology and use of the titles "licensed clinical laboratory technologist" and "licensed cytotechnologist".

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

§ 8603. Practice as a clinical laboratory technician and the use of the title "clinical laboratory technician".

No person shall practice as a clinical laboratory technician or hold himself or herself out as a clinical laboratory technician in this state unless he or she is certified or exempt pursuant to this article.

§ 8604. State board for clinical laboratory technology.

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 eleven 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, 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.

§ 8605. Requirements for a license as a clinical laboratory technologist or cytotechnologist.

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. Application: file an application with the department;
   2. 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 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. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
   4. Age: be at least eighteen years of age;
   5. Character: be of good moral character as determined by the department; and
   6. 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. Application: file an application with the department;
   2. 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. Examination: pass an examination acceptable to the board and in accordance with the commissioner's regulations;
   4. Age: be at least eighteen years of age;
   5. Character: be of good moral character as determined by the department; and
   6. 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.

§ 8606. Requirements for certification as a clinical laboratory technician.

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

1. Application: file an application with the department;
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;
3. Examination: pass an examination satisfactory to the board and in accordance with the commissioner's regulations;
4. Age: be at least eighteen years of age;
5. Character: be of good moral character as determined by the department; and
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.

§8607. Special provisions.

1. Notwithstanding the requirements of section eighty-six hundred five and eighty-six hundred six of this article, and for a period of time not to exceed two years from the effective date of this article, an individual may be licensed as a clinical laboratory technology practitioner, as defined in section eighty-six hundred one of this article 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 the effective date of this article; 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 the effective date of this article;
      2. been engaged full-time in the education of clinical laboratory practitioners for the equivalent of two of the past five years prior to the effective date of this article;
      3. performed the duties of a clinical laboratory technologist for at least five years prior to the effective date of this article as verified by the director of a clinical laboratory;
      4. become previously qualified under other regulatory requirements for that license or its equivalent; or
      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.
   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 the effective date of this article; or
      2. performed the duties of a clinical laboratory technician for at least five years prior to the effective date of this article or has previously qualified under other regulatory requirements for such a certification or such certification's equivalent.
   3. In the case of cytotechnologist, has 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 the effective date of this article or has previously qualified under other regulatory requirements for such a license or such license's equivalent.
2. For the purposes of subdivision one of this section, it shall be determined that the filing of an application with the department within one year of the effective date shall qualify for purposes of such subdivision, regardless of the time period required for processing such application.
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.

§ 8608. Limited permits.

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 or certification as a clinical laboratory technician, 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 one year, and may be renewed, at the discretion of the department, for one additional year.

§ 8609. Exempt persons.

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 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 thirtynine 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; provided, however, that no such person shall use the titles licensed laboratory technologist, cytotechnologist, or certified laboratory technician, 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 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 technology education programs 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, or student, and the persons work directly under the supervision of an individual licensed or exempt pursuant to subdivisions one, two, three and six 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. a director of a clinical laboratory.