Clinical Laboratory Technology

Questions & Answers

2008 Amendment

General Information

1. What amendments were made to Article 165 of Title VIII of the Education Law (the Clinical Laboratory Technology Act) and when did this happen?

   On July 7, 2008, Governor David A. Paterson signed Chapter 204 which made amendments to Article 165 of Title VIII of the Education Law – the Clinical Laboratory Technology Practice Act. These changes will add a new profession of certified histological technician, will provide changes and additions to the special provisions (grandparenting), and will establish new licensure types (limited licenses and restricted licenses) within the clinical laboratory technology professions under the oversight of the Board of Regents.

2. Did Chapter 204 include other additions or changes?

   Yes. The Department of Health may create within the Wadsworth Center for laboratories and research a master of science program in the field of laboratory science, subject to the approval of the Board of Regents and registration with the Department of Education. In addition, amendments were made to section 579 of the Public Health Law related to persons, partnerships, corporations, and other entities that hold a valid certificate of registration issued by the Department of Health authorizing the performance of waived tests and that these entities may perform only those tests authorized by the certificate of registration, as well as complying with all other requirements.

3. What are “waived tests?”

   A waived test is defined in this law as “a clinical laboratory test that has been designated as a waived test or is otherwise subject to certificate of waiver requirement pursuant to the federal Clinical Laboratory Improvement Act of 1988, as amended.”

   The federal regulations (42 CFR Part 493) describe waived tests as “simple laboratory examinations and procedures that are cleared by the Food and Drug Administration (FDA) for home use; employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or pose no reasonable risk of harm to the patient if the test is performed incorrectly.” They note that “under the current process, waiver may be granted to: 1) any test listed in the (federal) regulation, 2) any test system for which the manufacturer or producer applies for waiver if that test meets the statutory criteria and the manufacturer provides scientifically valid data verifying that the waiver criteria have been met, and 3) test systems cleared by the FDA for home use.”

4. When does the new law become effective?

   The law becomes effective on August 7, 2008. It cannot, however, be fully implemented until regulations are written and approved by the Board of Regents, which is expected to occur in September 2008.

5. May applicants who hold a letter authorizing them to work until September 1, 2008, continue to work after that date?

   Yes. An applicant who has received a letter authorizing him or her to work until September 1, 2008, or until his or her application is reviewed will receive a new letter extending that date to July 1, 2009. If you already have a letter authorizing you to work until September 1, 2008, you do not need to contact the Education Department for a new one to be issued; the new letter will be sent to you automatically.

6. Will those who have already submitted applications be able to use one of the new pathways or methods of licensure?

   Yes. During the coming weeks and months, all applications that have been submitted and all new ones will be reviewed based on all available pathways or methods for licensure. All applicants will be notified in writing of the outcome of this review. Applicants may find that they are eligible for licensure under more than one pathway. The Department will assist applicants in identifying such pathways. Applications for all pathways or methods will be available as soon as the regulations have been approved by the Board of Regents. Those who may qualify for licensure under a new pathway or method may receive a letter asking for additional information if this will be helpful in expediting licensure.

7. Will new application forms be required?

   New application forms are being developed for all pathways or methods and will be available as soon as the regulations have been enacted. In the meantime, those who are applying for licensure under the current pathways and methods should continue to use the application forms that can be found at on this website or can be obtained by writing to the Department at Forms Unit, Office of the Professions, 89 Washington Avenue, Albany, New York 12234.

   Those who plan to apply for a limited or a restricted license or for licensure as a certified histological technician should not apply until the applications for these licenses are published.

Licensure as a Certified Histological Technician

8. What are the requirements for the license as a certified histological technician?

   Those who seek licensure as a certified histological technician must submit an application and fee, and meet education, examination, moral character, and age requirements. The education requirement is:

   • an associate’s degree from an approved histotechnician program registered by the Department or determined by the Department to be the substantial equivalent, or
   • an associate’s degree that includes a minimum number of credit hours in the sciences and an appropriate clinical education in a histological technician program approved by the department or a program to be determined by the Department to be the substantial equivalent.

   The examination will be one that covers the functions of histological technicians and that is satisfactory to the Board and approved in accordance with the Commissioner’s regulations. The applicant must be of good moral character as determined by the Department, and an applicant must be 18 years old to receive a license.

9. What is the scope of practice of a certified histological technician?

   A certified histological technician is a clinical laboratory technology 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 require 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.

10. Is a license as a certified histological technician required to practice histological assays, tests and procedures?

    A license as a certified histological technician is required to practice histological assays, tests and procedures, but clinical laboratory technologists, cytotechnologists, and certified clinical laboratory technicians may practice the profession of certified histological technician. A limited license as a certified histological technician has also been established under the amendments to the law and will be described in the section on Limited Licenses.

11. Will the State Board for Clinical Laboratory Technology change since there is a new profession of certified histological technician?

    Yes. A certified histological technician will be appointed to the current State Board for Clinical Laboratory Technology by the Board of Regents upon the recommendation of the Commissioner to assist the Board of Regents and the Department on matters of professional licensing and professional conduct. The purpose of the State Board is to serve the public. To avoid a conflict of interest, Board members may not serve as officers or members of the governing councils of state, regional or national professional associations or as other policy makers or lobbyists for the professions in which they are licensed while they serve on the State Board. More information about Board membership can be found on this site.

Grandparenting - (Special Provisions)

12. Are there new grandparenting provisions for Clinical Laboratory Technology practitioners?

    Yes. To address some unintended consequences that occurred following the implementation of the licensing law for Clinical Laboratory Technology practitioners of 2004, several amendments have been made to the Special Provisions (grandparenting section) of that law, including the addition of new grandparenting pathways. In almost all instances, the experience needed for licensure by grandparenting for the old and new pathways must have been completed by December 31, 2007.

    • The application deadline for the grandparenting pathways which were established under the 2004 law has been extended to January 1, 2009 and applicants may be licensed under these provisions until July 1, 2009.
    • The application deadline for the new grandparenting pathway that has been established under the amendments of chapter 204 is September 1, 2013, and applicants under this pathway may be licensed under these provisions until December 31, 2013. This new pathway applies specifically to persons who competently performed the duties of a clinical laboratory technologist or clinical laboratory technician for a period of six months in the three years immediately preceding December 31, 2007 as verified by a director of a clinical laboratory. Such experience must have taken place in a clinical laboratory that was operated with a license (permit) from the Department of Health in accordance with Title 5 of Article V of the Public Health Law.
    
    
13. What are the grandparenting (special provision) pathways for Clinical Laboratory Technologists?
    • Having:
      • met the education requirements for a clinical laboratory technologist, or completed an approved baccalaureate program in biological, chemical or physical sciences from an accredited college or university, and
      • performed the duties of a clinical laboratory technologist for two of the past five years prior to December 31, 2007, or
    • Having been engaged full-time in the education of clinical laboratory practitioners for the equivalent of two of the past five years prior to December 31, 2007, or
    • Having performed the duties of a clinical laboratory technologist for at least five years prior to December 31, 2007, as verified by a director of a clinical laboratory, or
    • Having been licensed by the New York City Department of Health prior to 1995, or
    • Having competently performed the duties of a clinical laboratory technologist in a clinical laboratory that was operated with a license (permit) from the Department of Health in accordance with Title 5 of Article V of the Public Health Law for a period of not less than six months in the three years immediately preceding December 31, 2007, as verified by a director of a clinical laboratory, or
    • Having become a currently certified clinical laboratory technician with a bachelor’s degree from an accredited college that includes a minimum number of hours in the sciences and four years of documented work experience as a clinical laboratory technician, acceptable to the Department.
    
    
14. What are the grandparenting (special provision) pathways for Cytotechnologists?
    • Having met the educational requirements for a cytotechnologist and performed the duties of a cytotechnologist for two of the previous five years prior to December 31, 2007, or
    • Having performed the duties of a cytotechnologist for at least five years prior to December 31, 2007, as verified by the director of a clinical laboratory, or
    • Having been licensed by the New York City Department of Health prior to 1995.
    
    
15. What are the grandparenting (special provision) pathways for Certified Clinical Laboratory Technicians?
    • Having met the educational requirements for a clinical laboratory technician and performed the duties of a clinical laboratory technician for two of the past five years prior to December 31, 2007, or
    • Having performed the duties of a clinical laboratory technician for at least five years prior to December 31, 2007, as verified by a director of a clinical laboratory, or
    • Having been licensed by the New York City Department of Health prior to 1995, or
    • Having competently performed the duties of a clinical laboratory technician in a clinical laboratory that was operated with a license (permit) from the Department of Health in accordance with Title 5 of Article V of the Public Health Law for a period of not less than six months in the three years immediately preceding December 31, 2007, as verified by a director of a clinical laboratory.
    
    
16. What are the grandparenting (special provision) pathways for Histological Technicians?
    • Having met the educational requirements for a histological technician and performed the duties of a histological technician for two of the past five years prior to December 31, 2007, or
    • Having competently performed the duties of a histological technician in a clinical laboratory that was operated with a license (permit) from the Department of Health in accordance with Title 5 of Article V of the Public Health Law for a period of not less than six months in the three years immediately preceding December 31, 2007, as verified by a director of a clinical laboratory, or
    • Having performed the duties of a histological technician for at least five years prior to December 31, 2007, as verified by a director of a clinical laboratory, or
    • Having been licensed by the New York City Department of Health as a histological technician prior to 1995.

Restricted Clinical Laboratory Licenses

17. What are restricted Clinical Laboratory Licenses?

    The Department may issue a restricted license under which a person may receive a certificate to perform certain examinations and procedures that are within the definition of clinical laboratory technology, and the person may perform examinations and procedures only in the areas that are specifically listed in his or her certificate. These areas are histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology, and molecular diagnosis to the extent that this molecular diagnosis is included in genetic testing-molecular and molecular oncology.

    In addition, restricted licensees who are employed at National Cancer Institute designated cancer centers or eligible teaching hospitals may receive a certificate that also includes the practice of other areas of molecular diagnosis, but they may practice these additional areas only at such centers or teaching hospitals, or at other sites as designated by the Commissioner.

18. What is required to obtain a restricted license?

    To obtain a restricted license, a person must apply, pay the fee, and show evidence that he or she has met the education, training, moral character and age (18 years old) requirements.

19. What is the education requirement?

    To qualify for a restricted license, an applicant must have received 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.

20. What is the training requirement?

    The training program must be a planned sequence of supervised employment or engagement in activities appropriate for the area of certification, and must be satisfactory to the Department in quality, breadth, scope and nature. The program must include one year of full-time training in the specific area in which the applicant is seeking certification or the part-time equivalent. It must be provided by an entity that shall be responsible for the services that are provided.

21. How is the training program approved for each applicant?

    The training program must 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 successful completion of the program by the applicant shall be certified by the clinical director.

22. Is the license issued at the beginning of the yearlong training program?

    No. The person must apply for licensure prior to the start of the program, and the clinical director must attest and describe the program at that time. Once the year-long program is completed and certified by the clinical director who is responsible for overseeing the program, the license will be issued.

23. Does the applicant seeking a restricted license need a permit of some kind to practice during the year of training?

    No. Trainees in these approved training programs are exempt from the licensure requirement as long as the activities constitute a planned part of the program, and they are designated by a title, such as intern, trainee, fellow or student and work directly under the supervision of an individual licensed under the provisions of this law or of specified exempt individuals.

Limited Clinical Laboratory Technology Licenses

24. What is a limited license?

    The Department may grant a limited license and registration to a person who meets specific conditions for the purpose of performing examinations and procedures within the definition of clinical laboratory technology. The limited license may be issued to a person who is employed in a clinical laboratory under the direction of a clinical director so that the person may complete the education requirements and pass the examination required for licensure as a clinical laboratory technologist or histological technician in New York State. A limited license or registration shall not be valid beyond September 1, 2013 and cannot be renewed.

25. What is required to obtain a limited license and registration?

    To be granted a limited license, a person must apply, pay the fee, and show evidence that he or she has met one of the specific conditions for the limited license as a clinical laboratory technologist or for the limited license as a certified histological technician in addition to the moral character and age (18 years old) requirements. In addition, the applicant must 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.

26. What are the specific conditions that must be met for an applicant to qualify for a limited license?
    
    
    • Have a license as a clinical laboratory technologist, or the equivalent as determined by the Department, in another jurisdiction, or
    • 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
    • Have received a bachelor's degree in the biological, chemical or physical sciences or in mathematics, and 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 the laboratory, as defined in Title 5, Article V 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.
    
    
27. What are the specific conditions that can be met for an applicant to qualify for a limited license as a certified histological technician?
    
    
    • Have received an associate's degree that includes a minimum number of hours in the sciences, provided that such education is acceptable to the Department, and
    • Attest in the application for licensure that the applicant will provide only those services or activities that the applicant has reason to know he or she can perform competently based on education, training, and supervised experience.
    
    
28. What must a limited license holder do to obtain a license as a clinical laboratory technologist or a histological technician?

    To obtain a license as a clinical laboratory technologist or a histological technician, a person holding a limited license must complete all of the requirements for licensure, as they are defined in the Regulations of the Commissioner. The intention of the limited license is to enable persons who meet the above criteria, but who may have to remedy certain coursework deficiencies for full licensure and/or complete the New York State examination requirement, to do so. Persons with a limited license will be expected to complete the education and/or examination requirements by September 1, 2013, after which the limited license will no longer be valid. A limited license is not renewable.

29. Is the limited license holder subject to professional disciplinary provisions that are applicable to licensees?

    Yes, limited license holders are subject to the same disciplinary provisions found in subarticle three of article one hundred thirty of this title that apply to licensed clinical laboratory technologists and certified histological technicians.

30. Are limited license holders required to have reason to know that they are competent to provide clinical laboratory technology services before providing such services?

    Yes. Those who hold a limited license as a clinical laboratory technologist or a certified histological technician are required to provide only those services that they have reason to know they can perform competently. Such competence can be gained by education, training, or experience.

Additional Changes to Article 165, as Amended

31. Have there been changes other than licensure requirements in Article165, as amended?

    Yes. An addition to the section on exemptions has been added. The provisions of Article 165, as amended, do not apply to the 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 their official duties.