Clinical Laboratory Technology

Questions & Answers

2006 Implementation

1. What does the Clinical Laboratory Technology Practice Act do?

   Chapter 755 of the Laws of 2004 enacted a new Article 165 of the Education Law, entitled the "Clinical Laboratory Technology Practice Act," which 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.

2. Who are Clinical Laboratory Technology Practitioners?

   "Clinical laboratory technology practitioner" describes anyone who performs 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.

3. What are the three licenses that are issued under this new law that become effective on September 1, 2006?

   The three licenses are Clinical Laboratory Technologist, Cytotechnologist, and Certified Clinical Laboratory Technician.

4. What are the differences among these licenses?

   A "Clinical Laboratory Technologist" is 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 New York State Education Department.

   A "Cytotechnologist" is 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 Education Department.

   A "Certified 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. When does this law take effect?

   The law takes effect on September 1, 2006. The Education Department has promulgated emergency regulations to implement the law, which are effective as of August 1, 2006, and will enable the licensure process to begin. The Department is developing application materials that should be available by late August 2006. They will be posted on this site, and can be downloaded, printed and submitted to the Department. They will also become available in hard copy as soon as they can be printed.

6. What is the difference between licensure and certification?

   In general, under Title VIII of the Education Law, all of the professions are considered "licensed," even those with a certification title. Under professional licensure laws, the term "licensed" usually refers to persons whose profession has a restricted scope of practice. This means that someone may only engage in the practice of the profession if he or she is licensed in the profession or in another profession that includes the practice activities within its scope of practice, or is exempt under the terms of the law. "Certification" usually refers to professions where the title and the specific terms of the profession are protected, so that no one can use these titles or terms, alone or in combination with other words and phrases, unless the person is licensed in the profession. The practice of the certified profession, however, would not be protected. For example, while anyone may claim to be an interior designer, only a person licensed in that profession may use the title, "certified interior designer" when describing his or her practice.

   In this law, however, the profession of "clinical laboratory technician" has a defined and restricted scope of practice, as well as title protection, so the more traditional use of the term "certification law" would not apply. This is similar to the profession of "certified athletic trainer" where the title and practice both are protected, i.e., restricted to those who are licensed or legally exempt from licensure.

7. What has to occur before individuals may be licensed?

   In May 2005, the New York State Board of Regents appointed Dr. Kathleen M. Doyle as Executive Secretary for the State Board for Clinical Laboratory Technology Professions. She works within the Department with the State Board Office to oversee and support the work of the Board and carry out other duties within the Department. By November 2005, the State Board for Clinical Laboratory Technology was appointed by the Board of Regents. The State Board assists the Board of Regents and the Department in matters of professional licensing and professional conduct.

   The Department, with input from the State Board and interested parties, drafted regulations that were needed to implement the new licensing law. The proposed emergency regulations were submitted to all interested parties and published in the State Register for comment before being approved by the Board of Regents on July 26, 2006.

   The Department has now begun the process of preparing to accept applications for licensure, review them, and issue licenses.

   We expect the applications and forms to be available in late August 2006, both on this site and in hard copy publications. As soon as they are available, they will be published online first.

8. Do all Clinical Laboratory Technology Practitioners have to be licensed?

   Most persons who are Clinical Laboratory Technology Practitioners do have to be licensed if they work in laboratories in New York State, but there are some exemptions. These exceptions include:

   • persons who work in laboratories operated by the federal government;
   • persons licensed or otherwise authorized to practice or offer the services and activities of medicine, physician assistant, dentistry, podiatry, nurse practitioner, respiratory therapy, or respiratory therapy technician; provided, however, that these persons shall not use the titles licensed laboratory technologist, cytotechnologist, or certified laboratory technician, unless they are licensed or certified in the clinical laboratory technology professions;
   • 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;
   • 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, and these 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 under this law;
   • persons employed by a clinical laboratory to perform supportive functions not related to the direct performance of laboratory procedures or examinations;
   • a director of a clinical laboratory.

   In addition, the licensure requirement does not apply to a physician, registered physician's assistant, dentist, podiatrist or certified nurse practitioner, or their employees, who perform laboratory tests or procedures solely as an adjunct to the treatment of the patients of such professional.

9. Is a license required for persons, who are often called “accessioners,” “processors,” or “assistants,” who are employed in Clinical Laboratories doing the following, or similar, work:
   • Data entry into the computer, such as patient demographics, insurance information, test orders, and test results from reference labs
   • Specimen sorting for distribution to labs or reference labs
   • Identifying “stat” requests
   • Customer contact if the written order is unclear
   • Aliquot/centrifuge specimens according to established procedures
   • Specimen storage
   • Specimen retrieval for add-on tests or validity review of the initial results
   • Specimen packing and transport to other labs, if IOTA trained
   • Recording inappropriate requests with incomplete data and unsuitable specimens, or with discrepancies between the request and specimen label, and informing the supervisor or technologist of such specimens and requests
   • Limited assessment of specimen stability, based on guidelines; for example: the tube is leaking or broken; the specimen is not labeled
   • Logging in date and time of irretrievable biopsy specimen and giving notification to the pathology department
   • Telephone communications, record keeping, and participation in infection control processes, quality improvement and safety?

   Persons working in Clinical Laboratories in positions entitled “accessioners,” “processors,” or “assistants,” or a similar title, who perform the activities identified in this question (# 9) are not required to possess a license as a Clinical Laboratory Technologist, Cytotechnologist, or Certified Clinical Laboratory Technician unless these persons perform any other services or activities that fall within the scope of practice of these licensed professions. Accessioners, processors, or assistants should follow the instruction and direction provided by their employers and/or supervisors, as long as the activities they perform do not fall within the scope of practice of these professions. Licensed clinical laboratory technology practitioners for whom such individuals work are responsible for providing appropriate supervision and may be subject to disciplinary action for the failure to provide such supervision.

10. Are cytopreparatory technicians and individuals preparing samples for analysis by ThinPrep or other liquid-based techniques required to be licensed?

    Since the term cytopreparatory technician is not defined in the Education Law, this answer is based on the Department’s understanding that cytopreparatory technicians and individuals preparing liquid-based samples work under supervision and use limited independent judgment:

    • determine the specimen preparation protocol to follow based upon specific specimen characteristics;
    • are responsible for maintaining the quality control of the stains, reagents and instruments in the laboratory;
    • follow standard blood borne pathogens and chemical safety hazard protocols for the laboratory; and
    • use aseptic techniques to prevent cross-contamination with other samples, portions of which may be sent for molecular or microbiological testing.

    It is the Department's further understanding that the daily activities of cytopreparatory technicians and those preparing liquid-based samples for analysis affect the final outcome of the cytology tests, which in turn affect the health and well-being of the patients.

    The above description indicates that, in general, the work of cytopreparatory technicians and the process of preparing for analysis liquid-based samples, such as ThinPrep, falls within the scope of practice of clinical laboratory technicians – that is, the performance of cytological laboratory procedures pursuant to established and approved protocols which require limited exercise of independent judgment and which are performed under the supervision of a licensed cytotechnologist, laboratory supervisor, or director of a cytopathology laboratory. Unless subject to one of the statutory exemptions, individuals performing the preparation of cytology specimens as described above, from receipt of the sample from the accessioner to the performance of the analysis by a cytotechnologist or pathologist, must be licensed, at minimum, as a certified clinical laboratory technician.

11. What are the requirements to be licensed in the three professions?

    There are three pathways for licensure:

    • The special provisions (grandparenting): This will generally apply to those practicing in their fields for several years. Applicants may meet various special provisions including experience and/or education to be licensed without examination.
      
      
    • The transition pathway: This will apply to those who have recently graduated or who are currently in educational programs. This pathway provides a route for graduates of registered programs that currently prepare clinical laboratory practitioners to begin to work in the clinical laboratory professions while the educational programs they attended or are attending apply to be recognized as licensure-qualifying programs. This pathway ends on September 1, 2011, by which time programs must be registered as licensure qualifying under the standard requirements, or determined by the Department to be the substantial equivalent. Applicants who qualify for the transition pathway will be issued a limited permit for one year to enable them to continue to work until they pass the licensing exam. A limited permit may be renewed for good cause for one additional year.
      
      
    • The standard pathway: This will generally apply to those who will attend a program registered as licensure qualifying and then apply for licensure. Applicants must meet the standard requirements for licensure for each of the professions if they do not meet the qualifications for licensure under the transition pathway or by grandparenting. Such applicants must complete a licensure qualifying program, or its equivalent as determined by the Department, the examination, and all other requirements. Programs will begin to be registered as licensure qualifying after August 2006 upon their application to the Department and approval.
    
    
12. Explain more about the transition pathway.

    To enable applicants who have graduated from programs which do not meet the standard education requirements established in the new regulations and who have not had the opportunity to gain sufficient experience to meet any of the grandparenting provisions to qualify for limited permits, a transitional pathway to licensure was established for use while educational institutuions develop programs which meet the new requirements. Applicants who apply under this pathway must submit an application for licensure, the fees for licensure and registration, the application for a limited permit and fee and any other requirements found in the application packet. The director of the clinical laboratory in which they will be employed must sign the attestation in the application acknowledging that he or she will provide the general supervision that is established in statute and regulation. This transitional pathway will be available for applicants until September 1, 2011.

13. Explain the "Special provisions."

    Section 8607 of Article 165 of the Education Law, entitled "Special Provisions" provides that until September 1, 2008, there will be an opportunity for persons who meet the qualifications in this section, which could be referred to as the grandparenting provisions, to be licensed in one of the clinical laboratory technology professions. Applications and fees must be received no later than September 1, 2007 to be considered under "Special Provisions." The requirements for grandparenting will be explained in the application packet and on this site in detail, and specific questions about them will be addressed in these Questions and Answers.

14. Does a license that is issued under the grandparenting provisions expire on September 1, 2008, the date by which the last grandparenting alternative requirements must be completed?

    No. In New York State, a license is issued for life unless revoked, annulled or suspended for cause.

15. If a person is licensed now by grandparenting, will the person have to take an examination or meet other requirements after September 1, 2008?

    No. Once a license is issued, it means that a licensee has met all of the requirements for licensure in New York State. It is possible that new requirements may be established under State statute which would apply to licensees when they renew their registration. For example, a statute may be enacted in law that would establish a new requirement for registration, such as continuing education.

16. Does Chapter 755 which enacted the new Clinical Laboratory Technology Practitioner professions require continuing education?

    No. Continuing education requirements were not included in this law. The Department may not require continuing education in regulation unless such a mandate exists in the statute. Professionals are required, however, to maintain their competence to engage in practice by both law and regulation, and continuing education is one means to do so.

17. Who will determine if I can be licensed as a clinical laboratory technologist, cytotechnologist, or certified clinical laboratory technician?

    It is up to the applicant to demonstrate that he or she has met the requirements for licensure in the profession in which he or she seeks licensure. The Department will determine if the qualifications for licensure have been met.

18. I obtained a certificate of qualification (sometimes called a license) before 1994 from the New York City Department of Health as a technologist or technician. Can that be used to meet the grandparenting provisions?

    Yes. The New York City Department of Health certificate of qualification may be used to provide evidence that an applicant met one of the grandparenting provisions; however, other requirements may need to be met. The means for verifying that certificate will be provided later.

19. The titles of "clinical laboratory technologist" and "clinical laboratory technician" have not been commonly used in New York State. What titles describe these practices that are commonly used by employers or educational programs to describe the jobs of clinical laboratory technology practitioners?

    Titles, such as, "medical technologist," "medical technician," "clinical scientist," "clinical science practitioner," and "cytotechnologist," are some of the terms and titles that have been used to describe those persons whose job includes any or all of the practices that are contained in the scopes of practice of all of the clinical laboratory technology professions. Under this new law, the persons who wish to be employed in these positions must be licensed, hold a limited permit, or meet one of the exemption provisions.

20. I do not live in New York State and/or I do not work in New York State. May I obtain a license in any or all of the three professions if I meet the requirements?

    Yes. Licensure is not restricted to persons who live in New York State or who are engaged in practice in New York State.

21. I received my education in another state or country. May my education be accepted as meeting the education requirement for these professions?

    Yes. If your education meets the education requirements in the regulations, your education may be approved for licensure purposes. These requirements are in sections 79-13.1, 79-14.1 and 79-15.1 of the regulations.

22. I work in an out-of-state laboratory that has a license or permit from the New York State Department of Health to accept specimens from New York State. Do I have to have a New York State license to work in this laboratory?

    No. Both the language of Article 165 and the statements of the legislative sponsors of the bills make it clear that this law does not apply to out-of-state laboratories.

23. The regulations say that they are effective on August 1, 2006, and the law says that it is effective on September 1, 2006, but the grandparenting provisions say that I do not have to apply for grandparenting until September 1, 2007, and I do not have to meet some of the requirements until September 1, 2008. What is the correct date?

    They are all correct. The regulations enable the Department to begin the process of gathering application information for the licensure of practitioners, and that date begins on August 1, 2006. The actual date when a license is required for practice is September 1, 2006. Those who believe that they can be grandparented have until September 1, 2007 to apply for licensure under the special provisions. However, if they wish to work in a laboratory in which a license will be required on or after September 1, 2006, they will have to either:

    1. have a license to do so, or
    2. have received a letter acknowledging the receipt of their application under the grandparenting provisions that authorizes them to be employed until their application has been evaluated. Such letters will be issued upon receipt of a completed grandparenting application.

    Some grandparenting provisions enable applicants who have met some requirements to complete other requirements by September 1, 2008.

24. How can everyone be issued a license by September 1, 2006?

    Most applicants will not be issued a license by September 1, 2006, but if they submit an application, the fee, and any other required information, including an attestation that they believe in good faith that they meet the grandparenting or limited permit requirements with their application, they will receive a document that will enable them to engage in practice until their application is reviewed and a determination is made about their qualification for licensure.

    The statute provides the authority for the Department to process applications for as long as needed to do so. If the Department did not enable grandparenting and transition applicants to continue to practice while their applications are under consideration, the public would be harmed by the sudden lack of available clinical laboratory practitioners. Laboratories must continue to maintain the employment standards established by the New York State Department of Health, as well.

25. Does the licensure law permit licensure for specialty areas, such as immunohematology, molecular diagnosis, histology, or virology?

    No. The statute established only three licenses. There is no authority for the Department to establish specialty certifications with a limited scope of practice.

26. Does the license with a specific scope of practice mean that the licensee is authorized to practice everything that is within the scope of practice?

    Yes. A license does authorize the licensee to engage in any area of practice that falls within the scope of practice. The licensee, however, is obligated to practice competently and must have reason to know that he or she is competent to engage in a practice by education, training or experience. Licensees who practice with negligence or incompetence can be charged with professional misconduct, and, if found guilty, may be fined, suspended, or have their licenses revoked.

27. Do phlebotomists have to be licensed under this law?

    No. Phlebotomists, who perform those activities related to collecting samples, but do not conduct procedures and examinations conducted by a laboratory, are not required to be licensed under this law.

28. Do persons who perform "waived tests" have to be licensed as a clinical laboratory technology practitioner?

    The issue of "waived tests" has to do with the statutorily defined scope of practice and will be discussed with other agencies in the context of how such tests are dealt with by the federal government and the New York State Department of Health.

29. Can nurses and other licensed professionals perform activities that fall in the scopes of practice of the clinical laboratory technology professions?

    Depending on the activity, nurses and other licensed professionals may practice some of the activities that fall within the scope of practice of the three new professions. Whether they may engage in these practices depends on the language of their profession's scope of practice as determined by the Department. Education Law provides that the scope of practice of one profession does not prevent persons in other professions from performing similar acts authorized in the scopes of practice of such other professions.

30. What are the licensure and registration fees for these new professions?

    The fees for licensure and registration are established in statute, and payment of the appropriate fee(s) is one of the requirements for the license.

    • Cytotechnologists and clinical laboratory technologists pay a fee of one hundred seventy-five dollars ($175) for an initial license and a fee of one hundred seventy dollars ($170) for each triennial registration period.
    • Clinical laboratory technicians pay a fee of one hundred twenty-five dollars ($125) for an initial certification and a fee of one hundred twenty dollars ($120) for each triennial registration period.
    • A limited permit for each profession requires a fee of fifty dollars ($50).

    Your license and first registration are issued at the same time. Therefore, the fee for an initial license and the fee for the first registration are due in full when you submit your application for licensure. Your license is issued for life, so the licensure fee is paid only once. Licensees, however, are required to register with the Department and pay the required registration fee, every three years to actively practice in New York State.

31. Are the grandparenting provisions the same for each profession?

    No. Each of the three clinical laboratory technology professions has its own Special Provisions. Article 165 describes the Special Provisions for each profession.

32. If I have additional questions, whom shall I contact?

    Additional information is available through the following e-mail address: clinlabd@mail.nysed.gov. Letters can be sent to Kathleen M. Doyle, Ph.D., State Boards for the Professions, 89 Washington Avenue, Second Floor, East Wing, Albany, New York 12234.