A Notice of Proposed Rule Making concerning this regulation was published in the State Register on May 24, 2006. A Notice of Emergency Adoption and Revised Rule Making was published on August 16, 2006. A second Notice of Emergency Adoption and Revised Rule Making was published on November 15, 2006. The following is a summary of comments received by the State Education Department (SED) since the publication of the Notice of Emergency Adoption and Revised Rule Making on November 15, 2006, and the Department's response to the comments.

COMMENT: The regulations do not recognize specialist technologists who work solely in specialized laboratories, even though every teaching hospital in New York State employs these specialists. The regulation must permit licensure in specialty clinical titles or the result will be an acute shortage of personnel and an inability to provide adequate clinical laboratory services.

RESPONSE: Article 165 of the Education Law establishes three new professions, clinical laboratory technology, cytotechnology, and clinical laboratory technician, and provides a general scope of practice for each profession. SED does not have statutory authority to establish specialist fields within these licensed professions through regulation. The regulation does not prevent a licensed individual from specializing within the scope of practice of that profession.

COMMENT: The “grandparenting” provisions are onerous and unreasonably restrictive. The regulation should permit automatic licensure for all individuals working as qualified technicians and technologists as of September 30, 2006.

RESPONSE: The regulation implements statutory “grandparenting” provisions (Education Law section 8607). Such provisions do not provide for automatic licensure for those employed as laboratory technicians and technologists as of a certain date, and SED does not have statutory authority to establish such a provision in regulation. The statutory “grandparenting” provisions permit applicants to be licensed as a clinical laboratory technologist or certified as a clinical laboratory technician if they have at least five years of applicable experience prior to September 1, 2006, the effective date of the licensure law.

COMMENT: The regulation should be interpreted to allow any individual working as a technologist in a laboratory that is licensed by the New York State Department of Health (DOH) to obtain automatic licensure under the statutory provision that authorizes such licensure for persons previously qualified under other regulatory requirements for that license or its equivalent.

RESPONSE: The statutory “grandparenting” provisions at issue, Education Law section 8607 (1)(a)(iv), (b)(ii), and (c), require the individual to be “previously qualified under other regulatory requirements for the license or its equivalent.” DOH licenses laboratories and does not license individuals as clinical laboratory technologists, cytotechnologists, or clinical laboratory technicians. Therefore, this “grandparenting” provision may not be used to automatically license individuals based solely on the fact that they are employed at a DOH licensed clinical laboratory on a particular date, as suggested by the comment. However, another statutory “grandparenting” provision permits applicants to be licensed as a clinical laboratory technologist or certified as a clinical laboratory technician if they have at least five years of applicable experience prior to September 1, 2006, the effective date of the licensure law, and this “grandparenting” provision is prescribed in the regulation.

COMMENT: The regulation should permit cytotechnologists to be licensed through a “grandparenting” provision based upon having at least five years of applicable experience prior to September 1, 2006, as permitted for clinical laboratory technologists and clinical laboratory technicians.

RESPONSE: The “grandparenting” provisions are established in Education Law section 8607. This statute does not establish a “grandparenting” provision for cytotechnologists, based upon having at least five years of applicable experience prior to September 1, 2006, as is provided for clinical laboratory technologists and clinical laboratory technicians. SED does not have the statutory authority to establish this “grandparenting” provision in regulation.

COMMENT: Existing preparation programs in the State are inadequate to meet the need for clinical laboratory technologists. SED should work with practitioners in the field to devise hospital-based training programs.

RESPONSE: The current regulation permits an applicant to complete a portion of the education requirement for licensure as a clinical laboratory technologist through an accredited hospital-based program. SED is working with degree-granting institutions to develop registered programs that lead to licensure through a partnership between degree-granting institutions and the hospital-based programs.

COMMENT: It is my understanding that the SED will permit an individual to be licensed as a clinical laboratory technologist under “grandparenting” provisions based solely upon experience as a clinical laboratory technician. This should be clarified in the regulation.

RESPONSE: The regulation implements the “grandparenting” provisions in Education Law section 8607. The regulation is clear and does not permit licensure as a clinical laboratory technologist based solely upon experience as a clinical laboratory technician. One “grandparenting” provision establishes the following licensure requirement: the applicant must be a certified clinical laboratory technician and by September 1, 2008 must both complete a prescribed baccalaureate degree program and have four years of experience as a clinical laboratory technician. Another “grandparenting” provision requires the applicant to have performed the duties of a clinical laboratory technologist for five-years, meaning 7,200 clock hours, prior to September 1, 2006, as verified in writing by the Director of the Clinical Laboratory. This provision would not permit licensure as a clinical laboratory technologist based upon performing the duties of a clinical laboratory technician.

COMMENT: The regulation should be clarified to permit clinical laboratory supervisory experience to be creditable for the five years of experience under the “grandparenting” provision.

RESPONSE: A regulatory change is unnecessary. Under the existing regulation, SED has accepted appropriate experience supervising the work of clinical laboratory technologists to meet the five-years of experience for licensure as a clinical laboratory technologist under this “grandparenting” provision.

COMMENT: Laboratory assistants should be exempt from licensure.

RESPONSE: The scopes of practice for these new professions are defined in the Education Law. SED does not have the authority to modify the statutory scopes of practice in regulation. Laboratory assistants who perform work within the statutory scopes of practice must be licensed or certified.

COMMENT: Students who are enrolled in clinical laboratory technology and clinical laboratory technician programs, and who have been trained and deemed competent, should be able to perform supervised testing outside of their education program.

RESPONSE: Education Law section 8609(4) provides an exemption from the licensure requirement for students or trainees enrolled in approved clinical laboratory technology education programs for supervised activities that constitute part of a planned course in the program. SED does not have the authority to expand this exemption through regulation to authorize employment of unlicensed students to perform work within the scope of practice of these professions that is outside of their course of study.

COMMENT: The regulation does not consider the economic impact the licensure act will have on laboratories performing specialized cytogenetic testing.

RESPONSE: Cytogenetics is within the scope of practice of clinical laboratory technologists. The requirement for licensure is imposed by statute, not by the regulatory requirements. Any costs that a laboratory will have to bear to employ licensed individuals to perform specialized cytogenetic testing results from the statutory licensure requirement not this implementing regulation.

COMMENT: Requiring cytotechnologists to be licensed will negatively affect the ability of cytotechnologists in rural Chemung County to keep their jobs, negatively affecting employment.

RESPONSE: Article 165 of the Education Law establishes the requirement that cytotechnologists must be licensed in order to practice in New York State. The proposed regulation simply implements the statutory requirements for licensure. Any impact on jobs is attributable to the statute which requires licensure, not the regulation.