EDU-20-08-00030-P Licensure as a Clinical Laboratory Technologist  

  • 5/14/08 N.Y. St. Reg. EDU-20-08-00030-P
    NEW YORK STATE REGISTER
    VOLUME XXX, ISSUE 20
    May 14, 2008
    RULE MAKING ACTIVITIES
    EDUCATION DEPARTMENT
    PROPOSED RULE MAKING
    NO HEARING(S) SCHEDULED
     
    I.D No. EDU-20-08-00030-P
    Licensure as a Clinical Laboratory Technologist
    PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following proposed rule:
    Proposed action:
    Addition of sections 52.38, 52.39, 52.40, 79-13.1, 79-14.1, 79-15.1 and repeal of sections 79-13.1, 79-14.1, and 79-15.1 of Title 8 NYCRR.
    Statutory authority:
    Education Law, sections 207 (not subdivided), 210 (not subdivided), 6501 (not subdivided), 6504 (not subdivided), 6507(2)(a), (3)(a), (4)(a), 6508(1), 8605(1)(b), (2)(b) and 8606(2)
    Subject:
    Licensure as a clinical laboratory technologist and cytotechnologist and certification as a clinical laboratory technician.
    Purpose:
    To implement the provisions of article 165 of the Education Law by establishing educational requirements for licensure as a clinical laboratory technologist or cytotechnologist and for certification as a clinical laboratory technician, and standards for registered college preparation programs for these professions.
    Substance of proposed rule (Full text is posted at the following State website: www.op.nysed.gov):
    The Commissioner of Education proposes to promulgate regulations, relating to licensure as a clinical laboratory technologist and as a cytotechnologist and certification as a clinical laboratory technician. The following is a summary of the substance of the regulations.
    Section 52.38 of the Regulations of the Commissioner of Education is added to establish requirements for the registration of college preparation programs leading to licensure as a clinical laboratory technologist.
    Subdivision (a) of section 52.38 requires registered programs to be programs in clinical laboratory technology leading to a baccalaureate or higher degree or advanced certificate which contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/ quality improvement, and which is designed and conducted to prepare graduates to practice clinical laboratory technology using independent judgment and responsibility.
    Subdivision (b) of section 52.38 requires programs to include coursework, including a laboratory component, in each of the listed subject areas, or their equivalent as determined by the Department.
    Subdivision (c) requires programs to include curricular content in each of the listed subject areas, or their equivalent, as determined by the Department.
    Subdivision (d) requires supervised clinical experience of at least 30 hours per week for at least 24 weeks or its equivalent in the practice of clinical laboratory technology.
    Section 52.39 is added to establish requirements for the registration of programs leading to licensure as a cytotechnologist.
    Subdivision (a) of section 52.39 requires the registered program to be a program in cytotechnology leading to a baccalaureate or higher degree or advanced certificate which contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/ quality improvement; and which is designed to prepare graduates to practice cytotechnology using independent judgment and responsibility.
    Subdivision (b) requires the program to include coursework, including a laboratory component, in each area, in each of the listed subject areas.
    Subdivision (c) requires the program to include curricular content in each listed subject areas, or their equivalent, as determined by the department.
    Subdivision (d) requires supervised clinical experience of at least 30 hours per week for at least 10 weeks or its equivalent, as determined by the department in the practice of cytotechnology.
    Section 52.40 is added to establish requirements for the registration of programs leading to certification as a clinical laboratory technician.
    Subdivision (a) of section 52.40 requires the registered program to be a program in clinical laboratory technician leading to an associate or higher degree which contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/quality improvement.
    Subdivision (b) requires the program to include coursework, including a laboratory component, in each area, in each listed subject area or its equivalent as determined by the department.
    Subdivision (c) requires the registered program to include curricular content in each listed subject area.
    Subdivision (d) requires the program to include supervised clinical experience of at least 30 hours per week for at least 10 weeks or its equivalent in the practice of clinical laboratory technician.
    Section 79-13.1 is repealed and a new section 79-13.1 is added establishing professional study requirements for licensure as a clinical laboratory technologist.
    Subdivision (a) of section 79-13.1 states that applicants applying for licensure as a clinical laboratory technologist prior to September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in either subdivision (b) or (c) of this section. Applicants applying for licensure as a clinical laboratory technologist on or after September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in subdivision (b) of this section.
    Subdivision (b) of section 79-13.1 sets for the general professional education requirements for applicants applying for licensure as a clinical laboratory technologist.
    Paragraph (1) of subdivision (b) of section 79-13.1 defines acceptable accrediting agency.
    Paragraph (2) of subdivision (b) of section 79-13.1 sets forth the professional education requirements for admission to the licensing examination for clinical laboratory technologists which includes presenting satisfactory evidence of one of the following: (1) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology registered as leading to licensure; (2) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology that is substantially equivalent to such a registered program as leading to licensure as a clinical laboratory technologist; or (3) both, holding a baccalaureate or higher degree awarded upon successful completion of an acceptable baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences and completing a credit bearing program in clinical laboratory technology that is registered as leading to licensure as a clinical laboratory technologist or its substantial equivalent.
    Subdivision (c) of section 79-13.1 sets forth time-limited professional education requirements for applicants applying for licensure as a clinical laboratory technologist prior to September 1, 2013.
    Paragraph (1) of subdivision (c) of section 79-13.1 defines acceptable accrediting agency.
    Paragraph (2) of subdivision (c) of section 79-13.1 establishes alternative professional education requirements for applicants applying for licensure as clinical laboratory technologists prior to September 1, 2013. Such applicants may meet the educational requirements for admission to the licensing examination for clinical laboratory technologists if the program is registered by the department for general educational purposes but need not be specifically registered for licensure purposes or, if the program is accredited by an acceptable accrediting agency, or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist.
    Subdivision (d) of section 79-13.1 requires that applicants certify to the department that they have reviewed the regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to the practice of a clinical laboratory technologist.
    Section 79-14.1 is repealed and a new section 79-14.1 is added establishing professional study requirements for licensure as a cytotechnologist.
    Subdivision (a) of section 79-14.1 states that applicants applying for licensure as a cytotechnologist prior to September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in either subdivision (b) or (c) of this section. Applicants applying for licensure as a cytotechnologist on or after September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in subdivision (b) of this section.
    Subdivision (b) of section 79-14.1 sets forth the general professional education requirements for applicants applying for licensure as a cytotechnologist.
    Paragraph (1) of subdivision (b) of section 79-14.1 defines acceptable accrediting agency.
    Paragraph (2) of subdivision (b) of section 79-14.1 sets forth the professional education requirements for admission to the licensing examination for cytotechnologists which includes presenting satisfactory evidence of one of the following: (1) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in cytotechnology registered as leading to licensure; (2) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in cytotechnology that is substantially equivalent to such a registered program as leading to licensure as a cytotechnologist; or (3) both, holding a baccalaureate or higher degree awarded upon successful completion of an acceptable baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences and completing a credit bearing program in cytotechnology that is registered as leading to licensure as a cytotechnologist or its substantial equivalent.
    Subdivision (c) of section 79-14.1 sets forth time-limited professional education requirements for applicants applying for licensure as a cytotechnologist prior to September 1, 2013.
    Paragraph (1) of subdivision (c) of section 79-14.1 defines acceptable accrediting agency.
    Paragraph (2) of subdivision (c) of section 79-14.1 establishes alternative professional education requirements for applicants applying for licensure as a cytotechnologist prior to September 1, 2013. Such applicants may meet the educational requirement for admission to the licensing examination for cytotechnologists as an alternative to satisfying the requirements of subvision (b) of this section by presenting satisfactory evidence of a baccalaureate or higher degree in cytotechnology or a related title that is registered by the department for general educational purposes, but need not be specifically registered for licensure purposes, or is accredited by an acceptable accrediting agency, or is recognized by the appropriate civil authorities of the jurisdiction in which the programs are offered as programs that prepare the applicant for professional practice as a cytotechnologist.
    Subdivision (d) of section 79-14.1 requires that applicants certify to the department that they have reviewed the regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a cytotechnologist, as directed by the department.
    Section 79-15.1 is repealed and a new section 79-15.1 is added establishing professional study requirements for licensure as a clinical laboratory technician.
    Subdivision (a) of section 79-15.1 states that applicants applying for licensure as a clinical laboratory technician prior to September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in either subdivision (b) or (c) of this section. Applicants applying for licensure as a clinical laboratory technician on or after September 1, 2013 shall meet the professional education requirements for admission to the licensing examination set forth in subdivision (b) of this section.
    Subdivision (b) of section 79-15.1 sets forth the general professional education requirements for applicants applying for licensure as a clinical laboratory technician.
    Paragraph (1) of subdivision (b) of section 79-15.1 defines acceptable accrediting agency.
    Paragraph (2) of subdivision (b) of section 79-15.1 sets forth the professional education requirements for admission to the licensing examination for clinical laboratory technicians which includes presenting satisfactory evidence of one of the following: (1) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technician registered as leading to licensure; (2) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technician that is the substantial equivalent of such a registered program as leading to licensure as a clinical laboratory technician; or (3) both, holding a baccalaureate or higher degree awarded upon successful completion of an acceptable baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences and completing a credit bearing program in clinical laboratory technician that is registered as leading to licensure as a clinical laboratory technician or its substantial equivalent.
    Subdivision (c) of section 79-15.1 sets forth time-limited professional education requirements for applicants applying for licensure as a clinical laboratory technician prior to September 1, 2013.
    Paragraph (1) of subdivision (c) of section 79-15.1 defines acceptable accrediting agency.
    Paragraph (2) of subdivision (c) of section 79-15.1 establishes alternative professional education requirements for applicants applying for licensure as a clinical laboratory technician prior to September 1, 2013. Such applicants may meet the educational requirement for admission to the licensing examination for clinical laboratory technicians as an alternative to satisfying the requirements of subdivision (b) of this section by presenting satisfactory evidence of a baccalaureate or higher degree in a clinical laboratory technician program or a related title that is registered by the department for general educational purposes, but need not be specifically registered for licensure purposes, or is accredited by an acceptable accrediting agency, or is recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technician.
    Subdivision (d) of section 79-15.1 requires that applicants certify to the department that they have reviewed the regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to the practice of a clinical laboratory technician.
    Text of proposed rule and any required statements and analyses may be obtained from:
    Anne Marie Koschnick, Legal Assistant, Office of Counsel, Education Department, State Education Bldg., Rm. 148, 89 Washington Ave., Albany, NY 12234, (518) 473-8296, e-mail: legal@ mail.nysed.gov
    Data, views or arguments may be submitted to:
    Frank Muñoz, Associate Commissioner, Education Department, Office of the Professions, State Education Bldg., 89 Washington Ave., Albany, NY 12234, (518) 486-1765, e-mail: opopr@mail.nysed.gov
    Public comment will be received until:
    45 days after publication of this notice.
    Regulatory Impact Statement
    1. STATUTORY AUTHORITY:
    Section 207 of the Education Law grants general rule making authority to the Board of Regents to carry into effect the laws and policies of the State relating to education.
    Section 210 of the Education Law grants to the Board of Regents the authority to register domestic and foreign institutions in terms of New York standards.
    Section 6501 of the Education Law provides that, to qualify for admission to a profession, an applicant must meet requirements prescribed in the article of the Education Law that pertains to the particular profession.
    Section 6504 of the Education Law authorizes the Board of Regents to supervise the admission to and regulation of the practice of the professions.
    Paragraph (a) of subdivision (2) of section 6507 of the Education Law authorizes the Commissioner of Education to promulgate regulations in administering the admission to and practice of the professions.
    Paragraph (a) of subdivision (3) of section 6507 of the Education Law provides that the State Education Department shall establish standards for pre-professional and professional education, experience, and licensing examinations, as required to implement the article for each profession.
    Paragraph (a) of subdivision (4) of section 6507 of the Education Law authorizes the State Education Department to establish standards for and register or approve educational programs designed for the purpose of providing educational preparation for licensure.
    Subdivision (1) of section 6508 of the Education Law authorizes the state boards for the professions to assist the Regents and the Department in matters of professional licensure and practice.
    Paragraph (b) of subdivision (1) of section 8605 of the Education Law authorizes the State Education Department to establish implementing standards for education that must be successfully completed by an applicant to qualify for a license as a clinical laboratory technologist.
    Paragraph (b) of subdivision (2) of section 8605 of the Education Law authorizes the State Education Department to establish implementing standards for education that must be successfully completed by an applicant to qualify for a license as a cytotechnologist.
    Subdivision (2) of section 8606 of the Education Law authorizes the State Education Department to establish implementing standards for education that must be successfully completed to qualify for certification as a clinical laboratory technician.
    2. LEGISLATIVE OBJECTIVES:
    The proposed regulation carries out the intent of Article 165 of the Education Law by establishing educational standards for licensure as a clinical laboratory technologist and cytotechnologist and certification as a clinical laboratory technician.
    3. NEEDS AND BENEFITS:
    The purpose of the proposed regulation is to implement the provisions of Article 165 of the Education Law by establishing educational requirements for licensure as a clinical laboratory technologist or cytotechnologist and for certification as a clinical laboratory technician and the standards for registered college preparation programs for these professions.
    Chapter 755 of the Laws of 2004 added a new Article 165 to the Education Law. Article 165 provides for the licensing of clinical laboratory technologists and cytotechnologists and the certification of clinical laboratory technicians, and establishes these three professions as practice and title protected, under a State Board for Clinical Laboratory Technology. The proposed regulation is needed to implement Article 165 of the Education Law by establishing specific education requirements that an applicant for licensure or certification must meet.
    In addition, the proposed regulation is needed to set forth standards for registered college preparation programs that lead to licensure in these professions.
    4. COSTS:
    (a) Costs to State government: The proposed regulation will not impose any additional cost on State government, including the State Education Department, over and above the costs imposed by Article 165 of the Education Law for administering these professions.
    (b) Cost to local government: The proposed amendment establishes requirements for licensure as a clinical laboratory technologist and cytotechnologist and certification as a clinical laboratory technician. The regulation will not impose additional costs on local government.
    (c) Cost to private regulated parties: The proposed regulation will not impose any other costs on applicants for the three new licenses over and above those imposed by Article 165 of the Education Law. The proposed regulation simply establishes the content of the coursework and imposes no additional educational costs beyond those imposed by the statutory requirement.
    (d) Cost to the regulatory agency: As stated above in Costs to State government, the proposed regulation does not impose costs on the State Education Department beyond those imposed by statute.
    5. LOCAL GOVERNMENT MANDATES:
    The proposed regulation implements the requirements of Article 165 of the Education Law by establishing educational standards that individuals must meet to be licensed as clinical laboratory technologists and cytotechnologists and certified as clinical laboratory technicians and the standards for college preparation programs in these professions. Therefore, the proposed regulation does not impose any program, service, duty or responsibility upon local governments.
    6. PAPERWORK:
    The proposed regulation imposes no additional reporting or recordkeeping requirements beyond those imposed by Article 165 of the Education Law. In accordance with Article 165, applicants for licensure will be required to submit to the State Education Department evidence of meeting licensure requirements. Colleges and universities seeking registration of college preparation programs leading to licensure in these three professions will be required to submit to the State Education Department evidence of meeting program registration requirements.
    7. DUPLICATION:
    The proposed regulation does not duplicate other existing State or Federal requirements.
    8. ALTERNATIVES:
    There have been extensive discussions concerning the content of the college preparation program requirements. The proposed regulation incorporates some of the suggestions made during those discussions.
    9. FEDERAL STANDARDS:
    There are no Federal standards for the licensure of clinical laboratory technologists, cytotechnologists or clinical laboratory technicians, the subject of the proposed regulation. The education requirements for licensure or certification in these fields requires applicants to certify that they have reviewed the rules and regulations of the U.S. Department of Health and Human Services, relating to practice in these fields, in accordance with written guidance by the State Education Department.
    10. COMPLIANCE SCHEDULE:
    Applicants for licensure or certification must comply with the regulation on the stated effective date. The regulation includes a transition period of approximately five years for college preparation programs to implement the new requirements.
    Regulatory Flexibility Analysis
    The proposed amendment implements the provisions of Article 165 of the Education Law by establishing educational requirements for the licensure of individuals as clinical laboratory technologists or cytotechnologists and certification of individuals as clinical laboratory technicians and standards for registered college preparation programs leading to licensure in these fields. The proposed amendment will have no effect on small businesses and does not regulate local governments.
    The amendment will not impose any adverse economic impact, recordkeeping, reporting, or other compliance requirements on small businesses or local governments. Because it is evident from the nature of the regulation that it does not affect small businesses or local governments, no further steps were needed to ascertain that fact and none were taken.
    Rural Area Flexibility Analysis
    1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:
    The proposed regulation will apply statewide to all individuals who apply for licensure as clinical laboratory technologists and cytotechnologists and certification as clinical laboratory technicians (approximately 18,000 individuals), and colleges statewide that seek registration of programs leading to licensure and certification in these field, including those located in the 44 rural counties of New York State with less than 200,000 inhabitants and the 71 towns in urban counties with a population density of 150 per square mile or less.
    2. REPORTING, RECORDKEEPING AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:
    Chapter 755 of the Laws of 2004 added a new Article 165 to the Education Law. Article 165 provides for the licensing of clinical laboratory technologists and cytotechnologists and the certification of clinical laboratory technicians, and establishes these three professions as practice and title protected, under a State Board for Clinical Laboratory Technology. The proposed regulation implements the requirements of Article 165 of the Education Law by establishing specific education standards that an applicant for licensure or certification must meet.
    In addition, in accordance with the requirements of Article 165 of the Education Law, the proposed regulation sets forth standards for registered college preparatory programs that lead to licensure or certification in these fields.
    The proposed regulation does not impose reporting requirements over and above those required by statue. In accordance with statutory requirements, applicants for licensure or certification in these three professions will have to submit to the State Education Department evidence of meeting licensure or certification requirements. Colleges and universities seeking registration of programs leading to licensure or certification in these fields will be required to submit to the State Education Department evidence of meeting program registration requirements.
    The proposed regulation will not impose recordkeeping requirements on regulated parties beyond those already required by statute or regulation, and will not require regulated parties to obtain professional services to comply.
    3. COSTS:
    The proposed regulation will not impose any other costs on applicants for the three new licenses over and above those imposed by Article 165 of the Education Law. The proposed regulation simply establishes the content of the coursework and imposes no additional educational costs beyond those imposed by the statutory requirement.
    4. MINIMIZING ADVERSE IMPACT:
    The proposed amendment implements and clarifies education standards required for licensure as a clinical laboratory technologist or cytotechnologist and certification as a clinical laboratory technician, as directed by Article 165 of the Education Law. It also establishes requirements for college programs registered as leading to licensure in these fields. The statute makes no exception for individuals or entities located in rural areas of the State. The State Education Department has determined that such requirements should apply to all individuals seeking licensure no matter their geographic location to ensure an adequate standard of competency across the State. Likewise, the Department has determined that registered college programs that lead to licensure should be subject to the same requirements, regardless of their geographic location, to ensure that candidates for licensure are adequately prepared. Because of the nature of the proposed rule, alternative approaches for entities located in rural areas of the State were not considered.
    5. RURAL AREA PARTICIPATION:
    Comments on the proposed regulation were solicited from statewide organizations representing parties having an interest in the practice of the three professions. Included in this group were the State Board for Clinical Laboratory Technology, colleges and universities, professional associations and collective bargaining organizations representing individuals practicing these professions. These groups have members who live or work in rural areas. Staff of the State Education Department met with large groups of individuals who are employed in the three fields to obtain their input during the development of the regulation. These groups included individuals from rural areas of New York State. In addition, comments were solicited from colleges and universities in the State that offer programs that prepare clinical laboratory technologists, cytotechnologists, and clinical laboratory technicians, some of which are located in rural areas. The Department also sent the proposed regulation to licensed clinical laboratories across the State, including those that are located in rural areas of New York State.
    Job Impact Statement
    Article 165 of the Education Law establishes a requirement that clinical laboratory technologists and cytotehnologists be licensed to practice in New York State and that clinical laboratory technicians be certified to practice in this State. The proposed amendment implements the requirements of Article 165 of the Education Law by establishing education standards for licensure or certification. It also sets forth standards for registered college preparation programs that lead to licensure or certification in these fields, in accordance with statutory requirements.
    The proposed regulation implements statutory requirements and directives. Because it is evident from the nature of the proposed regulation that it will have no impact on jobs or employment opportunities, no further steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.

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