EDU-41-08-00007-E Licensure of Clinical Laboratory Technologists, Cytotechnologists, Clinical Laboratory Technicians and Histological Technicians  

  • 1/7/09 N.Y. St. Reg. EDU-41-08-00007-E
    NEW YORK STATE REGISTER
    VOLUME XXXI, ISSUE 1
    January 07, 2009
    RULE MAKING ACTIVITIES
    EDUCATION DEPARTMENT
    EMERGENCY RULE MAKING
     
    I.D No. EDU-41-08-00007-E
    Filing No. 1325
    Filing Date. Dec. 19, 2008
    Effective Date. Dec. 19, 2008
    Licensure of Clinical Laboratory Technologists, Cytotechnologists, Clinical Laboratory Technicians and Histological Technicians
    PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
    Action taken:
    Addition of sections 52.41, 79-13.5, 79-13.6 and Subpart 79-16 and amendment of sections 79-13.4, 79-14.4 and 79-15.4 of Title 8 NYCRR.
    Statutory authority:
    Education Law, sections 207 (not subdivided); 210 (not subdivided); 212(3); 6501 (not subdivided); 6504 (not subdivided); 6507(2)(a), (3)(a) and (4)(a); 6508(1); 8606-a(2) and (3); 8610(3)
    Finding of necessity for emergency rule:
    Preservation of public health and general welfare.
    Specific reasons underlying the finding of necessity:
    The proposed amendment implements the requirements of Article 165 of the Education Law, as amended by Chapter 204 of the Laws of 2008, among other things, establishing a new profession for histological technicians and extending grandparenting provisions for clinical laboratory technologists, clinical laboratory technicians and cytotechnologists. It also establishes standards for registered college preparation programs that lead to licensure or certification as a histological technician, in accordance with the statutory requirements.
    We estimate that approximately 1,000 persons are employed in these four professional areas and will require either licensure or submission of an application under the extended grandparenting provisions by January 1, 2009, in order to continue to practice these professions. The State Education Department expects that most current practitioners will be licensed under the grandparenting provisions established in the proposed amendment. These clinical laboratory practitioners are employed in the State's clinical laboratories to perform tests needed for the diagnosis and treatment of illness and disease. They perform important functions that protect the general welfare, health, and safety of residents of New York State.
    The proposed amendment was adopted at the September 15-16, 2008 Regents meeting as an emergency measure, effective September 23, 2008, to preserve the general welfare, to ensure that procedures and standards are in place to license individuals by the effective date of the statutory licensure requirement for histological technicians and so that clinical laboratory technicians, cytotechnologists and clinical laboratory technologists can apply for licensure under the expanded grandparenting provisions by the application deadline of January 1, 2009, thereby enabling such practitioners to be licensed in a timely manner to meet the health care needs of the residents of New York State. A Notice of Emergency Adoption and Proposed Rule Making will be published in the State Register on October 8, 2008.
    The proposed rule will be adopted as a permanent rule at the December 15-16, 2008 Regents meeting. Pursuant to the State Administrative Procedure Act section 203(1), the earliest the adopted rule can become effective is upon its publication in the State Register on January 8, 2009. However, the September emergency rule will expire on December 21, 2008, 90 days after its filing with the Department of State on September 23, 2008.
    An emergency adoption is therefore necessary for the preservation of the general welfare to ensure that the emergency rule remains continuously in effect until the effective date of its adoption as a permanent rule.
    Subject:
    Licensure of clinical laboratory technologists, cytotechnologists, clinical laboratory technicians and histological technicians.
    Purpose:
    To implement the provisions of Article 165 of the Education Law, as amended by Chapter 204 of the Laws of 2008.
    Substance of emergency rule:
    The Board of Regents proposes to add sections 52.41, 79-13.5, 79-13.6 and Subpart 79-16 and amend sections 79-13.4, 79-14.4 and 79-15.4 of the Regulations of the Commissioner of Education, effective September 23, 2008.
    Section 52.41 sets forth the requirements for a registered program leading to licensure as a certified histological technician.
    Sections 52.41(a), (b) and (c) require that a registered program be a histologoical technician program leading to an associate or higher degree and contain didactic and clinical education and include curricular content in specific subject areas and a supervised clinical experience of at least 30 hours per week for 8 weeks or their equivalent, as determined by the department, in the practice of histological technician.
    Section 79-13.4(a) provides that an applicant may be licensed by the department as a clinical laboratory technologist by meeting the requirements specified in the special provisions of section 8607(1)(a) of the Education Law if he or she applies for licensure by January 1, 2009 and meets the requirements for licensure by July 1, 2009, unless an earlier date is required.
    Section 79-13.4(b) requires an applicant to file an application and pay the fee for the license and initial registration by January 1, 2009, except as provided by section 79-13.4(b)(4)(vii).
    Sections 79-13.4(b)(4)(i),(ii),(iii) and (iv) provide for licensing under special provisions if applicants have performed duties of a clinical laboratory technologist, as prescribed in each subparagraph, by December 31, 2007.
    Section 79-13.4(b)(4)(vi) provides for licensing under special provisions if applicants are certified as clinical laboratory technicians and hold a specified baccalaureate or higher degree by July 1, 2009, and have completed the required experience by July 1, 2009.
    Section 79-13.4(b)(4)(vii) provides for licensing under special provisions for applicants who have competently performed the duties of a clinical laboratory technologist in a clinical laboratory operated in accordance with Title V of Article 5 of the Public Health Law for a period of not less than six months over the three years immediately preceding December 31, 2007, as verified by a director of the clinical laboratory, and have filed an application, paid the fee for the initial license and first registration period on or before September 1, 2013.
    Section 79-13.4(c) provides that applicants who have filed an application for licensure as a clinical laboratory technologist by January 1, 2009 and have met the requirements for licensure under this section by July 1, 2009, shall be deemed qualified to practice from the date of application until the department has acted on the application.
    Section 79-13.5(a) provides for a restricted clinical laboratory license to perform certain examinations and procedures within the definition of clinical laboratory technology in the areas of histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology, and molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology.
    Section 79-13.5(b) authorizes the Department to issue a certificate that also includes the practice of molecular diagnosis to restricted licensees employed at National Cancer Institute designated cancer centers or at teaching hospitals that are eligible for distributions pursuant to section 2807-m(3)(c) of the Public Health Law.
    Sections 79-13.5(c)(1) and (2) require applicants seeking a restricted license to meet the requirements set forth in Section 8610(1) of the Education Law and successfully complete a baccalaureate or higher degree program in the major of biology, chemistry, the physical sciences, or mathematics from a program registered by the department or the substantial equivalent and complete a training program meeting certain requirements.
    Sections 79-13.5(c)(2)(v)(a),(b),(c),(d) and (e) provide specific training content requirements for applicants seeking a certificate in the areas of histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology, and molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology.
    Section 79-13.5(c)(2)(v)(f) provides for a certificate in the area of molecular diagnosis for applicants employed at a National Cancer Institute designated cancer center or at a teaching hospital that is eligible for distributions pursuant to Public Health Law section 2807-m(3)(c) if the applicants meets specified training requirements.
    Section 79-13.5(c)(3) requires an applicant seeking a restricted license to certify 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, relating to practice as a clinical laboratory technologist, in accordance with written guidance from the department.
    Section 79-13.6(a) authorizes the department to issue a limited license and registration enabling a limited licensee to perform certain examinations and procedures to an applicant who meets one of the following three requirements: (1) the applicant is licensed as a clinical laboratory technologist, or the equivalent as determined by the department, in another jurisdiction; (2) the applicant has received a baccalaureate degree or higher in the biological, chemical, or physical sciences and received training in a clinical laboratory, provided such education and training are acceptable to the department; and (3) the applicant received a baccalaureate degree or higher in the biological, chemical, or physical sciences or in mathematics, and has served as a research assistant in a research laboratory working on specified research, procedures and examinations.
    Section 79-13.6(b) requires an applicant seeking a limited license to certify that he or she has reviewed New York State and federal rules and regulations relating to practice as a clinical laboratory technologist in New York State in accordance with written guidance from the Department.
    Section 79-14.4(a) provides that an applicant may be licensed by the department as a cytotechnologist by meeting the requirements specified in the special provisions of section 8607(1)(c) of the Education Law if he or she applies for licensure by January 1, 2009 and meets the requirements for licensure by July 1, 2009, unless an earlier date is required.
    Section 79-14.4(b)(1) requires that applicants file an application and pay the fee for the license and initial registration by January 1, 2009.
    Section 79-14.4(b)(4)(i) changes the date by which an applicant shall have completed his or her education requirements to July 1, 2009 and the date by which he/she shall have successfully performed the duties of a cytotechnologist for two years over the past five years to December 31, 2007.
    Section 79-14.4(b)(4)(iii) provides a new grandparenting pathway for applicants who have performed the duties of a cytotechnologist for at least five years (7200 hours) prior to December 31, 2007, as verified in writing by a director of a clinical laboratory, as defined in the Public Health Law.
    Section 79-14.4(c) permits an applicant seeking a cytotechnology license who files before January 1, 2009 and meets the requirements for licensure by July 1, 2009 to be deemed qualified to practice as a cytotechnologist from the date of filing the application until the department has acted on it.
    Sections 79-15.4 (a) and (b)(1) provide that an applicant may be certified by the department as a clinical laboratory technician by meeting the requirements specified in the special provisions of section 8607(1)(b) of the Education Law if he or she applies for licensure and pays the fee for the initial certification and registration by January 1, 2009, except as otherwise provided in 79-15(b)(4)(iv) and meets the requirements for certification by July 1, 2009, unless an earlier date is required.
    Sections 79-15.4(b)(4)(i) and (ii) extend the date by which applicants shall meet the professional education requirements for certification to July 1, 2009 and the date by which applicants shall successfully perform the duties of a clinical laboratory technician until December 31, 2007, as required in each subparagraph for licensure under such special provisions.
    Section 79-15.4(b)(4)(iv) adds a special provision to provide for the licensure of applicants who have competently performed the duties of a clinical laboratory technician in a clinical laboratory operated in accordance with Title V of Article 5 of the Public Health Law for a period of not less than six months over the three years immediately preceding December 31, 2007, as verified by a director of the clinical laboratory, and have filed an application, paid the fee for the initial license and first registration period on or before September 1, 2013.
    Section 79-15.4(c) provides that applicants who have applied for licensure as a clinical laboratory technician by January 1, 2009 and certified that he or she will have met the requirements for licensure under this section by July 1, 2009, shall be deemed qualified to practice from the date of application until the department has acted on the application.
    Section 79-16.1(a) provides that applicants seeking certification as histological technicians prior to September 1, 2013 may meet the professional education requirements for admission to the examination in either subdivision (b) or (c) of this section and for those applying after September 1, 2013, they must meet the requirements of subdivision (b).
    Section 79-16.1(b)(1) defines "acceptable accrediting agency" for purposes of subdivision (b).
    Sections 79-16.1(b)(2)(i) and (ii) require an applicant seeking certification as a histological technician to hold an associate or higher degree from a program in histological technician registered as leading to certification, or a substantially equivalent program that is accredited by an acceptable accrediting agency or recognized by the civil authorities of the jurisdiction in which it is located as a histological technician program.
    Sections 79-16.1(c) (1) and (2) establish time-limited alternative professional education requirements for those applying for licensure prior to September 1, 2013 and define acceptable accrediting agency for purposes of such subdivision.
    Section 79-16.1(d) requires an applicant seeking admission to the examination to certify that he or she has reviewed New York State and federal rules and regulations relating to practice as a clinical laboratory technologist in New York State, in accordance with written guidance from the Department.
    Sections 79-16.2(a) and (b) require applicants to pass a general licensing examination for histological technicians, acceptable to the department, with a converted score of at least 75, as determined by the State Board for Clinical Laboratory Technology.
    Section 79-16.3(a) provides for a limited permit to practice as a histological technician to be issued upon the recommendation of the State Board for Clinical Laboratory Technology.
    Sections 79-16.3(b)(1), (2) and (3) require an applicant to file an application for a limited license, pay a fee of $50.00 and meet all requirements for certification, except the examination requirement and submit documentation that the application will be under the general supervision of a clinical laboratory director and defines general supervision for purposes of this paragraph.
    Section 79-16.3(d) provides that the limited permit is valid for not more than one year and may be renewed at the discretion of the department for one additional year for documented good cause.
    Section 79-16.4(a) provides that an applicant may be licensed under the grandparenting provisions of section 8607(1)(d) of the Education Law by applying for certification by January 1, 2009, except as otherwise provided in section 79-16.4(b)(2)(iv), and shall meet the requirements for certification by July 1, 2009, unless an earlier date is required in this section.
    Sections 79-16.4(b)(1), (2), (3) and (4) provide for licensure under special grandparenting provisions if the applicant meets certain requirements.
    Section 79-16.3(c)provides that an applicant who applies on or before January 1, 2009 and who meets certain requirements by July 1, 2009 shall be deemed qualified to practice from the date of filing the application until such time as the department has acted upon the application.
    Section 79-16.5 (a) provides for the issuance of a limited license and registration as a histological technician to perform certain examinations and duties of histological technicians if the applicant satisfies the requirements established in Education Law section 8610(2) and has received an education acceptable to the department, including an associate or higher degree in the biological, chemical, or physical sciences.
    Section 79-16.5(b) requires an applicant seeking a limited license to certify that he or she has reviewed the New York State and federal rules and regulations relating to practice as a histological technician in accordance with guidance from the department.
    This notice is intended
    to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. EDU-41-08-00007-EP, Issue of October 8, 2008. The emergency rule will expire February 16, 2009.
    Text of rule and any required statements and analyses may be obtained from:
    Lisa Struffolino, Office of Counsel, New York State Education Department, Counsel's Office, Room 148, 89 Washington Avenue, Albany, New York 12234, (518) 473-4921, email: lstruffo@mail.nysed.gov
    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 the Board of Regents the authority to register domestic and foreign institutions in terms of New York standards.
    Subdivision (3) of section 212 of the Education Law authorizes the State Education Department to determine and set fees for certification and permits, for which fees are not set otherwise provided.
    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 for 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.
    Subdivision (2) section 8606-a of the Education Law authorizes the State Education Department to establish implementing standards for the education that must be successfully completed to qualify for certification as a histological technician.
    Subdivision (3) section 8606-a of the Education Law authorizes the State Education Department to establish requirements for the examination that must be successfully completed to qualify for certification as a histological technician.
    Subdivision (3) section 8610 of the Education Law authorizes the State Education Department to establish implementing standards for the issuance of restricted licenses and limited licenses.
    2. LEGISLATIVE OBJECTIVES:
    The proposed regulation carries out the intent of the aforementioned statutes in that it establishes standards implementing education, examination, limited permit, and grandparenting requirements for certification as a histological technician; establishes program content and other requirements for the issuance of restricted and limited licenses; and updates the grandparenting requirements for clinical laboratory technologists, cytotechnologists, and clinical laboratory technicians in accordance with statutory changes made to Article 165 of the Education Law by Chapter 204 of the Laws of 2008.
    3. NEEDS AND BENEFITS:
    Chapter 204 of the Laws of 2008 amended Article 165 of the Education Law. Article 165, as amended, establishes a new profession, certified histological technicians, which is a profession that is both title and practice protected, under the State Board for Clinical Laboratory Technology. In addition, it amends Article 165 to provide special provisions to grandparent clinical laboratory technologists, cytotechnologists and certified clinical laboratory technicians and histological technicians and to establish restricted licenses and limited licenses for clinical laboratory technologists and limited licenses for histological technicians. The proposed regulation is needed to implement Article 165 of the Education Law by establishing professional study, examination, limited permits, limited licenses and special grandparenting provisions for histological technicians; to establish training and other requirements that applicants for restricted licenses as clinical laboratory technologists and limited licenses as clinical laboratory technologists and histological technicians must meet; and to expand the grandparenting provisions for clinical laboratory technologists, clinical laboratory technicians and cytotechnologists.
    In addition, in accordance with the requirements of Article 165 of the Education Law, the proposed regulation is needed to set forth standards for registered college programs that lead to certification as a histological technician.
    4. COSTS:
    (a) Costs to State government: The proposed regulation will not impose any additional costs on State government, including the State Education Department, over and above the costs imposed by Article 165 of the Education Law for administering this new profession.
    (b) Cost to local government: The proposed promulgation establishes requirements for licensure as a clinical laboratory technologist and cytotechnologist and certification as a clinical laboratory technician and as a histological technician. The regulation will not impose additional costs on local government. The regulation will not impose additional costs on licensed clinical laboratories that are operated by local governments.
    (c) Cost to private regulated parties: The proposed regulation will not impose any other costs on regulated parties over and above those imposed by Article 165 of the Education Law. Article 165 establishes licensure and registration fees. Article 165 requires applicants for certification as a histological technologist to be educated with an associates degree. The proposed amendment establishes the content of the course work for the program, and imposes no additional educational costs beyond those imposed by the statutory requirement. The proposed regulation establishes the content of the training programs for persons seeking a restricted license as a clinical laboratory technologist in the practice of histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology, and molecular diagnosis to the extent such molecular diagnosis is included in genetic testing-molecular and molecular oncology.
    (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 and concerns requirements that individuals must meet to be licensed as clinical laboratory technologists and cytotechnologists and certified as clinical laboratory technicians and as histological technicians. Therefore, the regulation does not regulate local governments.
    6. PAPERWORK:
    The proposed regulation imposes no additional reporting or recordkeeping requirements beyond those imposed by Article 165 of the Education Law.
    7. DUPLICATION:
    The proposed regulation does not duplicate other existing State or Federal requirements.
    8. ALTERNATIVES:
    There are no viable alternatives to the proposed regulation and none were considered. The proposed regulation implements statutory requirements.
    9. FEDERAL STANDARDS:
    There are no Federal standards for the licensure of clinical laboratory technologists, cytotechnologists or clinical laboratory technicians and certified histological technicians, the subject of the proposed regulation. The education requirements for the licensure or certification in these fields require 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 dates. In accordance with section 8607(2) of the Education Law, the regulation permits a transition period for applicants who apply on or before January 1, 2009 under the special provisions available to certain individuals who have already practiced in these fields or who have specified related education and/or experience (grandparenting applicants). Such applicants who certify to a good faith belief that they will have met the requirements for licensure or certification by the prescribed completion dates, which in no case will be later than July 1, 2009, will be deemed qualified to practice from the date of filing the application with the State Education Department until such time as the Department has acted upon the application. In addition, the regulation permits a transition period for applicants to apply on or before September 1, 2013, if they have competently provided clinical laboratory technology services for a period of not less than six months in the three years immediately preceding December 31, 2007, as verified by a director of the clinical laboratory, in a clinical laboratory operated in accordance with Title V of Article 5 of the Public Health Law and the regulations promulgated thereunder.
    Regulatory Flexibility Analysis
    1. EFFECT OF RULE:
    This proposed amendment implements Chapter 204 of the Laws of 2008 which amends Article 165 of the Education Law by establishing requirements for the licensure of individuals as clinical laboratory technologists or cytotechnologists and certification of individuals as clinical laboratory technicians or histological technicians, and establishes standards for registered college preparation programs leading to licensure as certified histological technicians. Such licensed and certified individuals are employed at clinical laboratories licensed and regulated by the New York State Department of Health. There are approximately 3,800 such licensed clinical laboratories in New York State, of which about 586 are classified as small businesses and 183 are operated by local governments of New York State.
    2. COMPLIANCE REQUIREMENTS:
    The regulation establishes education and examination requirements for individuals to be licensed as certified histological technicians and content for training programs for clinical laboratory technologists with restricted licenses in histocompatibility, cytogenetics, stem cell process, flow cytometry/cellular immunology, or molecular diagnosis. Therefore, the regulation does not regulate small businesses or local governments, except for one provision. That provision concerns the definition for "general supervision" by the director of a clinical laboratory for holders of limited permits in these professions or for those in training programs for restricted licenses as clinical laboratory technologists. Education Law section 8606 requires the Department to define this term. While the regulation does not directly regulate the clinical facility, it requires the applicant for the limited permit to document that the level of supervision will meet the regulatory requirement before a limited permit will be issued by the State Education Department.
    The regulation requires the director of the clinical laboratory to be readily available for consultation with the permit holder, as needed, and to be responsible for the performance and findings of all tests carried out by the permit holder, either by directly overseeing such testing, or by delegating this responsibility to an authorized supervisor who is on-site within the laboratory.
    3. PROFESSIONAL SERVICES:
    The proposed regulation will not require licensed clinical laboratories that are classified as small businesses or operated by local governments to hire professional services to comply.
    4. COMPLIANCE COSTS:
    The regulation will not impose additional costs on licensed clinical laboratories that are small businesses or are operated by local governments. The standard for general supervision by the director of a licensed clinical laboratory of limited permit holders in the three professions was developed after consultation with the Department of Health, and is consistent with the level of supervision that the director already is required to provide such employees by Department of Health regulations. Therefore, the regulation will not impose additional costs on the licensed clinical laboratories that are classified as small businesses or operated by local governments.
    5. ECONOMIC AND TECHNOLOGICAL FEASIBILITY:
    The proposed regulation will not impose any technological requirements on regulated parties, including those that are classified as small businesses, and is economically feasible. See above "Compliance Costs" for the economic impact of the regulation.
    6. MINIMIZING ADVERSE IMPACT:
    The standard for general supervision by a director of a clinical laboratory for limited permit holders in the four professions will allow licensed clinical laboratories, including those that are small businesses or operated by local governments, a great deal of flexibility to determine how the limited permit holder will be supervised. The proposed regulatory standards for general supervision by directors of licensed clinical laboratories of limited permit holders in the three professions of cytotechnologists, clinical laboratory technicians and clinical laboratory technologists are consistent with the level of supervision that the director already is required to provide such employees by the Department of Health regulations. Because of the flexibility of the proposed standards and the fact that they are consistent with Department of Health requirements, different standards for licensed clinical laboratories that are small businesses or operated by local governments are not appropriate or necessary.
    7. SMALL BUSINESS AND LOCAL GOVERNMENT PARTICIPATION:
    The State Board for Clinical Laboratory Technology and its extended panel include members who have experience working in clinical laboratories that are classified as small businesses or operated by local governments. Both the Board and its extended panel worked with staff of the State Education Department to develop the proposed regulation. In addition, the State Education Department communicated with directors and other supervisory staff of clinical laboratories, including those that are small businesses or operated by local governments, during the development of the proposed regulation. Staff of the Department met with individuals who are or have been employed as clinical laboratory technologists, cytotechnologists, clinical laboratory technicians and histological technicians at clinical laboratories that are small businesses and operated by local governments, among others, to obtain their input during the development of the regulation. The Department also worked with the Department of Health to provide the proposed regulation to licensed clinical laboratories across the State, including those that are small businesses and operated by local governments of the State.
    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 and histological technicians (approximately 1,000 individuals), and colleges statewide that seek registration of programs leading to licensure and certification as a histological technician, 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 204 of the Laws of 2008 amends Article 165 of the Education Law. Article 165, as amended, provides for the licensing of clinical laboratory technologists and cytotechnologists and the certification of clinical laboratory technicians and histological technicians, and establishes the profession of certified histological technician 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, as amended, by establishing specific education and examination standards that an applicant for certification as a histological technician must meet and the training program content that clinical laboratory technologists seeking a restricted license 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 certification as a histological technician.
    The proposed regulation establishes requirements for a limited permit to practice as a certified histological technician. It establishes a definition for general supervision by the director of a clinical laboratory of the limited permit holder, and a fee for the limited permit.
    As authorized by statute, the proposed regulation also implements statutory provisions designed to permit applicants in all four clinical laboratory technology professions who are already practicing in these fields or have related education and/or experience to be licensed or certified under special provisions (grandparenting applicants).
    The proposed regulation does not impose reporting requirements over and above those required by statue. In accordance with the statutory requirements, applicants for licensure or certification in these four 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, and will not require regulated parties to obtain professional services to comply beyond the educational services needed to meet the professional education requirements for licensure or certification.
    3. COSTS:
    The proposed regulation requires an applicant for a limited permit to practice as a histological technician to pay an application fee of $50. The regulation will not impose any other costs on regulated parties over and above those imposed by Article 165 of the Education Law, which establishes licensure and registration fees. Article 165 requires applicants for certification as a histological technician to be educated at the associate degree level. The proposed regulation simply establishes the content of the coursework for the college preparation program, and imposes no additional educational costs beyond those imposed by the statutory requirement. The proposed regulation's standard for general supervision by the director of a licensed clinical laboratory of limited permit holders in the new profession of histological technician is consistent with the level of supervision that the director already is required to provide such employees pursuant to Department of Health regulations and is similar to the requirements for limited permits in the other three clinical laboratory professions. Therefore, the regulation will not impose additional costs on clinical laboratories for supervision. The proposed regulation will not require regulated parties to incur capital costs.
    4. MINIMIZING ADVERSE IMPACT:
    The proposed regulation implements and clarifies education and examination standards required for certification as a histological technician, as directed by Article 165 of the Education Law. It also establishes requirements for college programs registered as leading to licensure in that field. 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 AREAS PARTICIPATION:
    Comments on the proposed regulation were solicited from statewide organizations representing parties having an interest in the practice of the clinical laboratory technology professions. Included in this group was the State Board for Clinical Laboratory Technology, and 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 individuals who are employed in the four 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 the sole college in the State that offers programs that prepare histological technicians, which is located in a rural area. The Department also worked with the Department of Health to provide 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
    Chapter 204 of the Laws of 2008 amends Article 165 of the Education Law by establishing education and examination standards, grandparenting provisions and requirements for limited licenses and limited permits for the certification of histological technicians. It also expands the grandparenting provisions for the licensure of clinical laboratory technologists and cytotechnologists and the certification of clinical laboratory technicians and creates limited licenses and restricted licenses for clinical laboratory technologists. The proposed amendment implements the requirements of Article 165, as amended by Chapter 204 of the Laws of 2008 and establishes standards for registered college preparation programs that lead to certification as a histological technician, in accordance with statutory requirements.
    The proposed amendment implements statutory requirements and directives and will have no impact on jobs or employment opportunities, beyond the impact of Article 165 of the Education Law. Therefore, any impact on jobs and employment opportunities by establishing a licensure requirement for histological technicians is attributable to the statutory requirements, not the proposed rule, which simply establishes consistent implementing standards as directed by statute.
    Because it is evident from the nature of the proposed amendment 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.

Document Information

Effective Date:
12/19/2008
Publish Date:
01/07/2009