THE STATE EDUCATION DEPARTMENT / THE UNIVERSITY OF THE STATE OF NEW YORK / ALBANY, NY 12234

 

TO:

Higher Education and Professional Practice Committee

 

FROM:

Johanna Duncan-Poitier

 

 

 

SUBJECT:

Proposed Amendment to the Regulations of the Commissioner of Education Relating to Licensure as a Clinical Laboratory Technologist and as a Cytotechnologist and Certification as a Clinical Laboratory Technician

 

DATE:

December 19, 2006

 

STRATEGIC GOAL:

Goals 2 and 3

 

AUTHORIZATION(S):

 

 

 

 

SUMMARY

 

 

Issue for Decision (Consent  Agenda)

 

            Should the Regents amend the Regulations of the Commissioner of Education to add new Subparts 79-13, 79-14, and 79-15, relating to licensure as a clinical laboratory technologist and as a cytotechnologist and certification as a clinical laboratory technician?

 

Reason(s) for Consideration

 

             Required by State statute.

 

Proposed Handling

 

The proposed amendment is submitted for confirmation of the proposed amendment as a permanent rule at the January 2007 Regents meeting.  The rule was adopted as an emergency measure at the December 2006 Regents meeting in order to ensure that the emergency rule remains continuously in effect until it may be adopted as a permanent rule in January 2007. 

 

Procedural History

 

            A Notice of Proposed Rule Making concerning an earlier version of the proposed amendment was published in the State Register on May 24, 2006.  That version was discussed at the meeting of the Higher Education and Professional Practice Committee in June 2006. Following the June meeting, the proposal was revised, and the Board of Regents adopted the revised proposal as an emergency measure at its July 2006 Regents meeting.  A Notice of Emergency Adoption and Revised Rule Making was published in the State Register on August 16, 2006.  The proposal was again revised and the current regulation was adopted as an emergency measure at the October and December Regents meetings.  A Notice of Emergency Adoption and Revised Rule Making was published in the State Register on November 15, 2006, and a Notice of Emergency Adoption will be published in the State Register on December 27, 2006.  The proposed amendment is now submitted for adoption as a permanent rule.  Supporting materials for the proposed amendment are available upon request from the Secretary to the Board of Regents.  Attached is an Assessment of Public Comment. 

Background Information

 

            Chapter 755 of the Laws of 2004 added a new Article 165 to the Education Law, establishing three new professions that are practice and title protected: clinical laboratory technologist, cytotechnologist, and clinical laboratory technician.  The purpose of the proposed regulations is to implement the provisions of Article 165 of the Education Law by establishing requirements for licensure as a clinical laboratory technologist or cytotechnologist and for certification as a clinical laboratory technician and requirements for limited permits in these fields.

 

            At its July meeting, the Board of Regents approved on an emergency basis proposed regulations to implement Article 165 of the Education Law by establishing educational program and licensure requirements for the three new professions, including examination, limited permit, and grandparenting requirements.  The July emergency action also established specific education requirements that an applicant must meet for licensure or certification in these new professions, and established content requirements for registered college preparation programs for the three new professions.

 

             One major issue raised before the July Regents meeting was the need to address the status of recent graduates of college programs and those in the pipeline in college programs who will not meet the requirements of the grandparenting provisions.   In response to this concern, transitional educational requirements were included in the emergency regulations approved by the Regents in July to provide an opportunity for these individuals to meet the education requirement for licensure and obtain a limited permit to practice until such time as they have taken the required examination.  Specifically, under the July emergency regulations, applicants who apply for licensure prior to September 1, 2011 will have to complete a registered or accredited program that meets a general standard that is consistent with national accreditation standards and the scope of practice for each profession.  The Department expects that existing registered and accredited programs in these fields will meet these requirements.  This transition period will allow registered college preparation programs in these fields sufficient time to meet revised requirements that the Department plans to promulgate, and will not disadvantage new and recent graduates.

 

            At the June and July Regents meetings, the Regents raised concerns about the specific courses recommended for licensure-qualifying higher education programs, and the Department indicated that it was continuing to assess those concerns, which were also raised by educational institutions offering such programs and others, through ongoing conversations with relevant staff and other interested stakeholders.  The Department indicated that it would report how those concerns have been addressed and recommend modifications if appropriate.  Since July, Department staff have participated in numerous meetings to address these and similar issues with members and staff in the legislature, administrators and faculty of higher education professional programs, managers of clinical laboratories throughout the State, representatives of relevant professional and hospital organizations, and have visited a large clinical laboratory to observe and gather additional information on the broad range of clinical laboratory technology services that they provide. 

 

            A meeting was held on October 12th at Broome Community College with representatives of the major educational programs, including SUNY Stony Brook, SUNY Buffalo, SUNY Upstate Medical Center, Broome Community College, Marist College, Albany College of Pharmacy, and others.  Based upon that detailed and productive discussion, the State Board for Clinical Laboratory Technology met the next day to consider the recommendations made at the Broome Community College meeting, and has recommended to the Department revisions to the educational program requirements that would be deemed to be substantial. 

 

Until the new revisions could be fully considered by the Department and the Board of Regents and published in the State Register prior to Regents action, it was necessary to adopt an emergency measure that would enable the Department to continue to accept applications and issue licenses in these professions. Such emergency regulations were adopted by the Regents in October.  They differed from the regulations adopted by the Regents in July in that the registration requirements for licensure-qualifying programs were deleted. It is anticipated that such requirements will be submitted to the Regents for approval once discussions concerning the requirements are completed and the draft language is finalized. In the meantime, the October emergency regulations continued to include the transitional requirements, originally approved by the Board of Regents in July, to provide an opportunity for recent graduates of college programs and those currently in college programs to meet the educational requirement for licensure and obtain a limited permit to practice until such time as they have taken the required examination. Because the October emergency regulations would expire prior to the January Regents meeting, when they can be adopted on a permanent basis, it was necessary to adopt them again in December 2006 as an emergency measure to maintain their continuity.

 

Accordingly, we are recommending that the attached regulations be adopted as a permanent rule and that recommendations for specific standards for registered licensure-qualifying educational programs for these professions, which were the subject of the concerns raised by the Regents in July, continue to be deferred for further discussion and submission to the Regents in the near future. 

 

Recommendation

 

            I recommend that the Board of Regents take the following action:

 

            VOTED:  That Subparts 79-13, 79-14, and 79-15 of the Regulations of the Commissioner of Education be added, as submitted, effective February 10, 2007.

 

Timetable for Implementation

 

            The effective date of the permanent rule is February 10, 2007.

 

 

 

 

Attachments

 

 

 

AMENDMENT TO THE REGULATIONS OF THE COMMISSIONER OF EDUCATION

            Pursuant to sections 207, 210, 212, 6501, 6504, 6507, 6508, 8605, 8606, 8607, and 8608 of the Education Law.

            1.  Subpart 79-13 of the Regulations of the Commissioner of Education is added, effective February 10, 2007, as follows:

SUBPART 79-13

CLINICAL LABORATORY TECHNOLOGIST

            79-13.1 Professional study of clinical laboratory technology.

            (a) As used in this section, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accrediting clinical laboratory technology programs on a national or regional basis, as having reasonable accreditation standards, and as an organization that applies its criteria for granting accreditation of programs in a fair, consistent, and nondiscriminatory manner.

            (b) To meet the professional education requirement for admission to the licensing examination for clinical laboratory technologists, the applicant shall present satisfactory evidence of meeting the requirements of one of the following paragraphs:

(1)  applicants who apply for licensure prior to September 1, 2011  may meet the following requirement: holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology or a related title which:

(i) prepares graduates for employment as a clinical laboratory technologist, as defined in Education Law section 8601(2)(a),

(ii) 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, and

(iii) 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 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; or  

(2) applicants who apply for licensure prior to September 1, 2011 may alternatively meet the requirement by both:

            (i) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences registered pursuant to Part 52 of this Title or its substantial equivalent as determined by the department, and

(ii) completing a program which:

(a)  prepares graduates for employment as a clinical laboratory technologist, as defined in Education Law section 8601(2)(a),

(b) 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, and

(c)  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 technologist.

            (c) To meet the professional education requirement for admission to the licensing examination for clinical laboratory technologists, the applicant must also certify to the department that he or she has reviewed the rules and regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a clinical laboratory technologist in New York State, in accordance with written guidance from the department. 

            79-13.2 Licensing examination.

            (a) Content.  To meet the examination requirement for licensure as a clinical laboratory technologist, the candidate shall pass a general examination for clinical laboratory technologists that is determined by the department to measure the applicant's knowledge, judgment, and skills concerning practice as a clinical laboratory technologist, as defined in section 8601(2)(a) of the Education Law, and to be offered by an organization that has satisfactory administrative and psychometric procedures in place to offer the examination.

            (b) Passing score.  The department shall accept scores on the examination satisfactory to the State Board for Clinical Laboratory Technology, as meeting the requirement for passing the licensing examination. The applicant shall pass the examination with a converted score of at least 75, as determined by the State Board for Clinical Laboratory Technology.

            79-13.3 Limited permits.

            (a) As authorized by section 8608 of the Education Law, upon recommendation of the State Board for Clinical Laboratory Technology, the department may issue a limited permit to practice as a clinical laboratory technologist to an applicant for licensure who meets the requirements of this section. 

            (b) The applicant for a limited permit to practice as a clinical laboratory technologist shall: 

            (1) file an application for a limited permit with the department and pay the initial licensure and registration fee, as prescribed in section 8605(1) of the Education Law, and a limited permit fee of fifty dollars;

            (2) have met all requirements for licensure as a clinical laboratory technologist, except the examination requirement;

            (3) submit adequate documentation that the applicant will be under the general supervision of the director of a clinical laboratory, as defined in section 571 of the Public Health Law, in accordance with the requirements of this paragraph. 

            (i) Such documentation shall identify the director of the clinical laboratory who has responsibility for providing general supervision of the applicant's work while under the limited permit, and include a signed statement by the director of the clinical laboratory certifying that he or she will provide general supervision of the applicant's experience.  If a director cannot carry out his or her duties, or is replaced by a new or interim director, the limited permit holder shall submit to the department on a form prescribed by the department the name of the new director who has assumed supervisory responsibility of the permit holder.

            (ii)  For purposes of this section, under the general supervision of the director of a clinical laboratory shall mean that the permit holder shall be supervised by a director of a clinical laboratory who shall:

            (a) serve the laboratory full-time, or on a regular part-time basis; 

            (b) ensure the supervision of the technical performance of the permit holder, and be readily available for consultation with the permit holder, as needed; and

            (c) be responsible for the performance and findings of all tests carried out by the limited permit holder, either by directly overseeing such testing, or by delegating this responsibility to authorized qualified supervisors who are on site within the laboratory.

            (c)  The limited permit issued pursuant to this section shall be valid for a period of not more than one year from the date of issuance.  Such limited permit may be renewed at the discretion of the department for one additional one-year period, provided that the applicant documents good cause, such as, a specific physical or mental disability certified by an appropriate health care professional or other good cause which in the judgment of the department made it impossible for the applicant to complete requirements for licensure as a clinical laboratory technologist while under the original limited permit.

            79-13.4 Special provisions.

            (a) In accordance with section 8607(1)(a) of the Education Law, an applicant may be licensed by the department as a clinical laboratory technologist by meeting the requirements of this subdivision.  The applicant must apply for licensure under this section by September 1, 2007, and meet the requirements for licensure under this section by September 1, 2008, unless the particular requirement prescribes an earlier date for completion, in which case the requirement must be completed by that earlier date.     

            (b) The applicant shall:

            (1) file the application for licensure with the department and pay the fee for the initial license and the fee for the first registration period, as prescribed in section 8605(1) of the Education Law, all by September 1, 2007;

            (2) be of good moral character as determined by the department;

            (3) be at least 18 years of age; and

            (4) meet one of the following requirements:

            (i)  the applicant shall meet the professional education requirement for licensure, as prescribed in section 79-13.1 of this Subpart by September 1, 2008, and shall have successfully performed the duties of a clinical laboratory technologist for two years, meaning 2,880 clock hours, over the five years immediately preceding September 1, 2006; or

            (ii) the applicant shall have successfully completed by September 1, 2008 a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences offered by an institution that is accredited by an acceptable accrediting agency, meaning an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent and nondiscriminatory manner, such as an agency recognized for these purposes by the U.S. Department of Education or that is recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as an institution authorized to offer postsecondary degree study,  and shall have successfully performed the duties of a clinical laboratory technologist for two years, meaning 2,880 clock  hours, over the five years immediately preceding September 1, 2006; or

            (iii) the applicant has been engaged full-time as a faculty member or managing administrator involved directly in the development or planning of curricula or the provision of instruction for education programs in clinical laboratory technology for clinical laboratory practitioners, at an organized entity that provides postsecondary education, for the equivalent of two years, meaning 2,700 clock hours, over the five years immediately preceding September 1, 2006; or

            (iv) the applicant shall have successfully performed the duties of a clinical laboratory technologists for five years, meaning 7,200 clock  hours, prior to September 1, 2006, as verified in writing by the director of the clinical laboratory, as defined in section 571 of the Public Health Law ;  or

            (v) the applicant, at the time of application, shall have been previously qualified for a license or its equivalent to practice as a clinical laboratory technologist in New York State through other regulatory requirements of a governmental unit of New York State authorized by law to qualify individuals for such licensure or its equivalent; or

            (vi) the applicant, at the time of application, shall be currently certified as a clinical laboratory technician, and by September 1, 2008 shall hold a baccalaureate or higher  degree based upon successful completion of a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences offered by an institution that is accredited by an acceptable accrediting agency, meaning an organization accepted by the department as a reliable authority for the purpose of accreditation at the postsecondary level, applying its criteria for granting accreditation in a fair, consistent and nondiscriminatory manner, such as an agency recognized for these purposes by the U.S. Department of Education or that is recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as an institution authorized to offer postsecondary degree study, and by September 1, 2008 shall have successfully performed the duties of a clinical laboratory technician for four years, meaning 5,760 clock  hours.

            (c) In accordance with subdivision (2) of section 8607 of the Education Law, an individual who on or before September 1, 2007 files with the department an application for licensure as a clinical laboratory technologist under this section and certifies to a good faith belief that he or she has or will have met the requirements for licensure under this section by the prescribed completion dates which shall in no case be later than September 1, 2008, shall be deemed qualified to practice as a clinical laboratory technologist from the date of filing the application with the department until such time as the department has acted upon such application.    

            2.  Subpart 79-14 of the Regulations of the Commissioner of Education is added, effective February 10, 2007, as follows:

SUBPART 79-14

CYTOTECHNOLOGIST

            79-14.1 Professional study of cytotechnology.

            (a) As used in this section, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accrediting cytotechnology programs on a national or regional basis, as having reasonable accreditation standards, and as an organization that applies its criteria for granting accreditation of programs in a fair, consistent, and nondiscriminatory manner.

            (b) To meet the professional education requirement for admission to the licensing examination for cytotechnologists, the applicant shall present satisfactory evidence of meeting the requirements of one of the following paragraphs:

(1)  applicants who apply for licensure prior to September 1, 2011 may meet the following requirement: holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in cytotechnology or a related title which:

(i) prepares graduates for employment as a cytotechnologist, as defined in Education Law section 8601(2)(b),

(ii) 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 cytotechnology using independent judgment and responsibility, and

(iii) 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 appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a cytotechnologist; or  

(2) applicants who apply for licensure prior to September 1, 2011 may alternatively meet the requirement by both:

            (i) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in the major of biology, chemistry, or the physical sciences registered pursuant to Part 52 of this Title or its substantial equivalent as determined by the department, and

(ii) completing a program which:

(a)  prepares graduates for employment as a cytotechnologist, as defined in Education Law section 8601(2)(b),

(b) 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 cytotechnology using independent judgment and responsibility, and

(c)  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 cytotechnologist.

            (c) To meet the professional education requirement for admission to the licensing examination for cytotechnologists, the applicant must also certify to the department that he or she has reviewed the rules and regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a  cytotechnologist in New York State, in accordance with written guidance from the department. 

            79-14.2 Licensing examination.

            (a) Content.  To meet the examination requirement for licensure as a cytotechnologist, the candidate shall pass a general examination for cytotechnologists that is determined by the department to measure the applicant's knowledge, judgment, and skills concerning practice as a cytotechnologist, as defined in section 8601(2)(b) of the Education Law, and to be offered by an organization that has satisfactory administrative and psychometric procedures in place to offer the examination.

            (b) Passing score.  The department shall accept scores on the examination satisfactory to the State Board for Clinical Laboratory Technology, as meeting the requirement for passing the licensing examination. The applicant shall pass the examination with a converted score of at least 75, as determined by the State Board for Clinical Laboratory Technology.

            79-14.3 Limited permits.

            (a) As authorized by section 8608 of the Education Law, upon recommendation of the State Board for Clinical Laboratory Technology, the department may issue a limited permit to practice as a cytotechnologist to an applicant for licensure who meets the requirements of this section. 

            (b) The applicant for a limited permit to practice as a cytotechnologist shall: 

            (1) file an application for a limited permit with the department and pay the initial licensure and registration fee, as prescribed in section 8605(2) of the Education Law, and a limited permit fee of fifty dollars;

            (2) have met all requirements for licensure as a cytotechnologist, except the examination requirement; and 

            (3) submit adequate documentation that the applicant will be under the general supervision of the director of a clinical laboratory, as defined in section 571 of the Public Health Law, in accordance with the requirements of this paragraph. 

            (i) Such documentation shall identify the director of the clinical laboratory who has responsibility for providing general supervision of the applicant's work while under the limited permit, and include a signed statement by the director of the clinical laboratory certifying that he or she will provide general supervision of the applicant's experience.  If a director cannot carry out his or her duties, or is replaced by a new or interim director, the limited permit holder shall submit to the department on a form prescribed by the department the name of the new director who has assumed supervisory responsibility of the permit holder.

            (ii)  For purposes of this section, under the general supervision of the director of a clinical laboratory shall mean that the permit holder shall be supervised by a director of a clinical laboratory who shall:

            (a) serve the laboratory full-time, or on a regular part-time basis; 

            (b) ensure the supervision of the technical performance of the permit holder, and be readily available for consultation with the permit holder, as needed; and

            (c) be responsible for the performance and findings of all tests carried out by the limited permit holder, either by directly overseeing such testing, or by delegating this responsibility to authorized qualified supervisors who are on site within the laboratory.

            (c)  The limited permit issued pursuant to this section shall be valid for a period of not more than one year from the date of issuance.  Such limited permit may be renewed at the discretion of the department for one additional one-year period, provided that the applicant documents good cause, such as, a specific physical or mental disability certified by an appropriate health care professional or other good cause which in the judgment of the department made it impossible for the applicant to complete requirements for licensure as a cytotechnologist while under the original limited permit.

            79-14.4 Special provisions.

            (a) In accordance with section 8607(1)(c) of the Education Law, an applicant may be licensed by the department as a cytotechnologist through meeting the requirements of this subdivision.  The applicant must apply for licensure under this section by September 1, 2007, and meet the requirements for licensure under this section by September 1, 2008, unless the particular requirement prescribes an earlier date for completion, in which case the requirement must be completed by that earlier date.   

            (b) The applicant shall:

            (1) file the application for licensure with the department and pay the fee for the initial license and the fee for the first registration period, as prescribed in section 8605(2) of the Education Law, all by September 1, 2007;

            (2) be of good moral character as determined by the department;

            (3) be at least 18 years of age; and

            (4) meet one of the following requirements:

            (i)  the applicant shall meet the professional education requirement for licensure, as prescribed in section 79-14.1 of this Subpart by September 1, 2008, and shall have successfully performed the duties of a cytotechnologist for two years, meaning 2,880 clock hours, over the five years immediately preceding September 1, 2006; or

            (ii) the applicant, at the time of application, shall have previously been qualified for a license or its equivalent to practice as a cytotechnologist  in New York State through other regulatory requirements of a governmental unit of New York State authorized by law to qualify individuals for such licensure or its equivalent.

            (c) In accordance with subdivision (2) of section 8607 of the Education Law, an individual who on or before September 1, 2007 files with the department an application for licensure as a cytotechnologist under this section and certifies to a good faith belief that he or she has or will have met the requirements for licensure under this section by the prescribed completion dates which shall in no case be later than September 1, 2008, shall be deemed qualified to practice as a cytotechnologist from the date of filing the application with the department until such time as the department has acted upon such application.   

            3.  Subpart 79-15 of the Regulations of the Commissioner of Education is added, effective February 10, 2007, as follows:

SUBPART 79-15

CLINICAL LABORATORY TECHNICIAN

            79-15.1 Professional study of clinical laboratory technician.

            (a) As used in this section, acceptable accrediting agency shall mean an organization accepted by the department as a reliable authority for the purpose of accrediting clinical laboratory technician programs on a national or regional basis, as having reasonable accreditation standards, and as an organization that applies its criteria for granting accreditation of programs in a fair, consistent, and nondiscriminatory manner.

            (b) To meet the professional education requirement for admission to the examination for professional certification for clinical laboratory technicians, applicants  who apply for licensure prior to September 1, 2011 shall present satisfactory evidence of meeting the following requirement: holding an associate or higher degree awarded upon successful completion of an associate or higher degree program in clinical laboratory technician or a related title which:

(1) prepares graduates for employment as a clinical laboratory technician, as defined in Education Law section 8601(2)(c),

(2) 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 as clinical laboratory technicians under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory,  and

(3) 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 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.

            (c) To meet the professional education requirement for admission to the examination for professional certification as a clinical laboratory technician, the applicant must also certify to the department that he or she has reviewed the rules and regulations of the New York State Department of Health and the U.S. Department of Health and Human Services, relating to practice as a clinical laboratory technician in New York State, in accordance with written guidance from the department. 

            79-15.2 Licensing examination.

            (a) Content.  To meet the examination requirement for professional certification as a clinical laboratory technician, the candidate shall pass a general examination for clinical laboratory technicians that is determined by the department to measure the applicant's knowledge, judgment, and skills concerning practice as a clinical laboratory technician, as defined in section 8601(2)(c) of the Education Law, and to be offered by an organization that has satisfactory administrative and psychometric procedures in place to offer the examination.

            (b) Passing score.  The department shall accept scores on the examination satisfactory to the State Board for Clinical Laboratory Technology, as meeting the requirement for passing the licensing examination. The applicant shall pass the examination with a converted score of at least 75, as determined by the State Board for Clinical Laboratory Technology.

            79-15.3 Limited permits.

            (a) As authorized by section 8608 of the Education Law, upon recommendation of the State Board for Clinical Laboratory Technology, the department may issue a limited permit to practice as a clinical laboratory technician to an applicant for certification who meets the requirements of this section. 

            (b) The applicant for a limited permit to practice as a clinical laboratory technician shall: 

            (1) file an application for a limited permit with the department and pay the initial certification and registration fee, as prescribed in section 8606 of the Education Law, and a limited permit fee of fifty dollars;

            (2) have met all requirements for certification as a clinical laboratory technician, except the examination requirement;

            (3) submit adequate documentation that the applicant will be under the general supervision of the director of a clinical laboratory, as defined in section 571 of the Public Health Law, in accordance with the requirements of this paragraph. 

            (i) Such documentation shall identify the director of the clinical laboratory who has responsibility for providing general supervision of the applicant's work while under the limited permit, and include a signed statement by the director of the clinical laboratory certifying that he or she will provide general supervision of the applicant's experience.  If a director cannot carry out his or her duties, or is replaced by a new or interim director, the limited permit holder shall submit to the department on a form prescribed by the department the name of the new director who has assumed supervisory responsibility of the permit holder.

            (ii)  For purposes of this section, under the general supervision of the director of a clinical laboratory shall mean that the permit holder shall be supervised by a director of a clinical laboratory who shall:

            (a) serve the laboratory full-time, or on a regular part-time basis; 

            (b) ensure the supervision of the technical performance of the permit holder, and be readily available for consultation with the permit holder, as needed; and

            (c) be responsible for the performance and findings of all tests carried out by the limited permit holder, either by directly overseeing such testing, or by delegating this responsibility to authorized qualified supervisors who are on site within the laboratory.

            (c)  The limited permit issued pursuant to this section shall be valid for a period of not more than one year from the date of issuance.  Such limited permit may be renewed at the discretion of the department for one additional one-year period, provided that the applicant documents good cause, such as, a specific physical or mental disability certified by an appropriate health care professional or other good cause which in the judgment of the department made it impossible for the applicant to complete requirements for certification as a clinical laboratory technician while under the original limited permit.

            79-15.4 Special provisions.

            (a) In accordance with section 8607(1)(b) of the Education Law, an applicant may be certified by the department as a clinical laboratory technician through meeting the requirements of this subdivision.  The applicant must apply for certification under this section by September 1, 2007, and meet the requirements for certification under this section by September 1, 2008, unless the particular requirement in this section prescribes an earlier date, in which case the earlier date must be met.   

            (b) The applicant shall:

            (1) file the application for certification with the department and pay the fee for the initial certification and the fee for the first registration period, as prescribed in section 8606 of the Education Law, all by September 1, 2007;

            (2) be of good moral character as determined by the department;

            (3) be at least 18 years of age; and

            (4) meet one of the following requirements:

            (i)  the applicant shall meet the professional education requirement for certification, as prescribed in section 79-15.1 of this Subpart by September 1, 2008, and shall have successfully performed the duties of a clinical laboratory technician for two years, meaning 2,880 clock hours, over the five years immediately preceding September 1, 2006; or

            (ii) the applicant shall have successfully performed the duties of a clinical laboratory technician for five years, meaning 7,200 clock  hours, prior to September 1, 2006, as verified in writing by the director of a clinical laboratory, as defined in section 571 of the Public Health Law; or

            (iii) the applicant, at the time of application, shall have previously been qualified for a certification or its equivalent to practice as a clinical laboratory technician in New York State through other regulatory requirements of a governmental unit of New York State authorized by law to qualify individuals for such certification or its equivalent.

            (c) In accordance with subdivision (2) of section 8607 of the Education Law, an individual who on or before September 1, 2007 files with the department an application for certification as a clinical laboratory technician under this section and certifies to a good faith belief that he or she has or will have met the requirements for certification under this section by the prescribed completion dates which shall in no case be later than September 1, 2008, shall be deemed qualified to practice as a clinical laboratory technician from the date of filing the application with the department until such time as the department has acted upon such application.

 

 

PROPOSED SUBPARTS 79-13, 79-14, AND 79-15  OF THE REGULATIONS OF THE COMMISSIONER OF EDUCATION PURSUANT TO SECTIONS 207, 210, 212, 6501, 6504, 6507, 6508, 8605, 8606, 8607, AND 8608 OF THE EDUCATION LAW RELATING TO LICENSURE AS A CLINICAL LABORATORY TECHNOLOGIST AND AS A CYTOTECHNOLOGIST AND CERTIFICATION AS A CLINICAL LABORATORY TECHNICIAN

ASSESSMENT OF PUBLIC COMMENT

            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.