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

 

TO:	The Honorable the Members of the Board of Regents
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:	October 16, 2006
STRATEGIC GOAL:	Goals 2 and 3
AUTHORIZATION(S):

 

SUMMARY

 

 

 

Issue for Decision

 

            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 adoption as an emergency measure at the October 2006 Regents meeting.  Confirmation of the proposed amendment as a permanent rule is scheduled for the January 2007 Regents meeting.  Because emergency actions can only be effective for a limited period, the regulations will also be submitted as an emergency item at the December 2006 Regents meeting, in order to maintain the continuity of the regulations until they can be adopted on a permanent basis.

 

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.  Comments on the emergency regulations, as revised, have been received, and additional revisions have been made, as discussed below.  An Assessment of Public Comment is attached.  A Notice of Emergency Adoption and Revised Rule Making will be published in the State Register on November 15, 2006.  Supporting materials for the proposed amendment are available upon request from the Secretary to the Board of Regents.

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, and representatives of relevant professional and hospital organizations. 

 

            Most recently, a meeting was held on October 12^th 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 can be fully considered by the Department and the Board of Regents and published in the State Register prior to Regents action, it is necessary to adopt an emergency measure that will enable the Department to continue to accept applications and issue licenses in these professions.

 

The attached proposed regulations differ from those adopted by the Regents in July in that the registration requirements for licensure-qualifying programs have been 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 attached regulations continue 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 times as they have taken the required examination.

 

Accordingly, we are recommending that the attached regulations be approved on an emergency basis 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, be deferred for further discussion and submission to the Regents in the near future. 

 

The recommended action is proposed as an emergency measure because such action is necessary to preserve the general welfare to ensure that procedures and standards are in place to continue to license clinical laboratory practitioners while final determinations are made concerning the requirements for the registration of licensure-qualifying educational programs, thereby enabling such practitioners to meet the health care needs of residents of New York State.  A statement of the facts and circumstances which necessitate emergency action is attached.

 

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 October 30, 2006, as an emergency action upon a finding by the Board of Regents that such action is necessary for the preservation of the general welfare to ensure that procedures and standards are in place to continue to license clinical laboratory practitioners while final determinations are made concerning the requirements for the registration of licensure-qualifying educational programs, thereby enabling such practitioners to meet the health care needs of residents of New York State.

 

Timetable for Implementation

 

            The emergency adoption will take effect on October 30, 2006.

 

 

 

 

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 October 30, 2006, 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 October 30, 2006, 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 October 30, 2006, 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 PROMULGATION OF 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 CYTOTECHNOLOGIST AND CERTIFICATION AS A CLINICAL LABORATORY TECHNICIAN

STATEMENT OF FACTS AND CIRCUMSTANCES WHICH NECESSITATE EMERGENCY ACTION

            Article 165 of the Education Law establishes three new licensed professions in New York State: clinical laboratory technologist, cytotechnologist, and clinical laboratory technician.  This statute requires individuals who practice these professions to be licensed or under application for a license under the special "grandparenting" requirements in order to practice these professions in New York State on or after September 1, 2006.

             Based on recent estimates, approximately 20,000 persons are employed in these three professional areas and, as of September 1, 2006, require licensure or submission of an application under the grandparenting provisions in order to continue to practice these professions.  As of October 13, 2006, in excess of 15,000 applications have been received.   The State Education Department expects that most current practitioners will be licensed under the grandparenting provisions.  These clinical laboratory technology practitioners are employed in the State's clinical laboratories to perform tests and procedures 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 regulation implements the requirements of Article 165 of the Education Law by establishing education and examination standards for licensure or certification, special requirements for licensure or certification for applicants already practicing in these field or who have related education and/or experience (grandparenting applicants), and requirements for limited permits in the three professions.  It also sets forth interim standards for meeting the educational requirement for licensure or certification in these fields, consistent with statutory requirements.  These requirements must be in place in order for the State Education Department to license individuals to practice these new professions.  The interim standards are expected to be in place for a transition period of five years while educational institutions make required changes in their educational programs.

            The State Education Department originally planned to adopt these regulations in July 2006, but in response to public comment, the Department needed to make substantial changes to the regulations.  These changes required a new public comment period and delayed permanent adoption of the rule past September 1, 2006.  Further public comment has led to continued discussions concerning the appropriate requirements for educational programs seeking registration by the Department as licensure qualifying programs, requiring further substantial revisions to the regulations.   A second emergency action, as revised, is necessary to ensure that the requirements for licensure continue in place past the expiration date of the emergency regulations adopted in July 2006.  This second emergency action will enable applications to continue to be submitted so that the State Education Department can continue to license individuals in a timely manner and so that practitioners can continue to provide clinical laboratory services.

            The recommended action is proposed as an emergency measure because such action is necessary to preserve the general welfare to ensure that procedures and standards are in place to continue to license clinical laboratory practitioners while final determinations are made concerning the requirements for the registration of licensure-qualifying educational program, thereby enabling such practitioners to meet the health care needs of residents of New York State.

            It is anticipated that the proposed amendment will be presented to the Board of Regents for adoption as a permanent rule at its January 2007 meeting.

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.  The following is a summary of comments received by the State Education Department since the publication of the Notice of Emergency Adoption and Revised Rule Making, and the Department's response to the comments. 

            COMMENT:  Experienced cytotechnologists who have worked in the field for many years, have completed an associate or certificate program, are registered by the Department Health, are engaged in the training of new cytotechnologists, have completed continuing education in the field, and have passed proficiency examinations should receive licensure through the "grandparenting" provisions without having to complete a baccalaureate program in cytotechnology or a related field.          

            RESPONSE:  The "grandparenting" provisions at issue are mandated by statute and permit the applicant to be licensed through two alternatives:  The first alternative requires the applicant to complete a baccalaureate program in cytotechnology or a related title or a baccalaureate program in the major of biology, chemistry, or the physical science plus a program in cytotechnology and complete two years of experience performing the duties of a cytotechnologist.   The second alternative requires the applicant to have previously 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.  

            The Department may not change these statutory requirements through a regulation change.  However, the Department understands the concerns expressed in the comment, and is exploring both legislative and administrative remedies to address these concerns.       

            COMMENT: The "grandparenting" provision that permits an applicant to be licensed as a cytotechnologist based upon the applicant having successfully performed the duties of a cytotechnologist for two years over the five years immediately preceding September 1, 2006 should be changed to permit this experience to be earned over the five years immediately preceding September 1, 2010. 

            RESPONSE:  The "grandparenting" provisions are mandated in statute.  Education Law section 8607(1)(c) requires the applicant to have performed the duties of a cytotechologist for two years of the previous five years prior to the effective date of Article 165 of the Education Law, which is September 1, 2006.  Consequently, the Department does not have the authority to change this date in regulation.

            COMMENT:   The New York State Department of Health raised concerns that the implementation of the proposed regulations will have a negative impact on several public health programs, including the Woman, Infant and Children (WIC) program and rapid HIV testing program.   The Department of Health states that these public health programs involve the administration of simple to use tests, designated by the Clinical Laboratory Improvement Act as "waived" tests and should not have to be conducted by licensed clinical laboratory technologists or technicians.   The Department of Health maintains that technicians at limited service laboratories should not have to be licensed to perform routine tests.

            COMMENT: The New York City Department of Health raised the concern that if the regulations are interpreted to restrict non-licensed individuals from performing Clinical Laboratory Improvement Act waived testing, this would seriously impair the City's rapid HIV testing program.  The New York City Department of Health maintains that such waived testing should not have to have to be performed by licensed individuals.   

            RESPONSE:   Licensure in these new professions is mandated by statute, not by the proposed regulation.  The purpose of the proposed regulation is to establish implementing requirements that an applicant for licensure must meet in order to qualify for licensure in these fields.   It does not address scope of practice issues.  The scope of practice for these new professions is specifically prescribed in Education Law section 8601, and exemptions to the licensure requirements are prescribed in Education Law section 8609.   The Department may not expand exemptions to the licensure requirement beyond what is prescribed in statute.  The Department is consulting with the New York State and New York City Departments of Health and the State Legislature to determine the scope of practice issues within the context of the statutory mandates.  The Department plans to address the scope of practice issues in Practice Alerts and guidelines.     

            COMMENT:  We support the revisions in the proposed regulation that establish a transitional path for applicants who apply for licensure in clinical laboratory technology prior to September 1, 2011.   This will allow our medical technology program sufficient time to meet newly mandated curricular requirements.  

            RESPONSE:  As a result of public comment, the regulation was previously substantially revised to establish education standards for licensure for applicants who apply prior to September 1, 2011.  The Department has maintained this transitional pathway to licensure in the current revised regulation.  The Department plans to revise the education requirement in the future through establishing requirements in regulation for registered programs leading to licensure in the three fields.  These new requirements would be for applicants who apply for licensure on or after September 1, 2011. 

            COMMENT: The regulation that establishes course content requirements for registered programs in clinical laboratory technology (Section 52.36[b]) should provide that "for programs that are accredited by an acceptable accrediting agency or an equivalent institution, such acceptable accrediting agency shall determine which courses shall be deemed appropriate."

            COMMENT: I think that specific training of at least six months in an area of clinical laboratory technology is needed.   The 30 hour per week 24 week requirement in the registered program covering all areas of clinical laboratory technology practice will not provide the level of skill needed to practice.  

             COMMENT:  We offer an accredited program in clinical laboratory technology.  Our program would not meet the requirements for a registered programs leading to licensure in clinical laboratory technology because it does not include a laboratory component in: organic chemistry, biochemistry, physiology, and immunology courses.   Laboratory experience in these fields is not needed to practice as a clinical laboratory technologist.  RESPONSE:  These three comments relate to requirements for registered preparation programs for licensure in these three fields (sections 52.36, 52.37, and 52.38 of Commissioners regulations).  Based upon consultation with New York State colleges offering programs in these fields and other public comment, the Department has decided to delete these requirements from the rule making.  The Department will consult with the colleges and other interested parties and work with the State Board for Clinical Laboratory Technology to revise the requirements for registered programs leading to licensure.  In the meantime, the transitional education requirements prescribed in Subparts 79-13, 79-14, and 79-15 will apply.

            However, the Department must note that the Education Law requires the State Education Department to establish the education requirements for licensure in the three new professions.  This authorizes the Department to require applicants to complete prescribed course work to help ensure their competency for entry-level practice.  It would be improper for the Department to delegate this responsibility to a private accrediting agency.   Therefore, the Department plans to establish in Part 52 course work requirements for registered programs leading to licensure in these fields. 

            COMMENT:   ASCP/NCA certification examinations should be used to test individuals for state licensure since these are the primary means of certification for laboratory-based allied health professionals and are taken nationwide.  They are available internationally and would facilitate laboratory professionals in moving into New York State.

            RESPONSE:  The regulation does not name specific examinations but establishes a general standard for their selection.  The Department, in consultation with the State Board for Clinical Laboratory Technology, will select licensure examinations that are in accord with the regulatory standards. 

            COMMENT:   Will there be a separate Blood Banking examination as has been the practice?

            RESPONSE:  Article 165 of the Education Law established a generalist license in each of the three professions.  General examinations are necessary to ensure entry-level competency given the broad scope of practice for each profession.  Clinical laboratories and other entities in New York State may establish additional specific requirements for employment, including examinations.      

            COMMENT:  A detailed syllabus for the specific course requirements would be helpful.

            RESPONSE:  The proposed regulation establishes transitional requirements for education to meet the licensure requirement, including general subject areas that must be covered.  It is inappropriate to establish the content requirements for specific courses in regulation.  

            COMMENT: The sole physician member of the State Board for Clinical Laboratory Technology was not appointed until July 2006, so this member did not have adequate opportunity to participate in the development of the regulation.  In addition, the Board has not had adequate opportunity to discuss the public comments that were submitted.

            RESPONSE:  A physician member of the Board was appointed in July 2006 after an extensive search.  Several nominees did not respond to their nomination or determined that they were not interested in appointment following interviews.  The physician has participated in board discussion regarding the proposed rule and received the minutes of board proceedings regarding this matter on the date of his appointment.  The board has been closely involved in the development of this regulation and has discussed the public comments. 

            COMMENT:  The Department did not timely implement the application process for licensure in these new professions. 

            RESPONSE:  The licensure law was enacted in January 30, 2005 with an implementation date of September 1, 2006.  The process of appointing a State Board, developing the proposed regulations and publishing these in the State Register, receiving comment and responding to the comment required the sequential flow of prescribed activities that took a number of months before the Board of Regents could enact the emergency regulations in July 2006.  Within two weeks of this action by the Board of Regents, applications were available online and in hard copy.   Applicants had adequate time to apply for licensure under the "grandparenting" provisions.

            COMMENT:  Licensure and the fees are just ways to add money to the State’s general fund and are excessive.

            RESPONSE:  The licensure and registration fees for these professions are established in statute.  The Department does not have the statutory authority to change them in regulation.   Licensure fees are placed into a protected revenue account to be used solely for the process of carrying out the activities related to licensing, conduct and determinations of professional practice to ensure the health, safety and welfare of the public.