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

 

TO:

Full Board

 

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:

July 20, 2006

 

STRATEGIC GOAL:

Goal 2 and 3

 

AUTHORIZATION(S):

 

 

 

 

SUMMARY

 

 

 

Issue for Decision

 

          Should the Regents amend the Regulations of the Commissioner of Education to add new sections 52.36, 52.37, and 52.38, and 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 July 2006 Regents meeting.  Confirmation of the proposed amendment as a permanent rule is scheduled for the October 2006 Regents meeting.

Procedural History

 

          The proposed amendment was discussed at the meeting of the Higher Education and Professional Practice Committee in June 2006.  A Notice of Proposed Rule Making concerning the proposed amendment was published in the State Register on May 24, 2006.  Since the June meeting, the proposed amendment has been revised, 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 August 16, 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 Education Law.  Article 165 provides for the establishment of three new professions that are practice and title protected: clinical laboratory technologist, cytotechnologist, and certified clinical laboratory technician.  The purpose of the proposed regulation 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, requirements for limited permits in these fields, and standards for registered college preparation programs for these professions.  

 

          The new licensure statute (Article 165 of the Education Law) was enacted in January 2005 to ensure the quality of the analysis performed at clinical laboratories by these professionals. These laboratories provide critical information needed for the diagnosis and treatment of illness and disease, ensure accurate blood and tissue typing and transfusion services, and provide the core knowledge and skill needed to identify bioterrorism agents.  As with all professions, licensure is also intended to hold these practitioners accountable for the professional services they provide.  The statutory licensure requirement is effective September 1, 2006.  There are approximately 30,000 persons who are employed in these three professional areas who will require licensure.  Most of these will be able to be licensed through special "grandparenting" requirements authorized in statute.

 

          The new statute raises the minimum education requirement in all three professions in New York State:

 

       It eliminates a route for persons with less than a baccalaureate in clinical laboratory technology to be eligible for employment; 

       With respect to cytotechnologists, it raises the existing employment requirement of an associateís degree to now require a bachelorís degree for licensure; and

       It requires that clinical laboratory technicians must have an associateís degree for licensure, whereas, currently there is no mandate for a higher education degree.

 

This proposed regulation establishes specific education and examination requirements that an applicant must meet for licensure or certification in these new professions.  It also establishes content requirements for registered college preparation programs for the three new professions.

 

          As authorized by statute, the proposed regulation implements special licensure and certification requirements for applicants who are already practicing in these fields or who have related education and/or experience (grandparenting applicants).   This will ease the transition to licensure or certification for these individuals who have experience in these fields. 

 

          In developing the draft regulations, Department staff and the newly formed State Board for Clinical Laboratory Technology have reviewed existing state and national educational programs, licensure requirements in other jurisdictions, and the current Federal and state Public Health Laws, among many other sources, to determine the appropriate core content needed to meet licensure standards with respect to education and the licensing examination for each profession. 

 

          A number of comments were submitted about the draft regulations. While several comments praised the draft, others criticized the licensure standards recommended by the State Board for Clinical Laboratory Technology, as well as expressed concern about a number of requirements mandated by the law which the Department has no authority to change. For example, some feel that the grandparenting provisions are too restrictive; some have complained about the exclusion of physician-office laboratories from the requirements, and some have said that continuing education should be required for these licensees, however, these and other issues raised required legislative action and cannot be addressed in the regulations.

 

           One major issue raised 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 have been included in these emergency regulations 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 revised requirements, 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.  Effective September 1, 2011, the newly established education requirements will be mandated.  This transition period will allow registered college preparation programs in these fields sufficient time to meet the more rigorous requirements, and will not disadvantage new and recent graduates.

 

          The Department also received additional feedback regarding the specific courses recommended for licensure-qualifying higher education programs. The Department is continuing to assess this feedback through ongoing conversations with relevant program staff and other interested stakeholders. When the Department brings these regulations back to the Board of Regents in October for confirmation, we will report how those concerns have been addressed and recommend modifications if appropriate.

 

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 license individuals by the effective date of the statutory licensure requirement for clinical laboratory practitioners, thereby enabling such practitioners to be licensed in a timely manner 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 sections 52.36, 52.37, and 52.38, and Subparts 79-13, 79-14, and 79-15 of the Regulations of the Commissioner of Education be added as submitted, effective August 1, 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 license individuals by the effective date of the statutory licensure requirement for clinical laboratory practitioners, thereby enabling such practitioners to be licensed in a timely manner to meet the health care needs of residents of New York State.

 

Timetable for Implementation

 

          The emergency adoption will take effect on August 1, 2006.

 

 

 

 

Attachments


PROPOSED PROMULGATION OF SECTIONS 52.36, 52.37, AND 52.38 AND 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 to 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.

           Approximately 30,000 persons are employed in these three professional areas and will require licensure or submission of an application under the grandparenting provisions by September 1, 2006 in order to continue to practice these professions.   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 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 standards for registered college preparation programs that lead to licensure or certification in these fields, in accordance 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 State Education Department originally planned to adopt these regulations in July 2006, but in response to public comment, the Department needed to make substantive changes to the regulation.  These changes required a new public comment period and will delay permanent adoption of the rule past September 1, 2006.  An emergency action is necessary to ensure that the requirements for licensure are in place on August 1, 2006, so that that applications may be submitted to meet the September 1, 2006 deadline under the grandparenting provisions and to enable the State Education Department to license individuals in a timely manner.

          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 license individuals by the effective date of the statutory licensure requirement for clinical laboratory practitioners, thereby enabling such practitioners to be licensed in a timely manner 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 October 2006 meeting.


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. Section 52.36 of the Regulations of the Commissioner of Education is added, effective August 1, 2006, as follows:

          52.36 Clinical laboratory technology.

          In addition to meeting all applicable provisions of this Part, to be registered as a program recognized as leading to licensure as a clinical laboratory technologist, which meets the requirements of section 79-13.1 of this Title, the program shall:

          (a) be a program in clinical laboratory technology leading to a baccalaureate or higher degree or advanced certificate which contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/quality improvement, and which is designed and conducted to prepare graduates to practice clinical laboratory technology using independent judgment and responsibility;

          (b) include courses, each of which shall include a laboratory component, in each of the following subjects or their equivalent as determined by the department:

          (1) inorganic chemistry;

          (2) organic chemistry;

          (3) analytic chemistry and/or biochemistry;

          (4) clinical chemistry;

          (5) anatomy and physiology;

          (6) immunology/serology;

          (7) immunohematology (Blood Bank);

          (8) hematology/hemostasis, and body fluids;

          (9) molecular biology and diagnostics;

          (10) microbiology and clinical microbiology, including bacteriology, mycology, parasitology, and virology; and

          (11) histological techniques;

          (c) include curricular content in each of the following subjects or their equivalent, as determined by the department:

          (1) statistics;

          (2) infection control and universal precautions;

          (3) the maintenance of equipment and records; and

          (4) ethics; and

          (d) include a supervised clinical experience of at least 30 hours per week for at least 24 weeks or its equivalent as determined by the department, in the practice of clinical laboratory technology, which provides the student with clinical experience that includes but is not  limited to: hematology/hemostasis, clinical chemistry, immunohematology, urinalysis/body fluids, clinical microbiology, and immunology.

          2. Section 52.37 of the Regulations of the Commissioner of Education is added, effective August 1, 2006, as follows:

          52.37 Cytotechnology.

          In addition to meeting all applicable provisions of this Part, to be registered as a program recognized as leading to licensure as a cytotechnologist, which meets the requirements of section 79-14.1 of this Title, the program shall:

          (a) be a program in cytotechnology leading to a baccalaureate or higher degree or advanced certificate which contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/quality improvement; and which is designed to prepare graduates to practice cytotechnology using independent judgment and responsibility;

          (b) include courses, each of which shall include a laboratory component, in each of the following subjects or their equivalent as determined by the department:

          (1) inorganic chemistry;

          (2) organic chemistry;

          (3) anatomy and physiology;

          (4) cell biology;

          (5) human genetics;

          (6) immunology;

          (7) clinical microbiology;

          (8) cytopathology, including but not limited to, female genital tract, respiratory tract, gastro-intestinal and genitourinary tracts, body fluids, evaluation of specimens from washes and brushes of all body sites, and evaluation of specimens form fine needle aspiration biopsies of all body sites;

          (9) cytopreparatory techniques, including but not limited to, preparation, staining and processing of body samples; and

          (10) microscopic evaluation and interpretation of cytopathology of the sample types and body systems identified in paragraph (8) of this subdivision;

          (c) include curricular content in each of the following subjects or their equivalent as determined by the department: 

          (1)  mathematics and statistics;

          (2) infection control and universal precautions;

          (3) the maintenance of equipment and records, and

          (4) ethics; and

          (d) include a supervised clinical experience of at least 30 hours per week for at least 10 weeks or its equivalent as determined by the department, in the practice of cytotechnology. 

          3. Section 52.38 of the Regulations of the Commissioner of Education is added, effective August 1, 2006, as follows:

          52.38 Clinical laboratory technician.

          In addition to meeting all applicable provisions of this Part, to be registered as a program recognized as leading to certification as a clinical laboratory technician, which meets the requirements of section 79-15.1 of this Title, the program shall:

          (a) be a clinical laboratory technician program leading to an associate or higher degree which contains didactic and clinical education that integrates pre-analytical, analytical, and post-analytical components of laboratory services, including the principles and practices of quality assurance/quality improvement;

          (b) include courses, each of which shall include a laboratory component, in each of the following subjects or their equivalent as determined by the department:

          (1) inorganic chemistry;

          (2) clinical chemistry;

          (3) anatomy and physiology;

          (4) microbiology, including clinical microbiology;

          (5) immunology and serology;

          (6) hematology;

          (7) hemostasis;

          (8) clinical microscopy, including body fluids;

          (9) histological techniques; and

          (10) immunohematology;

          (c) include curricular content in each of the following subjects or their equivalent as determined by the department:

          (1) statistics,

          (2) infection control and universal precautions, and

          (3) ethics; and

          (d) include a supervised clinical experience of at least 30 hours per week for at least 10 weeks or its equivalent as determined by the department, in the practice of clinical laboratory technician, which provides the student with clinical experience that includes but is not  limited to: hematology, hemostasis,  immunohematology, immunology, clinical chemistry,  urinalysis/body fluids, and clinical microbiology.

          4.  Subpart 79-13 of the Regulations of the Commissioner of Education is added, effective August 1, 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) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in clinical laboratory technology registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.36 of this Title; or

          (2) 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 that is substantially equivalent to a program registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.36 of this Title as determined by the department, which program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist, and must be designed and conducted by the degree-granting institution to prepare graduates to practice as clinical laboratory technologist using independent judgment and responsibility; or

          (3) 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 credit bearing program in clinical laboratory technology in addition to such baccalaureate or higher degree study that is registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.36 of this Title or substantially equivalent to such a registered program as determined by the department.  Such equivalent program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technologist, and must be designed and conducted by the degree-granting institution to prepare graduates to practice as a clinical laboratory technologist using independent judgment and responsibility; or

(4)  applicants who apply for licensure prior to September 1, 2011  may alternatively 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  

(5) 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.     

          5.  Subpart 79-14 of the Regulations of the Commissioner of Education is added, effective August 1, 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) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in cytotechnology registered as leading to licensure as a cytotechnologist pursuant to section 52.37 of this Title; or

          (2) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate or higher degree program in cytotechnology or a related title that is substantially equivalent to a program registered as leading to licensure as a cytotechnologist pursuant to section 52.37 of this Title as determined by the department, which program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a cytotechnologist, and must be designed and conducted by the degree-granting institution to prepare graduates to practice as a cytotechnologist using independent judgment and responsibility; or

          (3) both:

          (i) holding a baccalaureate or higher degree awarded upon successful completion of a baccalaureate 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 credit bearing program in cytotechnology in addition to such baccalaureate or higher degree study that is registered as leading to licensure in cytotechnology pursuant to section 52.37 of this Title or substantially equivalent to such a registered program as determined by the department.  Such equivalent program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a cytotechnologist, and must be designed and conducted by the degree-granting institution to prepare graduates to practice as a cytotechnologist using independent judgment and responsibility; or

(4)  applicants who apply for licensure prior to September 1, 2011 may alternatively 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  

(5) 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.  

          6.  Subpart 79-15 of the Regulations of the Commissioner of Education is added, effective August 1, 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, the applicant shall present satisfactory evidence of meeting the requirements of one of the following paragraphs:

          (1) holding an associate or higher degree awarded upon successful completion of an associate or higher degree program in clinical laboratory technician registered as leading to certification as a clinical laboratory technician pursuant to section 52.38 of this Title; or

          (2) 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 that is substantially equivalent to a program registered as leading to certification as a clinical laboratory technician pursuant to section 52.38 of this Title as determined by the department, which program must be accredited by an acceptable accrediting agency or recognized by the appropriate civil authorities of the jurisdiction in which the program is offered as a program that prepares the applicant for professional practice as a clinical laboratory technician; or

(3)  applicants who apply for licensure prior to September 1, 2011  may alternatively meet 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:

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

(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 as clinical laboratory technicians under the supervision of a clinical laboratory technologist, laboratory supervisor, or director of a clinical laboratory,  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 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 SECTIONS 52.36, 52.37, AND 52.38 AND 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

          The proposed regulation was published in the State Register on May 24, 2006.  Below is a summary of comments received by the State Education Department and the Departmentís response.

          COMMENT: The regulation will exacerbate staff shortages in clinical laboratories.

          RESPONSE:  The regulation implements statutory requirements mandating licensure in these new professions.  To ease the transition to licensure, the regulation includes "grandparenting" provisions, as prescribed in Education Law section 8607.  In response to public comment, the regulation has been substantially revised to establish education standards for licensure for applicants who apply prior to September 1, 2011, permitting the graduates of most existing programs to meet the education requirement and thereby easing the transition for recent and new graduates.

          COMMENT:  The regulation should clarify that the requirements do not apply to personnel employed at out-of-state laboratories.

          COMMENT: The regulation should clarify that the requirements cover the licensure of personnel employed at out-of-state laboratories, including those that are regulated by the New York State Department of Health.

          RESPONSE:  Based upon a review of the legislative history of Chapter 755 of the Laws of 2004, and the language of the statute, the intent of Article 165 of the Education Law is to require licensure for individuals practicing the new professions in New York State.  The Legislature did not intend to require licensure for personnel providing services in out-of-state laboratories, including those that may be regulated by the Department of Health.

          COMMENT: Article 165 of the Education Law does not clearly define the scope of practice for these three new professions (e.g., waived testing that may be performed by unlicensed individuals). The State Education should clarify scope of practice issues.

          RESPONSE:  The scope of practice for these new professions is prescribed in the Education Law.   The Department plans to address scope of practice issues in Practice Alerts and guidelines. 

          COMMENT:  The regulation should permit categorical licensure in specialized areas with limited scopes of practice.

          RESPONSE:  Education law section 8605 provides for a single generic license in each profession.  The statute does not permit the Department to issue specialized licenses in these fields.

          COMMENT: The regulation should permit an applicant to meet the education requirement for licensure by completing a program that is accredited by national accrediting agencies, rather than a registered program or its equivalent.

          RESPONSE: Education Law sections 8605 and 8606 require the State Education Department to establish education requirements for licensure, including requirements for registered programs leading to licensure in these fields.  The regulations are tailored to prescribe course requirements for the licensure-qualifying registered programs, based upon the scope of practice of these professions in New York State.  State standards ensure that applicants will have adequate educational preparation for the scope of practice in New York State.

          COMMENT:  A phase-in period should be established to allow programs to meet the new requirements. 

          RESPONSE:  As a result of public comment, the regulation has been substantially revised to establish education standards for licensure for applicants who apply prior to September 1, 2011.   After this date, the requirements will be increased. This will allow registered college programs and applicants for licensure sufficient time to meet more rigorous requirements.

          COMMENT: The regulations should permit applicants for licensure to satisfy clinical training requirements at accredited laboratory training programs, rather than degree-granting institutions.

          RESPONSE:  In response to public comment, the regulation has been revised to permit individuals who apply for licensure in clinical laboratory technology and cytotechnolgy prior to September 1, 2011 to obtain clinical training at non-credit bearing facilities that are accredited.  This will enable such clinical facilities sufficient time to affiliate with credit-bearing institutions.

          COMMENT: The regulation requires licensure-qualifying programs to provide generalist training, rather than specialist training, detrimentally affecting laboratory testing in the State.

          RESPONSE: Article 165 of the Education Law established a general scope of practice for each profession.  Consequently, the education preparation for licensure must be general in scope.

          COMMENT: New York should allow on-the-job training and military training as acceptable alternatives to completing an accredited or registered training program.

          RESPONSE: The statutory requirements require the applicant to complete degree requirements and college programs registered by the Department or equivalent programs offered in other jurisdictions.  These statutory requirements for licensure do not recognize on-the-job or military training.  However, such individuals may qualify for licensure under the '"grandparenting" provisions, based upon experience in the field.      

          COMMENT:  Requirements for registered programs leading to licensure in clinical laboratory technology and clinical laboratory technician should not include histology because accreditation standards do not require this coursework.

          RESPONSE:  Education Law section 8601(1) establishes the definition of clinical laboratory technology, which includes "histological procedures and examinations."   Therefore, training in this subject is necessary to prepare applicants for permitted practice.

          COMMENT: The requirements for registered programs leading to licensure in clinical laboratory technology and clinical laboratory technician are too prescriptive because they list specific courses.

          RESPONSE:  The requirements for registered programs were carefully designed to provide the necessary competencies to practice these professions.

          COMMENT: Cell biology, human genetics, hematology, and mathematics should be required in the curricula of clinical laboratory technology and cytotechnology programs.  Histological techniques should be required in cytotechnology programs.  Cytopreparatory techniques and biochemistry should be required in clinical laboratory technician programs. 

          RESPONSE:  The requirements for the three licensure-qualifying programs were developed through careful analysis of the scope of practice of these professions, existing programs, national accreditation standards, and expert advice.  These requirements do not preclude registered programs from adding requirements, including those suggested.        

          COMMENT: The curricula for medical technology programs are already filled to capacity. 

          RESPONSE:  The requirements for the registered programs were developed after extensive study of existing New York programs and national accreditation standards.   Almost all of the required courses are currently being offered.  The requirements for registered programs may be accommodated within four years.
          COMMENT: Requiring a laboratory component for courses in registered programs leading to licensure is inflexible.

          RESPONSE: The registered programs require that a portion of the class time for prescribed courses be devoted to laboratory work.  This is an appropriate requirement considering the field.

          COMMENT: Requirements for clinical laboratory technology programs should not include separate courses in anatomy and physiology.  Two additional courses cannot be accommodated within four years.

          RESPONSE: The requirement only prescribes one course that includes the subjects of anatomy and physiology.

          COMMENT:  The curriculum for registered clinical laboratory technology programs should permit clinical experience at the academic institution, as well as outside the institution.

          RESPONSE: The requirements do not prohibit clinical experience to be obtained at the academic institution.          

          COMMENT: Department of Health regulations for a certificate of qualification for a director of clinical laboratories do not require applicants to have a four-year medical technology degree. Typically, they have a doctoral degree and on-the-job training as a technologist.  The licensure requirement would make this on-the-job training illegal.

          RESPONSE: Article 165 of the Education Law establishes licensure requirements for the clinical laboratory technology professions.  The statute makes no exception for unlicensed individuals to receive on-the-job training to qualify as a director.       

          COMMENT:  The "grandparenting" provisions should establish special requirements for recent or new graduates.

          RESPONSE:  The "grandparenting" provisions are mandated in statute (Education Law section 8607), and do not provide special requirements for recent or new graduates.  However, as a result of public comment, the regulations have been revised to ease the transition for these graduates by changing the education requirement for applicants who apply for licensure prior to September 1, 2011.   The Department expects that graduates of most existing programs in these fields will meet the education requirement for licensure.

          COMMENT: The "grandparenting" provision that permits an applicant to be licensed as a clinical laboratory technologist if he or she was "previously qualified under other regulatory requirements for that license or its equivalent," should be interpreted broadly.

          RESPONSE:  The Department will interpret this provisions in a reasonable fashion based upon the plain meaning of the statutory language.    

          COMMENT:  The "grandparenting" provision should permit licensure as a clinical laboratory technologist based upon employment in these fields in the five years before a year in the future, rather than September 1, 2006. 

          RESPONSE:  This statutory provision requires the applicant to have performed the duties of a clinical laboratory technologist for at least five years prior to the effective date of Article 165 of the Education Law, September 1, 2006.  The Department does not have the authority to change this date.

          COMMENT: The "grandparenting" provision based upon prior performance of the duties of a clinical laboratory technologist should permit the crediting of experience gained in other jurisdictions.

          RESPONSE: The regulation does not preclude the crediting of experience gained in other jurisdictions to meet this requirement.  

          COMMENT: The "grandparenting" provision based upon prior performance of the duties of a clinical laboratory technologist is too restrictive.  Related employment should be credited.   

          COMMENT: The "grandparenting" provision based upon prior performing the duties of a clinical laboratory technologist is too liberal and will permit the licensing of unqualified individuals.

          RESPONSE:  The requirement is established in statute.  The State Education Department does not have the statutory authority to change the requirement in regulation.    

          COMMENT: The director of a clinical laboratory in a foreign country or other state should be permitted to verify the experience of the applicant for licensure under the "grandparenting" provisions.

          RESPONSE:  The regulation does not preclude a director of a clinical laboratory in another jurisdiction from verifying the experience.           

          COMMENT:  The applicant should be permitted to meet the examination requirement for licensure by passing a specialty test offered by recognized national certifying agencies, rather than general examinations.

          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.

          COMMENT: The licensure examinations require the candidate to pass with a converted score of at least 75, which may not be consistent with examining agency scoring.

          RESPONSE:  The Department, in consultation with the State Board for Clinical Laboratory Technology, will convert the passing score of the examining agency to 75.

          COMMENT: The regulation does not address reciprocity with other states.

          RESPONSE: Education Law provides that the Department may endorse the license of another jurisdiction.  The Department determined not to include endorsement requirements at the present time because only 12 other states license these professions and the scopes of practice in these jurisdictions differ.  This will require further study.        

          COMMENT:  The regulation should extend the licensure requirement to individuals employed in physician office laboratories.

          RESPONSE:  Education Law section 8601(2) provides that clinical laboratory practitioners are not required to be licensed to work in a laboratory operated by a licensed physician or other specified health professionals, solely for the treatment of the health professional's patients.

          COMMENT:  The regulation should mandate continuing education for these professions. 

          RESPONSE:  Education Law does not mandate continuing education for these professions, and the Department does not have the statutory authority to mandate it in regulation.

          COMMENT: The requirement that applicants for licensure be of good moral character should be eliminated. 

          RESPONSE:  This is a statutory requirement and may not be changed in regulation. 

          COMMENT: The licensure and registration fees for these professions are too high, considering the salaries paid.

          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.