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

 

TO:

Higher Education and Professional Practice Committee

FROM:

Johanna Duncan-Poitier

 

 

 

SUBJECT:

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

 

DATE:

May 30, 2006

STRATEGIC GOAL:

Goals 2 and 3

AUTHORIZATION(S):

 

 

 

 

 

SUMMARY

 

Issue for Discussion

 

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 before the Higher Education and Professional Practice Committee for discussion in June 2006 and will be submitted for action at the July 2006 Regents meeting.

 

 

Procedural History

 

A Notice of Proposed Rule Making was published in the State Register on May 24, 2006.  Supporting materials for the proposed amendment are available upon request from the Secretary to the Board of Regents. 

 

Background Information

 

          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.   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 clinical laboratory technician. 

 

          The proposed regulation is needed to implement Article 165 of the Education Law by establishing specific education and examination requirements that an applicant must meet for licensure or certification in these new professions.  It is also needed to establish 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 have related education and/or experience (grandparenting applicants).   This will ease the transition to licensure or certification for these individuals.

 

          The State Education Department consulted with the State Department of Health during the development of this regulation to obtain its input and ensure that the proposed regulation coordinates with the Health Department's regulatory requirements for licensed clinical laboratories.

 

Recommendation

 

N/A

 

Timetable for Implementation

 

The effective date of the proposed regulation is August 17, 2006. 

 

 

 

 

Attachment

 

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 17, 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 17, 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, 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 17, 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 17, 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, having accreditation standards that are substantially equivalent to the requirements for programs registered as leading to licensure as a clinical laboratory technologist pursuant to section 52.36 of this Title, and applying 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:

          (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 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.

          (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 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 technologists 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 manor, 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 manor, 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 17, 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, having accreditation standards that are substantially equivalent to the requirements for programs registered as leading to licensure as a cytotechnologist pursuant to section 52.37 of this Title, and applying 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:

          (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 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 cytotechologist, 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.

          (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 17, 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, having accreditation standards that are substantially equivalent to the requirements for programs registered as leading certification in clinical laboratory technician pursuant to section 52.38 of this Title, and applying 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:

          (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 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.

          (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.