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THE STATE
EDUCATION DEPARTMENT / THE UNIVERSITY
OF THE STATE OF |
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TO: |
Higher Education and
Professional Practice Committee
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FROM: |
Johanna
Duncan-Poitier |
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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 |
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DATE: |
December 19,
2006 |
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STRATEGIC GOAL: |
Goals 2 and
3 |
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AUTHORIZATION(S): |
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SUMMARY
Issue for Decision
(Consent
Agenda)
Should the Regents amend the Regulations of the Commissioner of Education
to add new Subparts 79-13, 79-14, and 79-15, relating to licensure as a clinical
laboratory technologist and as a cytotechnologist and certification as a
clinical laboratory technician?
Reason(s) for
Consideration
Required by State
statute.
Proposed
Handling
The proposed amendment is
submitted for confirmation of the proposed amendment as a permanent rule at the
January 2007 Regents meeting. The
rule was adopted as an emergency measure at the December 2006 Regents meeting in
order to ensure that the emergency rule remains continuously in effect until it
may be adopted as a permanent rule in January 2007.
Procedural
History
A Notice of Proposed Rule Making concerning an earlier version of the
proposed amendment was published in the State Register on May 24, 2006. That version was discussed at the
meeting of the Higher Education and Professional Practice Committee in June
2006. Following the June meeting, the proposal was revised, and the Board of
Regents adopted the revised proposal as an emergency measure at its July 2006
Regents meeting. A Notice of
Emergency Adoption and Revised Rule Making was published in the State Register
on August 16, 2006. The proposal
was again revised and the current regulation was adopted as an emergency measure
at the October and December Regents meetings. A Notice of Emergency Adoption and
Revised Rule Making was published in the State Register
on November 15, 2006, and a Notice of Emergency Adoption will be published in
the State Register on December 27, 2006.
The proposed amendment is now submitted for adoption as a permanent
rule. Supporting materials for the
proposed amendment are available upon request from the Secretary to the Board of
Regents. Attached is an Assessment
of Public Comment.
Background
Information
Chapter 755 of the Laws of 2004 added a new Article 165 to the Education
Law, establishing three new professions that are practice and title protected:
clinical laboratory technologist, cytotechnologist, and clinical laboratory
technician. The purpose of the
proposed regulations is to implement the provisions of Article 165 of the
Education Law by establishing requirements for licensure as a clinical
laboratory technologist or cytotechnologist and for certification as a clinical
laboratory technician and requirements for limited permits in these
fields.
At its July meeting, the Board of Regents approved on an emergency basis
proposed regulations to implement Article 165 of the Education Law by
establishing educational program and licensure requirements for the three new
professions, including examination, limited permit, and grandparenting
requirements. The July emergency
action also established specific education requirements that an applicant must
meet for licensure or certification in these new professions, and established
content requirements for registered college preparation programs for the three
new professions.
One major issue raised
before the July Regents meeting was the need to address the status of recent
graduates of college programs and those in the pipeline in college programs who
will not meet the requirements of the grandparenting provisions. In response to this concern,
transitional educational requirements were included in the emergency regulations
approved by the Regents in July to provide an opportunity for these individuals
to meet the education requirement for licensure and obtain a limited permit to
practice until such time as they have taken the required examination. Specifically, under the July emergency
regulations, applicants who apply for licensure prior to September 1, 2011
will have to
complete a registered or accredited program that meets a general standard that
is consistent with national accreditation standards and the scope of practice
for each profession. The Department
expects that existing registered and accredited programs in these fields will
meet these requirements. This
transition period will allow registered college preparation programs in these
fields sufficient time to meet revised requirements that the Department plans to
promulgate, and will not disadvantage new and recent graduates.
At the June and July Regents meetings, the Regents raised concerns about
the specific courses recommended for licensure-qualifying higher education
programs, and the Department indicated that it was continuing to assess those
concerns, which were also raised by educational institutions offering such
programs and others, through ongoing conversations with relevant staff and other
interested stakeholders. The
Department indicated that it would report how those concerns have been addressed
and recommend modifications if appropriate. Since July, Department staff have
participated in numerous meetings to address these and similar issues with
members and staff in the legislature, administrators and faculty of higher
education professional programs, managers of clinical laboratories throughout
the State, representatives of relevant professional and hospital organizations,
and have visited a large clinical laboratory to observe and gather additional
information on the broad range of clinical laboratory technology services that
they provide.
A meeting was held on October 12th at
Until the new revisions
could be fully considered by the Department and the Board of Regents and
published in the State Register prior to Regents action, it was necessary to
adopt an emergency measure that would enable the Department to continue to
accept applications and issue licenses in these professions. Such emergency
regulations were adopted by the Regents in October. They differed from the regulations
adopted by the Regents in July in that the registration requirements for
licensure-qualifying programs were deleted. It is anticipated that such
requirements will be submitted to the Regents for approval once discussions
concerning the requirements are completed and the draft language is finalized.
In the meantime, the October emergency regulations continued to include the
transitional requirements, originally approved by the Board of Regents in July,
to provide an opportunity for recent graduates of college programs and those
currently in college programs to meet the educational requirement for licensure
and obtain a limited permit to practice until such time as they have taken the
required examination. Because the October emergency regulations would expire
prior to the January Regents meeting, when they can be adopted on a permanent
basis, it was necessary to adopt them again in December 2006 as an emergency
measure to maintain their continuity.
Accordingly, we are
recommending that the attached regulations be adopted as a permanent rule and
that recommendations for specific standards for registered licensure-qualifying
educational programs for these professions, which were the subject of the
concerns raised by the Regents in July, continue to be deferred for further
discussion and submission to the Regents in the near future.
Recommendation
I recommend that the Board of Regents take the following
action:
VOTED: That Subparts 79-13, 79-14, and 79-15 of the Regulations of
the Commissioner of Education be added, as submitted, effective February 10,
2007.
Timetable for
Implementation
The effective date of the permanent rule is February 10,
2007.
Attachments
AMENDMENT
TO THE REGULATIONS OF THE COMMISSIONER OF EDUCATION
Pursuant to sections 207, 210, 212, 6501, 6504, 6507, 6508, 8605, 8606,
8607, and 8608 of the Education Law.
1. Subpart 79-13 of the
Regulations of the Commissioner of Education is added, effective February 10,
2007, as follows:
SUBPART
79-13
CLINICAL
LABORATORY TECHNOLOGIST
79-13.1 Professional study of clinical laboratory
technology.
(a) As used in this section, acceptable accrediting agency shall mean
an organization accepted by the department as a reliable authority for the
purpose of accrediting clinical laboratory technology programs on a national or
regional basis, as having reasonable accreditation standards, and as an
organization that applies its criteria for granting accreditation of programs in
a fair, consistent, and nondiscriminatory manner.
(b) To meet the professional education requirement for admission to
the licensing examination for clinical laboratory technologists, the applicant
shall present satisfactory evidence of meeting the requirements of one of the
following paragraphs:
(1) applicants who apply for licensure prior
to September 1, 2011 may meet the
following requirement: holding a baccalaureate or higher degree awarded upon
successful completion of a baccalaureate or higher degree program in clinical
laboratory technology or a related title which:
(i) prepares graduates for
employment as a clinical laboratory technologist, as defined in Education Law
section 8601(2)(a),
(ii)
contains didactic and clinical education that integrates pre-analytical,
analytical, and post-analytical components of laboratory services, including the
principles and practices of quality assurance/quality improvement, and which is
designed and conducted to prepare graduates to practice clinical laboratory
technology using independent judgment and responsibility,
and
(iii)
is registered by the department for general educational purposes but need not be
specifically registered for licensure purposes, or is accredited by an
acceptable accrediting agency, or is recognized by appropriate civil authorities
of the jurisdiction in which the program is offered as a program that prepares
the applicant for professional practice as a clinical laboratory technologist;
or
(2)
applicants who apply for licensure prior to September
1, 2011 may alternatively meet the requirement by
both:
(i) holding a baccalaureate or higher degree
awarded upon successful completion of a baccalaureate or higher degree program
in the major of biology, chemistry, or the physical sciences registered pursuant
to Part 52 of this Title or its substantial equivalent as determined by the
department, and
(ii)
completing a program which:
(a) prepares
graduates for employment as a clinical laboratory technologist, as defined in
Education Law section 8601(2)(a),
(b)
contains didactic and clinical education that integrates pre-analytical,
analytical, and post-analytical components of laboratory services, including the
principles and practices of quality assurance/quality improvement, and which is
designed and conducted to prepare graduates to practice clinical laboratory
technology using independent judgment and responsibility,
and
(c) is registered by the department for
general educational purposes but need not be specifically registered for
licensure purposes, or is accredited by an acceptable accrediting agency, or is
recognized by the appropriate civil authorities of the jurisdiction in which the
program is offered as a program that prepares the applicant for professional
practice as a clinical laboratory technologist.
(c) To meet the professional education requirement for admission to
the licensing examination for clinical laboratory technologists, the applicant
must also certify to the department that he or she has reviewed the rules and
regulations of the New York State Department of Health and the U.S. Department
of Health and Human Services, relating to practice as a clinical laboratory
technologist in New York State, in accordance with written guidance from the
department.
79-13.2 Licensing
examination.
(a) Content. To meet the
examination requirement for licensure as a clinical laboratory technologist, the
candidate shall pass a general examination for clinical laboratory technologists
that is determined by the department to measure the applicant's knowledge,
judgment, and skills concerning practice as a clinical laboratory technologist,
as defined in section 8601(2)(a) of the Education Law, and to be offered by an
organization that has satisfactory administrative and psychometric procedures in
place to offer the examination.
(b) Passing score. The
department shall accept scores on the examination satisfactory to the State
Board for Clinical Laboratory Technology, as meeting the requirement for passing
the licensing examination. The applicant shall pass the examination with a
converted score of at least 75, as determined by the State Board for Clinical
Laboratory Technology.
79-13.3 Limited
permits.
(a) As authorized by section 8608 of the Education Law, upon
recommendation of the State Board for Clinical Laboratory Technology, the
department may issue a limited permit to practice as a clinical laboratory
technologist to an applicant for licensure who meets the requirements of this
section.
(b) The applicant for a limited permit to practice as a clinical
laboratory technologist shall:
(1) file an application for a limited permit with the department and
pay the initial licensure and registration fee, as prescribed in section 8605(1)
of the Education Law, and a limited permit fee of fifty
dollars;
(2) have met all requirements for licensure
as a clinical laboratory technologist, except the examination
requirement;
(3) submit adequate documentation that the
applicant will be under the general supervision of the director of a clinical
laboratory, as defined in section 571 of the Public Health Law, in accordance
with the requirements of this paragraph.
(i) Such documentation shall identify the
director of the clinical laboratory who has responsibility for providing general
supervision of the applicant's work while under the limited permit, and include
a signed statement by the director of the clinical laboratory certifying that he
or she will provide general supervision of the applicant's experience. If a director cannot carry out his or
her duties, or is replaced by a new or interim director, the limited permit
holder shall submit to the department on a form prescribed by the department the
name of the new director who has assumed supervisory responsibility of the
permit holder.
(ii) For purposes of this
section, under the general supervision of the director of a clinical laboratory
shall mean that the permit holder shall be supervised by a director of a
clinical laboratory who shall:
(a) serve the laboratory full-time, or on a
regular part-time basis;
(b) ensure the supervision of the technical
performance of the permit holder, and be readily available for consultation with
the permit holder, as needed; and
(c) be responsible for the performance and findings of all tests
carried out by the limited permit holder, either by directly overseeing such
testing, or by delegating this responsibility to authorized qualified
supervisors who are on site within the laboratory.
(c) The limited permit
issued pursuant to this section shall be valid for a period of not more than one
year from the date of issuance.
Such limited permit may be renewed at the discretion of the department
for one additional one-year period, provided that the applicant documents good
cause, such as, a specific physical or mental disability certified by an
appropriate health care professional or other good cause which in the judgment
of the department made it impossible for the applicant to complete requirements
for licensure as a clinical laboratory technologist while under the original
limited permit.
79-13.4 Special
provisions.
(a) In accordance with section 8607(1)(a) of
the Education Law, an applicant may be licensed by the department as a clinical
laboratory technologist by meeting the requirements of this subdivision. The applicant must apply for licensure
under this section by September 1, 2007, and meet the requirements for licensure
under this section by September 1, 2008, unless the particular requirement
prescribes an earlier date for completion, in which case the requirement must be
completed by that earlier date.
(b) The applicant shall:
(1) file the application for licensure with the department and pay the
fee for the initial license and the fee for the first registration period, as
prescribed in section 8605(1) of the Education Law, all by September 1,
2007;
(2) be of good moral character as determined
by the department;
(3) be at least 18 years of age; and
(4) meet one of the following
requirements:
(i)
the applicant shall meet the professional education requirement for
licensure, as prescribed in section 79-13.1 of this Subpart by September 1,
2008, and shall have successfully performed the duties of a clinical laboratory
technologist for two years, meaning 2,880 clock hours, over the five years
immediately preceding September 1, 2006; or
(ii) the applicant shall have successfully completed by September 1,
2008 a baccalaureate or higher degree program in the major of biology,
chemistry, or the physical sciences offered by an institution that is accredited
by an acceptable accrediting agency, meaning an organization accepted by the
department as a reliable authority for the purpose of accreditation at the
postsecondary level, applying its criteria for granting accreditation in a fair,
consistent and nondiscriminatory manner, such as an agency recognized for these
purposes by the U.S. Department of Education or that is recognized by the
appropriate civil authorities of the jurisdiction in which the program is
offered as an institution authorized to offer postsecondary degree study, and shall have successfully performed
the duties of a clinical laboratory technologist for two years, meaning 2,880
clock hours, over the five years
immediately preceding September 1, 2006; or
(iii) the applicant has been engaged full-time as a faculty member or
managing administrator involved directly in the development or planning of
curricula or the provision of instruction for education programs in clinical
laboratory technology for clinical laboratory practitioners, at an organized
entity that provides postsecondary education, for the equivalent of two years,
meaning 2,700 clock hours, over the five years immediately preceding September
1, 2006; or
(iv) the applicant shall have successfully performed the duties of a
clinical laboratory technologists for five years, meaning 7,200 clock hours, prior to September 1, 2006, as
verified in writing by the director of the clinical laboratory, as defined in
section 571 of the Public Health Law ;
or
(v) the applicant, at the time of application, shall have been
previously qualified for a license or its equivalent to practice as a clinical
laboratory technologist in New York State through other regulatory requirements
of a governmental unit of New York State authorized by law to qualify
individuals for such licensure or its equivalent; or
(vi) the applicant, at the time of application, shall be currently
certified as a clinical laboratory technician, and by September 1, 2008 shall
hold a baccalaureate or higher
degree based upon successful completion of a baccalaureate or higher
degree program in the major of biology, chemistry, or the physical sciences
offered by an institution that is accredited by an acceptable accrediting
agency, meaning an organization accepted by the department as a reliable
authority for the purpose of accreditation at the postsecondary level, applying
its criteria for granting accreditation in a fair, consistent and
nondiscriminatory manner, such as an agency recognized for these purposes by the
U.S. Department of Education or that is recognized by the appropriate civil
authorities of the jurisdiction in which the program is offered as an
institution authorized to offer postsecondary degree study, and by September 1,
2008 shall have successfully performed the duties of a clinical laboratory
technician for four years, meaning 5,760 clock hours.
(c) In accordance with subdivision (2) of section 8607 of the
Education Law, an individual who on or before September 1, 2007 files with the
department an application for licensure as a clinical laboratory technologist
under this section and certifies to a good faith belief that he or she has or
will have met the requirements for licensure under this section by the
prescribed completion dates which shall in no case be later than September 1,
2008, shall be deemed qualified to practice as a clinical laboratory
technologist from the date of filing the application with the department until
such time as the department has acted upon such application.
2. Subpart 79-14 of the
Regulations of the Commissioner of Education is added, effective February 10,
2007, as follows:
SUBPART
79-14
CYTOTECHNOLOGIST
79-14.1 Professional study of cytotechnology.
(a) As used in this section, acceptable accrediting agency shall mean
an organization accepted by the department as a reliable authority for the
purpose of accrediting cytotechnology programs on a
national or regional basis, as having reasonable accreditation standards, and as
an organization that applies its criteria for granting accreditation of programs
in a fair, consistent, and nondiscriminatory manner.
(b) To meet the professional education requirement for admission to
the licensing examination for cytotechnologists, the
applicant shall present satisfactory evidence of meeting the requirements of one
of the following paragraphs:
(1) applicants who
apply for licensure prior to September 1, 2011 may meet the following
requirement: holding a baccalaureate or higher degree awarded upon successful
completion of a baccalaureate or higher degree program in cytotechnology or a related title which:
(i) prepares graduates for
employment as a cytotechnologist, as defined in
Education Law section 8601(2)(b),
(ii)
contains didactic and clinical education that integrates pre-analytical,
analytical, and post-analytical components of laboratory services, including the
principles and practices of quality assurance/quality improvement, and which is
designed and conducted to prepare graduates to practice cytotechnology using independent judgment and
responsibility, and
(iii)
is registered by the department for general educational purposes but need not be
specifically registered for licensure purposes, or is accredited by an
acceptable accrediting agency, or is recognized by appropriate civil authorities
of the jurisdiction in which the program is offered as a program that prepares
the applicant for professional practice as a cytotechnologist; or
(2)
applicants who apply for licensure prior to September
1, 2011 may alternatively meet the requirement by
both:
(i) holding a baccalaureate or higher degree
awarded upon successful completion of a baccalaureate or higher degree program
in the major of biology, chemistry, or the physical sciences registered pursuant
to Part 52 of this Title or its substantial equivalent as determined by the
department, and
(ii)
completing a program which:
(a) prepares
graduates for employment as a cytotechnologist, as
defined in Education Law section 8601(2)(b),
(b)
contains didactic and clinical education that integrates pre-analytical,
analytical, and post-analytical components of laboratory services, including the
principles and practices of quality assurance/quality improvement, and which is
designed and conducted to prepare graduates to practice cytotechnology using independent judgment and
responsibility, and
(c) is registered by the department for
general educational purposes but need not be specifically registered for
licensure purposes, or is accredited by an acceptable accrediting agency, or is
recognized by the appropriate civil authorities of the jurisdiction in which the
program is offered as a program that prepares the applicant for professional
practice as a cytotechnologist.
(c) To meet the professional education requirement for admission to
the licensing examination for cytotechnologists, the
applicant must also certify to the department that he or she has reviewed the
rules and regulations of the New York State Department of Health and the U.S.
Department of Health and Human Services, relating to practice as a cytotechnologist in New York State, in accordance with
written guidance from the department.
79-14.2 Licensing
examination.
(a) Content. To meet the
examination requirement for licensure as a cytotechnologist, the candidate shall pass a general
examination for cytotechnologists that is determined
by the department to measure the applicant's knowledge, judgment, and skills
concerning practice as a cytotechnologist, as defined
in section 8601(2)(b) of the Education Law, and to be
offered by an organization that has satisfactory administrative and psychometric
procedures in place to offer the examination.
(b) Passing score. The
department shall accept scores on the examination satisfactory to the State
Board for Clinical Laboratory Technology, as meeting the requirement for passing
the licensing examination. The applicant shall pass the examination with a
converted score of at least 75, as determined by the State Board for Clinical
Laboratory Technology.
79-14.3 Limited
permits.
(a) As authorized by section 8608 of the Education Law, upon
recommendation of the State Board for Clinical Laboratory Technology, the
department may issue a limited permit to practice as a cytotechnologist to an applicant for licensure who meets the
requirements of this section.
(b) The applicant for a limited permit to practice as a cytotechnologist shall:
(1) file an application for a limited permit with the department and
pay the initial licensure and registration fee, as prescribed in section 8605(2)
of the Education Law, and a limited permit fee of fifty
dollars;
(2) have met all requirements for licensure
as a cytotechnologist, except the examination
requirement; and
(3) submit adequate documentation that the
applicant will be under the general supervision of the director of a clinical
laboratory, as defined in section 571 of the Public Health Law, in accordance
with the requirements of this paragraph.
(i) Such documentation shall identify the
director of the clinical laboratory who has responsibility for providing general
supervision of the applicant's work while under the limited permit, and include
a signed statement by the director of the clinical laboratory certifying that he
or she will provide general supervision of the applicant's experience. If a director cannot carry out his or
her duties, or is replaced by a new or interim director, the limited permit
holder shall submit to the department on a form prescribed by the department the
name of the new director who has assumed supervisory responsibility of the
permit holder.
(ii) For purposes of this
section, under the general supervision of the director of a clinical laboratory
shall mean that the permit holder shall be supervised by a director of a
clinical laboratory who shall:
(a) serve the laboratory full-time, or on a
regular part-time basis;
(b) ensure the supervision of the technical
performance of the permit holder, and be readily available for consultation with
the permit holder, as needed; and
(c) be responsible for the performance and findings of all tests
carried out by the limited permit holder, either by directly overseeing such
testing, or by delegating this responsibility to authorized qualified
supervisors who are on site within the laboratory.
(c) The limited permit
issued pursuant to this section shall be valid for a period of not more than one
year from the date of issuance.
Such limited permit may be renewed at the discretion of the department
for one additional one-year period, provided that the applicant documents good
cause, such as, a specific physical or mental disability certified by an
appropriate health care professional or other good cause which in the judgment
of the department made it impossible for the applicant to complete requirements
for licensure as a cytotechnologist while under the
original limited permit.
79-14.4 Special
provisions.
(a) In accordance with section 8607(1)(c) of
the Education Law, an applicant may be licensed by the department as a cytotechnologist through meeting the requirements of this
subdivision. The applicant must
apply for licensure under this section by September 1, 2007, and meet the
requirements for licensure under this section by September 1, 2008, unless the
particular requirement prescribes an earlier date for completion, in which case
the requirement must be completed by that earlier date.
(b) The applicant shall:
(1) file the application for licensure with the department and pay the
fee for the initial license and the fee for the first registration period, as
prescribed in section 8605(2) of the Education Law, all by September 1,
2007;
(2) be of good moral character as determined
by the department;
(3) be at least 18 years of age; and
(4) meet one of the following
requirements:
(i)
the applicant shall meet the professional education requirement for
licensure, as prescribed in section 79-14.1 of this Subpart by September 1,
2008, and shall have successfully performed the duties of a cytotechnologist for two years, meaning 2,880 clock hours,
over the five years immediately preceding September 1, 2006;
or
(ii) the applicant, at the time of application, shall have previously
been qualified for a license or its equivalent to practice as a cytotechnologist
in New York State through other regulatory requirements of a governmental
unit of New York State authorized by law to qualify individuals for such
licensure or its equivalent.
(c) In accordance with subdivision (2) of section 8607 of the
Education Law, an individual who on or before September 1, 2007 files with the
department an application for licensure as a cytotechnologist under this section and certifies to a good
faith belief that he or she has or will have met the requirements for licensure
under this section by the prescribed completion dates which shall in no case be
later than September 1, 2008, shall be deemed qualified to practice as a cytotechnologist from the date of filing the application
with the department until such time as the department has acted upon such
application.
3. Subpart 79-15 of the
Regulations of the Commissioner of Education is added, effective February 10,
2007, as follows:
SUBPART
79-15
CLINICAL
LABORATORY TECHNICIAN
79-15.1 Professional study of clinical laboratory
technician.
(a) As used in this section, acceptable accrediting agency shall mean
an organization accepted by the department as a reliable authority for the
purpose of accrediting clinical laboratory technician programs on a national or
regional basis, as having reasonable accreditation standards, and as an
organization that applies its criteria for granting accreditation of programs in
a fair, consistent, and nondiscriminatory manner.
(b) To meet the professional education requirement for admission to
the examination for professional certification for clinical laboratory
technicians, applicants who apply
for licensure prior to September 1, 2011 shall present satisfactory evidence of
meeting the following requirement: holding an associate or higher degree awarded
upon successful completion of an associate or higher degree program in clinical
laboratory technician or a related title which:
(1)
prepares graduates for employment as a clinical laboratory technician, as
defined in Education Law section 8601(2)(c),
(2)
contains didactic and clinical education that integrates pre-analytical,
analytical, and post-analytical components of laboratory services, including the
principles and practices of quality assurance/quality improvement, and which is
designed and conducted to prepare graduates to practice as clinical laboratory
technicians under the supervision of a clinical laboratory technologist,
laboratory supervisor, or director of a clinical laboratory, and
(3) is
registered by the department for general educational purposes but need not be
specifically registered for licensure purposes, or is accredited by an
acceptable accrediting agency, or is recognized by appropriate civil authorities
of the jurisdiction in which the program is offered as a program that prepares
the applicant for professional practice as a clinical laboratory
technician.
(c) To meet the professional education requirement for admission to
the examination for professional certification as a clinical laboratory
technician, the applicant must also certify to the department that he or she has
reviewed the rules and regulations of the New York State Department of Health
and the U.S. Department of Health and Human Services, relating to practice as a
clinical laboratory technician in New York State, in accordance with written
guidance from the department.
79-15.2 Licensing
examination.
(a) Content. To meet the
examination requirement for professional certification as a clinical laboratory
technician, the candidate shall pass a general examination for clinical
laboratory technicians that is determined by the department to measure the
applicant's knowledge, judgment, and skills concerning practice as a clinical
laboratory technician, as defined in section 8601(2)(c) of the Education Law,
and to be offered by an organization that has satisfactory administrative and
psychometric procedures in place to offer the examination.
(b) Passing score. The
department shall accept scores on the examination satisfactory to the State
Board for Clinical Laboratory Technology, as meeting the requirement for passing
the licensing examination. The applicant shall pass the examination with a
converted score of at least 75, as determined by the State Board for Clinical
Laboratory Technology.
79-15.3 Limited
permits.
(a) As authorized by section 8608 of the Education Law, upon
recommendation of the State Board for Clinical Laboratory Technology, the
department may issue a limited permit to practice as a clinical laboratory
technician to an applicant for certification who meets the requirements of this
section.
(b) The applicant for a limited permit to practice as a clinical
laboratory technician shall:
(1) file an application for a limited permit with the department and
pay the initial certification and registration fee, as prescribed in section
8606 of the Education Law, and a limited permit fee of fifty
dollars;
(2) have met all requirements for
certification as a clinical laboratory technician, except the examination
requirement;
(3) submit adequate documentation that the
applicant will be under the general supervision of the director of a clinical
laboratory, as defined in section 571 of the Public Health Law, in accordance
with the requirements of this paragraph.
(i) Such documentation shall identify the
director of the clinical laboratory who has responsibility for providing general
supervision of the applicant's work while under the limited permit, and include
a signed statement by the director of the clinical laboratory certifying that he
or she will provide general supervision of the applicant's experience. If a director cannot carry out his or
her duties, or is replaced by a new or interim director, the limited permit
holder shall submit to the department on a form prescribed by the department the
name of the new director who has assumed supervisory responsibility of the
permit holder.
(ii) For purposes of this
section, under the general supervision of the director of a clinical laboratory
shall mean that the permit holder shall be supervised by a director of a
clinical laboratory who shall:
(a) serve the laboratory full-time, or on a
regular part-time basis;
(b) ensure the supervision of the technical
performance of the permit holder, and be readily available for consultation with
the permit holder, as needed; and
(c) be responsible for the performance and findings of all tests
carried out by the limited permit holder, either by directly overseeing such
testing, or by delegating this responsibility to authorized qualified
supervisors who are on site within the laboratory.
(c) The limited permit
issued pursuant to this section shall be valid for a period of not more than one
year from the date of issuance.
Such limited permit may be renewed at the discretion of the department
for one additional one-year period, provided that the applicant documents good
cause, such as, a specific physical or mental disability certified by an
appropriate health care professional or other good cause which in the judgment
of the department made it impossible for the applicant to complete requirements
for certification as a clinical laboratory technician while under the original
limited permit.
79-15.4 Special
provisions.
(a) In accordance with section 8607(1)(b) of
the Education Law, an applicant may be certified by the department as a clinical
laboratory technician through meeting the requirements of this subdivision. The applicant must apply for
certification under this section by September 1, 2007, and meet the requirements
for certification under this section by September 1, 2008, unless the particular
requirement in this section prescribes an earlier date, in which case the
earlier date must be met.
(b) The applicant shall:
(1) file the application for certification with the department and pay
the fee for the initial certification and the fee for the first registration
period, as prescribed in section 8606 of the Education Law, all by September 1,
2007;
(2) be of good moral character as determined
by the department;
(3) be at least 18 years of age; and
(4) meet one of the following
requirements:
(i)
the applicant shall meet the professional education requirement for
certification, as prescribed in section 79-15.1 of this Subpart by September 1,
2008, and shall have successfully performed the duties of a clinical laboratory
technician for two years, meaning 2,880 clock hours, over the five years
immediately preceding September 1, 2006; or
(ii) the applicant shall have successfully performed the duties of a
clinical laboratory technician for five years, meaning 7,200 clock hours, prior to September 1, 2006, as
verified in writing by the director of a clinical laboratory, as defined in
section 571 of the Public Health Law; or
(iii) the applicant, at the time of application, shall have previously
been qualified for a certification or its equivalent to practice as a clinical
laboratory technician in New York State through other regulatory requirements of
a governmental unit of New York State authorized by law to qualify individuals
for such certification or its equivalent.
(c) In accordance with subdivision (2) of section 8607 of the
Education Law, an individual who on or before September 1, 2007 files with the
department an application for certification as a clinical laboratory technician
under this section and certifies to a good faith belief that he or she has or
will have met the requirements for certification under this section by the
prescribed completion dates which shall in no case be later than September 1,
2008, shall be deemed qualified to practice as a clinical laboratory technician
from the date of filing the application with the department until such time as
the department has acted upon such application.
PROPOSED SUBPARTS 79-13, 79-14, AND 79-15 OF THE REGULATIONS OF THE COMMISSIONER
OF EDUCATION PURSUANT TO SECTIONS 207, 210, 212, 6501, 6504, 6507, 6508, 8605,
8606, 8607, AND 8608 OF THE EDUCATION LAW RELATING TO LICENSURE AS A CLINICAL
LABORATORY TECHNOLOGIST AND AS A CYTOTECHNOLOGIST AND CERTIFICATION AS A
CLINICAL LABORATORY TECHNICIAN
ASSESSMENT OF PUBLIC
COMMENT
A Notice of Proposed Rule Making concerning this regulation was published
in the State Register on May 24, 2006.
A Notice of Emergency Adoption and Revised Rule Making was published on August 16, 2006. A second Notice of Emergency Adoption
and Revised Rule Making was published on November 15,
2006. The following is a summary of
comments received by the State Education Department (SED) since the publication
of the Notice of Emergency Adoption and Revised Rule Making on November 15,
2006, and the Department's response to the comments.
COMMENT: The regulations do
not recognize specialist technologists who work solely in specialized
laboratories, even though every teaching hospital in
RESPONSE: Article 165
of the Education Law establishes three new professions, clinical laboratory
technology, cytotechnology, and clinical laboratory
technician, and provides a general scope of practice for each profession. SED does not have statutory
authority to establish specialist fields within these licensed professions
through regulation. The
regulation does not prevent a licensed individual from specializing within the
scope of practice of that profession.
COMMENT: The "grandparenting" provisions are onerous and unreasonably
restrictive. The regulation should
permit automatic licensure for all individuals working as qualified technicians
and technologists as of September 30, 2006.
RESPONSE: The regulation
implements statutory "grandparenting" provisions
(Education Law section 8607). Such
provisions do not provide for automatic licensure for those employed as
laboratory technicians and technologists as of a certain date, and SED does not
have statutory authority to establish such a provision in regulation. The statutory "grandparenting" provisions permit applicants to be licensed
as a clinical laboratory technologist or certified as a clinical laboratory
technician if they have at least five years of applicable experience prior to
September 1, 2006, the effective date of the licensure law.
COMMENT: The regulation should be interpreted to allow any individual
working as a technologist in a laboratory that is licensed by the New York State
Department of Health (DOH) to obtain automatic licensure under the statutory
provision that authorizes such licensure for persons previously qualified under
other regulatory requirements for that license or its
equivalent.
RESPONSE: The
statutory "grandparenting" provisions at issue,
Education Law section 8607 (1)(a)(iv), (b)(ii), and
(c), require the individual to be "previously qualified under other regulatory
requirements for the license or its equivalent." DOH licenses laboratories and does not
license individuals as clinical laboratory technologists, cytotechnologists, or clinical laboratory technicians. Therefore, this ''grandparenting" provision may not be used to automatically
license individuals based solely on the fact that they are employed at a DOH
licensed clinical laboratory on a particular date, as suggested by the
comment. However, another statutory
"grandparenting" provision permits applicants to be
licensed as a clinical laboratory technologist or certified as a clinical
laboratory technician if they have at least five years of applicable experience
prior to September 1, 2006, the effective date of the licensure law, and this
"grandparenting" provision is prescribed in the
regulation.
COMMENT: The regulation should permit cytotechnologists to be licensed through a "grandparenting" provision based upon having at least five
years of applicable experience prior to September 1, 2006, as permitted for
clinical laboratory technologists and clinical laboratory
technicians.
RESPONSE: The "grandparenting" provisions are established in Education Law
section 8607. This statute does not
establish a "grandparenting" provision for cytotechnologists, based upon having at least five years of
applicable experience prior to September 1, 2006, as is provided for clinical
laboratory technologists and clinical laboratory technicians. SED does not have the statutory
authority to establish this "grandparenting" provision
in regulation.
COMMENT: Existing
preparation programs in the State are inadequate to meet the need for clinical
laboratory technologists. SED
should work with practitioners in the field to devise hospital-based training
programs.
RESPONSE: The current regulation permits an applicant to complete a
portion of the education requirement for licensure as a clinical laboratory
technologist through an accredited hospital-based program. SED is working with degree-granting
institutions to develop registered programs that lead to licensure through a
partnership between degree-granting institutions and the hospital-based
programs.
COMMENT: It is my understanding that the SED will permit an individual to
be licensed as a clinical laboratory technologist under "grandparenting" provisions based solely upon experience as a
clinical laboratory technician.
This should be clarified in the regulation.
RESPONSE: The regulation implements the "grandparenting" provisions in Education Law section
8607. The regulation is clear
and does not permit licensure as a clinical laboratory technologist based solely
upon experience as a clinical laboratory technician. One "grandparenting" provision establishes the following
licensure requirement: the
applicant must be a certified clinical laboratory technician and by September 1,
2008 must both complete a prescribed baccalaureate degree program and have four
years of experience as a clinical laboratory technician. Another "grandparenting" provision requires the applicant to have
performed the duties of a clinical laboratory technologist for five-years,
meaning 7,200 clock hours, prior to September 1, 2006, as verified in writing by
the Director of the Clinical Laboratory.
This provision would not permit licensure as a clinical laboratory
technologist based upon performing the duties of a clinical laboratory
technician.
COMMENT: The regulation should be clarified to permit clinical laboratory
supervisory experience to be creditable for the five years of experience under
the "grandparenting" provision.
RESPONSE: A regulatory change is unnecessary. Under the existing regulation, SED has
accepted appropriate experience supervising the work of clinical laboratory
technologists to meet the five-years of experience for licensure as a clinical
laboratory technologist under this "grandparenting"
provision.
COMMENT: Laboratory assistants should be exempt from
licensure.
RESPONSE: The scopes of
practice for these new professions are defined in the Education Law. SED does not have the authority to modify
the statutory scopes of practice in regulation. Laboratory assistants who perform work
within the statutory scopes of practice must be licensed or certified.
COMMENT: Students who are enrolled in clinical laboratory technology and
clinical laboratory technician programs, and who have been trained and deemed
competent, should be able to perform supervised testing outside of their
education program.
RESPONSE: Education Law
section 8609(4) provides an exemption from the licensure requirement for
students or trainees enrolled in approved clinical laboratory technology
education programs for supervised activities that constitute part of a planned
course in the program. SED
does not have the authority to expand this exemption through regulation to
authorize employment of unlicensed students to perform work within the scope of
practice of these professions that is outside of their course of study.
COMMENT: The regulation does
not consider the economic impact the licensure act will have on laboratories
performing specialized cytogenetic
testing.
RESPONSE: Cytogenetics is within the scope of practice of clinical
laboratory technologists. The
requirement for licensure is imposed by statute, not by the regulatory
requirements. Any costs that a laboratory will
have to bear to employ licensed individuals to perform specialized cytogenetic testing results from the statutory licensure
requirement not this implementing regulation.
COMMENT: Requiring cytotechnologists to be
licensed will negatively affect the ability of cytotechnologists in rural
RESPONSE:
Article 165 of the Education Law establishes the requirement that cytotechnologists must be licensed in order to practice in