Epinephrine Auto-Injectors

NY-ADR

2/25/15 N.Y. St. Reg. EDU-01-15-00011-E
NEW YORK STATE REGISTER
VOLUME XXXVII, ISSUE 8
February 25, 2015
RULE MAKING ACTIVITIES
EDUCATION DEPARTMENT
EMERGENCY RULE MAKING
 
I.D No. EDU-01-15-00011-E
Filing No. 103
Filing Date. Feb. 10, 2015
Effective Date. Feb. 27, 2015
Epinephrine Auto-Injectors
PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:
Action taken:
Addition of section 136.6 to Title 8 NYCRR.
Statutory authority:
Education Law, sections 207(not subdivided), 305(1), (2), 921(1) and (2); L. 2014, ch. 424
Finding of necessity for emergency rule:
Preservation of general welfare.
Specific reasons underlying the finding of necessity:
The proposed rule is necessary to implement Chapter 424 of the Laws of 2014, which adds a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, boards of cooperative educational services (BOCES), county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in the State to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. Section 921 also provides that school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state or any person employed by any such entity may administer epinephrine auto-injectors in the event of an emergency pursuant to the requirements of section three-thousand-c of the Public Health Law.
Since the Board of Regents meets at fixed intervals, the earliest the proposed rule can be presented for regular (non-emergency) adoption, after expiration of the required 45-day public comment period provided for in the State Administrative Procedure Act (SAPA) sections 201(1) and (5), would be the March 16-17, 2015 Regents meeting. Furthermore, pursuant to SAPA section 203(1), the earliest effective date of the proposed rule, if adopted at the March meeting, would be April 1, 2015, the date a Notice of Adoption would be published in the State Register. However, the provisions of Chapter 424 become effective on February 27, 2015 and section 3 of the statute directs the Commissioner to promulgate necessary regulations for the timely implementation of the statute on its effective date.
Therefore, emergency action is necessary at the February 2015 Regents meeting for the preservation of the general welfare in order to immediately establish standards for the provision, maintenance and administration of epinephrine auto-injectors pursuant to Education Law section 921, as added by Chapter 424 of the Laws of 2014, and thus ensure the timely implementation of the statute on its effective date.
It is anticipated that the proposed rule will be presented for adoption as a permanent rule at the March 16-17, 2015 Regents meeting, which is the first scheduled meeting after expiration of the 45-day public comment period prescribed in the State Administrative Procedure Act for State agency rule makings.
Subject:
Epinephrine auto-injectors.
Purpose:
Prescribe standards for provision, maintenance, and administration of epinephrine auto-injectors in the event of an emergency.
Text of emergency rule:
Section 136.6 of the Regulations of the Commissioner of Education is added, effective February 27, 2015, as follows:
§ 136.6 Authorized Use of Epinephrine Auto-Injector
(a) Definitions. As used in this section:
(1) Epinephrine auto-injector means an automated injection delivery device, approved by the United States Food and Drug Administration, for injecting a measured dose of the drug epinephrine.
(2) Trained school personnel means any person employed by a school district, board of cooperative educational services, county vocational education and extension board, charter school or non-public elementary and secondary school, including but not limited to, health professionals who have successfully completed a training course in the use of epinephrine auto-injector devices approved by the Department of Health pursuant to Public Health Law section 3000-c.
(3) Collaborative agreement means a written agreement with an emergency health care provider pursuant to Public Health Law section 3000-c that incorporates written practice protocols, and policies and procedures that shall ensure compliance with the provisions of Public Health Law section 3000-c.
(4) Emergency health care provider means: (i) a physician with knowledge and experience in the delivery of emergency care; or (ii) a hospital licensed under Article 28 of the Public Health Law that provides emergency care.
(5) Regional Council means a regional emergency medical services council established pursuant to Public Health Law section 3003.
(6) Instructional school facility means a building or other facility maintained by a school district, board of cooperative educational services, a county vocational education and extension board, charter school, or non-public elementary and secondary school where instruction is provided to students pursuant to its curriculum.
(b) Each school district, board of cooperative educational services, county vocational education and extension board, charter school, and non-public elementary and secondary school may provide and maintain on-site in each instructional school facility epinephrine auto-injectors for use during emergencies in accordance with Public Health Law section 3000-c. Each such facility shall have sufficient epinephrine auto-injectors available to ensure ready and appropriate access for use during emergencies to any student or staff having symptoms of anaphylaxis whether or not there is a previous history of severe allergic reaction. In determining the quantity and placement of epinephrine auto-injectors in collaboration with the emergency health care provider, consideration shall be given to:
(1) the number of students, staff and other individuals that are customarily or reasonably anticipated to be within such facility; and
(2) the physical layout of the facility, including but not limited to:
(i) location of stairways and elevators;
(ii) number of floors in the facility;
(iii) location of classrooms and other areas of the facility where large congregations of individuals may occur; and
(iv) any other unique design features of the facility.
(c) The school district, board of cooperative educational services, county vocational education and extension board, charter school, or non-public elementary and secondary school shall file a copy of the collaborative agreement with the appropriate Regional Council. Trained school personnel shall not administer an epinephrine auto-injector in accordance with Public Health Law 3000-c prior to the filing of the collaborative agreement with the Regional Council.
(d) In the event of an emergency, trained school personnel may administer an epinephrine auto-injector to any student or school personnel having symptoms of anaphylaxis in an instructional school facility, whether or not there is a previous history of severe allergic reaction pursuant to Public Health Law section 3000-c.
(e) Every use of an epinephrine auto-injector device pursuant to this section and Public Health Law section 3000-c shall immediately be reported to the emergency health care provider.
This notice is intended
to serve only as a notice of emergency adoption. This agency intends to adopt the provisions of this emergency rule as a permanent rule, having previously submitted to the Department of State a notice of proposed rule making, I.D. No. EDU-01-15-00011-P, Issue of January 7, 2015. The emergency rule will expire May 10, 2015.
Text of rule and any required statements and analyses may be obtained from:
Kirti Goswami, State Education Department, Office of Counsel, State Education Building, Room 148, 89 Washington Ave., Albany, NY 12234, (518) 474-6400, email: [email protected]
Regulatory Impact Statement
1. STATUTORY AUTHORITY:
Education Law section 207 empowers the Board of Regents and the Commissioner of Education to adopt rules and regulations to carry out the laws of the State regarding education and the functions and duties conferred on the State Education Department by law.
Education Law section 305(1) and (2) provide the Commissioner, as chief executive officer of the State's education system, with general supervision over all schools and institutions subject to the Education Law, or any statute relating to education, and responsibility for executing all educational policies of the Regents.
Chapter 424 of the Laws of 2014 added a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, boards of cooperative educational services (BOCES), county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in the State to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. Section 921 also provides that school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state or any person employed by any such entity may administer epinephrine auto-injectors in the event of an emergency pursuant to the requirements of section three-thousand-c of the Public Health Law.
2. LEGISLATIVE OBJECTIVES:
The proposed rule is necessary to implement Education Law section 921, as added by Chapter 242 of the Laws of 2014, by prescribing standards for the provision, maintenance, and administration of epinephrine auto-injectors in the event of an emergency.
3. NEEDS AND BENEFITS:
Chapter 424 of the Laws of 2014 added a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. The proposed rule prescribes standards for the maintenance and use of epinephrine auto-injectors pursuant to Education Law section 921, so as to ensure their ready and appropriate use in the emergency event of a student or staff having anaphylactic symptoms on site at an instructional school facility.
4. COSTS:
(a) Costs to State government: The proposed rule will not impose any additional costs on State government, including the State Education Department.
(b) Costs to local governments and private regulated parties: The amendment will not impose any additional costs on local governments or private regulated parties. Chapter 424 of the Laws of 2014 Chapter 424 of the Laws of 2014 added a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in the State to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. The proposed rule is necessary to implement this statute, and merely provides definitions and otherwise clarifies the circumstances regarding the emergency use of epinephrine auto-injectors. The proposed rule does not impose any additional costs on these entities beyond those imposed by the statute. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public schools may, but are not required to, provide and maintain epinephrine auto-injectors.
5. LOCAL GOVERNMENT MANDATES:
The proposed rule does not impose any mandatory program, service, duty, or responsibility upon local government, including school districts or BOCES. It merely provides definitions and otherwise clarifies the circumstances regarding the use of epinephrine auto-injectors on-site in an instructional school facility in an emergency situation pursuant to Education Law section 921, as added by Chapter 424 of the Laws of 2014. The proposed rule restates the statutory authority which allows school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public schools may, but are not required to, provide and maintain epinephrine auto-injectors.
In determining the quantity and placement of epinephrine auto-injectors in collaboration with the emergency health care provider, consideration shall be given to:
(1) the number of students, staff and other individuals that are customarily or reasonably anticipated to be within such facility; and
(2) the physical layout of the facility, including but not limited to:
(i) location of stairways and elevators;
(ii) number of floors in the facility;
(iii) location of classrooms and other areas of the facility where large congregations of individuals may occur; and
(iv) any other unique design features of the facility.
6. PAPERWORK:
Pursuant to the requirements of Public Health Law section 3000-c, any emergency administration of an epinephrine auto-injector must be reported to the physician or hospital representative listed in the collaborative agreement. The school district, BOCES, county vocational education and extension board, charter school, or non-public elementary and secondary school shall file a copy of the collaborative agreement with the appropriate Regional Council.
7. DUPLICATION:
The amendment does not duplicate any existing State or Federal requirements, and is necessary to implement Education Law section 921, as added by Chapter 424 of the Laws of 2014.
8. ALTERNATIVES:
The proposed rule is necessary to implement Education Law 921, as added by Chapter 424 of the Laws of 2014. There were no significant alternatives and none were considered.
9. FEDERAL STANDARDS:
There are no applicable Federal standards.
10. COMPLIANCE SCHEDULE:
It is anticipated that regulated parties can achieve compliance with the proposed rule by its effective date. The proposed rule merely provides definitions and otherwise clarifies the circumstances regarding the use of epinephrine auto-injectors on-site in an instructional school facility in an emergency situation pursuant to Education Law section 921, as added by Chapter 424 of the Laws of 2014. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public schools may, but are not required to, provide and maintain epinephrine auto-injectors.
Regulatory Flexibility Analysis
(a) Small businesses:
The proposed rule applies to school districts, boards of cooperative educational services (BOCES), county vocational education and extension boards, charter schools, and non-public elementary and secondary schools, and relates to the availability and use of epinephrine auto-injectors in the event of an anaphylactic emergency. The proposed rule does not impose any economic impact, or other compliance requirements on small businesses. Because it is evident from the nature of the proposed rule that it does not affect small businesses, no further measures were needed to ascertain that fact and none were taken. Accordingly, a regulatory flexibility analysis for small businesses is not required and one has not been prepared.
(b) Local governments:
The proposed rule applies to school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools, and relates to the availability and use of epinephrine auto-injectors in the event of an anaphylactic emergency.
1. EFFECT OF RULE:
The rule applies to school personnel in each of the 695 school districts, 37 BOCES, 248 charter schools, and one existing county vocational education and extension board in the State.
2. COMPLIANCE REQUIREMENTS:
The proposed rule does not impose any additional compliance requirements upon local governments. It merely provides definitions and otherwise clarifies the circumstances regarding the use of epinephrine auto-injectors on-site in an instructional school facility in an emergency situation pursuant to Education Law section 921, as added by Chapter 424 of the Laws of 2014. The proposed rule restates the statutory authority which allows school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public schools may, but are not required to, provide and maintain epinephrine auto-injectors.
In determining the quantity and placement of epinephrine auto-injectors in collaboration with the emergency health care provider, consideration shall be given to:
(1) the number of students, staff and other individuals that are customarily or reasonably anticipated to be within such facility; and
(2) the physical layout of the facility, including but not limited to:
(i) location of stairways and elevators;
(ii) number of floors in the facility;
(iii) location of classrooms and other areas of the facility where large congregations of individuals may occur; and
(iv) any other unique design features of the facility.
Pursuant to the requirements of Public Health Law section 3000-c, any emergency administration of an epinephrine auto-injector must be reported to the physician or hospital representative listed in the collaborative agreement. The school district, BOCES, county vocational education and extension board, charter school, or non-public elementary and secondary school shall file a copy of the collaborative agreement with the appropriate Regional Council.
3. PROFESSIONAL SERVICES:
The proposed rule does not impose any additional professional services requirements on local governments.
4. COMPLIANCE COSTS:
The proposed rule does not impose any additional compliance costs on local governments. Chapter 424 of the Laws of 2014 Chapter 424 of the Laws of 2014 added a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, boards of cooperative educational services, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. The proposed rule is necessary to implement this statute, and merely provides definitions and otherwise clarifies the circumstances regarding the emergency use of epinephrine auto-injectors. The proposed rule does not impose any additional costs on these entities beyond those imposed by the statute. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public school may, but are not required to, provide and maintain epinephrine auto-injectors.
5. ECONOMIC AND TECHNOLOGICAL FEASIBILITY:
The proposed rule does not impose any additional costs or technological requirements on local governments.
6. MINIMIZING ADVERSE IMPACT:
The proposed rule does not impose any additional compliance requirements or costs on local government. Chapter 424 of the Laws of 2014 Chapter 424 of the Laws of 2014 added a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, boards of cooperative educational services, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. The proposed rule is necessary to implement this statute, and merely provides definitions and otherwise clarifies the circumstances regarding the emergency use of epinephrine auto-injectors. The proposed rule does not impose any additional compliance requirements or costs on these entities beyond those imposed by the statute. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public schools may, but are not required to, provide and maintain epinephrine auto-injectors.
7. LOCAL GOVERNMENT PARTICIPATION:
Comments on the proposed rule were solicited from school districts through the offices of the district superintendents of each supervisory district in the State, from the chief school officers of the five big city school districts and from charter schools.
8. INITIAL REVIEW OF RULE (SAPA § 207):
Pursuant to State Administrative Procedure Act section 207(1)(b), the State Education Department proposes that the initial review of this rule shall occur in the fifth calendar year after the year in which the rule is adopted, instead of in the third calendar year. The justification for a five year review period is that the proposed rule is necessary to implement the statutory requirements of Chapter 424 of the Laws of 2014, and, therefore, the substantive provisions of the proposed rule cannot be repealed or modified unless there is a further statutory change. Accordingly, there is no need for a shorter review period. The Department invites public comment on the proposed five year review period for this rule. Comments should be sent to the agency contact listed in item 10 of the Notice of Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.
Rural Area Flexibility Analysis
1. TYPES AND ESTIMATED NUMBER OF RURAL AREAS:
The proposed rule applies to school districts, boards of cooperative educational services (BOCES), county vocational education and extension boards, charter schools, and non-public elementary and secondary schools, including those located in the 44 rural counties with fewer than 200,000 inhabitants and the 71 towns and urban counties with a population density of 150 square miles or less.
2. REPORTING, RECORDKEEPING, AND OTHER COMPLIANCE REQUIREMENTS; AND PROFESSIONAL SERVICES:
The proposed rule does not impose any additional reporting, recordkeeping or other compliance requirements. It merely provides definitions and otherwise clarifies the circumstances regarding the use of epinephrine auto-injectors on-site in an instructional school facility in an emergency situation pursuant to Education Law section 921, as added by Chapter 424 of the Laws of 2014. The proposed rule restates the statutory authority which allows school districts, BOCES, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public schools may, but are not required to, provide and maintain epinephrine auto-injectors.
In determining the quantity and placement of epinephrine auto-injectors in collaboration with the emergency health care provider, consideration shall be given to:
(1) the number of students, staff and other individuals that are customarily or reasonably anticipated to be within such facility; and
(2) the physical layout of the facility, including but not limited to:
(i) location of stairways and elevators;
(ii) number of floors in the facility;
(iii) location of classrooms and other areas of the facility where large congregations of individuals may occur; and
(iv) any other unique design features of the facility.
Pursuant to the requirements of Public Health Law section 3000-c, any emergency administration of an epinephrine auto-injector must be reported to the physician or hospital representative listed in the collaborative agreement. The school district, BOCES, county vocational education and extension board, charter school, or non-public elementary and secondary school shall file a copy of the collaborative agreement with the appropriate Regional Council.
The proposed rule does not require any additional professional services upon entities in rural areas.
3. COSTS:
The proposed rule does not impose any additional compliance costs on local governments. Chapter 424 of the Laws of 2014 Chapter 424 of the Laws of 2014 added a new section 921 of the Education Law, effective February 27, 2015, to allow school districts, boards of cooperative educational services, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. The proposed rule is necessary to implement this statute, and merely provides definitions and otherwise clarifies the circumstances regarding the emergency use of epinephrine auto-injectors. The proposed rule does not impose any additional costs on these entities beyond those imposed by the statute. Consistent with the statute, school districts, BOCES, county vocational education and extension boards, charter schools, and non-public school may, but are not required to, provide and maintain epinephrine auto-injectors.
4. MINIMIZING ADVERSE IMPACT:
The proposed rule is necessary to implement Chapter 424 of the Laws of 2014. The statutory requirements do not make exceptions for entities located in rural areas. Because the statutory requirements upon which the proposed rule is based applies throughout the State, it is not possible to establish differing compliance or reporting requirements or timetables or to exempt entities in rural areas from the provisions of the proposed rule. The State Education Department does not believe that making a change for school personnel who live or work in rural areas is warranted because uniform standards are necessary across the State to ensure the health and safety of student and school personnel.
5. RURAL AREA PARTICIPATION:
The State Education Department has sent the proposed rule to the Rural Advisory Committee, which has members who live or work in rural areas across the State.
6. INITIAL REVIEW OF RULE (SAPA § 207):
Pursuant to State Administrative Procedure Act section 207(1)(b), the State Education Department proposes that the initial review of this rule shall occur in the fifth calendar year after the year in which the rule is adopted, instead of in the third calendar year. The justification for a five year review period is that the proposed rule is necessary to implement the statutory requirements of Chapter 424 of the Laws of 2014, and, therefore, the substantive provisions of the proposed rule cannot be repealed or modified unless there is a further statutory change. Accordingly, there is no need for a shorter review period. The Department invites public comment on the proposed five year review period for this rule. Comments should be sent to the agency contact listed in item 10 of the Notice of Proposed Rule Making published herewith, and must be received within 45 days of the State Register publication date of the Notice.
Job Impact Statement
The proposed rule is necessary to implement Education Law section 921, as added by Chapter 424 of the Laws of 2014, which allows school districts, boards of cooperative educational services, county vocational education and extension boards, charter schools, and non-public elementary and secondary schools in this state to provide and maintain on-site in each instructional school facility epinephrine auto-injectors in quantities and types deemed by the Commissioner, in consultation with the Commissioner of Health, to be adequate to ensure ready and appropriate access for use during emergencies to any student or staff having anaphylactic symptoms whether or not there is a previous history of severe allergic reaction. The proposed rule is necessary to implement this statute, and merely provides definitions and otherwise clarifies the circumstances regarding the maintenance and emergency use of epinephrine auto-injectors. Because it is evident from the nature of the proposed rule that it will have no impact on the number of jobs or employment opportunities in New York State, no further steps were needed to ascertain that fact and none were taken. Accordingly, a job impact statement is not required and one has not been prepared.
End of Document