Specific reasons underlying the finding of necessity:
The proposed rule is necessary to implement Education Law sections 916, 916-a, 916-b, 902-a, 902-b and 921, as added and amended by Chapter 423 of the Laws of 2014. The proposed rule sets forth standards for the self-administration by students of prescribed inhaled rescue medications and epinephrine auto-injectors, and standards for allowing students to carry and self-administer prescribed insulin, carry glucagon, and carry and use equipment and supplies necessary to check blood glucose and/or ketone levels, during the school day on school property and at a school function, including requirements for the written consent of the parent or person in parental relation and written permission (also referred to as an order) and an attestation from a duly authorized health care provider providing certain specified information including the expiration date of the order, name and dose of prescribed medication, times when medication is to be self-administered, and circumstances which may warrant the use of the medication. The proposed rule is also necessary to establish standards for the training of unlicensed school personnel to administer prescribed epinephrine auto-injectors and glucagon to specific students under specified conditions, consistent with Chapter 423 of the Laws of 2014, for those school districts and BOCES that choose to provide such training.
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the proposed amendment has been substantially revised in response to public comment, as set forth in the Revised Regulatory Impact Statement submitted herewith. Since the Board of Regents meets at fixed intervals, and does not meet during the month of August, the earliest the proposed rule can be presented for regular (non-emergency) adoption, after expiration of the required 30-day public comment period provided for in State Administrative Procedure Act (SAPA) section 202(4-a), would be the September 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 October 7, 2015, the date a Notice of Adoption would be published in the State Register. However, the proposed rule is necessary to implement Education Law sections 916, 916-a, 916-b, 902-a, 902-b and 921, as added and amended by Chapter 423 of the Laws of 2014, which takes effect on July 1, 2015.
Therefore, emergency action is necessary at the June 2015 Regents meeting for the preservation of the general welfare in order to immediately adopt revisions to the proposed amendment in response to public comment, and to otherwise ensure that the proposed amendment is timely implemented pursuant to statutory requirements.
It is anticipated that the proposed rule will be presented for adoption as a permanent rule at the September 16-17, 2015 Regents meeting, which is the first scheduled meeting after expiration of the 30-day public comment period prescribed in the State Administrative Procedure Act for State agency revised rule makings.
Subject:
Self-administration of certain medications by students.
Purpose:
To establish standards for the self-administration by students of certain prescribed medications on school property and at school functions; and to establish standards for the training of unlicensed school personnel to administer prescribed epinephrine auto injectors and glucagon to specified students under specified conditions.
Substance of emergency/revised rule:
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the proposed rule has been substantially revised as set forth in the Revised Regulatory Impact Statement submitted herewith.
The following is a summary of the revised proposed rule.
Section 136.7(a) sets forth definitions of “inhaled rescue medications”, “epinephrine auto-injector”, “ketone test”, “blood glucose test”, “insulin”, “glucagon”, “duly authorized health care provider”, “cumulative health record”, “emergency action plan”, “diabetes management plan”, “school day”, “school property”, and “school function”.
Section 136.7(b) sets forth standards for the self-administration by students of prescribed inhaled rescue medications during the school day on school property or at a school function, including requirements for:
(1) written consent from the parent or person in parental relation; and
(2) written permission (also referred to as an order) and an attestation from a duly authorized health care provider of the following:
(i) that the student has a diagnosis of asthma or other respiratory disease for which inhaled rescue medications are prescribed;
(ii) that the student has demonstrated that he/she can self-administer the prescribed medication effectively; and
(iii) the expiration date of the order, name and dose of prescribed medication, times when medication is to be self-administered, and circumstances which may warrant the use of the medication.
A record of the written consents shall be maintained in the student’s cumulative health record.
Upon written request of a parent or person in parental relation, the school district or board of cooperative educational services (BOCES) shall allow the student to maintain an extra inhaled rescue medication in the care and custody of a licensed nurse, nurse practitioner, physician assistant, or physician employed by the district or BOCES.
Such medication provided by the parent or person in parental relation shall be made available to the student as needed in accordance with school policy and the written permission provided by the duly authorized health provider.
Each student who is permitted to self-administer medication should have an emergency action plan on file with the district or BOCES.
Section 136.7(c) sets forth standards for the self-administration by students of prescribed epinephrine auto-injectors during the school day on school property or at a school function, including requirements for:
(1) written consent of the parent or person in parental relation; and
(2) written permission (also referred to as an order) and an attestation from a duly authorized health care provider of the following:
(i) the student has a diagnosis of an allergy for which an epinephrine auto-injector is needed:
(ii) the student has demonstrated that he/she can self-administer the epinephrine auto-injector effectively; and
(iii) the expiration date of the order, name and dose of prescribed medication, times when medication is to be self-administered, and circumstances which may warrant the use of the medication.
A record of such written consents shall be maintained in the student’s cumulative health record.
Upon written request of a parent or person in parental relation, the school district or board of cooperative educational services (BOCES) shall allow the student to maintain an extra epinephrine auto-injector in the care and custody of a licensed nurse, nurse practitioner, physician assistant, or physician employed by the district or BOCES.
Such epinephrine auto-injector provided by the parent or person in parental relation shall be made available to the student as needed in accordance with school policy and the orders prescribed by the duly authorized health provider.
Each student who is permitted to self-administer an epinephrine auto-injector should have an emergency action plan on file with the district or BOCES.
Section 136.7(d) sets forth standards for allowing students to carry and self-administer prescribed insulin, carry glucagon, and carry and use equipment and supplies necessary to check blood glucose and/or ketone levels during the school day on school property or at a school function, including requirements for:
(1) written consent of the parent or person in parental relation; and
(2) written permission (also referred to as an order) and an attestation from a duly authorized health care provider of the following:
(i) that the student has a diagnosis of diabetes for which insulin and glucagon, and the use of equipment and supplies to check glucose and/or ketone levels are necessary;
(ii) that the student has demonstrated that he/she can self-administer the insulin effectively, can self-check glucose or ketone levels independently, and can independently follow prescribed treatment orders; and
(iii) the expiration date of the order, name of the prescribed insulin or glucagon, the type of insulin delivery system, the dose of insulin to be administered, the times when the insulin is to be self-administered, the dose of glucagon to be administered, and the circumstances which may warrant the administration of insulin or glucagon.
(iv) The written permission must also identify the prescribed blood glucose or ketone test, the times testing is to be done, and any circumstances which warrant testing.
A written diabetes management plan shall be provided. A record of the written consents shall be maintained in the student’s cumulative health record.
Upon written request of a parent or person in parental relation, the school district or board of cooperative educational services (BOCES) shall allow the student to maintain extra insulin, insulin delivery system, glucagon, blood glucose meter and related supplies in the care and custody of a licensed nurse, nurse practitioner, physician assistant, or physician employed by the district or BOCES, and shall be readily accessible to such pupil.
Such insulin, insulin delivery system, glucagon, blood glucose meter and related supplies provided by the parent or person in parental relation shall be made available to the student as needed in accordance with school policy and the orders prescribed by the duly authorized health provider.
Students with diabetes may also carry food, oral glucose, or other similar substances necessary to treat hypoglycemia pursuant to district policy, provided such policy shall not unreasonably interfere with a student’s ability to treat hypoglycemia.
A record of such written consents shall be maintained in the student’s cumulative health record.
Each student who is permitted to self-administer and self-test should have an emergency action plan on file with the district or BOCES.
Licensed nurses, nurse practitioners, physician assistants, or physicians employed by school districts or BOCES are authorized to calculate prescribed insulin dosages, administer prescribe insulin, program the prescribed insulin pump, refill the reservoir in the insulin pump, change the infusion site, inject prescribed glucagon, teach an unlicensed person to administer glucagon, and perform other authorized services within their scope of practice to students diagnosed with diabetes and who are permitted to self-administer and self-test.
Section 136.7(f)(1) establishes standards for the training of unlicensed school personnel to administer prescribed epinephrine auto-injectors to a student. Such training must be provided and documented by an authorized licensed health professional and include, but not be limited to:
(i) identification of the specific allergen(s) of the student, review of each student’s emergency action plan if available;
(ii) signs and symptoms of a severe allergic reaction warranting administration of epinephrine;
(iii) how to access emergency services per school policy;
(iv) steps for administering the prescribed epinephrine auto-injector;
(v) observation of the trainee suing an auto-injector training device;
(vi) steps for providing ongoing care while waiting for emergency services;
(vii) notification of appropriate school personnel; and
(viii) methods of safely storing, handling and disposing of auto-injectors.
Section 136.7(2) establishes standards for the training of unlicensed school personnel to administer prescribed glucagon to a student. Such training must be provided and documented by an authorized licensed health professional and include, but not be limited to:
(i) overview of diabetes and hypoglycemia per Department of Health approved webinar;
(ii) review of student’s emergency action plan if available, including treatment of mild or moderate hypoglycemia;
(iii) signs and symptoms of a severe hypoglycemia warranting administration of glucagon;
(iv) how to access emergency services per school policy;
(v) steps for mixing and administering the prescribed glucagon;
(vi) observation of the trainee using a glucagon training device;
(vii) steps for providing ongoing care while waiting for emergency services;
(viii) notification of appropriate school personnel; and
(ix) methods of safely storing, handling, and disposing of glucagon and used needles and syringes.
This notice is intended
to serve as both a notice of emergency adoption and a notice of revised rule making. The notice of proposed rule making was published in the State Register on April 8, 2015, I.D. No. EDU-14-15-00003-P. The emergency rule will expire September 27, 2015.
Emergency rule compared with proposed rule:
Substantive revisions were made in section 136.7(d)(1) and (3).
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: legal@mail.nysed.gov
Data, views or arguments may be submitted to:
Charles A. Szuberla, Jr. Acting Deputy Commissioner, State Education Department, Office of P-12 Education, State Education Building, 2M West, 89 Washington Ave., Albany, NY 12234, (518) 474-5520, email: NYSEDP12@nysed.gov
Public comment will be received until:
30 days after publication of this notice.
Revised Regulatory Impact Statement
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the proposed rule has been revised in response to public comment to make technical corrections to clarify the text, consistent with the statute, as follows:
Section 136.7(d)(1) has been amended to include the following underlined language to make technical corrections which conform to the statute:
“Each board of education or trustees of each school district and each board of cooperative educational services shall allow a student to carry and self-administer their prescribed insulin through an appropriate medication delivery device, carry glucagon…”
Section 136.7(d)(3) has been amended to include the following underlined language to make technical corrections which conform to the statute:
“(3) Upon written request of a parent or person in parental relation, the school district or board of cooperative educational service shall allow the student to maintain extra insulin, insulin delivery system, glucagon, blood glucose meter and related supplies to treat such student’s diabetes provided by the parent or person in parental relation in the care and custody of a licensed nurse, nurse practitioner, physician assistant, or physician employed by such district of board of cooperative education services, and shall be readily accessible to such pupil.”
The above revisions to the proposed rule do not require any changes to the previously published Regulatory Impact Statement.
Revised Regulatory Flexibility Analysis
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the proposed rule has been revised in response to public comment as set forth in the Statement Concerning the Regulatory Impact Statement submitted herewith.
The above revisions to the proposed rule do not require any changes to the previously published Regulatory Flexibility Analysis.
Revised Rural Area Flexibility Analysis
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the proposed rule has been revised in response to public comment as set forth in the Statement Concerning the Regulatory Impact Statement submitted herewith.
The above revisions to the proposed rule do not require any changes to the previously published Rural Area Flexibility Analysis.
Revised Job Impact Statement
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the proposed rule has been revised in response to public comment as set forth in the Statement Concerning the Regulatory Impact Statement submitted herewith.
The purpose of the proposed rule, as revised, is to establish standards for the self-administration by students of certain prescribed medications on school property and at school functions; and to establish standards for the training of unlicensed school personnel to administer prescribed epinephrine auto injectors and glucagon to specific students under specified conditions, consistent with Chapter 423 of the Laws of 2015. Because it is evident from the nature of the revised 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.
Assessment of Public Comment
Since publication of a Notice of Proposed Rule Making in the State Register on April 8, 2015, the State Education Department (SED) received the following comments:
1. COMMENT:
Revise provisions in § 136.7(b)(3)(i), (c)(3)(i), (d)(3)(i), providing a school district is not required to hire a nurse, to instead provide that: “While a school district is not required to hire a school nurse, best practice would encourage that each school has a school nurse who is licensed to administer to the medical needs of children with diabetes, life-threatening anaphylaxis, and other special health care needs."
DEPARTMENT RESPONSE:
The language in 136.7(b)(3)(i), (c)(3)(i), (d)(3)(i) reflects the language in the statute upon which the proposed rule is based [see Chapter 423 of the Laws of 2014; more specifically Education Law § § 916(1), 916-a(1), 916-b(1)]. While SED agrees that best practice would encourage each school to provide a school nurse to address the needs of students with chronic health conditions, such best practice is not specifically required by Chapter 423 to be codified in regulation, and is more appropriately left to guidance. SED may consider issuing guidance as to what is best practice.
2. COMMENT:
Support expressed for proposed rule, related to self-administration of prescribed inhaled rescue medications. Students diagnosed with asthma should have unobstructed access to their prescribed medication on school property and at school sponsored events/functions with documentation of training by the child’s medical practitioner and parental consent.
DEPARTMENT RESPONSE:
SED appreciates the support for the proposed rule. Students who meet the requirements of the law will have unobstructed access to their inhaled rescue medications during the school day, on school property, and at any school function. The parent/guardian may provide additional rescue medication to the school, and such medication shall be made available to the student as needed in accordance with the school’s policy along with the authorized health care provider’s orders.
3. COMMENT:
What if staff refuses to administer medication? Is it only going to be for students that have the medication ordered by their own doctor and not standing orders by school physician? Does this include every school activity after school hours?
DEPARTMENT RESPONSE:
Chapter 423 of the Laws of 2014, and the proposed rule which conforms to the statute, establish a framework by which school districts, BOCES and nonpublic schools are required to permit students diagnosed with asthma or other respiratory conditions, allergies, and diabetes to carry and self-administer such prescribed medications during the school day, on school property and at any school function. Students who are permitted to self-carry and use such medications must provide written consent from the parent/guardian, along with written permission of a physician or other duly authorized health care provides attesting to the student’s diagnosis, and that the student has demonstrated that he/she can self-administer the medication effectively.
In addition to the framework established for students to carry and self-administer prescribed medications under this section, Chapter 423 provides that boards of education or trustees of each school district and board of cooperative educational services (BOCES) and nonpublic schools are authorized, but not obligated, to permit licensed registered professional nurses, nurse practitioners, physician assistants, and physicians train unlicensed school personnel to inject prescribed glucagon or epinephrine auto injectors in emergency situations, where an appropriately licensed health professional is not available, to pupils who have the written permission of a physician or other duly authorized health care provider along with written parental consent. The law permits, but does not require, schools to allow unlicensed personnel to be trained to administer such medication in an emergency to students who have both written parental consent and the written order of a physician or other duly authorized health care provider for the administration of such medication during the school day, on school property and at any school function.
For purposes of clarification, it should be noted that Chapter 423 and the proposed rule relating to the administration of medication by unlicensed personnel, apply solely to those students who have the written permission of a physician or other duly authorized health care provider for the administration of injectable glucagon or emergency epinephrine auto injector, along with written parental consent.
4. COMMENT:
Does this regulation apply to school bus drivers and/or school bus attendants/monitors? That is to say, are those individuals or other school transportation officials (such as supervisors or dispatchers) included in the definition of unlicensed school personnel? If this regulation does apply to those individuals, will there be State-authorized training and preparation to ensure they carry out their responsibilities? This becomes significant since the regulation could apply to school functions which are defined to include extra-curricular events or activities regardless of their location, including out-of-state locations.
DEPARTMENT RESPONSE:
Chapter 423 of the Laws of 2014 and the proposed rule state that boards of education or trustees of each school district and BOCES and nonpublic schools are authorized, but not obligated, to permit licensed registered professional nurses, nurse practitioners, physician assistants, and physicians to train unlicensed school personnel to inject prescribed glucagon or epinephrine auto injectors in emergency situations, where an appropriately licensed health professional is not available, to pupils who have the written permission of a physician or other duly authorized health care provider. The term “unlicensed school personnel” is inclusive of all school personnel who are not licensed health professionals as defined by 8 NYCRR § 136.1(b).
5. COMMENT:
Given that insulin can only be self-administered through an appropriate medication delivery device, and consistent with the statute, revise § 136.7(d)(1) as follows: “Each board of education or trustees of each school district and each board of cooperative educational services shall allow a student to carry and self-administer their prescribed insulin through an appropriate medication delivery device, carry glucagon. . .”
DEPARTMENT RESPONSE:
The proposed rule has been revised to include the suggested language.
6. COMMENT:
In § 136.7(d)(2), please include the underlined language to simplify needed documentation: “(2) A written diabetes management plan shall be provided and may include written permissions and attestation.”
DEPARTMENT RESPONSE:
Chapter 423 of the Laws of 2014 and the proposed rule merely require that before a student is permitted to carry and self-administer such medication, such student must obtain the written permission of a physician or other duly authorized health care provider, and does not specify where a written provider’s order must be placed. The existing language requiring a written diabetes management plan does not exclude the written permissions and attestation from the diabetes management plan, therefore orders could be placed on the diabetes management plan or could be on a separate document. Accordingly, there is no need to explicitly specify this possibility in § 136.7(d)(2) of the proposed rule.
7. COMMENT:
Revise § 136.7(d)(3) as follows, to ensure a student has access to needed medications and supplies: “(3) Upon written request of a parent or person in parental relation, the school district or board of cooperative educational service shall allow the student to maintain extra insulin, insulin delivery system, glucagon, blood glucose meter and related supplies to treat such student’s diabetes provided by the parent or person in parental relation in the care and custody of a licensed nurse, nurse practitioner, physician assistant, or physician employed by such district of board of cooperative education services, and shall be readily accessible to such pupil.”
DEPARTMENT RESPONSE:
The proposed rule has been revised to include the suggested language.
8. COMMENT:
Revise § 136.7(d)(6) as follows, to clarify that this authorization is not restricted to students who self-manage: “(6) Licensed nurses, nurse practitioners, physician assistants, or physicians employed by school districts or boards of cooperative educational services are authorized to calculate prescribed insulin dosages, administer prescribed insulin, program the prescribed insulin pump, refill the reservoir in the insulin pump, change the infusion site, inject prescribed glucagon, teach an unlicensed person to administer glucagon to an individual, and perform other authorized services pursuant to the scope of practice of the licensed individual under Title VIII of the Education Law, to students diagnosed with diabetes by a physician or other duly authorized health care provider and who [are] may be permitted under this section to self-administer their prescribed insulin and carry glucagon, and carry and use equipment and supplies necessary to check blood glucose and/or ketone levels during the school day. . .”
DEPARTMENT RESPONSE:
The proposed rule specifically addresses the requirements of Education Law § 902-a, which is limited to students who have received a written provider order and parent/guardian consent to carry and use their insulin and glucagon. The intent of this section is to clarify that appropriate licensed health professionals may administer the self-managing student’s insulin or glucagon, or assist in other aspects of diabetes management if needed- inclusive of training an unlicensed person to administer the student’s glucagon.
As stated in § 136.7(e), only licensed health professionals may administer medication to a student in a school setting, except as otherwise permitted by law. Nothing in the proposed rule changes the scope of practice of certain licensed health professionals to administer medications to students. Therefore students who are unable to self-manage would still be able to have their medications administered, or have other aspects of their diabetes management performed by an appropriate licensed health professional.
9. COMMENT:
The language in § 136.7(d)(7) does not reflect the statute in that glucagon can be needed by any student with diabetes, not just students who self-manage their diabetes. Revise the rule as follows, to clarify that unlicensed personnel can administer glucagon to any child with diabetes for which there is an appropriate prescription for glucagon and related permission: “(7) The board of each school district and board of cooperative educational services and nonpublic schools are authorized, but not required to have licensed registered professional nurses, nurse practitioners, physician assistants, and physicians train unlicensed school personnel to administer prescribed glucagon in emergency situations where an appropriately licensed health care professional is not available, to pupils who have the written permission of a physician or other duly authorized health care provider for the administration of injectable glucagon, along with written parental consent, during the school day on school property and at any school function.[to students who are permitted under this section to self-administer their prescribed insulin and carry glucagon, and carry and use equipment and supplies necessary to check blood glucose and/or ketone levels during the school day.] Training by the licensed health professional is to be provided in a competent manner and in accordance with subdivision (f) of this section.”
DEPARTMENT RESPONSE:
The intent of this paragraph is to clarify that unlicensed persons trained by appropriate licensed health professionals may administer the self-administering student’s glucagon if needed. The needs of students who are not able to self-manage their diabetes are addressed in Education Law § 921, which provides that appropriate licensed health professionals may train unlicensed personnel to administer glucagon to a student with a provider order and written parent/guardian consent, where an appropriate licensed health professional is not available.
10. COMMENT:
Revise § 136.7(e) as follows, to affirm that unlicensed personnel are authorized to administer glucagon and epinephrine: “(e) In accordance with Title 1, Section 921 of the Education Law, trained unlicensed personnel may administer glucagon and epinephrine to a student in a school setting.”
DEPARTMENT RESPONSE:
The proposed rule which governs the use and self-administration of certain medications, provides that only licensed health professionals may administer certain medications to a student in a school setting, except as otherwise permitted by law and provides a list of the laws permitting exceptions, including § 921(as added by Chapter 423 of the Laws of 2014). Education Law § 921 specifically applies to any student with a provider order and written parent/guardian consent, and provides that appropriate licensed health professionals, may train unlicensed personnel to administer glucagon to a student with a provider order and written parent/guardian consent, in an emergency where an appropriate licensed health professional is not available. The proposed rule § 136.7(f)(2) specifies how appropriate licensed health professionals may train unlicensed personnel to administer glucagon to any such student.
