ARC 2311C
EDUCATION DEPARTMENT[281]
Adopted and Filed
Pursuant to the authority of Iowa Code section 256.7(5) and 2015 Iowa Acts, Senate File 462, the Department of Education hereby adopts new Chapter 14, “School Health Services,” Iowa Administrative Code.
The 86th General Assembly, in 2015 Iowa Acts, Senate File 462, established that school districts and accredited nonpublic schools may stock an epinephrine auto-injector supply and directed the Department of Education to adopt rules necessary for schools to voluntarily implement the Act. This new chapter includes rules for the implementation of 2015 Iowa Acts, Senate File 462.
An agencywide waiver provision is provided in 281—Chapter 4.
Notice of Intended Action was published in the October 14, 2015, Iowa Administrative Bulletin as ARC 2183C. Public comments were allowed until 4:30 p.m.	on November 3, 2015. A public hearing was held on that date. Three people were in attendance, and two provided public comments at the hearing. One person provided written comments prior to the hearing.
Of the comments received, one comment asserted that the definition of “school building” was too broad. As a result of the comment, the Department made a change to this definition to clarify that a school building is an attendance center within a school district or an accredited nonpublic school in which students or other individuals are present, as provided for in 2015 Iowa Acts, Senate File 462.
There were comments regarding the requirement of having both one adult dose and one pediatric dose in each school building; some were in favor and some were against. This requirement ensures equitable access for all students and other individuals regardless of size, weight, or age and ensures that the proper dosing is available.
There were also comments regarding the Department’s authority to implement the rules as written. The statute provides broad statutory authority to the Department to write rules in this area with the collaboration of the Board of Pharmacy, the Board of Nursing, the Board of Medicine, the Iowa Department of Public Health, and the Iowa School Nurse Organization, all of which provided feedback on these rules.
After analysis and review of this rule making, no impact on jobs has been found.
These rules are intended to implement 2015 Iowa Acts, Senate File 462.
These rules will become effective January 13, 2016.
The following amendment is adopted.
	Adopt the following new 281—Chapter 14:
CHAPTER 14
SCHOOL HEALTH SERVICES
281—14.1 and 14.2  Reserved.
281—14.3(256) School district and accredited nonpublic school stock epinephrine auto-injector voluntary supply.
	14.3(1) Definitions. For the purpose of this rule, the following definitions apply:
“Act” means 2015 Iowa Acts, Senate File 462, which amends Iowa Code section 280.16 and creates Iowa Code section 280.16A.
“Department” means the department of education.
“Epinephrine auto-injector” means a disposable drug delivery device that has a spring-activated concealed needle and is designed for immediate self-administration or administration by another trained individual of a measured dose of epinephrine to a student or individual at risk of anaphylaxis.
“Licensed health care professional” means a person who has prescriptive authority and is licensed under Iowa Code chapter 148 to practice medicine and surgery, an advanced nurse practitioner licensed pursuant to Iowa Code chapter 152, or a physician assistant licensed to practice under the supervision of a physician as authorized in Iowa Code chapters 147 and 148C.
“Medication administration course” means a course approved or provided by the department that includes safe storage of medication, handling of medication, general principles, procedural aspects, skills demonstration and documentation requirements of safe medication administration in schools.
“Medication error” means the failure to administer an epinephrine auto-injector to a student or individual by proper route, failure to administer the correct dosage, or failure to administer an epinephrine auto-injector according to generally accepted standards of practice.
“Medication incident” means accidental injection of an epinephrine auto-injector into a digit of the authorized personnel administering the medication.
“Personnel authorized to administer epinephrine” means a school employee who has successfully completed the medication administration course requirements and who completes an annual anaphylaxis training program approved by the department and conducted by the school nurse, including a return-skills demonstration on the use of an epinephrine auto-injector.
“School building” means each attendance center within a school district or accredited nonpublic school where students or other individuals are present.
“School nurse” means a registered nurse holding current licensure recognized by the Iowa board of nursing who practices in the school setting to promote and protect the health of the school population by using knowledge from the nursing, social, and public health sciences.
	14.3(2) Applicability. This rule applies to and permits:
	a. 	A licensed health care professional to prescribe a stock epinephrine auto-injector in the name of a school district or accredited nonpublic school for use in accordance with the Act and this rule,
	b. 	A pharmacist to dispense epinephrine auto-injectors pursuant to a prescription issued in the name of a school district or accredited nonpublic school, and
	c. 	A school district or accredited nonpublic school to acquire and maintain a stock supply of epinephrine auto-injectors pursuant to a prescription issued in accordance with the Act.
	14.3(3) Prescription for stock epinephrine auto-injector. A school district or accredited nonpublic school may obtain a prescription for epinephrine auto-injectors from a licensed health care professional annually in the name of the school district or accredited nonpublic school for administration to a student or individual who may be experiencing an anaphylactic reaction. The school district or accredited nonpublic school shall maintain the supply of such auto-injectors in a secure, dark, temperature-controlled location in each school building. If a school district or accredited nonpublic school obtains a prescription pursuant to the Act and these rules, the school district or accredited nonpublic school shall stock a minimum of one pediatric dose and one adult dose epinephrine auto-injector for each school building. A school district or accredited nonpublic school may obtain a prescription for more than the minimum and may maintain a supply in other buildings.
	14.3(4) Authorized personnel and stock epinephrine auto-injector administration. A school nurse or personnel trained and authorized may provide or administer an epinephrine auto-injector from a school supply to a student or individual if the authorized personnel or school nurse reasonably and in good faith believes the student or individual is having an anaphylactic reaction.
	a. 	The following persons, provided they have acted reasonably and in good faith, shall not be liable for any injury arising from the provision, administration, failure to administer, or assistance in the administration of an epinephrine auto-injector:
	(1)	Authorized personnel and the school nurse,
	(2)	The school district or accredited nonpublic school employing the personnel or school nurse,
	(3)	The board of directors in charge of the school district or authorities in charge of the accredited nonpublic school, and
	(4)	The prescriber of the epinephrine auto-injector.
	b. 	Pursuant to Iowa Code section 280.23, authorized personnel will submit a signed statement to the school nurse stating that the authorized personnel agree to perform the service of administering a stock epinephrine auto-injector to a student or individual who may be experiencing an anaphylactic reaction.
	c. 	Emergency medical services (911) will be contacted immediately after a stock epinephrine auto-injector is administered to a student or individual, and the school nurse or authorized personnel will remain with the student or individual until emergency medical services arrive.
	d. 	The administration of an epinephrine auto-injector in accordance with this chapter is not the practice of medicine.
	14.3(5) Stock epinephrine auto-injector training. School employees may obtain a signed certificate to become authorized personnel.
	a. 	Training to obtain a signed certificate may be accomplished by:
	(1)	Successfully completing, every five years, the medication administration course provided by the department;
	(2)	Annually demonstrating to the school nurse a procedural return-skills check on medication administration;
	(3)	Annually completing an anaphylaxis training program approved by the department;
	(4)	Demonstrating to the school nurse a procedural return-skills check on the use of an epinephrine auto-injector using information from the training, authorized prescriber instructions regarding the administration of the stock epinephrine auto-injector, and as directed by the prescription epinephrine auto-injector’s manufacturing label; and
	(5)	Providing to the school nurse a signed statement, pursuant to Iowa Code section 280.23, that the person agrees to perform the service of administering a stock epinephrine auto-injector to a student or individual who may be experiencing an anaphylactic reaction.
	b. 	Training required after a medication error or medication incident. Authorized personnel or the school nurse directly involved with a medication error or medication incident with the administration of stock epinephrine auto-injectors shall be required to follow the medication error or medication incident protocol adopted by the board of directors of the school district or authorities in charge of the school district or accredited nonpublic school. To retain authorization to administer stock epinephrine auto-injectors in the school setting, authorized personnel directly involved with a medication error or medication incident will be required to provide a procedural skills demonstration to the school nurse demonstrating competency in the administration of stock epinephrine auto-injectors.
	14.3(6) Procurement and maintenance of stock epinephrine auto-injector supply. A school district or accredited nonpublic school may obtain a prescription to stock, possess, and maintain epinephrine auto-injectors.
	a. 	Stock epinephrine auto-injectors shall be stored in a secure, easily accessible area for an emergency within the school building, or in addition to other locations as determined by the school district or accredited nonpublic school, that is dark and maintained at room temperature (between 59 to 86 degrees) or in accordance with the manufacturing label of the stock epinephrine auto-injector.
	b. 	A school district or school will designate an employee to routinely check stock epinephrine auto-injectors and document in a log monthly throughout the calendar year for:
	(1)	The expiration date;
	(2)	Any visualized particles; or
	(3)	Color change.
	c. 	The school district or school shall develop a protocol to replace as soon as reasonably possible any logged epinephrine auto-injector that is used, close to expiration, or discolored or has particles visible in the liquid.
	14.3(7) Disposal of used stock epinephrine auto-injectors. The school district or school that administers epinephrine auto-injectors shall dispose of used cartridge injectors as infectious waste pursuant to the department’s medication waste guidance.
	14.3(8) Reporting. A school district or school that obtains a prescription for stock epinephrine auto-injectors shall report each medication incident with the administration of stock epinephrine, medication error with the administration of stock epinephrine, or the administration of a stock epinephrine auto-injector to the department within 48 hours, using the reporting format approved by the department.
	14.3(9) School district or accredited nonpublic school policy. A school district or school may stock epinephrine auto-injectors. The board of directors in charge of the school district or authorities in charge of the accredited nonpublic school that stocks epinephrine auto-injectors shall establish a policy and procedure for the administration of a stock epinephrine auto-injector, which shall comply with the minimum requirements of this rule.
	14.3(10) Rule of construction. This rule shall not be construed to require school districts or accredited nonpublic schools to maintain a stock of epinephrine auto-injectors. An election not to maintain such a stock shall not be considered to be negligence.
281—14.4(256,280) Severability. If any provisions of these rules or the application thereof to any person or circumstance shall be held invalid, such invalidity shall not affect the provisions or application of these rules which can be given effect, and to this end the provisions of these rules are declared to be severable.
These rules are intended to implement 2015 Iowa Acts, Senate File 462.
[Filed 11/18/15, effective 1/13/16]
[Published 12/9/15]
Editor’s Note: For replacement pages for IAC, see IAC Supplement 12/9/15.