Title of Regulation: 8VAC20-671. Regulations Governing the Operation of Private Schools for Students with Disabilities (amending 8VAC20-671-710).

Statutory Authority: § 62.1-44.15 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: September 20, 2017.

Effective Date: October 5, 2017.

Agency Contact: John Eisenberg, Special Education and Student Services, Department of Education, 101 North 14th Street, Richmond, VA 23219, telephone (804) 786-8079, or email john.eisenberg@doe.virginia.gov.

Basis: Chapter 387 of the 2015 Acts of Assembly amends §§ 8.01-225, 54.1-3408, and 22.1-321.1 of the Code of Virginia, relating to the possession and administration of epinephrine in private schools for students with disabilities. Specifically, § 22.1-321.1 requires that the Board of Education promulgate regulations for the possession and administration of epinephrine in every school for students with disabilities, to be administered by any employee of the school who is authorized by a prescriber and trained in the administration of epinephrine to any student believed to be having an anaphylactic reaction.

Purpose: The amendments to 8VAC20-671-710 conform the regulations to the provisions of Chapter 387 of the 2015 Acts of Assembly. Without amending 8VAC20-671-710 to include requirements related to the possession and use of epinephrine, students who are believed to be having an anaphylactic reaction could be put at significant risk of a serious medical condition or potentially death. The amended regulation will provide the administrators of private schools for students with disabilities with much needed and requested provisions related to the possession and use of epinephrine.

Rationale for Using Fast-Track Rulemaking Process: Use of the fast-track rulemaking process for the amendments to 8VAC20-671-710 is appropriate because (i) the Board of Education does not foresee a significant human resource or fiscal impact on the private school facilities; (ii) there is no fiscal impact on the Commonwealth; and (iii) these amendments are long awaited by the private school community and its accrediting agencies, primarily the Virginia Council for Private Education and the Virginia Association of Independent Specialized Education Facilities.

Substance: The amendments to 8VAC20-671-710 address the requirements for procurement, storage, and use of epinephrine and also address the training requirements for staff and the required reporting activities when epinephrine is administered to a student enrolled in a private school licensed by the Virginia Department of Education.

Issues: An advantage for the public is that parents of children who are enrolled in such private schools will have access to the required expectations when a child experiences an anaphylactic episode at school or during a school sponsored activity off of school grounds and how care will be provided by trained personnel in accordance with established guidelines and protocols. An advantage for the Virginia Department of Education and the Commonwealth of Virginia is that there will be a defined protocol for monitoring and enforcing what were already established in guidelines but are now incorporated by reference into law. There are no foreseen disadvantages to the public or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 387 of the 2015 Acts of Assembly, the Board of Education (Board) proposes to establish requirements for the possession and administration of epinephrine in private schools for students with disabilities. Epinephrine is used to treat persons believed to be having an anaphylactic reaction.

Result of Analysis. The benefits likely exceed the costs.

Estimated Economic Impact. Anaphylaxis is a severe, potentially life-threatening allergic reaction. It can occur within seconds or minutes of exposure to something you're allergic to, such as peanuts or bee stings. Anaphylaxis causes your immune system to release a flood of chemicals that can cause you to go into shock — your blood pressure drops suddenly and your airways narrow, blocking breathing. Signs and symptoms include a rapid, weak pulse; a skin rash; and nausea and vomiting. Common triggers include certain foods, some medications, insect venom and latex. Anaphylaxis requires an injection of epinephrine. If anaphylaxis isn't treated right away with epinephrine, it can be fatal.¹

The Board proposes to require that each school has: 1) on campus at least two auto-injectable epinephrine units for both dosage sizes, 0.3 mg (for students weighing more than 66 pounds) and 0.15 mg (for students who weigh 33 to 66 pounds), 2) a written policy consistent with the Department of Education's (DOE) Guidelines for Recognition and Treatment of Anaphylaxis in the School Setting for its procedures to address students with severe allergies who may be at risk of an anaphylactic reaction necessitating the use of an epinephrine auto-injector, 3) for students with known life threatening allergies, "student specific" written instructions from the student's health care provider for handling anaphylaxis and all necessary medications, and 4) a standing order (from an authorized medical provider) to prescribe "non-student specific" epinephrine for students within the school who do not presently have a health care plan addressing the administration of epinephrine. Additionally, the Board proposes to specify documentation and storage requirements, as well as procedures once epinephrine is administered. Finally, the Board proposes to require that at least two school employees in addition to the school nurse are trained in the administration of epinephrine by auto-injector.

As of May 10, 2017, generic auto-injectable epinephrine units were listed at a cost of $109.99 for a two-pack on CVS's website.² Thus requiring that each school has at least two auto-injectable epinephrine units for both dosage sizes would cost about $220. The auto-injectable epinephrine units are expected to last at least 12 months before expiry.³ Thereafter, the replacement costs for used and expired auto-injectors is projected to be at about the same rate. DOE's Guidelines for Recognition and Treatment of Anaphylaxis in the School Setting provides the information needed for schools to produce a written policy related to its procedures to address students with severe allergies who may be at risk of an anaphylactic reaction necessitating the use of an epinephrine auto-injector. The annual administrative costs for recordkeeping and other administrative costs required for compliance is projected at $240 (1hr per month at $20 per hour).⁴ Thus most years, obtaining and maintaining the required auto-injectable epinephrine units and the associated procedures would likely cost less than $500.

Given the not insignificant chance that the presence of auto-injectable epinephrine and staff who know how to properly administer it could save the life of a child at the school, the benefits of the proposed amendments likely exceed the costs (less than $500 annually most years).

Businesses and Entities Affected. The proposed amendments affect the 136 licensed private schools for students with disabilities in the Commonwealth.⁵ Most would likely qualify as small businesses.

Localities Particularly Affected. The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect employment.

Effects on the Use and Value of Private Property. The proposed amendments are unlikely to significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments increase costs for small private schools for students with disabilities.

Alternative Method that Minimizes Adverse Impact. There is no apparent alternative that would reduce costs while meeting the intended policy goal of increasing the likelihood that children at private schools for students with disabilities who go into anaphylactic shock survive.

Adverse Impacts:

Businesses. The proposed amendments increase costs for private schools for students with disabilities.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

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¹ Source: Mayo Clinic http://www.mayoclinic.org/diseases-conditions/anaphylaxis/home/ovc-20307210

² See https://www.cvs.com/content/epipen-alternative

³ See http://www.epipen.ca/en/about-epipen/frequently-asked-questions

⁴ Source: Department of Education

⁵ Ibid

Agency's Response to Economic Impact Analysis: The agency concurs with the economic impact analysis completed by the Department of Planning and Budget.

Summary:

Pursuant to Chapter 387 of the 2015 Acts of Assembly, the amendments establish requirements for the possession and administration of epinephrine in private schools for students with disabilities.

8VAC20-671-710. Medication and health.

A. Each student shall have on file evidence of a comprehensive physical examination prescribed by the State Health Commissioner from a qualified licensed (i) physician, (ii) nurse practitioner, or (iii) physician assistant acting under the supervision of a licensed physician. The examination must contain, at a minimum, information required on the Commonwealth of Virginia School Entrance Health Form.

B. Each student shall have an up-to-date certificate of immunization.

C. Any student or staff with a medical condition that is contagious or infectious shall take leave from school while in that condition unless attendance is approved by a qualified health care provider. Conditions meeting this requirement must be provided in the parent/student handbook or other print materials.

D. A first aid kit shall be maintained and readily accessible for minor injuries and medical emergencies in each building used for instruction or other school activity.

E. Each private school for students with disabilities shall develop a written policy related to its procedures to address students with severe allergies who may be at risk of an anaphylactic reaction necessitating the use of an epinephrine auto-injector. The policy shall address, but is not limited to (i) an overview of anaphylaxis and its symptoms; (ii) staff training in the possession and administration of epinephrine auto-injectors; (iii) standing orders; (iv) responding to anaphylaxis; (v) post administration of epinephrine actions; and (vi) storage, access, and maintenance. School administrators shall ensure that the school's policy is consistent with the Recognition and Treatment of Anaphylaxis in the School Setting guidelines dated June 28, 2012 that are published on the Virginia Department of Education's website.

F. Each private school for students with disabilities shall ensure that it has at least two auto-injectable epinephrine units in both dosage sizes, 0.3 mg for a student who weighs more than 66 pounds and 0.15 mg for a student who weighs 33 to 66 pounds, on school premises, to be administered by any employee of a school for students with disabilities licensed by the Board of Education who is authorized by a prescriber and trained in the administration of epinephrine to any student believed to be having an anaphylactic reaction. Stock epinephrine is intended for use on school premises and should not be carried offsite. Additional epinephrine should be made available along with arrangements for administration during field trips and other official offsite school activities.

E. G. Procurement and acceptance of medication.

1. All medications shall be accepted only in the original container with written permission signed and dated by the parent to administer to the child.

2. The use of all prescriptive medication must be authorized in writing by a licensed prescriber.

3. For students enrolled in private schools for students with disabilities with known life threatening allergies or anaphylaxis the school administrator shall obtain on an annual basis, through the student's parent or legal guardian, "student specific" written instructions from the student's health care provider for handling anaphylaxis and all necessary medications for implementing the student specific order.

4. The private school for students with disabilities administrator shall designate an authorized medical provider with prescriptive authority, such as a medical doctor, doctor of osteopathy, physician assistant, or nurse practitioner, and obtain a standing order to prescribe "non-student specific" epinephrine for students within the school who do not presently have a health care plan addressing the administration of epinephrine, to be administered to any student believed to be having an anaphylactic reaction.

5. School administrators shall coordinate with, among other resources as they deem appropriate, placing school divisions, local health department directors, local practitioners, and the Virginia Chapter of the American Academy of Pediatrics to assist them in obtaining the required standing orders for treatment of anaphylaxis and prescriptions to order auto-injectable epinephrine.

6. Standing orders and prescriptions shall be renewed annually and with any change in prescriber.

H. The expiration date of epinephrine solutions shall be checked periodically but not less than monthly. The auto-injector unit should be replaced if it is approaching its expiration date. The contents should be inspected through the clear window of the auto-injector. The solution should be clear; if it is discolored or contains solid particles, discard and replace the unit. Used, expired, or epinephrine auto-injectors with discolored solution or solid particles shall not be used and shall be discarded in a sharps container. The school shall maintain a sufficient number of extra doses of epinephrine for replacement of used or expired school stock on the day it is used or discarded. Each school shall maintain documentation that its stock of epinephrine has been checked on a monthly basis to ensure proper storage, review of expiration dates, medication stability, and replacement upon use or disposal under the criteria in this subsection.

F. I. All medication and medical paraphernalia, with the exception of epinephrine auto-injectors, shall be properly labeled and securely locked or stored in accordance with the Virginia School Health Guidelines. Epinephrine auto-injectors must be stored in a safe, unlocked, and accessible location in a dark place at room temperature (between 59°F - 86°F). Epinephrine cannot be stored in a refrigerator. Although epinephrine should not be maintained in a locked cabinet or behind locked doors, precautions must be in place to ensure that the epinephrine auto-injectors are not readily available to student access. The location of the epinephrine must be clearly marked at the storage location, and staff must be made aware of the storage location in each school.

G. J. An individual medication administration record shall be maintained for each medication a student receives and shall include student name, date the medication is to begin, drug name, schedule for administration, strength, route, identification of the individual who administered the medication, and dates the medication was discontinued or changed.

K. Once epinephrine is administered, local Emergency Medical Services (911) shall be activated and the student transported to the emergency room for follow-up care. In some reactions, the symptoms go away, only to return one to three hours later. This is called a "biphasic reaction." Often these second-phase symptoms occur in the respiratory tract and may be more severe than the first-phase symptoms. Therefore, follow-up care with a health care provider is necessary. The student will not be allowed to remain at school or return to school on the day epinephrine is administered. The administration of epinephrine shall be treated as a serious incident and shall be reported to the parent or legal guardian immediately using all means of contact provided by the parent (i.e., home, cell, or work telephone number, email, or text message), but no later than the end of the school day. The school administrator shall ensure that an appropriate serious incident form is completed by the end of the day on which the administration of epinephrine occurred. The incident report shall include the following information: (i) the date and time the incident occurred; (ii) the name of the staff who administered the epinephrine; (iii) a record of the attempts made (including date, time, and mode of communication, and name of employee making the attempt) to notify the parent of the use of epinephrine; (iv) summary of contact with parent; and (v) the name of the person who completed the incident report. The school administrator shall provide a copy of the incident report via email or facsimile to the department within 24 hours of completing the report.

H. L. The provider shall develop and implement written policies and procedures regarding:

1. Managing medication errors to include the following: administering first aid; contacting the poison control center; notifying the prescribing physician; taking action as directed; documenting the incident; reviewing medication errors and staff responses; and reporting errors to the parent and placing agency;

2. Handling adverse drug reactions;

3. Revising procedures as events may warrant;

4. Disposing of medication and medical supplies such as needles, syringes, lancets, etc.;

5. Storing of controlled substances;

6. Distributing medication off campus; and

7. Documenting medication refusal.

I. M. The telephone number of a regional poison control center and other emergency numbers shall be posted on or near the phone.

J. N. Medication training.

1. All staff responsible for medication administration shall have successfully completed medication training, including refresher training, in a program approved by the Board of Nursing or be licensed by the Commonwealth of Virginia to administer medication before they can administer medication.

2. The school administrator shall identify an appropriate number of staff, but not less than two employees, in addition to the school nurse, as appropriate, to be trained in the administration of epinephrine by auto-injector. Only trained personnel shall administer epinephrine to a student believed to be having an anaphylactic reaction. Training shall be conducted in accordance with the most current edition of the Virginia Department of Education's Manual for Training Public School Employees in the Administration of Medication or other approved training programs, such as, Medication Administration Training for Youth or Medication Administration Training. Training shall be conducted as often as needed to ensure adequate staff are trained, but not less than annually.

3. Training shall be provided to staff in medication procedures and effects and infection control measures, including the use of standard precautions.

3. 4. Staff certified in first aid and CPR shall be available at all times on the school grounds and during any school-sponsored activity.

4. 5. Documentation of medication training must be maintained in personnel files.

5. 6. Staff authorized to administer medication shall be informed of any known side effects of the medication and the symptoms of the effects.

K. O. Monitoring the supply of medications.

1. Upon receiving any medication, staff members handling medication shall count individual tablets and measure the level of liquid medicine in the presence of the parent(s) parent or another staff member and record the count on the medication log.

2. The medication log shall include the signature or initials of the staff member who counted the medication and the parent or staff who witnessed the occurrence. When initials are used, the medication administration record must contain the full name of the staff with corresponding initials for identification purposes.

3. Students shall be prohibited from transporting medication unless directed otherwise by the student's health care plan.

P. The requirements outlined in subsections F and K of this section related to the possession and administration of epinephrine extend to activities off the school premises. Therefore, school policies shall include specific protocols for responding to anaphylaxis in the school setting, both onsite and at offsite school events, such as field trips.

Q. In accordance with § 8.01-225 A 13 of the Code of Virginia, any person who is an employee of a school for students with disabilities, as defined in § 22.1-319 of the Code of Virginia and licensed by the Board of Education, who is authorized by a prescriber and trained in the administration of epinephrine and who administers or assists in the administration of epinephrine to a student believed in good faith to be having an anaphylactic reaction, or is the prescriber of the epinephrine, shall not be liable for any civil damages for ordinary negligence in acts or omission resulting from rendering of such treatment. Whenever any employee is covered by the immunity granted in § 8.01-225 A 13 of the Code of Virginia, the school shall not be liable for any civil damages for ordinary negligence in acts or omission resulting from such administration or assistance.

DOCUMENTS INCORPORATED BY REFERENCE (8VAC20-671)

Virginia School Health Guidelines - General Guidelines for Administering Medication in School (pages 253-256), May 1999, Virginia Department of Health

Dietary Guidelines for Americans 2010, 7th Edition, December 2010, U.S. Department of Agriculture and U.S. Department of Health and Human Services, Washington, D.C.: U.S. Government Printing Office, www.dietary guidelines.gov

Virginia School Health Guidelines - Recognition and Treatment of Anaphylaxis in the School Setting, dated June 28, 2012, Virginia Department of Health