Title of Regulation: 18VAC90-21. Medication Administration Training and Immunization Protocol (amending 18VAC90-21-30).

Statutory Authority: §§ 54.1-2400 and 54.1-3005 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: December 3, 2014.

Effective Date: December 18, 2014.

Agency Contact: Jay P. Douglas, R.N., Executive Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4515, FAX (804) 527-4455, or email jay.douglas@dhp.virginia.gov.

Basis: Section 54.1-2400 of the Code of Virginia establishes the general powers and duties of health regulatory boards including the responsibility to promulgate regulations.

The second enactment clause of Chapter 183 of the 2013 Acts of the Assembly mandates that the Board of Nursing promulgate regulations to implement the provisions of Chapter 183 relating to medication administration training for the administration of epinephrine and glucagon.

Purpose: The purpose of the amendments is to include training in the signs of hypoglycemia and the administration of glucagon to the module on training in the administration of insulin. The 32-hour training program set out in 18VAC30-21-30 is used for training unlicensed persons to administer medications in certain facilities as prescribed in § 54.1-3408 L of the Code of Virginia. If a person is authorized to assist with the administration of insulin, he should also be trained in the administration of a rescue dose of glucagon. Since Chapter 183 provides that employees of or persons providing services pursuant to a contract with a provider licensed by the Department of Behavioral Health and Developmental Services (DBHDS) may administer insulin, glucagon, and epinephrine pursuant to a written order issued by a prescriber in certain circumstances, training in administration of those drugs is essential to protect public health and safety for persons receiving services in a DBHDS facility.

Rationale for Using Fast-Track Process: The amendments are mandated by and necessary to implement the statute. The amendments are not controversial, and the curriculum already exists for such training.

Substance: This action will amend the 32-hour medication administration program to add "signs of severe hypoglycemia and administration of glucagon" to the insulin module. It will also add a provision to the curriculum for the purpose of "Facilitating client self-administration or assisting with the administration of auto-injectable epinephrine pursuant to an order issued by the prescriber for a specific client in a facility licensed by the Department of Behavioral Health and Developmental Services under provisions of subsection D of § 54.1-3408 of the Code of Virginia."

Issues: The primary advantage is to those persons who are receiving services in a DBHDS licensed facility and who may have diabetes or severe allergies. There are no advantages or disadvantages to the general public.

There are no advantages or disadvantages to the Department of Health Professions, but there are advantages to DBHDS, which will be able to train and utilize unlicensed persons to administer insulin, glucagon, and auto-injectable epinephrine.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 183 of the 2013 Acts of the Assembly, the Board of Nursing (Board) proposes to add training in epinephrine and glucagon administration to the curriculum for the classroom instruction provided to certain individuals

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. Pursuant to Chapter 183 of the 2013 Acts of the Assembly, the proposed regulations add training in epinephrine and glucagon administration to the curriculum for the classroom instruction established by the Board for the employees of or persons providing services based on a written contract with a provider licensed by the Department of Behavioral Health and Developmental Services (DBHDS).

The Board does not plan to increase the length of the required classroom instruction and does not anticipate any reduction in the quantity and quality of other topics that need to be covered by the training. Thus, no significant economic costs are expected from the proposed expansion of the training curriculum. However, the proposed new training is expected to improve chances of survival if and when epinephrine or glucagon has to be administered to a patient in an emergency. DBHDS estimates that there are less than 200 occasions where epinephrine or glucagon would need to be administered per year. If the nearby unlicensed individuals providing care to a patient are not trained in epinephrine and glucagon administration, a patient has no choice but to wait for a qualified care provider such as an emergency medical services provider to arrive. According to the Department of Health Professions, the time lost for waiting for such a person could make the difference between life and death.

Businesses and Entities Affected. According to DBHDS, there are about 11,000 staff in group homes and 2,000 staff in sponsored residential facilities that will be affected by the proposed training requirement.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. No significant impact on employment is expected.

Effects on the Use and Value of Private Property. No significant impact on the use and value of private property is expected.

Small Businesses: Costs and Other Effects. No costs or other effects on small businesses are expected.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed regulations do not pose an adverse impact on small businesses.

Real Estate Development Costs. No impact on real estate development costs is expected.

Legal Mandate. The Department of Planning and Budget (DPB) has analyzed the economic impact of this proposed regulation in accordance with § 2.2-4007.04 of the Administrative Process Act and Executive Order Number 14 (10). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, a determination of the public benefit, the projected number of businesses or other entities to whom the regulation would apply, the identity of any localities and types of businesses or other entities particularly affected, the projected number of persons and employment positions to be affected, the projected costs to affected businesses or entities to implement or comply with the regulation, and the impact on the use and value of private property. Further, if the proposed regulation has an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include (i) an identification and estimate of the number of small businesses subject to the regulation; (ii) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the regulation, including the type of professional skills necessary for preparing required reports and other documents; (iii) a statement of the probable effect of the regulation on affected small businesses; and (iv) a description of any less intrusive or less costly alternative methods of achieving the purpose of the regulation. The analysis presented above represents DPB's best estimate of these economic impacts.

Agency's Response to Economic Impact Analysis: The Board of Nursing concurs with the analysis of the Department of Planning and Budget on the proposed amendments to 18VAC90-21, Medication Administration Training and Immunization Protocol.

Summary:

Pursuant to Chapter 183 of the 2013 Acts of Assembly, the proposed amendments provide for the medication administration training curriculum to include training in (i) the signs of hypoglycemia and administration of glucagon and (ii) epinephrine and glucagon administration for the classroom instruction established by the Board of Nursing for the employees of the Department of Behavioral Health and Developmental Services (DBHDS) or persons providing services based on a written contract with a provider licensed by DBHDS.

18VAC90-21-30. Content of medication administration training.

The curriculum shall include a minimum of 32 hours of classroom instruction and practice in the following:

1. Preparing for safe administration of medications to clients in specific settings by:

a. Demonstrating an understanding of the client's rights regarding medications, treatment decisions, and confidentiality.

b. Recognizing emergencies and other health-threatening conditions and responding accordingly.

c. Identifying medication terminology and abbreviations.

2. Maintaining aseptic conditions by:

a. Implementing universal precautions.

b. Insuring cleanliness and disinfection.

c. Disposing of infectious or hazardous waste.

3. Facilitating client self-administration or assisting with medication administration by:

a. Reviewing administration records and prescriber's orders.

b. Facilitating client's awareness of the purpose and effects of medication.

c. Assisting the client to interpret prescription labels.

d. Observing the five rights of medication administration and security requirements appropriate to the setting.

e. Following proper procedure for preparing medications.

f. Measuring and recording vital signs to assist the client in making medication administration decisions.

g. Assisting the client to administer oral medications.

h. Assisting the client with administration of prepared instillations and treatments of:

(1) Eye drops and ointments.

(2) Ear drops.

(3) Nasal drops and sprays.

(4) Topical preparations.

(5) Compresses and dressings.

(6) Vaginal and rectal products.

(7) Soaks and sitz baths.

(8) Inhalation therapy.

(9) Oral hygiene products.

i. Reporting and recording the client's refusal to take medication.

j. Documenting medication administration.

k. Documenting and reporting medication errors.

l. Maintaining client records according to facility policy.

m. Sharing information with other staff orally and by using documents.

n. Storing and securing medications.

o. Maintaining an inventory of medications.

p. Disposing of medications.

4. Facilitating client self-administration or assisting with the administration of insulin. Instruction and practice in the administration of insulin shall be included only in those settings where required by client needs and shall include:

a. Cause and treatment of diabetes.

b. The side effects of insulin.

c. Preparation and administration of insulin.

d. Signs of severe hypoglycemia and administration of glucagon.

5. Facilitating client self-administration or assisting with the administration of auto-injectable epinephrine pursuant to an order issued by the prescriber for a specific client in a facility licensed by the Department of Behavioral Health and Developmental Services under the provisions of subsection D of § 54.1-3408 of the Code of Virginia.