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: January 28, 2015.

Effective Date: February 13, 2015.

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. Section 54.1-3408 L of the Code of Virginia provides for administration of drugs by an unlicensed person to a person receiving services from a program licensed by the Department of Behavioral Health and Developmental Services (DBHDS) via a gastrostomy tube provided the unlicensed person has successfully completed a training program approved by the Board of Nursing.

Purpose: The goal of the amendment to 18VAC90-21-30 is for the Board of Nursing to include a training module in gastrostomy tubes approved by DBHDS, which is designed to ensure that unlicensed persons have adequate competency to administer medications in a manner that protects the health and safety to persons receiving services in a DBHDS-approved program. The training prepared by DBHDS is an addition to the basic content of the curriculum for medication administration training program as authorized in § 54.1-3408 of the Code of Virginia.

Rationale for Using Fast-Track Process: An emergency regulation became effective on October 11, 2013, and a Notice of Intended Regulatory Action was published for the replacement of the emergency. During the 30-day comment period, there was no comment, and there have been no issues reported by providers or DBHDS with the regulation and training curriculum.

Substance: The key provision of the regulation is the inclusion of a requirement to complete the curriculum approved by the DBHDS for unlicensed persons to administer medication via a gastrostomy tube.

Issues: The primary advantage of the amendment to the public is better management of clients in facilities licensed by DBHDS who require a gastrostomy tube. There are no disadvantages to the public.

There are no advantages or disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 114 of the 2013 Acts of the Assembly, the Board of Nursing (Board) proposes to amend its regulations to require unlicensed individuals to complete training approved by the Board if they will be administering medication via a gastronomy tube to individuals who are being served by a program licensed by Department of Behavioral Health and Development Services (DBHDS). This proposed amendment will replace identical language promulgated under emergency regulation provisions that will expire April 11, 2015.

Result of Analysis. Benefits likely outweigh costs for this proposed regulatory change.

Estimated Economic Impact. Prior to 2013, only nurses, doctors and pharmacists had the authority to administer medication to patients through a gastronomy tube. This made it prohibitively expensive to move affected intellectually disabled individuals from the state's training centers (where nurses were available to administer such medication) to community-based group homes (which usually do not employ nurses). In 2013, the General Assembly passed legislation that addressed this issue by allowing unlicensed individuals to administer medication through clients' gastronomy tubes after they successfully completed a training course approved by the Board.

Board staff reports that the approved training course is six hours long. Staff at DBHDS reports that roughly 400 individuals who require medication administration through gastronomy tubes are currently being cared for in group homes licensed by the Department. Several hundred workers at these homes have completed or will complete training approved by the Board under these regulations. DBHDS staff further estimates that the six hour training course costs several hundred dollars and that group home staff members typically earn an hourly wage between $10 and $12. Using these estimates, owners of group homes who wish to serve clients who would need medication administered through their gastronomy tubes will likely incur costs that include the training course fee as well as wage costs of between $60 and $72 for each worker who completes training. These costs are likely much lower than hiring a nurse to administer these medications.

Businesses and Entities Affected. Staff for DBHDS estimates that several hundred group homes, as well as all intellectually disabled individuals who require medication administration through gastronomy tubes, will be affected by these regulations.

Localities Particularly Affected. No locality will be particularly affected by this proposed regulatory action.

Projected Impact on Employment. Because this regulatory change likely allows a greater number of intellectually disabled individuals to be served by group homes, employment in such homes is likely to slightly increase.

Effects on the Use and Value of Private Property. To the extent that this regulatory change allows a greater number of intellectually disabled individuals to live in group homes, the revenue of such homes is likely to increase.

Small Businesses: Costs and Other Effects. Affected small businesses will likely incur costs for training fees and wages paid to workers completing training; these costs are likely much lower than costs would be if affected small businesses had to hire nurses to administer medication through gastronomy tubes.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Affected small businesses will likely incur costs for training fees and wages paid to workers completing training; these costs are likely much lower than costs would be if affected small businesses had to hire nurses to administer medication through gastronomy tubes.

Real Estate Development Costs. This proposed regulatory change will likely have no effect on real estate development costs in the Commonwealth.

Legal Mandate.

General: 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 Code of Virginia and Executive Order Number 14 (2010). Section 2.2-4007.04 requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the report should include but not be limited to:

• the projected number of businesses or other entities to whom the proposed 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.

Small Businesses: If the proposed regulation will have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include:

• an identification and estimate of the number of small businesses subject to the proposed regulation,

• the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents,

• a statement of the probable effect of the proposed regulation on affected small businesses, and

• a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation.

Additionally, pursuant to § 2.2-4007.1, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules (JCAR) is notified at the time the proposed regulation is submitted to the Virginia Register of Regulations for publication. This analysis shall represent DPB's best estimate for the purposes of public review and comment on the proposed regulation.

Agency's Response to Economic Impact Analysis: The Board of Nursing concurs with the analysis of the Department of Planning and Budget on proposed amended regulations for 18VAC90-20.

Summary:

The amendments require unlicensed individuals to complete the curriculum approved by the Department of Behavioral Health and Developmental Services if they will be administering medication via a gastronomy tube to individuals who are being served by a program licensed by Department of Behavioral Health and Developmental Services.

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.

B. Pursuant to subsection L of § 54.1-3408 of the Code of Virginia, the board requires successful completion of the curriculum approved by the Department of Behavioral Health and Developmental Services (DBHDS) for unlicensed persons to administer medication via a gastrostomy tube to a person receiving services from a program licensed by the DBHDS.