Title of Regulation: 18VAC90-60. Regulations Governing the Registration of Medication Aides (amending 18VAC90-60-110).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: February 22, 2017.

Effective Date: March 9, 2017.

Agency Contact: Jay P. Douglas, R.N., Executive Director, Board of Nursing, 9960 Mayland Drive, Suite 300, Richmond, VA 23233-1463, telephone (804) 367-4520, FAX (804) 527-4455, or email jay.douglas@dhp.virginia.gov.

Basis: Regulations are promulgated under the general authority § 54.1-2400 of the Code of Virginia, which provides the Board of Nursing the authority to promulgate regulations. In addition, there is statutory authority for the board to approve training and curriculum for medication aide programs and to establish standards of conduct regulations to administer the regulatory system in § 54.1-3005 of the Code of Virginia.

Purpose: The amendments clarify that subcutaneous administration of medication is not within the scope of practice for a medication aide, with the exception of three medications essentially used for emergencies and as taught in the medication aide curriculum. The amendments ensure that medication aides do not inappropriately administer drugs by a subcutaneous route. Since medication aides work solely in assisted living facilities, clearly worded regulations are necessary to protect a very vulnerable population in a facility where it is unlikely that another health care provider is present.

Rationale for Using Fast-Track Rulemaking Process: The board is using the fast-track rulemaking process because the change will ensure that medication aides can administer certain medications that may save the life of a resident in an assisted living facility. Therefore, the board would like to promulgate those amendments as soon as possible. There should be no opposition to the amendment, so a fast-track rulemaking action is appropriate.

Substance: 18VAC90-60-110 is amended to clarify that medication aides are not allowed to administer by subcutaneous route except for insulin medications, glucagon, or auto-injectable epinephrine. An exception for insulin and glucagon is already listed for administration by intramuscular or intravenous routes, but it is more appropriately a subcutaneous administration.

Issues: The primary advantage is to residents of assisted living facilities, which are the only settings in which medication aides practice, for trained individuals to be able to administer a potentially life-saving drug. There are no primary disadvantages to the public. The primary advantage to the Board of Nursing is the clarification about whether medication aides may administer by a subcutaneous route. Such administration is not taught in the training programs and is not part of the curriculum, with the exception of limited rescue medications.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Nursing (Board) proposes to clarify that medication aides¹ may not administer any medications other than insulin, glucagon and auto-injectable epinephrine by subcutaneous² route.

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

Estimated Economic Impact. Current regulation prohibits medication aides from transmitting verbal orders to pharmacies; making an assessment of a client or deviating from the medication regime ordered by the prescriber; or mixing, diluting or reconstituting two or more drug products (with the exception of insulin and glucagon). Medication aides are also currently prohibited from administering any medication except glucagon via nasogastric or percutaneous endoscopic gastric tube and any medications by intramuscular or intravenous routes. Although medication aides are not allowed to administer any medications by intravenous or intramuscular injection, they are currently trained to administer three types medication via subcutaneous injections: insulin, glucagon and auto-injectable epinephrine.

Board staff reports that they have had inquiries from both medication aides, and the assisted living facilities where they are employed, as to whether they are allowed to administer any subcutaneous injections other than insulin, glucagon or auto-injectable epinephrine. Section 54.1-3408 M of the Code of Virginia requires, among other things, that medication aides practice in accordance with regulations governing their practice promulgated by the Board of Nursing. Board of Nursing regulation 18VAC90-60-120 (2) (b) prohibits medication aides from "assuming duties and responsibilities within the practice of medication aides without adequate training or when competency has not been maintained." Because of this language in the COV and regulation, it is the Board's position that medication aides may not administer any subcutaneous injections other than the three on which they are specifically trained. To clarify this, the Board now proposes to add administering any subcutaneous injections, other than of insulin, glucagon and auto-injectable epinephrine, to the list of prohibited acts for medication aides.

Board staff reports that no assisted living facilities are known to currently allow medication aides to administer subcutaneous injections other than those for which they are specifically trained. Therefore, no assisted living facilities are likely to incur any costs on account of this proposed regulatory change. Medication aides and assisted living facilities, as well as the clients at such facilities, will benefit from this change as it will clear up any confusion that might exist about the limits of practice for medication aides vis-a-vis subcutaneous injections.

Businesses and Entities Affected. Board staff reports that there are approximately 6,000 registered medication aides currently registered with the Board. All of these individuals, as well as any individuals who become registered in the future, will be affected by this proposed regulatory change.

Localities Particularly Affected. No locality will be particularly affected by these proposed regulatory changes.

Projected Impact on Employment. This proposed regulatory change is unlikely to affect employment in the Commonwealth.

Effects on the Use and Value of Private Property. This proposed change will likely not affect the use or value of private property in the Commonwealth.

Real Estate Development Costs. This proposed regulatory change is unlikely to affect real estate development costs in the Commonwealth.

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. No small businesses are likely to incur any additional costs on account of this clarifying change.

Alternative Method that Minimizes Adverse Impact. No small businesses are likely to incur any additional costs on account of this clarifying change.

Adverse Impacts:

Businesses. No businesses are likely to incur any additional costs on account of this clarifying change.

Localities. Localities in the Commonwealth are unlikely to see any adverse impacts on account of this proposed regulatory change.

Other Entities. No other entities are likely to be adversely affected by this proposed change.

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¹ Medication aides are registered with the Board of Nursing, work in assisted living facilities licensed by the Board of Social Services and are authorized by Code to administer drugs that would normally be self-administered by residents of such facilities.

² Subcutaneous means located beneath the skin. Subcutaneous injections deliver medication to the fatty tissue just under the skin.

Agency's Response to Economic Impact Analysis: The Board of Nursing concurs with the analysis of the Department of Planning and Budget.

Summary:

The amendment clarifies that medication aides may not administer any medications other than insulin, glucagon, or auto-injectable epinephrine by subcutaneous route.

18VAC90-60-110. Standards of practice.

A. A medication aide shall:

1. Document and report all medication errors and adverse reactions immediately to the licensed health care professional in the facility or to the client's prescriber;

2. Give all medications in accordance with the prescriber's orders and instructions for dosage and time of administration and document such administration in the client's record; and

3. Document and report any information giving reason to suspect the abuse, neglect, or exploitation of clients immediately to the licensed health care professional in the facility or to the facility administrator.

B. A medication aide shall not:

1. Transmit verbal orders to a pharmacy;

2. Make an assessment of a client or deviate from the medication regime ordered by the prescriber;

3. Mix, dilute, or reconstitute two or more drug products, with the exception of insulin or glucagon; or

4. Administer by intramuscular or intravenous routes or medications via a nasogastric or percutaneous endoscopic gastric tube except for administration of glucagon; or

5. Administer by subcutaneous route, except for insulin medications, glucagon, or auto-injectable epinephrine.