Title of Regulation: 18VAC90-60. Regulations Governing the Registration of Medication Aides (amending 18VAC90-60-20, 18VAC90-60-40, 18VAC90-60-60, 18VAC90-60-90, 18VAC90-60-92, 18VAC90-60-100, 18VAC90-60-110).

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: July 31, 2013.

Effective Date: August 15, 2013.

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.

Purpose: The purpose of the amendments to the regulation is to update language and eliminate unnecessary or outdated provisions. Inclusion of language consistent with current practices will facilitate administration of medications and submission of documentation for registration. The goal is to enable qualified applicants to obtain registration that provides the public with some assurance of competency and accountability in the administration of medications to residents of assisted living facilities.

Rationale for Using Fast-Track Process: The amendments are less restrictive and not controversial. There were no comments received during the comment period on periodic review.

Substance: The amendments (i) facilitate electronic submission of documents and forms, (ii) allow the board to accept a certificate of naturalization as evidence of a name change, (iii) clarify the process for application approval and requesting of an informal conference if an application is denied, (iv) allow up to 20% of the skills practice to be done by simulation, (v) allow completion of a nursing education to count for training in client care, and (vi) allow an exception to the prohibition for intramuscular administration of medication for glucagon.

Issues: The primary advantages to the public are facilitation of applications; expansion of educational opportunity; and elimination of confusing, outdated language. There are no disadvantages to the public. The advantage to the Commonwealth is clarity in the regulations, which reduces queries to board staff.

Small Business Impact Report of Findings: This regulatory action serves as the report of findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Nursing proposes 1) to allow 20% of the required 20 hours of supervised skills practice in medication aide training to be a simulation experience, 2) to allow registered aides to report their change of address electronically, 3) to allow registrants to use a certificate of naturalization as documentation of a name change, and 4) to clarify a number of existing requirements.

Result of Analysis. The benefits likely exceed the costs for one or more proposed changes. There is insufficient data to accurately compare the magnitude of the benefits versus the costs for at least one change.

Estimated Economic Impact. One of the proposed changes will allow 20% (four hours) of the required 20 hours of supervised skills practice in medication aide training to be a simulation experience. The proposed percentage is consistent with the allowance for simulation in nursing education programs. This change will primarily affect training institutions and new medication aides. Currently, there are 141 training institutions in the Commonwealth. The number of new medication aides registered in fiscal years (FY) 2011 and 2012 was 899 and 861, respectively. However, the number of affected medication aides will be larger than those who are registered because some applicants who take the training may not qualify for registration.

Being able to substitute simulation experience for actual experience is likely to reduce training costs as the simulation method is probably more conducive to train a large number of people simultaneously. If the training costs are reduced for the training institutions, some of the reduction will likely be passed on to the applicants depending on the competitiveness of the training industry. However, the Department of Health Professions (DHP) acknowledges that the simulation method may not be as effective as real hands on training. This is the reason why only 20% of required training is allowed to be a simulation experience.

Another proposed change will allow registered aides to report their change of address electronically in addition to via a written submission. This change is expected to facilitate the submission of address change information and produce net benefits by reducing compliance costs such as time, travel, and postage costs on registered aides. DHP states that medication aides are generally very mobile and a fairly large proportion of them change their address in a given year. Currently, there are 4,936 medication aides registered in Virginia.

In addition, one of the proposed changes will allow registrants to use a certificate of naturalization as documentation of a name change. Under the current rules, a court order or a marriage certificate is required. This change is expected to produce net benefits by reducing compliance costs for those who have a certificate of naturalization at hand, but not a court order or marriage certificate. However, the number of people who may be affected by this change is likely to be very small.

The remaining changes are clarifications of the current requirements and are not anticipated to create a significant economic impact other than perhaps avoiding some potential confusion among the medication aides.

Businesses and Entities Affected. The proposed regulations apply to 141 training institutions and approximately 4,936 medication aides registered in Virginia.

Localities Particularly Affected. No locality will be disproportionately affected.

Projected Impact on Employment. Allowance of simulation experience to meet the required real supervised skills practice is likely to increase the demand for training staff involved in simulation while reducing the demand for staff providing real world supervision. Remaining proposed changes are not anticipated to have a significant impact on employment.

Effects on the Use and Value of Private Property. Allowance of simulation experience to meet the required real supervised skills practice is likely to positively affect the asset value of the training centers offering this option as the demand for their services is likely to increase while the opposite is expected for the training institutions that do not offer the simulation method.

Small Businesses: Costs and Other Effects. The proposed regulation is expected to have an impact on 141 medication aide training institutions most if not all of which are small businesses. While no small business costs are expected, other effects on them are the same as discussed above.

Small Businesses: Alternative Method that Minimizes Adverse Impact. The proposed changes are not anticipated to have 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 a fast-track action for 18VAC90-60, Regulations Governing the Registration of Medication Aides, to promulgate changes recommended pursuant to the Governor's Regulatory Reform Project.

Summary:

This regulatory action is in response to the Governor's Regulatory Reform Initiative. The amendments (i) facilitate electronic submission of documents and forms, (ii) allow the board to accept a certificate of naturalization as evidence of a name change, (iii) clarify the process for application approval and requesting of an informal conference if an application is denied, (iv) allow up to 20% of the skills practice to be done by simulation, (v) allow completion of a nursing education to count for training in client care, and (vi) allow an exception to the prohibition for intramuscular administration of medication for glucagon.

18VAC90-60-20. Identification; accuracy of records.

A. Any person regulated by this chapter shall, while on duty, wear identification that is clearly visible to the client and that indicates the person's first and last name and the appropriate title issued to such person by the board under which he is practicing in that setting.

B. A medication aide who has changed his name shall submit as legal proof to the board a copy of the marriage certificate, a certificate of naturalization, or a court order evidencing the change. A duplicate certificate shall be issued by the board upon receipt of such evidence.

C. A medication aide shall maintain an address of record with the board. Any change in the address of record or in the public address, if different from the address of record, shall be submitted electronically or in writing to the board within 30 days of such change. All notices required by law and by this chapter to be mailed by the board to any registrant shall be validly given when mailed to the latest address of record on file with the board.

Part II
Medication Aide Training Programs

18VAC90-60-40. Establishing and maintaining a medication aide training program.

A. Establishing a medication aide training program.

1. A program provider wishing to establish a medication aide training program shall submit a completed application and pay the prescribed fee to the board at least 90 days in advance of the first expected offering of the program.

2. The application shall provide evidence Initial approval may be granted when all documentation of the program's compliance with requirements as set forth in this part has been submitted and deemed satisfactory to the board.

3. The committee shall, If approval is denied, the applicant may request, within 30 days of the mailing of the decision, an informal conference committee to be convened in accordance with § 2.2-4019 of the Code of Virginia, receive and review the application and shall make a recommendation to the board to grant or deny approval.

4. If the committee's recommendation is to deny approval, no further action will be required of the board unless the program requests a hearing before the board or a panel thereof in accordance with § 2.2-4020 and subdivision 11 of § 54.1-2400 of the Code of Virginia.

B. Maintaining an approved medication aide training program. To maintain approval, the program shall:

1. Continue to comply with requirements as set forth in this part.

2. Document that the cumulative passing rate for the program's first-time test takers taking the competency evaluation required for registration over the past two years is not less than 80%.

3. Report all substantive changes within 10 days of the change to the board to include, but not be limited to, a change in the program instructors, curriculum or program location.

4. Cooperate with any unannounced visits to the program conducted by board representatives for the purpose of ensuring compliance with requirements for approval or in response to complaints about the program.

5. Provide documentation that each student enrolled in such program has been given a copy of applicable Virginia law and regulation for the registration and practice of medication aides.

6. Provide each student with a certificate of completion.

18VAC90-60-60. Requirements for the program curriculum.

A. Prerequisite for the program. A student seeking enrollment in a medication aide training program shall have successfully completed the direct care staff training required by the Department of Social Services for employment in an assisted living facility or an approved nurse aide education program.

B. Hours of instruction. An approved program shall consist of a minimum of 68 hours of student instruction and training to include:

1. At least 40 hours of classroom or didactic instruction over and above any facility orientation program or training in direct client care provided by the facility;

2. At least 20 hours of supervised skills practice in medication administration to residents of an assisted living facility, after which the training program shall evaluate the student's minimal competency in the clinical skills of administering medications on a form provided by the board. Up to 20% of the supervised skills practice may be completed by a simulation experience in a simulation laboratory. The clinical evaluation shall be conducted one-on-one with a qualified instructor with experience in medications in long-term care; and

3. An eight-hour module in facilitating client self-administration or assisting with the administration of insulin to include instruction and skills practice in the administration of insulin as specified in the board-approved curriculum.

C. Content of the curriculum. An approved program shall use the curriculum developed and provided by the board, which shall, at a minimum, include the following topics:

1. Preparing for safe administration of medications to clients in assisted living facilities;

2. Maintaining aseptic conditions;

3. Understanding of basic pharmacology;

4. Facilitating client self-administration or assisting with medication administration;

5. Following proper procedure for preparing, administering, and maintaining medications; and

6. Following appropriate procedures for documentation and reporting to the licensed healthcare professional on duty at the facility or to the client's prescriber.

D. In addition to the training curriculum, the program shall provide one or more four-hour modules that can be used by facilities as refresher courses or by medication aides to satisfy requirements for continuing education.

Part III
Registration of Medication Aides

18VAC90-60-90. Requirements for initial registration.

A. To be registered as a medication aide, an applicant shall:

1. Provide documentation of successful completion of a staff training program in direct client care approved by the Department of Social Services, a nursing education program, or of an approved nurse aide education program;

2. Provide documentation of successful completion of one of the following:

a. A medication aide training program approved by the board in accordance with this chapter; or

b. A nursing education program preparing for registered nurse licensure or practical nurse licensure; or

c. An eight-hour refresher course preparing a person to take the competency evaluations required for registration and one year of experience working as a medication aide in an assisted living facility. The one year of experience working as a medication aide in an assisted living facility shall be completed prior to December 31, 2008, and may only be accepted as evidence of training until August 1, 2009;

3. Submit the required application and fee as prescribed by the board;

4. Disclose whether there are grounds for denial of registration as specified in § 54.1-3007 of the Code of Virginia; and

5. Provide documentation of successful completion of competency evaluations consisting of:

a. A clinical evaluation of minimal competency in the skills of administering medications as specified in 18VAC90-60-60 B 2; and

b. A written examination as specified by the board with a passing score determined by the board.

B. An applicant who fails to take the board-approved examination within one year of completion of the training or who has failed the examination in three attempts shall reenroll and successfully complete another approved medication aide training program before reapplying for registration.

18VAC90-60-92. Requirements for registration by endorsement.

An applicant applying for registration by endorsement who has met the requirements for registration or certification as a medication aide in another state or the District of Columbia may be deemed eligible to sit for the competency evaluation if there are no grounds for denial of registration as specified in § 54.1-3007 of the Code of Virginia and upon submission of:

1. A completed application and fee; and

2. Verification of registration or certification as a medication aide in another state or the District of Columbia that is current or eligible for reinstatement.

18VAC90-60-100. Renewal or reinstatement of registration.

A. Renewal of registration.

1. Registered medication aides shall renew by the last day of their birth month each year.

2. The medication aide shall complete the application and submit it with the required fee and an attestation that he has completed continuing education as required by subsection B of this section.

3. Failure to receive the application for renewal shall not relieve the medication aide of the responsibility for renewing his registration by the expiration date.

4. The registration shall automatically lapse if the medication aide fails to renew by the expiration date.

5. Any person administering medications in an assisted living facility during the time a registration has lapsed shall be considered an illegal practitioner and shall be subject to prosecution under the provisions of § 54.1-3008 of the Code of Virginia.

B. Continuing education required for renewal.

1. In addition to hours of continuing education in direct client care required for employment in an assisted living facility, a medication aide shall have four the following:

a. Four hours each year of population-specific training in medication administration in the assisted living facility in which the aide is employed; or a

b. A refresher course in medication administration offered by an approved program.

2. A medication aide shall maintain documentation of continuing education for a period of four years following the renewal period for which the records apply.

3. The board shall periodically conduct a random audit of at least 1.0% of its registrants to determine compliance. A medication aide selected for audit shall provide documentation as evidence of compliance within 30 days of receiving notification of the audit.

4. The board may grant an extension for compliance with continuing education requirements for up to one year, for good cause shown, upon a written request from the registrant prior to the renewal deadline.

C. Reinstatement of registration.

1. An individual whose registration has lapsed for less than one renewal cycle may renew by payment of the renewal fee and late fee and attestation that he has completed all required continuing education for the period since his last renewal.

2. An individual whose registration has lapsed for more than one year shall:

a. Apply for reinstatement of registration by submission of a completed application and fee;

b. Provide evidence of completion of all required continuing education for the period since his last renewal, not to exceed eight hours of training in medication administration;

c. Retake the written and practical competency evaluation as required by the board; and

d. Attest that there are no grounds for denial of registration as specified in § 54.1-3007 of the Code of Virginia.

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 healthcare 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 healthcare 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.