Vol. 27 Iss. 26 - August 29, 2011

Chapter 381
Final Regulation

REGISTRAR'S NOTICE: The State Board of Health is claiming an exemption from the Administrative Process Act in accordance with § 2.2-4006 A 4 a of the Code of Virginia, which excludes regulations that are necessary to conform to changes in Virginia statutory law where no agency discretion is involved. The State Board of Health will receive, consider, and respond to petitions from any interested person at any time with respect to reconsideration or revision.

Title of Regulation: 12VAC5-381. Regulations for the Licensure of Home Care Organizations (amending 12VAC5-381-330, 12VAC5-381-350, 12VAC5-381-360).

Statutory Authority: §§ 32.1-12 and 32.1-162.12 of the Code of Virginia.

Effective Date: September 29, 2011.

Agency Contact: Carrie Eddy, Policy Analyst, Department of Health, 3600 West Broad Street, Richmond, VA 23230-4920, telephone (804) 367-2102, FAX (804) 367-2149, or email


In conformance with Chapter 245 of the 2010 Acts of Assembly, the amendment allows home attendants to assist with administering normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act, including nonoral or nontopical drugs.

12VAC5-381-330. Home attendants assisting with skilled services.

A. Home attendants assisting with providing skilled services may:

1. Assist clients with (i) activities of daily living, (ii) ambulation and prescribed exercise, and (iii) other special duties with appropriate training and demonstrated competency;

2. Assist with oral or topical medications that the client can normally self-administer Administer normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia);

3. Measure and record fluid intake and output;

4. Take and record blood pressure, pulse and respiration;

5. Record and report to the appropriate health care professional changes in the client's condition;

6. Document services and observations in the client's record; and

7. Perform any other duties that the attendant is qualified to do by additional training and demonstrated competency as allowed by state or federal guidelines.

B. Prior to the initial delivery of services, the home attendant shall receive specific written instructions for the client's care from the appropriate health care professional responsible for the care.

C. Home attendants shall work under the supervision of the appropriate health care professional responsible for the client's care.

D. Relevant in-service education or training for home attendants shall consist of at least 12 hours annually. In-service training may be in conjunction with on-site supervision.

Part IV
Pharmaceutical Services

12VAC5-381-350. Pharmacy services.

A. All prescription drugs shall be prescribed and properly dispensed to the client according to the provisions of the Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and the regulations of the Virginia Board of Pharmacy, except for prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushes for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

B. Home attendants may assist only with those topical and oral medications that the client would normally self-administer administer normally self-administered drugs as allowed by § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia). Any other drug shall be administered only by a licensed nurse or physician assistant.

C. The organization shall develop written policies and procedures for the administration of home infusion therapy medications that include, but are not limited to:

1. Developing a plan of care or service;

2. Initiation of medication administration based on a prescriber's order and monitoring of the client for response to the treatment and any adverse reactions or side effects;

3. Assessment of any factors related to the home environment that may affect the prescriber's decisions for initiating, modifying, or discontinuing medications;

4. Communication with the prescriber concerning assessment of the client's response to therapy, any other client specific needs, and any significant change in the client's condition;

5. Communication with the client's provider pharmacy concerning problems or needed changes in a client's medication;

6. Maintaining a complete and accurate record of medications prescribed, medication administration data, client assessments, any laboratory tests ordered to monitor response to drug therapy and results, and communications with the prescriber and pharmacy provider;

7. Educating or instructing the client, family members, or other caregivers involved in the administration of infusion therapy in the proper storage of medication, in the proper handling of supplies and equipment, in any applicable safety precautions, in recognizing potential problems with the client, and actions to take in an emergency; and

8. Initial and retraining of all organization staff providing infusion therapy.

D. The organization shall employ a registered nurse, who has completed training in infusion therapy, and has the knowledge, skills, and competencies to safely administer infusion therapy, to supervise medication administration by staff. This person shall be responsible for ensuring compliance with applicable laws and regulations, adherence to the policies and procedures related to administration of medications, and conducting periodic assessments of staff competency in performing infusion therapy.

Part V
Personal Care Services

12VAC5-381-360. Personal care services.

A. An organization may provide personal care services in support of the client's health and safety in his home. The organization shall designate a registered nurse responsible for the supervision of personal care services.

B. The personal care services shall include:

1. Assistance with the activities of daily living. A need for assistance exists when the client is unable to complete an activity due to cognitive impairment, functional disability, physical health problems, or safety. The client's functional level is based on the client's need for assistance most or all of the time to perform the tasks of daily living in order to live independently;

2. Administration of normally self-administered drugs as allowed in § 54.1-3408 of the Virginia Drug Control Act (Chapter 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia);

3. Taking and recording vital signs, if specified in the plan of service;

3. 4. Recording and reporting to the supervisor any changes regarding the client's condition, behavior or appearance; and

4. 5. Documenting the services delivered in the client's record.

Personal care services may also include the instrumental activities of daily living related to the needs of the client.

C. Such services shall be delivered based on a written plan of services developed by a registered nurse, in collaboration with the client and client's family. The plan shall include at least the following:

1. Assessment of the client's needs;

2. Functional limitations of the client;

3. Activities permitted;

4. Special dietary needs;

5. Specific personal care services to be performed; and

6. Frequency of service.

D. The plan shall be retained in the client's record. Copies of the plan shall be provided to the client receiving services and reviewed with the assigned home attendant prior to delivering services.

E. Supervision of services shall be provided as often as necessary as determined by the client's needs, the assessment of the registered nurse, and the organization's written policies not to exceed 90 days.

F. A registered nurse or licensed practical nurse shall be available during all hours that personal care services are being provided.

G. Home attendants providing personal care services shall receive at least 12 hours annually of inservice training and education. Inservice training may be in conjunction with on-site supervision.

VA.R. Doc. No. R11-2858; Filed August 3, 2011, 2:02 p.m.