Title of Regulation: 12VAC5-391. Regulations for the Licensure of Hospice (amending 12VAC5-391-330, 12VAC5-391-340, 12VAC5-391-350, 12VAC5-391-380, 12VAC5-391-440).

Statutory Authority: §§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: March 31, 2021.

Effective Date: April 15, 2021.

Agency Contact: Rebekah E. Allen, Senior Policy Analyst, Virginia Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2102, FAX (804) 527-4502, or email regulatorycomment@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia gives the State Board of Health the responsibility to make, adopt, promulgate, and enforce such regulations as may be necessary to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-162.5 of the Code of Virginia requires the board to adopt regulations governing the activities and services provided by hospices as may be necessary to protect the public health, safety and welfare.

Purpose: This regulation is being amended due to public comments and the professional opinions of subject matter experts within the agency. The board is required by the General Assembly to promulgate regulations for the licensure of hospice in order to protect the health, safety, and welfare of citizens utilizing hospices. This regulatory change removes the requirement that the medical director of a hospice have admitting privileges at one or more hospitals and nursing facilities that provide inpatient service to the hospice's patients. Public comment indicated that this requirement was difficult for hospices to meet and disqualified candidates that would otherwise have been suitable. Subject matter experts within the agency agreed that this requirement was burdensome to hospices and did not improve protection of the public health, safety, and welfare. The regulatory change is also intended to update outdated references to other documents and citations.

Rationale for Using Fast-Track Rulemaking Process: The rulemaking is expected to be noncontroversial because all public comments received during periodic review supported the repeal of subsection B of 12VAC5-391-330, and the agency's subject matter experts believe that repeal would not jeopardize the protection of public health, safety, and welfare. Further, the additional updates to the regulation do not alter the intent of the regulation or the requirements placed on regulated entities.

Substance: The board has repealed subsection B of 12VAC5-391-330. Updates were made to references to Board of Nursing regulation sections; to the requirements for personal care aide training; to Department of Health Professions references; and to the current edition of the Guidelines for Design and Construction of Residential Health, Care, and Support Facilities. A document regarding personal care aide training that is no longer referenced in the regulation is removed from the documents incorporated by reference list.

Issues: The primary advantages are to hospices and their administrators, who will face less burdensome requirements in employing a medical director. Subject matter experts within the agency have determined that there are no disadvantages to repealing the requirement that hospice medical directors have admitting privileges at hospitals or nursing homes. Further, more up-to-date regulations will ensure that the industry is regulated accurately and efficiently, and will reduce confusion among regulated entities. There are no disadvantages to the public. There are no advantages or disadvantages to the agency or to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Virginia Board of Health (Board) proposes to: 1) eliminate the requirement that the medical director have admitting privileges at one or more hospitals and nursing facilities that provide inpatient service to the hospice program's patients, 2) set out requirements that would allow hospice programs to set up in-house training for volunteer home attendants, 3) make clarifying changes, and 4) correct citations and remove obsolete language.

Background. The Board conducted a periodic review¹ of 12 VAC 5-391 Regulations for the Licensure of Hospices, in which it decided to amend the regulation.

The current regulation lists six options for home attendants to qualify to work at a hospice. The first five options are for either paid or volunteer home attendants. Under the regulation volunteer home attendants can also qualify through the sixth option, which is that the individual Have satisfactorily completed training using the Personal Care Aide Training Curriculum, dated 2003, of the Department of Medical Assistance Services (DMAS). According to the Virginia Department of Health (VDH), this training is no longer available. The Board proposes to remove this obsolete option and set out requirements that would allow hospice programs to set up in-house training for volunteer home attendants.

Estimated Benefits and Costs. Public comments have indicated that the requirement that the medical director have admitting privileges at one or more hospitals and nursing facilities that provide inpatient service to the hospice programs patients has made it difficult for hospices to find qualified medical directors. The proposal to remove this requirement may therefore reduce hiring costs for some hospices. Subject matter experts from VDH believe that repealing this requirement would not jeopardize public health, safety, and welfare.

Since the DMAS training for personal care aides is no longer available, volunteer home attendants must currently qualify to serve hospices by one of the five options available to paid home attendants. VDH believes that the proposal to allow hospice programs to set up in-house training for volunteer home attendants would likely have a positive impact on a hospices ability to have qualified volunteers.

Businesses and Other Entities Affected. The proposals potentially affect the 133 licensed hospice agencies in Virginia.² No proposal would increase costs for businesses or other entities. No adverse impact is indicated.

Small Businesses Affected.

Types and Estimated Number of Small Businesses Affected. According to VDH, an estimated 18 of the hospices are independently owned and operated and have fewer than 500 full-time employees, therefore statutorily qualifying as small businesses.³

Costs and Other Effects. The proposal to no longer require that the medical director have admitting privileges at one or more hospitals and nursing facilities that provide inpatient service to the hospice programs patients may reduce the cost for small hospices to hire medical directors.

Alternative Method that Minimizes Adverse Impact. No proposal adversely impacts small businesses.

Localities⁴ Affected.⁵ The proposals do not disproportionately affect any particularly locality nor appear to introduce additional costs for local governments.

Projected Impact on Employment. The proposals do not appear to substantively affect total employment.

Effects on the Use and Value of Private Property. The proposal to no longer require that the medical director have admitting privileges at one or more hospitals and nursing facilities that provide inpatient service to the hospice programs patients may reduce the cost for hospices to hire medical directors, commensurately increasing their value.

The proposals do not affect real estate development costs.

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¹See https://townhall.virginia.gov/l/GetFile.cfm?File=C:\TownHall\docroot\Review\1473\PReview_VDH_1473_v1.pdf

²Data source: VDH

³Pursuant 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."

⁴Locality can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

⁵§ 2.2-4007.04 "defines particularly affected" as bearing disproportionate material impact."

Agency's Response to Economic Impact Analysis: The Virginia Department of Health has reviewed and concurs with the Department of Planning and Budget's economic impact analysis.

Summary:

The amendments (i) repeal a requirement that a hospice's medical director have admitting privileges at one or more hospitals or nursing homes that provide inpatient service to the hospice's patients; (ii) update references to other regulations and personal aide training curriculum; and (iii) update the documents incorporated by reference.

12VAC5-391-330. Medical direction.

A. There shall be a medical director, who shall be a physician licensed by the Virginia Board of Medicine, responsible for the overall direction and management of the medical component of care. The individual shall have training and experience in the psychological and medical needs of the terminally ill.

B. The medical director shall have admitting privileges at one or more hospitals and nursing facilities that provide inpatient service to the hospice program's patients.

C. B. The duties and responsibilities of the medical director shall include at least the following:

1. Consulting with attending physicians regarding pain and symptom management;

2. Reviewing patient eligibility for hospice services according to the law and the hospice program's admission policies;

3. Acting as a medical resource to the IDG;

4. Coordinating with attending physicians to assure a continuum of medical care in cases of emergency or in the event the attending physician is unable to retain responsibility for the patient's care;

5. Acting as medical liaison with physicians in the community; and

6. Determining, in consultation with the patient's physician, when a patient can no longer remain at home and should be moved to a congregate living facility of the patient's choosing.

12VAC5-391-340. Nursing services.

A. All nursing services shall be provided directly or under the supervision of a registered nurse, currently licensed by the Virginia Board of Nursing, who has education and experience in the needs of the terminally ill. Duties and responsibilities of the supervising nurse shall include:

1. Assuring that nursing services delivered are provided according to established hospice program policies;

2. Assuring that nursing services are available 24 hours a day, 7 days a week and that licensed practical nurses and home attendants work under the direct supervision of a registered nurse;

3. Participating in the development and implementation of orientation and in-service training hospice programs for all levels of nursing staff employed by the hospice program;

4. Acting as nurse liaison with staff and other agencies, hospice programs and individuals that have contractual agreements to provide nursing services;

5. Participating in quality improvement reviews and evaluations of the nursing services provided; and

6. Directing or supervising the delivery of nursing services.

B. Nursing services shall include, but are not limited to:

1. Assessing a patient's needs and admission for service as appropriate;

2. Working with the IDG to develop a plan of care;

3. Implementing the plan of care;

4. Obtaining physician's orders when necessary;

5. Providing those services requiring substantial and specialized nursing skill;

6. Educating the patient and patient's family in the care of the patient, including pain management;

7. Evaluating the outcome of services;

8. Coordinating and communicating the patient's physical or medical condition to the IDG;

9. Preparing clinical notes; and

10. Supervising licensed practical nurses and home attendants providing delegated nursing services.

C. A registered nurse shall coordinate the implementation of each patient's plan of care.

D. If nursing duties are delegated, the hospice program shall develop and implement an organizational plan pursuant to 18VAC90-20-420 18VAC90-19-240 through 18VAC90-20-460 of the Virginia Administrative Code 18VAC90-19-280.

E. Licensed practical nurses shall be currently licensed by the Virginia Board of Nursing.

F. The services provided by a licensed practical nurse may include, but are not limited to:

1. Delivering nursing services according to the hospice program's policies and standard nursing practices;

2. Assisting the registered nurse in performing specialized procedures;

3. Assisting the patient with activities of daily living, including the teaching of self-care techniques;

4. Preparing equipment and supplies for treatment that requires adherence to sterile or aseptic techniques; and

5. Preparing clinical notes.

12VAC5-391-350. Home attendant services.

A. Services of the home attendants may include, but are not limited to:

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

2. Administration of normally self-administered drugs in a patient's private residence 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. Taking and recording vital signs as indicated in the plan of care;

4. Measuring and recording fluid intake and output;

5. Recording and reporting to the health care professional changes in the patient's physical condition, behavior or appearance;

6. Documenting services and observations in the medical record; and

7. Performing any other duties that the attendant is qualified to do by additional training and demonstrated competency, within state guidelines.

B. Prior to the initial delivery of services, the home attendant shall receive specific written instructions for the patient'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 patient's care.

D. The nurse responsible for supervising the home attendant shall make visits to the patient's home as frequently as necessary, but not less than every two weeks. The results of each visit shall be documented in the medical record.

E. 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.

F. Home attendants shall be able to speak, read and write English and shall meet one of the following qualifications before providing services to the hospice program's patients:

1. Have satisfactorily completed a nursing education hospice program preparing for registered nurse licensure or practical nurse licensure;

2. Have satisfactorily completed a nurse aide education hospice program approved by the Virginia Board of Nursing;

3. Have certification as a nurse aide issued by the Virginia Board of Nursing;

4. Be successfully enrolled in a nursing education hospice program preparing for registered nurse or practical nurse licensure and have currently completed at least one nursing course that includes clinical experience involving patient care; or

5. Have satisfactorily passed a competency evaluation that meets the criteria of 42 CFR 484.36 (b); or.

6. Have satisfactorily completed training using the "Personal Care Aide Training Curriculum," dated 2003, of the Department of Medical Assistance Services. However, the training is permissible for volunteers only.

If the home attendant is a volunteer, the home attendant shall meet one of the qualifications listed in subdivisions 1 through 5 of this subsection or have satisfactorily completed training provided by a hospice program or other entity that meets the requirements of subsection G.

G. Hospice programs may develop a 40-hour training program for volunteers. The program shall:

1. Include education addressing:

a. Goals of personal care;

b. Prevention of skin breakdown;

c. Physical and biological aspects of aging;

d. Physical and emotional needs of older adults;

e. Orientation to types of physical disabilities;

f. Personal care and rehabilitative services;

g. Body mechanics;

h. Home management;

i. Safety and accident prevention in the home;

j. Policies and procedures regarding accidents or injuries;

k. Food, nutrition, and meal preparation;

l. Special considerations in preparation of special diets;

m. Care of the home and personal belongings; and

n. Documentation requirements for Medicaid individuals.

2. Be conducted by a registered nurse who meets the requirements in 18VAC90-26-30.
3. Issue and maintain certificates of completion containing:

a. The instructor's printed name and signature;

b. The participant's printed name; and

c. The date of completion of the program.

12VAC5-391-380. Dietary or nutritional counseling.

Dietary or nutritional counselors shall meet the requirements of 18VAC75-30 pursuant to Chapter 27.1 (§ 54.1-2730 et seq.) of Title 54.1 of the Code of Virginia and have at least two years experience in a health care food or nutrition delivery system.

12VAC5-391-440. General facility requirements.

A. All construction of new buildings and additions, renovations or alterations of existing buildings for occupancy as a hospice facility shall conform to state and local codes, zoning and building ordinances and the Uniform Statewide Building Code.

In addition, hospice facilities shall be designed and constructed according to section 4.2 of Part 4 of the 2006 3.2 of Part 3 of the 2018 Guidelines for Design and Construction of Health Care Residential Health, Care, and Support Facilities of the American Institute of Architects. However, the requirements of the Uniform Statewide Building Code and local zoning and building ordinances shall take precedence. the Facility Guidelines Institute.

B. All buildings shall be inspected and approved as required by the appropriate regional state fire marshal's office or building and fire regulatory official. Approval shall be a Certificate of Use and Occupancy indicating the building is classified for its proposed licensed purpose.

C. The facility must have space for private patient family visiting and accommodations for family members after a patient's death. Patients shall be allowed to receive guests, including small children, at any hour.

D. Patient rooms shall not exceed two beds per room and must be at grade level or above, enclosed by four ceiling-high walls. Each room shall be equipped for adequate nursing care, the comfort and privacy of patients, and with a device for calling the staff member on duty.

E. Designated guest rooms for family members or patient guests and beds for use by employees of the facility shall not be included in the bed capacity of a hospice facility provided such beds and locations are identified and used exclusively by staff, volunteers or patient guests.

Employees shall not utilize patient rooms nor shall bedrooms for employees be used by patients.

F. Waste storage shall be located in a separate area outside or easily accessible to the outside for direct pickup or disposal. The use of an incinerator shall require permitting from the nearest regional permitting office for the Department of Environmental Quality.

G. The facility shall provide or arrange for under written agreement, laboratory, x-ray, and other diagnostic services, as ordered by the patient's physician.

H. There shall be a plan implemented to assure the continuation of essential patient support services in case of power outages, water shortage, or in the event of the absence from work of any portion of the workforce resulting from inclement weather or other causes.

I. No part of a hospice facility may be rented, leased or used for any purpose other than the provision of hospice care at the facility.

J. A separate and distinct entrance shall be provided if the program intends to administer and provide its community-based hospice care from the facility so that such traffic and noise shall be diverted away from patient care areas.

K. The hospice facility shall maintain a complete set of legible "as built" drawings showing all construction, fixed equipment, and mechanical and electrical systems, as installed or built.

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-391)

Personal Care Aide Training Curriculum, 2003, Department of Medical Assistance Services.

2006 Guidelines for Design and Construction of Health Care Facilities, The Facility Guidelines Institute, The American Institute of Architects Academy of Architecture for Health, 1-800-242-3837.

2018 Guidelines for Design and Construction of Residential Health, Care, and Support Facilities, The Facility Guidelines Institute.