12VAC5-391 Regulations for the Licensure of Hospice

REGULATIONS

Vol. 25 Iss. 6 - November 24, 2008

TITLE 12. HEALTH

STATE BOARD OF HEALTH

Chapter 391

Proposed Regulation

Title of Regulation: 12VAC5-391. Regulations for the Licensure of Hospice (amending 12VAC5-391-10, 12VAC5-391-120, 12VAC5-391-150, 12VAC5-391-160, 12VAC5-391-180, 12VAC5-391-300, 12VAC5-391-440, 12VAC5-391-450, 12VAC5-391-460, 12VAC5-391-480, 12VAC5-391-500; adding 12VAC5-391-395, 12VAC5-391-445, 12VAC5-391-446, 12VAC5-391-485, 12VAC5-391-495, 12VAC5-391-510).

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

Public Hearing Information: No public hearings are scheduled.

Public Comments: Public comments may be submitted until 5 p.m. on January 23, 2009.

Agency Contact: Carrie Eddy, Policy Analyst, Department of Health, 3600 West Broad Street, Richmond, VA 23230, telephone (804) 367-5100, or email [e-mail].

Basis: Section 32.1-12 of the Code of Virginia authorizes the board to make, adopt, and promulgate regulations and provide for reasonable variances and exemptions therefrom as may be necessary to carry out the provisions of Title 32.1 of the Code of Virginia and other laws of the Commonwealth administered by it, the commissioner or the department.

The regulation is promulgated under the authority of § 32.1-162.5 of the Code of Virginia, which grants the Board of Health the legal authority "to prescribe such regulation governing the activities and services provided by hospices as may be necessary to protect the public health, safety and welfare." The passage of the 2007 Acts of Assembly requires that 12VAC5-391 be subsequently amended.

Purpose: This action establishes standards for those hospice providers seeking to establish dedicated board and care facilities for diagnosed terminally ill consumers receiving hospice care, but who can no longer remain in their own homes. The proposed regulations address patient care and safety, physical plant, maintenance and housekeeping, and emergency preparedness. The proposed amendments also rectify some omissions in the 2005 revised regulation. The amendments are intended to protect the health and safety of the patient receiving care in a hospice facility while allowing providers to be more responsive to the needs of patients.

Substance: The department has developed facility regulatory standards replicating the patient safety and physical plant standards under which hospice facilities operated prior to the enactment of Chapter 397 of the 2007 Acts of Assembly. Such facilities were dually licensed as an assisted living facility, a nursing facility or as a hospital and subject to the physical plant, safety, and maintenance and housekeeping standards as contained in the proposed amendments. The department expanded the existing hospice facility standards established in 2005 as part of the comprehensive revision of Regulations for the Licensure of Hospices. At that time, the department promulgated only those facility standards deemed essential to ensure basic patient care. The department relied on national standards of care, the hospice facility regulations of other states, as well as Virginia’s other facility licensure standards when developing the proposed amendments.

Issues: A segment of Virginia’s hospice community has endeavored to establish identifiable hospice facilities for some years. Until the enactment of Chapter 397 of the 2007 Acts of Assembly, those efforts proved unsuccessful because providers felt that dual licensure as an assisted living facility, nursing facility or hospital, as required, was overly burdensome and that the facility licensure regulations were not sufficiently flexible to implement services reflecting the hospice philosophy of care.

The 2005 comprehensive revision to the hospice licensure regulations included facility specific regulations, one of which required a registered nurse on duty on all shifts. Some hospice providers objected to this requirement. The department knew that a registered nurse on all shifts met with the hospice facility licensure provision in other states, as well as with federal hospice facility regulation. The department conducted a year-long pilot study to gather data to assess the impact of this requirement. At the end of the study, it was mutually agreed that appropriate care could be provided without an RN on duty if an RN was on-call within 20 minutes. However, the department learned there were still objections to the proposed staffing requirements. Some facility providers, in fact, advocated for no RN staffing in the dedicated hospice facilities. The department believes that these objections are primarily based on costs. Hospice patient care advocates do not consider costs a legitimate reason for opposing the registered nurse on duty criteria. Advocates cite the complexities of terminal illnesses, such as Alzheimer’s Disease, and the potential for medication errors and adverse drug reactions as sufficient cause to require a registered nurse on duty on all shifts. The department believes that the agreed-upon exception to the RN requirement for those facilities with six beds or less appropriately and adequately addresses the concerns of both parties.

No particular locality is affected more than another by this regulation. Promulgation of these amendments to 12VAC5-391 create no known advantages or disadvantages to the agency, the Commonwealth, or the hospice community. Every effort has been made to ensure the regulation protects the health and safety of patient receiving care in a hospice facility while allowing providers to be more responsive to the needs of their patients. Failure to implement the regulation will not negatively impact the overall provision of hospice care in Virginia.

The Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The Board of Health proposes to establish licensure requirements for providers of hospice services in a facility.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. The proposed regulations will establish licensure requirements under the authority of the Board of Health for the providers of hospice services in a facility. Hospice programs provide palliative care to terminally ill patients. The main purpose of a hospice program is to provide physical, psychological, and spiritual comfort during the final stages of a terminal illness and during dying and bereavement.

Approximately 100 hospice providers are licensed by the Virginia Department of Health (VDH). Most of these hospice providers provide services at the home of their patients and are already regulated by existing regulations. However, three hospice providers have been providing services at a designated facility in addition to serving most of their patients in their homes. Pursuant to 2003 Acts of Assembly, HB1822, the providers that offer services at a hospice facility were licensed under the Department of Social Services (DSS) regulations as an Assisted Living Facility. The 2003 legislation required a hospice provider wishing to provide services at a facility be licensed as an Assisted Living Facility under DSS regulations. Though not required, all of the facilities provide hospice services at home to most of their patients. Thus, if a facility wanted to provide hospice services at a facility they were subject to dual licensure by two different regulatory entities.

The 2007 Acts of Assembly, HB1965, establishes that providers wishing to provide services at a facility be licensed by VDH instead of DSS. Consequently, the Board of Health proposes regulations to establish rules for hospice providers wishing to provide services at a facility.

Because the providers of hospice services at a facility are already subject to DSS regulations, the net economic impact of the proposed regulations stems from the differences between existing DSS regulations and the proposed VDH regulations.

On one hand proposed regulations may increase compliance costs by adding that a hospice facility must have a registered nurse available at the facility or one must be available to respond to emergency calls within twenty minutes. This particular requirement appears to have created some controversy among the regulated facilities. Whether this proposed requirement is necessary or not is a medical question. As the Commonwealth’s regulatory medical authority, VDH believes the presence or accessibility of a registered nurse is essential for a hospice provider to provide services at a facility to ensure the health, safety, and welfare of the patients served. VDH also points out that hospice providers serving patients only at their homes are already required to comply with this requirement. Considering the patients at a facility are under the direct care of a hospice provider, it appears that they should be able to access a level of care at least as high as the level of care afforded to the patients served at their homes.

The economic effect of this proposed change is the cost difference between having a licensed practical nurse (LPN) and a registered nurse on staff. According to VDH, mean hourly wage rate for an RN is $27.89 and for a LPN is $17.73. If the facility pays for an RN for 24 hours everyday and 365 days in a year to comply with this requirement, the added compliance costs would be $89,002 annually. However, this estimate should be considered as the upper ceiling for the added costs because some facilities may be able to comply with this requirement by utilizing their existing RNs for a much lower compensation.

On the other hand, the proposed regulations may reduce compliance costs because a number of proposed rules are less stringent than the rules the facilities must have complied with under the DSS regulations. Among the less stringent requirements are no longer requiring licensure of the administrator, annual administrative training, Tuberculosis testing, and medication administration reports and manuals. These less stringent requirements have the potential to create some savings, offsetting some of the added compliance costs.

Businesses and Entities Affected. The proposed regulations apply to hospice providers providing services at a facility. Currently, there are three such facilities serving four or less patients each.

Localities Particularly Affected. The proposed regulations apply throughout the Commonwealth.

Projected Impact on Employment. The proposed regulations are expected to increase the demand for RN hours but the likely size of the actual increase cannot be determined.

Effects on the Use and Value of Private Property. The proposed regulations may reduce the asset value of hospice providers providing services at a facility if the additional compliance cost of complying with the RN staffing requirement is not fully offset by the cost savings from less stringent requirements. However, the likely size of net costs cannot be determined.

Small Businesses: Costs and Other Effects. All three hospice facilities affected are considered to be small businesses. Thus, the proposed regulations are estimated to increase the compliance costs as a result of the proposed RN staffing requirement and estimated to decrease the compliance costs as result of the proposed less stringent requirements. However, the likely size of net costs is not known.

Small Businesses: Alternative Method that Minimizes Adverse Impact. Given VDH’s determination that the RN services are medically necessary to ensure health, safety, and welfare of patients served at a hospice facility, there is no other alternative method that minimizes potential adverse impact on affected small businesses.

Real Estate Development Costs. The proposed regulations are not anticipated to create any real estate development costs.

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 36 (06). Section 2.2-4007.04 requires that such economic impact analyses include, but need not be limited to, 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 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 the Department of Planning and Budget's Economic Impact Analysis: The department concurs generally with the economic impact analysis performed by the Department of Planning and Budget.

Summary:

Chapter 391 of the 2007 Acts of Assembly places oversight of hospice facilities with the Department of Health and establishes that continuity of hospice services provided in a patient's home also be provided in a dedicated facility. This change in law necessitates amending the current regulation by expanding the standards addressing patient care and safety in hospice facilities. The proposed amendments also address omissions in the regulation when it was revised in 2005.

The proposed amendments (i) clarify definitions pertaining to hospice facility and inpatient services; (ii) provide clarification between a hospice facility and inpatient services in a hospital or nursing facility; (iii) require notifying the Department of Health of the relocation of a hospice facility; (iv) add provisions for handling medical errors and drug reactions; (v) require compliance with state and local codes, zoning and building ordinances and the Uniform Statewide Building Code; (vi) prohibit a hospice facility from being used for any purpose other than the provision of hospice services; (vii) require that a set of as-built plans be retained; (viii) establish additional physical plant requirements for operating a hospice facility; (ix) establish necessary hospice facility financial controls and requirements for handling patient funds; (x) require 24-hour nursing services including trained and supervised staff to meet the total needs of the hospice patients; (xi) allow facilities with six or fewer beds to have a single licensed nurse as long as patient needs are met; (xii) provide for a 20-minute response time if a registered nurse is not present at the facility; and (xiii) make changes to provide consistency with other facility-type regulations.

Part I
Definitions and General Information

12VAC5-391-10. Definitions.

The following words and terms when used in these regulations shall have the following meaning unless the context clearly indicates otherwise.

"Activities of daily living" means bathing, dressing, toileting, transferring, bowel control, bladder control and eating/feeding.

"Administer" means the direct application of a controlled substance, whether by injection, inhalation, ingestion or any other means, to the body of a patient by (i) a practitioner or by his authorized agent and under his supervision or (ii) the patient at the direction and in the presence of the practitioner as defined in § 54.1-3401 of the Code of Virginia.

"Administrator" means a person designated, in writing, by the governing body as having the necessary authority for the day-to-day management of the hospice program. The administrator must be a member of the hospice staff. The administrator, director of nursing, or another clinical director may be the same individual if that individual is dually qualified.

"Attending physician" means a physician licensed in Virginia, according to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, or licensed in an adjacent state and identified by the patient as having the primary responsibility in determining the delivery of the patient's medical care. The responsibilities of physicians contained in this chapter may be implemented by nurse practitioners or physician assistants as assigned by the supervising physician and within the parameters of professional licensing.

"Available at all times during operating hours" means an individual is available on the premises or by telecommunications.

"Barrier crimes" means certain offenses specified in § 32.1-162.9:1 of the Code of Virginia that automatically bar an individual convicted of those offenses from employment with a hospice program.

"Bereavement service" means counseling and support offered to the patient's family after the patient's death.

"Commissioner" means the State Health Commissioner.

"Coordinated program" means a continuum of palliative and supportive care provided to a terminally ill patient and his family, 24 hours a day, seven days a week.

"Core services" means those services that must be provided by a hospice program. Such services are: (i) nursing services, (ii) physician services, (iii) counseling services, and (iv) medical social services.

"Counseling services" means the provision of bereavement services, dietary services, spiritual and any other counseling services for the patient and family while the person is enrolled in the program.

"Criminal record report" means the statement issued by the Central Criminal Records Exchange, Virginia Department of State Police.

"Dedicated hospice facility" means an institution, place, or building providing room, board, and appropriate patient care 24 hours a day, seven days a week to individuals diagnosed with a terminal illness requiring such care pursuant to a physician's orders.

"Dispense" means to deliver a drug to the ultimate user by or pursuant to the lawful order of a practitioner, including the prescribing and administering, packaging, labeling or compounding necessary to prepare the substance for that delivery as defined in § 54.1-3401 of the Code of Virginia.

"Employee" means an individual who is appropriately trained and performs a specific job function for the hospice program on a full or part-time basis with or without financial compensation.

"Governing body" means the individual, group or governmental agency that has legal responsibility and authority over the operation of the hospice program.

"Home attendant" means a nonlicensed individual performing personal care and environmental services, under the supervision of the appropriate health professional, to a patient in the patient's residence. Home attendants are also known as certified nursing assistants or CNAs, home care aides, home health aides, and personal care aides.

"Hospice" means a coordinated program of home and inpatient care provided directly or through an agreement under the direction of an identifiable hospice administration providing palliative and supportive medical and other health services to terminally ill patients and their families. A hospice utilizes a medically directed interdisciplinary team. A hospice program of care provides care to meet the physical, psychological, social, spiritual and other special needs that are experienced during the final stages of illness, and during dying and bereavement. Hospice care shall be available 24 hours a day, seven days a week.

"Hospice facility" means an institution, place or building as defined in § 32.1-162.1 of the Code of Virginia.

"Inpatient" means services provided to a hospice patient who is admitted to a hospital or nursing facility on a short-term basis for the purpose of curative care unrelated to the diagnosed terminal illness. Inpatient does not mean services provided in a dedicated hospice facility the provision of services, such as food, laundry, housekeeping and staff to provide health or health-related services, including respite and symptom management, to hospice patients, whether in a hospital, nursing facility, or hospice facility.

"Interdisciplinary group" means the group responsible for assessing the health care and special needs of the patient and the patient's family. Providers of special services, such as mental health, pharmacy, and any other appropriate associated health services may also be included on the team as the needs of the patient dictate. The interdisciplinary group is often referred to as the IDG.

"Licensee" means a licensed hospice program provider.

"Medical director" means a physician currently licensed in Virginia, according to Chapter 29 (§ 54.1-2900 et seq.) of Title 54.1 of the Code of Virginia, and responsible for the medical direction of the hospice program.

"Medical record" means a continuous and accurate documented account of services provided to a patient, including the prescription and delivery of the treatment or care.

"Medication error" means one or more violations of the five principles of medication administration: the correct drug to the right patient at the prescribed time in the prescribed dose via the prescribed route.

"Nursing services" means the patient care performed or supervised by a registered nurse according to a plan of care.

"OLC" means the Office of Licensure and Certification of the Virginia Department of Health.

"Operator" means any individual, partnership, association, trust, corporation, municipality, county, local government agency or any other legal or commercial entity responsible for the day-to-day administrative management and operation of the hospice.

"Palliative care" means treatment directed at controlling pain, relieving other symptoms, and focusing on the special needs of the patient and family as they experience the stress of the dying process. Palliative care means treatment to enhance comfort and improve the quality of a patient's life during the last phase of his life.

"Patient" means a diagnosed terminally ill individual, with an anticipated life expectancy of six months or less, who, alone or in conjunction with designated family members or representatives, has voluntarily requested admission and been accepted into a licensed hospice program.

"Patient's family" means the hospice patient's immediate kin, including spouse, brother, sister, child or parent. Other relations and individuals with significant personal ties to the hospice patient may be designated as members of the patient's family by mutual agreement among the patient, the relation or individual.

"Patient's residence" means the place where the individual or patient makes his home.

"Person" means any individual, partnership, association, trust, corporation, municipality, county, local government agency or any other legal or commercial entity that operates a hospice.

"Plan of care" means a written plan of services developed by the interdisciplinary group to maximize patient comfort by symptom control to meet the physical, psychosocial, spiritual and other special needs that are experienced during the final stages of illness, during dying, and bereavement.

"Primary caregiver" means an individual that, through mutual agreement with the patient and the hospice program, assumes responsibility for the patient's care.

"Progress note" means a documented statement contained in a patient's medical record, dated and signed by the person delivering the care, treatment or service, describing the treatment or services delivered and the effect of the care, treatment or services on the patient.

"Quality improvement" means ongoing activities designed to objectively and systematically evaluate the quality of care and services, pursue opportunities to improve care and services, and resolve identified problems. Quality improvement is an approach to the ongoing study and improvement of the processes of providing services to meet the needs of patients and their families.

"Staff" means an employee who receives financial compensation.

"Supervision" means the ongoing process of monitoring the skills, competencies and performance of the individual supervised and providing regular face-to-face guidance and instruction.

"Terminally ill" means a medical prognosis that life expectancy is six months or less if the illness runs its usual course.

"Volunteer" means an employee who receives no financial compensation.

12VAC5-391-120. Dedicated hospice Hospice facilities.

A. Providers seeking to operate a dedicated hospice facility shall comply with the appropriate facility licensing regulation as follows:

1. Up to five patient beds, facilities shall be licensed as: Facilities with 16 or fewer beds shall be licensed as a hospice facility pursuant to this chapter. Such facilities with six or more beds shall obtain a Certificate of Use and Occupancy with a Use Group designation of I-2; or

a. An assisted living facility pursuant to 22VAC40-71;

b. A hospital pursuant to 12VAC5-410; or

c. A nursing facility pursuant to 12VAC5-371; or

2. Six or more patient beds, facilities shall be licensed as: Facilities with more than 16 beds shall be licensed as a hospital pursuant to 12VAC5-410 or as a nursing facility pursuant to 12VAC5-371. Such facilities shall obtain the applicable Certificate of Public Need prior to the development or construction of the facility.

a. An assisted living facility, pursuant to 22VAC40-71 with a classified Use Group of I-2;

b. A hospital pursuant to 12VAC5-410; or

c. A nursing facility pursuant to 12VAC5-371.

Facilities to be licensed as a hospital or a nursing facility shall obtain the applicable Certificate of Public Need (COPN).

B. Only patients diagnosed terminally ill shall be admitted to a dedicated hospice facility. The facility shall admit only those patients whose needs can be met by the accommodations and services provided by the facility.

C. To the maximum extent possible, care shall be provided in the patient's home. Admission to a dedicated hospice facility shall be the decision of the patient in consultation with the patient's physician. No patient shall be admitted to a hospice facility at the discretion of, or for the convenience of, the hospice provider.

D. No dedicated hospice facility shall receive for care, treatment, or services patients in excess of the its licensed bed capacity. However, facilities licensed as a nursing facility may provide temporary shelter for evacuees displaced due to a disaster. In those cases, the facility may exceed the licensed capacity for the duration of that emergency only provided the health, safety, and well being of all patients is not compromised and the OLC is notified.

E. All hospice providers operating a hospice facility shall provide, to the extent possible, respite and symptom management services for their patients needing such services.

E. F. No dedicated hospice facility provider shall add additional patient beds or renovate facility space without first notifying the OLC and the applicable facility licensing authority. OLC notifications must be in writing to the director of the OLC.

F. G. The OLC will not accept any requests for variances to this section.

12VAC5-391-150. Return of a license.

A. The circumstances under which a license must be returned include, but are not limited to:

(i) change 1. A change in ownership or operator,;

(ii) change in hospice 2. A change in program name,;

(iii) relocation 3. The relocation of the administrative office,;

(iv) discontinuation 4. The discontinuation of any core services,; and

(v) establishment of a dedicated 5. The relocation of a hospice facility.

B. The licensee shall notify its patients and the OLC in writing 30 days prior to discontinuing any services.

C. If the hospice program is no longer operational, or the license is revoked or suspended, the license shall be returned to the OLC within five working days. The licensee is responsible for notifying its patients and the OLC where all medical records will be located.

Part II
Administrative Services

12VAC5-391-160. Management and administration.

A. No person shall establish or operate a hospice program or a hospice facility, as defined in § 32.1-162.1 of the Code of Virginia, without having obtained a license.

B. The hospice program must comply with:

1. This chapter (12VAC5-391);

2. Other applicable federal, state or local laws and regulations; and

3. The hospice program's own policies and procedures.

When applicable regulations are similar, the more stringent regulation shall take precedence.

C. The hospice program shall submit or make available reports and information necessary to establish compliance with this chapter and applicable law.

D. The hospice program shall permit representatives from the OLC to conduct inspections to:

1. Verify application information;

2. Determine compliance with this chapter;

3. Review necessary records and documents; and

4. Investigate complaints.

E. The hospice program shall notify the OLC 30 working days in advance of changes effecting the hospice program, including the:

1. Location of the administrative office or mailing address of the hospice program;

2. Ownership or operator;

3. Services provided;

4. Administrator;

5. Hospice program name;

6. Establishment or relocation of a dedicated hospice facility; and

7. Closure of the hospice program.

F. The current license from the department shall be posted for public inspection.

G. Service providers or individuals under contract must comply with the hospice program's policies and this chapter, as appropriate.

H. The hospice program shall not use any advertising that contains false, misleading or deceptive statements or claims, or false or misleading disclosures of fees and payment for services.

I. The hospice program shall have regular posted business hours and be fully operational during business hours. Patient care services shall be available 24 hours a day, seven days a week. This does not mean that a hospice program must accept new clients on an emergency basis during nonbusiness hours.

J. The hospice program shall accept a patient only when the hospice program can adequately meet that patient's needs.

K. The hospice program must have an emergency preparedness plan in case of inclement weather or natural disaster to include contacting and providing essential care to patients, coordinating with community agencies to assist as needed, and maintaining current information on patients who would require specialized assistance.

L. The hospice program shall encourage and facilitate the availability of flu shots for its staff and patients.

12VAC5-391-180. Administrator.

A. The governing body shall appoint as administrator an individual who has evidence of at least one year of training and experience in direct health care service delivery with at least one year, within the last five years, of supervisory or administration management experience in hospice care or a related health care delivery system.

B. The administrator shall have operational knowledge of Virginia's hospice laws and regulations and the interrelationship between state licensure and national certification or accrediting organizations such as the Centers for Medicare and Medicaid Services and The Joint Commission (formerly the Joint Commission on Accreditation and Healthcare Organizations).

B. C. The administrator shall be responsible for the day-to-day management of the hospice program, including but not limited to:

1. Organizing and supervising the administrative functions of the hospice program;

2. Maintaining an on-going ongoing liaison with the governing body, the professional personnel and staff;

3. Employing qualified personnel and ensuring adequate employee orientation, training, education and evaluation;

4. Ensuring the accuracy of public information materials and activities;

5. Implementing an effective budgeting and accounting system;

6. Maintaining compliance with applicable laws and regulations and implementing corrective action in response to reports of hospice program committees and regulatory agencies;

7. Arranging and negotiating services provided through contractual agreement; and

8. Implementing the policies and procedures approved by the governing body.

C. An individual who meets the qualifications of subsection A of this section shall be D. The individual designated in writing to perform the duties of the administrator when the administrator is absent from the hospice program shall be able to perform those duties of the administrator as identified in subsection C of this section.

Hospice programs shall have one year from the effective date of this chapter to ensure that the individuals currently designated meet the qualifications of subsection A of this section.

D. E. The administrator or alternate shall be available at all times during operating hours and for emergency situations.

Part III
Hospice Program Services

Article 1
Hospice Services

12VAC5-391-300. Hospice services.

A. Each hospice shall provide a coordinated program of services encompassing the hospice philosophy that:

1. The unit of care consists of the patient, the primary caregiver, and the patient's family;

2. Emphasizes in-home care;

3. A designated interdisciplinary group supervises the patient's care;

4. A patient's symptoms and physical pain will be appropriately assessed and managed;

5. Services are available 24 hours a day, 7 days a week;

6. Inpatient care is provided in an atmosphere as home-like as practical;

7. Bereavement services are available to the family after the death of the patient; and

8. Trained volunteers are utilized to perform specific job functions in the hospice service delivery system.

B. Specific services provided according to the plan of care shall include:

1. Nursing services;

2. Counseling services;

3. Medical social services;

4. Physician services;

5. Physical therapy, occupational therapy, speech-language pathology;

6. Home attendant services;

7. Short-term inpatient care; and

8. Medical appliances and supplies, including drugs and biologicals, relevant to the patient's terminal illness.

C. Inpatient services shall be provided in a licensed hospital or nursing facility.

D. C. There shall be a written transfer agreement with an inpatient facility for one or more hospitals sufficiently close to the hospice's service area to permit the transfer of patients if medical complications arise. Such agreement shall include, but is not limited to, interagency communication processes and coordination of the patient's plan of care, and shall clearly identify the services to be provided by the facility and the hospice each entity while the patient is at the inpatient facility hospital.

D. Provisions shall be made to obtain appropriate transportation in cases of emergency.

E. All prescription drugs shall be prescribed and properly dispensed to patients according to the provisions of 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 the prescription drugs authorized by § 54.1-3408 of the Drug Control Act, such as epinephrine for emergency administration, normal saline and heparin flushed for the maintenance of IV lines, and adult immunizations, which may be given by a nurse pursuant to established protocol.

12VAC5-391-395. Medication errors and drug reactions.

A. In the event of a medication error or adverse drug reaction, employees shall promptly notify the patient's physician, the medical director, the nurse and the patient's family and shall take action as directed.

B. Actions taken shall be documented in the patient's record.

C. The hospice facility shall review all medication errors at least quarterly as part of its quality assurance program.

Part IV
Dedicated Hospice Facilities

12VAC5-391-440. General facility requirements.

A. In addition to the facility licensure requirements in 12VAC5-391-120, providers of dedicated hospice facilities shall maintain compliance with the standards of this section.

B. A. All construction of new buildings and additions, renovations or alterations of existing buildings for occupancy as a dedicated hospice facility shall comply with applicable state and federal laws and regulations 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 Guidelines for Design and Construction of Health Care 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.

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 shall provide 24-hour nursing services sufficient to meet the total nursing needs according to individual plans of care, including treatments, medication, and diet as prescribed, of the patients and shall keep patients comfortable, clean, well-groomed, and protected from accident, injury, and infection.

D. 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.

E. D. Patient rooms shall not exceed two beds per room and must be at grade level or above, enclosed by four ceiling-high walls, and able to house one or more patients. 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.

F. 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.

G. 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.

H. The facility shall assist in obtaining transportation, when necessary, to obtain medical and psychiatric care, routine and emergency dental care, diagnostic or other services outside the facility.

I. 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.

J. 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. 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.

12VAC5-391-445. Additional building regulations and standards.

A. Water shall be obtained from an approved water supply system. Hospice facilities shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

B. Each hospice facility shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

C. The hospice facility's food services shall comply with 12VAC5-421.

D. A hospice facility's pharmacy services shall comply with Chapters 33 (§ 54.1-3300 et seq.) and 34 (§ 54.1-3400 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20.

12VAC5-391-446. Financial controls and patient funds.

A. All financial records, including resident funds, shall be kept according to generally accepted accounting principles.

B. Hospice facilities choosing to handle patient funds shall, upon receipt of a patient's written delegation of this responsibility:

1. Give the patient at least a quarterly accounting of financial transactions made on his behalf and shall permit the patient access to the records of financial transactions made on his behalf at least once a month;

2. Purchase a surety bond or otherwise provide assurance for the security of all personal funds deposited with the facility; and

3. Provide for separate accounting of patient funds.

C. In the event the hospice facility is sold, the provider shall verify that all patient funds have been transferred or returned to the patient and shall obtain a signed receipt from the new owner of all patient funds transferred. Upon receipt, the new owner shall provide an accounting of resident funds transferred to the respective patient.

D. When a patient with funds deposited with the facility leaves or is discharged, the facility shall give a final accounting, within 30 days, of those funds to the patient or the individual administering the patient's estate and, if appropriate, refund any money due.

12VAC5-391-450. Required staffing.

A. Each shift must include at least one registered nurse providing direct patient care There shall be an individual, designated in writing, responsible for the day-to-day management and operation of the hospice facility. Such individual shall report directly to the program administrator and shall be qualified to perform the duties identified in 12VAC5-391-180 C.

B. Minimum staffing for a hospice facility with five patient beds shall consist of one registered nurse and one additional direct care staff member on duty at all times. Staffing for hospice facilities with six or more beds shall be based on the assessed needs of the patients in the facility The facility shall provide 24-hour nursing services sufficient to meet the total nursing needs of its patients according to individual plans of care, including treatments, medication, and diet as prescribed, and shall keep patients comfortable, clean, well-groomed, and protected from accident, injury and infection.

C. The hospice facility shall have a sufficient number of trained and supervised staff to meet the needs of each patient. At least two staff, one of which is a licensed nurse, must be on duty when patients are present. However, facilities with six or fewer beds may staff with a single licensed nurse provided compliance with subsection B of this section is maintained.

If the nurse on duty is not a registered nurse, then a registered nurse must be on call and able to respond to emergent calls within 20 minutes.

12VAC5-391-460. Pharmacy services.

A. Provision shall be made for the procurement, storage, dispensing, and accounting of drugs and other pharmacy products. This may be by arrangement with an off-site pharmacy, but must include provisions for 24-hour emergency service Whether medications and biologicals are obtained from community or institutional pharmacies, the hospice facility is responsible for assuring availability for medications and biologicals, including 24-hour emergency services, for its patients and for ensuring that pharmaceutical services are provided according to accepted professional principles and appropriate federal and state laws.

B. The dedicated facility shall comply with the Virginia Board of Pharmacy regulations related to pharmacy services in long-term care facilities, i.e., Part XII (18VAC110-20-530 et seq.) of the Virginia Board of Pharmacy Regulations.

C. Each dedicated hospice facility shall develop and implement policies and procedures for the handling of drugs and biologicals, including procurement, storage, administration, medication errors, self-administration and, disposal and accounting of drugs and other pharmacy products.

D. Each facility shall have a written agreement with a qualified pharmacist to provide consultation on all aspects of the provision of pharmacy services in the facility.

The consultant pharmacist shall make regularly scheduled visits, at least monthly quarterly, to the facility for a sufficient number of hours to carry out the function of the agreement.

E. Each prescription container shall be individually labeled by the pharmacist for each patient or provided in an individualized unit dose system.

F. No drug or medication shall be administered to any patient without a valid verbal order or a written, dated and signed order from a physician, dentist or podiatrist, nurse practitioner or physician assistant, licensed in Virginia.

G. Verbal orders for drugs or medications shall only be given to a licensed nurse, pharmacist or physician.

H. Each patient's medication regimen shall be reviewed by a pharmacist licensed in Virginia. Any irregularities identified by the pharmacist shall be reported to the physician and the director of nursing, and their response documented.

I. Medication orders shall be reviewed at least every 60 days by the attending physician, nurse practitioner, or physician's assistant.

J. Prescription and nonprescription drugs and medications may be brought into the facility by a patient's family, friend or other person provided:

1. The individual delivering the drugs and medications assures timely delivery, in accordance with the facility's written policies, so that the patient's prescribed treatment plan is not disrupted;

2. Each drug or medication is in an individual container; and

3. Delivery is not allowed directly to an individual patient.

In addition, prescription medications shall be:

4. Obtained from a pharmacy licensed by the state or federal authority; and

5. Securely sealed and labeled by a licensed pharmacist according to 18VAC110-20-330 and 18VAC110-20-340.

12VAC5-391-480. Food Dietary and food service.

A. The facility shall provide dietary services to meet the daily nutritional needs of patients.

B. If the facility has patients requiring medically prescribed special diets, the menus for such diets shall be planned by a dietitian qualified according to Chapter 27.1 (§ 54.1-2730 et seq.) of Title 54.1 of the Code of Virginia, or shall be reviewed and approved by a physician. The facility shall provide supervision of the preparation and serving of any special diets The hospice facility shall employ sufficient assigned food service personnel trained to provide a hygienic dietary service that meets the daily nutritional and special dietary needs of patients, and provides palatable and attractive meals.

C. When meals are catered to a hospice facility, such meals shall be obtained from a food service establishment licensed by the Virginia Department of Health. There shall be a current written contract with the food service establishment pursuant to 12VAC5-391-230.

D. The hospice facility shall contract with a consulting registered dietitian, who meets the qualifications of § 54.1-2731 of the Code of Virginia, to provide guidance to the facility's food service personnel on methods for maintaining the dietary service, planning of nutritionally balanced meals, and assessing the dietary needs of individual patients. The dietitian's duties shall include the following:

1. Developing menus, including therapeutic diets prescribed by a patient's physician;

2. Developing, revising, and annually reviewing dietary policies, procedures and job descriptions;

3. Assisting in planning and conducting regularly scheduled inservice training that includes, but is not limited to:

a. Therapeutic diets;

b. Food preparation requirements; and

c. Principles of sanitation.

4. Visiting patients on a regular basis to discuss nutritional problems, depending upon their needs and level of care, and recommending appropriate solutions.

E. Menus shall meet the dietary allowances of the Food and Nutritional Board of the National Academy of Sciences, as adjusted for age, sex, and activity level.

F. A copy of a diet manual containing acceptable practices and standards for nutrition must be kept current and on file in the food preparation area.

G. Food service facilities shall be located in a designated area and shall include the following rooms or spaces:

1. Kitchen;

2. Dishwashing;

3. Food storage; and

4. Dining room.

H. At least three meals, served at regular intervals, shall be provided daily to each patient, unless contraindicated as documented by the attending physician in the patient's medical record.

I. Special attention shall be given to preparation and prompt serving in order to maintain correct food temperatures for serving.

J. Between meal snacks of nutritional value shall be available upon request to each patient according to their plan of care.

K. Therapeutic diets shall be prepared and served as prescribed by the attending physician.

L. Employees assigned to other duties in the facility and visitors shall not be allowed in the food preparation area during food preparation and patient meal service hours, except in cases of emergency.

M. Weekly menus, including therapeutic diets, substitutes, and copies of menus, as served, shall be retained on file for 12 months.

N. Disposable dinnerware or tableware shall be used only for emergencies, for infection control, as part of special activities, or as indicated in a patient's plan of care.

O. For hospice facilities with 13 or more patient beds:

1. The dietary and food service operation shall meet all applicable sections of 12VAC5-421; and

2. There shall be a food service manager, qualified as allowed in 12VAC5-421-60, responsible for the full-time management and supervision of the dietary service.

12VAC5-391-485. Maintenance and housekeeping.

A. The hospice facility shall be maintained and equipped to provide a functional, sanitary, safe, and comfortable environment.

B. A documented preventive maintenance program shall be established to ensure that equipment is operative and that the interior and exterior of the building or buildings are maintained in good repair and free from hazards and litter.

C. The administrator shall designate an employee responsible for carrying out these functions and for training and supervising housekeeping and maintenance personnel.

D. The heating, ventilation and air conditioning system shall be capable of maintaining temperatures between 70°F and 80°F throughout patient areas.

E. The hospice facility shall have an effective pest control program either by maintenance personnel or by contract with a pest control company.

F. The hospice facility shall provide adequate space, equipment and supplies for any special services to be offered.

G. All furniture shall be kept clean and safe for use.

H. Over bed tables shall be available as needed.

I. Stretchers and wheelchairs shall be stored out of the path of normal traffic.

J. A sufficient number of wheelchairs and chairs shall be provided for patients whose physical conditions indicate a need for such equipment.

K. Refuse containers shall be emptied and cleaned at frequent intervals.

L. Hazardous cleaning solutions, compounds and substances shall be labeled, stored and kept under lock in a safe place separate from other materials.

12VAC5-391-495. Transportation.

The hospice facility shall assist a patient in obtaining transportation when it is necessary to obtain medical, psychiatric, dental, diagnostic or other services outside the facility.

12VAC5-391-500. Pet care.

A. If the facility chooses to permit pets, then healthy animals that are free of fleas, ticks and intestinal parasites, that have been screened by a veterinarian prior to entering the facility, that have received required inoculations and that represent no apparent threat to the health, safety, and well-being of the patients may be permitted provided they are properly cared for and the pet and its housing or bedding are kept clean The hospice facility shall implement policies regarding pets, whether the pet is visiting or in residence.

B. Pets shall not be allowed near patients with pet allergies or patients choosing not to be disturbed by animals. The hospice facility shall ensure that any patient's rights, preferences, and medical needs are not compromised by the presence of an animal. Pets shall not be allowed in dining and kitchen areas when food is being prepared or served.

C. All pets, whether visiting or in residence, shall be in good health, clean and well-groomed, show no evidence of carrying disease, have a suitable temperament, and pose no significant health or safety risks to patients, staff, volunteers, or visitors.

D. For pets in residences, the facility shall:

1. Disclose to potential and current patients the types of pets and the conditions under which pets are allowed in residence;

2. Maintain documentation of disclosure of pet policies in the patients' records;

3. Ensure that, before living in the facility, the pet's owner provides current documentation that the pet has had all recommended or required immunizations;

4. Ensure that regular pet examinations and immunizations are maintained; and

5. Ensure that resident pets are properly cared for and that the pet and its housing or bedding are kept clean.

12VAC5-391-510. Safety and emergency preparedness.

A. A written emergency preparedness plan shall be developed, reviewed, and implemented when needed. The plan shall address responses to natural disasters, as well as fire or other emergencies that disrupts the normal course of operations. The plan shall include, but not be limited to:

1. The continuation of essential patient support services in case of power outages, water shortages, or in the event of absences from work of any portion of the workforce resulting from inclement weather or other causes;

2. The preparation of patients for potential or imminent emergencies and disasters;

3. Alerting emergency personnel and sounding alarms;

4. Using, maintaining and operating emergency equipment;

5. Accessing patient emergency medical information;

6. Utilizing community support services;

7. A sheltering plan that addresses, but is not limited to:

a. Sheltering in place as well as off-site relocation arrangements;

b. Implementing evacuation procedures; and

c. A letter of agreement with off-site sheltering locations;

8. A transportation plan including:

a. Agreements with entities for relocating patients;

b. Number and type of vehicles required; and

c. Procedures for providing appropriate medical support and medications during relocation; and

9. A staffing plan for relocated patients, including:

a. The number and type of staff needed to provide appropriate care to relocated patients; and

b. Plans for relocating staff or assuring transportation to the sheltering facility.

B. All staff shall participate in periodic emergency preparedness training.

C. Staff shall have documented knowledge of, and be prepared to implement, the emergency preparedness plan in the event of an emergency.

D. At least one telephone shall be available in each area to which patients are admitted and additional telephones or extensions as are necessary to ensure availability in case of need.

E. In the event of a disaster, fire, medication error, suspicious death, emergency or any other condition that may jeopardize the health, safety and well-being of patients, the facility shall notify the department of the conditions and status of the patients and the hospice facility as soon as possible, but no later than 24 hours after the incident.

F. The hospice facility shall have a policy on smoking.

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.

VA.R. Doc. No. R08-964; Filed October 30, 2008, 3:05 p.m.