Administrative Code

Virginia Administrative Code
1/27/2023

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 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 untrue, deceptive, or misleading statements or claims or untrue, deceptive, 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, natural disaster, or pandemic disease outbreaks 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.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008; Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-170. Governing body.

A. The hospice program shall have a governing body that is legally responsible for the management, operation and fiscal affairs of the hospice program. The governing body of the hospital, nursing facility or home health agency that operates a hospice shall include in its internal organizational structure an identifiable unit of hospice services.

B. The governing body shall adopt written by-laws describing the hospice program structure, including the:

1. Hospice program's objectives;

2. Scope of services;

3. Relationship of the hospice program's services to other services operated by the governing body, if applicable, or by written agreement with the governing body of an affiliated medical service provider; and

4. Establishment of a quality improvement committee.

At least every two years, the governing body shall review and approve necessary changes to the program's by-laws.

C. The governing body shall review annually and approve the recommendations of the quality improvement committee.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

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 other applicable state laws and regulations as well as national certification or accrediting organizations such as the Centers for Medicare and Medicaid Services and The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations).

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 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.

D. The individual designated 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.

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

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 27, Issue 11, eff. March 2, 2011.

12VAC5-391-190. Written policies and procedures.

A. The hospice program shall implement written policies and procedures approved by the governing body.

B. All policies and procedures shall be reviewed at least annually, with recommended changes submitted to the governing body for approval, as necessary.

C. Administrative and operational policies and procedures shall include:

1. Administrative records;

2. Admission and discharge criteria;

3. Informed consent;

4. Advance directives, including Durable Do Not Resuscitate Orders;

5. Patient rights;

6. Pain assessment and management;

7. Medical supplies and appliances including drugs and biologicals, disposal of controlled drugs when no longer needed by patients, and handling of medications procured from a pharmacy of the patient's choice;

8. Contract services;

9. Transfer of patients to an inpatient facility including arrangements for an ambulance and the patient escort, when appropriate, to the facility by a professional staff member of the hospice program;

10. Medical social services;

11. Quality improvement;

12. Communicable and reportable diseases;

13. Post-mortem activities;

14. Mandated reporting of abuse, neglect, and exploitation pursuant to § 63.2-1606 of the Code of Virginia;

15. Medical records, including confidentiality;

16. Record retention, including termination of services;

17. Supervision and delivery of services;

18. Interdisciplinary group duties and responsibilities;

19. Bereavement and spiritual services;

20. Volunteer services;

21. Infection control;

22. Special services;

23. Emergency preparedness;

24. Handling consumer complaints; and

25. Approved variances.

D. Financial policies and procedures shall include:

1. Admission agreements;

2. Data collection and verification of services delivered;

3. Methods of billing for services by the hospice program and contractors;

4. Patient notification of changes in fees and charges;

5. Refund policy and correction of billing errors; and

6. Collection of delinquent patient accounts.

E. Personnel policies and procedures shall include a:

1. Written job description specifying responsibility, qualifications, and authority for each job classification;

2. Process for obtaining a criminal background check;

3. Process for maintaining an accurate, complete, and current personnel record for each employee;

4. Process for verifying current professional credentials and training of employees, or independent contractors;

5. Process for annually evaluating employee performance and competency;

6. Process for verifying that contractors and their employees meet the personnel qualifications of the hospice program; and

7. Process for reporting licensed and certified medical personnel for violations of the licensing or certification to the appropriate board within the Department of Health Professions.

F. Admission and discharge policies and procedures shall include:

1. Criteria for accepting patients;

2. The process for assessing a patient and maintaining a plan of care;

3. Criteria for determining discharge from hospice and referral to other agencies or community services; and

4. Process for notifying patients of intent to discharge or refer, including:

a. Oral and written notice and explanation of the reason for discharge or referral;

b. The name, address, telephone number, and contact name at the referral hospice program; and

c. Documentation in the medical record of the referral or notice.

G. Policies shall be made available for review, upon request, to patients and their designated representatives.

H. Policies and procedures shall be readily available for staff use at all times.

I. The hospice program shall establish policies and procedures for the disposal of drugs dispensed as part of the hospice plan of care to include:

1. Disposal shall be performed by a licensed nurse, physician assistant, or physician employed by or under contract with the hospice program;

2. Disposal shall be witnessed by a patient's family member or another employee of the hospice program who is licensed by a health regulatory board within the Department of Health Professions;

3. Disposal shall be documented in the patient's medical record; and

4. Disposal shall comply with all state and federal requirements for the safe disposal of drugs.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 35, Issue 4, eff. November 14, 2018.

12VAC5-391-200. Financial controls.

A. The hospice program shall document financial resources to operate based on a working budget showing projected revenue and expenses. Hospice programs operating dedicated hospice facilities shall have financial resources to operate based on a separate working budget showing projected revenue and expenses.

B. All financial records shall be kept according to generally accepted accounting principles (GAAP).

C. All financial records shall be audited at least triennially by an independent certified public accountant or audited as otherwise provided by law.

D. The hospice program shall have documented financial controls to minimize risk of theft or embezzlement.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-210. Personnel practices.

A. Personnel management and employment practices shall comply with applicable state and federal laws and regulations.

B. The hospice program shall design and implement a staffing plan that reflects the types of services offered and shall provide qualified staff in sufficient numbers to meet the assessed needs of all patients, including those patients residing in the provider's hospice facility, if applicable.

C. Employees and contractors shall be licensed or certified as required by the Department of Health Professions.

D. The hospice program shall implement a mechanism to verify professional credentials.

E. Any person who assumes the responsibilities of any staff position or positions shall meet the minimum qualifications for that position or positions. Professional staff may be assigned multiple job responsibilities provided the individual is appropriately qualified.

F. The hospice program shall obtain the required sworn statement and criminal record check for each compensated employee as specified in § 32.1-162.9:1 of the Code of Virginia.

G. Each employee position shall have a written job description that includes:

1. Job title;

2. Duties and responsibilities required of the position;

3. Job title of the immediate supervisor; and

4. Minimum knowledge, skills, and abilities or professional qualifications required for entry level.

H. Employees shall have access to their current position description. There shall be a mechanism for advising employees of changes to their job responsibilities.

I. New employees and contract individuals shall be oriented commensurate with their function or job-specific responsibilities. Orientation shall include:

1. Objectives and philosophy of the hospice program;

2. Confidentiality practices;

3. Patient rights;

4. Mandated reporting of abuse, neglect and exploitation;

5. Applicable personnel policies;

6. Emergency preparedness procedures;

7. Infection control practices and measures; and

8. Applicable laws, regulations, and other policies and procedures that apply to specific positions and specific duties and responsibilities.

J. The hospice program shall implement a policy for evaluating employee performance.

K. Individual staff development needs and plans shall be a part of the performance evaluation.

L. The hospice program shall provide opportunities for and record participation in staff development activities designed to enable staff to perform the responsibilities of their positions.

M. All individuals who enter a patient's home for or on behalf of the hospice program shall be readily identifiable by employee nametag.

N. The hospice program shall maintain an organized system to manage and protect the confidentiality of personnel files and records.

O. Employee personnel records, whether hard-copy or electronic, shall include:

1. Identifying information;

2. Education and training history;

3. Employment history;

4. Results of the verification of applicable professional licenses or certificates;

5. Results of reasonable efforts to secure job-related references and reasonable verification of employment history;

6. Results of performance evaluations;

7. A record of disciplinary actions taken by the hospice program, if any;

8. A record of adverse action by any licensing bodies and hospice programs, if any;

9. A record of participation in staff development activities, including orientation;

10. The criminal record check; and

11. A signed job description.

P. Each employee personnel record shall be retained in its entirety for a minimum of three years after termination of employment.

Q. Personnel record information shall be safeguarded against loss and unauthorized use.

R. Employee health-related information shall be maintained separately within the hospice program's personnel files, but may be maintained in a separate secure section for confidentiality.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-220. Indemnity coverage.

A. The governing body shall ensure the hospice program and its contractors have appropriate indemnity coverage to compensate patients for injuries and losses resulting from services provided.

B. To protect the interests of patients, employees, and the hospice program from risks of liability, there shall be indemnity coverage to include:

1. General liability insurance covering personal property damages, bodily injuries, product liability, liable and slander of at least $1 million comprehensive general liability per occurrence; and

2. Malpractice insurance for all nursing and medical professional employees consistent with § 8.01-581.15 of the Code of Virginia.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-230. Contract services.

A. If the hospice program contracts for services, there shall be a written agreement for the provision of those services.

B. The written agreement shall include, but is not limited to:

1. The services to be furnished by each party to the contract;

2. The contractor's responsibility for participating in developing plans of care;

3. The manner in which services will be controlled, coordinated, and evaluated by the hospice program;

4. The procedures for submitting clinical and progress notes, scheduling of visits, and periodic patient evaluation;

5. The process for payment for services furnished under the contract; and

6. Adequate indemnity coverage.

C. The hospice program shall have procedures for providing patient services in the event the contractor is unable to comply with the plan of care.

D. The contractor shall conform to applicable hospice program policies and procedures as specified in the contract, including the required sworn statement and criminal record check.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-240. Patient rights.

A. The hospice program shall establish and implement written policies and procedures regarding the rights of patients. A copy of the patient's rights shall be displayed in the hospice office for public review.

B. Written procedures to implement the policies shall ensure that each patient is:

1. Treated with courtesy, consideration and respect;

2. Assured the right to privacy;

3. Assured confidential treatment of his medical and financial records as provided by law;

4. Free from mental and physical abuse and property exploitation;

5. Assured the right to participate in the planning of his care, including appropriate assessment and management of pain and the right to refuse services;

6. Served by individuals who are properly trained and competent to perform their duties;

7. Assured the right to voice grievances and complaints related to hospice program services without fear of reprisal;

8. Advised, before care is initiated, of the extent to which payment for services may be expected from federal or state programs, and the extent to which payment may be required from the patient;

9. Advised orally and in writing of any changes in fees for services that are the patient's responsibility. The hospice program shall advise the patient of these changes as soon as possible but no later than 30 calendar days from the date the hospice program became aware of the change;

10. Provided with advance directive and Durable Do Not Resuscitate Order information prior to start of services; and

11. Given five days oral and written notice when the hospice program determines to terminate services.

C. At the time of admission, patient rights shall be reviewed with patients and primary caregivers who shall receive a written summary of the policies. The review shall be documented in the patient's record.

D. Before care is initiated, the hospice program shall inform the patient, orally and in writing, of the general nature of hospice care and policies of the hospice program, including, but not limited to:

1. The type and frequency of service or services to be delivered, the purpose of the service or services, and the name of the individual supervising the service or services;

2. Any anticipated effects of treatment, as applicable:

3. A schedule of charges for services;

4. The method of billing and payment for services, including the:

a. Services to be billed to third party payers;

b. Extent to which payment may be expected from third party payers known to the hospice program; and

c. Services that may not be covered by third party payers;

5. The charges that the individual may have to pay;

6. The requirements of notice for cancellation or reduction in services by the hospice program and the patient; and

7. The refund policies of the hospice program.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-250. Complaints.

A. The hospice program shall establish and maintain complaint handling procedures that specify the:

1. System for logging receipt, investigation and resolution of complaints;

2. Format of the written record;

3. Method in which the adult protective services unit of the local social services department is to be informed and for what complaints; and

4. Description of the appeal rights if a complainant is not satisfied with the resolution.

B. The hospice program shall designate staff responsible for complaint resolution, including:

1. Complaint intake, including acknowledgment of complaints;

2. Investigation of the complaint;

3. Review of the investigation of findings and resolution of the complaint; and

4. Written notification to the complainant of the proposed resolution within 30 days from the date of receipt of the complaint.

C. The patient or his designee shall be given a copy of the hospice program's procedures for filing a complaint at the time of admission to service. The hospice program shall provide each patient or his designee with the name, mailing address, and telephone number of the:

1. Hospice program contact person;

2. State Ombudsman; and

3. Complaint Unit of the OLC.

D. The hospice program shall maintain documentation of all complaints received and the status of each complaint from date of receipt through its final resolution. Records shall be maintained from the date of the last licensure inspection and for no less than three years.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-260. Quality improvement.

A. The hospice program shall implement an on-going, comprehensive, integrated, self-assessment program of the quality and appropriateness of care provided, including services provided under contract. The quality improvement program shall address actual patient outcomes (results of care), clinical, administrative, and cost-of-care issues. The findings shall be used to correct identified problems and revise policies and practices, as necessary. Exclusive concentration on administrative or cost-of-care issues does not fulfill this requirement.

B. The following areas shall be evaluated to identify unacceptable or unexpected trends or occurrences that influence patient outcomes (results of care):

1. Staffing patterns and clinical performance;

2. Admissions and discharges;

3. Supervision appropriate to the level of service;

4. Emergency preparedness plan;

5. Medical records;

6. Appropriateness and effectiveness of pain management;

7. Patient satisfaction and complaint resolution;

8. Infection control;

9. Staff concerns; and

10. Provision of services appropriate to patient needs.

C. The administrator or governing body shall designate a quality improvement committee, which is responsible for the oversight and supervision of the quality improvement program. The committee shall consist of:

1. A physician with association with the hospice program;

2. A member of the administrative staff;

3. Representatives of each of the services provided by the hospice program, including contracted services; and

4. An individual with demonstrated ability to represent the rights and concerns of patients. The individual may be a member of the hospice program's staff, a patient, or a patient's family member.

In selecting members of this committee, consideration shall be given to a candidate's abilities and sensitivity to issues relating to confidentiality, quality of care and services provided to hospice patients.

D. Measures shall be implemented to resolve important problems or concerns that have been identified. Health care practitioners, as well as administrative staff, shall participate in the resolution of the problems or concerns that are identified.

E. Results of the quality improvement program shall be reported annually in writing to the governing body and the administrator, and to the staff as appropriate. The report shall be acted upon by the governing body and the hospice program. All corrective actions shall be documented.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-270. Infection control.

A. The hospice program shall implement a program to reduce the risk of infection.

B. Infection control activities shall include, but are not limited to:

1. Staff, patient, patient family or caregiver education regarding infection risk-reduction behaviors;

2. Use of universal precautions;

3. Handling, storing, processing and transporting of regulated medical waste according to applicable procedures;

4. Handling, storing, processing and transporting supplies and equipment in a manner that prevents the spread of infection; and

5. Monitoring of staff performance of infection control practices.

C. Accumulated waste, including all contaminated sharps, dressings, or similar infectious waste, shall be disposed of in a manner compliant with the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030).

D. Dedicated hospice facilities shall have provisions for isolating patients with infectious diseases.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

12VAC5-391-280. Medical record system.

A. The hospice program shall maintain an organized medical record system according to accepted standards of practice. Written policies and procedures shall specify retention, reproduction, access, storage, content, and completion of the record.

B. Medical record information shall be safeguarded against loss or unauthorized use.

C. Medical records shall be confidential. Only authorized personnel shall have access as specified in state and federal law.

D. Provisions shall be made for the safe storage of the original record and for accurate and legible reproductions of the original.

E. Policies shall specify arrangements for retention and protection of records if the hospice program discontinues operation and shall provide for notification to the OLC and the patient of the location of the records.

F. An accurate and complete medical record shall be maintained for each patient receiving services and shall include, but shall not be limited to:

1. Patient identifying information;

2. Identification of the attending physician;

3. Admitting information, including a patient history;

4. A psychosocial and spiritual assessment, including information regarding composition of the household, safety issues in the physical environment, coping skills of the family and the patient, and identification of the individuals to be instructed in the care of the patient;

5. Physical assessment;

6. Documentation and results of all medical tests ordered by the physician or other health care professionals and performed by the hospice program's staff;

7. Physician's orders;

8. The plan of care including, but not limited to, the type and frequency of each service to be delivered by hospice program or contract service personnel and appropriate assessment and management of pain;

9. Medication sheets that include the name, dosage, frequency of administration, route of administration, date started, changed or discontinued for each medication, and possible side effects;

10. Copies of all summary reports sent to the attending physician;

11. Documentation of patient rights review;

12. Services provided, including any volunteer services; and

13. A discharge summary that includes continuing symptom management needs.

G. Signed and dated progress notes by each individual delivering service shall be written on the day the service is delivered and incorporated in the medical record within seven working days.

H. All services provided to the patient by the hospice program shall be documented in the patient's medical record.

I. Entries in the medical record shall be current, legible, dated and authenticated by the person making the entry. Errors shall be corrected by striking through and initialing.

J. Verbal orders shall be documented within 24 hours in the medical record by the health care professional receiving the order and shall be countersigned by the health professional initiating the order according to the procedures of the hospice program.

K. Originals or reproductions of individual patient medical records shall be maintained in their entirety for a minimum of five years following discharge or date of last contact unless otherwise specified by state or federal requirements. Records of minors shall be kept for at least five years after the minor reaches 18 years of age.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005; amended, Virginia Register Volume 24, Issue 11, eff. March 5, 2008.

12VAC5-391-290. Discharge.

A. Patients shall receive five days oral and written notice of a transfer or discharge initiated by the hospice program except under the following circumstances:

1. When a medical emergency exists;

2. For the welfare of the patient or the welfare of employees; or

3. The welfare of other patients in a dedicated hospice facility operated by the hospice program.

B. The hospice program shall make all arrangements necessary to assure continuing care and services including a discharge summary for the receiving hospice or provider.

Statutory Authority

§§ 32.1-12 and 32.1-162.5 of the Code of Virginia.

Historical Notes

Derived from Virginia Register Volume 21, Issue 23, eff. November 1, 2005.

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