Title of Regulation: 12VAC5-371. Regulations for the Licensure of Nursing Facilities (amending 12VAC5-371-10, 12VAC5-371-140, 12VAC5-371-180).

Statutory Authority: §§ 32.1-12 and 32.1-127 of the Code of Virginia.

Effective Date: November 11, 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.

Summary:

Pursuant to Chapter 219 of the 2021 Acts of Assembly, Special Session I, an amendment requires each nursing home and certified nursing facility establish and implement policies to ensure a patient's access to and use of an intelligent personal assistant provided by a patient while the patient is receiving inpatient services.

Pursuant to Chapter 525 of the 2021 Acts of Assembly, Special Session I, the other amendment requires each nursing home and certified nursing facility establish a protocol to allow patients to receive visits from clergy consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with any applicable federal or state guidance having the effect of limiting visitation when there is a declared public health emergency related to a communicable disease of public health threat.

12VAC5-371-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Abuse" means the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish, or deprivation by an individual, including caretaker, of goods or services that are necessary to attain or maintain physical, mental, and psychosocial well-being. This includes verbal, sexual, physical, or mental abuse.

"Administrator" means the individual licensed by the Virginia Board of Long-Term Care Administrators and who has the necessary authority and responsibility for management of the nursing facility.

"Admission" means the process of acceptance into a nursing facility, including orientation, rules and requirements, and assignment to appropriate staff. Admission does not include readmission to the facility after a temporary absence.

"Advance directive" means (i) a witnessed written document, voluntarily executed by the declarant in accordance with the requirements of § 54.1-2983 of the Code of Virginia, or (ii) a witnessed oral statement, made by the declarant subsequent to the time he is diagnosed as suffering from a terminal condition and in accordance with the provision of § 54.1-2983 of the Code of Virginia.

"Assessment" means the process of evaluating a resident for the purpose of developing a profile on which to base services. Assessment includes information gathering, both initially and on an ongoing basis, designed to assist the multi-disciplinary staff in determining the resident's need for care, and the collection and review of resident-specific data.

"Attending physician" means a physician currently licensed by the Virginia Board of Medicine and identified by the resident, or legal representative, as having the primary responsibility in determining the delivery of the resident's medical care.

"Barrier crime" means any offense set forth in clause (i) of the definition of barrier crime in § 19.2-392.02 of the Code of Virginia.

"Board" means the Board of Health.

"Cannabidiol oil" means the same as the term is defined in subsection A of § 54.1-3408.3 of the Code of Virginia.

"Certified nurse aide" means the title that can only be used by individuals who have met the requirements to be certified, as defined by the Virginia Board of Nursing, and who are listed in the nurse aide registry.

"Chemical restraint" means a psychopharmacologic drug (a drug prescribed to control mood, mental status, or behavior) that is used for discipline or convenience and not required to treat medical symptoms or symptoms from mental illness or mental retardation that prohibit an individual from reaching his highest level of functioning.

"Clinical record" means the documentation of health care services, whether physical or mental, rendered by direct or indirect resident-provider interactions. An account compiled by physicians and other health care professionals of a variety of resident health information, such as assessments and care details, including testing results, medicines, and progress notes.

"Commissioner" means the State Health Commissioner.

"Complaint" means any allegation received by the Department of Health other than an incident reported by the facility staff. Such allegations include abuse, neglect, exploitation, or violation of state or federal laws or regulations.

"Comprehensive plan of care" means a written action plan, based on assessment data, that identifies a resident's clinical and psychosocial needs, the interventions to meet those needs, treatment goals that are measurable and that documents the resident's progress toward meeting the stated goals.

"Construction" means the building of a new nursing facility or the expansion, remodeling, or alteration of an existing nursing facility and includes the initial and subsequent equipping of the facility.

"Criminal record report" means either the criminal record clearance with respect to convictions for barrier crimes or the criminal history record from the Central Criminal Records Exchange of the Virginia Department of State Police.

"Department" means the Virginia Department of Health.

"Dignity" means staff, in their interactions with residents, carry out activities which assist a resident in maintaining and enhancing the resident's self-esteem and self-worth.

"Discharge" means the process by which the resident's services, delivered by the nursing facility, are terminated.

"Discharge summary" means the final written summary of the services delivered, goals achieved and post-discharge plan or final disposition at the time of discharge from the nursing facility. The discharge summary becomes a part of the clinical record.

"Drug" means (i) articles or substances recognized in the official United States "Drug" Pharmacopoeia National Formulary or official Homeopathic Pharmacopoeia of the United States, or any supplement to any of them; (ii) articles or substances intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animal; (iii) articles or substances, other than food, intended to affect the structure or any function of the body of man or other animal; and (iv) articles or substances intended for use as a component of any article specified in clause (i), (ii), or (iii). This does not include devices or their components, parts or accessories.

"Electronic monitoring" means an unmanned video recording system with or without audio capability installed in the room of a resident.

"Emergency preparedness plan" means a component of a nursing facility's safety management program designed to manage the consequences of natural disasters or other emergencies that disrupt the nursing facility's ability to provide care.

"Employee" means a person who performs a specific job function for financial remuneration on a full-time or part-time basis.

"Facility-managed" means an electronic monitoring system that is installed, controlled, and maintained by the nursing facility with the knowledge of the resident or legal representative in accordance with the facility's policies.

"Full-time" means a minimum of 35 hours or more worked per week in the nursing facility.

"Intelligent personal assistant" means a combination of an electronic device and a specialized software application designed to assist users with basic tasks using a combination of natural language processing and artificial intelligence, including such combinations known as digital assistants or virtual assistants.

"Legal representative" means a person legally responsible for representing or standing in the place of the resident for the conduct of his affairs. This may include a guardian, conservator, attorney-in-fact under durable power of attorney, trustee, or other person expressly named by a court of competent jurisdiction or the resident as his agency in a legal document that specifies the scope of the representative's authority to act. A legal representative may only represent or stand in the place of a resident for the function for which he has legal authority to act.

"Medication" means any substance, whether prescription or over-the-counter drug, that is taken orally or injected, inserted, topically applied, or otherwise administered.

"Neglect" means a failure to provide timely and consistent services, treatment, or care to a resident necessary to obtain or maintain the resident's health, safety, or comfort or a failure to provide timely and consistent goods and services necessary to avoid physical harm, mental anguish, or mental illness.

"Nursing facility" means any nursing home as defined in § 32.1-123 of the Code of Virginia.

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

"Person" means any individual, corporation, partnership, association, trust, or other legal entity, whether governmental or private, owning, managing, or operating a nursing facility.

"Physical restraint" means any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident's body that the individual cannot remove easily which restricts freedom of movement or normal access to one's own body.

"Policy" means a written statement that describes the principles and guides and governs the activities, procedures and operations of the nursing facility.

"Procedures" means a series of activities designed to implement program goals or policy, which may or may not be written, depending upon the specific requirements within this chapter. For inspection purposes, there must be evidence that procedures are actually implemented.

"Progress note" means a written statement, signed and dated by the person delivering the care, consisting of a pertinent, chronological report of the resident's care. A progress note is a component of the clinical record.

"Qualified" means meeting current legal requirements of licensure, registration or certification in Virginia; having appropriate training and experience commensurate with assigned responsibilities; or, if referring to a professional, possessing an appropriate degree or having documented equivalent education, training or experience.

"Quality assurance" means systematic activities performed to determine the extent to which clinical practice meets specified standards and values with regard to such things as appropriateness of service assignment and duration, appropriateness of facilities and resources utilized, adequacy and clinical soundness of care given. Such activities should also assure changes in practice that do not meet accepted standards. Examples of quality assurance activities include the establishment of facility-wide goals for resident care, the assessment of the procedures used to achieve the goals, and the proposal of solutions to problems in attaining those goals.

"Readmission" means a planned return to the nursing facility following a temporary absence for hospitalization, off-site visit or therapeutic leave, or a return stay or confinement following a formal discharge terminating a previous admission.

"Resident" means the primary service recipient, admitted to the nursing facility, whether that person is referred to as a client, consumer, patient, or other term.

"Resident-managed" means an electronic monitoring system that is installed, controlled, and maintained by the resident with the knowledge of the nursing facility.

"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.

"Sworn disclosure" means a written statement or affirmation disclosing any criminal convictions or any pending criminal charges, whether within or outside the Commonwealth, by an applicant for compensated employment with a nursing facility.

"THC-A oil" means the same as the term is defined in subsection A of § 54.1-3408.3 of the Code of Virginia.

"Volunteer" means a person who, without financial remuneration, provides services to the nursing facility.

12VAC5-371-140. Policies and procedures.

A. The nursing facility 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.

C. A written record of the annual policy review, including at least the review dates, participants, recommendations and action dates of the governing body, shall be maintained.

D. Administrative and operational policies and procedures shall include:

1. Administrative records;

2. Admission, transfer and discharge;

3. Medical direction and physician services;

4. Nursing direction and nursing services;

5. Pharmaceutical services, including drugs purchased outside the nursing facility;

6. Dietary services;

7. Social services;

8. Activities services;

9. Restorative and rehabilitative resident services;

10. Contractual services;

11. Clinical records;

12. Resident rights and grievances;

13. Quality assurance and infection control and prevention;

14. Safety and emergency preparedness procedures;

15. Professional and clinical ethics, including:

a. Confidentiality of resident information;

b. Truthful communication with residents;

c. Observance of appropriate standards of informed consent and refusal of treatment; and

d. Preservation of resident dignity, with special attention to the needs of the aged, the cognitively impaired, and the dying; and

16. Nursing facility security.

E. Personnel policies and procedures shall include:

1. Written job descriptions that specify authority, responsibility, and qualifications for each job classification;

2. An on-going plan for employee orientation, staff development, in-service training and continuing education;

3. An accurate and complete personnel record for each employee including:

a. Verification of current professional license, registration, or certificate or completion of a required approved training course;

b. Criminal record check;

c. Verification that the employee has reviewed or received a copy of the job description;

d. Orientation to the nursing facility, its policies and to the position and duties assigned;

e. Completed continuing education program approved for the employee as determined by the outcome of the annual performance evaluation;

f. Annual employee performance evaluations; and

g. Disciplinary action taken; and

4. Employee health-related information retained in a file separate from personnel files.

F. Financial policies and procedures shall include:

1. Admission agreements;

2. Methods of billing:

a. Services not included in the basic daily or monthly rate;

b. Services delivered by contractors of the nursing facility; and

c. Third party payers;

3. Resident or designated representative notification of changes in fees and charges;

4. Correction of billing errors and refund policy;

5. Collection of delinquent resident accounts; and

6. Handling of resident funds.

G. A nursing facility shall establish and implement policies to ensure the permissible access to and use of an intelligent personal assistant provided by a patient while receiving inpatient services. Such policies shall ensure protection of health information in accordance with the requirements of the federal Health Insurance Portability and Accountability Act of 1996 (42 USC § 1320d et seq.).

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

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

12VAC5-371-180. Infection control.

A. The nursing facility shall establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment and to prevent the development and transmission of disease and infection.

B. The infection control program shall encompass the entire physical plant and all services.

C. The infection control program addressing the surveillance, prevention and control of infections in the nursing facility shall include:

1. Procedures to isolate the infecting organism;

2. Access to handwashing equipment for staff;

3. Training of staff in proper handwashing techniques, according to accepted professional standards, to prevent cross contamination;

4. Implementation of universal precautions by direct resident care staff;

5. Prohibiting employees with communicable diseases or infections from direct contact with residents or their food, if direct contact will transmit disease;

6. Monitoring staff performance of infection control practices;

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

8. Handling, storing, processing and transporting regulated medical waste in accordance with applicable regulations;

9. Maintaining an effective pest control program; and

10. Staff education regarding infection risk-reduction behavior.

D. The nursing facility shall report promptly to its local health department diseases designated as "reportable" according to 12VAC5-90-80 when such cases are admitted to or are diagnosed in the nursing facility and shall report any outbreak of infectious disease as required by 12VAC5-90. An outbreak is defined as an increase in incidence of any infectious disease above the usual incidence at the nursing facility.

E. During a declared public health emergency related to a communicable disease of public health threat, the nursing facility shall establish a protocol to allow residents to receive visits from a rabbi, priest, minister, or clergy of any religious denomination or sect consistent with guidance from the Centers for Disease Control and Prevention and the Centers for Medicare and Medicaid Services and subject to compliance with any executive order, order of public health, department guidance, or any other applicable federal or state guidance having the effect of limiting visitation.

1. Such protocol may restrict the frequency and duration of visits and may require visits to be conducted virtually using interactive audio or video technology.

2. Any such protocol may require the person visiting a resident pursuant to this subsection to comply with all reasonable requirements of the nursing facility adopted to protect the health and safety of the person, residents, and staff of the nursing facility.