Title of Regulation: 12VAC5-371. Regulations for the Licensure of Nursing Facilities (amending 12VAC5-371-10; adding 12VAC5-371-191).

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

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: November 28, 2018.

Effective Date: December 13, 2018.

Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Virginia Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, FAX (804) 527-4502, or email erik.bodin@vdh.virginia.gov.

Basis: Chapter 600 of the 2016 Acts of Assembly mandates the State Board of Health to promulgate regulations governing the implementation of voluntary electronic monitoring in the rooms of residents of nursing homes. Chapter 600 requires the board to convene a workgroup that includes representatives of nursing facilities, advocates for residents of nursing facilities, and other stakeholders to make recommendations to the board concerning such regulations. This regulatory action is mandated by law.

Purpose: Chapter 600 of the 2016 Acts of Assembly mandates the State Board of Health to promulgate regulations governing the implementation of voluntary electronic monitoring in the rooms of residents of nursing homes. Installing such equipment is not mandatory; however, if installed, facilities must safeguard a resident's autonomy and rights according to current federal and state privacy laws and regulations. This regulatory action provides the framework to address policies and procedures, informed consent, admission, and discharge or transfer. The amendments include the equipment request process and notice procedures, retention and ownership of tapes or recordings, and reporting suspected abuse, neglect, accident, or injury discovered through electronic monitoring. The amendments will protect and promote public health, safety, and welfare of citizens through the establishment of a framework that sets standards regarding electronic monitoring in nursing facility resident rooms. This framework will ensure that resident privacy and autonomy is paramount when electronic monitoring is used.

Rationale for Using Fast-Track Rulemaking Process: Chapter 600 of the 2016 Acts of Assembly mandates the State Board of Health to promulgate regulations governing the implementation of voluntary electronic monitoring in the rooms of residents of nursing homes. The amendments were developed cooperatively with the assistance of a workgroup convened pursuant to Chapter 600 and rely heavily on language included in a Virginia Department of Health (VDH) guidance document in use since 2004. Therefore, VDH believes the amendments will be noncontroversial, allowing use of the fast-track rulemaking process.

Substance: Electronic monitoring in resident rooms provides the framework for policies and procedures, informed consent, right of implementation or refusal, retention of tapes and recordings, and reporting of abuse, neglect, accident, or injury discovered via electronic monitoring.

Issues: The primary advantages of the regulatory action to the public are increased safety of nursing facility patients. There are no known disadvantages to the public. The primary advantages to the agency and the Commonwealth are increased quality of care and safety for nursing home residents throughout the Commonwealth who chose to utilize electronic monitoring. There are no known disadvantages to the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. Pursuant to Chapter 600 of the 2016 General Assembly,¹ the State Board of Health (Board) proposes to establish provisions for voluntary audio-visual recording of residents in nursing facilities.

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

Estimated Economic Impact. Electronic monitoring/audio-visual recording of residents in nursing facilities is completely optional. All requests for electronic monitoring must be made in writing and signed by the resident or the resident's responsible party if the resident has been properly assessed incapable of requesting and authorizing the monitoring.

Chapter 600 states that the Board shall promulgate regulations:

"… for the audio-visual recording of residents in nursing facilities. Such regulations shall include provisions related to (i) resident privacy, (ii) notice and disclosure, (iii) liability, (iv) ownership and maintenance of equipment, (v) cost, (vi) recording and data security, and (vii) nursing facility options for both nursing facility-managed recording and resident-managed recording. The Department of Health shall convene a workgroup that includes representatives of nursing facilities, advocates for residents of nursing facilities, and other stakeholders to make recommendations to the Board on such regulations and shall report its recommendations to the Board and the General Assembly."

The Board proposes provisions to address each of the items delineated in the legislation. According to the Virginia Department of Health, the proposed amendments are a combination of the Board's 2004 guideline "Electronic Monitoring of Residents' Rooms" which were developed to assist facilities with the privacy issues that may arise when installing electronic monitoring equipment and the work of the workgroup assembled pursuant to Chapter 600.

Concerning cost, the proposed regulation states that:

"A facility may require a resident or a resident's responsible party to pay for all costs, other than the cost of electricity, associated with installing electronic monitoring equipment. Such costs shall be reasonable and may include, but are not limited to: equipment, recording media and installation, compliance with life safety and building and electrical codes, maintenance or removal of the equipment, posting and removal of any public notices, or structural repairs to the building resulting from the removal of the equipment. Facilities shall give 45 days notice of an increase in monthly monitoring fees."

The proposed amendments provide clarity concerning rules and requirements for the optional electronic monitoring/audio-visual recording of residents in nursing facilities. The specificity of the proposed language would reduce the likelihood of misunderstandings and disagreements. Under the proposed regulation, nursing facilities would not be burdened by significant costs if residents or their representatives request electronic monitoring. Thus, the proposed amendments should produce a net benefit.

Businesses and Entities Affected

The proposed amendments affect the 281 licensed nursing facilities within the Commonwealth of Virginia, as well as the patients or residents of those facilities and their family members or legal representatives. Based upon Virginia Employment Commission data, all but one of the nursing facilities likely qualify as small businesses.

Localities Particularly Affected

The proposed amendments do not disproportionately affect particular localities.

Projected Impact on Employment. The proposed amendments are unlikely to significantly affect total employment.

Effects on the Use and Value of Private Property. The proposed amendments would not significantly affect the use and value of private property.

Real Estate Development Costs. The proposed amendments do not affect real estate development costs.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. The proposed amendments do not significantly affect costs for small businesses.

Alternative Method that Minimizes Adverse Impact. The proposed amendments do not adversely affect small businesses.

Adverse Impacts:

Businesses. The proposed amendments do not adversely affect businesses.

Localities. The proposed amendments do not adversely affect localities.

Other Entities. The proposed amendments do not adversely affect other entities.

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¹See http://leg1.state.va.us/cgi-bin/legp504.exe?161+ful+CHAP0600

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

Summary:

Pursuant to Chapter 600 of the 2016 Acts of Assembly, which mandates the State Board of Health promulgate regulations governing the implementation of voluntary electronic monitoring in the rooms of residents of nursing homes, the amendments provide the framework to assist nursing facilities with the privacy issues that may arise when installing electronic monitoring equipment and include (i) the equipment request process and notice procedures; (ii) informed consent, admission, and discharge or transfer; (iii) retention and ownership of tapes or recordings; and (iv) reporting suspected abuse, neglect, accident, or injury discovered through electronic monitoring.

Part I
Definitions and General Information

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.

"Board" means the Board of Health.

"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, but are not limited to, 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.

"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 resident's responsible party in accordance with the facility's policies.

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

"Guardian" means a person legally invested with the authority and charged with the duty of taking care of the resident, managing his property, and protecting the rights of the resident who has been declared by the circuit court to be incapacitated and incapable of administering his own affairs. The powers and duties of the guardian are defined by the court and are limited to matters within the areas where the resident in need of a guardian has been determined to be incapacitated.

"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 or residents that are necessary to obtain or maintain the resident or residents' 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.

"Responsible person or party" means an individual authorized by the resident to act for him as an official delegate or agent. The responsible person may be a guardian, payee, family member or any other individual who has arranged for the care of the resident and assumed this responsibility. The responsible person or party may or may not be related to the resident. A responsible person or party is not a guardian unless so appointed by the court.

"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.

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

12VAC5-371-191. Electronic monitoring in resident rooms.

A. All requests for electronic monitoring shall be made in writing and signed by the resident or the resident's responsible party if the resident has been properly assessed incapable of requesting and authorizing the monitoring.

B. Only electronic monitoring in accordance with this section is permitted.

C. A facility shall not refuse to admit an individual and shall not discharge or transfer a resident due to a request to conduct authorized electronic monitoring.

D. Family members cannot obtain electronic monitoring over the objections of the resident, the resident's roommate, or the resident's responsible party. No equipment may be installed pursuant to subsection Q of this section over the objections of the resident, or if the resident is incapable, the resident's responsible party. Facilities shall not use monitoring equipment in violation of the law based solely on a family member's request or approval.

E. Consent for electronic monitoring shall be kept in the resident's medical record.

F. Facilities shall designate one staff person to be responsible for managing the electronic monitoring program.

G. Facilities may designate custodial ownership of any recordings from monitoring devices to the resident or the resident's responsible party. Facility retained recordings shall be considered part of the resident's medical record and shall be retained for no less than two years or as required by state and federal laws.

H. If a facility chooses to retain ownership of recordings, the facility shall not permit viewings of recordings without consent of the resident or the resident's responsible party except to the extent that disclosure is required by law through a court order or pursuant to a lawful subpoena duces tecum. Should a resident or a resident's responsible party approve viewing, the facility shall accommodate viewing of any recordings in a timely manner, including providing:

1. Appropriate playing or viewing equipment;

2. Privacy during viewing; and

3. Viewing times convenient to the resident or the resident's responsible party.

If unauthorized viewing is discovered, the facility shall report any such violation to the Office of Long-Term Care Ombudsman and to OLC.

I. A facility shall require its staff to report any incidents regarding safety or quality of care discovered as a result of viewing a recording immediately to the facility administrator and to the OLC. Facilities shall instruct the resident or the resident's responsible party of this reporting requirement and shall provide the resident or the resident's responsible party with the OLC's complaint hotline telephone number.

J. A facility shall have no obligation to seek access to a recording in its possession or to have knowledge of a recording's content, unless the facility is aware of a recorded incident of suspected abuse, neglect, accident, or injury, or the resident, the resident's responsible party, or a government agency seeks to use a recording. Facilities shall immediately report suspected abuse and neglect discovered as a result of using monitoring devices, as required by law.

K. A facility may require the resident or the resident's responsible party to be responsible for all aspects of the operation of the monitoring equipment, including the removal and replacement of recordings; adherence to local, state, and federal privacy laws; and for firewall protections to prevent images that would violate obscenity laws from being inadvertently shown on the Internet.

L. A facility shall prohibit assigned staff from refusing to enter a resident's room solely because of electronic monitoring.

M. Any electronic monitoring equipment shall be installed in a manner that is safe for residents, employees, or visitors who may be moving about the resident's room.

N. A facility shall make reasonable physical accommodation for monitoring equipment, including:

1. Providing a reasonably secure place to mount the device; and

2. Providing access to power sources for the device.

O. A facility may require a resident or a resident's responsible party to pay for all costs, other than the cost of electricity, associated with installing electronic monitoring equipment. Such costs shall be reasonable and may include equipment, recording media and installation, compliance with life safety and building and electrical codes, maintenance or removal of the equipment, posting and removal of any public notices, or structural repairs to the building resulting from the removal of the equipment. Facilities shall give 45 days' notice of an increase in monthly monitoring fees.

P. Any equipment installed for the purpose of monitoring a resident's room shall be fixed and unable to rotate.

Q. The informed consent of all residents, or if a resident is incapable, a resident's responsible party, assigned to the monitored room shall be obtained prior to any electronic monitoring equipment being installed.

R. A copy of any signed consent form shall be kept in the resident's medical record as well as on file with the facility's designated electronic monitoring coordinator.

S. Any resident or the resident's responsible party of a monitored room may condition consent for use of monitoring devices. Such conditions may include pointing the camera away or limiting or prohibiting the use of certain devices. If conditions are placed on consent, then electronic monitoring shall be conducted according to those conditions.

T. The facility shall conspicuously post and maintain a notice at the entrance to the resident's room stating that an electronic monitoring device is in operation.

U. Facilities shall notify all staff and their OLC Long-Term Care Supervisor that electronic monitoring is in use.

V. A facility shall prohibit staff from covert monitoring in violation of this chapter. Facilities shall instruct the resident or the resident's responsible party of this prohibition and shall provide the resident or the resident's responsible party with the OLC's complaint hotline telephone number.

W. If covert monitoring is discovered, the facility shall report any such violation to the Office of Long-Term Care Ombudsman and OLC, and the facility may require a resident or a resident's responsible party to meet all the requirements for authorized monitoring, if permitted by the facility.

X. Each nursing facility, including those that choose not to offer electronic monitoring, shall adopt policies and procedures for electronic monitoring. These policies and procedures shall address all the elements of this section.

Y. A facility shall prohibit staff from tampering with electronic monitoring in violation of this chapter. Facilities shall instruct the resident or the resident's responsible party of this prohibition and shall provide the resident or the resident's responsible party with the OLC's complaint hotline telephone number.