TITLE 12. HEALTH

STATE BOARD OF HEALTH

Fast-Track Regulation

Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-10, 12VAC5-410-230, 12VAC5-410-280, 12VAC5-410-1170).

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

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: May 7, 2025.

Effective Date: May 22, 2025.

Agency Contact: Val Hornsby, Policy Analyst, Virginia Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 875-1089, FAX (804) 527-4502, or email val.hornsby@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia requires the State Board of Health to promulgate and enforce such regulations as may be necessary to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-127 of the Code of Virginia requires the board to adopt regulations that include minimum standards for (i) the construction and maintenance of hospitals, nursing homes, and certified nursing facilities to ensure the environmental protection and the life safety of patients, employees, and the public; (ii) the operation, staffing, and equipping of hospitals, nursing homes, and certified nursing facilities; (iii) qualifications and training of staff of hospitals, nursing homes, and certified nursing facilities, except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital or nursing home may provide medical and nursing services to patients in their places of residence; and (v) policies related to infection prevention, disaster preparedness, and facility security of hospitals, nursing homes, and certified nursing facilities.

Purpose: The board is required by § 32.1-127 of the Code of Virginia to promulgate regulations for the licensure of hospitals in order to protect the health, safety, and welfare of citizens receiving care in hospitals.

Rationale for Using Fast-Track Rulemaking Process: This action is expected to be noncontroversial and therefore appropriate for the fast-track rulemaking process because it is being used to conform the regulation to statute and does not add requirements beyond what is mandated by Chapters 219, 233, and 525 of the 2021 Acts of Assembly.

Substance: The amendments (i) add a definition for intelligent personal assistant; (ii) require general and surgical hospitals to have a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of any religious denomination or sect during public health emergencies related to communicable diseases; (iii) require general hospitals to establish policies governing the access and use of intelligent personal assistants; and (iv) require each hospital with an emergency department to establish a protocol for the treatment and discharge of individuals experiencing a substance use-related emergency.

Issues: The advantage to the public, the agency, and the Commonwealth is that the regulation will be in compliance with statute. There are no disadvantages to the public, the agency, or the Commonwealth.

Department of Planning and Budget Economic Impact Analysis:

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 Code of Virginia and Executive Order 19. The analysis presented represents DPB's best estimate of the potential economic impacts as of the date of this analysis.¹

Summary of the Proposed Amendments to Regulation. Pursuant to several legislative mandates, the State Board of Health (board) proposes to amend this regulation to require all licensed hospitals (i) to establish and implement policies to ensure patient access to and use of an intelligent personal assistant, provided by a patient, while receiving inpatient services; (ii) to establish a protocol allowing patients to receive visits from the clergy of any religious denomination or sect during a declared public health emergency related to a communicable disease of public health threat; and (iii) with an emergency department, to establish a protocol for the treatment and discharge of individuals experiencing a substance use-related emergency.

Background. This regulatory action is a result of legislative mandates from Chapters 219, 233, and 525 of the 2021 Acts of Assembly, Special Session I. Chapter 219² amended § 32.1-127 of the Code of Virginia to require that the regulations, require each hospital, nursing home, and certified nursing facility to establish and implement policies to ensure the permissible access to and use of an intelligent personal assistant provided by a patient, in accordance with such regulations, while receiving inpatient services. According to the Virginia Department of Health (VDH), this legislative mandate occurred as the result of a complaint from a constituent, whose mother became seriously ill with COVID-19 and had to be transported to a hospital. The hospital refused to allow her to use her Amazon Echo to communicate with her family, claiming that they had a policy prohibiting its use, despite no such policy existing. Chapter 233³ amended § 32.1-127 of the Code of Virginia to require that each hospital with an emergency department establish a protocol for the treatment and discharge of individuals experiencing a substance use-related emergency. This protocol is required to include the following provisions: appropriate screening and assessment of individuals experiencing substance use-related emergencies, to identify medical interventions necessary for the treatment of the individual in the emergency department; and recommendations for follow-up care following discharge of certain patients, which may include dispensing or prescribing an opioid antagonist used for overdose reversal at discharge. In addition, Chapter 233 allows the protocol to provide for referrals of individuals experiencing a substance use-related emergency to peer recovery specialists and community-based providers of behavioral health services, or to providers of pharmacotherapy for the treatment of drug or alcohol dependence or mental health diagnoses. VDH is not aware of any constituent complaint or other background information regarding the impetus for Chapter 233. Chapter 525⁴ amended §§ 32.1-127, 32.1-162.5, and 63.2-1732 of the Code of Virginia pertaining to the regulations of hospitals, nursing homes, certified nursing facilities, assisted living facilities, and hospices. For these regulations, the board is required to include that during a declared public health emergency, related to a communicable disease of public health threat, each facility must establish a protocol allowing patients and residents to receive visits from a rabbi, priest, minister, or clergy of any religious denomination or sect. The mandate allows the protocol to: restrict the frequency and duration of visits; require visits to be conducted virtually using interactive audio or video technology; and require the person visiting a patient under this protocol to comply with all reasonable requirements of the facility adopted to protect the health and safety of the person, patients, and staff of the facility. According to VDH, this legislative mandate occurred as a result of complaints received from the public during the COVID-19 pandemic. However, while VDH received numerous complaints about being unable to visit family and friends in hospitals and nursing homes, only a single complaint concerned denial of access to clergy.

Estimated Benefits and Costs: The proposed changes to the regulatory text are identical to the requirements established in the legislative mandates with the exception of some formatting and technical differences.⁵ Thus, the costs associated with implementing the mandated changes result from the legislation rather than these regulations. VDH estimates that these legislative requirements amount to onetime compliance costs of $867,000 to hospitals, which is broken down as follows: onetime cost of $525,000 to 105 hospitals ($5,000 per hospital) to establish and implement policies related to patient access and use of intelligent personal assistants; onetime cost of $212,500 to 170 hospitals ($1,250 per hospital) to develop a protocol to allow patients to receive visits from a clergy of any religious denomination or sect during public health emergencies related to communicable diseases; onetime cost of $130,000 to 104 hospitals ($1,250 per hospital) to amend protocols for substance use-related emergencies to incorporate new statutory minimums such as: referrals to providers of pharmacotherapy for the treatment of drug or alcohol dependence or mental health diagnoses, and expanding what information and access is provided about opioid antagonists.⁶ Although the benefits are not quantified, VDH asserts that intelligent personal assistants are often utilized by persons with disabilities and the elderly to access information or stay connected with friends and family; access to clergy provides spiritual support during end-of-life care and can improve patient well-being by alleviating or reducing anger, fear, or depression and that both patients and their family members can receive assistance in processing grief before, during, and after death; the changes to protocols for substance use-related emergencies improve the likelihood of positive outcomes for individuals experiencing a substance use-related emergency, as the changes are based on recommended best practices. However, all licensed hospitals are already required to comply with the Code of Virginia. Thus, the main impact of the proposed changes is to conform the regulatory text to the amended sections of the Code of Virginia and eliminate a potential source for confusion among the regulated entities and the public about the requirements (e.g., obligations and rights regarding intelligent personal assistants; visitation during a public health emergency; and the treatment and discharge of individuals experiencing a substance use-related emergency).

Businesses and Other Entities Affected. The proposed changes apply to 106 licensed general hospitals and 63 outpatient surgical hospitals. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁷ An adverse impact is indicated if there is any increase in net cost or reduction in net revenue for any entity, even if the benefits exceed the costs for all entities combined. The proposed changes do not introduce any new requirements beyond those already mandated by the Code of Virginia. Thus, no adverse impact on any entity is indicated on account of the proposed regulations.

Small Businesses⁸ Affected.⁹ According to VDH, three of the outpatient surgical hospitals are estimated to meet the definition of small business. However, the proposed amendments to the regulatory text do not adversely affect small businesses as they do not impose any additional costs beyond what the legislation requires.

Localities¹⁰ Affected.¹¹ The proposed changes also apply to the Lee County Hospital Authority and the Chesapeake Hospital Authority. However, the proposed amendments to the regulatory text do not introduce costs for local governments as they do not impose any additional costs beyond what the legislation requires.

Projected Impact on Employment. The proposed amendments to the regulatory text do not appear to affect total employment as they do not impose any additional impacts beyond what the legislation requires.

Effects on the Use and Value of Private Property. The proposed amendments to the regulatory text do not appear to affect the use and value of property or the real estate development costs as they do not impose any additional impacts beyond what the legislation requires.

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¹ Section 2.2-4007.04 of the Code of Virginia requires that such economic impact analyses determine the public benefits and costs of the proposed amendments. Further the analysis should include but not be limited to: (1) the projected number of businesses or other entities to whom the proposed regulatory action would apply, (2) the identity of any localities and types of businesses or other entities particularly affected, (3) the projected number of persons and employment positions to be affected, (4) the projected costs to affected businesses or entities to implement or comply with the regulation, and (5) the impact on the use and value of private property.

² https://lis.virginia.gov/cgi-bin/legp604.exe?212+ful+CHAP0219&212+ful+CHAP0219. Chapter 219 also defined personal digital assistant to mean, 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.

³ https://lis.virginia.gov/cgi-bin/legp604.exe?212+ful+CHAP0233.

⁴ https://lis.virginia.gov/cgi-bin/legp604.exe?212+ful+CHAP0525.

⁵ According to VDH, this regulatory package was first prepared as an exempt action under § 2.2-4006 A 4 a of the Code of Virginia, which requires regulations to be filed with the Registrar within 90 days of the law's effective date. Because the action was not filed within the required timeframe due to personnel changes in the Office of the Commissioner, the regulatory action does not qualify as an exempt action.

⁶ ORM Economic Impact Document.

⁷ Pursuant to § 2.2-4007.04 D: In the event this economic impact analysis reveals that the proposed regulation would have an adverse economic impact on businesses or would impose a significant adverse economic impact on a locality, business, or entity particularly affected, the Department of Planning and Budget shall advise the Joint Commission on Administrative Rules, the House Committee on Appropriations, and the Senate Committee on Finance. Statute does not define "adverse impact," state whether only Virginia entities should be considered, nor indicate whether an adverse impact results from regulatory requirements mandated by legislation.

⁸ Pursuant to § 2.2-4007.04, 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."

⁹ If the proposed regulatory action may have an adverse effect on small businesses, § 2.2-4007.04 requires that such economic impact analyses include: (1) an identification and estimate of the number of small businesses subject to the proposed regulation, (2) the projected reporting, recordkeeping, and other administrative costs required for small businesses to comply with the proposed regulation, including the type of professional skills necessary for preparing required reports and other documents, (3) a statement of the probable effect of the proposed regulation on affected small businesses, and (4) a description of any less intrusive or less costly alternative methods of achieving the purpose of the proposed regulation. Additionally, pursuant to § 2.2-4007.1 of the Code of Virginia, if there is a finding that a proposed regulation may have an adverse impact on small business, the Joint Commission on Administrative Rules shall be notified.

¹⁰ "Locality" can refer to either local governments or the locations in the Commonwealth where the activities relevant to the regulatory change are most likely to occur.

¹¹ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The agency concurs with the economic impact analysis prepared by the Department of Planning and Budget (DPB) with the following exceptions:

Estimated Benefits and Costs: DPB states, The Virginia Department of Health estimates that these legislative requirements amount to onetime compliance costs of $867,000 to hospitals, which is broken down as follows: onetime cost of $525,000 to 105 hospitals ($5,000 per hospital) to establish and implement policies related to patient access and use of intelligent personal assistants; onetime cost of $212,500 to 170 hospitals ($1,250 per hospital) to develop a protocol to allow patients to receive visits from a clergy of any religious denomination or sect during public health emergencies related to communicable diseases; onetime cost of $130,000 to 104 hospitals ($1,250 per hospital) to amend protocols for substance use-related emergencies to incorporate new statutory minimums such as: referrals to providers of pharmacotherapy for the treatment of drug or alcohol dependence or mental health diagnoses, and expanding what information and access is provided about opioid antagonists. The agency has updated the ORM form, which was originally published on September 9, 2022, to reflect the current number of hospitals and hospitals with emergency departments in the Commonwealth, and thus the current costs. Those costs would be as follows: a total cost of $863,750 to hospitals, a onetime cost of $525,000 to 105 inpatient hospitals ($5,000 per hospital) to establish and implement policies related to patient access and use of intelligent personal assistants; onetime cost of $232,500 to 186 hospitals ($1,250 per hospital) to develop a protocol to allow patients to receive visits from a clergy of any religious denomination or sect during public health emergencies related to communicable diseases; onetime cost of $106,250 to 85 hospitals with an emergency department ($1,250 per hospital) to amend protocols for substance use-related emergencies to incorporate new statutory minimums such as: referrals to providers of pharmacotherapy for the treatment of drug or alcohol dependence or mental health diagnoses, and expanding what information and access is provided about opioid antagonists.

Businesses and Other Entities Affected: DPB states, "The proposed changes apply to 106 licensed general hospitals and 63 outpatient surgical hospitals." The agency has updated ORM form to reflect that the proposed changes apply to 105 inpatient hospitals and 81 outpatient surgical hospitals.

Summary:

Pursuant to Chapters 219, 233, and 525 of the 2021 Acts of Assembly, Special Session I, the amendments (i) add a definition for intelligent personal assistant; (ii) require general and surgical hospitals to have a protocol to allow patients to receive visits from a rabbi, priest, minister, or clergy member of any religious denomination or sect during public health emergencies related to communicable diseases; (iii) require general hospitals to establish policies governing the access and use of intelligent personal assistants; and (iv) require each hospital with an emergency department to establish a protocol for the treatment and discharge of individuals experiencing a substance use-related emergency.

12VAC5-410-10. Definitions.

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

"Board" means the State Board of Health.

"Chief executive officer" means a job descriptive term used to identify the individual appointed by the governing body to act in on its behalf in the overall management of the hospital. Job titles may include administrator, superintendent, director, executive director, president, vice-president, and executive vice-president.

"Commissioner" means the State Health Commissioner.

"Consultant" means one who provides services or advice upon request.

"Department" means an organized section of the hospital.

"Designated support person" means a person who is knowledgeable about the needs of a person with a disability and who is designated, orally or in writing, by the individual with a disability, the individual's guardian, or the individual's care provider to provide support and assistance, including physical assistance, emotional support, assistance with communication or decision-making, or any other assistance necessary as a result of the person's disability, to the person with a disability at any time during which health care services are provided.

"Direction" means authoritative policy or procedural guidance for the accomplishment of a function or activity.

"Facilities" means building(s) buildings, equipment, and supplies necessary for implementation of services by personnel.

"Full-time" means a 37-1/2 to 40 hour work week.

"General hospital" means institutions as defined by § 32.1-123 of the Code of Virginia with an organized medical staff; with permanent facilities that include inpatient beds; and with medical services, including physician services, dentist services, and continuous nursing services, to provide diagnosis and treatment for patients who have a variety of medical and dental conditions that may require various types of care, such as medical, surgical, and maternity.

"Home health care department/service/program" means a formally structured organizational unit of the hospital that is designed to provide health services to patients in their place of residence and that meets Part II (12VAC5-381-150 et seq.) of the regulations adopted by the board for the licensure of home care organizations in Virginia Regulations for the Licensure of Home Care Organizations.

"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 combinations known as digital assistants or virtual assistants.

"Medical" means pertaining to or dealing with the healing art and the science of medicine.

"Nursing care unit" means an organized jurisdiction of nursing service in which nursing services are provided on a continuous basis.

"Nursing home" means an institution or any identifiable component of any institution as defined by § 32.1-123 of the Code of Virginia with permanent facilities that include inpatient beds and whose primary function is the provision, on a continuing basis, of nursing and health related services for the treatment of patients who may require various types of long term care, such as skilled care and intermediate care.

"Nursing services" means patient care services pertaining to the curative, palliative, restorative, or preventive aspects of nursing that are prepared or supervised by a registered nurse.

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

"Organized" means administratively and functionally structured.

"Organized medical staff" means a formal organization of physicians and dentists with the delegated responsibility and authority to maintain proper standards of medical care and to plan for continued betterment of that care.

"Outpatient hospital" means institutions as defined by § 32.1-123 of the Code of Virginia that primarily provide facilities for the performance of surgical procedures on outpatients. Such patients may require treatment in a medical environment exceeding the normal capability found in a physician's office, but do not require inpatient hospitalization.

"Ownership/person" means any individual, partnership, association, trust, corporation, municipality, county, governmental agency, or any other legal or commercial entity that owns or controls the physical facilities and/or or manages or operates a hospital.

"Rural hospital" means any general hospital in a county classified by the federal Office of Management and Budget (OMB) as rural, any hospital designated as a critical access hospital, any general hospital that is eligible to receive funds under the federal Small Rural Hospital Improvement Grant Program, or any general hospital that notifies the commissioner of its desire to retain its rural status when that hospital is in a county reclassified by the OMB as a metropolitan statistical area as of June 6, 2003.

"Service" means a functional division of the hospital. Also and is also used to indicate the delivery of care.

"Special hospital" means institutions as defined by § 32.1-123 of the Code of Virginia that provide care for a specialized group of patients or limit admissions to provide diagnosis and treatment for patients who have specific conditions (e.g., tuberculosis, orthopedic, pediatric, maternity).

"Special care unit" means an appropriately equipped area of the hospital where there is a concentration of physicians, nurses, and others who have special skills and experience to provide optimal medical care for patients assigned to the unit.

"Special hospital" means institutions, as defined by § 32.1-123 of the Code of Virginia, that provide care for a specialized group of patients or limit admissions to provide diagnosis and treatment for patients who have specific conditions (e.g., tuberculosis, orthopedic, pediatric, maternity).

"Staff privileges" means authority to render medical care in the granting institution within well-defined limits, based on the individual's professional license and the individual's experience, competence, ability, and judgment.

"Unit" means a functional division or facility of the hospital.

12VAC5-410-230. Patient care management.

A. All patients shall be under the care of a member of the medical staff.

B. Each hospital shall have a plan that includes effective mechanisms for the periodic review and revision of patient care policies and procedures.

C. Each hospital shall establish a protocol relating to the rights and responsibilities of patients based on the Joint Commission on Accreditation of Healthcare Organizations' Organizations 2000 Hospital Accreditation Standards, January 2000. The protocol shall include a process reasonably designed to inform patients of their patient rights and responsibilities. Patients shall be given a copy of their patient rights and responsibilities upon admission.

D. No medication or treatment shall be given except on the signed order of a person lawfully authorized by state statutes statute.

1. Hospital personnel, as designated in medical staff bylaws, rules and regulations, or hospital policies and procedures, may accept emergency telephone and other verbal orders for medication or treatment for hospital patients from physicians and other persons lawfully authorized by state statute to give patient orders.

2. As specified in the hospital's medical staff bylaws, rules and regulations, or hospital policies and procedures, emergency telephone and other verbal orders shall be signed within a reasonable period of time not to exceed 72 hours, by the person giving the order, or, when such person is not available, cosigned by another physician or other person authorized to give the order.

E. Each hospital shall have a reliable method for identification of each patient, including newborn infants.

F. Each hospital shall include in its visitation policy a provision allowing each adult patient to receive visits from any individual from whom the patient desires to receive visits, subject to other restrictions contained in the visitation policy, including the patient's medical condition and the number of visitors permitted in the patient's room simultaneously.

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

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

2. The protocol may require the person visiting a patient pursuant to this subsection to comply with all reasonable requirements of the hospital adopted to protect the health and safety of the person, patients, and staff of the hospital.

G. If the Governor has declared a public health emergency related to the novel coronavirus (COVID-19), each hospital shall allow a person with a disability who requires assistance as a result of such disability to be accompanied by a designated support person at any time during which health care services are provided.

1. In any case in which health care services are provided in an inpatient setting, and the duration of health care services in such inpatient setting is anticipated to last more than 24 hours, the person with a disability may designate more than one designated support person. However, no hospital shall be required to allow more than one designated support person to be present with a person with a disability at any time.

2. A designated support person shall not be subject to any restrictions on visitation adopted by such hospital. However, such designated support person may be required to comply with all reasonable requirements of the hospital adopted to protect the health and safety of patients and staff of the hospital.

3. Every hospital shall establish policies applicable to designated support persons and shall:

a. Make such policies available to the public on a website maintained by the hospital; and

b. Provide such policies, in writing, to the patient at such time as health care services are provided.

H. Each hospital that is equipped to provide life-sustaining treatment shall develop a policy to determine the medical or ethical appropriateness of proposed medical care, which shall include:

1. A process for obtaining a second opinion regarding the medical and ethical appropriateness of proposed medical care in cases in which a physician has determined proposed care to be medically or ethically inappropriate;

2. Provisions for review of the determination that proposed medical care is medically or ethically inappropriate by an interdisciplinary medical review committee and a determination by the interdisciplinary medical review committee regarding the medical and ethical appropriateness of the proposed health care of the patient;

3. Requirements for a written explanation of the decision of the interdisciplinary medical review committee, which shall be included in the patient's medical record; and

4. Provisions to ensure the patient, the patient's agent, or the person authorized to make the patient's medical decisions in accordance with § 54.1-2986 of the Code of Virginia is informed of the patient's right to obtain the patient's medical record and the right to obtain an independent medical opinion and afforded reasonable opportunity to participate in the medical review committee meeting.

The policy shall not prevent the patient, the patient's agent, or the person authorized to make the patient's medical decisions from obtaining legal counsel to represent the patient or from seeking other legal remedies, including court review, provided that the patient, the patient's agent, person authorized to make the patient's medical decisions, or legal counsel provide provides written notice to the chief executive officer of the hospital within 14 days of the date of the physician's determination that proposed medical treatment is medically or ethically inappropriate as documented in the patient's medical record.

I. Each hospital shall establish a protocol requiring that, before a health care provider arranges for air medical transportation services for a patient who does not have an emergency medical condition as defined in 42 USC § 1395dd(e)(1), the hospital shall provide the patient or the patient's authorized representative with written or electronic notice that the patient (i) may have a choice of transportation by an air medical transportation provider or medically appropriate ground transportation by an emergency medical services provider and (ii) will be responsible for charges incurred for such transportation in the event that the provider is not a contracted network provider of the patient's health insurance carrier or such charges are not otherwise covered in full or in part by the patient's health insurance plan.

J. Each hospital shall provide written information about the patient's ability to request an estimate of the payment amount for which the participant will be responsible pursuant to § 32.1-137.05 of the Code of Virginia. The written information shall be posted conspicuously in public areas of the hospital, including admissions or registration areas, and included on any website maintained by the hospital.

K. Each hospital shall establish protocols to ensure that any patient scheduled to receive an elective surgical procedure for which the patient can reasonably be expected to require outpatient physical therapy as a follow-up treatment after discharge is informed that the patient:

1. Is expected to require outpatient physical therapy as a follow-up treatment; and

2. Will be required to select a physical therapy provider prior to being discharged from the hospital.

L. Each hospital 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. The 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.).

12VAC5-410-280. Emergency service.

A. Hospitals with an emergency department or service shall have 24-hour staff coverage and shall have at least one physician on call at all times. Hospitals without emergency service shall have written policies governing the handling of emergencies.

B. No fewer than one registered nurse shall be assigned to the emergency service on each shift. Such assignment need not be exclusive of other duties, but must have priority over all other assignments.

C. Those hospitals that provide ambulance services shall comply with Article 2.1 (§ 32.1-111.1 et seq.) of Chapter 4 of Title 32.1 of the Code of Virginia and 12VAC5-31.

D. The hospital shall provide equipment, drugs, supplies, and ancillary services commensurate with the scope of anticipated needs, including radiology and laboratory services and facilities for handling and administering of blood and blood products. Emergency drugs and equipment shall remain accessible in the emergency department at all times.

E. Current A current roster of medical staff members on emergency call, including alternates and medical specialists or consultants, shall be posted in the emergency department.

F. Hospitals shall make special training available, as required, for emergency department personnel.

G. Toxicology reference material and poison antidote information shall be available along with telephone numbers of the nearest poison control centers.

H. Each emergency department shall post notice of the existence of a human trafficking hotline to alert possible witnesses or victims of human trafficking to the availability of a means to gain assistance or report crimes. This notice shall be in a place readily visible and accessible to the public, such as the patient admitting area or public or patient restrooms. The notice shall meet the requirements of § 40.1-11.3 C of the Code of Virginia.

I. Every hospital with an emergency department shall establish a security plan for each emergency department that:

1. Is developed using standards established in the Healthcare Security Industry Guidelines, 13th Edition (International Association for Healthcare Security and Safety);

2. Is based on:

a. The results of a security risk assessment of each emergency department location of the hospital; and

b. Risks for the emergency department identified in consultation with the emergency department medical director and nurse director, including:

(1) Trauma level designation;

(2) Overall patient volume;

(3) Volume of psychiatric and forensic patients;

(4) Incidents of violence against staff;

(5) Level of injuries sustained from such violence; and

(6) Prevalence of crime in the community;

3. Includes the presence of one or more off-duty law-enforcement officers or trained security personnel in the emergency department at all times, except as provided in subsection L of this section, and as indicated to be necessary and appropriate by the security risk assessment; and

4. Outlines training requirements for security personnel in:

a. The potential use of and response to weapons;

b. Defensive tactics;

c. De-escalation techniques;

d. Appropriate physical restraint and seclusion techniques;

e. Crisis intervention;

f. Trauma-informed approaches; and

g. Safely addressing situations involving patients, family members, or other persons who pose a risk of harm to themselves or others due to mental illness or substance abuse or who are experiencing a mental health crisis.

J. The hospital may:

1. Accept from its security personnel the satisfactory completion of the Department of Criminal Justice Services minimum training standards for auxiliary police officers as required by § 15.2-1731 of the Code of Virginia in lieu of the training prescribed by subdivision I 4 of this section; and

2. Request to use industry standards other than those specified in subdivision I 1 of this section by submitting a written request for alternative industry standards to the OLC that:

a. Specifies the title, edition if applicable, and author of the alternative industry standards; and

b. Provides an explanation of how the alternative industry standards are substantially similar to those specified in subdivision I 1 of this section.

K. Every hospital with an emergency department shall update its security plan, including its security risk assessment, for each emergency department location of the hospital as often as necessary but not to exceed two years.

L. The commissioner shall provide a waiver from the requirement that at least one off-duty law-enforcement officer or trained security personnel be present at all times in the emergency department if the hospital demonstrates that a different level of security is necessary and appropriate for any of its emergency departments based upon findings in the security risk assessment.

1. A hospital shall submit a written request for a waiver pursuant to this subsection and shall:

a. Specify the location of the emergency department for which the waiver is requested;

b. Provide a dated copy of the security risk assessment performed for the specified emergency department that has been reviewed and approved by the governing body or its designee; and

c. Indicate the requested duration of the waiver.

2. The commissioner shall specify in any waiver granted pursuant to this subsection:

a. The location of the emergency department for which the waiver is granted;

b. The level of security to be provided at the specified emergency department location;

c. The effective date of the waiver; and

d. The duration of the waiver, which may not exceed two years from the date of issuance.

3. A hospital granted a waiver pursuant to this subsection shall:

a. Notify the commissioner in writing no less than 30 calendar days after its security risk assessment changes if such change impacts when or how many off-duty law-enforcement officers or trained security personnel should be present at the emergency department for which a waiver was granted;

b. Provide a dated copy of the changed security risk assessment performed for the specified emergency department that has been reviewed and approved by the governing body or its designee; and

c. Indicate whether the hospital is:

(1) Requesting a modification to its existing waiver; or

(2) Surrendering its existing waiver.

4. The commissioner may request additional information from the hospital in evaluating the requested waiver.

5. The commissioner may modify or rescind a waiver granted pursuant to this subsection if:

a. Additional information becomes known that alters the basis for the original decision, including if the security risk assessment changes regarding how many off-duty law-enforcement officers or trained security personnel should be present at the emergency department for which a waiver was granted; or

b. Results of the waiver jeopardize the health or safety of patients, employees, contractors, or the public.

6. Pursuant to the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia), the Virginia Department of Health:

a. May not release to the public information that a hospital discloses pursuant to this subsection, the waiver request, or the response to the waiver to the extent those records are exempt from disclosure; and

b. Shall notify the Secretary of Public Safety and Homeland Security of any request for records specified in subdivision L 6 a of this section, the person making such request, and the Virginia Department of Health's response to the request.

M. Each hospital with an emergency department shall establish a protocol for the treatment and discharge of individuals experiencing a substance use-related emergency to, which shall include the completion of appropriate assessments or screenings provisions for:

1. Appropriate screening and assessment of individuals experiencing substance use-related emergencies to identify medical interventions necessary for the treatment of the individual in the emergency department. The protocol may also include a process for patients who are discharged directly from the emergency department for the recommendation of; and

2. Recommendations for follow-up care following discharge for any patient identified as having a substance use disorder, depression, or mental health disorder, as appropriate. For patients who have been treated for substance use-related emergencies, including opioid overdose, or other high-risk patients, that recommendations may include:

1. Instructions for distribution a. The dispensing of naloxone; 2. Referrals or other opioid antagonist used for overdose reversal pursuant to § 54.1-3408 X of the Code of Virginia at discharge; or

b. Issuance of a prescription for and information about accessing naloxone or other opioid antagonist used for overdose reversal, including information about accessing naloxone or other opioid antagonist used for overdose reversal at a community pharmacy, including an outpatient pharmacy operated by the hospital, or through a community organization or pharmacy that may dispense naloxone or other opioid antagonist used for overdose reversal without a prescription pursuant to a statewide standing order.

The protocol may also provide for referrals of individuals experiencing a substance use-related emergency to peer recovery specialists and community-based providers of behavioral health services; or 3. Referrals for to providers of pharmacotherapy for the treatment of drug or alcohol dependence or mental health diagnoses.

12VAC5-410-1170. Policy and procedures manual.

A. Each outpatient surgical hospital shall develop a policy and procedures manual that shall include provisions covering the following items:

1. The types of emergency and elective procedures that may be performed in the facility.

2. Types of anesthesia that may be used.

3. Admissions and discharges, including:

a. Criteria for evaluating the patient before admission and before discharge; and

b. Protocols to ensure that any patient scheduled to receive an elective surgical procedure for which the patient can reasonably be expected to require outpatient physical therapy as a follow-up treatment after discharge is informed that the patient:

(1) Is expected to require outpatient physical therapy as a follow-up treatment; and

(2) Will be required to select a physical therapy provider prior to being discharged from the hospital.

4. Written informed consent of patient prior to the initiation of any procedures.

5. Procedures for housekeeping and infection control and prevention.

6. Disaster preparedness.

7. Facility security.

B. A copy of approved policies and procedures and revisions thereto shall be made available to the OLC upon request.

C. Each outpatient surgical hospital shall establish a protocol relating to the rights and responsibilities of patients based on the Joint Commission on Accreditation of Healthcare Organizations' Organizations Standards for Ambulatory Care (2000 Hospital Accreditation Standards, January 2000). The protocol shall include a process reasonably designed to inform patients of their patient rights and responsibilities. Patients shall be given a copy of their patient rights and responsibilities upon admission.

D. If the Governor has declared a public health emergency related to the novel coronavirus (COVID-19), each outpatient surgical hospital shall allow a person with a disability who requires assistance as a result of such disability to be accompanied by a designated support person at any time during which health care services are provided.

1. A designated support person shall not be subject to any restrictions on visitation adopted by such outpatient surgical hospital. However, such designated support person may be required to comply with all reasonable requirements of the outpatient surgical hospital adopted to protect the health and safety of patients and staff of the outpatient surgical hospital.

2. Every outpatient surgical hospital shall establish policies applicable to designated support persons and shall:

a. Make such policies available to the public on a website maintained by the outpatient surgical hospital; and

b. Provide such policies, in writing, to the patient at such time as health care services are provided.

E. Each outpatient surgical hospital shall obtain a criminal history record check pursuant to § 32.1-126.02 of the Code of Virginia on any compensated employee not licensed by the Board of Pharmacy whose job duties provide access to controlled substances within the outpatient surgical hospital pharmacy.

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

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

2. The protocol may require the person visiting a patient pursuant to this subsection to comply with all reasonable requirements of the hospital adopted to protect the health and safety of the person, patients, and staff of the hospital.