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, 12VAC5-410-50, 12VAC5-410-60, 12VAC5-410-100, 12VAC5-410-130 through 12VAC5-410-160, 12VAC5-410-230, 12VAC5-410-370, 12VAC5-410-380, 12VAC5-410-442, 12VAC5-410-444, 12VAC5-410-445, 12VAC5-410-447, 12VAC5-410-650, 12VAC5-410-760, 12VAC5-410-1170, 12VAC5-410-1190, 12VAC5-410-1260, 12VAC5-410-1350; adding 12VAC5-410-215, 12VAC5-410-227, 12VAC5-410-235, 12VAC5-410-237, 12VAC5-410-465, 12VAC5-410-1171, 12VAC5-410-1178; repealing 12VAC5-410-1175).

Statutory Authority: §§ 32.1-12, 32.1-23.2, 32.1-127, and 32.1-127.001 of the Code of Virginia.

Public Hearing Information: No public hearing is currently scheduled.

Public Comment Deadline: May 20, 2026.

Effective Date: June 4, 2026.

Agency Contact: Geoff Garner, Senior Policy Analyst, Virginia Department of Health, 9960 Mayland Drive, Suite 401, Henrico, VA 23233, telephone (804) 367-2157, or email regulatorycomment@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia requires the State Board of Health to make, adopt, promulgate, and enforce regulations necessary to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-23.2 of the Code of Virginia requires the Virginia Department of Health to designate the form and due date of reports required by Chapter 1088 of the 2020 Acts of Assembly. 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 and certified nursing facilities; (ii) the operation, staffing, and equipping of hospitals and certified nursing facilities; (iii) qualifications and training of staff of hospitals and certified nursing facilities, except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital 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 and certified nursing facilities. Section 32.1-127.001 requires the board to promulgate regulations that include minimum standards for the design and construction of hospitals and certified nursing facilities consistent with the current edition of the Facility Guidelines Institute (FGI) guidelines.

Purpose: This action is essential to protect the health, safety, and welfare of citizens because the regulation does not currently reference the most current clinical and industry practices, including those for infection prevention and control, and does not address all mandated subjects affecting patient rights.

Rationale for Using Fast-Track Rulemaking Process: This action is expected to be noncontroversial and therefore appropriate for the fast-track rulemaking process because the amendments conform the regulation to the statutes, legislative mandates, existing clinical, and industry practices and accurately detail the department's licensing procedures and practices. The department's subject matter experts believe that the changes do not jeopardize the protection of public health, safety, and welfare.

Substance: The amendments (i) update definitions; (ii) clarify the licensure and inspection process; (iii) revise plan of correction requirements and ensure consistency of those requirements throughout; (iv) add minimum requirements for hospitals to provide information about charity care and financial assistance and for payment plans; (v) add minimum requirements for operation of a newborn safety device if a hospital has elected to install a device; (vi) add minimum requirements for providing a person with a disability access to a designated support person; (vii) add minimum statutory standards for certified nursing facilities that are operated under a general hospital's license; (viii) update standards for medical record storage and access and fetal death reporting; (ix) clarify language regarding quarterly reports from hospitals; (x) update breast milk storage times to match current CDC recommendations; (xi) update documents incorporated by references; and (xii) remove outdated and duplicative language.

Issues: The primary advantages to the public are removal of language or requirements that are unclear, inconsistent, or outdated and addition of legislative mandates that are not incorporated into the regulation. The primary advantages to the agency and the Commonwealth are clarity on the minimum requirements for hospitals and the department in the administration of the hospital licensing program. There are no disadvantages to the public 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. The State Board of Health (board) proposes to amend the regulation for the licensure of hospitals to implement changes resulting from a periodic review, conform to the Code of Virginia (Code), and implement multiple recent legislative mandates. The proposed changes would also group related requirements, remove outdated language, make certain terminology more consistent throughout the regulation, and update the text to reflect current practice.

Background. The proposed changes are intended to implement the results of a 2020 periodic review, which include incorporating legislative mandates that were inadvertently omitted, addressing current clinical and industry practices, and updating licensing processes and procedures.² This action would also implement more recent legislative mandates, which the Virginia Department of Health (VDH) reports have largely been previously implemented in practice because statutory requirements apply even if a regulation has not yet been updated to reflect a particular mandate. The relevant legislative mandates are as follows:

Chapter 72 of the 2021 Acts of Assembly, Special Session I, which prohibits discriminating against health insurance enrollees on the basis of the enrollee being a litigant or potential litigant due to a motor vehicle accident. This mandate is already in effect. Chapters 1080 and 1081 of the 2020 Acts of Assembly, which prohibited balance billing by out-of-network providers. This mandate is already in effect. Chapter 1088 of the 2020 Acts of Assembly, which requires hospitals to provide quarterly reports pertaining to the employment of certified sexual assault nurse examiners. This reporting requirement would be implemented through the proposed changes to 12VAC5-410-380 and 12VAC5-410-1190 for general and outpatient surgical hospitals, respectively. Chapter 220 of the 2021 Acts of Assembly, which requires medical care facilities to allow individuals with disabilities who require assistance as a result of a disability to be accompanied by a designed support person during admission to a medical care facility. This mandate is already in effect. Chapters 80 and 81 of the 2022 Acts of Assembly, which were identical, require that hospitals and emergency medical services agencies that voluntarily install newborn safety devices for the reception of children must ensure that the devices meet specified safety and security standards. This mandate is already in effect. Chapter 218 of the 2022 Acts of Assembly requires hospitals and health care providers that choose to make health care records available through a secure website must also make a minor's records available to the parent unless the hospital or health care provider cannot make the record available in a way that prevents information disclosure. This mandate would be implemented through the proposed changes to 12VAC5-410-370 and 12VAC5-410-1260 for general and outpatient surgical hospitals, respectively. Chapters 678 and 679 of the 2022 Acts of Assembly require hospitals to make reasonable efforts to screen uninsured patients to determine whether the patient is eligible for medical assistance from the Department of Medical Assistance Services or for financial assistance under the hospital financial assistance policy. This mandate would be implemented through the proposed changes to 12VAC5-410-215 and 12VAC5-410-1178 for general and outpatient surgical hospitals, respectively. Chapters 177 and 222 of the 2005 Acts of Assembly, which directed the board to add minimum design and construction guidelines for hospitals and nursing facilities in the regulations for licensure. The proposed changes in this action would replace references to the Facility Guidelines Institute (FGI) 2018 Guidelines for Design and Construction of Hospitals (FGI Guidelines) with the 2022 edition and update the documents incorporated by reference. This change will only be binding for facility plans that are dated after this regulatory action is effective. Accordingly, the board proposes to make a number of changes to the regulation. The most substantive changes are summarized. The 15 sections indicated with an asterisk include changes that would implement a legislative mandate. 12VAC5-410-130 specifies that a hospital must notify the director of VDH Office of Licensure and Certification (OLC) in writing 30 calendar days before changing (i) hospital location (including the location of any emergency department not located on the hospital campus), ownership, operator, or name of the nursing facility; (ii) bed capacity, except as provided in 12VAC5-410-110 with respect to disasters and public health emergencies; or (iii) the services provided, regardless of whether licensure is required for that service; and closure of the hospital. The proposed changes to the regulation would add that OLC shall determine if any of the changes listed above affect either the terms of the license or the continuing eligibility for a license, and that an inspector may inspect the hospital during the process of evaluating a proposed change. The proposed changes would also add stipulations that licenses cannot be transferred or assigned, and that a change in the operator of the hospital requires that a new license be issued. Further, if the hospital facility is closing, it shall notify patients, legal representatives, and the OLC at least seven calendar days prior to closing where all clinical records are to be located following closure or cessation of operations. 12VAC5-410-140 Inspection procedure. The proposed changes include adding language about frequency of inspections, which matches OLC current practice. The board also proposes to add more details regarding the inspection process so that facilities know what to expect during an inspection and to create a rebuttable compliance presumption for outpatient surgical hospitals. 12VAC5-410-150 specify the minimum elements of a plan of correction, and also add a 15-day timeline for the submission of a plan of correction upon receiving an inspection report and a 45-day timeline for submission and completion of a plan of correction. The board intent is to standardize the plan of correction process and make it more similar to the federal plan of correction process so that the same requirements for the documentation and completion of remedial actions are consistently applies across all hospitals. 12VAC5-410-160 provides a more specific and detailed list of the grounds upon which the VDH commissioner may take disciplinary action against a hospital, the options available to the commissioner for disciplinary action, and how a hospital may obtain a license after suspension or revocation. The proposed changes would also implement the legislative mandates relating to prohibitions on balance billing and discriminating against health insurance enrollees on the basis of the enrollee being a litigant or potential litigant due to a motor vehicle accident. 12VAC5-410-215 and 12VAC5-410-1178 are new sections to describe the minimum requirements for information disclosure about financial assistance, for payment plans, and for renegotiation of payment plans. Adding these sections would implement Chapters 678 and 679 of the 2022 Acts of Assembly. 12VAC5-410-225 is a new section to add the safety standards for those hospitals that voluntarily install newborn safety devices, as specified in Chapters 80 and 81 of the 2022 Acts of Assembly. The requirements include that the device be located inside the hospital in an area that is conspicuous and visible to employees or personnel, be staffed 24 hours a day by a health care provider, is climate controlled and serves as a safe sleep environment for an infant, and identifiable by appropriate signage. However, hospitals are not required to install such a device. 12VAC5-410-235 and 12VAC5-410-1171 are new sections to add minimum requirements for access to a designated support person at the time of admission to each type of facility respectively. The intention is to clarify what requirements apply outside of a Governor-declared public health emergency due to COVID-19. These changes would implement Chapter 220 of the 2021 Acts of Assembly. 12VAC5-410-370 and 12VAC5-410-1260 are amended to conform with Chapter 218 of the 2022 Acts of Assembly, which requires hospitals that choose to make health care records available through a secure website to also make a minor's records available to the parent or guardian through that website. 12VAC5-410-380 and 12VAC5-410-1190 specify that a hospital quarterly reports about nursing services are due no later than 30 calendar days after January 1, April 1, July 1, and October 1, and that the reports include the total number of certified sexual assault nurse examiners employed by the hospital and that the locations and contact information for each location these services are provided. These changes would implement Chapter 1088 of the 2020 Acts of Assembly. 12VAC5-410-444 updates the breast milk storage times to match current Centers for Disease Control and Prevention (CDC) recommendations.³ The current language requires milk stored under refrigeration to be consumed or disposed of within 24-48 hours of collection. The new language would increase the threshold to within 96 hours of collection. 12VAC5-410-465 repeats certain requirements found in Regulation for the Licensure of Nursing Facilities (12VAC5-390). The intention is to easily ensure that hospitals are aware that these requirements also apply to long-term care service units, which are certified nursing facilities that operate under a general hospital license. 12VAC5-410-442, 12VAC5-410-445, 12VAC5-410-650, 12VAC5-410-760, and 12VAC5-410-1350 reference applicable sections of the 2018 Guidelines; the proposed changes would update these references and update the list of documents incorporated by reference to the 2022 FGI Guidelines, thereby maintaining compliance with the 2005 legislative mandate.

Estimated Benefits and Costs. The primary benefit of the proposed changes would be to improve clarity for hospitals surrounding the requirements to maintain their license, what to expect in an inspection, how to submit and undertake a plan of correction (if necessary), other current requirements, and the provisions of the CDC guidelines. Entities wishing to build new facilities would know to use the updated 2022 FGI Guidelines for construction plans. To the extent that these changes improve the quality of service, transparency of hospital policies (especially regarding financial assistance), and patient outcomes, both patients and their families would also benefit from the proposed changes. Hospitals are expected to face some costs to comply with some of the proposed changes. VDH reports that the new reporting requirements for specific nurse staffing would lead to new ongoing recordkeeping costs for all hospitals; however, VDH estimates that these costs are not expected to exceed $5,000 per year. Hospitals that use secure websites to share health records with patients may incur some costs to provide access to minor patients parents and guardians; however, these costs are expected to be minimal. The requirements for certified nursing facilities operated under a hospital's license may results in some costs for hospitals that operate such long-term nursing care units if they were not previously aware of those requirements. Hospitals are also expected to face one-time costs from updating their internal policies and procedures related to designated support persons, certified nursing facilities, parent or guardian electronic access to minor patient records, discharge planning, financial assistance, and infection control and prevention. VDH estimates that it would cost $1,250 one-time to amend an existing policy on each topic to conform to the regulatory minimums. If hospitals do not already have policies and procedures on these topics, VDH estimates that hospitals would incur a one-time cost of $5,000 per topic to develop these policies and procedures. Some hospitals may not incur any costs if the policies and procedures meet or exceed the proposed regulatory minimums. Other new costs may optionally arise if a hospital meets one of the newly added criteria for reporting a mid-term change of license, or if the facility is closing and must comply with new requirements with respect to informing patients and legal representatives about where medical records will be located. VDH also reports that as a result of the mandate to comply with the 2022 FGI Guidelines, there may be a quantifiable indirect cost equal to a 1.4% increase in construction costs for a 160-bed general hospital, a 2.7% increase in construction costs for a 12-bed general hospital that is certified as a critical access hospital, and a 0.7% to 1.3% increase in construction costs for a multi-specialty outpatient surgical hospital.

Businesses and Other Entities Affected. VDH reports that there are 106 licensed general hospitals and 67 outpatient surgical hospitals, that will all be required to comply with the regulatory changes.⁴ These include public bodies, the VCU Health Systems Authority, Lee County Hospital Authority, and Chesapeake Hospital Authority, which all run licensed hospitals. The remaining facilities are privately owned and operated, often with a single entity operating multiple facilities in multiple locations. The Code of Virginia requires DPB to assess whether an adverse impact may result from the proposed regulation.⁵ An adverse impact is indicated if there is any increase in net cost or reduction in net benefit for any entity, even if the benefits exceed the costs for all entities combined.⁶ The proposed changes would create new costs for licensed general hospitals and outpatient surgical hospitals, even if some of those changes are required by federal and state law and have already been borne by nursing facilities. Thus, an adverse impact is indicated.

Small Businesses⁷ Affected.⁸ The proposed amendments appear to adversely affect some small businesses. Types and Estimated Number of Small Businesses Affected: VDH estimates that three of the outpatient surgical hospitals may meet the definition of small business. Costs and Other Effects: Small businesses would face the same costs. Specifically, they would incur costs arising from the new recordkeeping and reporting requirements for certain nursing staff. They may also incur costs associated with updating existing policies or developing new policies as needed. Thus, an adverse impact is indicated for small businesses. Alternative Method that Minimizes Adverse Impact: Because the proposed changes reflect statutory requirements, there are no clear alternative methods that both reduce adverse impact and meet the intended policy goals.

Localities⁹ Affected.¹⁰ The proposed amendments do not introduce direct costs for local governments. Lee County Hospital Authority and Chesapeake Hospital Authority operate hospitals. Consequently, to the extent that local funding is provided for these Authorities, an adverse economic impact is indicated for Lee County and the City of Chesapeake.

Projected Impact on Employment. The proposed amendments are unlikely to impact the number of general hospitals and outpatient surgical facilities that obtain and remain licensed and the staffing in those facilities. Thus, the proposed amendments are not projected to significantly impact employment.

Effects on the Use and Value of Private Property. The proposed amendments raise costs for general hospitals and outpatient surgical facilities, which would reduce their value. The proposed amendments do not affect real estate development costs in general but would result in a small increase in construction costs for new facilities based on changes contained in the updated 2022 FGI Guidelines.

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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 See https://townhall.virginia.gov/L/ViewPReview.cfm?PRid=1960. Some changes recommended to the board by commenters were deemed inappropriate for a Fast-track action and will be implemented separately..

³ See https://www.cdc.gov/breastfeeding/recommendations/handling_breastmilk.htm.

⁴ On a call with DPB, VDH noted that The University of Virginia Hospital, hospitals administered by Veterans Affairs, and psychiatric hospitals licensed by the Department of Behavioral Health and Developmental Services were all exempt from licensure by VDH. Accordingly, the requirements of this regulation would not apply to them.

⁵ 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.

⁶ 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. As a result, DPB has adopted a definition of adverse impact that assesses changes in net costs and benefits for each affected Virginia entity that directly results from discretionary changes to the regulation.

⁷ 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."

⁸ 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.

⁹ "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.

¹⁰ Section 2.2-4007.04 defines "particularly affected" as bearing disproportionate material impact.

Agency Response to Economic Impact Analysis: The State Board of Health has reviewed the economic impact analysis prepared by the Department of Planning and Budget and finds it substantively complete and accurate and no modification warranted.

Summary:

Pursuant to a periodic review, the action updates Regulations for the Licensure of Hospitals in Virginia (12VAC5-410), including conforming the chapter to multiple legislative mandates from 2020, 2021, and 2022. Specifically, the amendments (i) add minimum requirements (a) for hospitals to provide information about charity care and financial assistance and for payment plans, (b) for operation of a newborn safety device if a hospital has elected to install a device, and (c) for providing a person with a disability access to a designated support person; (ii) require hospitals that make a minor's health records available through a website to make the records available to the minor's parent or guardian; (iii) add minimum statutory standards for certified nursing facilities that are operated under a general hospital's license; (iv) clarify and update quarterly reporting requirements of hospital employment of certified sexual assault nurse examiners; (v) update breast milk storage requirements; (vi) update and clarify policies, procedures, and clinical standards throughout the chapter; and (vii) update documents incorporated by reference.

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:

"ACIP" means the Advisory Committee on Immunization Practices of the CDC.

"Activity of daily living" or "ADL" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"Board" means the State Board of Health.

"Business day" means a day that is not a Saturday, Sunday, legal holiday, or day on which the OLC is closed. For the purposes of this chapter, a day on which the Governor authorizes the closing of the state government is considered a legal holiday.

"Campus" means the physical area that is immediately adjacent to the hospital's main buildings, other areas and structures not strictly contiguous to the main buildings but located within 250 yards of the main buildings, and any other areas determined on an individual case basis by the OLC, in accordance with 42 CFR 431.65, to be part of the hospital's campus.

"Care provider" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"CDC" means the Centers for Disease Control and Prevention.

"Certified nursing facility" has the same meaning as ascribed to the term in § 32.1-123 of the Code of Virginia.

"Certified sexual assault nurse examiner" means a nurse who is board certified by the International Association of Forensic Nurses as either a Sexual Assault Nurse Examiner-Pediatric (SANE-P) or a Sexual Assault Nurse Examiner-Adult/Adolescent (SANE-A).

"Chief executive officer" means a job descriptive term used to identify the individual appointed by the governing body to act 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.

"CMS" means the Centers for Medicare and Medicaid Services.

"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 or "DSP" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia and is not a visitor.

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

"Emergency department" means a department of the hospital that provides emergency services and is located on or within a 35-mile radius of the campus of the hospital.

"Facilities" means 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 a hospital with an organized medical staff; with permanent facilities that may 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.

"General hospital accrediting organization" means the Accreditation Commission for Health Care, the Center for Improvement in Healthcare Quality, DNV - Healthcare, the Joint Commission, or any accrediting organization that has been granted deeming authority for hospitals by CMS.

"Home health care department/service/program services" 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 for the Licensure of Home Care Organizations.

"Hospital" has the same meaning ascribed to the term in § 32.1-123 of the Code of Virginia and includes general hospitals and outpatient surgical hospitals.

"Inspector" means an individual employed by or contracted by the Virginia Department of Health and designated by the commissioner to conduct inspections, investigations, or evaluations.

"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.

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

"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 has the same meaning as ascribed to the term in § 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.

"Operating room" means a room in a hospital designated for the performance of surgery.

"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. Organized medical staff may include other practitioners, including independent practice midwives.

"Outpatient surgical hospital" means institutions as defined by § 32.1-123 of the Code of Virginia a hospital that primarily provide provides 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.

"Outpatient surgical hospital accrediting organization" means the Accreditation Commission for Ambulatory Health Care, the Accreditation Commission for Health Care, the American Association for Accreditation of Ambulatory Surgery Facilities, the Joint Commission, or any accrediting organization that has been granted deeming authority for ambulatory surgical centers by CMS.

"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 or manages or operates a hospital.

"Person with a disability" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"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 and is also used to indicate the delivery of care.

"Smoke evacuation system" means the same as that term is defined in § 32.1-127 B 32 of the Code of Virginia.

"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.

"Support and assistance necessary due to the specifics of the person's disability" has the same meaning as ascribed to the term in § 32.1-137.08 A of the Code of Virginia.

"Surgery" has the same meaning as ascribed to the term in § 54.1-2400.01:1 A of the Code of Virginia.

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

"Urine drug screening" means a chemical analysis intended to test patients for the presence of multiple drugs, including cocaine, opioids, and phencyclidine.

12VAC5-410-50. Classification.

Hospitals to be licensed shall be classified as general hospitals, special hospitals or outpatient surgical hospitals defined by 12VAC5-410-10.

12VAC5-410-60. Separate license.

A. A separate license shall be required by hospitals maintained on separate premises campuses even though they the hospitals are operated under the same management. Separate license is not required for separate buildings on the same grounds campus or within the same complex of buildings or for an emergency department of a general hospital.

B. Hospitals which that have separate organized sections, units, or buildings to provide services of a classification covered by provisions of other state statutes or regulations may be required to have an additional applicable license for that type or classification of service (e.g., psychiatric, nursing home, home health services, and outpatient surgery).

12VAC5-410-100. Name.

Every hospital shall be designated by a permanent and appropriate name which that shall appear on the application for license. Any change of name shall be reported to the OLC within 30 days.

12VAC5-410-130. Return of Surrender of license; mid-term change of license.

A. Upon revocation or suspension of a license, the hospital shall surrender its license to the OLC.

B. The hospital shall notify the director of the OLC shall be notified in writing at least within by submitting a mid-term change application no fewer than 30 working calendar days in advance of any proposed change in location or ownership of the facility. A license shall not be transferred from one owner to another or from one location to another. The license issued by the commissioner shall be returned to the OLC for correction or reissuance when any of the following changes occur during the licensing year implementing any of the following:

1. Revocation;

2. 1. Change of location of the hospital, including change of location of any emergency department, not located on the hospital's campus;

3. 2. Change of ownership of the hospital;

3. Change of operator of the hospital;

4. Change of name of the hospital;

5. Change of bed capacity, except as provided in 12VAC5-410-110 C, which shall be accompanied by an approved Certificate of Public Need if the requested change is for an increase in bed capacity; or

6. Voluntary closure Change of services being provided, including any proposed addition or discontinuation, regardless of whether licensure is required for the service; or

7. Closure of the hospital.

C. The OLC shall:

1. Consider the submission date of a mid-term change application to be the date it is postmarked or the date it is received, whichever is earlier; and

2. Notify the licensee in writing if the commissioner will issue a changed license.

D. The commissioner's issuance of a changed license to the hospital shall satisfy the requirements of subdivision C 2 of this section.

E. Upon receipt of the changed license, the licensee shall return its prior license issued by the commissioner to the OLC and destroy any copies of the prior license.

F. A license may not be transferred or assigned. The commissioner may not issue a changed license in response to a change of operator of the hospital, but shall instead require the hospital to obtain a new license. If the hospital intends to implement a change of operator, it shall:

1. File for a new license in accordance with 12VAC5-410-70 no fewer than 30 calendar days in advance of any change of operator; and

2. Upon receipt of the new license, surrender its prior license issued by the commissioner to the OLC and destroy any copies of the prior license.

G. If the hospital is closing or will otherwise no longer be operational, it shall:

1. Notify patients, legal representatives, and the OLC no fewer than seven calendar days prior to closing or ceasing operations where all clinical records are to be located following closure or cessation of operations; and

2. Surrender its license to the OLC and destroy all copies of its license no more than five calendar days after the hospital closes or ceases operations.

H. The OLC shall determine if any changes listed in subsection B of this section affect the terms of the license or the continuing eligibility for a license. An inspector may inspect the hospital during the process of evaluating a proposed change.

12VAC5-410-140. Inspection procedure.

A. The OLC shall make periodic unannounced on-site inspections of a hospital as necessary but not less frequently than biennially. The OLC may make on-site inspections of applicants for licensure. Compliance with all standards shall be determined by the OLC.

B. The hospital or applicant shall:

1. Make available to the inspector any requested records;

2. Permit an inspector to enter upon and into its property to inspect or investigate as the inspector reasonably deems necessary in order to determine the state of compliance with the provisions of this chapter and all laws administered by the board; and

3. Allow the inspector access to interview the agents, employees, independent contractors, patients, legal representatives, patient family members, and any person under the hospital's or applicant's control, direction, or supervision.

C. After the on-site inspection, the inspector shall:

1. Discuss the findings of the inspection with the chief executive officer or the chief executive officer's designee; and

2. Provide a written inspection report to the chief executive officer or the chief executive officer's designee.

D. If the OLC cites one or more licensing violations in the written inspection report, the chief executive officer or the chief executive officer's designee shall submit a plan of correction in accordance with 12VAC5-410-150.

E. The OLC may presume that a general hospital accredited deemed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) a general hospital accrediting organization and certified for participation in Title XVIII of the Social Security Act (Medicare) (42 USC § 301 et seq.) generally meets the requirements of Part II (12VAC5-410-170 et seq.) of this chapter provided the following conditions are met:

1. The general hospital provides to the OLC, upon request, a copy of the most current accreditation survey findings made by the Joint Commission on Accreditation of Healthcare Organizations general hospital accrediting organization; and

2. The general hospital notifies the OLC within 10 days after receipt of any notice of revocation or denial of accreditation by the Joint Commission on Accreditation of Healthcare Organizations general hospital accrediting organization.

B. F. The OLC may presume that an outpatient surgical hospital deemed by an outpatient surgical hospital accrediting organization and certified for participation in Title XVIII of the Social Security Act (42 USC § 301 et seq.) generally meets the requirements of Part IV (12VAC5-410-1150 et seq.) of this chapter provided the following conditions are met:

1. The outpatient surgical hospital provides to the OLC, upon request, a copy of the most current accreditation survey findings made by the outpatient surgical hospital accrediting organization; and

2. The outpatient surgical hospital notifies the OLC within 10 days after receipt of any notice of revocation or denial of accreditation by the outpatient surgical hospital accrediting organization.

G. The OLC may presume that a unit or part of a general hospital licensed or certified by another state agency, or another section, bureau, or division of the OLC meets the requirements of Part II (12VAC5-410-170 et seq.) of this chapter for that specific unit or part provided the following conditions are met:

1. The general hospital provides the OLC, upon request, a copy of the most current inspection report made by the other state agency; and

2. The general hospital notifies the OLC within 10 days after receipt of any notice of revocation or suspension by the other state agency.

C. H. The OLC may presume that a unit or part of an outpatient surgical hospital licensed or certified by another state agency or another section, bureau, or division of the OLC meets the requirements of Part IV (12VAC5-410-1150 et seq.) of this chapter for that specific unit or part provided the following conditions are met:

1. The outpatient surgical hospital provides the OLC, upon request, a copy of the most current inspection report made by the other state agency; and

2. The outpatient surgical hospital notifies the OLC within 10 days after receipt of any notice of revocation or suspension by the other state agency.

I. Notwithstanding any other provision of this chapter to the contrary, if the licensing agency OLC finds, after inspection, violations pertaining to environmental health or life safety, the hospital shall receive a written licensing report of such findings. The hospital shall be required to submit a plan of correction in accordance with provisions of 12VAC5-410-150.

12VAC5-410-150. Plan of correction.

A. Upon receipt of a written licensing inspection report each hospital, the chief executive officer or the chief executive officer's designee shall prepare a written plan for correcting any of correction addressing each licensing violations violation cited at the time of inspection.

B. The chief executive officer or the chief executive officer's designee plan of correction shall be submit to the OLC a written plan of correction no more than 15 business days after receipt of within the specified time limit set forth in the licensing inspection report. The plan of correction shall contain at least the following information, for each licensing violation cited:

1. The methods implemented A description of the corrective action to correct any violations of this chapter be taken and the position title of the employees to implement the corrective action. If employees share the same position title, the chief executive officer or the chief executive officer's designee shall assign the employees a unique identifier to distinguish them; and

2. The expected correction date on which such corrections are expected to be completed, not to exceed 45 business days from the exit date of the inspection; and

3. A description of the measures implemented to prevent a recurrence of each licensing violation.

B. C. The chief executive officer or the chief executive officer's designee shall ensure that the person responsible for the validity of the plan of correction signs, dates, and indicates their title on the plan of correction.

D. The OLC shall notify the hospital chief executive officer or the chief executive officer's designee, in writing, whenever if the OLC determines any item in the plan of correction is determined to be unacceptable.

E. The OLC may conduct an inspection to verify that any portion of a plan of correction has been implemented.

F. The chief executive officer or the chief executive officer's designee shall ensure the plan of correction is implemented and monitored so that compliance is maintained.

G. The commissioner may deny licensure or renewal of licensure if the chief executive officer or the chief executive officer's designee fails to submit an acceptable plan of correction or fails to implement an acceptable plan of correction.

H. The OLC shall consider the submission date of a plan of correction to be the date the plan of correction is postmarked or the date it is received, whichever is earlier.

12VAC5-410-160. Revocation of license Disciplinary action.

The commissioner may revoke or suspend the license to operate a hospital in accordance with § 32.1-135 of the Code of Virginia for the following reasons: A. A hospital may not:

1. Violation of any provision Violate the provisions of these rules and regulations. Violations which in the judgment of the commissioner jeopardize the health or safety of patients shall be sufficient cause for immediate revocation or suspension this chapter or Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia; or

2. Willfully permitting, aiding Permit, aid, or abetting abet the commission of any illegal act in the hospital.;

3. Engage in a pattern of violations pursuant to § 38.2-3445.01 of the Code of Virginia; or

4. Engage in a pattern of violations of § 38.2-3407.15 B 13 of the Code of Virginia.

B. The commissioner may:

1. For each violation of subsection A of this section:

a. Deny, revoke, or suspend the license to operate a hospital, in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia);

b. Refer a hospital for criminal prosecution pursuant to § 32.1-27 A of the Code of Virginia; or

c. Petition an appropriate court for an injunction, mandamus, or other appropriate remedy or imposition of a civil penalty against a hospital pursuant to § 32.1-27 B or C of the Code of Virginia;

2. For each violation of subsection A of this section by or occurring in a long-term care nursing unit of a general hospital if that unit is a certified nursing facility:

a. Restrict or prohibit new admissions to the long-term care nursing unit in accordance with the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia);

b. Petition an appropriate court for imposition of a civil monetary penalty against a hospital pursuant to § 32.1-27.1 A of the Code of Virginia; or

c. Petition an appropriate court for appointment of a receiver for the long-term care nursing unit pursuant to § 32.1-27.1 B of the Code of Virginia; and

3. For each violation of subdivision A 3 of this section, levy a fine upon the hospital in an amount not to exceed $1,000 per violation, in accordance with the Administrative Process Act.

C. Suspension of a license shall in all cases be for an indefinite time.

D. For each violation of subsection A of this section and with the consent of the person who has violated subsection A of this section, the board may provide, in an order issued by the board, for the payment of civil charges for past violations in specific sums, which may not exceed the limits specified in § 32.1-27 of the Code of Virginia or if applicable, the limits specified in § 32.1-27.1 of the Code of Virginia.

E. Upon receipt of a completed application and a nonrefundable service charge, the commissioner may issue a new license to a hospital that has had its license revoked if the commissioner determines that:

1. The conditions upon which revocation was based have been corrected; and

2. The applicant is in compliance with this chapter, Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 of the Code of Virginia, and all other applicable state and federal laws and regulations.

F. Upon receipt of a completed application, the commissioner may partially or completely restore a suspended license to a hospital if the commissioner determines that:

1. The conditions upon which suspension was based have been completely or partially corrected; and

2. The interests of the public will not be jeopardized by resumption of operation.

G. The commissioner may not require an additional service charge for restoring a license pursuant to subsection F of this section.

H. The hospital shall submit evidence relevant to subdivisions E 1, E 2, F 1, and F 2 of this section that is satisfactory to the commissioner or the commissioner's designee. The commissioner or the commissioner's designee may conduct an inspection prior to making a determination.

Part II

Organization and Operation of General and Special Hospitals

12VAC5-410-215. Financial assistance in general hospitals.

A. As used in this section, "patient" and "uninsured patient" have the same meanings as ascribed to these terms in § 32.1-137.010 A of the Code of Virginia.

B. A general hospital shall make reasonable efforts to screen every uninsured patient to determine whether the individual is eligible for medical assistance pursuant to the state plan for medical assistance or for financial assistance under the general hospital's financial assistance policy.

C. A general hospital shall inform every uninsured patient who receives services at the general hospital and who is determined to be eligible for assistance under the general hospital's financial assistance policy of the option to enter into a payment plan with the general hospital.

1. A payment plan entered into pursuant to this subsection shall be provided to the patient in writing or electronically and shall provide for repayment of the cumulative amount owed to the general hospital.

2. The amount of monthly payments and the term of the payment plan shall be determined based upon the patient's ability to pay.

3. Any interest on amounts owed pursuant to the payment plan shall not exceed the maximum judgment rate of interest pursuant to § 6.2-302 of the Code of Virginia.

4. The general hospital may not charge any fees related to the payment plan.

5. The payment plan shall allow prepayment of amounts owed without penalty.

D. A general hospital shall develop a process by which either an uninsured patient who agrees to a payment plan pursuant to subsection C of this section or the general hospital may request and shall be granted the opportunity to renegotiate the payment plan.

1. Renegotiation shall include opportunity for a new screening in accordance with subsection B of this section.

2. A general hospital may not charge any fees for renegotiation of a payment plan pursuant to this subsection.

E. A general hospital shall provide written information about:

1. The general hospital's charity care policies, including:

a. Policies related to free and discounted care;

b. Specific eligibility criteria for charity care; and

c. Procedures for applying for charity care;

2. The availability of a payment plan for the payment of debt owed to the general hospital pursuant to subsection C of this section; and

3. The renegotiation process described in subsection D of this section.

F. To provide the information required by subsection E of this section, a general hospital shall:

1. Post the information conspicuously in public areas of the general hospital, including admissions or registration areas, emergency departments, and associated waiting rooms;

2. Make the information available to:

a. A patient at the time of admission or discharge, or at the time services are provided; and

b. Persons with limited English proficiency in accordance with the U.S. Department of Health and Human Services Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons (August 8, 2003, 68 FR 47311), if the general hospital is subject to the requirements of Title VI of the Civil Rights Act of 1964 (Pub. L. No. 88-352), as amended; and

3. Include the information:

a. With any billing statements sent to uninsured patients; and

b. On any website maintained by the general hospital.

G. Notwithstanding any other provision of law, a general hospital may not engage in any action described in § 501(r)(6) of the Internal Revenue Code as it was in effect on January 1, 2020, to recover a debt for medical services against any patient unless the general hospital has made all reasonable efforts to determine whether the patient:

1. Qualifies for medical assistance pursuant to the state plan for medical assistance; or

2. Is eligible for financial assistance under the general hospital's financial assistance policy.

H. Nothing in this section shall be construed to:

1. Prohibit a general hospital, as part of its financial assistance policy, from requiring a patient to:

a. Provide necessary information needed to determine eligibility for financial assistance under the general hospital's financial assistance policy, medical assistance pursuant to Title XVIII or XIX of the Social Security Act (42 USC § 301 et seq.), 10 USC § 1071 et seq., or other programs of insurance; or

b. Undertake good faith efforts to apply for and enroll in the programs of insurance for which the patient may be eligible as a condition of awarding financial assistance;

2. Require a general hospital to grant or continue to grant any financial assistance or payment plan pursuant to this section when:

a. A patient has provided false, inaccurate, or incomplete information required for determining eligibility for the general hospital's financial assistance policy; or

b. A patient has not undertaken good faith efforts to comply with any payment plan pursuant to this section; or

3. Prohibit the coordination of benefits as required by state or federal law.

12VAC5-410-227. Newborn safety devices.

A general hospital that voluntarily installs a newborn safety device, as provided for in clause (c) of § 18.2-371 of the Code of Virginia, for the reception of children shall ensure that:

1. The device is located inside the hospital in an area that is conspicuous and visible to employees or personnel;

2. The device is staffed 24 hours a day by a health care provider;

3. The device is climate controlled and serves as a safe sleep environment for an infant;

4. The device is equipped with a dual alarm system that sounds 60 seconds after a child is placed in the device and automatically places a call to 911 if the alarm is not deactivated within 60 seconds from within the hospital;

5. The dual alarm system is visually checked at least two times per day and tested at least one time per week to ensure the alarm system is in working order;

6. The device automatically locks when a child is placed in the device; and

7. The device is identifiable by appropriate signage that shall include written and pictorial operational instructions.

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 2000 Hospital Accreditation Standards, January 2000 42 CFR 482.13. The protocol shall include a process reasonably designed to inform patients of patient rights and responsibilities. Patients shall be given a copy of 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 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. G. 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 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. H. 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. I. 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. J. 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.).

12VAC5-410-235. Persons with a disability; designated support person in general hospitals.

A. For the purposes of this section:

1. "Admission" means accepting a person for bed occupancy and care that is anticipated to span at least two midnights or for observation;

2. "General hospital" means a general hospital other than one that is certified as a long-term acute care hospital or specialty rehabilitation hospital.

B. A general hospital shall allow a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP who will provide support and assistance necessary due to the specifics of the person's disability to the person with a disability during an admission.

1. In any case in which the duration of the admission lasts more than 24 hours, the person with a disability may designate more than one DSP.

2. No general hospital shall be required to allow more than one DSP to be present with a person with a disability at any time.

C. A general hospital may:

1. Not subject a DSP to any restrictions on visitation;

2. Require a DSP to comply with all reasonable requirements of a general hospital adopted to protect the health and safety of the person with a disability; the DSP; the staff and other patients of, or visitors to, a general hospital; and the public; and

3. Restrict a DSP's access to specified areas of and movement on the premises of a general hospital when such restrictions are determined by a general hospital to be reasonably necessary to protect the health and safety of the person with a disability; the DSP; the staff and other patients of, or visitors to, a general hospital; and the public.

D. A general hospital may request that a person with a disability provide documentation indicating status as a person with a disability.

1. If the person with a disability fails, refuses, or is unable to provide documentation requested pursuant to subsection D of this section, a general hospital may perform an objective assessment of the person to determine qualification as a person with a disability.

2. If a general hospital fails to perform an objective assessment pursuant to subdivision D 1 of this section, a general hospital may not prohibit a DSP from accompanying a person with a disability for the purpose of providing support and assistance necessary due to the specifics of the person's disability.

E. A general hospital shall

1. Establish protocols to inform patients, at the time of admission, of the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP for the purpose of providing support and assistance necessary due to the specifics of the person's disability;

2. Develop and make available to a patient or the patient's guardian, authorized representative, or care provider upon request written information regarding the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP and any policies related to that right; and

3. Make the written information described in subdivision E 2 of this section available to the public on the general hospital's website.

G. This section may not:

1. Alter the obligation of a general hospital to provide patients with effective communication support or other required services, regardless of the presence of a DSP or other reasonable accommodation, consistent with applicable federal or state law or regulations; and

2. Be interpreted to:

a. Prevent a general hospital from complying, or interfere with the ability of a general hospital to comply, with or cause a general hospital to violate any federal or state law or regulation;

b. Deem a DSP to be acting under the direction or control of a general hospital or as an agent of a general hospital; or

c. Require a general hospital to allow a DSP to perform any action or provide any support or assistance necessary due to the specifics of the person's disability when a general hospital reasonably determines that the performance of the action or provision would be:

(1) Medically or therapeutically contraindicated; or

(2) A threat to the health and safety of the person with a disability, the DSP, or the staff or other patients of, or visitors to, a general hospital.

12VAC5-410-237. Discharge planning.

A. A general hospital shall provide each patient admitted as an inpatient or the patient's legal guardian the opportunity to designate:

1. An individual who will care for or assist the patient in the patient's residence following discharge from the general hospital; and

2. To whom the general hospital shall provide information regarding the patient's discharge plan and any follow-up care, treatment, and services that the patient may require.

B. Upon admission, a general hospital shall record in the patient's medical record:

1. The name of the individual designated by the patient;

2. The relationship between the patient and the person; and

3. The person's telephone number and address.

C. If the patient fails or refuses to designate an individual to receive information regarding the patient's discharge plan and any follow-up care, treatment, and services, a general hospital shall record the patient's failure or refusal in the patient's medical record.

D. A patient may change the designated individual at any time prior to the patient's release, and the general hospital shall record the changes, including the information referenced in subsection B of this section, in the patient's medical record within 24 hours of such a change.

E. Prior to discharging a patient who has designated an individual pursuant to subsection A or D of this section, the general hospital shall:

1. Notify the designated individual of the patient's discharge;

2. Provide the designated individual with a copy of the patient's discharge plan and instructions and information regarding any follow-up care, treatment, or services that the designated individual will provide; and

3. Consult with the designated individual regarding the designated individual's ability to provide the care, treatment, or services.

F. The discharge plan prescribed in subdivision E 2 of this section shall include:

1. The name and contact information of the designated individual;

2. A description of follow-up care, treatment, and services that the patient requires; and

3. Information, including contact information, about any health care, long-term care, or other community-based services and supports necessary for the implementation of the patient's discharge plan.

G. A general hospital shall include a copy of the discharge plan and any instructions or information provided to the designated individual in the patient's medical record.

H. A general hospital shall provide each individual designated pursuant to subsection A or D of this section the opportunity for a demonstration of specific follow-up care tasks that the designated individual will provide to the patient in accordance with the patient's discharge plan prior to the patient's discharge, including opportunity for the designated individual to ask questions regarding the performance of follow-up care tasks in a culturally competent manner and in the designated individual's native language.

I. A general 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 a general hospital.

12VAC5-410-370. Medical records.

A. The medical record department shall be staffed and equipped to facilitate the accurate processing, checking, indexing, filing, and retrieval of all medical records.

B. A medical record shall be established and maintained for every person treated on an inpatient, outpatient (ambulatory), or emergency basis, in any unit of the hospital. The record shall be available to all other units.

A separate medical record shall be maintained for each newborn infant. Entered on the chart of the newborn shall be notes of gestational history, including any pathology and information regarding complications of delivery and mother's medication during labor and delivery.

C. Written policies and procedures shall be established regarding content and completion of medical records.

D. Entries in the medical record shall be made by the responsible person in accordance with hospital policies and procedures.

E. Provisions shall be made for the safe storage of medical records or and the accurate and legible reproductions thereof of medical records according to § 32.1-127.1:03 of the Code of Virginia and the Health Insurance Portability and Accountability Act, or HIPAA (42 USC § 1320d et seq.) (Pub. L. No. 104-191).

F. All medical records, either original or accurate reproductions, shall be preserved for a minimum of five years following discharge of the patient.

1. Records of minors shall be kept for at least five years after such minor has reached the age of 18 years of age.

2. Birth and death information shall be retained for 10 years in accordance with § 32.1-274 of the Code of Virginia.

3. Record of abortions and proper information for the issuance of a fetal death certificate shall be furnished to the Virginia Department of Health Office of Vital Records as required by law.

G. A general hospital that makes health records, as defined in § 32.1-127.1:03 of the Code of Virginia, of patients who are minors available to patients through a secure website shall make the health records available to the patient's parent or guardian through the secure website, unless the general hospital cannot make the health record available:

1. In a manner that prevents disclosure of information, the disclosure of which has been denied pursuant to § 32.1-127.1:03 F of the Code of Virginia; or

2. Because the consent required in accordance with § 54.1-2969 E of the Code of Virginia has not been provided.

12VAC5-410-380. Nursing service.

A. Each hospital shall have an organized nursing department. A registered nurse qualified on the basis of education, experience, and clinical ability shall be responsible for the direction of nursing care provided the patients.

B. The number and type of nursing personnel on all shifts shall be based upon the needs of the patients and the capabilities of the nursing staff assigned to the patient care unit. All registered nurses and licensed practical nurses shall hold a current license issued by the Virginia Board of Nursing or a current multistate licensure privilege to practice nursing in Virginia.

C. All nursing services shall be directly provided by an appropriately qualified registered nurse or licensed practical nurse, except for those nursing tasks that may be delegated by a registered nurse according to 18VAC90-20-420 18VAC90-19-240 through 18VAC90-20-460 of the regulation of the Virginia Board of Nursing 18VAC90-19-280 with a plan developed and implemented by the hospital.

D. Nursing personnel shall be assigned to patient care units in a manner that minimizes the risk of cross infection and accidental contamination.

E. Each hospital shall quarterly report to the department no later than 30 calendar days after January 1, April 1, July 1, and October 1:

1. The total number of certified sexual assault nurse examiners employed by the hospital; and

2. The location, including street address, and contact information for each location at which the certified sexual assault nurse examiners provide services.

Each hospital shall report the information required by this subsection to the Virginia Department of Health Office of Family Health Services.

12VAC5-410-442. Obstetric service design and equipment criteria.

A. Renovation or construction of a hospital's obstetric unit shall be consistent with (i) section 2.2-2.9 2.2-2.10 of Part 2 of the 2018 Guidelines for Design and Construction of Hospitals of the, 2022 Edition (The Facility Guidelines Institute) pursuant to § 32.1-127.001 of the Code of Virginia and (ii) the Virginia Uniform Statewide Building Code (13VAC5-63).

B. Delivery rooms; labor, deliver, and recover (LDR) rooms; labor, delivery, recovery, and postpartrum postpartum (LDRP) rooms; and nurseries shall be equipped to provide emergency resuscitation for mothers and infants.

C. Equipment and supplies shall be assigned for exclusive use in the obstetric and newborn units.

D. The same equipment and supplies required for the labor room and delivery room shall be available for use in the LDR/LDRP rooms during periods of labor, delivery, and recovery.

E. Sterilizing equipment shall be available in the obstetric unit or in a central sterilizing department. Flash sterilizing equipment or sterile supplies and instruments shall be provided in the obstetric unit.

F. Daily monitoring is required of the stock of necessary equipment in the LDR rooms and LDRP rooms and nursery.

G. The hospital shall provide the following equipment in the labor, delivery, and recovery rooms and, except where noted, in the LDR/LDRP rooms:

1. Labor rooms.

a. A labor or birthing bed with adjustable side rails.

b. Adjustable lighting adequate for the examination of patients.

c. An emergency signal and intercommunication system.

d. A sphygmomanometer, stethoscope, and fetoscope or doppler.

e. Fetal monitoring equipment with internal and external attachments.

f. Mechanical infusion equipment.

g. Wall-mounted oxygen and suction outlets.

h. Storage equipment.

i. Sterile equipment for emergency delivery to include at least one clamp and suction bulb.

j. Neonatal resuscitation cart.

2. Delivery rooms.

a. A delivery room table that allows variation in positions for delivery. This equipment is not required for the LDR/LDRP rooms.

b. Adequate lighting for vaginal deliveries or cesarean deliveries.

c. Sterile instruments, equipment, and supplies to include sterile uterine packs for vaginal deliveries or cesarean deliveries, episiotomies or laceration repairs, postpartum sterilizations, and cesarean hysterectomies.

d. Continuous in-wall oxygen source and suction outlets for both mother and infant.

e. Equipment for inhalation and regional anesthesia. This equipment is not required for LDR/LDRP rooms.

f. A heated, temperature-controlled infant examination and resuscitation unit.

g. An emergency call system.

h. Plastic pharyngeal airways, adult and newborn sizes.

i. Laryngoscope and endotracheal tubes, adult and newborn sizes.

j. A self-inflating bag with manometer and adult and newborn masks that can deliver 100% oxygen.

k. Separate cardiopulmonary crash carts for mothers and infants.

l. Sphygmomanometer.

m. Cardiac monitor. This equipment is not required for the LDR/LDRP rooms.

n. Gavage tubes.

o. Umbilical vessel catheterization trays. This equipment is not required for LDR/LDRP rooms.

p. Equipment that provides a source of continuous suction for aspiration of the pharynx and stomach.

q. Stethoscope.

r. Fetoscope.

s. Intravenous solutions and equipment.

t. Wall clock with a second hand.

u. Heated bassinets equipped with oxygen and transport incubator.

v. Neonatal resuscitation cart.

3. Recovery rooms.

a. Beds with side rails.

b. Adequate lighting.

c. Bedside stands, overbed tables, or fixed shelving.

d. An emergency call signal.

e. Equipment necessary for a complete physical examination.

f. Accessible oxygen and suction equipment.

12VAC5-410-444. Newborn service medical direction; physician consultation and coverage; nursing direction, nurse staffing, and coverage; policies and procedures.

A. The governing body shall appoint a physician as medical director of the organized newborn service who meets the qualifications specified in the medical staff bylaws. In addition, the medical director must meet the qualifications specified for the medical direction of the highest level of newborn service provided by the hospital.

1. If a hospital offers only general level newborn services, the medical director shall be a physician qualified to provide normal newborn care, including the ability to immediately resuscitate and stabilize a sick newborn for transfer to a higher level of service.

2. If a hospital offers intermediate level newborn services, the medical director shall be a board-certified or board-eligible pediatrician with training and experience in the care of preterm neonates, including stabilization and ventilation management.

3. If a hospital offers specialty level newborn services, the medical director shall be a board-certified or board-eligible neonatologist.

4. If a hospital offers subspecialty level newborn services, the medical director shall be a board-certified or board-eligible neonatologist.

B. The duties and responsibilities of the medical directors of all levels of newborn service shall include the:

1. General supervision of the quality of care provided patients admitted to the service;

2. Establishment of criteria for admission to the service;

3. Adherence of the service to standards of professional practices, policies and procedures, the medical protocol, and the hospital's collaboration agreements adopted by the medical staff and governing body applicable to the service;

4. Development of recommendations to the medical staff on standards of professional practice and staff privileges applicable to the service;

5. Identification of clinical conditions and medical and surgical procedures that require physician consultation;

6. Conducting conferences, at least quarterly, to review routine and emergency surgical procedures, complications, and infant and maternal mortality and morbidity. Infant mortality and morbidity shall be discussed with the obstetric service staff; and

7. Active participation in the service's quality assurance program.

C. The hospital shall provide the following physician consultation and coverage in the general level newborn nursery service and all higher level nursery services unless unique requirements are specifically imposed for the higher level nursery services:

1. A physician with pediatric privileges capable of arriving on site within 30 minutes of notification shall be on the 24-hour on-call duty roster. If a physician is not available, a certified nurse midwife, licensed certified midwife, or pediatric nurse practitioner may be on the 24-hour on-call duty roster for nursery care. In order to be on the 24-hour on-call duty roster, such health care providers shall have pediatric privileges and a neonatal resuscitation certification from the American Academy of Pediatrics, including endotracheal intubation training. Such health care providers shall be subject to the same requirement that applies to physicians regarding the capability of arriving on site within 30 minutes of notification. A physician may provide consultation via telehealth, including audio-only consultation, when a certified nurse midwife, licensed certified midwife, or pediatric nurse practitioner is providing coverage for the 24-hour on-call duty roster and a physician is incapable of arriving on site within 30 minutes of notification;.

2. A physician or nurse skilled in neonatal cardiopulmonary resuscitation (CPR) shall be available in the hospital at all times.

3. A current roster of physicians, with a delineation of their newborn, pediatric, medical, and surgical privileges shall be posted at each nurses' station in the newborn service unit.

4. A copy of the 24-hour on-call duty schedule, including a list of on-call consulting physicians, shall be posted at each nurses' station in the newborn service unit.

5. If the medical director is not a board-certified or board-eligible pediatrician, the hospital shall have a written agreement with one or more board-certified or board-eligible pediatricians to be available to provide consultation on a 24-hour basis. Consultation may be by telephone.

6. If a hospital does not have a neonatologist on staff available on a 24-hour basis, it shall have a written agreement with another hospital to provide consultation, at least by telephone, on a 24-hour basis, by a board-certified or board-eligible neonatologist. The consultant shall be available to advise on the development of a protocol for the care and transport of sick newborns.

D. The physician consultation and coverage for the intermediate level newborn nursery service shall be the same as the general level newborn service with the following exceptions:

1. Subdivision C 1 of this section shall not apply.

2. Physician coverage shall be provided on a 24-hour on-call basis by a board-certified or board-eligible pediatrician or pediatricians capable of arriving on-site on site within 30 minutes of notification.

E. The physician consultation and coverage for the specialty level and the subspecialty level newborn services shall be the same as for the lower level newborn services with the following exceptions:

1. Subdivision C 1 of this section shall not apply.

2. In-house physician consultation and coverage shall be provided 24 hours a day by a:

a. Board-certified or board-eligible neonatologist;

b. Board-certified or board-eligible pediatrician;

c. Second year or higher level pediatric resident; or

d. Neonatal nurse practitioner.

3. Whenever in-house coverage is provided as stated in subdivision 2 b, c, or d of this subsection, a board-certified or board-eligible neonatologist shall be on-call and available to be on site within 20 minutes of request.

F. The nursing direction, staff, and coverage required for the general level newborn service shall be as follows:

1. The neonatal nursing program shall be under the direction of a registered nurse.

2. The nursing director's responsibilities shall include:

a. Directing neonatal nursing services;

b. Guiding the development and implementation of neonatal nursing policies and procedures;

c. Collaborating with the medical staff; and

d. Consulting with referral hospitals with which a hospital has transfer agreements applicable to the service or services.

3. Each occupied unit of the newborn service shall be under the direct supervision of a registered nurse 24 hours a day. The registered nurse shall have documented competence in neonatal nursing appropriate to the level of service provided.

4. If a general level newborn nursery is organized as a separate nursing unit, staffing shall be based on a formula of a minimum of one nursing personnel to every eight newborns. Staffing shall include at least one registered nurse for the unit for each duty shift to provide direct supervision for nursing care.

5. If the postpartum and general level newborn units are organized as combined rooming-in or modified rooming-in units, staffing shall be based on a formula of one nursing personnel for every four mother-baby units. The rooming-in units shall always be staffed with no less than two nursing personnel assigned to each shift. One of the two nursing personnel shall be a registered nurse to provide direct supervision of nursing care.

6. When infants are present in the nursery, at least one nursing personnel trained in the care of newborn infants, with duties restricted to the care of the infants, shall be assigned to the nursery at all times. This nursing personnel is in addition to the registered nurse who is required to provide supervision.

7. To ensure adequate nursing staff for the nursery for normal newborns, duty schedules shall be developed and actual shift staffing shall occur according to the following minimum nurse-to-patient ratios:

a. 1:4 Recently born infants and those needing close observation.

b. 1:8 Newborns needing only routine care.

c. 1:4 Mother-newborn routine care.

8. Student nurses, licensed practical nurses, and nursing aides who assist in the nursing care of newborn infants shall be under the direct supervision of a registered nurse.

9. At least one nurse on each shift who is skilled in neonatal cardiopulmonary resuscitation must be immediately available to the nursery.

10. All nursing personnel assigned to the newborn service shall have orientation to the nursery, including orientation to patient care appropriate for the service level provided.

G. The nursing direction, staff, and coverage required of the intermediate level newborn service shall be the same as required of the general level newborn service with the following exceptions:

1. To ensure adequate nursing staff for the nursery, duty schedules shall be developed and actual shift staffing shall occur according to a ratio of at least one nurse to four neonates.

2. All registered nurses assigned to the newborn service shall be trained in neonatal cardiopulmonary resuscitation (CPR).

H. The nursing direction, staff, and coverage for the specialty level newborn service shall be the same as the lower level newborn service levels with the following exceptions:

1. The newborn nursery service shall have a nurse manager. The nurse manager shall be a registered nurse with advanced training and experience in the nursing management of high-risk neonates and their families. The responsibilities of the nurse manager shall include:

a. Daily management of the nursery;

b. Supervision and evaluation of nursing personnel assigned to the nursery;

c. Ensuring nursing coverage 24 hours a day; and

d. Implementing nursing policies and procedures at the service level.

2. All registered nurses shall have advanced training and experience in the management of neonatal patients, including specialized care technology and ventilator care for neonates. Only registered nurses with this advanced training and experience shall be assigned to care for neonates on ventilators.

3. To ensure adequate nursing staff for the nursery, duty schedules shall be developed and actual shift staffing shall occur according to a ratio of at least one nurse to three patients for neonates requiring specialty level care. For those neonates who have been assessed as no longer needing specialty level care, nurse to patient ratios shall be according to the neonate's appropriate level of service.

I. The nursing direction, staff, and coverage for the subspecialty level newborn service shall be the same as all lower levels of newborn services with the following exceptions:

1. A neonatal clinical nurse specialist shall be assigned to the nursery, and whose duties and responsibilities shall include staff consultation, collaboration, and teaching.

2. All registered nurses shall have advanced training and experience, beyond what is required of nurses in the lower level nurseries, in the management of high-risk neonates, including the care of unstable neonates with multisystem problems.

3. To ensure adequate nursing staff for the nursery, duty schedules shall be developed and actual shift staffing shall occur according to the following minimum nurse to patient ratios for neonates requiring subspecialty level care:

a. 1:2 Neonates requiring subspecialty level care; and

b. 1:1 Neonates requiring multisystem support.

For those neonates who have been assessed as no longer needing subspecialty level care, nurse to patient ratios shall be according to the neonate's appropriate level of service.

4. All nursing patient care shall be provided by registered nurses assigned to the subspecialty level nursery.

J. The governing body shall adopt written policies and procedures approved by the medical and nursing staff of the service, for the medical care of newborns.

K. The policies and procedures for the general level nursery and all higher levels of newborn services shall include:

1. Medical criteria for the identification of high-risk neonatal patients.

2. Protocols for the management of all neonatal medical conditions that are routinely managed by the service as well as protocols for the stabilization and transfer of neonates that require a higher level of newborn service. These protocols shall be maintained in the nursery in addition to the telephone numbers of each nursery and the names of each referral newborn service medical director.

3. Written collaboration agreements with hospitals with higher levels of newborn services. A hospital may enter into more than one collaboration agreement. The collaboration agreements shall specifically identify those medical conditions that require consultation and may necessitate a neonatal transfer as well as the interim treatment required prior to transfer. Nothing in the regulation shall require a birth hospital to enter into a collaboration agreement with a referral hospital that disagrees with the medical, consultation, and transfer protocols adopted by the birth hospital. All neonatal transfers shall conform with § 1867 of the Social Security Act, its amendments in force to date, and implementing regulations. At the time of any transfer, the medical treatment at the referral hospital shall outweigh the risks to the neonate from affecting the transfer. The collaboration agreements shall include:

a. Criteria for neonatal transfer to the referral nursery;

b. Procedures for neonatal transport;

c. Back transfer criteria which provides for the return of the neonate to the referring hospital when medically appropriate;

d. Annual review by both parties of all cases of neonatal transfer;

e. Annual review by both parties of the collaboration agreements; and

f. Annual evaluation by both parties of the collaboration agreement and modification of the agreement, as necessary, as indicated by the evaluation results.

4. Establishment and maintenance of an ongoing, documented quality assurance program by the service that utilizes a multidisciplinary team of health practitioners and administrators for review and is integrated with the hospital's overall quality assurance program.

a. The quality assurance program shall include:

(1) Problem identification;

(2) Action plans;

(3) Evaluation; and

(4) Follow-up.

b. The quality assurance program shall include an annual review of the following:

(1) Neonatal transfer cases;

(2) Management of in-house neonatal cases; and

(3) Staff in-house inservice in-service programs.

c. Outcome statistics, including morbidity, mortality, and the appropriateness of neonatal transfers, shall be compiled in a standardized manner and reviewed quarterly by a multidisciplinary committee.

5. Immediate resuscitation and stabilization of the sick neonate in accordance with current cardiopulmonary resuscitation (CPR) standards of the American Heart Association and the American Academy of Pediatrics.

6. Care of newborns after delivery to include the following:

a. Care of eyes, skin, and umbilical cord and the provision of a single parenteral dose of Vitamin K-1, water soluble, as a prophylaxis against hemorrhagic disorder;

b. Maintenance of the newborn's airway, respiration, and body temperature; and

c. Assessment of the newborn and recording of the one-minute and five-minute Apgar scores.

7. Performance of prophylaxis against ophthalmia neonatorum by the administration of a 1.0% solution of silver nitrate aqueous solution, erythromycin, or tetracycline ointment or solution. This process is to be performed within one hour of delivery with documentation entered in the newborn's medical record. The process may be performed in the nursery.

8. Clamping or tying of the umbilical cord and, when indicated, collecting a sample of cord blood.

9. Performance of Rh type and Coombs' test for every newborn born to a Rh negative mother and performing major blood grouping and Coombs' tests when indicated for every newborn born to an O blood group mother or a mother with a family history of blood incompatibility. If such qualitative tests are performed, the results shall be documented in the newborn's medical record.

10. Identification and treatment of hyperbilirubinemia and hypoglycemia.

11. Identification of each newborn, prior to leaving the delivery room, with two identification bands fastened on the newborn and one identification band fastened on the mother. The newborn's medical record shall accompany the infant from the delivery room.

12. Newborn transport, within the hospital, of all newborns who are either premature or compromised by using a heated bassinet equipped with oxygen, a transport incubator, or other similar equipment.

13. Registered nurse or physician assessment of a newborn within one hour after delivery and documentation of the assessment in the newborn's medical record. Assessment in the delivery area is permitted if the hospital permits a newborn and its the mother to remain together during the immediate post-delivery period.

14. Delineation of how infants are to be monitored during stays with their mothers and under what circumstances infants must be taken to the nursery immediately after delivery and not allowed to remain with their mothers.

15. Physician examination of the newborn consistent with guidelines of the American Academy of Pediatrics. A high-risk newborn shall be examined upon admission to the nursery.

16. Ensuring that every bassinet and incubator in the nursery bears the identification of the newborn's last name, sex, date and time of birth, the mother's last name, and the attending physician's name.

17. The management of mothers who utilize breast milk with their newborns. Breast milk shall be collected in aseptic containers, dated, stored under refrigeration, and consumed or disposed of within 24 to 48 96 hours of collection if the breast milk has not been frozen. This policy pertains to breast milk collected while in the hospital or at home for hospital use.

18. Preparation and use of formula, including:

a. The distribution of feeding units immediately after assembly;

b. The use of prepared formula only within the time period designated on the package; and

c. The use of presterilized formula only, except in the case of facility-defined emergencies.

19. Screening newborns for risk factors associated with hearing impairment as required in §§ 32.1-64.1 and 32.1-64.2 of the Code of Virginia and in accordance with the regulations Regulations for Administration of the Board of Health governing the Virginia Hearing Impairment Identification and Monitoring System (12VAC5-80).

20. Screening and treatment of genetic, metabolic, and other diseases identifiable in the newborn period as specified in § 32.1-65 of the Code of Virginia and in accordance with the Regulations Governing the Virginia Newborn Screening and Treatment Program Services (12VAC5-70 12VAC5-71).

21. Reporting to the Virginia Department of Health all required reportable congenital defects.

22. Visitor contact with the newborn, including newborns delivered by cesarean section, and premature, sick, congenitally malformed, and dying newborns.

23. Completion of birth certificates.

24. Discharge planning appropriate for the needs of the patient for at-risk infants.

L. The additional policies and procedures required for the intermediate level newborn service shall include:

1. Insertion and maintenance of peripheral intravenous lines and use of pediatric infusion pumps that are accurate to plus or minus one milliliter an hour;

2. Insertion and maintenance of umbilical arterial lines and the use of pediatric infusion pumps accurate to plus or minus one milliliter an hour;

3. Use of heated, humidified, and blended supplemental oxygen by hood with a recording of oxygen levels every hour using a calibrated constant oxygen analyzer. The policy shall address consultation with a higher level nursery identified in the collaboration agreement when oxygen levels exceed 40% and remain at 40% or greater for a period of four hours or more;

4. Administration of nasogastric or orogastric feedings;

5. Use of saturation monitor (pulse oximeter or equivalent) for any newborn requiring supplemental oxygen;

6. Use of assisted ventilation in preparation for transport;

7. Initiation of PgE1 prior to transport; and

8. Administration of blood components and a policy for provision of partial and total exchange transfusions.

M. The additional policies and procedures required for the specialty level newborn service shall include:

1. Provision of ongoing assisted ventilation;

2. Administration of surfactant;

3. Preparation and administration of total parenteral nutrition (TPN);

4. Initiation and maintenance of pressor medications;

5. Provision for developmental follow up;

6. Insertion and maintenance of central umbilical arterial catheters or peripheral arterial lines with constant pressure monitoring;

7. Placement of chest tubes with water seal on an emergency basis;

8. Use of heated, humidified, and blended supplemental oxygen by hood with a recording of oxygen levels every hour using a calibrated constant oxygen analyzer;

9. Administration and maintenance of CPAP including the requirement for in-house physician coverage;

10. Daily availability of appropriate drug peak and trough assays on one milliliter or less of blood;

11. Cardioversion capability specific for newborns; and

12. Provision for ophthalmology consult and requirements regarding the examination of high-risk newborns.

N. The additional policies and procedures required for the subspecialty level newborn service shall include:

1. Provision for returning patients to the operating room within 30 minutes, if indicated;

2. Provision for echocardiography evaluation;

3. Provision for patient treatment on an extracorporeal membrane oxygenator (ECMO) or a written collaboration agreement with a hospital with this capability;

4. Provision for maintenance of central venous pressure monitoring; and

5. Provision for the maintenance of neonates on prostaglandin E1 (PgE1).

O. A hospital with an emergency department or labor and delivery services, freestanding emergency department, or birthing center as defined in § 63.2-1914 of the Code of Virginia shall implement standardized protocols for identifying and responding to obstetric emergencies, including obstetric hemorrhage, preeclampsia, eclampsia, and other life-threatening conditions based on the protocols developed by the Virginia Neonatal Perinatal Collaborative.

12VAC5-410-445. Newborn service design and equipment criteria.

A. Construction or renovation of a hospital's nursery shall be consistent with (i) section 2.2-2.10 2.2-2.11 of Part 2 of the 2018 Guidelines for Design and Construction of Hospitals of the, 2022 Edition (The Facility Guidelines Institute) pursuant to § 32.1-127.001 of the Code of Virginia and (ii) the Virginia Uniform Statewide Building Code (13VAC5-63). Hospitals with higher-level nurseries shall comply with section 2.2-2.8 2.2-2.9 of Part 2 of the 2018 2022 edition of the guidelines as applicable.

B. The hospital shall provide the following equipment in the general level nursery and all higher level nurseries, unless additional equipment requirements are imposed for the higher level nurseries:

1. Resuscitation equipment as specified for the delivery room in 12VAC5-410-442 G 2 shall be available in the nursery at all times;

2. Equipment for the delivery of 100% oxygen concentration, properly heated, blended, and humidified, with the ability to measure oxygen delivery in fractional inspired concentration (FI02). The oxygen analyzer shall be calibrated every eight hours and serviced according to the manufacturer's recommendations by a member of the hospital's respiratory therapy department or other responsible personnel trained to perform the task;

3. Saturation monitor (pulse oximeter or equivalent);

4. Equipment for monitoring blood glucose;

5. Infant scales;

6. Intravenous therapy equipment;

7. Equipment and supplies for the insertion of umbilical arterial and venous catheters;

8. Open bassinets, self-contained incubators, open radiant heat infant care system or any combination thereof of this equipment appropriate to the service level;

9. Equipment for stabilization of a sick infant prior to transfer that includes a radiant heat source capable of maintaining an infant's body temperature at 99°F;

10. Equipment for insertion of a thoracotomy tube; and

11. Equipment for proper administration and maintenance of phototherapy.

C. The additional equipment required for the intermediate level newborn service and for any higher service level is:

1. Pediatric infusion pumps accurate to plus or minus 1 milliliter (ml) per hour;

2. On-site supply of PgE1;

3. Equipment for 24-hour cardiorespiratory monitoring for neonatal use available for every incubator or radiant warmer;

4. Saturation monitor (pulse oximeter or equivalent) available for every infant given supplemental oxygen;

5. Portable x-ray machine; and

6. If a mechanical ventilator is selected to provide assisted ventilation prior to transport, it shall be approved for the use of neonates.

D. The additional equipment required for the specialty level newborn service and a higher newborn service is as follows:

1. Equipment for 24-hour cardiorespiratory monitoring with central blood pressure capability for each neonate with an arterial line;

2. Equipment necessary for ongoing assisted ventilation approved for neonatal use with online capabilities for monitoring airway pressure and ventilation performance;

3. Equipment and supplies necessary for insertion and maintenance of chest tube for drainage;

4. On-site supply of surfactant;

5. Computed axial tomography equipment (CAT) or magnetic resonance imaging equipment (MRI);

6. Equipment necessary for initiation and maintenance of continuous positive airway pressure (CPAP) with ability to constantly measure delineated pressures and including alarm for abnormal pressure (i.e., vent with PAP mode); and

7. Cardioversion unit with appropriate neonatal paddles and ability to deliver appropriate small watt discharges.

E. The hospital shall document that it has the appropriate equipment necessary for any of the neonatal surgical and special procedures it provides that are specified in its medical protocol and that are required for the specialty level newborn service.

F. The additional equipment requirements for the subspecialty level newborn service are:

1. Equipment for emergency gastrointestinal, genitourinary, central nervous system, and sonographic studies available 24 hours a day;

2. Pediatric cardiac catheterization equipment;

3. Portable echocardiography equipment; and

4. Computed axial tomography equipment (CAT) and magnetic resonance imaging equipment (MRI).

G. The hospital shall document that it has the appropriate equipment necessary for any of the neonatal surgical and special procedures it provides that are specified in the medical protocol and are required for the subspecialty level newborn service.

12VAC5-410-447. Combined obstetric and clean gynecological service; infection control.

A. A hospital may combine obstetric and clean gynecological services. The hospital shall define clean gynecological cases in written hospital policy. A combined obstetric and clean gynecologic service shall be organized under written policies and procedures. The policies and procedures shall be approved by the medical and nursing staff of these services and adopted by the governing body and shall include, but not limited to the following requirements:

1. Cesarean section and obstetrically related surgery, other than vaginal delivery, shall be carried out in designated operating or delivery rooms. Vaginal deliveries may be performed in designated delivery or operating rooms that are used solely for obstetric or clean gynecologic procedures.

2. Clean gynecological cases may be admitted to the postpartum nursing unit of the obstetric service according to procedures determined by the obstetrics and gynecologic staff and the hospital's infection control committee.

3. Only members of the medical staff with approved privileges shall admit and care for patients in the combined service area. These admissions shall be subject to the medical staff bylaws.

4. Hospitals with a combined service shall limit admission to the service to those patients allowed by policies adopted by the obstetric and gynecological medical staff and the hospital's infection control committee.

5. Unoccupied beds shall be reserved daily in a combined service ready for use by obstetric patients.

6. Patients admitted to the combined service may be taken to radiology or other hospital departments for diagnostic procedures, before or after surgery, if it is not evident that these procedures may be hazardous to the patients or to other patients on the combined service.

7. Patients may receive postpartum or immediate postoperative care in the general recovery room prior to being returned to the combined service area if the following conditions prevail:

a. The recovery room or intensive care unit is a separate unit adjacent to or part of the general surgical operating suite or delivery suite; and

b. The recovery room is under the direct supervision of the chairman of the anesthesiology department of the hospital.

In separate obstetric recovery rooms, supervision shall be provided by the obstetrician in charge or by physicians approved by the medical staff of the combined service.

8. Nursing care of all patients shall be supervised by a registered nurse.

9. Nursing care of both obstetrical and gynecological patients may be given by the same nursing personnel.

10. Visitor regulations applicable to visitors of obstetric patients shall also apply to visitors of other patients admitted to the combined service.

B. In addition to the infection control requirements specified in 12VAC5-410-490, the hospital's infection control committee, in cooperation with the obstetric and newborn medical and nursing staff, shall establish written policies and procedures for infection control within the obstetric and newborn services. The policies and procedures shall be adopted by the governing body and shall include, but not be limited to, the following:

1. The establishment of criteria for determining infection-related maternal and newborn morbidity;

2. Written criteria for the isolation or segregation of mothers and newborns, in accordance with Guidelines for Perinatal Care, 8th Edition, 2017 (American Academy of Pediatrics/American College of Obstetricians and Gynecologists) and Control of Communicable Diseases in Man Manual, 21st Edition, 2022 (American Public Health Association) to include at least the following categories:

a. Birth prior to admission to the facility;

b. Birth within the facility but prior to admission to the labor and delivery area;

c. Readmission to the service after transfer or discharge;

d. Presence of infection;

e. Elevated temperature; and

f. Presence of rash, diarrhea, or discharging skin lesions;

3. Written policies and procedures for the isolation of patients in accordance with Guidelines for Perinatal Care (AAP/ACOG), 8th Edition, 2017 (American Academy of Pediatrics/American College of Obstetricians and Gynecologists) and Control of Communicable Diseases in Man Manual, 21st Edition, 2022 (American Public Health Association) including, but not limited to, the following:

a. Ensuring that a physician orders and documents in the patient's medical record the placement of a mother or newborn in isolation;

b. Ensuring that at least one labor room is available for use by a patient requiring isolation;

c. Provisions for the isolation of a mother and newborn together (rooming-in) or separately; and

d. Policies and procedures for assigning nursing personnel to care for patients in isolation;

4. Control of traffic, including personnel and visitors. Policies and procedures shall be established in the event that personnel from other services must work in the obstetric and newborn services or personnel from the obstetric and newborn services must work on other services. Appropriate clothing changes and handwashing shall be required of any individual prior to assuming temporary assignments or substitution from any other area or service in the hospital;

5. Determination of the health status of personnel, and control of personnel with symptoms of communicable infectious disease;

6. Review of cleaning procedures, agents, and schedules in use in the obstetric and newborn services. Incubators or bassinets shall be cleaned with detergent and disinfectant registered by the U.S. Environmental Protection Agency each time a newborn occupying it is discharged or at least every seven days;

7. Techniques of patient care, including handwashing and the use of protective clothing, such as gowns, masks, and gloves; and

8. Infection control in the nursery, including but not limited to:

a. Closing of the nursery immediately in the event of an epidemic, as determined by the infection control director in consultation with the medical director and the Virginia Department of Health;

b. Assigning a newborn to a clean incubator or bassinet at least every seven days;

c. Using an impervious cover that completely covers the surface of the scale pan if newborns are weighed on a common scale, and changing the cover after each newborn is weighed;

d. Gowning in isolation cases; and

e. Requiring nursery personnel wear clean scrub attire in the nursery when they are handling infants. Appropriate cover garments shall be worn over scrub attire when personnel are holding infants. Personnel shall wash their hands after contact with each patient and upon entering or leaving the nursery.

12VAC5-410-465. Long-term care nursing services.

A. The provisions of this section shall apply to a general hospital's long-term care nursing unit if that unit is a certified nursing facility. The general hospital shall be responsible for ensuring that its long-term care nursing unit meets the requirements of this section.

B. For the purposes of this section, "resident" means any person admitted to a general hospital's long-term care nursing unit.

C. A long-term care nursing unit shall fully disclose to the applicant for admission the unit's admissions policies, including any preferences given.

D. A long-term care nursing unit shall train, or arrange for training of, all employees who work in the long-term care unit and who are mandated to report adult abuse, neglect, or exploitation pursuant to § 63.2-1606 of the Code of Virginia on such reporting procedures and the consequences for failing to make a required report.

E. A long-term care nursing unit shall register with the Department of State Police to receive notice of the registration, reregistration, or verification of registration information of any person required to register with the Sex Offender and Crimes Against Minors Registry pursuant to Chapter 9 (§ 9.1-900 et seq.) of Title 9.1 of the Code of Virginia within the same or a contiguous zip code area in which the long-term care nursing unit is located, pursuant to § 9.1-914 of the Code of Virginia.

F. If a long-term care nursing unit anticipates that a potential resident will have a length of stay greater than three days or in fact stays longer than three days, the long-term care nursing unit shall ascertain, prior to admission, whether the potential resident is required to register with the Sex Offender and Crimes Against Minors Registry pursuant to Chapter 9 of Title 9.1 of the Code of Virginia.

G. Upon the request of the unit's family council, a long-term care nursing unit shall send notices and information about the family council mutually developed by the family council and the administration of the unit, and provided to the unit for such purpose, to the listed responsible party or a contact person of the resident's choice up to six times per year.

1. Such notices may be included together with a monthly billing statement or other regular communication.

2. Notices and information shall also be posted in a designated location within the unit.

3. No family member of a resident or other resident representative shall be restricted from participating in meetings in the unit with the families or resident representatives of other residents in the unit.

H. A general hospital shall maintain for its long-term care unit liability insurance coverage in a minimum amount of $1 million and professional liability coverage in an amount at least equal to the recovery limit set forth in § 8.01-581.15 of the Code of Virginia to compensate residents or individuals for injuries and losses resulting from the negligent or criminal acts of the unit.

I. During a public health emergency related to COVID-19, a long-term care unit shall establish a protocol to allow each resident to receive visits, consistent with guidance from the CDC and as directed by CMS and the board, which shall include:

1. Provisions describing:

a. The conditions, including conditions related to the presence of COVID-19 in the long-term care nursing unit and community, under which in-person visits will be allowed and under which in-person visits will not be allowed and visits will be required to be virtual;

b. The requirements with which in-person visitors will be required to comply to protect the health and safety of the residents and staff of the long-term care nursing unit;

c. The types of technology, including interactive audio or video technology, and the staff support necessary to ensure visits are provided as required by this subsection; and

d. The steps the long-term care unit will take in the event of a technology failure, service interruption, or documented emergency that prevents visits from occurring as required by this subsection;

2. A statement of the frequency with which visits, including virtual and in-person, where appropriate, will be allowed, which shall be at least once every 10 calendar days for each resident;

3. A provision authorizing a resident or the resident's personal representative to waive or limit visitation, provided that such waiver or limitation is included in the resident's health record; and

4. A requirement that the general hospital publish on its website or communicate to each resident or the resident's authorized representative, in writing or via electronic means, the long-term care unit's plan for providing visits to residents as required by this subsection.

J. Unless the vaccination is medically contraindicated or the resident declines the offer of vaccination, a general hospital shall provide or arrange for the administration to residents of an annual influenza vaccination and a pneumococcal vaccination in accordance with the following recommendations of ACIP:

1. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022–23 Influenza Season, MMWR 71 (1), 2022, CDC;

2. Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of ACIP — United States, MMWR 71 (4), 2022, CDC;

3. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >65 Years: Updated Recommendations of ACIP, MMWR 68 (46), 2019, CDC;

4. Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of ACIP, MMWR 64 (15), 2015, CDC;

5. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >65 Years: Recommendations of ACIP, MMWR 63 (37), 2014, CDC;

6. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Children Aged 6–18 Years with Immunocompromising Conditions: Recommendations of ACIP, MMWR 62 (25), 2013, CDC;

7. Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of ACIP, MMWR 61 (40), 2012, CDC;

8. Prevention of Pneumococcal Disease Among Infants and Children — Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine: Recommendations of ACIP, MMWR 59 (RR-11), 2010, CDC; and

9. Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23), MMWR 59 (34), 2010, CDC.

12VAC5-410-650. General building and physical plant information.

A. All construction of new buildings and additions, renovations, or alterations or repairs of existing buildings for occupancy as a hospital shall conform to state and local codes, zoning ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, hospitals shall be designed and constructed consistent with Part 1 and Part 2 of the 2018 Guidelines for Design and Construction of Hospitals of the, 2022 Edition (The Facility Guidelines Institute pursuant to § 32.1-127.001 of the Code of Virginia), as amended by the December 2024 Errata for Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute), and if applicable, Chapter 2.8 of Part 2 of the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

B. Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with Part 1 and Part 2 of the 2018 Guidelines for Design and Construction of Hospitals of the, 2022 Edition (The Facility Guidelines Institute), as amended by the December 2024 Errata for Guidelines for Design and Construction of Hospitals, 2022 Edition (The Facility Guidelines Institute), and if applicable, Chapter 2.8 of the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

12VAC5-410-760. Long-term care nursing units.

Construction and renovation of long-term care nursing units, including intermediate and skilled nursing care nursing units, shall be designed and constructed consistent with section 2.2-2.13 2.2-2.15 of Part 2 of the 2018 Guidelines for Design and Construction of Hospitals of the, 2022 Edition (The Facility Guidelines Institute pursuant to § 32.1-127.001 of the Code of Virginia).

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with section 2.2-2.13 2.2-2.15 of Part 2 of the 2018 Guidelines for Design and Construction of Hospitals of the, 2022 Edition (The Facility Guidelines Institute).

Part IV

Organization and Operation of Outpatient Surgical Hospitals: Organization, Operation, and Design Standards for Existing and New Facilities

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. Every outpatient surgical hospital where surgical procedures are performed shall adopt a policy requiring the use of a smoke evacuation system for all planned surgical procedures that are likely to generate surgical smoke.

C. A An outpatient surgical hospital shall provide a copy of approved policies and procedures and any subsequent revisions thereto shall be made available to the OLC upon request.

D. 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 Standards for Ambulatory Care (2000 Hospital Accreditation Standards, January 2000) 42 CFR 416.50. The protocol shall include a process reasonably designed to inform patients of patient rights and responsibilities. Patients shall be given a copy of patient rights and responsibilities upon admission.

E. 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.

F. 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.

G. 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.

12VAC5-410-1171. Persons with a disability; designated support person in outpatient surgical hospitals.

A. For the purposes of this section, "admission" means accepting a person for observation.

B. An outpatient surgical hospital shall allow a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP who will provide support and assistance necessary due to the specifics of the person's disability to the person with a disability during an admission.

1. In any case in which the duration of the admission lasts more than 24 hours, the person with a disability may designate more than one DSP.

2. No outpatient surgical hospital shall be required to allow more than one DSP to be present with a person with a disability at any time.

C. An outpatient surgical hospital may:

1. Not subject a DSP to any restrictions on visitation;

2. Require a DSP to comply with all reasonable requirements of the outpatient surgical hospital adopted to protect the health and safety of the person with a disability, the DSP, the staff and other patients of or visitors to the outpatient surgical hospital, and the public; and

3. Restrict a DSP's access to specified areas of and movement on the premises of the outpatient surgical hospital when such restrictions are determined by the outpatient surgical hospital to be reasonably necessary to protect the health and safety of the person with a disability, the DSP, the staff and other patients of or visitors to an outpatient surgical hospital, and the public.

D. An outpatient surgical hospital may request that a person with a disability provide documentation indicating status as a person with a disability.

1. If the person with a disability fails, refuses, or is unable to provide documentation requested pursuant to this subsection, an outpatient surgical hospital may perform an objective assessment of the person to determine qualification as a person with a disability.

2. If an outpatient surgical hospital fails to perform an objective assessment pursuant to subdivision 1 of this subsection, an outpatient surgical hospital may not prohibit a DSP from accompanying a person with a disability for the purpose of providing support and assistance necessary due to the specifics of the person's disability.

E. An outpatient surgical hospital shall:

1. Establish protocols to inform patients, at the time of admission, of the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP for the purpose of providing support and assistance necessary due to the specifics of the person's disability;

2. Develop and make available to a patient or the patient's guardian, authorized representative, or care provider, upon request, written information regarding the right of a person with a disability who requires support and assistance necessary due to the specifics of the person's disability to be accompanied by a DSP and any policies related to that right; and

3. Make the written information described in subdivision 2 of this subsection available to the public on the hospital's website.

F. This section may not:

1. Alter the obligation of an outpatient surgical hospital to provide patients with effective communication support or other required services, regardless of the presence of a DSP or other reasonable accommodation, consistent with applicable federal or state law or regulations; or

2. Be interpreted to:

a. Prevent an outpatient surgical hospital from complying, interfere with the ability of the outpatient surgical hospital to comply with, or cause an outpatient surgical hospital to violate any federal or state law or regulation;

b. Deem a DSP to be acting under the direction or control of an outpatient surgical hospital or as an agent of an outpatient surgical hospital; or

c. Require an outpatient surgical hospital to allow a DSP to perform any action or provide any support or assistance necessary due to the specifics of the person's disability when the outpatient surgical hospital reasonably determines that the performance of the action or provision would be:

(1) Medically or therapeutically contraindicated; or

(2) A threat to the health and safety of the person with a disability, the DSP, or the staff or other patients of or visitors to the outpatient surgical hospital.

12VAC5-410-1175. Discharge planning. (Repealed.)

A. Every hospital shall provide each patient admitted as an inpatient or his legal guardian the opportunity to designate an individual who will care for or assist the patient in his residence following discharge from the hospital and to whom the hospital shall provide information regarding the patient's discharge plan and any follow-up care, treatment, and services that the patient may require.

B. Every hospital upon admission shall record in the patient's medical record:

1. The name of the individual designated by the patient;

2. The relationship between the patient and the person; and

3. The person's telephone number and address.

C. If the patient fails or refuses to designate an individual to receive information regarding his discharge plan and any follow-up care, treatment, and services, the hospital shall record the patient's failure or refusal in the patient's medical record.

D. A patient may change the designated individual at any time prior to the patient's release, and the hospital shall record the changes, including the information referenced in subsection B of this section, in the patient's medical record within 24 hours of such a change.

E. Prior to discharging a patient who has designated an individual pursuant to subsection A or D of this section, the hospital shall (i) notify the designated individual of the patient's discharge, (ii) provide the designated individual with a copy of the patient's discharge plan and instructions and information regarding any follow-up care, treatment, or services that the designated individual will provide, and (iii) consult with the designated individual regarding the designated individual's ability to provide the care, treatment, or services. Such discharge plan shall include:

1. The name and contact information of the designated individual;

2. A description of follow-up care, treatment, and services that the patient requires; and

3. Information, including contact information, about any health care, long-term care, or other community-based services and supports necessary for the implementation of the patient's discharge plan.

A copy of the discharge plan and any instructions or information provided to the designated individual shall be included in the patient's medical record.

F. The hospital shall provide each individual designated pursuant to subsection A or D of this section the opportunity for a demonstration of specific follow-up care tasks that the designated individual will provide to the patient in accordance with the patient's discharge plan prior to the patient's discharge, including opportunity for the designated individual to ask questions regarding the performance of follow-up care tasks. Such opportunity shall be provided in a culturally competent manner and in the designated individual's native language.

12VAC5-410-1178. Financial assistance in outpatient surgical hospitals.

A. As used in this section, "patient" and "uninsured patient" have the same meanings as ascribed to these terms in § 32.1-137.010 A of the Code of Virginia.

B. An outpatient surgical hospital shall make reasonable efforts to screen every uninsured patient to determine whether the individual is eligible for medical assistance pursuant to the state plan for medical assistance or for financial assistance under the outpatient surgical hospital's financial assistance policy.

C. An outpatient surgical hospital shall inform every uninsured patient who receives services at the outpatient surgical hospital and who is determined to be eligible for assistance under the outpatient surgical hospital's financial assistance policy of the option to enter into a payment plan with the outpatient surgical hospital.

1. A payment plan entered into pursuant to this subsection shall be provided to the patient in writing or electronically and shall provide for repayment of the cumulative amount owed to the outpatient surgical hospital.

2. The amount of monthly payments and the term of the payment plan shall be determined based upon the patient's ability to pay.

3. Any interest on amounts owed pursuant to the payment plan shall not exceed the maximum judgment rate of interest pursuant to § 6.2-302 of the Code of Virginia.

4. The outpatient surgical hospital may not charge any fees related to the payment plan.

5. The payment plan shall allow prepayment of amounts owed without penalty.

D. An outpatient surgical hospital shall develop a process by which either an uninsured patient who agrees to a payment plan pursuant to subsection C of this section or the outpatient surgical hospital may request and shall be granted the opportunity to renegotiate the payment plan.

1. Renegotiation shall include opportunity for a new screening in accordance with subsection B of this section.

2. An outpatient surgical hospital may not charge any fees for renegotiation of a payment plan pursuant to this subsection.

E. An outpatient surgical hospital shall provide written information about:

1. The outpatient surgical hospital's charity care policies, including:

a. Policies related to free and discounted care;

b. Specific eligibility criteria for charity care; and

c. Procedures for applying for charity care;

2. The availability of a payment plan for the payment of debt owed to the outpatient surgical hospital pursuant to subsection C of this section; and

3. The renegotiation process described in subsection D of this section.

F. To provide the information required by subsection F of this section, an outpatient hospital shall:

1. Post the information conspicuously in public areas of the outpatient surgical hospital, including admissions or registration areas and associated waiting rooms;

2. Make the information available to:

a. A patient at the time of admission or discharge or at the time services are provided; and

b. Persons with limited English proficiency in accordance with the U.S. Department of Health and Human Services Guidance to Federal Financial Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons (August 8, 2003, 68 FR 47311), if the outpatient surgical hospital is subject to the requirements of Title VI of the Civil Rights Act of 1964 (Pub. L. No. 88-352), as amended; and

3. Include the information:

a. With any billing statements sent to uninsured patients; and

b. On any website maintained by the outpatient surgical hospital.

G. Notwithstanding any other provision of law, an outpatient surgical hospital may not engage in any action described in § 501(r)(6) of the Internal Revenue Code, as it was in effect on January 1, 2020, to recover a debt for medical services against any patient unless the outpatient surgical hospital has made all reasonable efforts to determine whether the patient:

1. Qualifies for medical assistance pursuant to the state plan for medical assistance; or

2. Is eligible for financial assistance under the outpatient surgical hospital's financial assistance policy.

H. Nothing in this section shall be construed to:

1. Prohibit an outpatient surgical hospital, as part of its financial assistance policy, from requiring a patient to:

a. Provide necessary information needed to determine eligibility for financial assistance under the outpatient surgical hospital's financial assistance policy, medical assistance pursuant to Title XVIII or XIX of the Social Security Act (42 USC § 301 et seq.) or 10 USC § 1071 et seq., or other programs of insurance; or

b. Undertake good faith efforts to apply for and enroll in the programs of insurance for which the patient may be eligible as a condition of awarding financial assistance;

2. Require an outpatient surgical hospital to grant or continue to grant any financial assistance or payment plan pursuant to this section when:

a. A patient has provided false, inaccurate, or incomplete information required for determining eligibility for the outpatient surgical hospital's financial assistance policy; or

b. A patient has not undertaken good faith efforts to comply with any payment plan pursuant to this section; or

3. Prohibit the coordination of benefits as required by state or federal law.

12VAC5-410-1190. Nursing staff.

A. The total number of nursing personnel will vary depending upon the number and types of patients to be admitted and the types of operative procedures to be performed or the services programmed.

1. A registered nurse qualified on the basis of education, experience, and clinical ability shall be responsible for the direction of nursing care provided the patients.

2. The number and type of nursing personnel, including registered nurses, licensed practical nurses, and supplementary staff, shall be based upon the needs of the patients and the types of services performed.

3. At least one registered nurse shall be on duty at all times while the facility is in use.

4. Job descriptions shall be developed for each level of nursing personnel and include functions, responsibilities, and qualifications.

5. Evidence of current Virginia registration required by state statute shall be on file in the facility.

B. Each outpatient surgical hospital shall quarterly report to the department no later 30 calendar days after January 1, April 1, July 1, and October 1:

1. The total number of certified sexual assault nurse examiners employed by the outpatient surgical hospital; and

2. The location, including street address, and contact information for each location at which the certified sexual assault nurse examiners provide services.

Each outpatient surgical hospital shall report the information required by this subsection to the Virginia Department of Health Office of Family Health Services.

12VAC5-410-1260. Medical records.

A. Medical records. An accurate and complete clinical record or chart shall be maintained on each patient. The record or chart shall contain sufficient information to satisfy the diagnosis or need for the medical or surgical service. It shall include, when applicable, but not be limited to the following:

1. Patient identification;

2. Admitting information, including patient history and physical examination;

3. Signed consent;

4. Confirmation of pregnancy, if applicable;

5. Physician orders;

6. Laboratory tests, pathologist's report of tissue, and radiologist's report of x-rays;

7. Anesthesia record;

8. Operative record;

9. Surgical medication and medical treatments;

10. Recovery room notes;

11. Physician and nurses' nurse progress notes,;

12. Condition at time of discharge,;

13. Patient instructions, preoperative and postoperative; and

14. Names of referral physicians or agencies.

B. Provisions shall be made for the safe storage of medical records or and the accurate and legible reproductions thereof of medical records according to § 32.1-127.1:03 of the Code of Virginia and the Health Insurance Portability and Accountability Act, or HIPAA (42 USC § 1320d et seq.) (Pub. L. No. 104-191).

C. All medical records, either original or accurate reproductions, shall be preserved for a minimum of five years following discharge of the patient.

1. Records of minors shall be kept for at least five years after such the minor has reached the age of 18 years of age.

2. Birth and death information shall be retained for 10 years in accordance with § 32.1-274 of the Code of Virginia.

3. Record of abortions and proper information for the issuance of a fetal death certificate shall be furnished to the Division Office of Vital Records, Virginia Department of Health, within 10 days after the abortion as required by law.

D. An outpatient surgical hospital that makes health records, as defined in § 32.1-127.1:03 of the Code of Virginia, of patients who are minors available to patients through a secure website shall make the health records available to the patient's parent or guardian through the secure website, unless the hospital cannot make the health record available:

1. In a manner that prevents disclosure of information, the disclosure of which has been denied pursuant to § 32.1-127.1:03 F of the Code of Virginia; or

2. Because the consent required in accordance with § 54.1-2969 E of the Code of Virginia has not been provided.

12VAC5-410-1350. Local and state codes and standards.

A. All construction of new buildings and additions, renovations, or alterations, or repairs to existing buildings for occupancy as a "free-standing" outpatient hospital shall conform to state and local codes, zoning ordinances, and the Virginia Uniform Statewide Building Code (13VAC5-63).

In addition, hospitals shall be designed and constructed consistent with Part 1 and sections Chapters 2.1 and 2.7 of Part 2 of the 2018 Guidelines for Design and Construction of Outpatient Facilities of the, 2022 Edition (The Facility Guidelines Institute pursuant to § 32.1-127.001 of the Code of Virginia), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with Part 1 and sections Chapters 2.1 and 2.7 of Part 2 of the 2018 Guidelines for Design and Construction of Outpatient Facilities of the, 2022 Edition (The Facility Guidelines Institute), as amended by the January 2025 Errata for the Guidelines for Design and Construction of Outpatient Facilities, 2022 Edition (The Facility Guidelines Institute).

B. The use of an incinerator shall require permitting from the nearest regional office of the Department of Environmental Quality.

C. Water shall be obtained from an approved water supply system. Outpatient surgery centers shall be connected to sewage systems approved by the Department of Health or the Department of Environmental Quality.

D. Each outpatient surgery center shall establish a monitoring program for the internal enforcement of all applicable fire and safety laws and regulations.

E. All radiological machines shall be registered with the Office of Radiological Health of the Virginia Department of Health. Installation, calibration and testing of machines and storage facilities shall comply with 12VAC5-481, the Virginia Radiation Protection Regulations (12VAC5-481).

F. Pharmacy services shall comply with Chapter 33 (§ 54.1-3300 et seq.) of Title 54.1 of the Code of Virginia and 18VAC110-20, Regulations Governing the Practice of Pharmacy (18VAC110-20).

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-410)

Guidelines for Design and Construction of Hospitals, 2018 Edition, Facility Guidelines Institute, Washington D.C., http://www.fgiguidelines.org

Guidelines for Design and Construction of Outpatient Facilities, 2018 Edition, Facility Guidelines Institute, Washington, D.C., https://fgiguidelines.org

Control of Communicable Diseases Manual, American Public Health Association, 21st Edition, 2022, https://www.apha.org.

Errata for Guidelines for Design and Construction of Hospitals, The Facility Guidelines Institute, 2022 Edition, https://fgiguidelines.org/guidelines/errata-addenda/ (eff. 5/2023).

Errata for Guidelines for Design and Construction of Outpatient Facilities, The Facility Guidelines Institute, 2022 Edition, https://fgiguidelines.org/guidelines/errata-addenda/ (eff. 5/2023).

Guidelines for Design and Construction of Hospitals, The Facility Guidelines Institute, 2022 Edition, https://fgiguidelines.org.

Guidelines for Design and Construction of Outpatient Facilities, The Facility Guidelines Institute, 2022 Edition, https://fgiguidelines.org.

Guidelines for Perinatal Care, American Academy of Pediatric/American College of Obstetricians and Gynecologists, 8th Edition, 2017, https://www.aap.org and https://www.acog.org.

Healthcare Security Industry Guidelines, International Association for Healthcare Security and Safety, 13th Edition, https://www.iahss.org/

Intervals Between PCV13 and PPSV23 Vaccines: Recommendations of ACIP, MMWR 64 (15), 2015, CDC.

Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022–23 Influenza Season, MMWR 71 (1), 2022, CDC.

Prevention of Pneumococcal Disease Among Infants and Children — Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine: Recommendations of ACIP, MMWR 59 (RR-11), 2010, CDC.

Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23), MMWR 59 (34), 2010, CDC.

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >65 Years: Recommendations of ACIP, MMWR 63 (37), 2014, CDC.

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Adults Aged >65 Years: Updated Recommendations of ACIP, MMWR 68 (46), 2019, CDC.

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine for Adults with Immunocompromising Conditions: Recommendations of ACIP, MMWR 61 (40), 2012, CDC.

Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine Among Children Aged 6–18 Years with Immunocompromising Conditions: Recommendations of ACIP, MMWR 62 (25), 2013, CDC.

Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of ACIP — United States, MMWR 71 (4), 2022, CDC.