TITLE 12. HEALTH

STATE BOARD OF HEALTH

Final Regulation

Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-10, 12VAC5-410-280, 12VAC5-410-441, 12VAC5-410-444; adding 12VAC5-410-225, 12VAC5-410-1176).

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

Effective Date: November 19, 2025.

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

Summary:

The amendments implement the provisions of Chapters 238, 423 and 428, 457 and 472, 488, 544 and 557, and 589 of the 2025 Acts of Assembly. Amendments include (i) requiring hospitals with an emergency department (ED), when conducting a urine drug screening to assist in diagnosing patient condition, to include fentanyl testing in such drug screening; (ii) requiring all hospitals with an ED or labor and delivery and all freestanding EDs to implement standardized protocols for identifying and responding to obstetric emergencies based on the protocols developed by the Virginia Neonatal Perinatal Collaborative; (iii) requiring hospitals to report and post threats or acts of violence against health care providers on hospital premises; (iv) allowing a certified nurse midwife, licensed certified midwife, or pediatric nurse practitioner to be on the 24-hour on-call duty roster for nursery care if a physician is not available and allow a physician to provide consultation to the listed providers via telehealth or audio-only if a physician cannot arrive on site in 30 minutes; (v) amending the definition of "organized medical staff" to clarify that an organized medical staff may include other practitioners, including independent practice midwives, in addition to physicians and dentists; and (vi) requiring health care facilities that provide services related to labor and childbirth to develop policies regarding childbirth, the postpartum process, and doulas.

12VAC5-410-10. Definitions.

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

"Board" means the State Board of Health.

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

"Commissioner" means the State Health Commissioner.

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

"Department" means an organized section of the hospital.

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

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

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

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

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

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

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

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

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

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

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

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

"Organized" means administratively and functionally structured.

"Organized medical staff" means a formal organization of physicians and dentists with the delegated responsibility and authority to maintain proper standards of medical care and to plan for continued betterment of that care. Organized medical staff may include other practitioners, including independent practice midwives.

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

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

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

"Service" means a functional division of the hospital 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.

"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.

12VAC5-410-225. Hospitals; reports of threats or acts of violence against health care providers.

A. For the purposes of this section:

"Employee of the hospital" or "employee" means an employee of the hospital or any health care provider credentialed by the hospital or engaged by the hospital to perform health care services on the premises of the hospital.

"Workplace violence" means any act of violence or threat of violence, without regard to the intent of the perpetrator, that occurs against an employee of the hospital while on the premises of such hospital and engaged in the performance of the employee's duties. "Workplace violence" includes (i) the threat or use of physical force against an employee that results in, or has a high likelihood of resulting in, injury, psychological trauma, or stress, regardless of whether physical injury is sustained, and (ii) any incident involving the threat of using dangerous weapons or using common objects as weapons or to cause physical harm, regardless of whether physical injury is sustained.

B. A hospital shall:

1. Establish a workplace violence incident reporting system, through which the hospital shall document, track, and analyze any incident of workplace violence reported.

2. Use the results of the analysis to make improvements in preventing workplace violence, including improvements achieved through continuing education in targeted areas including (i) de-escalation training, (ii) risk identification, and (iii) violence prevention planning.

3. Clearly communicate the reporting system to all employees, including to any new employees at the employee orientation. The reporting system shall include guidelines on when and how to report incidents of workplace violence to the employer, security agencies, and appropriate law-enforcement authorities;

4. Record all reported incidents of workplace violence as voluntarily reported by an employee; and

5. Adopt a policy that prohibits any person from discriminating or retaliating against any employee of the hospital for reporting to, or seeking assistance or intervention from, the employer, security agencies, law-enforcement authorities, local emergency services organizations, government agencies, or others participating in any incident investigation. The policy shall comply with the provisions of § 40.1-27.3 of the Code of Virginia.

C. A hospital shall maintain the record of reported incidents of workplace violence made pursuant to subsection B of this section for at least two years and shall include in the record, at a minimum:

1. The date and time of the incident;

2. A description of the incident, including the job title of the affected employee;

3. Whether the perpetrator was a patient, visitor, employee, or other person;

4. A description of where the incident occurred;

5. Information relating the type of incident, including whether the incident involved (i) a physical attack without a weapon; (ii) an attack with a weapon or object; (iii) a threat of physical force or use of a weapon or other object with the intent to cause bodily harm; (iv) sexual assault or the threat of sexual assault; or (v) anything else not listed in subdivisions (i) through (iv);

6. The response to and any consequences of the incident, including (i) whether security or law enforcement was contacted and, if so, their response and (ii) whether the incident resulted in any change to hospital policy; and

7. Information about the individual who completed the report, including the individual's name, job title, and the date of completion.

D. A hospital shall:

1. Report the data collected and reported pursuant to subsection C of this section to the chief medical officer and the chief nursing officer of the hospital on, at a minimum, a quarterly basis; and

2. Send a report to the department on an annual basis that includes, at a minimum, the number of incidents of workplace violence voluntarily reported by an employee pursuant to subsection B of this section. A report made to the department pursuant to this subsection shall be aggregated to remove any personally identifiable information.

12VAC5-410-280. Emergency service.

A. Hospitals with an emergency department or service shall have 24-hour staff coverage and shall have at least one physician who is primarily responsible for the emergency department on duty and physically present at all times. Hospitals without emergency service shall have written policies governing the handling of emergencies.

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

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

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

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

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

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

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

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

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

2. Is based on:

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

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

(1) Trauma level designation;

(2) Overall patient volume;

(3) Volume of psychiatric and forensic patients;

(4) Incidents of violence against staff;

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

(6) Prevalence of crime in the community;

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

4. Outlines training requirements for security personnel in:

a. The potential use of and response to weapons;

b. Defensive tactics;

c. De-escalation techniques;

d. Appropriate physical restraint and seclusion techniques;

e. Crisis intervention;

f. Trauma-informed approaches; and

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

J. The hospital may:

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

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

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

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

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

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

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

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

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

c. Indicate the requested duration of the waiver.

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

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

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

c. The effective date of the waiver; and

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

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

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

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

c. Indicate whether the hospital is:

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

(2) Surrendering its existing waiver.

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

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

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

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

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

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

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

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

1. Appropriate screening and assessment of individuals experiencing substance use-related emergencies to identify medical interventions necessary for the treatment of the individual in the emergency department; and

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

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

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

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

N. Beginning January 1, 2026, every hospital with an emergency department, if conducting a urine drug screening to assist in diagnosing a patient's condition, shall include testing for fentanyl in the urine drug screening.

12VAC5-410-441. Obstetric service requirements; medical direction; physician consultation and coverage; nurse staffing and coverage; policies and procedures.

A. The governing body shall appoint a physician as medical director of the organized obstetric service who meets the qualifications specified in the medical staff bylaws.

1. If the medical director is not a board certified obstetrician or board eligible in obstetrics, the hospital shall have a written agreement with one or more board-certified or board-eligible obstetricians to provide consultation on a 24-hour basis. Consultation may be by telephone.

2. The duties and responsibilities of the medical director of obstetric services shall include:

a. The general supervision of the quality of care provided patients admitted to the service;

b. The establishment of criteria for admission to the service;

c. The adherence to standards of professional practices and policies and procedures adopted by the medical staff and governing body;

d. The development of recommendations to the medical staff on standards of professional practice and staff privileges;

e. The identification of clinical conditions and medical or surgical procedures that require physician consultation; and

f. Arranging conferences, at least quarterly, to review obstetrical surgical procedures, complications, and infant and maternal mortality and morbidity. Infant mortality and morbidity shall be discussed jointly between the obstetric and newborn service staffs.

B. A physician with obstetrical privileges capable of arriving on-site within 30 minutes of notification shall be on a 24-hour on-call duty roster.

C. A physician with obstetrical privileges shall be accessible for patient treatment within 10 minutes during the administration of an oxytocic agent to an antepartum patient.

D. A physician or a certified nurse-midwife, under the supervision of a physician with obstetrical privileges, shall be in attendance for each delivery. Physician supervision of the nurse-midwife shall be in compliance with the regulations of the Boards of Nursing and Medicine.

E. A physician shall be in attendance during all high-risk deliveries. High-risk deliveries shall be defined by the obstetric service medical staff.

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

G. A current roster of physicians, with a delineation of their obstetrical, newborn, pediatric, medical, and surgical staff privileges, shall be posted at each nurses' station in the obstetric suite and in the emergency room.

H. A copy of the 24-hour on-call duty schedule, including the list of on-call consulting physicians, shall be posted at each nurses' station in the obstetric suite and in the emergency room.

I. An occupied unit of the obstetrics service shall be supervised by a registered nurse 24 hours a day.

J. If the postpartum unit is organized as a separate nursing unit, staffing shall be based on a formula of one nursing personnel for every six to eight obstetric patients. Staffing shall include at least one registered nurse for the unit for each duty shift.

K. If the postpartum and general care 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 be staffed at all times with no less than two nursing personnel each shift. At least one of the two nursing personnel on each shift shall be a registered nurse.

L. For the purposes of this section:

1. "Birth" includes both vaginal birth and cesarean section.

2. "Doula" means a person who provides physical, emotional, and informational support to a pregnant person before, during, and after pregnancy.

3. "Postpartum process" means the biologic process that happens to both the newborn and birthing person after delivery due to endogenous hormone systems.

M. A health care facility that provides services related to labor and childbirth shall develop policies that:

1. Allow every birthing person to have a companion or doula with the person during birth in addition to a partner or spouse when a partner or spouse is permitted to be present;

2. At the discretion of the treating physician, allow every birthing person to have a companion or doula with the person during birth when a partner or spouse is not permitted to be present;

3. Prioritize newborns bonding with the newborn's families in order to facilitate the postpartum process;

4. Will not exclude from care a person giving birth, or interrupt the process of birth without the informed consent of the birthing person, unless at the discretion of the treating physician;

5. Detail the facility's process related to receiving a pregnant person's patient information from any provider regulated under Title 54.1 of the Code of Virginia who has provided care for the pregnant person;

6. Establish processes to transfer and receive pregnant persons across levels of care of licensed facilities within the facility's capacity and capability; and

7. Establish a process to receive individuals who are pregnant, giving birth, or in the postpartum process from locations other than licensed facilities, including a process to receive verbal and written information from individuals with relevant information, including family members, doulas, or a health care provider regulated under Title 54.1 of the Code of Virginia.

L. N. A registered nurse shall be in attendance at all deliveries. The nurse shall be available on-site to monitor the mother's general condition and that of the fetus during labor, at least one hour after delivery, and longer if complications occur.

M. O. Nurse staffing of the labor and delivery unit shall be scheduled to ensure that the total number of nursing personnel available on each shift is equal to one half of the average number of deliveries in the hospital during a 24-hour period.

N. P. At least one of the personnel assigned to each shift on the obstetrics unit shall be a registered nurse. At no time when the unit is occupied shall the nursing staff on any shift be less than two staff members.

O. Q. Patients placed under analgesia or anesthesia during labor or delivery shall be under continuous observation by a registered nurse or a licensed practical nurse for at least one hour after delivery.

P. R. To ensure adequate nursing staff for labor, delivery, and postpartum units during busy or crisis periods, duty schedules shall be developed in accordance with the following nurse/patient nurse to patient ratios:

1. 1:1 to 2 Antepartum testing

2. 1:2 Laboring patients

3. 1:1 Patients in second stage of labor

4. 1:1 Ill patients with complications

5. 1:2 Oxytocin induction or augmentation of labor

6. 1:2 Coverage of epidural anesthesia

7. 1:1 Circulation for cesarean delivery

8. 1:6 to 8 Antepartum/postpartum patients without complications

9. 1:2 Postoperative recovery

10. 1:3 Patients with complications, but in stable condition

11. 1:4 Mother-newborn care

Q. S. Student nurses, licensed practical nurses and nursing aides who assist in the nursing care of obstetric patients shall be under the supervision of a registered nurse.

R. T. At least one registered nurse trained in obstetric and neonatal care shall be assigned to the care of mothers and infants at all times.

S. U. At least one member of the nursing staff on each shift who is skilled in cardiopulmonary resuscitation of the newborn must be immediately available to the delivery suite.

T. V. All nursing personnel assigned to the obstetric service shall have orientation to the obstetrical unit.

U. W. The governing body shall adopt written policies and procedures for the management of obstetric patients approved by the medical and nursing staff assigned to the service.

1. The policies and procedures shall include the following:

a. Criteria for the identification and referral of high-risk obstetric patients;

b. The types of birthing alternatives, if offered, by the hospital;

c. The monitoring of patients during antepartum, labor, delivery, recovery, and postpartum periods with or without the use of electronic equipment;

d. The use of equipment and personnel required for high-risk deliveries, including multiple births;

e. The presence of family members or chosen companions during labor, delivery, recovery, and postpartum periods;

f. The reporting, to the Virginia Department of Health, of all congenital defects;

g. The care of patients during labor and delivery to include the administration of Rh O(D) immunoglobulin to Rh negative mothers who have met eligibility criteria. Administration of RH O(D) immunoglobulin shall be documented in the patient's medical record;

h. The provision of family planning information, to each obstetric patient at time of discharge, in accordance with § 32.1-134 of the Code of Virginia;

i. The use of specially trained paramedical and nursing personnel by the obstetrics and newborn service units;

j. A protocol for hospital personnel to use to assist them in obtaining public health, nutrition, genetic, and social services for patients who need those services;

k. The use of anesthesia with obstetric patients;

l. The use of radiological and electronic services, including safety precautions, for obstetric patients;

m. 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 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;

n. Staff capability to perform cesarean sections within 30 minutes of notice;

o. Emergency resuscitation procedures for mothers and infants;

p. The treatment of volume shock in mothers;

q. Training of hospital staff in discharge planning for identified substance abusing, postpartum women and their infants;

r. Written discharge planning for identified substance abusing, postpartum women and their infants. The discharge plans shall include appropriate referral sources available in the community or locality for mother and infants such as:

(1) Substance abuse treatment services; and

(2) Comprehensive early intervention services for infants and toddlers with disabilities and their families pursuant to Part H of the Individuals with Disabilities Education Act, 20 USC § 1471 et seq.

(3) The discharge planning process shall be coordinated by a health care professional and shall include, to the extent possible: (a) The (i) the father of the infant; and (b) Any (ii) any family members who may participate in the follow-up care of the mother or infant. The discharge plan shall be discussed with the mother and documented in the medical record; and

s. The provision of information pursuant to § 32.1-134.01 of the Code of Virginia about the incidence of postpartum blues, perinatal depression, and perinatal anxiety; information to increase awareness of shaken baby syndrome and the dangers of shaking infants; and information about safe sleep environments for infants that is consistent with current information from the American Academy of Pediatrics.

2. The obstetric service shall adopt written policies and procedures for the use of the labor, delivery, and recovery rooms (LDR)/Labor, delivery, recovery and postpartum rooms (LDRP) that include, but are not limited to the following:

a. The philosophy, goals, and objectives for the use of the LDR/LDRP rooms;

b. Criteria for patient eligibility to use the LDR/LDRP rooms;

c. Identification of high-risk conditions which that disqualify patients from use of the LDR/LDRP rooms;

d. Patient care in LDR/LDRP rooms, including the following;

(1) Defining vital signs, the intervals at which they shall be taken, and requirements for documentation; and

(2) Observing, monitoring, and assessing the patient by a registered nurse, certified nurse midwife, or physician;

e. The types of analgesia and anesthesia to be used in LDR/LDRP rooms;

f. Specifications of conditions of labor or delivery requiring transfer of the patient from LDR/LDRP rooms to the delivery room;

g. Specification of conditions requiring the transfer of the mother to the postpartum unit or the newborn to the nursery;

h. Criteria for early or routine discharge of the mother and newborn;

i. The completion of medical records;

j. The presence of family members or chosen companions in the delivery room or operating room in the event that the patient is transferred to the delivery room or operating room;

k. The number of visitors allowed in the LDR/LDRP room, and their relationship to the mother; and

l. Infection control, including gowning and attire to be worn by persons in the LDR/LDRP room, upon leaving it, and upon returning.

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, but not be limited to 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 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, but not be limited to:

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, but not be limited to:

a. Daily management of the nursery;

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

c. Assuring 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 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, but not be limited to:

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 Section § 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, but not be limited to:

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 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 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 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, but not limited to:

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 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 Newborn Screening and Treatment Program (12VAC5-70).

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, but not be limited to:

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, but not be limited to:

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, but not be limited to:

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.

12VAC5-410-1176. Outpatient surgical hospitals; reports of threats or acts of violence against health care providers.

A. For the purposes of this section:

"Employee of the hospital" or "employee" means an employee of the outpatient hospital or a health care provider credentialed by the outpatient hospital or engaged by the hospital to perform health care services on the premises of the outpatient hospital.

"Workplace violence" means any act of violence or threat of violence, without regard to the intent of the perpetrator, that occurs against an employee of the hospital while on the premises of such hospital and engaged in the performance of his duties. "Workplace violence" includes (i) the threat or use of physical force against an employee that results in, or has a high likelihood of resulting in, injury, psychological trauma, or stress, regardless of whether physical injury is sustained, and (ii) any incident involving the threat of using dangerous weapons or using common objects as weapons or to cause physical harm, regardless of whether physical injury is sustained.

B. An outpatient hospital shall:

1. Establish a workplace violence incident reporting system, through which the outpatient hospital shall document, track, and analyze any incident of workplace violence reported.

2. Use the results of the analysis to make improvements in preventing workplace violence, including improvements achieved through continuing education in targeted areas, including (i) de-escalation training, (ii) risk identification, and (iii) violence prevention planning.

3. Clearly communicate the reporting system to all employees, including to any new employees at the employee orientation. The reporting system shall include guidelines on when and how to report incidents of workplace violence to the employer, security agencies, and appropriate law-enforcement authorities;

4. Record all reported incidents of workplace violence as voluntarily reported by an employee; and

5. Adopt a policy that prohibits any person from discriminating or retaliating against any employee of the outpatient hospital for reporting to, or seeking assistance or intervention from, the employer, security agencies, law-enforcement authorities, local emergency services organizations, government agencies, or others participating in any incident investigation. The policy shall comply with the provisions of § 40.1-27.3 of the Code of Virginia.

C. An outpatient hospital shall maintain the record of reported incidents of workplace violence made pursuant to subsection B of this section for at least two years and shall include in the record, at a minimum:

1. The date and time of the incident;

2. A description of the incident, including the job title of the affected employee;

3. Whether the perpetrator was a patient, visitor, employee, or other person;

4. A description of where the incident occurred;

5. Information relating the type of incident, including whether the incident involved (i) a physical attack without a weapon; (ii) an attack with a weapon or object; (iii) a threat of physical force or use of a weapon or other object with the intent to cause bodily harm; (iv) sexual assault or the threat of sexual assault; or (v) anything else not listed in subdivisions (i) through (iv);

6. The response to and any consequences of the incident, including (i) whether security or law enforcement was contacted and, if so, their response and (ii) whether the incident resulted in any change to outpatient hospital policy; and

7. Information about the individual who completed the report, including the individual's name, job title, and the date of completion.

D. The outpatient hospital shall:

1. Report the data collected and reported pursuant to subsection C of this section to the chief medical officer and the chief nursing officer of the outpatient hospital on, at a minimum, a quarterly basis; and

2. Send a report to the Virginia Department of Health on an annual basis that includes, at a minimum, the number of incidents of workplace violence voluntarily reported by an employee pursuant to subsection B of this section. A report made to the Virginia Department of Health pursuant to this subsection shall be aggregated to remove any personally identifiable information.