Title of Regulation: 12VAC5-410. Regulations for the Licensure of Hospitals in Virginia (amending 12VAC5-410-441).

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

Public Hearing Information: No public hearings are currently scheduled.

Public Comment Deadline: March 31, 2021.

Effective Date: April 15, 2021.

Agency Contact: Rebekah E. Allen, Senior Policy Analyst, Virginia Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2102, FAX (804) 527-4502, or email regulatorycomment@vdh.virginia.gov.

Basis: Section 32.1-12 of the Code of Virginia gives the State Board of Health the responsibility to make, adopt, promulgate, and enforce such regulations as may be necessary to carry out the provisions of Title 32.1 of the Code of Virginia. Section 32.1-127 of the Code of Virginia requires the board to adopt regulations that include minimum standards for hospitals, nursing homes and certified nursing facilities.

Purpose: This regulation is being amended due to the changes to § 32.1-143.01 of the Code of Virginia. The board is required by § 32.1-127 of the Code of Virginia to promulgate regulations for the licensure of hospitals in order to protect the health, safety, and welfare of citizens receiving care in hospitals. The goal of the regulatory change is to conform the regulations to the statute. It is intended to increase maternity patients' knowledge and awareness of certain information that protects the health, safety, and welfare of new mothers and their infants.

Rationale for Using Fast-Track Rulemaking Process: Chapter 433 of the 2019 Acts of Assembly amended and reenacted § 32.1-134.01 of the Code of Virginia to add perinatal anxiety to the list of information hospitals are required to make available to maternity patients, the father of the infant, and other relevant family members or caretakers prior to such patients' discharge. The existing list of information from that Code section is not currently included in the hospital regulations.

As the rulemaking is being utilized to conform to the statute and no new requirements are being developed, it is expected to be noncontroversial.

Substance: A new provision is added to require the information pursuant to § 32.1-134.01 of the Code of Virginia be provided.

Issues: This action is being used to conform the regulations to existing requirements in the statute. The advantage to the public and the Commonwealth is that the regulations are in compliance with legislative changes enacted by the 2019 General Assembly. There are no disadvantages to the public, the agency, or the Commonwealth.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. One of the requirements of 2VAC5-410 Regulations for the Licensure of Hospitals in Virginia is that the governing board of the hospital adopt written policies and procedures for the management of obstetric patients, to be approved by the medical and nursing staff assigned to the obstetric service. The regulation lists the minimum required contents of the policies and procedures. In addition, § 32.1-134.01 of the Code of Virginia states that prior to releasing each maternity patient, certain specified information be provided. The State Board of Health proposes to add the provision of the information specified in § 32.1-134.01 of the Code of Virginia to the list of minimum required contents of the policies and procedures.

Background. Section 32.1-134.01 of the Code of Virginia states that:

Every licensed nurse midwife, licensed midwife, or hospital providing maternity care shall, prior to releasing each maternity patient, make available to such patient and, if present, to the father of the infant and other relevant family members or caretakers, information 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 available from the American Academy of Pediatrics. This information shall be discussed with the maternity patient and the father of the infant and other relevant family members or caretakers who are present at discharge.

Estimated Benefits and Costs. To the extent that the specified information is not already being consistently conveyed to maternity patients and their relevant family members and caretakers, and to the extent that mandating that the provision of this information is added to hospitals written policies and procedures increases the frequency that the information is conveyed, the proposal may be beneficial to the wellbeing of new mothers and babies. Adding the provision of the information specified in § 32.1-134.01 to the policies and procedures would likely require minimal staff time for hospitals.

Businesses and Other Entities Affected. The proposal affects the 106 inpatient hospitals and 63 outpatient surgical hospitals licensed by the Virginia Department of Health (VDH). A minimal amount of staff time would be required to add the provision of specified information to the written policies and procedures.

Small Businesses Affected. Types and Estimated Number of Small Businesses Affected

VDH estimates that three of the outpatient surgical hospitals meet the statutory definition of small business.¹

Costs and Other Effects. As discussed, a minimal amount of staff time would be required to add the provision of specified information to the written policies and procedures.

Alternative Method that Minimizes Adverse Impact. There are no clear alternative methods that both reduce adverse impact and meet the intended policy goals.

Localities² Affected.³ The proposal does not disproportionately affect any particularly locality nor appear to introduce additional costs for local governments.

Projected Impact on Employment. The proposal does not appear to substantively affect total employment.

Effects on the Use and Value of Private Property. The proposal appears to neither substantively affect the use and value of private property, nor affect real estate development costs.

________________________________

¹Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million.

²Locality 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.

³§ 2.2-4007.04 defines particularly affected" as bearing disproportionate material impact.

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

Summary:

Pursuant to Chapter 433 of the 2019 Acts of Assembly, the amendment adds perinatal anxiety to the list of information hospitals are required to make available to maternity patients, the father of the infant, and other relevant family members or caretakers prior to such patients' discharge.

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

A. he 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 but not be limited to:

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

U. 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, but not be limited to, 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 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 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; and

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 father of the infant; and

(b) 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 disqualify patients from use of the LDR/LDRP rooms;

d. Patient care in LDR/LDRP rooms, including but not limited to, 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, but not limited to, gowning and attire to be worn by persons in the LDR/LDRP room, upon leaving it, and upon returning.