La. Admin. Code tit. 48 § I-9517

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-9517 - Obstetrical Unit Functions

A. Obstetrical Level I Unit (Basic Care)

1. General Provisions

a. Care and supervision for low risk pregnancies greater or equal to 35 weeks gestation and postpartum patients who are generally healthy and do not have medical, surgical, or obstetrical conditions that present a significant risk of maternal morbidity or mortality, shall be provided.

b. Participation in the state perinatal quality collaborative, which is under the authority of the Louisiana Commission on Perinatal Care and Prevention of Infant Mortality, is required and defined as reporting national perinatal measures determined by the Louisiana Commission on Perinatal Care and Prevention of Infant Mortality.

c. There shall be a triage system present in policies and procedures for identification, stabilization and referral of high risk maternal and fetal conditions beyond the scope of care of a level I unit, including situations where an infant will require a higher level of care than what may be provided by the neonatal level of care of the facility.

d. Postpartum care facilities shall be available onsite.

e. There shall be capability to provide for resuscitation and stabilization of inborn neonates.

f. The hospital shall have a policy for infant security and an organized program to prevent infant abductions.

g. The hospital shall have a program in place to address the needs of the family, including parent-siblingneonate visitation.

h. The hospital shall have a written transfer agreement with another hospital that has an approved appropriate higher level of care.

i. The hospital shall have the capability to screen, provide brief intervention and refer to treatment through consultation with appropriate personnel for behavioral health disorders, including depression, and substance use disorder.

j. Social services, pastoral care and bereavement services shall be provided as appropriate to meet the needs of the patient population served.

2. Personnel Requirements

a. Obstetrical services shall be under the medical direction of a qualified physician who is a member of the medical staff with obstetric privileges. The physician shall be board certified or board eligible in obstetrics/gynecology or family practice medicine. The physician has the responsibility of coordinating perinatal services with the pediatric chief of service.

b. The nursing staff shall be adequately trained and staffed to provide patient care at the appropriate level of service. Registered nurse to patient ratios may vary in accordance with patient needs.

c. The unit shall provide credentialed medical staff to ensure the capability to perform emergency cesarean delivery within a time interval that best incorporates maternal and fetal risks and benefits.

d. The maternal care providers, including midwives, family physicians or obstetricians, shall be readily available at all times.

e. Anesthesia, radiology, ultrasound, electronic fetal monitoring (along with personnel skilled in the use of these) and laboratory services shall be readily available at all times.

f. At least one credentialed physician or certified registered nurse midwife shall attend all deliveries, and at least one individual who is American Academy of Pediatrics (AAP) certified in neonatal resuscitation and capable of neonatal resuscitation shall attend all deliveries.

g. The nurse manager shall be a registered nurse (RN) with specific training and experience in obstetric care. The RN manager shall participate in the development of written policies, procedures for the obstetrical care areas, and coordinate staff education and budget preparation with the chief of service. The RN manager shall name qualified substitutes to fulfill duties during absences.

h. A facility shall have at least one individual with additional education in breastfeeding who is available for support, counseling and assessment of breastfeeding mothers.

i. A facility shall have ability to initiate education and quality improvement programs to maximize patient safety, and/or collaborate with higher-level facilities to do so.

3. Physical Plant

a. Laboring and postpartum patients shall not be placed in rooms with non-obstetrical patients.

b. Each room shall have at least one toilet and lavatory basin for the use of obstetrical patients.

c. The arrangement of the rooms and areas used for obstetrical patients shall be such as to minimize traffic of patients, visitors, and personnel from other departments and prevent traffic through the delivery room(s).

d. There shall be an isolation room provided with hand washing facilities for immediate segregation and isolation of a mother and/or baby with a known or suspected communicable disease.

e. For any new construction or major alteration of the obstetrical unit/suite, the hospital shall ensure that the OB unit has a cesarean delivery room (surgical operative room) to perform cesarean deliveries at all times.

4. Program Functions and Services

a. Laboratory and Blood Bank Services

i. There shall be protocols and capabilities for massive transfusion with process to obtain more blood and component therapy as needed, emergency release of blood products and management of multiple component therapy available on-site.

b. Medical Imaging Services

i. Ultrasound equipment shall be physically present at all times in the hospital and available during labor and delivery.

ii. Basic ultrasound imaging for maternal or fetal assessment including interpretation, shall be readily available at all times.

c. Obstetrical Services

i. Ensure the availability and interpretation of non-stress testing and electronic fetal monitoring.

ii. A trial of labor for patients with prior cesarean delivery may be attempted only if the necessary personnel to perform a cesarean delivery and perform maternal resuscitation are physically present. This personnel includes, all credentialed medical staff needed to perform an emergency cesarean delivery.

iii. The facility shall have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity and/or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols shall address at a minimum:

(a). massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination with the blood bank, including management of unanticipated hemorrhage and/or coagulopathy;

(b). hypertensive disorders in pregnancy;

(c). sepsis and/or systemic infection in the pregnant or postpartum patient; and

(d). venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, and early diagnosis and treatment.

B. Obstetrical Level II Unit (Specialty Care)

1. General Provisions

a. the role of an obstetrical level II unit is to provide care for pregnant and postpartum patients with medical, surgical and/or obstetrical conditions that present a moderate risk of maternal morbidity or mortality; and

b. women with high risk of morbidity or mortality or conditions that would result in the delivery of an infant weighing less than 1,500 grams or less than 32 weeks gestation that will require a higher level of care than what may be provided by the neonatal level of care of the facility, shall be referred to an approved level III or above unit unless the attending physician has documented that the patient is unstable to transport safely. Written transfer agreements with approved obstetrical level III and above units for transfer of these patients shall exist for all obstetrical level II units.

2. Personnel Requirements

a. Obstetric Service Leadership

i. The physician obstetric leader shall be a board-certified obstetrician or a board eligible candidate for certification in obstetrics. This obstetrician has the responsibility of coordinating perinatal services with the neonatal healthcare provider in charge of the neonatal intensive care unit (NICU).

b. Personnel

i. A board-certified or board eligible OB-GYN physician shall be readily available at all times.

EXCEPTION: For those hospitals whose staff OB-GYN physician(s) do not meet the provisions of §9517.B.2.b i, such physician(s) may be grandfathered as satisfying the requirement of §9517.B.2.b.i when the hospital has documented evidence that the OB-GYN physician(s) was granted clinical staff privileges by the hospital prior to the effective date of this Rule. This exception applies only to the physician at the licensed hospital location and shall not be transferrable.

ii. A licensed physician board-certified or board eligible in maternal fetal medicine (MFM) shall be readily available at all times for consultation on-site, by telephone or by telemedicine, as needed. Timing and need to be on-site or available by telemedicine shall be directed by the urgency of the clinical situation.

iii. Anesthesia services shall be readily available at all times to provide labor analgesia and surgical anesthesia. A board-certified anesthesiologist with specialized training or experience in obstetric anesthesia shall be readily available at all times for consultation.

iv. A board-certified radiologist and a board-certified clinical pathologist shall be readily available at all times. Internal or family medicine physician(s) and general surgeon(s) shall be readily available at all times for consultation to stabilize obstetric patients who have been admitted to the facility or transferred from other facilities.

v. There shall be a continuous availability of qualified RNs with the ability to stabilize and transfer high-risk women.

vi. A lactation consultant or counselor, on staff or contracted, holding certification by a nationally recognized board on breastfeeding shall be available to assist breastfeeding mothers as needed. Such services may be provided through the use of telehealth.

vii. Repealed.

3. Program Functions and Services

a. Medical Imaging Services

i. Computed tomography (CT) scan, magnetic resonance imaging (MRI), non-obstetric ultrasound imagining and maternal echocardiography with interpretation shall be readily available at all times.

ii. Specialized obstetric ultrasound and fetal assessment with interpretation shall be readily available at all times.

C. Obstetrical Level III Unit (Subspecialty Care)

1. General Provisions

a. This unit shall provide care for moderate to high-risk perinatal conditions. Women with such conditions requiring a medical team approach not available to the perinatologist in an obstetrical level III unit shall be transported to a higher-level unit.

b. The unit shall have written cooperative transfer agreements with approved higher level units for the transport of mothers and fetuses requiring care unavailable in an obstetrical level III unit or that are better coordinated at a higher level unit.

c. The hospital shall have advanced imaging services readily available at all times which shall include MRI and CT.

d. The hospital shall have medical and surgical ICUs to accept pregnant women and women in the postpartum period and, shall have qualified critical care providers readily available at all times to actively collaborate with MFM physicians.

e. Equipment and qualified personnel, adequate in number, shall be available on-site to ventilate and monitor women in labor and delivery until they can be safely transferred to the ICU.

f. This unit shall accept maternal transfers as deemed appropriate by the medical staff and governing body.

2. Personnel Requirements

a. Obstetric Leadership

i. The physician obstetric leader shall be a board-certified OB-GYN with active staff privileges in obstetrical care.

ii. A board-certified anesthesiologist with specialized training or experience in obstetric anesthesia shall be in charge of obstetric anesthesia services.

iii. The director of MFM services shall be a board-certified or board eligible MFM physician.

b. Personnel

i. This unit shall have a board-certified or board-eligible OB-GYN readily available at all times and available to be physically present within 20 minutes of request to be on-site.

ii. This unit shall have a board-certified or a board-eligible anesthesiologist qualified in the delivery of obstetric anesthesia services readily available at all times. Personnel with such credentials shall be required to be on staff and readily available on a 24-hour on-call basis, and demonstrate the ability to provide anesthesia services within 20 minutes.

iii. A board-certified or board-eligible MFM physician with inpatient privileges shall be readily available at all times, either on-site, by telephone or by telemedicine.

iv. A full complement of subspecialists, including subspecialists in critical care, general surgery, infectious disease, urology, hematology, cardiology, nephrology, neurology, gastroenterology, internal medicine, behavioral health, neonatology and pulmonology shall be readily available at all times for inpatient consultations.

v. Anesthesia services shall be physically present at all times, unless otherwise provided by R.S. 40:2109(B)(6).

vi. The delivery of safe and effective perinatal nursing care requires appropriately qualified registered nurses in adequate numbers to meet the nursing needs of each patient. The hospital shall develop, maintain and adhere to an acuity-based classification system based on nationally recognized staffing guidelines and shall have documentation of such.

vii. A nutritionist and a social worker shall be on staff and available for the care of these patients as needed.

D. Obstetrical Level III Regional Unit (Regional Transfer Unit).

1. General Provisions

a. This unit shall provide care for the most challenging of perinatal conditions. Women with such conditions requiring a medical team approach not available to the MFM physician in an obstetrical level III regional unit shall be transported to a level IV unit.

b. This unit shall have written cooperative transfer agreements with a level IV unit for the transport of mothers and fetuses requiring care that is unavailable in the level III regional unit or that is better coordinated at a level IV.

c. This unit shall accept maternal transfers as deemed appropriate by the medical staff and hospital governing body.

2. Personnel Requirements

a. This unit shall have a board-certified or board-eligible OB-GYN physically present at all times.

b. The director of MFM services for this unit shall be a board-certified MFM physician.

c. This unit shall have an anesthesiologist qualified in the delivery of obstetric anesthesia services physically present at all times.

E. Obstetrical Level IV Unit (Regional Subspecialty Perinatal Health Care Centers)

1. General Provisions

a. This unit shall provide on-site medical and surgical care of the most complex maternal conditions and critically ill pregnant women and fetuses throughout antepartum, intrapartum, and postpartum care.

2. Unit Requirements

a. This unit shall have perinatal system leadership, including facilitation of maternal referral and transport, outreach education for facilities and health care providers in the region and analysis and evaluation of regional data, including perinatal complications and outcomes and quality improvement.

3. Personnel

a. Obstetric Leadership

i. The physician obstetric leader for this unit shall be a board-certified MFM physician.

b. Personnel

i. This unit shall have a MFM care team with the expertise to assume responsibility for pregnant women and women in the postpartum period who are in critical condition or have complex medical conditions. This includes co-management of ICU-admitted obstetric patients. The MFM team members shall have full privileges and shall be available 24 hours per day for on-site consultation and management. This team shall be led by a board-certified MFM physician.

ii. This unit shall have qualified subspecialists on staff, readily available at all times, to provide consultation and treatment as needed on-site in the care of critically ill pregnant women in the following areas:

(a). cardiothoracic surgery and

(b). neurosurgery.

La. Admin. Code tit. 48, § I-9517

Promulgated by the Department of Health, Bureau of Health Services Financing, LR 482570 (10/1/2022), Amended by the Department of Health, Health Standards Section, LR 501493 (10/1/2024).

AUTHORITY NOTE: Promulgated in accordance with R.S.36:254 and R.S. 40:2100-2115.