Louisiana Administrative Code
Title 48 - PUBLIC HEALTH-GENERAL
Part I - General Administration
Subpart 3 - Licensing and Certification
Chapter 93 - Hospitals
Subchapter S - Obstetrical and Newborn Services (Optional)
Section I-9517 - Obstetrical Unit Functions
Universal Citation: LA Admin Code I-9517
Current through Register Vol. 50, No. 9, September 20, 2024
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 shall be on staff to assist breastfeeding mothers as
needed.
vii. The lactation
consultant or counselor shall be certified by a nationally recognized board on
breastfeeding. If individuals with such certification are not on staff,
services may be obtained from certified providers through the use of
telehealth, subject to requirements of any licensing board(s).
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.
AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2100-2115.
Disclaimer: These regulations may not be the most recent version. Louisiana may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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