Current through Register Vol. 50, No. 9, September 20, 2024
A.
Obstetrical Level I Unit
1. General
Provisions
a. Care and supervision for low
risk pregnancies greater or equal to 35 weeks gestation shall be
provided.
b. 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.
c. There shall be protocols and capabilities
for massive transfusion, emergency release of blood products, and management of
multiple component therapy available on-site.
d. Postpartum care facilities shall be
available on-site.
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-sibling-neonate visitation.
h. The hospital shall have a written transfer
agreement with another hospital that has an approved appropriate higher level
of care.
i. - l. Repealed.
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 30 minutes of the decision to operate (30 minutes from decision to
incision).
d. Anesthesia,
radiology, ultrasound, electronic fetal monitoring (along with personnel
skilled in the use of these) and laboratory services shall be available on a
24-hour basis. Anesthesia services shall be available to ensure performance of
a Cesarean delivery within 30 minutes as specified in Subparagraph c
above.
e. 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.
f. 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.
g. A facility shall have
at least one individual with additional education in breastfeeding who is
available for support, counseling and assessment of breastfeeding
mothers.
h. 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. Obstetrical 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.
B. Obstetrical Level II
Unit
1. General Provisions
a. The role of an obstetrical Level II unit
is to provide care for most obstetric conditions in its population, but not to
accept transports of obstetrical patients with gestation age of less than 32
weeks or 1,500 grams if delivery of a viable infant is likely to
occur.
b. Women with conditions
that would result in the delivery of an infant weighing less than 1,500 grams
or less than 32 weeks gestation 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.
c. Ultrasound equipment shall be on site, in
the hospital, and available to labor and delivery 24 hours a day.
d. - e. Repealed.
2. Personnel Requirements
a. The chief of obstetric services 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 neonatologist in charge of the neonatal intensive care unit
(NICU).
b. A board-certified
radiologist and a board-certified clinical pathologist shall be available 24
hours a day. Specialized medical and surgical consultation shall be readily
available.
c. There shall be a
continuous availability of qualified RNs with the ability to stabilize and
transfer high-risk women.
d. A
board-certified or board eligible OB-GYN physician shall be available 24 hours
a day.
EXCEPTION: For those hospitals whose staff OB-GYN
physician(s) do not meet the provisions of
§9509 B(2)d, such physician(s) may be
grandfathered as satisfying the requirement of
§9509 B(2)d 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
is not transferrable.
e. A
licensed physician board-certified in maternal fetal medicine (MFM) shall be
available 24 hours a day for consultation onsite, by telephone, or by
telemedicine, as needed.
f.
Anesthesia services shall be available 24 hours a day to provide labor
analgesia and surgical anesthesia.
g. A board-certified anesthesiologist with
specialized training or experience in obstetric anesthesia shall be available
24 hours a day for consultation.
h.
Medical and surgical consultants shall be available 24 hours a day to stabilize
obstetric patients who have been admitted to the facility or transferred from
other facilities.
C. Obstetrical Level III Unit
1. General Provisions
a. Women with 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 available 24 hours a day which will include magnetic resonance imaging
(MRI) and computed topography (CT).
d. The hospital shall have medical and
surgical ICUs to accept pregnant women and have qualified critical care
providers available as needed to actively collaborate with MFM physicians 24
hours a day.
e. Participation is
required in a statewide quality collaborative and database selected by the
Medicaid Quality Committee, Maternity Subcommittee, with a focus on quality of
maternity care. Proof of such participation will be available from the LDH
website.
f. Equipment and qualified
personnel, adequate in number, shall be available onsite to ventilate and
monitor women in labor and delivery until they can be safely transferred to the
ICU.
g. This unit shall accept
maternal transfers as deemed appropriate by the medical staff and governing
body.
2. Personnel
Requirements
a. 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.
i. - iii. Repealed.
b. A board-certified or
board-eligible MFM physician with inpatient privileges shall be available 24
hours a day, either onsite, by telephone, or by telemedicine.
c. The director of MFM services shall be a
board-certified or board eligible MFM physician.
d. The director of obstetric service shall be
a board-certified OB-GYN with active staff privileges in obstetrical
care.
e. Anesthesia services shall
be available 24 hours a day onsite.
f. A board-certified anesthesiologist with
specialized training or experience in obstetric anesthesia shall be in charge
of obstetric anesthesia services and shall be available onsite as
needed.
g. A full complement of
subspecialists, including subspecialists in critical care, general surgery,
infectious disease, urology, hematology, cardiology, nephrology, neurology,
neonatology and pulmonology shall be available for inpatient
consultations.
h. A lactation
consultant or counselor shall be on staff to assist breastfeeding mothers as
needed.
i. The lactation consultant
or counselor shall be certified by a nationally recognized board on
breastfeeding.
i. 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
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 I V.
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 available onsite 24 hours a
day.
b. The director of MFM
services for this unit shall be board-certified in MFM.
i.
- iv. Repealed.
c. This unit shall have an anesthesiologist
qualified in the delivery of obstetric anesthesia services available to be
onsite 24 hours a day.
c.i. - g.
Repealed.
E.
Obstetrical Level IV Unit
1. General
Provisions
a. This unit shall provide onsite
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.
b. Participation is required in the
departments designated statewide quality collaborative program.
NOTE: The hospital shall acquire and maintain documented
proof of participation.
c. - c,
NOTE. Repealed.
3. Personnel
a. 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 onsite consultation and management. This team shall be led by a
board-certified MFM physician.
b.
The director of obstetric services for this unit shall be a board-certified MFM
physician.
c. This unit shall have
qualified subspecialists on staff to provide consultation in the care of
critically ill pregnant women in the following areas:
i. cardiothoracic surgery;
ii. neurosurgery;
iii. endocrinology; and
iv. gastroenterology.
d. Obstetrical Medical Subspecialties
|
Table 1-Obstetrical Medical
Subspecialties
|
|
Each higher level obstetrical unit shall
meet the requirements of each lower level obstetrical unit.
|
|
Level I
|
Level II
|
Level III
|
Level III Regional
|
Level IV
|
|
Board Certified or Eligible OB/GYN or Family
Practice Physician
|
Board Certified/Eligible
OB/GYN
§9509
B(2)d -See Exception
|
Board Certified/Eligible Anesthesiologist
|
Board Certified/Eligible Anesthesiologist
|
Board Certified/Eligible Anesthesiologist
|
|
Anesthesia services
|
Anesthesia services*
|
Board Certified OB/GYN
|
Board Certified OB/GYN
|
Board Certified OB/GYN
|
|
Radiology services
|
Clinical
Pathologist1
|
Board Certified/Board Eligible
MFM1**
|
Board Certified/Board Eligible MFM**
|
Board Certified MFM**
|
|
Ultrasonography
|
Clinical Radiologist
|
Clinical
Pathologist1
|
Clinical
Pathologist1
|
Clinical
Pathologist1
|
|
Laboratory services
|
MFM1**
|
Clinical
Radiologist1
|
Clinical
Radiologist1
|
Clinical
Radiologist1
|
|
Electronic fetal monitoring
|
Lactation
Consultant/Counselor See
§9509. B(h i)
|
Critical Care1
|
Critical Care1
|
Critical Care1
|
|
|
General
Surgery1
|
General
Surgery1
|
General
Surgery1
|
|
|
Infectious
Disease1
|
Infectious
Disease1
|
Infectious
Disease1
|
|
|
Urology1
|
Urology1
|
Urology1
|
|
|
Hematology1
|
Hematology1
|
Hematology1
|
|
|
Cardiology1
|
Cardiology1
|
Cardiology1
|
|
|
Nephrology1
|
Nephrology1
|
Nephrology1
|
|
|
Neurology1
|
Neurology1
|
Neurology1
|
|
|
Neonatology1
|
Neonatology1
|
Neonatology1
|
|
|
Pulmonology1
|
Pulmonology1
|
Pulmonology1
|
|
|
Lactation Consultant/Counselor
|
Lactation Consultant/Counselor
|
Lactation Consultant/Counselor
|
|
|
Nutritionist
|
Nutritionist
|
Nutritionist
|
|
|
Social Worker
|
Social Worker
|
Social Worker
|
|
|
|
|
Cardiothoracic
Surgery1
|
|
|
|
|
Gastroenterology1
|
|
|
|
|
Endocrinology1
|
|
1
physician shall be available in person on site as needed by the
facility.
|
|
|
Neurosurgery1
|
|
*Anesthesia services shall be available 24 hours
a day to provide labor analgesia and surgical anesthesia. A
board-certified/eligible anesthesiologist with specialized training or
experience in obstetric anesthesia shall be available 24 hours a day for
consultation.
|
|
|
|
|
**Licensed MFM shall be available for
consultation onsite, by telephone, or by telemedicine, as needed.
|
|
|
|
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:2100-2115.
