La. Admin. Code tit. 48 § I-9509

Current through Register Vol. 50, No. 11, November 20, 2024
Section I-9509 - Obstetrical Unit Functions
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i. - l. Repealed.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.

La. Admin. Code tit. 48, § I-9509

Promulgated by the Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing, LR 29:2427 (November 2003), amended LR 33:284 (February 2007), Amended by the Department of Health, Bureau of Health Services Financing, LR 4376 (1/1/2017).
AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2100-2115.