410 Ind. Admin. Code 39-4-1

Current through November 6, 2024

Section 410 IAC 39-4-1 - Obstetric Level I facility requirements

Authority: IC 16-21-13-5

Affected: IC 16-21-13

Sec. 1.

(a) An Obstetric Level I facility is a facility that provides care of uncomplicated pregnancies with the ability to detect, stabilize, and initiate management of unanticipated maternal-fetal or neonatal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a facility at which specialty maternal care is available.

(b) An Obstetric Level I facility shall demonstrate its capability of providing uncomplicated and complicated obstetrical care through written standards, protocols, guidelines, and training, including the following:

(1) Each Obstetric Level I facility shall have all of the following facility capabilities:

(A) Ability to begin emergency cesarean delivery within a time interval that best incorporates maternal and fetal risks and benefits with the provision of emergency care.

(B) Ensuring availability of support services, including anesthesia, obstetric ultrasonography, laboratory testing, radiology, and blood bank supplies readily available at all times.

(C) Ability to initiate education and quality improvement programs to maximize patient safety, collaborate with higher level facilities to do so, or both.

(D) Selecting and managing obstetrical patients at a maternal risk level appropriate to its capability.

(E) Access to the hospital's laboratory services including twenty-four (24) hour capability to provide blood group, Rhesus factor (Rh) type, cross-matching, antibody testing, and basic emergency laboratory evaluations. The facility must have:

(i) ABO-Rh-specific or O-Rh-negative blood;

(ii) fresh frozen plasma; and

(iii) cryoprecipitate; at the facility at all times.

(F) Hospitals offering a trial of labor for patients with a prior cesarean delivery shall have appropriate facilities and personnel immediately available at all times during the trial of labor including:

(i) anesthesia provider;

(ii) provider capable of performing cesarean delivery; and

(iii) personnel certified in Neonatal Resuscitation Program (NRP).

(2) Each Obstetric Level I facility shall obtain and maintain current equipment and technology, including, but not limited to, the following:

(A) Obstetric ultrasonography.

(B) Nonstress and stress testing.

(C) Cardioversion and defibrillation capability for mothers.

(D) Resuscitation equipment for mothers.

(E) Oxygen and air outlets.

(F) Emergency call system.

(G) Laboratory testing supplies.

(H) Blood bank supplies.

(I) Fetal monitoring equipment.

(3) Each Obstetric Level I facility shall have the following medications:

(A) The following medications shall be readily available at all times to the delivery room:

(i) Uterotonics.

(ii) Narcotics.

(iii) Antibiotics.

(iv) Anticonvulsants.

(v) Antihemorrhagic medications.

(vi) Narcotic reversal medications.

(vii) Antihypertensive medications.

(viii) Medications to support the provision of anesthesia services.

(B) All emergency resuscitation medications needed to initiate and maintain resuscitation shall be readily available at all times in accordance with Advanced Cardiac Life Support (ACLS) and NRP training.

(4) Each Obstetric Level I facility shall establish and maintain the following policies and procedures:

(A) Protocols and capabilities for massive transfusion, emergency release of blood products, and management of multiple blood component therapy.

(B) Formal transfer plans in partnership with a higher-level facility that include, but are not limited to, the following:

(i) Risk identification.

(ii) Determination of conditions necessitating consultation.

(iii) Referral and transfer.

(iv) A reliable, accurate, and comprehensive communication system between participating hospitals and transport teams.

(C) The hospital shall provide care to the maternal patient in accordance with acceptable standards of practice, as provided for by 410 IAC 15-1.6-9(a). The current Centers for Disease Control and Prevention (CDC) and American College of Obstetricians and Gynecologists (ACOG) recommendations related to the care of the maternal patient shall be considered as authoritative sources of such acceptable standards of practice.

(c) Each Obstetric Level I facility shall ensure the following staffing requirements are met:

(1) Physician services. An obstetric provider, such as an obstetrician-gynecologist (OB-GYN), surgeon, or family medicine physician with additional training in obstetrics, with appropriate training and privileges to perform emergency cesarean delivery shall be readily available at all times to attend all deliveries.

(2) Nursing services, as follows:

(A) Adequate number of registered nurses (RNs) with competence in Level I care criteria and ability to stabilize and make preparations to transfer high-risk women, readily available at all times.

(B) Ensure minimum staffing according to Association of Women's Health, Obstetric and Neonatal Nurses (AWHONN) Guidelines for Professional Registered Nurse Staffing for Perinatal Units nurse-patient ratios, even when there are no perinatal patients.

(C) RN with demonstrated training and experience in the assessment, evaluation, and care of patients in labor present at all deliveries.

(D) Nursing staff shall be formally trained, certified, and competent in NRP.

(E) RN skilled in the recognition and nursing management of the complications of labor and delivery readily available at all times.

(F) On-duty RN whose responsibilities include the organization and supervision of antepartum, intrapartum, postpartum, and neonatal nursing services.

(G) Nursing leadership with expertise in perinatal nursing care.

(H) RN shall supervise licensed practical nurses and other licensed patient care staff who demonstrate knowledge and clinical competence in the nursing care of women, fetuses, and newborns during labor, delivery, and the postpartum and neonatal periods.

(I) Each delivering facility shall have a written plan for ensuring registered nurse-patient ratios as per current Guidelines for Perinatal Care, or AWHONN Guidelines for Professional Registered Nurse Staffing for Perinatal Units.

(3) Anesthesia services readily available at all times.

(4) Appropriately qualified medical staff readily available at all times to perform and interpret obstetric ultrasonography.

(5) At least one (1) person capable of initiating neonatal resuscitation shall attend every birth.

(6) Pharmaceutical services in accordance with 410 IAC 15-1.5-7.

(7) The hospital shall provide lactation support for the care of mothers and newborns per AWHONN and International Board Certified Lactation Consultant Staffing Recommendations for the Inpatient Setting Association (ILCA) recommendations on number of full-time equivalents per number of annual deliveries, based on the level of care at which the hospital is certified.

(8) Blood bank technicians shall be readily available at all times.

410 IAC 39-4-1

Indiana State Department of Health; 410 IAC 39-4-1; filed 8/14/2019, 3:32 p.m.: 20190911-IR-410180416FRA