(a) Level II (Specialty Care). The Level II maternal designated facility must:
  (1) provide care for pregnant and postpartum patients with medical, surgical, or obstetrical conditions that present a low to moderate risk of maternal morbidity or mortality; and
  (2) have skilled personnel with documented training, competencies, and annual continuing education specific for the patient population served.
(b) Maternal Medical Director (MMD). The MMD must be a physician who:
  (1) is a family medicine physician, an obstetrics and gynecology physician, or maternal fetal medicine physician, all with obstetrics training and experience, and with privileges in maternal care;
  (2) demonstrates administrative skills and oversight of the Quality Assessment and Performance Improvement (QAPI) Plan; and
  (3) has completed annual continuing education specific to maternal care, including complicated conditions.
(c) Program Functions and Services.
  (1) Triage and assessment of all patients admitted to the perinatal service.
    (A) Pregnant patients identified at high risk of delivering a neonate that requires a higher level of neonatal care than the scope of their neonatal facility must be transferred to a higher level neonatal designated facility before delivery unless the transfer is unsafe.
    (B) Pregnant or postpartum patients identified with conditions or complications that the managing physician determines require patient transfer to a higher level of maternal care must be transferred to a higher level maternal designated facility unless the transfer is unsafe.
  (2) Provide care for pregnant patients with the capability to detect, stabilize, and initiate management of unanticipated maternal-fetal or maternal problems that occur during the antepartum, intrapartum, or postpartum period until the patient can be transferred to a higher level of neonatal or maternal care.
  (3) An obstetrics and gynecology physician or family medicine physician with obstetrics training and experience, including operative training, and with maternal privileges, must be available at all times and arrive at the patient bedside within 30 minutes of an urgent request. Facilities that utilize family medicine physicians in this role must have a written plan for responding to obstetrical emergencies that require services or procedures outside the scope of privileges granted to the family physician, and regularly monitor outcomes in their QAPI Plan.
  (4) A board-certified or board-eligible maternal fetal medicine physician must be available at all times for consultation.
  (5) Medical and surgical physicians must be available at all times and arrive at the patient bedside within 30 minutes of an urgent request.
  (6) Specialists, including behavioral health, must be available at all times for consultation appropriate to the patient population served.
  (7) Ensure that a qualified physician or certified nurse midwife with appropriate physician back-up is available to attend all deliveries or other obstetrical emergencies.
  (8) The primary provider caring for a pregnant or postpartum patient who is a family medicine physician with obstetrics training and experience, obstetrics and gynecology physician, maternal fetal medicine physician, or a certified nurse midwife, physician assistant or nurse practitioner with appropriate physician back-up, whose credentials have been reviewed by the MMD and is on-call:
    (A) must arrive at the patient bedside within 30 minutes of an urgent request; and
    (B) must complete annual continuing education, specific to the care of pregnant and postpartum patients, including complicated conditions.
  (9) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:
    (A) must operate under guidelines reviewed and approved by the MMD; and
    (B) must have a formal arrangement with a physician with obstetrics training or experience, and with maternal privileges who must:
      (i) provide back-up and consultation;
      (ii) arrive at the patient bedside within 30 minutes of an urgent request; and
      (iii) meet requirements for medical staff as described in §133.205 of this title (relating to Program Requirements) respectively.
  (10) An on-call schedule of providers, back-up providers, and provision for patients without a physician must be readily available to facility and maternal staff and posted on the labor and delivery unit.
  (11) Ensure that the physician providing back-up coverage must arrive at the patient bedside within 30 minutes of an urgent request.
  (12) The appropriate anesthesia, laboratory, pharmacy, radiology, respiratory therapy, ultrasonography and blood bank services must be available on a 24-hour basis as described in §133.41 of this title (relating to Hospital Functions and Services) respectively.
    (A) Anesthesia personnel with training and experience in obstetric anesthesia must be available at all times and arrive to the patient bedside within 30 minutes of an urgent request.
    (B) An anesthesiologist with training or experience in obstetric anesthesia must be available at all times for consultation.
    (C) Laboratory and blood bank services must be capable of:
      (i) providing ABO-Rh specific or O-Rh negative blood, fresh frozen plasma or cryoprecipitate on-site at all times;
      (ii) implementing a massive transfusion protocol;
      (iii) ensuring guidelines for emergency release of blood components; and
      (iv) managing multiple blood component therapy.
    (D) Medical Imaging Services.
      (i) If preliminary reading of imaging studies pending formal interpretation is performed, the preliminary findings must be documented in the medical record.
      (ii) There must be regular monitoring of the preliminary versus final reading in the QAPI Plan.
      (iii) Computed Tomography (CT) imaging and interpretation available at all times.
      (iv) Basic ultrasonographic imaging for maternal or fetal assessment, including interpretation must be available at all times.
      (v) A portable ultrasound machine immediately available at all times to the labor and delivery and antepartum unit.
    (E) A pharmacist must be available for consultation at all times.
  (13) Obstetrical Services.
    (A) The ability to begin an emergency cesarean delivery and ensure the availability of a physician with the training, skills, and privileges to perform the surgery within a time period consistent with current standards of professional practice and maternal care.
    (B) Ensure the availability and interpretation of non-stress testing, and electronic fetal monitoring.
    (C) A trial of labor for patients with prior cesarean delivery must have the capability of anesthesia, cesarean delivery, and maternal resuscitation on-site during the trial of labor.
  (14) Resuscitation. The facility must have written policies and procedures specific to the facility for the stabilization and resuscitation of the pregnant or postpartum patient based on current standards of professional practice. The facility:
    (A) ensures staff members, not responsible for the neonatal resuscitation, are immediately available on-site at all times who demonstrate current status of successful completion of ACLS, or a department-approved equivalent course, and the skills to perform a complete resuscitation; and
    (B) ensures that resuscitation equipment, for pregnant and postpartum patients, is readily available in the labor and delivery, antepartum and postpartum areas. Difficult airway management equipment must be immediately available at all times to these areas.
  (15) The facility must have a written hospital preparedness and management plan for patients with placenta accreta spectrum disorder who are undiagnosed until delivery, including educating hospital and medical staff who may be involved in the treatment and management of placenta accreta spectrum disorder about risk factors, diagnosis, and management.
  (16) The facility must have written guidelines or protocols for various conditions that place the pregnant or postpartum patient at risk for morbidity or mortality, including promoting prevention, early identification, early diagnosis, therapy, stabilization, and transfer. The guidelines or protocols must address a minimum of:
    (A) massive hemorrhage and transfusion of the pregnant or postpartum patient in coordination of the blood bank, including management of unanticipated hemorrhage or coagulopathy;
Cont'd...
(B) obstetrical hemorrhage, including promoting the identification of patients at risk, early diagnosis, and therapy to reduce morbidity and mortality;
    (C) placenta accreta spectrum disorder, including team education, risk factor screening, evaluation, diagnosis, fostering telemedicine medical services and referral as appropriate, treatment and multidisciplinary management of both anticipated and unanticipated placenta accreta spectrum disorder cases, including postpartum care;
    (D) hypertensive disorders in pregnancy, including eclampsia and the postpartum patient to promote early diagnosis and treatment to reduce morbidity and mortality;
    (E) sepsis or systemic infection in the pregnant or postpartum patient;
    (F) venous thromboembolism in the pregnant and postpartum patient, including assessment of risk factors, prevention, early diagnosis and treatment;
    (G) shoulder dystocia, including assessment of risk factors, counseling of patient, and multidisciplinary management; and
    (H) behavioral health disorders, including depression, substance abuse and addiction that includes screening, education, consultation with appropriate personnel and referral.
  (17) The facility must have nursing leadership and staff with training and experience in the provision of maternal nursing care who must coordinate with respective neonatal services.
  (18) Perinatal Education. A registered nurse with experience in maternal care, including moderately complex and ill obstetric patients, must provide the supervision and coordination of staff education. Perinatal education for high risk events must be provided at frequent intervals to prepare medical, nursing, and ancillary staff for these emergencies.
  (19) Support personnel with knowledge and skills in breastfeeding and lactation to meet the needs of maternal patients must be available at all times.
  (20) Social services, pastoral care and bereavement services must be provided as appropriate to meet the needs of the patient population served.
  (21) Dietician or nutritionist available with appropriate training and experience for population served in compliance with the requirements in §133.41 of this title.

Source Note: The provisions of this §133.207 adopted to be effective March 1, 2018, 43 TexReg 875; amended to be effective January 8, 2023, 47 TexReg 8986