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RULE §133.206Maternal Designation Level I

(a) Level I (Basic Care). The Level I maternal designated facility must:

  (1) provide care for pregnant 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; 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 or an obstetrics and gynecology physician, 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.

(c) Program Functions and Services.

  (1) Triage and assessment of all patients admitted to the perinatal service.

    (A) Pregnant patients who are 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 require 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 patients with uncomplicated pregnancies 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 with obstetrics training and experience must be available for consultation, at all times.

  (4) Medical, surgical and behavioral health specialists must be available at all times for consultation appropriate to the patient population served.

  (5) Ensure that a qualified physician or certified nurse midwife with appropriate physician back-up is available to attend all deliveries or other obstetrical emergencies.

  (6) The family medicine physician, primary physician, or certified nurse midwife with competence in the care of pregnant patients, 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.

  (7) 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.

  (8) 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.

  (9) Ensure that physicians providing back-up coverage must arrive at the patient bedside within 30 minutes of an urgent request.

  (10) 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) Laboratory and blood bank services must have guidelines or protocols for:

      (i) massive blood component transfusion;

      (ii) emergency release of blood components; and

      (iii) management of multiple blood component therapy.

    (C) 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) Basic ultrasonographic imaging for maternal or fetal assessment, including interpretation available at all times.

      (iv) A portable ultrasound machine immediately available at all times to the labor and delivery and antepartum unit.

    (D) A pharmacist must be available for consultation at all times.

  (11) 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.

  (12) 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, including difficult airway management equipment for pregnant and postpartum patients, is immediately available at all times to the labor and delivery, antepartum and postpartum areas.

  (13) 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.

  (14) 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;

    (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


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