(a) A Level III (Subspecialty Care). The Level III maternal designated facility must:
(1) provide care for pregnant and postpartum patients with low risk conditions to significant complex medical, surgical or obstetrical conditions that present a high risk of maternal morbidity or mortality;
(2) ensure access to consultation to a full range of medical and maternal subspecialists, surgical specialists, and behavioral health specialists;
(3) ensure capability to perform major surgery on-site;
(4) have physicians with critical care training available at all times to actively collaborate with Maternal Fetal Medicine physicians or Obstetrics and Gynecology Physicians with obstetrics training and privileges in maternal care;
(5) have skilled personnel with documented training, competencies, and annual continuing education, specific for the population served;
(6) facilitate transports; and
(7) provide outreach education related to trends identified through the QAPI Plan, specific requests, and system needs to lower level designated facilities, and as appropriate and applicable, to non-designated facilities, birthing centers, independent midwife practices, and prehospital providers.
(b) Maternal Medical Director (MMD). The MMD must be a physician who:
(1) is a board-certified obstetrics and gynecology physician with obstetrics training and experience, or a board-certified maternal fetal medicine physician, both with privileges in maternal care;
(2) demonstrates administrative skills and oversight of the QAPI Plan; and
(3) has completed annual continuing education specific to maternal care, including complicated conditions.
(c) If the facility has its own transport program, there must be an identified Transport Medical Director (TMD). The TMD must be a physician who is a board-certified maternal fetal medicine specialist or board-certified obstetrics and gynecology physician with privileges and experience in obstetrical care and maternal transport.
(d) Program Functions and Services.
(1) Triage and assessment of all patients admitted to the perinatal service.
(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) Supportive and emergency care must be delivered by appropriately trained personnel for unanticipated maternal-fetal problems that occur requiring a higher level of maternal care, until the patient is stabilized or transferred;
(4) An obstetrics and gynecology physician with maternal privileges must be on-site at all times and available for urgent situations.
(5) A board-certified or board-eligible Maternal Fetal Medicine physician with inpatient privileges must be available at all times for inpatient consultation and arrive at the patient bedside within 30 minutes of an urgent request to co-manage patients.
(6) Intensive Care Services. The facility must provide critical care services for critically ill pregnant or postpartum patients, including fetal monitoring in the Intensive Care Unit (ICU), respiratory failure and ventilator support, procedure for emergency cesarean, coordination of nursing care, and consultative or co-management roles to facilitate collaboration.
(7) Level III maternal designated facilities that serve as referral centers for placenta accreta spectrum disorder must fulfill all of the Level IV requirements for a Placenta Accreta Spectrum Disorder Team defined in §133.209 of this title (relating to Maternal Designation Level IV).
(8) Medical and surgical physicians, including critical care specialists, must be available at all times and arrive at the patient bedside within 30 minutes of an urgent request.
(9) Consultation by a behavioral health professional, with training or experience in maternal counseling must be available at all times and arrive by telemedicine or in-person when requested within a time period consistent with current standards of professional practice and maternal care.
(10) Ensure that a qualified physician, or a certified nurse midwife with appropriate physician back-up, is available to attend all deliveries or other obstetrical emergencies.
(11) 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:
(12) Certified nurse midwives, physician assistants and nurse practitioners who provide care for maternal patients:
(13) 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.
(14) Ensure that the physician providing back-up coverage must arrive at the patient bedside within 30 minutes for an urgent request.
(15) Anesthesia Services must comply with the requirements found at §133.41 of this title (relating to Hospital Functions and Services) and must have:
(16) Laboratory Services must comply with the requirements found at §133.41 of this title and must have:
(17) Medical Imaging Services must comply with the requirements found at §133.41 of this title and must have:
(18) Pharmacy services must comply with the requirements found in §133.41 of this title and must have a pharmacist with experience in perinatal pharmacology available at all times.
(19) Respiratory Therapy Services must comply with the requirements found at §133.41 of this title and have a respiratory therapist immediately available on-site at all times.
(20) Obstetrical Services.
(21) 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:
(22) 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.
(23) 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: