|(a) Level II (Specialty Care). The Level II maternal
designated facility will:
(1) provide care for pregnant and postpartum patients
with medical, surgical, and/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
(b) Maternal Medical Director (MMD). The MMD shall
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
(2) demonstrates administrative skills and oversight
of the Quality Assessment and Performance Improvement (QAPI) program;
(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 shall be transferred to a higher level
neonatal designated facility prior to delivery unless the transfer
(B) Pregnant or postpartum patients identified with
conditions and/or complications that require a higher level of maternal
care shall 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 and/or maternal care.
(3) An obstetrics and gynecology physician with obstetrics
training and experience, and with maternal privileges, shall be available
at all times and arrives at the patient bedside within 30 minutes
of an urgent request.
(4) A board certified maternal fetal medicine physician
shall be available at all times for consultation.
(5) Medical and surgical physicians shall be available
at all times and arrive at the patient bedside within 30 minutes of
an urgent request.
(6) Specialists, including behavioral health, shall
be available at all times for consultation appropriate to the patient
(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) shall arrive at the patient bedside within 30 minutes
of an urgent request; and
(B) shall complete annual continuing education, specific
to the care of pregnant and postpartum patients, including complicated
(9) Certified nurse midwives, physician assistants
and nurse practitioners who provide care for maternal patients:
(A) shall operate under guidelines reviewed and approved
by the MMD; and
(B) shall have a formal arrangement with a physician
with obstetrics training and/or experience, and with maternal privileges
(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)
(10) An on-call schedule of providers, back-up providers,
and provision for patients without a physician will be readily available
to facility and maternal staff and posted on the labor and delivery
(11) Ensure that the physician providing back-up coverage
shall arrive at the patient bedside within 30 minutes of an urgent
(12) The appropriate anesthesia, laboratory, pharmacy,
radiology, respiratory therapy, ultrasonography and blood bank services
shall 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 shall be available at all times and arrive
to the patient bedside within 30 minutes of an urgent request.
(B) An anesthesiologist with training and/or experience
in obstetric anesthesia shall be available at all times for consultation.
(C) Laboratory and blood bank services shall be capable
(i) providing ABO-Rh specific or O-Rh negative blood,
fresh frozen plasma and/or cryoprecipitate, and platelet products
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 shall be regular monitoring of the preliminary
versus final reading in the QAPI Program.
(iii) Computed Tomography (CT) imaging and interpretation
available at all times.
(iv) Basic ultrasonographic imaging for maternal or
fetal assessment, including interpretation shall be available at all
(v) A portable ultrasound machine immediately available
at all times to the labor and delivery and antepartum unit.
(E) A pharmacist shall 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 shall have the capability of anesthesia, cesarean delivery,
and maternal resuscitation on-site during the trial of labor.
(14) Resuscitation. The facility shall 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 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
shall be immediately available at all times to these areas.
(15) The facility shall have written guidelines or
protocols for various conditions that place the pregnant or postpartum
patient at risk for morbidity and/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 and/or coagulopathy;
(B) obstetrical hemorrhage, including promoting the
identification of patients at risk, early diagnosis, and therapy to
reduce morbidity and mortality;
(C) hypertensive disorders in pregnancy, including
eclampsia and the postpartum patient to promote early diagnosis and
treatment to reduce morbidity and mortality;
(D) sepsis and/or systemic infection in the pregnant
or postpartum patient;
(E) venous thromboembolism in the pregnant and postpartum
patient, including assessment of risk factors, prevention, early diagnosis
(F) shoulder dystocia, including assessment of risk
factors, counseling of patient, and multi-disciplinary management;
(G) behavioral health disorders, including depression,
substance abuse and addiction that includes screening, education,
consultation with appropriate personnel and referral.
(16) The facility shall have nursing leadership and
staff with training and experience in the provision of maternal nursing
care who will coordinate with respective neonatal services.
(17) Perinatal Education. A registered nurse with experience
in maternal care, including moderately complex and ill obstetric patients,
shall provide the supervision and coordination of staff education.
Perinatal education for high risk events will be provided at frequent
intervals to prepare medical, nursing, and ancillary staff for these
(18) Support personnel with knowledge and skills in
breastfeeding and lactation to meet the needs of maternal patients
shall be available at all times.
(19) Social services, pastoral care and bereavement
services shall be provided as appropriate to meet the needs of the
patient population served.
(20) Dietician or nutritionist available with appropriate
training and experience for population served in compliance with the
requirements in §133.41 of this title.