| (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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