| (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;
(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.
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