|(a) A Level IV (Comprehensive Care). The Level IV maternal
designated facility will:
(1) provide comprehensive care for pregnant and postpartum
patients with low risk conditions to the most complex medical, surgical
and/or obstetrical conditions and their fetuses, that present a high
risk of maternal morbidity or mortality;
(2) ensure access to on-site consultation to a comprehensive
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 and/or Obstetrics and Gynecology physicians with obstetrics
training, experience and privileges in maternal care;
(5) have a maternal fetal medicine critical care team
with expertise and privileges to manage or co-manage highly complex,
critically ill or unstable maternal patients;
(6) have skilled personnel with documented training,
competencies and annual continuing education, specific for the patient
(7) facilitate transports; and
(8) provide outreach education to lower level designated
facilities, including the Quality Assessment and Performance Improvement
(b) Maternal Medical Director (MMD). The MMD shall
be a physician who:
(1) is a board certified obstetrics and gynecology
physician with expertise in the area of critical care obstetrics;
or a board certified maternal fetal medicine physician, both with
privileges in maternal care;
(2) demonstrates administrative skills and oversight
of the QAPI Program; and
(3) has completed annual continuing education specific
to maternal care, including complicated conditions.
(c) If the facility has its own transport program,
there shall be an identified Transport Medical Director (TMD). The
TMD shall be a physician who is a board certified maternal fetal medicine
physician or board certified obstetrics and gynecology physician with
obstetrics privileges, with expertise and experience in critically
ill maternal transport.
(d) 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
shall be transferred to a higher level neonatal designated facility
prior to delivery unless the transfer is unsafe.
(B) Pregnant or postpartum patients identified with
conditions and/or complications that require a service not available
at the facility, shall be transferred to an appropriate maternal designated
facility unless the transfer is unsafe.
(2) Supportive and emergency care shall be delivered
by appropriately trained personnel, for unanticipated maternal-fetal
problems that occur during labor and delivery, through the disposition
of the patient.
(3) A board certified obstetrics and gynecology physician
with maternal privileges shall be on-site at all times and available
for urgent situations.
(4) 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.
(5) Intensive Care Services. The facility shall have
an adult Intensive Care Unit (ICU) and critical care capabilities
for maternal patients, including:
(A) a comprehensive range of medical and surgical critical
care specialists and advanced subspecialists on the medical staff;
(B) a maternal fetal medicine critical care team with
experience and expertise in the care of complex or critically ill
maternal patients available to co-manage maternal patients; and
(C) availability of obstetric nursing and support personnel
with experience in care for critically ill maternal patients.
(6) Maternal Fetal Medicine Critical Care Team. The
facility shall have a Maternal Fetal Medicine (MFM) critical care
team whose members have expertise to assume responsibility for pregnant
or postpartum patients who are in critical condition or have complex
medical conditions, including;
(A) co-management of ICU-admitted obstetric patients;
(B) an MFM team member with full obstetrical privileges
available at all times for on-site consultation and management, and
to arrive at the patient bedside within 30 minutes of an urgent request;
(C) a board certified MFM physician with expertise
in critical care obstetrics to lead the team.
(7) Management of critically ill pregnant or postpartum
patients, including fetal monitoring in the ICU, respiratory failure
and ventilator support, procedure for emergency cesarean, coordination
of nursing care, and consultative or co-management roles to facilitate
(8) Behavioral Health Services.
(A) Consultation by a behavioral health professional,
with experience in maternal and/or neonatal counseling shall be available
on-site at all times for in-person visits when requested for prenatal,
peri-operative, and postnatal needs of the patient within a time period
consistent with current standards of professional practice and maternal
(B) Consultation by a psychiatrist, with experience
in maternal and/or neonatal counseling shall be available for in-person
visits when requested within a time period consistent with current
standards of professional practice and maternal care.
(9) 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
for an urgent request; and
(B) shall complete annual continuing education, specific
to the care of pregnant and postpartum patients, including complicated
and critical conditions.
(10) 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)
(11) 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
(12) Ensure that the physician providing back-up coverage
shall arrive at the patient bedside within 30 minutes for an urgent
(13) Anesthesia Services shall comply with the requirements
found at §133.41 of this title (relating to Hospital Functions
and Services) and shall have:
(A) anesthesia personnel with experience and expertise
in obstetric anesthesia shall be available on-site at all times;
(B) a board certified anesthesiologist with training
and/or experience in obstetric anesthesia in charge of obstetric anesthesia
(C) a board certified anesthesiologist with training
and/or experience in obstetric anesthesia, including critically ill
obstetric patients available for consultation at all times, and arrive
at the patient bedside within 30 minutes for urgent requests; and
(D) anesthesia personnel on call, including back-up
contact information, posted and readily available to the facility
and maternal staff and posted in the labor and delivery area.
(14) Laboratory Services shall comply with the requirements
found at §133.41 of this title and shall have:
(A) laboratory personnel on-site at all times;
(B) a blood bank capable of:
(i) providing ABO-Rh specific or O-Rh negative blood,
fresh frozen plasma, cryoprecipitate, and platelet components 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; and
(C) perinatal pathology services available.
(15) Medical Imaging Services shall comply with the
requirements found at §133.41 of this title and shall have:
(A) personnel appropriately trained in the use of x-ray
equipment available on-site at all times;
(B) advanced imaging, including computed tomography
(CT), magnetic resonance imaging (MRI), and echocardiography available
at all times;
(C) interpretation of CT, MRI and echocardiography
within a time period consistent with current standards of professional
practice and maternal care;
(D) a radiologist with critical interventional radiology
skills available at all times;
(E) advanced ultrasonographic imaging for maternal
or fetal assessment, including interpretation available at all times;
(F) a portable ultrasound machine available in the
labor and delivery and antepartum unit.
(16) Pharmacy services shall comply with the requirements
found in §133.41 of this title and shall have a pharmacist with
experience in perinatal pharmacology available at all times.
(17) Respiratory Therapy Services shall comply with
the requirements found at §133.41 of this title and shall have
a respiratory therapist immediately available on-site at all times.
(18) Obstetrical Services.
(A) The ability to begin an emergency cesarean delivery
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.
(19) 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, including
difficult airway management equipment for pregnant and postpartum
patients, is readily available in the labor and delivery, antepartum
and postpartum areas.
(20) 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.
(21) The facility shall have nursing leadership and
staff with training and experience in the provision of maternal critical
care who will coordinate with respective neonatal services.
(22) The facility shall have a program for genetic
diagnosis and counseling for genetic disorders, or a policy and process
for consultation referral to an appropriate facility.