| (a) A Level IV (Comprehensive Care). The Level IV maternal
designated facility must:
(1) provide comprehensive care for pregnant and postpartum
patients with low risk conditions to the most complex medical, surgical
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 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 a placenta accreta spectrum disorder multidisciplinary
care team with expertise to complete risk factor screening, evaluation,
diagnosis, consultation, and management of patients with anticipated
or unanticipated placenta accreta spectrum disorder, including postpartum
care;
(7) have skilled personnel with documented training,
competencies, and annual continuing education, specific for the patient
population served;
(8) facilitate transports; and
(9) 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 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 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
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
must 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 or complications that require a service not available at
the facility, must be transferred to an appropriate maternal designated
facility unless the transfer is unsafe.
(2) Supportive and emergency care must 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 or board-eligible obstetrics
and gynecology physician with maternal privileges must 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 must 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 must 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) a 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;
and
(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
collaboration.
(8) The facility must have a Placenta Accreta Spectrum
Disorder Team whose members have expertise in the diagnosis and management
of pregnant or postpartum patients with anticipated and unanticipated
placenta accreta spectrum disorder, including:
(A) a multidisciplinary primary response team must
be comprised of a minimum of the following:
(i) an anesthesiologist with training and expertise
in obstetrical anesthesiology;
(ii) obstetrics and gynecology physician or maternal
fetal medicine physician;
(iii) surgeon or surgeons with expertise in pelvic,
urologic, or gastroenterological surgery;
(iv) neonatologist;
(v) experienced nursing staff; and
(vi) experienced operating room personnel;
(B) a secondary response team must be comprised of
a minimum of the following:
(i) a radiologist with interventional radiology skills;
and
(ii) a blood bank or transfusion medicine specialist;
(C) all primary and secondary response team members
must have full hospital privileges; and
(i) a representative of each component of the primary
response team must be available at all times for inpatient consultation
and management, and arrive at the bedside within 30 minutes of an
urgent request to attend to a patient with placenta accreta spectrum
disorder;
(ii) a representative of each component of the secondary
response team must be available at all times for consultation and
management, and be available to arrive at the patient bedside within
a time frame commensurate with the clinical situation and consistent
with current standards;
(D) representatives of each component of the primary
and secondary response teams must participate in regular, ongoing
staff and team-based education and training to care for patients with
placenta accreta spectrum disorder;
(E) a board-certified maternal fetal medicine physician
or a board-certified obstetrics and gynecology physician, who has
expertise in the diagnosis and management of placenta accreta spectrum
disorder, must lead the team;
(F) evidence that the facility participates in regular,
ongoing outreach and education specific to placenta accreta spectrum
disorder to other maternal facilities not specializing in placenta
accreta spectrum disorder, inclusive of QAPI Plan;
(G) a documented on-call schedule of primary and secondary
response team members is readily available to the facility and maternal
staff on the labor and delivery unit and operating suite; and
(H) evidence that representatives of the primary and
secondary response teams participate in the maternal program's QAPI
process for the review of all placenta accreta spectrum disorder cases
and assist the PCR with the review of placenta accreta spectrum disorder
cases, as requested.
(9) Behavioral Health Services.
(A) Consultation by a behavioral health professional,
with experience in maternal or neonatal counseling must 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
care.
Cont'd... |
