| (a) A Level III (Subspecialty Care). The Level III
maternal designated facility will:
(1) provide care for pregnant and postpartum patients
with low risk conditions to significant complex medical, surgical
and/or obstetrical conditions that present a high risk of maternal
morbidity or mortality;
(2) ensure access to consultation to a full 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 and privileges in maternal care;
(5) have skilled personnel with documented training,
competencies and annual continuing education, specific for the population
served;
(6) facilitate transports; and
(7) provide outreach education to lower level designated
facilities, including the Quality Assessment and Performance Improvement
(QAPI) process.
(b) Maternal Medical Director (MMD). The MMD shall
be a physician who:
(1) is a board certified obstetrics and gynecology
physician with obstetrics training and experience, 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
specialist or board certified obstetrics and gynecology physician
with privileges and experience in obstetrical care and 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
than the scope of their neonatal facility 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 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) Supportive and emergency care shall be delivered
by appropriately trained personnel for unanticipated maternal-fetal
problems that occur requiring a higher level of maternal care, until
the patient is stabilized or transferred;
(4) An obstetrics and gynecology physician with maternal
privileges shall be on-site at all times and available for urgent
situations.
(5) Maternal Fetal Medicine physician with inpatient
privileges shall be available at all times for consultation and arrive
at the patient bedside within 30 minutes of an urgent request to co-manage
patients.
(6) Intensive Care Services. The facility shall provide
critical care services for critically ill pregnant or postpartum patients,
including fetal monitoring in the Intensive Care Unit (ICU), respiratory
failure and ventilator support, procedure for emergency cesarean,
coordination of nursing care, and consultative or co-management roles
to facilitate collaboration.
(7) Medical and surgical physicians, including critical
care specialists, shall be available at all times and arrive at the
patient bedside within 30 minutes of an urgent request.
(8) Consultation by a behavioral health professional,
with training and/or experience in maternal counseling shall be available
at all times and arrive for in-person visits when requested within
a time period consistent with current standards of professional practice
and maternal care.
(9) 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.
(10) 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.
(11) 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
who will:
(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.
(12) 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
unit.
(13) Ensure that the physician providing back-up coverage
shall arrive at the patient bedside within 30 minutes for an urgent
request.
(14) 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
or experience in obstetric anesthesia in charge of obstetric anesthesia
services;
(C) an 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.
(15) 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 the facility 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.
(16) 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) basic ultrasonographic imaging for maternal or
fetal assessment, including interpretation available at all times;
and
(E) a portable ultrasound machine available in the
labor and delivery and antepartum unit.
(17) 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.
(18) Respiratory Therapy Services shall comply with
the requirements found at §133.41 of this title and have a respiratory
therapist immediately available on-site at all times.
(19) 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.
(20) 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.
(21) 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
and treatment;
(F) shoulder dystocia, including assessment of risk
factors, counseling of patient, and multi-disciplinary management;
and
(G) behavioral health disorders, including depression,
substance abuse and addiction that includes screening, education,
consultation with appropriate personnel and referral.
(22) 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.
(23) 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.
(24) 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
emergencies.
(25) Support personnel with knowledge and skills in
breastfeeding to meet the needs of maternal patients shall be available
at all times.
(26) A certified lactation consultant shall be available
at all times.
(27) Social services, pastoral care and bereavement
services shall be provided as appropriate to meet the needs of the
patient population served.
(28) Dietician or nutritionist available with training
and experience in maternal nutrition and can plan diets that meet
the needs of the pregnant and postpartum patient shall comply with
the requirements in §133.41 of this title.
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