| (B) Consultation by a psychiatrist, with experience
in maternal or neonatal counseling must be available for in-person
visits when requested within a time period consistent with current
standards of professional practice and maternal care.
(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) must arrive at the patient bedside within 30 minutes
for an urgent request; and
(B) must 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) 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.
(12) 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.
(13) Ensure that the physician providing back-up coverage
must arrive at the patient bedside within 30 minutes for an urgent
request.
(14) Anesthesia Services must comply with the requirements
found at §133.41 of this title (relating to Hospital Functions
and Services) and must have:
(A) anesthesia personnel with experience and expertise
in obstetric anesthesia must 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) a board-certified or board-eligible anesthesiologist
with training 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 must comply with the requirements
found at §133.41 of this title and must 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.
(16) Medical Imaging Services must comply with the
requirements found at §133.41 of this title and must 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;
and
(F) a portable ultrasound machine available in the
labor and delivery and antepartum unit.
(17) Pharmacy services must comply with the requirements
found in §133.41 of this title and must have a pharmacist with
experience in perinatal pharmacology available at all times.
(18) Respiratory Therapy Services must comply with
the requirements found at §133.41 of this title and must 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 must have the capability of anesthesia, cesarean delivery,
and maternal resuscitation on-site during the trial of labor.
(20) 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 readily available in the labor and delivery, antepartum
and postpartum areas.
(21) 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 and training
hospital and medical staff who may be involved in the treatment and
management of placenta accreta spectrum disorder about risk factors,
diagnosis, and management.
(22) 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.
(23) The facility must have nursing leadership and
staff with training and experience in the provision of maternal critical
care who must coordinate with respective neonatal services.
(24) The facility must have a program for genetic diagnosis
and counseling for genetic disorders, or a policy and process for
consultation referral to an appropriate facility.
(25) 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.
(26) Support personnel with knowledge and skills in
breastfeeding to meet the needs of maternal patients must be available
at all times.
(27) A certified lactation consultant must be available
at all times.
(28) Social services, pastoral care and bereavement
services must be provided as appropriate to meet the needs of the
patient population served.
(29) 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 and critically ill
maternal patient must comply with the requirements in §133.41
of this title.
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