| (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.
(17) 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) 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.
(18) 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.
(19) Respiratory Therapy Services must comply with
the requirements found at §133.41 of this title and have a respiratory
therapist immediately available on-site at all times.
(20) 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.
(21) 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.
(22) 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.
(23) 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.
(24) 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.
(25) 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.
(26) 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.
(27) Support personnel with knowledge and skills in
breastfeeding to meet the needs of maternal patients must be available
at all times.
(28) A certified lactation consultant must be available
at all times.
(29) Social services, pastoral care and bereavement
services must be provided as appropriate to meet the needs of the
patient population served.
(30) 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 must comply with
the requirements in §133.41 of this title.
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