| (a) A Level III (Subspecialty Care). The Level III
maternal designated facility must:
(1) provide care for pregnant and postpartum patients
with low risk conditions to significant complex medical, surgical
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 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 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 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 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
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 must be transferred to a
higher level neonatal designated facility before delivery unless the
transfer is unsafe.
(B) Pregnant or postpartum patients identified with
conditions or complications that require a higher level of maternal
care must 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 or maternal care.
(3) Supportive and emergency care must 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 must be on-site at all times and available for urgent situations.
(5) A board-certified or board-eligible Maternal Fetal
Medicine physician with inpatient privileges must be available at
all times for inpatient consultation and arrive at the patient bedside
within 30 minutes of an urgent request to co-manage patients.
(A) When telehealth or telemedicine is utilized for
maternal fetal medicine co-management for non-urgent inpatient situations
where an in-person response is not required, the facility must have
the following:
(i) a written plan for the appropriate use of telehealth/telemedicine
for inpatient hospital care that is compliant with the Texas Medical
Board Telemedicine rules, Texas Administrative Code, Title 22, Chapter
174, and the Texas Occupations Code, Chapter 111;
(ii) a process for informed consent and agreement from
the patient for the use of telehealth or telemedicine; and
(iii) a maternal fetal medicine physician with inpatient
privileges at the facility, who regularly participates in the on-site
care of patients at the facility, has access to the patient's medical
record, and participates as needed in the QAPI Plan and process for
the facility's maternal program.
(B) The facility has processes to monitor the compliance
and outcomes of maternal telehealth and telemedicine encounters through
the QAPI Plan.
(C) The use of telemedicine for on call consultation
does not substitute for the requirement of maternal fetal medicine
availability for in-person consultation on complex and critically
ill patients on a regular basis.
(6) Intensive Care Services. The facility must 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) Level III maternal designated facilities that serve
as referral centers for placenta accreta spectrum disorder must fulfill
all of the Level IV requirements for a Placenta Accreta Spectrum Disorder
Team defined in §133.209 of this title (relating to Maternal
Designation Level IV).
(8) Medical and surgical physicians, including critical
care specialists, must be available at all times and arrive at the
patient bedside within 30 minutes of an urgent request.
(9) Consultation by a behavioral health professional,
with training or experience in maternal counseling must be available
at all times and arrive by telemedicine or in-person when requested
within a time period consistent with current standards of professional
practice and maternal care.
(10) 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.
(11) 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.
(12) 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.
(13) 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.
(14) Ensure that the physician providing back-up coverage
must arrive at the patient bedside within 30 minutes for an urgent
request.
(15) 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.
(16) 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 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;
Cont'd... |
