Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 133 - HOSPITAL LICENSING
Subchapter J - HOSPITAL LEVEL OF CARE DESIGNATIONS FOR NEONATAL CARE
Section 133.187 - Neonatal Designation Level II
Universal Citation: 25 TX Admin Code ยง 133.187
Current through Reg. 49, No. 38; September 20, 2024
(a) Level II (Special Care). The Level II neonatal designated facility must:
(1) provide care for mothers and their
infants of generally more than or equal to 32 weeks gestational age and birth
weight more than or equal to 1500 grams who have physiologic immaturity or
problems that are expected to resolve rapidly and are not anticipated to
require subspecialty services on an urgent basis; and
(A) if a facility is located more than 75
miles from the nearest Level III or IV designated neonatal facility and retains
a neonate less than 32 weeks of gestation or having a birth weight of less than
1500 grams, the facility must provide the same level of care that the neonate
would receive at a higher-level designated neonatal facility; and
(B) any facility that retains a neonate less
than 32 weeks of gestation or a birth weight less than 1500 grams, must,
through the neonatal QAPI Plan, complete an in-depth critical review and
assessment of the care provided;
(2) provide care, either by including
assisted endotracheal ventilation for less than 24 hours or nasal continuous
positive airway pressure (NCPAP) until the infant's condition improves or
arrange for appropriate transfer to a higher-level designated facility; and
(A) if the facility performs neonatal
surgery, it must provide the same level of care that the neonate would receive
at a higher-level designated facility; and
(B) the neonatal surgical procedure and
follow-up must be reviewed through the neonatal QAPI Plan; and
(3) have skilled medical staff and
personnel with documented training, competencies, and annual continuing
education specific for the patient population served.
(b) Neonatal Medical Director (NMD). The NMD must be a physician who:
(1) is a
board-eligible/certified neonatologist, with experience in the care of
neonates/infants and maintains a current status of successful completion of the
Neonatal Resuscitation Program (NRP) or a department-approved equivalent
course; or
(2) is a pediatrician or
neonatologist by the effective date of this section who:
(A) continuously provided neonatal care for
the last consecutive two years and has experience and training in the care of
neonates/infants, including assisted endotracheal ventilation and NCPAP
management;
(B) maintains a
consultative relationship with a board-eligible/certified
neonatologist;
(C) demonstrates
effective administrative skills and oversight of the neonatal QAPI
Plan;
(D) maintains a current
status of successful completion of the NRP or a department-approved equivalent
course; and
(E) must complete
annual continuing medical education specific to the care of neonates.
(c) Program Functions and Services.
(1) The neonatal program must
collaborate with the maternal program, consulting physicians, and nursing
leadership to ensure pregnant patients who are at high risk of delivering a
neonate that requires a higher-level of care are transferred to a higher-level
facility before delivery unless the transfer would be unsafe.
(2) The facility provides appropriate,
supportive, and emergency care delivered by trained personnel, for
unanticipated maternal-fetal or neonatal problems that occur during labor and
delivery through the disposition of the patient.
(3) The on-call physician, advanced practice
nurse, or physician assistant must have documented special competence in the
care of neonates, privileges and credentials to participate in neonatal/infant
care reviewed by the NMD, and:
(A) must
maintain a current status of successful completion of the NRP or a
department-approved equivalent course;
(B) must complete annual continuing education
specific to the care of neonates;
(C) must arrive at the patient bedside within
30 minutes of an urgent request;
(D) if not immediately available to respond
or is covering more than one facility, must ensure appropriate back-up coverage
is available, back-up call providers are documented in the neonatal on-call
schedule and must be readily available to respond to the facility staff;
(i) the back-up call physician, advanced
practice nurse, or physician assistant must arrive at the patient bedside
within 30 minutes of an urgent request; and
(ii) the on-call staff must be on-site to
provide ongoing care and to respond to emergencies when a neonate/infant is
maintained on endotracheal ventilation.
(4) The neonatal program ensures if surgeries
are performed for neonates/infants, a surgeon privileged and credentialed to
perform surgery on a neonate/infant is on-call and must arrive at the patient
bedside within a time period consistent with current standards of professional
practice and neonatal care. Surgeon response times must be reviewed and
monitored through the neonatal QAPI Plan.
(5) Anesthesia providers with pediatric
experience and competence must provide services in compliance with the
requirements in §
133.41 of this title (relating to
Hospital Functions and Services).
(6) Dietitian or nutritionist with
appropriate training and experience in neonatal nutrition provides services for
the population served in compliance with the requirements in §
133.41 of this title.
(7) Laboratory services must be in compliance
with the requirements in §
133.41 of this title and must
have:
(A) personnel on-site at all times as
defined by written management guidelines, which may include when a
neonate/infant is maintained on endotracheal ventilation; and
(B) a blood bank capable of providing blood
and blood component therapy within the timelines defined in approved blood
transfusion guidelines.
(8) The facility must provide neonatal/infant
blood gas monitoring capabilities.
(9) Pharmacy services must be in compliance
with the requirements in §
133.41 of this title and must have
a pharmacist with experience in neonatal/pediatric pharmacology available at
all times.
(A) If medication compounding is
done by a pharmacy technician for neonates/infants, a pharmacist must provide
immediate supervision of the compounding process.
(B) When medication compounding is done for
neonates/infants, the pharmacist must implement guidelines to ensure the
accuracy of the compounded final product and ensure:
(i) the process is monitored through the
pharmacy QAPI Plan; and
(ii)
summary reports of activities are presented at the Neonatal Program
Oversight.
(C) Total
parenteral nutrition appropriate for neonates/infants must be available, if
requested.
(10) A
speech, occupational, or physical therapist with sufficient neonatal expertise
must provide therapy services to meet the needs of the population
served.
(11) Radiology services
must be in compliance with the requirements in §
133.41 of this title, incorporate
the "As Low as Reasonably Achievable" principle when obtaining imaging in
neonatal patients, and must have:
(A)
personnel appropriately trained in the use of x-ray and ultrasound
equipment;
(B) personnel at the
bedside within 30 minutes of an urgent request;
(C) personnel appropriately trained,
available on-site to provide ongoing care and to respond to emergencies when an
infant is maintained on endotracheal ventilation;
(D) interpretation capability of neonatal and
perinatal x-rays and ultrasound studies are available at all times;
(E) if preliminary reading of imaging studies
pending formal interpretation is performed, the preliminary findings must be
documented in the medical record; and
(F) regular monitoring and comparison of
preliminary and final readings through the radiology QAPI Plan and provide
summary reports of activities at the Neonatal Program Oversight.
(12) A respiratory therapist, with
experience and specialized training in the respiratory support of
neonates/infants, whose credentials have been reviewed by the NMD, must be
immediately available on-site when:
(A) a
neonate/infant is on a respiratory ventilator to provide ongoing care and to
respond to emergencies; or
(B) a
neonate/infant is on a Continuous Positive Airway Pressure (CPAP)
apparatus.
(13) The
facility must have staff with appropriate training for managing
neonates/infants, written policies, procedures, and guidelines specific to the
facility for the stabilization and resuscitation of neonates based on current
standards of professional practice. Variances from these standards are
monitored through the neonatal QAPI Plan.
(A)
Each birth must be attended by at least one person who maintains a current
status of successful completion of the NRP or a department-approved equivalent
course, whose primary focus is management of the neonate and initiating
resuscitation.
(B) At least one
person must be immediately available on-site with the skills to perform a
complete neonatal resuscitation including endotracheal intubation,
establishment of vascular access, and administration of medications.
(C) Additional personnel who maintain a
current status of successful completion of the NRP or a department-approved
equivalent course must be on-site and immediately available upon request for
the following:
(i) multiple birth deliveries,
to care for each neonate;
(ii)
deliveries with unanticipated maternal-fetal problems that occur during labor
and delivery; and
(iii) deliveries
determined or suspected to be high-risk for the pregnant patient or
neonate.
(D) Variances
from these standards are monitored through the neonatal QAPI Plan and process
and reported at the Neonatal Program Oversight.
(E) Neonatal resuscitative equipment,
supplies, and medications must be immediately available for trained staff to
perform resuscitation and stabilization on any neonate/infant.
(14) A registered nurse with
experience in neonatal care, including special care, or perinatal care must
provide supervision and coordination of staff education.
(15) Social services, supportive spiritual
care, and counseling must be provided as appropriate to meet the needs of the
patient population served.
(16)
Written and implemented policies and procedures to ensure the timely evaluation
of retinopathy of prematurity, documented referral for treatment, and follow-up
of an at-risk infant, which must be monitored through the neonatal QAPI
Plan.
(17) The neonatal program
ensures the availability of support personnel with knowledge and expertise in
breastfeeding and lactation to assist and counsel mothers.
(18) The neonatal program ensures provisions
for follow-through care at discharge for infants at high risk for
neurodevelopmental, medical, or psychosocial complications.
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