| (a) The department reviews the applicant documents
and approves the appropriate level of facility designation.
(b) A facility is defined under this subchapter as
a single location where inpatients receive hospital services; or each
location, if there are multiple buildings where inpatients receive
hospital services and are covered under a single hospital license.
(c) Each location must be considered separately for
designation and the department approves the designation level for
each location based on the location's ability to demonstrate designation
criteria are met. A stand-alone children's facility that does not
provide obstetrical services is exempt from obstetrical requirements.
(d) The department determines requirements for the
levels of neonatal designation. Facilities seeking Levels II, III,
and IV neonatal designation must meet department-approved requirements
validated by a department-approved survey organization.
(e) Facilities seeking Level I neonatal designation
must submit a self-survey and attest to meeting department-approved
requirements.
(f) The four levels of neonatal designation are:
(1) Level I (Well Care). The Level I neonatal designated
facility must:
(A) provide care for mothers and their infants of generally
more than or equal to 35 weeks gestational age who have routine, transient
perinatal problems;
(B) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served; and
(C) provide the same level of care that the neonate
would receive at a higher-level designated neonatal facility and complete
an in-depth critical review and assessment of the care provided to
these infants through the neonatal QAPI Plan and process if an infant
less than 35 weeks gestational age is retained.
(2) Level II (Special Care). The Level II neonatal
designated facility must:
(A) 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;
(B) 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
(C) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served.
(3) Level III (Neonatal Intensive Care). The Level
III neonatal designated facility must:
(A) provide care for mothers and comprehensive care
for their infants of all gestational ages with mild to critical illnesses
or requiring sustained life support;
(B) ensure access to consultation to a full range of
pediatric medical subspecialists and pediatric surgical specialists,
and the capability to perform major pediatric surgery on-site or at
another appropriate neonatal designated facility;
(C) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served;
(D) facilitate neonatal transports; and
(E) provide outreach education related to trends identified
through the neonatal QAPI Plan, specific requests, and system needs
to lower-level neonatal designated facilities, and as appropriate
and applicable, to non-designated facilities, birthing centers, independent
midwife practices, and prehospital providers.
(4) Level IV (Advanced Neonatal Intensive Care). The
Level IV neonatal designated facility must:
(A) provide care for mothers and comprehensive care
for their infants of all gestational ages with the most complex and
critical medical and surgical conditions or requiring sustained life
support;
(B) ensure access to a comprehensive range of pediatric
medical subspecialists and pediatric surgical subspecialists available
to arrive on-site, in person for consultation and care, and the capability
to perform major pediatric surgery, including the surgical repair
of complex conditions on-site;
(C) have skilled medical staff and personnel with documented
training, competencies, and annual continuing education specific for
the patient population served;
(D) facilitate neonatal transports; and
(E) provide outreach education related to trends identified
through the neonatal QAPI Plan, specific requests, and system needs
to lower-level neonatal designated facilities, and as appropriate
and applicable, to non-designated facilities, birthing centers, independent
midwife practices, and prehospital providers.
(g) Facilities seeking neonatal designation must undergo
an on-site or virtual survey as outlined in this section and:
(1) are responsible for scheduling a neonatal designation
survey through a department-approved survey organization;
(2) must notify the department of the neonatal designation
survey date;
(3) are responsible for expenses associated with the
neonatal designation survey;
(4) must not accept surveyors with any known conflict
of interest; and
(5) must provide the survey team access to records
and documentation regarding the neonatal QAPI Plan and process related
to neonatal patients. The department may determine that failure by
a facility to provide access to these records does not meet the requirements
of this subchapter.
(h) If a known conflict of interest is present for
the facility seeking neonatal designation, the facility must decline
the assigned surveyor through the surveying organization. A conflict
of interest exists when a surveyor has a direct or indirect financial,
personal, or other interest which would limit or could reasonably
be perceived as limiting the surveyor's ability to serve in the best
interest of the public. The conflict of interest may include a surveyor
who personally trained a key member of the facility's leadership in
residency or fellowship, collaborated with a key member of the facility's
leadership team professionally, participated in a designation consultation
with the facility, had a previous working relationship with the facility
or facility leaders, or conducted a designation survey for the facility
within the past four years.
(1) Surveyors cannot be from the same PCR or TSA region
or a contiguous region of the facility's location.
(2) Designation site survey summary and medical record
reviews performed by a surveyor with an identified conflict of interest
may not be accepted by the department.
(i) The department, at its sole discretion, may appoint
an observer to accompany the survey team with the observer costs borne
by the department.
(j) The survey team evaluates the facility's evidence
that department-approved designation requirements are met and documents
all requirements that are not met in the neonatal designation site
survey summary and medical record reviews.
|
