Current through Reg. 49, No. 38; September 20, 2024
(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.
