| (1) A designated neonatal facility must provide written
or electronic notification of any significant change to the neonatal
program impacting patient care. The notification must be provided
to the following:
(A) all emergency medical services (EMS) providers
that transfer neonatal patients to or from the designated neonatal
facility;
(B) the hospitals to which it customarily transfers
out or transfers in neonatal patients;
(C) applicable PCRs and RACs; and
(D) the department.
(2) If the designated neonatal facility is unable to
meet the requirements to maintain its current designation, it must
submit to the department a POC as described in subsection (a)(1)(D)
of this section, and a request for a temporary exception to the designation
requirements. Any request for an exception must be submitted in writing
from the facility's Chief Executive Officer and define the facility's
timeline to meet the designation requirements. The department reviews
the request and the POC, and either grants the exception with a specific
timeline based on the public interest, geographic maternal care capabilities,
and access to care, or denies the exception. If the facility is not
granted an exception or it does not meet the designation requirements
at the end of the exception period, the department will elect one
of the following:
(A) re-designate the facility at the level appropriate
to its revised capabilities;
(B) outline an agreement with the facility to satisfy
all designation requirements for the level of care designation within
a time specified under the agreement, which may not exceed the first
anniversary of the effective date of the agreement; or
(C) waive one specific designation requirement for
a level of care designation if the facility meets all other designation
requirements for the level of care designation and the department
determines the waiver is justified considering:
(i) the expected impact on accessibility of neonatal
care in the geographic area served by the facility if the waiver is
not granted and the expected impact on the quality of care and patient
safety; or
(ii) whether these services can be met by other facilities
in the area or with telehealth/telemedicine services.
(3) Waivers expire with the expiration of the current
designation but may be renewed. The department may specify any conditions
for ongoing reporting during this time.
(4) The department maintains a current list on its
internet website of facilities that have contingency agreements or
an approved waiver with the department and an aggregated list of the
designation requirements conditionally met or waived.
(5) Facilities that have contingency agreements or
an approved waiver with the department must post on the facility's
internet website the nature and general terms of the agreement.
(s) An application for a higher or lower level of neonatal
designation may be submitted to the department at any time.
(1) A designated neonatal facility that is increasing
its neonatal capabilities may choose to apply for a higher-level of
designation at any time. The facility must follow the designation
process as described in subsection (a)(1) and (2) of this section
to apply for the higher-level.
(2) A designated neonatal facility that is unable to
maintain the facility's current level of neonatal designation may
choose to apply for a lower level of designation at any time.
(t) If the facility is relinquishing its neonatal designation,
the facility must provide 30 days written, advance notice of the relinquishment
to the department, the applicable PCRs/RACs, EMS providers, and facilities
it customarily transfers out or transfers in neonatal patients. The
facility is responsible for continuing to provide neonatal care services
or ensuring a plan for neonatal care continuity for the 30 days following
the written notice of relinquishing its neonatal designation.
(u) A hospital providing neonatal services must not
use the terms "designated neonatal facility" or similar terminology
in its signs, advertisements, facility internet website, social media,
or in the printed materials and information it provides to the public,
unless the facility is currently designated at that level of neonatal
care.
(v) During a virtual, on-site, or focused designation
review, conducted by the department or survey organization, the department
or surveyor has the right to review and evaluate neonatal patient
records, neonatal multidisciplinary QAPI Plan documents, and any action
specific to improving neonatal care and outcomes, as well as any other
documents relevant to neonatal care in a designated neonatal facility
or facility seeking neonatal designation to validate designation requirements
are met.
(w) The department and survey organization will comply
with all relevant laws related to the confidentiality of records.
(x) The department may deny, suspend, or revoke designation
if a designated neonatal facility ceases to provide services to meet
or maintain the designation requirements of this section.
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