| (a) Neonatal Program Philosophy. Designated facilities
must have a family-centered philosophy. Parents must have reasonable
access to their infants at all times and be encouraged to participate
in the care of their infants. The facility environment for perinatal
care must meet the physiologic and psychosocial needs of the mothers,
infants, and families.
(b) Neonatal Program Plan. The facility must develop
a written neonatal operational plan for the neonatal program that
includes a detailed description of the scope of services and clinical
resources available for all neonatal patients, mothers, and families.
The plan must define the neonatal patient population evaluated, treated,
transferred, or transported by the facility consistent with clinical
guidelines based on current standards of neonatal practice ensuring
the health and safety of patients.
(1) The written Neonatal Program Plan must be reviewed
and approved by Neonatal Program Oversight and be submitted to the
facility's governing body for review and approval. The governing body
must ensure the requirements of this section are implemented and enforced.
(2) The written Neonatal Program Plan must include,
at a minimum:
(A) clinical guidelines based on current standards
of neonatal practice, and policies and procedures that are adopted,
implemented, and enforced by the neonatal program;
(B) a process to ensure and validate these clinical
guidelines based on current standards of neonatal practice, policies,
and procedures, are reviewed and revised a minimum of every three
years;
(C) written triage, stabilization, and transfer guidelines
for neonatal patients that include consultation and transport services;
(D) the role and scope of telehealth/telemedicine practices,
if utilized, including:
(i) documented and approved written policies and procedures
that outline the use of telehealth/telemedicine for inpatient hospital
care or for consultation, including appropriate situations, scope
of care, and documentation that is monitored through the neonatal
QAPI Plan and process; and
(ii) written and approved procedures to gain informed
consent from the patient or designee for the use of telehealth/telemedicine,
if utilized, that are monitored for variances;
(E) written guidelines for discharge planning instructions
and appropriate follow-up appointments for all neonates/infants;
(F) written guidelines for the hospital disaster response,
including a defined neonatal evacuation plan and process to relocate
mothers and infants to appropriate levels of care with identified
resources, and this process must be evaluated annually to ensure neonatal
care can be sustained and adequate resources are available;
(G) written minimal education and credentialing requirements
for all staff participating in the care of neonatal patients, which
are documented and monitored by the managers who have oversight of
staff;
(H) written requirements for providing continuing staff
education, including annual competencies and skills assessment that
is appropriate for the patient population served, which are documented
and monitored by the managers who have oversight of staff;
(I) documentation of meeting the requirement for a
perinatal staff registered nurse to serve as a representative on the
nurse staffing committee under §133.41 of this title (relating
to Hospital Functions and Services);
(J) measures to monitor the availability of all necessary
equipment and services required to provide the appropriate level of
care and support for the patient population served; and
(K) documented guidelines for consulting support personnel
with knowledge and skills in breastfeeding and lactation, which includes
expected response times, defined roles, responsibilities, and expectations.
(3) The facility must have a documented and approved
neonatal QAPI Plan.
(A) The Chief Executive Officer, Chief Medical Officer,
and Chief Nursing Officer must implement a culture of safety for the
facility and ensure adequate resources are allocated to support a
concurrent, data-driven neonatal QAPI Plan.
(B) The facility must demonstrate that the neonatal
QAPI Plan consistently assesses the provision of neonatal care provided.
The assessment must identify variances in care, the impact to the
patient, and the appropriate levels of review. This process must identify
opportunities for improvement and develop a plan of correction to
address the variances in care or the system response. An action plan
will track and analyze data through resolution or correction of the
identified variance.
(C) The neonatal program must measure, analyze, and
track performance through defined quality indicators, core performance
measures, and other aspects of performance that the facility adopts
or develops to evaluate processes of care and patient outcomes. Summary
reports of these findings are reported through the Neonatal Program
Oversight.
(D) All neonatal facilities must participate in a neonatal
data initiative. Level III and IV neonatal facilities must participate
in benchmarking programs to assess their outcomes as an element of
the neonatal QAPI Plan.
(E) The Neonatal Medical Director (NMD) must have the
authority to make referrals for peer review, receive feedback from
the peer review process, and ensure neonatal physician representation
in the peer review process for neonatal cases.
(F) The NMD and Neonatal Program Manager (NPM) must
participate in PCR meetings, regional QAPI initiatives, and regional
collaboratives, and submit requested data to assist with data analysis
to evaluate regional outcomes as an element of the facility's neonatal
QAPI Plan.
(G) The facility must have documented evidence of neonatal
QAPI summary reports reviewed and reported by Neonatal Program Oversight
that monitor and ensure the provision of services or procedures through
telehealth and telemedicine, if utilized, is in accordance with the
standards of care applicable to the provision of the same service
or procedure in an in-person setting.
(H) The facility must have documented evidence of neonatal
QAPI summary reports to support that aggregate neonatal data are consistently
reviewed to identify developing trends, opportunities for improvement,
and necessary corrective actions. Summary reports must be provided
through the Neonatal Program Oversight, available for site surveyors,
and submitted to the department as requested.
(c) Medical Staff. The facility must have an organized,
effective neonatal program that is recognized by the facility's medical
staff and approved by the facility's governing body.
(1) The credentialing of the neonatal medical staff
must include a process for the delineation of privileges for neonatal
care.
(2) The neonatal medical staff must participate in
ongoing staff and team-based education and training in the care of
the neonatal patient.
(d) Medical Director. There must be an identified NMD
and an identified Transport Medical Director (TMD) if the facility
has its own transport program. The NMD and TMD must be credentialed
by the facility for treatment of neonatal patients and have their
responsibilities and authority defined in a job description. The NMD
and TMD must maintain a current status of successful completion of
the Neonatal Resuscitation Program (NRP) or a department-approved
equivalent course.
(1) The NMD is responsible for the provision of neonatal
care services and must:
(A) examine qualifications of medical staff and advanced
practice providers requesting privileges to participate in neonatal/infant
care, and make recommendations to the appropriate committee for such
privileges;
(B) ensure neonatal medical staff and advanced practice
provider competencies in managing neonatal emergencies, complications,
and resuscitation techniques;
(C) monitor neonatal patient care from transport, to
admission, stabilization, and operative intervention(s), as applicable,
through discharge, and review variances in care through the neonatal
QAPI Plan;
(D) participate in ongoing neonatal staff and team-based
education and training in the care of the neonatal patient;
(E) oversee the inter-facility neonatal transport as
appropriate;
(F) collaborate with the NPM, maternal teams, consulting
physicians, and nursing leaders and units providing neonatal care
to include developing, implementing, or revising:
(i) written policies, procedures, and guidelines for
neonatal care that are implemented and monitored for variances;
(ii) the neonatal QAPI Plan, specific reviews, and
data initiatives;
(iii) criteria for transfer, consultation, or higher-level
of care; and
Cont'd... |
