Current through Reg. 49, No. 38; September 20, 2024
(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
(iv)
medical staff, advanced practice providers, and personnel competencies,
education, and training;
(G) participate as a clinically active and
practicing physician in neonatal care at the facility where medical director
services are provided;
(H) ensure
that the neonatal QAPI Plan is specific to neonatal/infant care, is ongoing,
data driven, and outcome based;
(I)
frequently lead the neonatal QAPI meetings with the NPM and participate in the
Neonatal Program Oversight and other neonatal meetings, as
appropriate;
(J) maintain active
staff privileges as defined in the facility's medical staff bylaws;
and
(K) develop and maintain
collaborative relationships with other NMDs of designated neonatal facilities
within the applicable PCR.
(2) The TMD is responsible for the facility
neonatal transport program and must:
(A)
collaborate with the transport team to develop, revise, and implement written
policies, procedures, and guidelines, for neonatal care that are implemented
and monitored for variances;
(B)
participate in ongoing transport staff competencies, education, and
training;
(C) review and evaluate
transports from initial activation of the transport team through delivery of
patient, resources, quality of patient care provided, and patient outcomes;
and
(D) integrate review findings
into the overall neonatal QAPI Plan and process.
(3) The NMD may also serve as the
TMD.
(e) NPM. The
facility must identify an NPM who has the authority and oversight
responsibilities written in his or her job description, for the provision of
neonatal services through all phases of care, including discharge, and
identifying variances in care for inclusion in the neonatal QAPI Plan.
(1) The NPM must be a registered nurse with
defined education, credentials, and experience for neonatal care applicable to
the level of care being provided.
(2) The NPM must maintain a current status of
successful completion of the Neonatal Resuscitation Program (NRP) or a
department-approved equivalent course.
(3) The NPM must:
(A) ensure staff competency in resuscitation
techniques;
(B) participate in
ongoing staff and team-based education and training in the care of the neonatal
patient;
(C) monitor utilization of
telehealth/telemedicine, if used;
(D) collaborate with the NMD, maternal
program, 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
(iv)
staff competencies, education, and training;
(E) regularly and actively participate in
neonatal care at the facility where program manager services are
provided;
(F) consistently review
the neonatal care provided and ensure the neonatal QAPI Plan is specific to
neonatal/infant care, data driven, and outcome-based;
(G) frequently lead the meetings and
participate in Neonatal Program Oversight and other neonatal meetings as
appropriate; and
(H) develop and
maintain collaborative relationships with other NPMs of designated neonatal
facilities within the applicable PCR.