| (a) Designated facilities shall have a family centered
philosophy. Parents shall 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 shall meet the
physiologic and psychosocial needs of the mothers, infants, and families.
(b) Program Plan. The facility shall develop a written
plan of the neonatal program that includes a detailed description
of the scope of services available to all maternal and neonatal patients,
defines the neonatal patient population evaluated and/or treated,
transferred, or transported by the facility, that is consistent with
accepted professional standards of practice for neonatal and maternal
care, and ensures the health and safety of patients.
(1) The written plan and the program policies and procedures
shall be reviewed and approved by the facility's governing body. The
governing body shall ensure that the requirements of this section
are implemented and enforced.
(2) The written neonatal program plan shall include,
at a minimum:
(A) standards of neonatal practice that the program
policies and procedures are based upon that are adopted, implemented
and enforced for the neonatal services it provides;
(B) a periodic review and revision schedule for all
neonatal care policies and procedures;
(C) written triage, stabilization and transfer guidelines
for neonates and/or pregnant/postpartum women that include consultation
and transport services;
(D) ensure appropriate follow up for all neonates/infants;
(E) provisions for disaster response to include evacuation
of mothers and infants to appropriate levels of care;
(F) a QAPI Program as described in §133.41(r)
of this title (relating to Hospital Functions and Services). The facility
shall demonstrate that the neonatal program evaluates the provision
of neonatal care on an ongoing basis, identify opportunities for improvement,
develop and implement improvement plans, and evaluate the implementation
until a resolution is achieved. The neonatal program shall measure,
analyze, and track quality indicators or other aspects of performance
that the facility adopts or develops that reflect processes of care
and is outcome based. Evidence shall support that aggregate patient
data is continuously reviewed for trends and data is submitted to
the department as requested;
(G) requirements for minimal credentials for all staff
participating in the care of neonatal patients;
(H) provisions for providing continuing staff education;
including annual competency and skills assessment that is appropriate
for the patient population served;
(I) a perinatal staff registered nurse as a representative
on the nurse staffing committee under §133.41(o)(2)(F) of this
title;
(J) the availability of all necessary equipment and
services to provide the appropriate level of care and support of the
patient population served; and
(K) the availability of personnel with knowledge and
skills in breastfeeding.
(c) Medical Staff. The facility shall have an organized,
effective neonatal program that is recognized by the medical staff
and approved by the facility's governing body. The credentialing of
the medical staff shall include a process for the delineation of privileges
for neonatal care.
(d) Medical Director. There shall be an identified
Neonatal Medical Director (NMD) and/or Transport Medical Director
(TMD) as appropriate, responsible for the provision of neonatal care
services and credentialed by the facility for the treatment of neonatal
patients.
(1) The NMD and/or TMD shall have the authority and
responsibility to monitor neonatal patient care from admission, stabilization,
operative intervention(s) if applicable, through discharge, inclusive
of the QAPI Program.
(2) The responsibilities and authority of the NMD and/or
TMD shall include but are not limited to:
(A) examining qualifications of medical staff requesting
neonatal privileges and makes recommendations to the appropriate committee
for such privileges;
(B) assuring staff competency in resuscitation techniques;
(C) participating in ongoing staff education and training
in the care of the neonatal patient;
(D) oversight of the inter-facility neonatal transport;
(E) participating in the development, review and assurance
of the implementation of the policies, procedures and guidelines of
neonatal care in the facility including written criteria for transfer,
consultation or higher level of care;
(F) regular and active participation in neonatal care
at the facility where medical director services are provided;
(G) ensuring that the QAPI Program is specific to neonatal/infant
care, is ongoing, data driven and outcome based; and regularly participates
in the neonatal QAPI meeting; and
(H) maintaining active staff privileges as defined
in the facility's medical staff bylaws.
(e) Neonatal Program Manager (NPM). The NPM responsible
for the provision of neonatal care services shall be identified by
the facility and:
(1) be a registered nurse:
(2) have successfully completed and is current in the
Neonatal Resuscitation Program (NRP) or an office-approved equivalent:
(3) have the authority and responsibility to monitor
the provision of neonatal patient care services from admission, stabilization,
operative intervention(s) if applicable, through discharge, inclusive
of the QAPI Program as defined in subsection (b)(2)(E) of this section.
(4) collaborate with the NMD in areas to include, but
not limited to: developing and/or revising policies, procedures and
guidelines; assuring staff competency, education, and training; the
QAPI Program; and regularly participates in the neonatal QAPI meeting;
and
(5) develop collaborative relationships with other
NPM(s) of designated facilities within the applicable Perinatal Care
Region.
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