Current through Reg. 49, No. 38; September 20, 2024
(a) Maternal
Program Philosophy. Designated facilities must have a family centered
philosophy. The facility environment for perinatal care must meet the
physiologic and psychosocial needs of the mothers, infants, and families.
Parents must have reasonable access to their infants at all times and be
encouraged to participate in the care of their infants.
(b) Maternal Program Plan. The facility must
develop a written maternal operational plan for the maternal program that
includes a detailed description of the scope of services and clinical resources
available for all maternal patients and families. The plan will define the
maternal patient population evaluated, treated, transferred, or transported by
the facility consistent with clinical guidelines based on current standards of
maternal practice ensuring the health and safety of patients.
(1) The written Maternal Program Plan must be
reviewed and approved by Maternal Program Oversight and be submitted to the
facility's governing body for review and approval. The governing body must
ensure that the requirements of this section are implemented and
enforced.
(2) The written Maternal
Program Plan must include, at a minimum:
(A)
clinical guidelines based on current standards of maternal practice, and
policies and procedures that are adopted, implemented, and enforced by the
maternal program;
(B) a process to
ensure and validate that these clinical guidelines based on current standards
of maternal practice, policies, and procedures are reviewed and revised a
minimum of every three years;
(C)
written triage, stabilization, and transfer guidelines for pregnant and
postpartum patients that include consultation and transport services;
(D) written guidelines or protocols for
prevention, early identification, early diagnosis, and therapy for conditions
that place the pregnant or postpartum patient at risk for morbidity or
mortality;
(E) 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 inpatient consultation, including appropriate situations,
scope of care, and documentation that is monitored through the 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
compliance;
(F) written
guidelines for discharge planning instructions and appropriate follow up
appointments for all mothers and infants;
(G) written guidelines for the hospital
disaster response, including a defined mother and infant 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
maternal care can be sustained and adequate resources are available;
(H) requirements for minimal credentials for
all staff participating in the care of maternal patients;
(I) provisions for providing continuing staff
education, including annual competency and skills assessment that is
appropriate for the patient population served;
(J) a perinatal staff registered nurse as a
representative on the nurse staffing committee under §
133.41 of this title (relating to
Hospital Functions and Services); and
(K) the availability of all necessary
equipment and services to provide the appropriate level of care and support of
the patient population served.
(3) The facility must have a documented QAPI
Plan. The maternal program must measure, analyze, and track quality indicators
and other aspects of performance that the facility adopts or develops that
reflect processes of care and is outcome based.
(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 maternal QAPI Plan.
(B) The facility must demonstrate that the
maternal QAPI Plan consistently assesses the provision of maternal care
provided. The assessment will identify variances in care, the impact to the
patient, and the appropriate levels of review. This process will 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) Maternal facilities must review their
incidence and management of placenta accreta spectrum disorder through the QAPI
Plan and report the incidence and outcomes through the Maternal Program
Oversight.
(D) The Maternal Medical
Director (MMD) must have the authority to make referrals for peer review,
receive feedback from the peer review process, and ensure maternal physician
representation in the peer review process for maternal cases.
(E) The MMD and the Maternal Program Manager
(MPM) must participate in the PCR meetings, QAPI regional initiatives, and
regional collaboratives, and submit requested data to assist with data analysis
to evaluate regional outcomes as an element of their maternal QAPI
Plan.
(F) The facility must have
documented evidence of maternal QAPI summary reports reviewed and reported by
Maternal Program Oversight that monitor and ensure the provision of services or
procedures through the telehealth and telemedicine, if utilized, is in
accordance with the standard of care applicable to the provision of the same
service or procedure in an in-person setting.
(G) The facility must have documented
evidence of maternal QAPI summary reports to support that aggregate maternal
data are consistently reviewed to identify developing trends, opportunities for
improvement, and necessary corrective actions. Summary reports must be provided
through Maternal Program Oversight, available for site surveyors, and submitted
to the department as requested.
(c) Medical Staff. The facility must have an
organized maternal program that is recognized by the facility's medical staff
and approved by the facility's governing body.
(1) The credentialing of the maternal medical
staff must include a process for the delineation of privileges for maternal
care.
(2) The maternal medical
staff must participate in ongoing staff and team-based education and training
in the care of the maternal patient.
(d) Medical Director. There must be an
identified MMD and an identified Transport Medical Director (TMD) if the
facility has its own transport program. The MMD and TMD must be credentialed by
the facility for treatment of maternal patients and have their responsibilities
and authority defined in a job description. The MMD is responsible for the
provision of maternal care services and:
(1)
examining qualifications of medical staff requesting maternal privileges and
making recommendations to the appropriate committee for such
privileges;
(2) assuring maternal
medical staff competency in managing obstetrical emergencies, complications and
resuscitation techniques;
(3)
monitoring maternal patient care from transport if applicable, to admission,
stabilization, operative intervention(s) if applicable, through discharge, and
inclusive of the QAPI Plan;
(4)
participating in ongoing maternal staff and team-based education and training
in the care of the maternal patient;
(5) overseeing the inter-facility maternal
transport;
(6) collaborating with
the MPM in areas to include developing or revising policies, procedures and
guidelines, assuring medical staff and personnel competency, education and
training; and the QAPI Plan;
(7)
frequently leading the maternal QAPI meetings with the MPM and participating in
Maternal Program Oversight and other maternal meetings as
appropriate;
(8) ensuring that the
QAPI Plan is specific to maternal and fetal care, is ongoing, data-driven and
outcome-based;
(9) participating as
a clinically active and practicing physician in maternal care at the facility
where medical director services are provided;
(10) maintaining active staff privileges as
defined in the facility's medical staff bylaws; and
(11) developing collaborative relationships
with other MMD(s) of designated facilities within the applicable Perinatal Care
Region.
(e) MPM. The
facility must identify a MPM who has the authority and oversight
responsibilities written in his or her job description for the provision of
maternal services through all phases of care, including discharge and
identifying variances in care for inclusion in the QAPI Plan and:
(1) be a registered nurse with perinatal
experience;
(2) be a clinically
active and practicing registered nurse participating in maternal care at the
facility where program manager services are provided;
(3) has the authority and responsibility to
monitor the provision of maternal patient care services from admission,
stabilization, operative intervention(s) if applicable, through discharge, and
inclusive of the QAPI Plan;
(4)
collaborates with the MMD in areas to include developing or revising policies,
procedures and guidelines; assuring staff competency, education, and training
and the QAPI Plan;
(5) frequently
leads the maternal QAPI meetings and participates in Maternal Program Oversight
and other maternal meetings as appropriate;
(6) ensures that the QAPI Plan is specific to
maternal and fetal care, is ongoing, data-driven and outcome based, including
telehealth/telemedicine utilization, when used; and
(7) develops collaborative relationships with
other MPM(s) of designated facilities within the applicable Perinatal Care
Region.