| (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.
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