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RULE §133.205Program Requirements

(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;


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