FINALIZED – New National Health and Safety Standards

1^st Phase

Was Emergency Services Readiness for Hospitalist and CAHs, and Transfer Protocols for Hospitals with implementation being within 6 months following the effective date of the final rule. Read more about the 1^st phase and what this means for your facility in our prior newsletter.

2^nd Phase

Organization, Staffing, and Delivery of Services

CMS finalized the requirement that if a hospital or CAH offers obstetrical services, the services must be well organized and provided in accordance with nationally recognized acceptable standards of practice for physical and behavioral health care of pregnant, birthing, and postpartum patients (inclusive of both mental health and substance use disorders). It is further noted that if outpatient obstetrical services are offered, the services must be consistent in quality with inpatient care in accordance with the complexity of services offered. CMS noted that nationally recognized acceptable standards of practice may be based on medical professional society and/or accrediting organization standards and that, while these CoPs would not require adherence to a specific organization’s guideline or recommendations, CMS would expect that facilities be able to articulate their standards and the source(s) and demonstrate that their standards are based on evidence and nationally recognized sources. This overarching requirement for obstetric services is consistent with other hospital and CAH CoPs and is foundational to ensuring high-quality safe care.

CMS requires the organization of the obstetrical services be appropriate to the scope of services offered by the facility and integrated with other departments of the facility. It is further required that the OB patient care units (that is, labor rooms, delivery rooms, including rooms for operative delivery, and post-partum/recovery rooms whether combined or separate) be supervised by an individual with the necessary education and training, and CMS specified that the person be an experienced registered nurse, certified nurse midwife, nurse practitioner, physician assistant, or a doctor of medicine or osteopathy.

CMS finalized a reference to hospital medical staff bylaws and the requirements for agreements for credentialing and quality assurance for CAHs as it pertains to ensuring that practitioners have the necessary education, training, and experience to provide safe, effective obstetrical care and appropriately perform specific procedures.

CMS finalized ‘‘Delivery of services” requiring that OB services must be consistent with the needs and resources of the facility and that policies governing obstetrical care be designed to assure the achievement and maintenance of high standards of medical practice and patient care and safety. Additionally, certain basic equipment, including a call-in-system (call-bell), cardiac monitor, and fetal doppler or monitor must be kept at the hospital and be readily available for treating obstetrical cases to meet the needs of the patients.

Without modification, CMS finalized the requirement that the OB service ensure that it has protocols, consistent with evidence-based, nationally recognized guidelines, that equipment and personnel be ‘‘readily available’’ (that is, necessary supplies and equipment are on the unit or are in close proximity and easily accessed by unit personnel) for obstetrical emergencies, complications, immediate post-delivery care, and other patient health and safety events as identified as part of the facility’s QAPI program. While this requirement does not require any specific items, CMS would expect provisions to include equipment, supplies, blood, and medication used in treating emergency cases in addition to the equipment required under the delivery of services above.

What Does This Mean For Our Facilities?

Within the next year, hospitals and CAHs with Inpatient and/or Outpatient OB services should-

• Evaluate the obstetrical services standards of practice to ensure they include
  • physical and behavioral healthcare needs of the obstetrical patient (mental health and substance use disorder)
  • nationally recognized standards including evidence-based protocols that can be articulated and demonstrated
• Ensure integration of obstetrical services with other departments as appropriate
• Document education and training of obstetrical services supervisory personnel
• Develop and maintain a process for ensuring “readily available” equipment and supplies as described within the standard

3^rd Phase

Training for Obstetrical Staff

CMS finalized expectations that hospitals and CAHs with OB services would be required to develop policies and procedures that would ensure that relevant staff would be trained on select topics that reflect the scope and complexity of services offered, including but not limited to facility identified evidence-based best practices and protocols to improve the delivery of maternal care within the facility. Additions, revisions, or updates to topics should be informed by the hospital and CAH’s QAPI program findings. CMS also requires the governing body to identify and document which staff must complete initial training and subsequent biannual training. The hospital and CAH must document in the staff personnel records that the training was successfully completed. Further, CMS expects that the hospital and CAH be able to demonstrate staff knowledge on the topics identified.

Quality Assessment and Performance Improvement (QAPI)

CMS finalized revisions to the existing QAPI standards for hospitals and CAHs. These revisions include the requirement that hospitals and CAHs use their QAPI programs to assess and improve health outcomes and disparities among OB patients on an ongoing basis.

CMS added a new standard for Maternal Health QAPI activities for hospitals and CAHs that offer OB services. This standard states that leadership must be engaged in the facility’s QAPI activities. It further states that for this provision, leadership is defined as facility leadership, obstetrical services leadership, or their designate(s).

Additionally, CMS finalized that if a Maternal Mortality Review Committee (MMRC) is available at state or local jurisdiction in which the facility is located, hospitals and CAHs that offer OB services must have a process for incorporating MMRC data and recommendations into the facility’s QAPI program.

What Does This Mean For Our Facilities?

Within two (2) years, hospitals and CAHs with Inpatient and/or Outpatient OB services should-

• Develop policies and procedures to ensure relevant staff are trained on the select topics that reflect the scope and complexity of the services offered
  • The governing body should identify and document which staff should complete initial training and subsequent biannual training
  • Document and demonstrate training of staff
  • Topics should also be informed by QAPI program findings
• Evaluate and update QAPI programs to ensure at a minimum the facility must:

(1) analyze data and quality indicators collected for the QAPI program by diverse subpopulations as identified by the facility among OB patients;

(2) measure, analyze and track data, measures, and quality indicators on patient outcomes and disparities in processes of care, services and operations, and outcomes among OB patients;

(3) analyze and prioritize patient health outcomes and disparities, develop, and implement actions to improve patient health outcomes and disparities, measure results, and track performance to ensure improvements are sustained when disparities exist among OB patients; and

(4) conduct at least one performance improvement project focused on improving health outcomes and disparities among the hospital’s population(s) of OB patients annually.

• Ensure leadership engagement in Maternal Health QAPI activities
• Incorporate Maternal Mortality Review Committee (MMRC) data and recommendations within the QAPI if MMRC is available.