NEW – National Health and Safety Standards

Federal Register / Vol. 89, No. 229 / Wednesday, November 27, 2024

CMS has finalized new national health and safety standards, known as conditions of participation (CoPs), for hospitals and Critical Access Hospitals (CAHs) related to obstetrical services in an effort to address improvements needed in maternal health outcomes.

These CoPs include new requirements for maternal quality assessment and performance improvement (QAPI), baseline standards for the organization, staffing, delivery of OB care, staff training on evidence-based maternal health practices and emergency readiness related to pregnant, birthing, and postpartum women. These final requirements ensure that all Medicare and Medicaid participating hospitals and CAHs offering emergency services are held to a consistent standard of high-quality maternity care that protects the health and safety of this population of patients.

CMS is also finalizing revisions to the Discharge Planning CoP for hospitals related to transfer protocols. CMS has developed a phased implementation approach for the new requirements and revisions.

Regulatory Section(s)

  • Emergency Services Readiness for Hospitals (§482.55) and CAHs (§ 485.618) Transfer Protocols for Hospitals (§482.43)
  • Organization, Staffing, and Delivery of Services for Hospitals ((§482.59(a) and (b)) and CAHs
    §482.59(a) and (b))
  • Training for OB Staff in Hospitals (§482.59(c)) and CAHs (§485.649(c)) QAPI Program for OB Services in Hospitals (§482.21) and CAHs (§482.641)

Implementation Date

  • 6 months following the effective date of the final rule
  • 1 year following the effective date of the final rule
  • 2 years following the effective date of the final rule

1st Phase

Emergency Services’ Readiness

CMS has finalized a revised Emergency Services’ CoP to improve facility readiness in caring for emergency services’ patients, including pregnant, birthing, and postpartum women. These new requirements apply to all hospitals and CAHs offering emergency services, regardless of whether they provide specialty services, such as OB services. CMS will require that hospitals and CAHs with emergency services have adequate provisions such as equipment, supplies, medications, and protocols to meet the emergency needs of patients. Hospitals and CAHs must have protocols consistent with nationally recognized and evidence-based guidelines for the care of patients with emergency conditions and ensure applicable staff are trained on these protocols and provisions annually. It is also required to have documentation to support the fact that staff have successfully completed training and can demonstrate knowledge on these protocols and provisions.

CMS has also finalized, for hospitals only, a requirement that facilities set aside above-mentioned emergency provisions. Although CMS does not require specific items, the available provisions must include:

  • Drugs, blood and blood products, and biologicals commonly used in lifesaving procedures.
  • Equipment and supplies commonly used in lifesaving procedures.
  • Call-in system for each patient in each emergency services’ treatment area.

Given the CAH CoPs already contained similar existing provisions, no new emergency services equipment, supplies, or medications were added to the CAH CoPs.

What does this mean for our facilities?

Within the next six months focus on Emergency Services Readiness by convening an ED/OB team (including an executive sponsor) responsible for:

  • Evaluating existing supplies, equipment and medications related to emergent OB services
    • With sponsor assistance, order or requisition supplies, equipment, medications needed to support emergency services readiness
  • Reviewing existing protocols currently in use for OB services presenting to the Emergency Department
    • If no protocols are in place, research, evaluate, develop, and implement nationally recognized evidence-based emergency OB protocols
  • Develop staff education regarding the use of any new supplies, equipment, medications, and protocols added in response to Emergency Services Readiness

Transfer Protocols

CMS has finalized the requirement for a hospital to have written policies and procedures for transferring patients under its care, which will include intra-hospital transfers of hospital inpatients (for example, transfers from the emergency room to inpatient admissions, transfers between inpatient units in the same hospital, and transfers between inpatient units at different hospitals), to the appropriate level of care as needed to meet the patient’s needs.

Acute care hospitals must provide annual training to the relevant staff regarding the hospital policies and procedures for transferring patients under their care. This does not apply to CAHs.

What does this mean for our facilities?

Acute Care Hospitals- Within the next six months focus on Transfer Protocols by convening a care coordination team responsible for:

  • Evaluating written policies and procedures for transferring patients, including intra-hospital transfers of hospital patients and transfers between inpatient units at different hospitals, to the appropriate level of care as needed to meet the patient’s needs.
    • If no policies or procedures are in place regarding transfer protocols, research, evaluate, develop, and implement nationally recognized evidence-based transfer protocols.
  • Develop staff education regarding the hospital policies and procedures for transferring patients and add annual training for the relevant staff.