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CHA Comments on Revised Proposed Regulations on Adverse Events Reporting

For quality and patient safety staff, licensing & certification staff, legal counsel

The California Department of Public Health (CDPH) released revised proposed regulations on adverse events reporting on March 23 for a 15-day public comment period. On April 6, CHA submitted its comment letter. This reiterates CHA’s previous comments where clarification was still needed, namely:

  • Complying with federal and state laws on the confidentiality of root cause analyses
  • Maintaining consistent reporting time frames for all types of adverse events
  • Specifying that an adverse event has been detected when it is known by the hospital
  • Conforming definitions to national standards, cross referencing them wherever possible
  • Aligning acute psychiatric hospital requirements with those of general acute care hospitals

For context, in this new version of the proposed regulations, CDPH made the following revisions, which CHA had raised in its Aug. 14, 2020, comment letter:

  • Clarifying the definition of “medication error” to exclude medication in the control of the patient or consumer
    • Replacing reference to a nationally recognized survey tool as being one identified by the National Association of Healthcare Quality and corrected with reference to the Agency for Healthcare Research and Quality
  • Specifying date/time and witnesses are to be provided, “if known”
  • Specifying that the corrective or mitigating action to be reported is the “immediate” corrective or mitigating action
  • Adding that if the new web-based portal is not operational, the hospital can report the adverse event to the department via email or phone
  • Revising that the assessment of the hospital’s culture of safety is to be every 24 months instead of every 12 months as originally proposed
  • Specifying that a death associated with the use of restraints refers to physical (as opposed to chemical) restraints

The other requested revisions from CHA they did not make, hence CDPH’s comment letter. These regulations are not yet final, and CHA will keep members apprised once they are finalized by CDPH.