The California Department of Public Health (CDPH) has finalized regulations on adverse event reporting for general acute care hospitals (GACHs) and acute psychiatric hospitals, effective Jan. 1, 2022.
Hospitals have been required to report adverse events since 2009, when the adverse events reporting statute went into effect. These regulations are based on Health and Safety Code Sections 1279.1, 1279.2, and 1279.6 and they create additional requirements beyond those statutes for hospitals when it comes to reporting adverse events. Beginning Jan. 1, hospitals must meet the following requirements. Note that the regulation citations below, while for GACHs, have identical requirements for acute psychiatric hospitals in the regulations.
- Report Based on Detection Defined as First Business Day Known or Should Have Been Known: Continue to report adverse events upon detection within 24 hours of an ongoing urgent or emergent threat or five days for all other adverse events. However, detection is newly defined as occurring on the first business day on which such adverse event is known to the hospital, or by exercising reasonable diligence that would have been known to the hospital (Section 70971(a)(7)).
- Consider Serious Disability Triggered by List of Major Life Activities: Begin reporting adverse events that result in serious disability of a patient, personnel, or visitor utilizing the new definition of major life activity in the regulations (Section 70971(a)(11)). By defining major life activity, this regulation requires that reporting is required if there is a physical or mental impairment that substantially limits any of the following:
- Caring for oneself, performing manual tasks, seeing, hearing, eating, sleeping, walking, standing, lifting, bending, speaking, breathing, learning, reading, concentrating, thinking, communicating, and working
- A major bodily function, including functions of the immune system, normal cell growth, digestive, bowel, bladder, neurological, brain, respiratory, circulatory, endocrine, and reproductive functions
- Report Detection or Allegation of Sexual Assault Within 24 Hours: Report the detection or allegation of sexual assault within 24 hours (Section 70972(a)(2)). To date, hospitals have been required to report an adverse event that is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors within 24 hours. CDPH has included in the regulations that when sexual assault is detected or alleged, it is required to be reported within that same time period of 24 hours.
- Submit via CalHEART: Submit reports of adverse events through the department’s secure website (Section 70972(a)). CDPH will require hospitals to use the California Healthcare Event and Reporting Tool (CalHEART). This has been available since 2013, but not utilized by all CDPH district offices to date. Beginning Jan. 1, all hospitals will need to submit adverse events through this portal. If your hospital does not have an account, you can contact email@example.com to request to set one up.
- Assess Culture of Safety Every Two Years: These regulations create a new requirement for hospitals to assess their culture of safety at least every 24 months using a nationally recognized survey tool (Section 70974(a)(4)). This is then further defined as a valid and reliable survey tool identified by the Agency for Healthcare Research and Quality or another survey tool that raises awareness of patient safety, assesses status of culture of safety, evaluates impact of patient safety interventions, and identifies strengths and areas for culture of safety improvement (Section 70971(a)(13)).
- Reportable Medication Errors Do Not Include When Medication in Control of Patient or Consumer: Initially, the regulation proposed to define medication error to include an incident while the medication was in control of the patient or consumer. This was due to CDPH initially adopting the National Quality Forum’s (NQF’s) definition of medication error. However, CHA pointed out that state statute on adverse events is more focused and appropriate for hospital inpatient settings. The authorizing statute provides several examples of medication errors, none of which (unlike the proposed regulation) included instances where the patient or consumer is in control of the drug. CDPH’s final regulation adopted CHA’s requested revision and only requires reporting of a medication error that occurs while the medication is in the control of the health care professional.
- Reportable Events Associated with Restraints Do Not Include Chemical Restraints: Initially, the regulations proposed to require reporting of a patient death or serious disability associated with the use of restraints without defining restraints. Restraints could have been interpreted by CDPH surveyors as physical or chemical (e.g., pharmaceutical) restraints. CHA recommended that as NQF clarified in its 2011 update, noting the difficulty in defining chemical restraints, CDPH specify that restraints are physical restraints, as opposed to chemical restraints. CDPH added “physical” before “restraints” to specify that only events related to physical restraints must be reported.
- Email, Telephone Option if Online Site to Submit Reports is Down: This regulation requires electronic reporting as the sole method of submission. CHA noted that given the 24-hour reporting requirements for some adverse events, a system outage could render the hospital unable to submit the required information to CDPH. CDPH incorporated CHA’s feedback and added language that if the secure internet website is not operational, hospitals can instead report adverse events to CDPH by email or telephone.
- Flexibility on Frequency, Use of Terms in Culture of Safety Assessment: The regulation initially proposed an annual assessment of the hospital’s culture of safety. CHA noted it was not clear on what basis CDPH recommends that this occur annually and that the national standard from The Joint Commission is that leaders regularly evaluate the culture of safety. The final regulation requires the assessment to take place at least every 24 months. In addition, a prior version of the regulation would have used the term “patient safety culture.” CHA recommended it be restored to “culture of safety,” which is well understood in the health care field, which CDPH then adopted in the final regulation.
CDPH also released a summary of the adverse events reporting requirements. Note that this includes both new requirements from the regulations and existing statutory requirements restated in the regulations, so hospitals may want to review the above summary from CHA to determine what is new. This CDPH summary was contained in All Facilities Letter 21-40 released Nov. 12.