105-160, Reviews by the department; requests for information; required reporting. “D. 2. For all other Level II and Level II serious incidents, the reported information shall also include the consequences or risk of harm that resulted from the serious incident.” – The level of detail being requested of the reporter at the incident reporting period seems excessive. Providers have only 24-hours to gather all required information to submit to the Department. This proposed requirement in encroaching on the territory of the Root Cause Analysis (RCA) and can be more adequately addressed there. The incident report already requires information about outcome, discharge status, disposition, etc. The proposed, required information may not be available and/or the most accurate at the time of incident reporting.

105-520, Risk Management. “C. The provider shall conduct systemic risk assessment ….This process shall incorporate uniform risk triggers and thresholds as defined by the department.” – The proposed revision suggests that the department has offered guidance, instruction and/or training sufficient for providers to implement sufficient Risk Management programs to address the noted expectations. To our knowledge, there has been limited guidance and no substantive training, offered by the Department, on how to develop and maintain such a system. Requirements in the absence of resources and definitive standards would be setting providers up for failure.