12VAC35-15-160 D 2:  “For all other Level II and Level III serious incidents, the reported information shall also include the consequences or risk of harm that resulted from the serious incident.” 

Consequences can be clearly identified because they actually happen.  But “risk of harm” is speculative and open to interpretation.  A recent webinar regarding this regulation as it applies to the CHRIS system gave examples of complete versus incomplete responses to this specific issue.  The concern here is that with more scrutiny of CHRIS reports there will be a greater use of administrative time sending CHRIS reports back and forth for revisions based on who has the stronger speculative imagination.  For example, medical incidents have risks far beyond the grasp of staff members who don't have medical backgrounds.  However, one can assume that death is always a risk in any medical situation.  Is it the expectation that the provider determine all the avenues to that possible conclusion or will that conclusion suffice?

12VAC35-15-160 E: 

Very much agree with language that excludes Level III incidents that do not occur on provider premises or during the provision of services.  Far too many Root Cause Analyses are being completed as the language currently stands (all Level II and Level III incidents).  Even a simple RCA where the contributing factors are beyond the scope of the provider (seizure activity, family crises, etc.) takes administrative time to complete and review.  

However, the phrase:  “A more detailed root cause analysis, including convening a team, collecting and analyzing data, mapping processes, and charting causal factors should be considered based upon the circumstances of the incident” is not regulatory language and should be kept in guidance documents and/or training materials.  By including this suggestion in regulations, the state risks inconsistent interpretations between providers and specialists of when “a more detailed RCA” should be conducted.  It also implies that the current RCA requirement is not ideal.  This language is suggestive of an unfunded mandate as providers (especially small businesses) simply do not have the resources to “convene a team” to complete what DBHDS is implying is an adequate Root Cause Analysis whenever an incident meeting the undefined criteria presents itself. 

12VAC35-105-520 A:  “who has training and expertise in conducting investigations, root cause analysis, and data analysis”

This language is overly restrictive without providing enough information to determine what “training and expertise” really is.  The concern is another opportunity for inconsistency in interpretation.  It also creates an unfunded mandate and undue burden to providers (primarily small providers) to obtain some formal documentation of this undefined “training and expertise.” 

There are a number of options out there for half-day courses in “Conducting Investigations” “Root Cause Analysis” and “Data Analysis” developed and presented by professionals familiar with and/or in the field whose qualification to do so is about as clear as this regulation. 

Essentially, we’ll have more providers paying for their staff to attend training seminars either designed by other providers or any other outside entity that can put together a decent Power Point presentation and print off a certificate.  And even then, there's no clarity as to whether or not this will suffice.