Re: Definition of a Level II Serious Incident

“Please note that residential providers are responsible for individuals 24 hours a day and, therefore, are required to report all incidents once notified”

While your example may be reasonable (a group home provider reporting based on information obtained from the individual’s AR of an incident which occurred while the individual was on a home visit), it is not reasonable nor efficient for the residential provider to report an incident which occur during the provision of service or on the premises of another licensed provider (which by regulation is required to report and conduct the appropriate investigation/quality review)

 While I understand your attempt to capture serious incidents which happen while the individual is with family or independently away from their program, this does not conform to the regulation which clearly states that a “’Level II serious incident’ means a serious incident that occurs or originates during the provision of a service or on the premises of the provider . . .”  You are attempting, by Guidance, to expand the regulatory requirement. We request that you remove the language and the explanatory example above.

 Re: Unplanned medical hospitalization

“If an individual is taken to the hospital after a qualifying event in the accordance with their medical protocol, and is not admitted following evaluation, then the provider does not have to report the incident. If it is determined that the individual should be admitted, then the incident shall be reported.”

 It may be a factor of ER capacity and not patient need that dictates if an individual is “admitted for observation.”  We request that you change the language  to include the following:

“If it is determined that the individual should be admitted for treatment, then the incident shall be reported.”

 Re: Ingestion of any hazardous material

Your example is so broad as to make this unmanageable, esp if the provider supports any individual with PICA behavior.  Replace the example with a suggestion that “if, following consultation with Poison Control or EMS, emergency medical care is sought, the incident shall be reported.”

 Re: Any death of an individual

The guidance does not address the previously identified issue of duplicative reporting.  We would suggest that once the Licensing Specialist receives the initial report in the CHRIS system, they identify the CM and notify other providers that a report has already been made.

Re: Root Cause Analysis

The definition of Root Cause Analysis (RCA) is clear and does not include a specific method or approach; while a “team approach” may be a good system to use, the regulatory requirement that the RCA be conducted within 30 days places constraints on the options providers may have.

The paragraph beginning “The best way . . . “ ends with a reference to a “requirement” which does not appear in the regulation and, thereby, you are attempting, by Guidance, to expand the regulatory requirement. We request that you remove the entire paragraph.