The Regulatory Perspective Root Cause Analysis: Understanding The Regulatory Perspective Kris Lohrke Office of Health Facility Complaints

What is an investigation? To observe or study by close examination and systematic inquiry To make a systematic examination To conduct an official inquiry

Why do we investigate? To determine the cause of the incident To prevent re-occurrence of the incident Improve resident safety and care To identify breaks in the system To identify training needs Identify if more supervision is needed

Why do we investigate? State and federal law require that all incidents are investigated. Vulnerable Adults Act, MN. Statute 626.557 subdivision 9b Response to Reports states: Each lead agency shall complete the investigative process for reports within its jurisdiction. Federal law CFR 483.13(c) (3) The facility must have evidence that all alleged violations are thoroughly investigated, and must prevent further potential abuse while the investigation is in progress. OHFC must review each complaint and facility reported incident to make a determination as to what investigative process will be employed to resolve the allegation

OHFC Background Created in mid 70s under MN Statute 144A.52 A program within the MN Department of Health’s Division of Compliance Monitoring. Responsible for investigating complaint and facility reported incidents of maltreatment in licensed care entities in Minnesota. OHFC receives this information from two different sources: Complaints from the public Incident reports from facilities.

Volume of OHFC Investigations 2007 892 complaints 2769 facility reports 3661 Total Of this total, OHFC completed 397 onsite investigations at nursing homes during 2007 (approximately 11%).

Volume of OHFC Investigations April 2008: enforcement of federal regulation for nursing home reports changed. 4/14/07 – 9/21/07: 1300 incident reports from Nursing Homes. 4/14/08 – 9/21/08: 4152 incident reports from Nursing Homes.

Volume of OHFC Investigations Each complaint or facility reported incident might contain more than one allegation, each of which must be reviewed for investigative purposes. Example: an allegation that a resident was neglected might also indicate that inadequate staffing was a concern. Both of these issues would have to be reviewed to determine how to investigate.

OHFC Process Intake: Each complaint and report must be reviewed to determine which investigative option should be used Facilities must submit a summary of their internal investigation to OHFC. This internal investigation can be a very important factor when deciding if there will be a site investigation. CFR 483.13(c) (4) The results of all investigations must be reported to the administrator or his designated representative and to other officials in accordance with State law (including to the State survey and certification agency) within 5 working days of the incident, and if the alleged violation is verified appropriate corrective action must be taken.

OHFC Process Triage: Not all reports can be investigated. All necessary information must be submitted Information reviewed to determine extent of investigation Facility’s internal investigation is a key factor Is onsite investigation needed? Not all reports can be investigated. Information OHFC receives is crucial for triage. There have been times when a thorough facility report has prevented a site investigation.

What is a thorough investigation? carried through to completion marked by full detail, careful about detail complete in all respects

OHFC Process Assessing the internal investigation: Is the incident clearly described? Can we understand what is reported? Is the resident or other residents still at risk? Were there interviews with the resident involved and other pertinent people such as witnesses? What factors may have contributed? Is there an identified alleged perpetrator? Have any system problems been identified? What correction action has the facility taken?

OHFC Process On-Site investigation: Document review: medical records, policies, internal investigation, interview notes Interviews: residents involved, witnesses, alleged perpetrator, physician Observations: staff interactions with residents, delivery of care, equipment that is used One of the most important questions the investigator asks during the investigation is WHY.

OHFC investigations and RCA How are they similar? #1 goal is to protect the resident and prevent further occurrences.

OHFC investigations and RCA Both include evaluation of the following areas: Communication: care plans, assignment sheets, flow of information to direct care staff Training of staff Staffing levels Equipment/environment Policies and procedures

Alleged Perpetrators The investigation does not stop with the identification of an alleged perpetrator and their termination. The investigation must include enough information to determine, if the maltreatment is substantiated, who is responsible for the incident (one person or the facility). The investigation goes beyond identifying that the incident was the result of one person’s actions.

Alleged Perpetrators Investigation must look at possible reasons why the person acted the way they did. There is a need for this comprehensive approach to keep alleged perpetrators from moving from one program to another.

Alleged Perpetrators Did the AP know the resident’s needs? Are there policies and procedures in place and did the AP follow them? Was the AP trained in the policies and procedures? Was there a staffing issue ? Did the AP use the correct equipment for the resident, had they been trained how to use equipment, was the equipment in good working order? What is the AP’s history at the facility? If there were problem areas did facility address them? Does the facility have an overall system in place to prevent the incident?

Under the VAA, MDH must look at mitigating factors to determine: Whether the facility or individual is the responsible party for substantiated maltreatment - OR - Whether both the facility and individual are responsible

Mitigating Factors In considering mitigating factors, OHFC must look at at least the following: Were actions in accordance with an erroneous order, prescription, or care plan? What was the comparative responsibility between the facility, other caregivers, and requirements on the employee? Including, but not limited to: facility policies/procedures adequacy of training adequacy of individual’s participation in training adequacy of supervision adequacy of staffing levels individual’s scope of authority 3) Did the facility or individual follow professional standards in exercising professional judgment?

Impact of RCA on investigations What does OHFC see when a thorough investigation has happened? Much more open attitude Staff more open to talk to investigator Less intimidation and fear of investigation Organized written, detailed summary Often the facility is able to reach a conclusion instead of waiting for state’s conclusion.

RCA and Plan of Correction Under federal regulation facilities are required to submit a plan of correction if federal deficiencies have been issued. Next step after thorough investigation/ identification of problem Ensure that all necessary steps have been taken to prevent a re-occurrence of the incident. Include monitoring plan to ensure that your plan is working.