Root Cause Analysis: Understanding the Regulatory Perspective (Powerpoint Presentation: 2MB)

Root Cause Analysis:
The Regulatory
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
To conduct an official
Why do we investigate?
To determine the cause of the incident
To prevent re-occurrence of the
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
– 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
– 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
– Complaints from the public
– Incident reports from facilities.
Volume of OHFC Investigations
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
– 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:
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
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
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
Training of staff
Staffing levels
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
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?
Mitigating Factors
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:
1) Were actions in accordance with an erroneous
order, prescription, or care plan?
2) 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
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
– Include monitoring plan to ensure that your
plan is working.