1. Root Cause Analysis (RCA)
The Veteran’s Health Administration uses the Root Cause Analysis process to investigate and take action on patient safety adverse events and close calls. This process is defined in the VHA National Patient Safety Improvement Handbook
The VA National Center for Patient Safety leads the VA Patient Safety program.
The VA intranet website is
The Root Cause Analysis process is frequently abbreviated as RCA.
VA National Center for Patient Safety
Beth J. King, R.N., B.S.N., M.A., C.C.M.

2. Patient Safety Definition
Protection
From
Inadvertent
Harm
Patient Safety Event or Close Call
Reported to Patient Safety Manager (PSM)
Investigated and SAC’d by PSM
Entered into SPOT database
Possible National Implications? Yes/No
RCA? Yes/No
National Surveillance for Patient Safety If Yes- 1) Investigation at NCPS 2) Possible Alert/Advisory
The RCA process is surrounded by a nationwide system for patient safety. This dynamic system is operational to be knowledgeable of patient safety issues throughout VHA and to learn from each other.
At the facility, events reported by staff are received and investigated by the facility Patient Safety Manager. The Patient Safety Improvement Handbook specifies a scoring method and each and every reported event is reviewed and scored. This objective scoring activity identifies which patient safety events raise to the level requiring study by the RCA process.
NCPS has had a national electronic patient safety database since All VA facilities submit patient safety events as well as RCAs to the National Center for Patient Safety database, which is nicknamed SPOT.
While this database is confidential and privileged. Each facility can view the events and RCAs from their facility; the VISN Patient Safety Office can view all activity from facilities within their VISN and the National Center for Patient Safety can view all submissions nationwide.
NCPS staff review every submitted RCA. This large national database provides a highly valuable composite of patient safety information used for facility-requested searches, trending and learning about patient safety.

3. RCAs are Confidential and Privileged under 38 U.S.C. 5705
Talk
In Patient Safety the RCA process is confidential and privileged under 38 U.S.C This means staff participating in an RCA cannot divulge or share what was learned during the RCA and the RCA cannot be called into court, it is protected from subpoena. There are a few entities that can review RCAs, like the Office of General Counsel for instance. Should you ever be asked to share what happened in an RCA, do not discuss the RCA and refer that individual to your facility Patient Safety Manager.
Multiple professionals may use the term “Root Cause Analysis” but in VHA, this should not be used in ways other than patient safety because it denotes a protected and confidential process used in patient safety to indicate a specific focused review.
With a smile, we sometimes say a good way to remember this concept is…..what happens in the RCA stays in the RCA.

4. Getting Started Analysis Take Action Follow up RCA Process
Like many improvement processes, the RCA includes start-up, analysis and action plan.
RCAs are taken very seriously in VHA. The Facility Director is directly involved and his or her signature charters the team and also concludes the RCA with the action plan. The facility Director has the authority to concur or non-concur with each action recommended by the RCA team.
NCPS encourages RCA teams complete a thorough investigation and advance the strongest action plan possible to improve safety. Teams are asked to avoid self-editing their recommendation before sharing the action plan with the Director.

5. RCA Process Steps – Getting Started
Immediate Actions as Required
Charter/Appoint RCA Team
Just in Time Training
Lets discuss the start-up of an RCA.
Local staff take any actions required to immediately protect patient safety.
If equipment was involved, this may need to be sequestered.
The facility Patient Safety Manager leads the start up of the RCA.
As the RCA team is developed obtain advance support by supervisor’s if possible to strengthen team member’s participation.
The RCA team generally consists of four to six VHA staff and/or providers. While there is no rule on how many staff participate in any given RCA, NCPS considers two staff as too few and ten as too many.
The Charter is signed by the facility Director, which confirms the 38 U.S.C protections.

6. RCA Process Steps - Analysis
Initial Sequence of Events
Identify Information Gaps
Specify Needed Information – Timeline and Who will Provide the Information
Use Triage Cards to Frame Questions
Conduct Fact-Finding Interviews, Chart and Literature Reviews
Final Sequence of Events
Repeat analysis until Final Sequence is Complete
Identify Root Causes/Contributing Factors

7. Training Example:
Keith (name changed) eloped on Saturday, January 19 at 3:00 pm while an inpatient on the locked psychiatric unit. Keith has a history of major depressive disorder and cross addiction to alcohol and prescription narcotics. Keith had voiced to staff during this hospitalization that he, “had to get out of here.” He had multiple inpatient psychiatric admissions over the past 5 years, with no history of prior elopement.
Keith eloped through a double door with a self-locking mechanism during an exchange of a supply cart. The supply cart, 48 inches wide, was stocked with items such that it was over 6 feet high. The staff person pushing the cart had access to unlock the doors and enter the locked psychiatric unit. With the width of the cart, both doors had to open to allow it to enter. There were no mirrors, cameras or electronic monitoring devices associated with this door. The doors closed automatically after being opened. There were no reported maintenance problems.
The nursing desk/station was located near the center of the unit. A senior staff member had called-in ill that day, leaving the unit with adequate staff, yet with less experience.
The patient lounge was located next to the unit entrance doors. Other patients reported Keith was waiting in the lounge and exited the unit after the cart passed through while the doors were slowly closing. He was unnoticed by the staff person pushing the cart.
Keith was found walking around, un-injured, in the parking garage on the facility grounds 90 minutes later.

8. The “Swiss Cheese” Model of Accident Causation Jim Reason, 1991
James Reason creates a model for us to understand how harm may reach a patient. In this graphic, you see what looks like slices of Swiss cheese in the middle. The systematic barriers designed to protect the patient (in yellow boxes) are listed below the “slices of Swiss cheese.” Each protective barrier, e.g. policies, teamwork, equipment, can prevent harm from reaching the patient. In reality, like a slice of Swiss cheese, there are holes/vulnerabilities in every barrier. The model is dynamic and the gaps can vary widely moment to moment depending the situation, e.g. the environment or action of the healthcare professionals, etc.
Above the Swiss cheese, examples of the vulnerabilities (black boxes) are illustrated. Strengthening the protective barriers is key to patient safety. Actions are taken to minimize the size of the holes and/or block the alignment of the holes to prevent harm from reaching the patient.
For example, your unit may have a policy on how to remove a central line catheter from a patient, yet the policy is hard to find when its needed so staff don’t reference it. In this example a policy is available as a barrier but the lack of use presents a pretty large hole in that barrier.
Reason, J. (2000). Human error: models and management. British Medical Journal, 320,

9. Other patients reported
Initial Flow Diagram A B C
Patient eloped
through double door
In locked psych unit
Other patients reported
seeing patient
leave when
supply cart entered
Patient was found
Un-Injured
90 minutes later
Chronological
Case Example

10. Other patients reported
Working Diagram
Patient eloped
through double door
In locked psych unit
Other patients reported
seeing patient
leave when
supply cart entered
Patient was found
Un-Injured
90 minutes later
Why?
Why did staff not see patient?
Why was cart entering at this time?
Why couldn’t cart staff see patient?
Why was door unlocked?
Was this patient a known risk?
Why no electronic monitoring of door?
????

11. Final Flow Diagram Patient sitting in patient lounge Supply cart
enters requiring
both doors
to be opened
No electronic
monitor of
patient or door
Patient found
90 minutes
later
Patient previously
communicates
desire to elope
Patient leaves
through door
Patient in locked
unit at 3PM
Double doors
close
slowly
Less
experienced
Staff

12. Final Flow Diagram with Vulnerabilities
Staff did not receive training on documentation
No alternative area available
Patient in locked
Unit at 3PM
Patient previously
communicates
desire to elope
Patient sitting in
Patient lounge
Supply cart
Enters requiring
both doors
To be opened
Design of doors not assessed
Double doors
close
slowly
Budget would not allow
Too busy to supervise lounge area
Patient found
90 minutes
later
No electronic
monitor of
patient or door
Patient leaves
Through door
Less
Experienced
Staff

13. RCA Process
Getting Started
Analysis
Take Action
Follow up

14. RCA Process Steps – Take Action
Identify Actions Implemented in Similar Past Event(s)
Develop Action Plan - Consists of RC/CF Statements, Actions and Outcome Measures
Provide Feedback to Reporter
Identify What was Learned and Who Needs to Know
Create Action Plan for Director Concur/Non-Concur
Iterate and Record as Necessary
Final Sign-Off RCA and Action Plan

15. RCA Action Plan
RC/CF Statement
Action
Outcome Measure

16. Defining Root Causes
Adverse Event
Prevented

17. Root Cause/Contributing Factor Statements -Three parts:
(Something) ___________________________
(led to something else) ___________________
(increasing the likelihood something might/would happen) ______________________________.
Example:
The ability of multiple staff to enter the locked psychiatric unit unannounced and unmonitored
allowed the patient to leave unescorted
increasing the likelihood he may cause self harm.

18. Root Cause/Contributing Factor Statements -Three parts:
(Something) ___________________________
(led to something else) ___________________
(increasing the likelihood something might/would happen) ______________________________.
Example 2:
The absence of a standardized checklist
used to validate the presence of required equipment and medications every 12 hours
increased the likelihood the emergency crash cart would be inadequately stocked with supplies.

19. Recommended Hierarchy of Actions
Stronger actions
Architectural/physical plant changes
New device with usability testing before purchasing
Engineering control or interlock (forcing functions)
Simplify the process and remove unnecessary steps
Standardize on equipment or process or caremaps
Tangible involvement and action by leadership in support of patient safety
Intermediate Actions
Increase in staffing/decrease in workload
Software enhancements/modifications
Eliminate/reduce distractions (sterile medical environment)
Checklist/cognitive aid
Eliminate look and sound alikes
Read back
Enhanced documentation/communication
Redundancy
Weaker Actions
Double checks
Warnings and labels
New procedure/memorandum/policy
Training
Additional study/analysis

20. “put the knowledge in the world”…
Donald Norman
“put the knowledge in the world”…
Put the information needed right there and reduce the burden on human memory and vigilance.

21. RCA Action Plan
RC/CF Statement
Action
Outcome Measure

22. Should include: Did the action make a difference?
Outcome Measures
Did the action make a difference?
What will be measured
How long it will be measured
Numerator
Denominator
The expected level of compliance (Threshold)
Should include:

23. Numerator (new group/process) = Threshold Denominator (whole group) N = Patients with contraband search prior to entering unit D= All Patients Admitted to the unit Threshold = 98%

24. Examples
Outcome Measure: Ten orthopedic surgical trays over the next 60 days will be inspected in the OR and a hand saw will be present 100% of the time.
N=orthopedic trays with hand saw = 100% (threshold)
D=ten orthopedic trays inspected
Outcome Measure: 30 patient records will be reviewed during 4th quarter FY16 and a minimum of 27 (90%) records will have the assessment completed within 12 hours of admission.
N = records with assessment done within 12 hours = 90% (threshold)
D = 30 records

25. Measure effectiveness vs. completion of action
Outcome Measures
Measure effectiveness vs. completion of action
Staff knowledge vs. training attended
New procedure is used vs. written and signed procedure
RCA team sets the threshold
Acceptable performance levels

26. RCA Process Steps – Determining Cost and Follow-Up
Determine Approximate Cost of RCA
RCA Advisor Checks Follow-up

27. Outcome Measure Much Better Better No Change Worse Much Worse
Follow Up
Outcome Measure
Much Better
Better
No Change
Worse
Much Worse
National Patient Safety Database includes effectiveness of each action
Supports learning database
NCPS can search and share much better/ better actions.
The follow up step within the RCA process provides a critical value to the learning database.
Patient Safety Managers return to the RCA in the database to indicated whether the situation is better or worse. This rating is based on a 5 levels between much better and much worse. Each action is rated for effectiveness in this way.
The value is noted when an RCA team requests a search on a specific topic, RCAs can be reviewed with the actions reported as making the situation better selected and shared.