A root cause analysis (RCA) is the process for identifying the most basic or causal factor(s) that underlie variation in performance. An RCA

- does not blame for negligence.

- is used to figure out how to improve processes/systems.

- is used to prevent recurrence.

- is used to identify process/systems changes that can be made.

- is a dynamic process that can be completed in several different ways.

-is credible when performed by more than one individual.

Senior Leadership Responsibilities

• Facilitates cultural issues for reducing blame,
• Developes policies and procedures to move organizations toward a "blame-free" workplace
• Ensures that Patient Safety Manager identifies SAC Scores for all reported events and close calls
• Ensures that all SAC 3 events have RCAs completed.
• Ensures that RM completes items 1-9 on RCA Form and sends electronically to RCA Team Leader or Advisor.
• Provides IM/IT support to facilitate completion of RCA via computer.
• Provides incentives for staff to encourage participation.

RCA Team Membership

RCA Advisor/Facilitator

The membership should include one RCA Advisor/Facilitator that knows how to use Performance Improvement and Statistical Analysis Tools and ensures that flip charts, white boards, computer, etc. are available for meetings.

Team Leader

The team Leader should be a content expert on the event under investigation. The leader will facilitate team introductions and clarify the team purpose (find out about the "event" - how it happened, how it might be prevented in the future - without finding fault but to prevent future mishaps). In addition, the leader will dentify team members by position on RCA document,  clearly identify roles/responsibilities, schedule as frequently as necessary to ensure RCA completion within required time line, and communicate progress/findings to senior leadership.

Team Members 
The Advisor and Team Leader  in consultation with a Senior Leader (DCCS) will select the team members. Over-inclusion is preferred to under inclusion because everyone learns the process and some of the best ideas come from those not involved in the event. This is an opportunity to tear down walls and grow!

Membership should include all levels of personnel closest to the issue; they need to be individuals critical to implementation of recommended process improvement. It should include someone with decision making authority.  Staff who were "directly" involved in the event should not be on the team as it may be too difficult/painful for objective analysis and may place blame rather than seek solutions

THE RCA PROCESS

1.  ORGANIZE THE EVENT

Objective:  Develope a "reporters view" of the event; identify those involved in the event (by job position or title); those directly involved in the incident should be interviewed to obtain facts, sequence of events leading to adverse outcome (RCA Form # 10).

-Include review of medical records/documentation/maintenance records/instruction manuals/policy manuals/literature, etc. (RCA Form 11-13)

- Determine if Team membership is correct and select minimum scope of RCA from JC Matrix

- Resist "should have" discussions

- May include reenactment/mock-up of environment; what data has to be acquired and/or safeguarded; who should do it and how; medical records, statements from personnel, maintenance records; instruction manuals; policy manuals, literature, etc.

- Identify responsible Team Member an timeline for acquiring information  

2.  DENTIFY RELEVANT PROCESSES

- What was the process(es) associated with the event?

- What area/service(s) was impacted?

- Use Triage Questions - "Starting Point" to identify Human Factors categories to evaluate (Patient Assessment; Staff Training/ Competency; Equipment; Lack of Information; Rules/Policies/Procedures;Barriers; Personnel/Personal Issues)

3.  PERFORMANCE IMPROVEMENT TOOLS

A. INITIAL UNDERSTANDING OF EVENT:

(1) DEVELOP FLOW DIAGRAM(S):

- Flow chart the actual process as documented (RCA Form # 10); at a later time may want to flow chart the "desired" process

- Breakdown the processes into steps and look for variation; Study the "process" to learn its steps and decision points

- Avoid discussing anything but sequence of events

- Don't allow team to "jump to action"; During this time people may begin to suggest causes, solutions and "jump to action". Write "ideas to be addressed later" on flip chart or white board for later use (Parking Lot)

- When all the facts are gathered and information gap closed Flow Chart Team's final interpretation of what actually happened (RCA Form #14)

B. CONSENSUS BUILDING TOOLS:

(1) BRAINSTORMING: In order to identify all possible causes and potential problems encountered during the assessment and treatment of the patient, the team utilizes brainstorming as a technique. - In alignment with quality management recommendations and guidelines, the session is conducted with ground rules to facilitate/encourage identification of all ideas of possible contributing causes and/or known problems be identified.

- All team members participate in this process and all ideas are documented.

- Focus on processes NOT people

- Keep asking "what" and "why" - Possible causes are based on Team opinion

(2) AFFINITY DIAGRAMMING:

- Identify Driving and Restraining Forces

(3) ROOT CAUSE/CONTRIBUTING FACTORS

- Mark sequence of event items on flow diagram which may be contributory factors

- Complete Root Cause/Contributing Factors Table (RCA FORM #15)

(4) CAUSE & EFFECT DIAGRAM (consider use of): - All possible causes and potential problems identified in the brainstorming session are graphically illustrated via the cause and effect diagram. This tool allows the team to organize all information regarding the event into common categories.

- The possible causes and potential problems identified may be categorized under an appropriate "major cause" categories to include personnel, procedures, policies, environment, etc:

Personnel &  Procedures

- Orientation/Training- Literature review

- Competency/Credential/Privileges- Followed/not followed

- Staffing Levels- Adequacy of support, personnel & - Communicationtechnological

- Supervision- Availability of information

- Patient/Family Factors- Adequacy of supplies/equipment

- Human Factors- Documentation

Policies & Environment:

- Clear written policy- Uncontrollable Factors

- Policies in tune with higher authority- Controllable Factors

- Literature review/benchmarks- What factors were influential?

- Policies followed

- Determine which process/system(s) each cause is a part of - special cause

- Common cause analysis progresses from special causes in clinical processes to common causes in organizational processes.

4. CONSIDER USE OF "STATISTICAL" TOOLS

- Pareto Charts (rank frequency of causes)

- Scatter Diagrams

5.  FACTORS TO CONSIDER

a. Human Resource Factors:

-How well did staff qualifications and current competencies match their duties in relevant process(es)?

- How did actual staffing compare with ideal levels?

- Is there a plan for dealing with contingencies that would tend to reduce effective staffing levels?

- How has the staff performance in the relevant process(es) been assessed? When was this done last?

- How can orientation & inservice training be revised to reduce the risk of such events in the future?

b. Environmental Factors:

- What environmental factors directly affected the outcome?

- How might the physical environment be redesigned to reduce the risk of this type of event?

- What systems can be put in place to identify environmental risks?

- What uncontrollable external factors influenced the event?

- Are there any other factors that have directly influenced this outcome?

c. Information Management Factors:

- To what degree was all necessary information available when needed? (accurate, complete, unambiguous??)

- Was available technology available as needed?

- How might technology be introduced or redesigned to reduce risk in the future?

` - How can communication among participants be improved?

d. Leadership Issues:

- How might the culture better support risk identification and reduction?

- What are the barriers to communication of potential risk factors?

- How is the prevention of adverse outcomes communicated as a high priority?

6. SELECT THE PROCESS IMPROVEMENT(S)

- Use RCA grid to organize data

- List all findings related to the issue

- One finding may go under several issues

-Suggestion: assign one major issue to each team member to expedite process

7. DEVELOP ACTION PLAN

(RCA Form #19): - Risk Reduction Strategies/Recommendations - Prioritization similar to root cause list

- Timeline for multiple actions

- Highest impact house/system wide

- Identify Reporting/Oversight Responsibility

- Time line/follow-up dates identified

- Linked to measurement

- Actions must be measurable

- Who/How/What/When action will be measured

- Pilot Study for "new" clinical process

- Set reasonable/attainable goals

8. IMPLEMENT IMPROVEMENT(S)

- RCA grid assigns who & when

- Funding concerns are raised as priority to Command

- Agreement from all team members & departments

9. CHECK IMPLEMENATATION PROGRESS

- Risk Manager follows-up per timeline

- Timeframe 6 months & 1 year

- Closure at 1 year

10. ACT TO MAINTAIN

- Use Sentinel Event/Near Miss as learning experience for MTF

- Incorporate new policies/procedures in departments

- Incorporate lessons learned into orientation

11. RESOURCES

a. SE/Near Miss Management:

- DoDI - MHS Patient Safety Program

- MEDCOM SE Policy/QMD Staff Officers

- JC Sentinel Event Alerts

- JC Sentinel Event Hotline (630) 792-3700

b. Web Sites:

- JCAHO - www.jcaho.org

- QM Directorate - www.cs.amedd.army.mil/qmo/

- National Patient Safety Foundation - www.npsf.org

- Institute of Safe Medication Practices - www.ismp.org

- Health Care Safety Institute - www.hcsinstitute.com

c. References:

Sholtes, Joiner & Streibel. The TEAM Handbook, 2^nd Edition, 1996.

Error Reduction in Healthcare: A Systems Approach to Improving Patient Safety. Jossey-Bass/AHA Press,

 

Make the safest way the easiest way!!

---

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Prepared By:

COL Judy L. Powers

Chief, Quality Operations

Quality Management Directorate U.S.A. MEDCOM 10/00