1. Conducting a Proactive Risk Analysis
Victoria M. Steelman, PhD, RN, CNOR, FAAN 1

2. Victoria Steelman, PhD, RN, CNOR, FAAN
Dr. Steelman has focused on implementing evidence-based practice (EBP) changes for over 20 years and has extensively published and presented on EBP and perioperative issues, and authored many of the AORN Recommended Practices. She received two AORN Outstanding Achievement awards for this work. In 2008, she received the AORN Award for Excellence in recognition of her contributions to perioperative nursing. In 2007, she was inducted into the American Academy of Nursing in recognition of the national and global impact of her work. She is currently the President-Elect of AORN. 3

3. Disclosure Information
Planning Committee:
Ellice Mellinger MS, BSN, RN, CNOR
Discloses no conflict
Speaker:
Victoria M. Steelman, RN, PhD, CNOR, FAAN
AORN’s policy is that the subject matter experts for this product must disclose any financial relationship in a company providing grant funds and/or a company whose product(s) may be discussed or used during the educational activity. Financial disclosure will include the name of the company and/or product and the type of financial relationship, and includes relationships that are in place at the time of the activity or were in place in the 12 months preceding the activity.  Disclosures for this activity are indicated according to the following numeric categories:
Consultant/Speaker’s Bureau: Consultant to RF Surgical Systems, Inc.
Employee
Stockholder
Product Designer
Grant/Research Support : Principal Investigator , University of Iowa, RF Surgical Grant
Other relationship (specify) : RF Surgical - Honoraria
Has no financial interest:
Accreditation Statement
AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.
AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP
AORN IS PLEASED TO PROVIDE THIS WEBINAR ON THIS IMPORTANT TOPIC. HOWEVER, THE VIEWS EXPRESSED IN THIS WEBINAR ARE THOSE OF THE PRESENTERS AND DO NOT NECESSARILY REPRESENT THE VIEWS OF, AND SHOULD NOT BE ATTRIBUTED TO AORN. 4

4. Objectives
Provide an overview of the steps to conduct a proactive risk analysis, a Healthcare Failure Mode and Effect Analysis
Provide the tools necessary to conduct a proactive risk analysis 5

5. Method of Learning from this Webinar
From Instructor
20%
From Doing
80% 6

6. Proactive Risk Analysis
Risk Analyses
Root Cause Analysis
Proactive Risk Analysis
Reactive
Analyze a single event
Learn root cause and contributing factors
Make a change to address root cause or contributing factor
Proactive
Analyze processes
Learn from many events
Prioritize resources
Redesign processes to build in controls to improve safety 7

7. Why use a proactive risk analysis?
Can include actual events and near misses
Wealth of the knowledge used is much greater
Develops a group mental model about the issues and solutions
Provides enhanced support for a change 8

8. Types of Proactive Risk Analyses
Failure Mode and Effect Analysis (FMEA)
Institute for Healthcare Improvement (IHI)
odesandEffectsAnalysisTool.aspx
Healthcare Failure Mode and Effect Analysis (HFMEA)
National Patient Safety Center, Department of Veterans Affairs (NCPS)
ndex.html#page=page-1 9

9. http://www. patientsafety. va. gov/CogAids/HFMEA/index 10

10. http://www. patientsafety. va. gov/CogAids/HFMEA/index 11

11. Steps of a HFMEA 12 Define the topic Assemble the team
Graphically describe the process
Conduct the analysis
Identify actions and outcome measures
Definitions based upon the Healthcare Failure Mode and Effect Analysis (HFMEA) from the VA National Center for Patient Safety
I wanted to find a way to communicate with administrators, surgeons, and others outside of the operating room that a failure in the count is not because nurses can’t count to ten.
A Healthcare Failure Mode and Effect Analysis is a way to examine a process and identify the risks involved, before something bad happens.
This analysis involves:
Mapping the process involved, and identifying key steps
List all potential failures that can occur during these steps
Identify the causes for these failures
Rate the likelihood of occurrence of each failure (remote, uncommon, occasional, frequent)
Rate the severity if the failure occurred and was not detected (catastrophic)
Calculate a hazard score. This score ranges from A hazard score of =/>8 for a potential failure indicates it should be controlled.
This HFMEA was supported by the Department of Veterans Affairs Quality Scholar program
All nurses and technicians in the operating room at the VAMC is Iowa City participated in this HFMEA. 12

12. 1. Define the Topic Example
The management of surgical sponges in order to prevent inadvertently retained sponges after surgery
from case preparation in the operating room to surgery completion

13. 2. Assemble the Team Content experts Methods expert(s)
Include subject-matter experts and those with no knowledge of the process under review.
Consider appointing two representatives from critical services so that you have coverage at all meetings.
Some teams at smaller facilities have been successful with fewer team members; when needed, others are called in as consultants.
Avoid assigning the leader the additional responsibility of being the recorder.

14. Example of a Team Experts on the process
RN circulators - 2
Surgical technologists - 2
Surgeons – 2
PA/APRN/RNFA – 1
Expert on methods and facilitation
Quality improvement specialist – 1
Critical members
OR staff nurse
Surgical technologist
Surgeon
Assistant
Quality management rep
Other members not critical
Anesthesiologist
Risk manager
Other???
Number of each??
Selection
influence

15. 3. Graphically Describe the Process
Observe the entire process
Not the policy, but the actual practice
There is always a difference
Select one type of surgery as exemplar
Which type??
How many observations??

16. Process Mapping 17 List the steps involved in the process
Map the process
Example:
Routine colon resections -3
No relief, 1 circulator, 1 scrub tech
Day shift
Develop and verify the Flow Diagram (this is a process vs. chronological event diagram).
Consecutively number each process step identified in the process flow diagram.
If the process is complex, identify the area of the process to focus on (manageable bite).
Identify all sub-processes under each block of this flow diagram. Consecutively letter these sub-steps.
Create a flow diagram composed of the sub-processes.
Step 3: Hints
Fully develop your process and sub-process diagram before proceeding.
Use recommended numbering convention to keep track of your work.
You may need to help group narrow scope of area to review.
Once you think you have an understanding, confirm with the process owners.
If feasible, take the whole team to actually observe the process under review.
The team leader can do pre-work of developing an initial draft of the process flow diagram outside of whole group meetings 17

17. Example: Steps of Process
Room preparation
Initial count
Adding sponges
Removing sponges
First closing count
Final closing count
You may want to put relief count in your process
Steelman & Cullen (2011)

18. 4. Conduct the Analysis For each step of the process:
Identify all failures that could occur in each step
Identify the causes of these potential failures
For each failure cause combination in each step:
Determine severity
Determine probability
Calculate a hazard score
This is the real heart and soul of the analysis.
Remember - failure modes are different ways the process or sub-process can fail to provide the anticipated result -- they represent what can go wrong.
We suggest a flip chart and large post-it notes.
Some will want to jump to fixes or failure mode causes -- groups report more success if they first fully develop failure modes

19. Identify Potential Failures
Brainstorming
May include more staff at this point
Process failures, not outcome 20

20. Potential Failure Points in Phases of Sponge Management
Step
# Failures
Room preparation 6
Initial count 7
Adding sponges 9
Removing sponges
First closing count 14
Final closing count
Total Potential Failure Points* 57
Steelman & Cullen (2011)

21. Identify the Causes of Potential Failures
Focus on each potential failure
Identify all causes 22

22. Examples of Causes Room inadequately cleaned after last case
Manufacturing defect
Knowledge deficit
Not following procedure
Distraction
Multitasking
Emergency event or procedure
Time pressure
Unable to see- person counting too fast

23. Determine Scores
Done by consensus
Severity
Probability 24

24. *Severity if the failure is undetected
Severity Rating*
Severity
Definition (Patient Outcome)
Score
Catastrophic
Death or major permanent loss of function, suicide, rape, hemolytic transfusion reaction, surgery / procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family (Failure could cause death or injury) 4
Major
Permanent lessening of bodily functioning, disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patients
(Failure could cause a high degree of customer dissatisfaction) 3
Moderate
Increased length of stay or increased level of care for 1 or 2 patients (minor performance loss) 2
Minor
No injury, nor increased length of stay nor increased level of care (failure would not be noticeable to customer and would not affect delivery of the service) 1
*Severity if the failure is undetected

25. Probability Rating Severity Definition
Score
Frequent
Likely to occur immediately or within a short period (may happen several times in one year 4
Occasional
Probably will occur (may happen several times in 1 to 2 years) 3
Uncommon
Possible to occur (may happen sometime in 2 to 5 years) 2
Remote
Unlikely to occur (may happen sometime in 5 to 30 years) 1

26. HFMEA Scoring Matrix 16 12 8 4 9 6 3 2 1 Severity Catastrophic (4)
Major (3)
Moderate (2)
Minor
(1)
Frequent (4) 16 12 8 4
Occasional (3) 9 6 3
Uncommon (2) 2
Remote (1) 1

27. Causes of High Risk Potential Failures
Cause of Failures
Frequency (%)
Distraction
21%
Multitasking
18%
Not following procedure
14%
Time pressure
13%
Emergency 5%
Surgeon continues to close wound
Circulator unable to see from location 4%
Steelman & Cullen (2011)

28. Causes of High Risk Potential Failures (cont)
Dressings unwrapped during procedure 2%
Mixing trash and sponges
Pockets stacked and not all visible
Scrub person counting too fast
Sponges in use
Other
11%
Other:
manufacturing defect,
using radiopaque sponges by anesthesia,
drapes added,
sponge intentionally packed,
sponge kicked under bed,
sponge in kick bucket,
sponge cut,
sponge attached to specimen,
sponge stuck to specimen,
sponges stuck together,
sponge in glove when removed,
4 X 4 in laparotomy sponge
Steelman & Cullen (2011)

29. HFMEA Decision Tree
Failure/cause combination: sufficient hazard to warrant control (=/>8)
Single point weakness?
Effective existing control in place?
Is the hazard so obvious & readily apparent that a control measure is not needed?
Single Point Weakness
Will this failure, if undetected result in an adverse event?
Effective existing control in place? .
Is the hazard so obvious & readily apparent that a control measure is not needed?
Detection is so obvious that it will occur before the failure/case combination interferes with completion of the task

30. Single Point Weakness
Will this failure, if undetected result in an adverse event?
Single Point Weakness
Will this failure, if undetected result in an adverse event?
Effective existing control in place? .
Is the hazard so obvious & readily apparent that a control measure is not needed?
Detection is so obvious that it will occur before the failure/case combination interferes with completion of the task

31. Effective Existing Control
Effective existing control in place?
Is a barrier in place to eliminate or substantially reduce the likelihood of an adverse event? Example: pin indexing of anesthesia machines
Single Point Weakness
Will this failure, if undetected result in an adverse event?
Effective existing control in place? .
Is the hazard so obvious & readily apparent that a control measure is not needed?
Detection is so obvious that it will occur before the failure/case combination interferes with completion of the task

32. No Need for Control
Is the hazard so obvious & readily apparent that a control measure is not needed?
Detection is so obvious that it will occur before the failure/cause combination interferes with completion of the task
If yes, accept it and stop
If no, eliminate or control it
Single Point Weakness
Will this failure, if undetected result in an adverse event?
Effective existing control in place? .
Is the hazard so obvious & readily apparent that a control measure is not needed?
Detection is so obvious that it will occur before the failure/case combination interferes with completion of the task

33. 5. Identify Actions & Outcome Measures
Describe an action for each failure mode cause that will eliminate or control it
Decide to "Eliminate," "Control," or "Accept" the failure mode cause .
Describe an action for each failure mode cause that will eliminate or control it.
Identify outcome measures that will be used to analyze and test the redesign process.
Identify a single, responsible individual by title to complete the recommended action.
Indicate whether top management has concurred with the recommended actions. 34

34. Control Measures Knowledge deficit Education Multitasking ?
Need to target causes of the high risk failures
Cause
Eliminate/Control
Knowledge deficit
Education
Multitasking ?
Distraction
Time pressure

35. Outcome Measures 36 How will you test your redesigned process?
Outcomes of the process changes
How do you measure a reduction in multitasking?
It is inadequate to only use “no retained sponges” 36

36. Identify the Person Responsible
Who is the person to implement and evaluate that change? 37

37. Is there adequate support?
Provide a compelling rationale
Presenting the HFEMA is powerful
Having someone outside of the OR on your team is helpful
Use your team to spread influence
You may need to provide a cost analysis 38

38. Summary
If you always do what you always did you will always get what you always got.
Albert Einstein
We need to design safer processes
A proactive risk analysis (HFMEA) provides an effective tool
Resources are provided
Sensitivity
Surgical Count %
Intraop Radiographs2 67%
RF Wand3 ,4 100%
RF Mat (non-morbidly obese)4 100%
RF mat (morbidly obese) %

39. References
Steelman, VM., Cullen, JJ. Sponges: A Healthcare Failure Mode and Effect Analysis. AORN J. 2011; 94.
VA National Center for Patient Safety. HFMEA
page-1 40

40. The End 41