Conducting a Proactive Risk Analysis

Victoria M. Steelman, PhD, RN, CNOR, FAAN

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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.

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Disclosure Information

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:

1.Consultant/Speaker’s Bureau: Consultant to RF Surgical Systems, Inc.

2.Employee

3.Stockholder

4. Product Designer

5.Grant/Research Support : Principal Investigator , University of Iowa, RF Surgical Grant

6.Other relationship (specify) : RF Surgical - Honoraria

7. Has no financial interest:

Speaker: Victoria M. Steelman, RN, PhD, CNOR,

FAAN

Accreditation StatementAORN 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 13019.

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.

Planning Committee: Ellice Mellinger MS, BSN, RN, CNOR

Discloses no conflict

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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

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Method of Learning from this Webinar

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From Doing80%

From Instructor20%

Risk Analyses

Root Cause Analysis• Reactive

• Analyze a single event

• Learn root cause and contributing factors

• Make a change to address root cause or contributing factor

Proactive Risk Analysis • Proactive

• Analyze processes

• Learn from many events

• Prioritize resources

• Redesign processes to build in controls to improve safety

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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

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Types of Proactive Risk Analyses

• Failure Mode and Effect Analysis (FMEA)

- Institute for Healthcare Improvement (IHI)

- http://www.ihi.org/knowledge/Pages/Tools/FailureModesandEffectsAnalysisTool.aspx

• Healthcare Failure Mode and Effect Analysis (HFMEA)

- National Patient Safety Center, Department of Veterans Affairs (NCPS)

- http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1

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http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1

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http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-15

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Steps of a HFMEA

1. Define the topic

2. Assemble the team

3. Graphically describe the process

4. Conduct the analysis

5. Identify actions and outcome measures

Definitions based upon the Healthcare Failure Mode and Effect Analysis (HFMEA) from the VA National Center for Patient Safety

http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-15

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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

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2. Assemble the Team

• Content experts

• Methods expert(s)

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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

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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??

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Process Mapping

• List the steps involved in the process

• Map the process

• Example:

• Routine colon resections -3

• No relief, 1 circulator, 1 scrub tech

• Day shift

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Example: Steps of Process

Step

1. Room preparation

2. Initial count

3. Adding sponges

4. Removing sponges

5. First closing count

6. Final closing count

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Steelman & Cullen (2011)

4. Conduct the Analysis

For each step of the process:

A. Identify all failures that could occur in each step

B. Identify the causes of these potential failures

For each failure cause combination in each step:

a) Determine severity

b) Determine probability

c) Calculate a hazard score

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Identify Potential Failures

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Potential Failure Points in Phases of Sponge Management

Step # Failures

1. Room preparation 6

2. Initial count 7

3. Adding sponges 9

4. Removing sponges 7

5. First closing count 14

6. Final closing count 14

Total Potential Failure Points* 57

20Steelman & Cullen (2011)

Identify the Causes of Potential Failures

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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

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Determine Scores

Done by consensus

1.Severity

2.Probability

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Severity Rating*

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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)

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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)

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Moderate Increased length of stay or increased level of care for 1 or 2 patients (minor performance loss)

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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)

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http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

*Severity if the failure is undetected

Probability Rating

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Severity Definition Score

Frequent Likely to occur immediately or within a short period (may happen several times in one year

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Occasional Probably will occur (may happen several times in 1 to 2 years)

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Uncommon Possible to occur (may happen sometime in 2 to 5 years)

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Remote Unlikely to occur (may happen sometime in 5 to 30 years)

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http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

HFMEA Scoring Matrix

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Severity Catastrophic (4)

Major (3) Moderate (2)

Minor (1)

Frequent (4) 16 12 8 4

Occasional (3) 12 9 6 3

Uncommon (2) 8 6 4 2

Remote (1) 4 3 2 1

http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

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 5%Circulator unable to see from location 4%

27Steelman & Cullen (2011)

Causes of High Risk Potential Failures (cont)

Dressings unwrapped during procedure 2%

Mixing trash and sponges 2%

Pockets stacked and not all visible 2%

Scrub person counting too fast 2%

Sponges in use 2%

Other11%

28Steelman & Cullen (2011)

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?

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Single Point Weakness

• Will this failure, if undetected result in an adverse event?

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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

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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

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5. Identify Actions & Outcome Measures

• Describe an action for each failure mode cause that will eliminate or control it

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Control Measures

• Need to target causes of the high risk failures

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Cause Eliminate/Control

Knowledge deficit Education

Multitasking ?

Distraction ?

Time pressure ?

Outcome Measures

• 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”

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Identify the Person Responsible

• Who is the person to implement and evaluate that change?

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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

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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

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References• Steelman, VM., Cullen, JJ. Sponges: A Healthcare Failure Mode and

Effect Analysis. AORN J. 2011; 94.

• VA National Center for Patient Safety. HFMEA. 2013.

http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1

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The End

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