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

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

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 7. 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 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. 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

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

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

Types of Proactive Risk Analyses Failure Mode and Effect Analysis (FMEA) Institute for Healthcare Improvement (IHI) http://www.ihi.org/knowledge/Pages/Tools/FailureM odesandEffectsAnalysisTool.aspx Healthcare Failure Mode and Effect Analysis (HFMEA) National Patient Safety Center, Department of Veterans Affairs (NCPS) http://www.patientsafety.va.gov/CogAids/HFMEA/i ndex.html#page=page-1 9

http://www. patientsafety. va. gov/CogAids/HFMEA/index http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1 10

http://www. patientsafety. va. gov/CogAids/HFMEA/index http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-15 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 0-16. 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. http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-15 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

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.

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

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??

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

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)

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

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

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

Determine Scores Done by consensus Severity Probability 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 http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

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

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 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 Circulator unable to see from location 4% Steelman & Cullen (2011)

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)

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

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

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

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

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

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

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

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

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 Count1 77.2% Intraop Radiographs2 67% RF Wand3 ,4 100% RF Mat (non-morbidly obese)4 100% RF mat (morbidly obese) 4 96.9%

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 40

The End 41