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J. Robert Wyatt, MD, MBAOtolaryngology – Head & Neck SurgeryBaylor Health SystemDallas, Texas
Glenn Rothman, MDChairman, Department of SurgeryHead & Neck OncologyBanner Desert Medical CenterMesa, Arizona
Wrong Site Surgery:The myths, the realities, the solutions
www.sitemarx.com 2
Agenda
Introduction: speaker credentials
The problem: wrong site surgery
The mandate: JCAHO requirements
Case studies
New solution: Sitemarx stamp
Conclusion
www.sitemarx.com 3
Surgeon background
Glenn Rothman MD:
Head and Neck Cancer Surgeon
Chairman, Department of Surgery
Medical-legal and Medical Board consultant
JCAHO compliance consultant
Sentinel Event leadership
Proposed “solution” unavailable
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Surgeon background
J. Robert Wyatt, MD, MBA:
Otolaryngology – Head and Neck Surgery
Expert consultant, Texas Medical Board
Board of Managers, Baylor Surgicare, North Garland
Executive Committee, North Texas ENT Associates
Medical legal consultant
Licensed pilot since 1982
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Agenda
Introduction: speaker credentials
The problem: wrong site surgery
The mandate: JCAHO requirements
Case studies:
New solution: Sitemarx stamp
Conclusion
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Your surgeon makes errors
To err is human – every 15 seconds
8 errors = one accident
Active task vs. passive task
Faith in others reinforces errors
Multi-tasking increases errors
Aviation and nuclear safety principles not adopted by healthcare industry
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Fundamentals of errors
Error Type Description Example Prevention
Skill-based errors
Familiar act, little attention
Slips, lapses Pay attention
Rule-based errors
Act requiring application of rules to familiar event
Wrong rule, misapplication of correct rule, non-compliant with rule
Educate, critical thinking,accountability
Knowledge-based errors
Unfamiliar situation, no rule, problem solving task
Faulty strategy to solve problem
Stop, teach decision making skills
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Learning from the experts
Aviation and Nuclear power expertise
Investigation versus problem-solving “Root-cause Analysis”
Systems thinking versus get rid of the bad apples
Reliance on diagnostic tools versus reliance of profound knowledge
Safety as a “core value” versus safety as a “priority”
STAR: stop…think…act…review
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The frequency debate
1 in 5,000 – 10,000 cases
Near misses not tracked
Near misses not analyzed
Numbers debate undermines public trust
Corrective efforts compromised by the numbers debate
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Impact of wrong site cases
Physical injury and possibly assault
Loss of faith in the healthcare providers
Surgeon litigation and licensure penalties
Hospital litigation and accreditation penalties
Indefensible public image risk
Undermines surgery team cohesion
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Agenda
Introduction: speaker credentials
The problem: wrong site surgery
The mandate: JCAHO requirements
Case studies:
New solution: Sitemarx stamp
Conclusion
www.sitemarx.com 12
Joint Commission mandate
Who gets site marked?
Who does the site marking?
What is the acceptable mark?
Who confirms the mark?
The “time out”
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Has JCAHO solved wrong site?
JCAHO has brought focus to the problem
JCAHO has required redundancy
JCAHO has improved provider “buy-in”
JCAHO mandated root cause analysis
JCAHO agrees there is no evidence these measures have decreased the incidence of wrong site surgery
No requirement to track near-misses
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Factors contributing to failures
“Captain of the Ship” mentality
Surgery team hierarchy
Culture of blame and punishment
Compelling incentives for speed
Little attention to near misses
Failure to adopt “best practices”
Litigation and confidentiality
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Agenda
Introduction: speaker credentials
The problem: wrong site surgery
The mandate: JCAHO requirements
Case studies:
New solution: Sitemarx stamp
Conclusion
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Case 1: Correct and incorrect sites both marked
RN spouse marked husband to avoid error
Wrong testicle removed
Betadine site preparation blurred the words leaving both marks “the same”
Analysis: More than one mark means nothing unique about the correct site
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Case 2: Wrong site marked
Laparascopic LEFT inguinal hernia repair
“L” placed on the RIGHT groin
Analysis: “R” and “L” didn’t hold meaning for the team…added to confusion
Failure to correlate with medical record
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Case 3: Ambiguous site marking
Surgery on lumbar instead of thoracic level
Surgeon signed site in letters that covered both the lumbar and thoracic levels
Physician was thinking of a different patient
Analysis: Mark too large for clarity or guidance
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Case 4: Imprecise site mark
Index finger surgery instead of ring finger
Neither finger was normal
Mark correctly identified the hand but not the digit
Analysis: Lack of specificity of the site mark
No rules to guide the team as to acceptability
Different error than back surgery mistake
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Case 5: Authorship of site mark unclear
Surgery intern marked wrong kidney
Nurse assumed attending initials
Attending assumed fellow initials
Patient assumed academia meant accuracy
Analysis: Relied on system of initials to avoid errors.
No one knew owner of site mark initials
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Case 6: Site mark washed off
Correct knee marked by surgeon but incorrect knee prepped for surgery
Surgery team members not bothered by lack of mark as they frequently see the ink washed away in the preparation
Analysis: The use of markers not specifically designed for site marking caused failure because the marker itself was unreliable
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Case 7: Unclear if site marking required
Ear surgery performed on incorrect ear without any preoperative site mark
Patient was hospital employee and the surgeon well liked by staff
Nurses later pointed out that not every surgery requires a site mark
Analysis: The rules for marking are flawed by a loophole
The correct rule was not applied by any surgery team members
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Agenda
Introduction: speaker credentials
The problem: wrong site surgery
The mandate: JCAHO requirements
Case studies:
New solution: Sitemarx stamp
Conclusion
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A new solution…
A tool specifically engineered to reduce the risk of wrong site procedures and facilitate meeting Joint Commission requirements
This tool leads to a standardized system for surgery site marking that does not vary from patient to patient, or from surgeon to surgeon.
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The solution: Key requirements
A consistent and unambiguous mark
Able to withstand a skin prep
Does not introduce increased risk or complexity to the preoperative process
No added risk of perioperative infection
Meets or exceeds JCAHO requirements
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The Sitemarx stamp
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Stamp benefits: Consistency
Consistency
From patient to patient and surgeon to surgeon, the same mark is used. This provides a visual expectation in the OR. Industrial engineering has shown that humans are visual creatures, and if a subconscious visual expectation is not met it is usually rapidly consciously noted.
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Stamp benefits: Unambiguous
Unambiguous
The stamp face can be made to imprint an unambiguous message - in this case “CORRECT SURGERY SITE”
With this system, every patient, every surgeon, will be marked unambiguously
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Stamp benefits: Withstanding the prep
Withstanding the prep
The stamp uses an non-toxic skin ink designed for marking voters. Testing has demonstrated that this ink will withstand the sterile prep far better than current markers.
Most of the markers currently used withstand the sterile prep very poorly. Many use inks with the warning label “avoid contact with unprotected skin”
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Stamp benefits: Safety
Safety
The stamp uses a non-toxic skin ink.
The ink used in some of the markers currently bear the warning label “avoid contact with unprotected skin”
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Stamp benefits: Reduced complexity
Reduced complexity
The complexity of current methods for preventing wrong site procedures is increased due to the variability of the marking process. Using the stamp, the processes are simplified.
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Stamp benefits: Reduced infection risk
Reduced infection risk
Current markers are frequently not sterile and often used on multiple patients.
The stamp is individually packaged and sterilized for single-use.
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JCAHO requirements
"The method of marking and type of mark should be consistent throughout the organization." JCAHO 2003, Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.
"... the mark must be unambiguous and the process should be consistent throughout the organization." JCAHO, January 3, 2005, Frequently Asked Questions About the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.
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JCAHO requirements
A single use, sterile, indelible ink, disposable surgical site marking stamp provides a consistent, lasting, and unambiguous mark on the surgical site.
Facilities that adopt this stamp as part of their process for site marking can achieve the uniformity, consistency and lack of ambiguity that is JCAHO's goal.
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JCAHO requirements
In addition, multiple facilities utilizing this stamp in the same geographic area further meets JCAHO's goal of achieving consistency and uniformity. JCAHO recognizes that since physicians, nurses, anesthesiologists and other health care workers work in multiple institutions, consistency between institutions, not just within an institution, improves patient safety and decreases patient errors.
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Case review: How stamp would impact results
Case 1: Correct and incorrect sites marked
Stamp clearly and unambiguously intended for the correct site only
Case 2: Wrong site marked
Interpreting the nature of individualized marks adds a distracting additional task to the site marking process. The consistency of the stamp eliminates this interpretation task, simplifying the process and eliminating a source of error
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Case review: How stamp would impact results
Case 3: Ambiguous site mark
Mark made by the stamp is clear, unambiguous, and does not vary from surgeon to surgeon
The use of "R" and "L" and other surgeon individualized marks distracts from the task at hand and therefore lends itself to increased probability of error. The nurse must attend to that individualized mark instead of confirming a visually expected mark and correlating location with the chart
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Case review: How stamp would impact results
Case 4: Imprecise site mark
Stamp size (2 cm) facilitates precise, consistent site marking, including small sites such as fingers and toes
Case 5: Authorship of site mark unclear
The mark made by the stamp is consistent from surgeon to surgeon. Authorship lies not in the nature of mark but in the identity of the user of the stamp. This eliminates variability that can lead to error.
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Case review: How stamp would impact results
Case 6: Site mark washed off
The ink used in the stamp is specifically designed to withstand a sterile skin prep.
Case 7: Unclear if site marking required
Could still occur, but the ease of use of the stamp should facilitate its use in any case where the need for site marking is questioned.
VA: All sites must be marked. The ease of use of the stamp facilitates this goal.
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Agenda
Introduction: speaker credentials
The problem: wrong site surgery
The mandate: JCAHO requirements
Case studies: failures to meet JCAHO measures
New solution: Sitemarx stamp
Conclusion
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What Can JCAHO Do Now?
Incorporate principles of error reduction into safety procedures
Collect near-miss data without penalty Committee of clinicians and safety experts to analyze
data Mandate best practices such as a “correct site”
stamp
Don’t be afraid to reassess and change
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What can the rest of us do? Adopt safety as a core value from the top down Collect near-miss data without punishment Teach principles of error reduction Work with statewide organizations for consistency
across facilities
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Conclusion
Wrong site and wrong patient surgery remains a problem
Eliminating wrong site and wrong patient surgery will require widespread utilization of principles of error management, accepting safety as a core value
Healthcare leaders need to embrace a commitment to studying our mistakes, developing best practices and sharing solutions nationwide
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Conclusion
However, many of the errors occurring today are related to specific problems with the site marking process
A single use, sterile, indelible ink, disposable surgical site marking stamp provides a consistent, lasting, and unambiguous mark on the surgical site
In a simple and easy to use manner, this device addresses many of the problems with the current site marking process that lead to wrong site and wrong patient errors
