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What’s New in Safety in the OR?. Keith P. Lewis, R.Ph., MD Professor and Chairman Department of Anesthesiology Boston University School of Medicine June 10, 2014 8:00-9:00 AM. Why Do Accidents Happen?.

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What s new in safety in the or

What’s New in Safety in the OR?

Keith P. Lewis, R.Ph., MD

Professor and Chairman

Department of Anesthesiology

Boston University School of Medicine

June 10, 2014

8:00-9:00 AM

Why do accidents happen

Why Do Accidents Happen?

Accidents appear to be the result of highly complex coincidences which could rarely be foreseen by the people involved. The unpredictability is caused by the large number of causes and by the spread of information over the participants...accidents do not occur because people gamble and lose, they occur because people do not believe that the accident that is about to occur is at all possible.

Wagenaar and Groeneweg, Best Medicine

Lucian leape md

Lucian Leape, MD

Everyone makes errors everyday

No one makes an error on purpose

An error is not misconduct

We make errors for a reason

Why do errors occur

Why Do Errors Occur?




Failure to follow-up

Poor hand-offs (hand-overs)

Ineffective communication

Workload fluctuations

Harvard closed claims review

Harvard Closed Claims Review

Ten years of closed OB claims from Harvard hospitals

2-3 reviewers

Structured review form

Consensus required

Most common team-related deficiencies

Failure to cross-monitor: 76%

Poor communication:67%

42% of cases could have been prevented or mitigated with better teamwork

Teamwork is a solution

Teamwork is a Solution

It is the unidentified, uninterrupted error that may cause harm.

Professionals trained in team behaviors are prepared to recognize, manage, and/or mitigate the impact of an unfolding error.

- Team Performance Plus

Potential crises

Potential Crises


Transfusion Reactions

Malignant Hyperthermia

Difficult Airway


Electrical Safety

Cardiac Arrest

But what do they have

in common?

What s new in safety in the or

Recognition, Management, and Prevention

of Specific

Operating Room Catastrophes

Presented at the American College of Surgeons 89th Annual Clinical Congress,

Chicago, IL

Christopher R. McHenry MD, Ramon Berguer MD, FACS, Rafael A. Ortega MD

Journal of the American College of Surgeons

Volume 198, Issue 5 , May 2004, Pages 810-821

It’s Everyone’s Business!

Features in common

Features in Common

Critical incidents

Reason’s Swiss Cheese

Relatively Rare

Training (and re-training) Required

Communication issues

Fixation Errors

Reportable events

Litigation Prone

What is a critical incident

What is a “Critical Incident”?

Term made famous by Cooper

Defined: Occurrences that are “significant or pivotal, in causing undesirable consequences

Also defined as: An event that led, or could have led to a problem

Critical Incidents provide opportunity to learn about factors that can be remedied

Preventable anesthesia mishaps: a study of human factors. Anesthesiology. 1978 Dec;49(6):399-406.

What s new in safety in the or


Reason’s Swiss Cheese

Successive Layers of Defenses



Precondition for

Unsafe Acts





Based on: Reason, J. (1990) Human Error. Cambridge: University Press, Cambridge

What s new in safety in the or

Aligned Holes

Example: wrong site / wrong patient

Failed or Absent


Based on: Reason, J. (1990) Human Error. Cambridge: University Press, Cambridge

What s new in safety in the or

System Failure

Based on: Reason, J. (1990) Human Error. Cambridge: University Press, Cambridge

What s new in safety in the or


Analyze all critical incidents, including the ones that could have led to a problem

Use a standardized approach to identify causes, system failures, and opportunities for improvement.

Where was the “hole” in the Swiss cheese?

What s new in safety in the or

Cardiac Case

“Eight thousand of heparin”


“A thousand of heparin”

Communication Error

Communication challenges

Communication Challenges

Language barrier


Physical space



Varying Communication Styles


Lack of Verification of Information

Shift Change/Handoffs

Communication is

Communication is…

The effective and accurate transfer of information from one provider to another

More than simply speaking

The responsibility of both the sender and receiver to ensure that the information has been transferred

Communication is the response you get to a message you sent regardless of the intent anonymous

“Communication is the response you get to a message you sent regardless of the intent” (anonymous)

Words account for 7% of message*

Tone of voice accounts for 38%

Body language accounts for 55%

*Mehrabian 1971

What s new in safety in the or

Stairway of Communication








Not said

Not done

Not understood


Not heard



Closing the loop

Modified from Miller’s Anesthesia. Elsevier 2009

Standards of effective communication

Standards of Effective Communication




Avoid jargon (e.g. prohibited abbreviations)


Directed at an individual


What s new in safety in the or

Communication Error

Standard practice in the military, esp. in the Navy, is to use “voice procedure” to maximize clarity of spoken communication and reduce misunderstanding.

Control Room aboard USS Seawolf submarine. (courtesy of www.navy.mil)



  • Use Closed-Loop Communication whenever possible.

The ether screen

“The Ether Screen”

What s new in safety in the or

Transparent Drapes

Transparent Ether Screens: The Road to New Transparency

Ortega R, Gonzalez M, Lewis K

ASA Newsletter , February, 2010

What s new in safety in the or

The Missing Kidney

In December 1954, Dr. Murray performed the world's first successful kidney transplant between the identical Herrick twins at the Peter Bent Brigham Hospital.

What s new in safety in the or


Foreign Body










Chest Rigidity



What s new in safety in the or

Safety Trumps Efficiency

Is it ok to proceed

Is it OK to Proceed?







What s new in safety in the or

Most Departments



What s new in safety in the or



Ideal Department

Ok model card

OK Model Card

What s new in safety in the or



Small chin

Short neck





MP l

Small chin

Short neck

MP lll

Small chin

MP ll


What s new in safety in the or


Use an approach that prompts matching preparationwith the complexity of the challenge ahead.

Application of ok to proceed

Application of OK to Proceed

Retained Foreign Body

Wrong Site Surgery

Retained foreign body

Retained Foreign Body

Axial CT of face showing foreign body in right TM joint region

Agarwal et al., Otolaryngology 2013, 3:3

Retained foreign bodies

Retained Foreign Bodies

Incidence: 1/8001 to 1/18,760

Final Instrument Count Often Correct

Never Event

Devastating for the patient: Infection, abscess, need for additional surgery

Assess complexity before your proceed

Assess COMPLEXITY Before Your Proceed

  • Know Risk Factors

    • Multiple Surgeons Present

    • BMI >40

    • Rapid Closure/Changed Procedure

    • Procedure Done Different from Original Plan

    • Multiple Team Changes

      NEJM 2003;348:229-35

Add levels of preparedness


Part of Universal Protocol

Mandate X-ray for High Risk Procedures

Manual/Visual Inspection of the Cavity

Notification of Location on Field

Retained Foreign Body Alert

Train and Educate the Radiologist

Avoid CUTTING pledgets

Wrong site surgery

Wrong Site Surgery

Wrong site surgery1

Wrong Site Surgery

  • Incidence: 1/112,000

    • Per year in a 300 bed hospital

    • Wrong-side arthroscopy: $450,000

      Wrong cervical disc: $1,175,000


  • National Quality Forum – Never Event

  • Joint Commission – Sentinel Event

    Ann Surg 2007;246:395-405

Joint commission s evaluation of 126 cases

Joint Commission’s Evaluation of 126 Cases


General Surgery20%

Maxillofacial, CV,14%

Oto, Ophthalmology


All Others14%

Ambulatory (58%), Inpt OR (29%), ER/ICU (13%)

Sentinel Event Alert 2001;Dec 5:24:1-3

Wrong site surgery in otolaryngology head and neck surgery

Wrong Site Surgery in Otolaryngology-Head and Neck Surgery

  • Medline database 1980-2013

  • 0.3%-4.5% of all wrong site surgery events

  • Wrong site surgery accounts for 5-6% of OTO medical errors

  • 9-21% of otolaryngologists report experience with WSS

  • Major issues: Inverted imaging and ambiguity on site marking

  • Temporary injuries with few cases of permanent disability or death

  • Future: Standardized protocol to confirm imaging accuracy and specialty or procedure specific checklist

    Liou T, et al. Laryngoscope, May 2013

What are the system breakdowns

What Are The System Breakdowns?

Not verifying consent or site markings

Surgeon specifying the wrong site

Not completing a PROPER TIMEOUT

Inaccurate consents/diagnostic reports/images

Patient positioning (either concealing mark or promoting site confusion)

Anesthesia interventions prior to Timeout

Complexity what are the risk factors

COMPLEXITY: What Are The Risk Factors?

  • Unusual physical characteristics/equipment

    set up

  • Multiple procedures/multiple surgeons

  • Surgeon characteristics (left-handed surgeons)

  • Time pressures

  • Permanency of marking

  • Lack of patient/family involvement

For preparedness need a standardized approach

For PREPAREDNESS: Need A Standardized Approach

Everyone marks the same way with same pen

Always before induction of anesthesia

Always use the preoperative checklist


Conducted by specific provider

For preparedness need a standardized approach1

For PREPAREDNESS: Need A Standardized Approach

  • Final Pause Occurs Before Incision


  • Repeat for multiple surgeons

  • Anyone can say Stop (TEAMS work)

  • Verification of discrepancies and resolution

  • Monitor compliance with protocol

The who checklist

The WHO Checklist

  • Divides the operation into 3 phases

    • Before induction (Sign In)

    • Before incision (Time Out)

    • Before leaving the OR (Sign Out)

  • Aim: “to reinforce accepted safety practices and foster better communication and teamwork between clinical disciplines…it is intended as a tool for use by clinicians interested in improving the safety of their operations and reducing unnecessary deaths and complications.”

Concepts for success

Concepts for Success

  • Sincere commitment and embraced by surgery, anesthesia and nursing

  • Adapted to local routines and expectations


  • Identified “coordinator” or “leader”

  • Verbal process

  • Includes the patient whenever possible

Bmc s universal protocol has

BMC’s Universal Protocolhas

81 Boxes

Crisis checklists for the or development and pilot testing

Crisis Checklists for the OR: Development and Pilot Testing

  • Developed checklists

  • 12 of the most frequent OR crises

  • Evidence-based metrics of essential care

  • Checklists resulted in a 6-fold increase in adherence to critical steps in management

  • Patient harm persists despite QI and patient safety initiatives

    J Am Coll Surg 2011;213:212-219, Gawande

What s new in safety in the or

Ziewacz et al; J Am Coll Surg; 2011

Or scenario

OR Scenario

  • Mandated attendance

  • 2 entire OR teams

  • Delayed start of OR in 2 rooms (9:30 AM)

  • Fire/bleed

  • Robust debriefing

  • 2 sessions/month

Top 10 saves

Top 10 Saves

Air Embolism

Malignant Hyperthermia


Stent Thrombosis

Pulmonary Hypertension

Critical Aortic Stenosis

Positioning Injuries

Negative Pressure Pulmonary Edema


Torsades de Pointe


Transformational changes

Transformational Changes

  • New forms of care delivery

    -TIVA, pumps, closed-loop

  • New reimbursement

  • New configuration of skill set

  • Disruptive changes

    -Population based care, full risk care, ACOs, bundled payments, outcomes-based reimbursement

    Those that make things happen, those who watch things happen and those that wondered what happened

    Ellison Pierce

Or trauma spine plasma screen

OR Trauma/Spine Plasma Screen

What s new in safety in the or


What s new in safety in the or


Airway teams training

Airway Teams Training

A Comprehensive Difficult Airway Team Training and Evaluation: Impact on Staff Education, Patient Outcomes and Patient Safety

Team Training Program in Simulation

Test train in our simulation center

Test/Train in Our Simulation Center

No longer induction to emergence

No Longer “Induction to Emergence”

Dismantling cultural barriers

Dismantling Cultural Barriers

“Precious as this passion for patients’ interests might be, physician autonomy is not synonymous with quality. For the needed structural and operational changes--performance measurement, process improvement, teamwork--to become mainstream, doctors must accept that to be all-caring is different from being all-knowing or all-controlling”.

Turning Doctors into Leaders

Thomas Lee, HBR, April 2010

What s new in safety in the or


Is it OK to Proceed?

Universal Protocol


Take a look at yourself

Take A Look At Yourself

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