Surgical safety

Man Mohan HarjaiPatient safety is the absence of preventable harm

to a patient during the process of health care

Magnitude of the problem

• 234 million operations globally

» 1:25» Live births

• 1 million deaths• 7 million disabling

complications• >50% preventable

NEJM Jan 2009

Magnitude of the problem

– 50-60% of all hosp adm will require surgery

– Major complications: 3 -16%

– Deaths: 0.4 - 0.8% (Developing countries: 5-10% mortality)

– Surgical site infections 14%

NEJM Jan 2009

Incorrect surgery

0%5%

10%15%20%25%30%35%40%45%50%

Left right mix up

wrong patient

wrong implant

wrong site

Seiden, Archives of Surgery, 2006

Incorrect surgery– There are between 1500 and 2500 wrong site surgery

incidents every year in the United States (Seiden, Archives of Surgery, 2006)

– In a survey of 1050 hand surgeons, 21% reported having performed wrong-site surgery at least once during their careers (Classen, New England Journal of Medicine, 1992)

Causes: Management related• Lack of protocols and checks • Shortfalls in training• Lack of supervision of junior surgeons

when performing surgeries• Understaffing• Time constraints• Inadequate equipment• Communication breakdown

Causes: Surgeon related

• Inappropriate or delayed referrals• Improper planning of the operations• Operating outside ones expertise• Lack of teamwork skills

• Communication breakdown at various levels between

-Operating surgeon and assistant surgeon and the patient-Anesthetist and the surgeon/patient

From JCAHO website as of July, 2007

Least No of doctors and nurses per patient authorised

S No Recommending auth Type of Authority Medical Officer Spl Offrs Nur Offrs

1 Ganga Ram Corporate 1 per 4 beds 1 per 4 beds 1 per 1.1 beds

2 Escorts Corporate 1 per 4 beds 1 per 3 beds 2 per 1 beds

3 Batra Corporate 1 per 3 beds 1 per 5 beds 1.3 per 1 beds

4 NIHFW 1988 Autonomous 1 per 15 beds 1 per 18-22 beds 1 per 3 beds

5 BIS 2001 Govt 1 per 10 beds 6 per 30 beds 1 per 3 beds

6 Bajaj Commitee Govt 1 per 15 beds 1 per 17 beds 1 per 3 beds

7 Army Norms 1960 Govt 1 per 50 beds 1 per 33 beds 1 per 5-20 beds

Commercial aviation has many errorsBut few crashes

Different Perspective

• Odds of dying in air crash 1 in 10 million

• Odds of dying in hospital 1 in 300

• 33,000 X risk

Human Error-Costly

Errors COST - LIFE

Surgeon• Long hours over a number of

years spent in surgical training may make a surgeon competent but that does not always translate into safe surgeon

Surgeon• At the beginning of the surgical career the

surgeon learns “how to operate”

• Then with experience “when to operate”

• It is only with maturity he or she realizes “when not to operate”

Has anyone seen my watch? Wait a minute, if this is his spleen, then what's that?What do you mean he wasn't in for a sex change!Everybody stand back! I lost my contact lens!What do you mean, he's not insured?Let's hurry, I don't want to miss “Bay Watch”

SurgeonA List of Things You Don't Want to Hear During Surgery Oops!

Operation theatres Dangerous places

• Swabs retained -1 in 8801 to 1 in 18,260 operations -88% reported correct sponge count

N Engl J Med 2003; 348: 229 - 35

avoidable negligence

Operation theatresDangerous places

• Clamps left in situ• Wrong side surgery• Anaesthesia deaths

N Engl J Med 2003; 348: 229 - 35

ERROR

“Behaviour which fails to achieve its desired result”

“Doing the wrong thing when meaning to do the right thing”

Make Headlines!

Wrong side surgery

Surgical errors on the front pages of papers -Amputation of the wrong leg-Removal of the wrong breast-Operation on the wrong side of the brain

When a patient dies-----

• Medical case–What happened?

•Surgical case

–What did you do?

Conventional approach to any failure• “Blame and Shame” • Not helpful in improving patient safety or

reducing the incidence of severe complications– concealed – rather than studied, understood and prevented

Report an eventTo prevent the next

Medical Errors as Systems Problems

• Wrong site surgery represents a "classical" system error rather than pure human failure by an individual surgeon

• Systems can be designed to back up human error (sometimes imperfect human memory)

To err is human . . .To cover up is unforgivable . . .To fail to learn is inexcusable . . .

- Liam Donaldson

Cost of errors

• UK - £02 billion annually

• (850,000 adverse events / yr)

• USA - $29 billion each year

Lessons from AviationIndustry decided to look beyond pilot error or individual failure

Mandatory reporting of any mishap within 24hrs

Pilots are taught to acknowledge their own limitations

Susceptibility to error• Surgeons and nurses tend to downplay

the effects of stress and fatigue

• This denial is ingrained from the time of medical college & residency

• Leads to adverse events

• This attitudes of personal invulnerability – needs change to prevent errors

Sexton et al BMJ 2000; 320: 745 - 9

Zero Error state is impossible• It is important

not to blame individuals for what went wrong but to understand why what they did at the time made sense to them

Sidney Dekker

 

Expected to work error free• In an environment

– we perform multiple concurrent tasks

– in a setting of very high workload

– with often-minimal organisational support

Methods to prevent errors

• System of universal reporting (anonymous)

• Human factors• Situational awareness• Speak up• Red flags

• Standard Operating Procedures

• Safety checklists (WHO)

• Briefing and Debriefing

• Scripted handoffs

Human Factors • 90% communication breakdowns occur verbally

– 40% the information was transmitted in an inaccurate fashion

– 50% it was never transmitted at all• Written orders and checklists should support

inter-individual verbal communication including – the count of sponges and surgical instruments– in order to reduce the incidence of adverse events

American College of Surgeons' closed claims study

Standard Operating Procedure (SOP):

Resident

CT

ConsultantTO

O STE

EP

Hierarchy

Speak up

Surgery Count Whiteboard

Never happen to

me

25% of surgeons in 35 yr career

Leadership-WHO

WAPS (World alliance for patient safety)Global Patient safety challenges

2005 - Clean care is safer care2007 - Safe surgery saves lives 2010 - Tackling antimicrobial resistance

What Can an Operating Room Learn from a Cockpit?

> 70% aviation accidents due to human error

Checklist For standard procedure like take off and landing

Ten Objectives of Safe Surgery Saves Lives

1. Correct patient / correct site2. Prevent harm from anaesthetics3. Prepare for airway emergencies4. Prepare for high blood loss5. Avoid allergies6. Minimize surgical site infections7. Prevent retention of instruments/ sponges8. Accurately secure and identify specimens9. Effectively communicate critical information10. Establish surveillance of capacity/ volume/ results

Check listAim

• Timely and efficient steps Pre, intra and post op

• Follow a few critical steps

minimize common risks

Surgical Safety Checklist (WHO)

19 item checklist

• Sign In (before induction of anaesthesia)

• Time out (before skin incision)

• Sign out (before patient leaves OT)

Additions and alterations encouraged at local practice

Examples of benefit of Checklist

• Severe OA-Knee replacement• Policy-put TED stocking on healthy

leg by nurse• Pt himself puts on the stocking• OT with stocking on Right leg• Sign In• Wrong leg had been marked

Examples of benefit of Checklist• Severe OA- Knee replacement• OT• Preop Antibiotic• Anaesthetised• Time out before Incision• Correct Knee prosthesis NA

Testing the Checklist

London, UK EURO EMRO

WPRO I

SEARO

AFRO

PAHO I

Amman, JordanToronto, Canada

New Delhi, India

Manila, Philippines

Ifakara, Tanzania

WPRO II

Auckland, NZ

PAHO II

Seattle, USA

The Results

Site Cases Inpatient Complication Inpatient Death

1 524 11.6% 1.0%2 357 7.8% 1.1%3 497 13.5% 0.8%4 520 7.5% 1.0%5 370 21.4% 1.4%6 496 10.1% 3.6%7 525 12.4% 2.1%8 444 6.1% 1.4%

Total 3733 11.0% 1.5%

Outcomes at BaselineOutcomes at Baseline

N Engl J Med 2009; 360:491-499

Results - Process Measures Results - Process Measures Baseline Checklist P-value

Objective Airway Evaluation 64.0% 77.2% <0.001

Abx at 0-60 Mins Except Dirty Cases

56.1% 82.6% <0.001

Verbal Pt/Site Confirmation 54.4% 92.3% <0.001

Two IVs /Central Line if EBL≥500

58.1% 63.2% 0.32

Pulse Oximeter 93.6% 96.8% <0.001Sponge Count 84.6% 94.6% <0.001All Six Safety Indicators Done

34.2% 56.7% <0.001

N Engl J Med 2009; 360:491-499

Results – All SitesResults – All SitesBaseline Checklist P value

Cases 3733 3955 -

Death 1.5% 0.8% 0.003

Any Complication 11.0% 7.0% <0.001

SSI 6.2% 3.4% <0.001

Unplanned Reoperation 2.4% 1.8% 0.047

N Engl J Med 2009; 360:491-499

Change in Death and Complications Change in Death and Complications by Income ClassificationIncome Classification

Change in Complications

Change in Death

High Income 10.3% -> 7.1%* 0.9% -> 0.6%

Low and Middle Income 11.7% -> 6.8%* 2.1% -> 1.0%*

* p<0.05Haynes et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. New England Journal of Medicine 360:491-9. (2009)

effect was of similar magnitude in both high and low/middle income country sites

Advantages of using a Checklist

Customizable to local setting and needs Supported by evidence Evaluated in diverse settings around the world Promotes adherence to established safety

practices Minimal resources required to implement a far-

reaching safety intervention

Never EventsSerious reportable surgical events (“never events”) as defined by the

National Quality Forum consensus reportSurgical “never-events”

1 Surgery performed on the wrong body part

2 Surgery performed on the Wrong patient

3 Wrong surgical procedure performed on a patient

4 Unintended retention of a foreign object in a patient after surgery or other procedure

5 Intra-operative or immediate postoperative death in an ASA grade I patient

A culture of zero tolerance for "never events" is a key to keeping patients safe

Universal adoption!!!• Pilots-checklists

– Careless mistake/oversight– lead to his death

• Surgeon’s physicians mistake-patient dies

NEJM 2009

What papers say• Interprofessional checklist briefings reduced

the number of communication failures by 34% Arch Surg. 2008

• Makes operations safer everywhere BMJ 2009

• Handover errors 39% - 12% Paediatr Anaesth.

2007

• Giving antibiotics within two hours of incision reduced the risk of surgical site infection by one third

Joint Commission, Sentinel Event Statistics, 2006

Currently surgical teams do most of the right things, on most patients, most of the time

The checklist helps us do all the right things, on all the patients, all of the time

Reality check

Challenges for futureBalancing No Blame

With accountability

NEJM Oct 2009

How we can achieve………..• Developing a culture of safety • Show support from the top and the middle • Promote reporting • Involve and communicate with patients and the

public

• Exhibit dogged and determined leadership

• Integrate the effort

• Provide recurrent training• Implement solutions to prevent harm

ConclusionError• Is a starting point

– not a conclusion

• Demands explanation– Is not an explanation for trouble – Not from individual– From the system– To prevent such errors being repeated

Conclusion

• The surgical safety can be enhanced by implementation of surgical time-out paradigm as a quality control tool for standard surgical care

visionEvery surgical patient in Shri Mata Vaishno Devi Narayana Superspeciality Hospital will receive the highest quality and safest care in all surgical settings

purposeDevelop an integrated system for hospital surgical teams to provide the highest quality of care and the safest environment using evidence based medicine in the surgical setting

Conclusion