Checklists after Gawande

Transcription

1 Checklists after Gawande John A Windsor University of Auckland Member, WHO Safer Surgery Study Group

2 CAUSE OF DEATH Lack of clean water and basic healthcare for children DEATHS PER DAY 30,000 Smoking 14,000 Iatrogenic harm acute care 10,000 HIV / AIDS 8,000 Road traffic accidents 3,000 Natural disasters 100 Terrorism 20 Runciman et al. Safety and Ethics in Healthcare. 2007

3 BMJ May 2009

4 Where to start? WHO formed the Safer Surgery Study Group

5 50% of avoidable error occurs in the OR

6 Some errors in the OR Risk of Infection Giving antibiotics within one hour before incision can cut the risk of surgical site infection by 50% ¹ Bratzler, The American Journal of Surgery, Classen, New England Journal of Medicine, 1992.

7 Some errors in the OR Wrong site surgery wrong site surgery incidents every year in the United States.¹ 21% of 1050 hand surgeons reported having performed wrong-site surgery at least once during their careers.² ¹ Seiden, Archives of Surgery, ² Joint Commission, Sentinel Event Statistics, 2006.

8 Some errors in the OR Anaesthetic incidents An analysis of 1256 incidents involving general anaesthesia in Australia showed that pulse oximetry on its own would have detected 82% of them.¹ ¹ Webb, Anaesthesia and Intensive Care, 1993.

9 Some errors in the OR Miscommunication Root cause of nearly 70% of the events reported to the Joint Commission from ¹ A preoperative team briefing was associated with enhanced prophylactic antibiotic choice and timing, and appropriate maintenance of intraoperative temperature and glycemia.², ³ ¹ Joint Commission, Sentinel Event Statistics, ² Makary, Joint Commission Journal on Quality and Patient Safety, ³ Altpeter, Journal of the American College of Surgeons, 2007.

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12 Checklists in Healthcare Not novel Google checklist 53,200 hits checklist + operating room 27 hits Checklists are only one strategy to improve quality and institute a safety culture others include: systematic incident monitoring root cause analysis of adverse events training based on objective assessment

13 Functions of checklists Overall to ensure the correct execution of a given procedure or set of tasks Range of functions of checklists Help create and maintain a safety culture A defense strategy to prevent human errors A memory-aid to enhance task performance Standardization of the tasks Facilitate team coordination Support quality control by management Verdaasdonk et al. Surg Endosc 2009

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15 Methods Two phase observational study Initial baseline measures (~3 months) Deliberate introduction of checklist Repeat measurements (~3 months) Three phase checklist Sign-in, before induction Time-out, after induction and before incision Sign-out, before patient leaves theatre

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17 The Checklist was piloted in 8 cities PAHO I Toronto, Canada EURO London, UK EMRO Amman, Jordan PAHO II Seattle, USA WPRO I Manila, Philippines AFRO Ifakara, Tanzania SEARO New Delhi, India WPRO II Auckland, NZ

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20 Results All Sites Baseline Checklist P value Cases Death 1.5% 0.8% Any Complication 11.0% 7.0% <0.001 SSI 6.2% 3.4% <0.001 Unplanned Reoperation 2.4% 1.8% Haynes et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. New England Journal of Medicine 360: (2009)

21 Advantages of Surgical Safety Checklist Customizable to local setting and needs Deployable in an incremental fashion Supported by evidence and expert consensus Evaluated in diverse settings around the world Aids adherence to established safety practices Minimal resources required to implement WHO

22 Enthusiastic endorsement

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24 Global adoption of SSC As of April ,791 hospitals registered in 120 countries 25 countries have a national policy on the Surgical Safety Checklist WHO SSSL Newsletter April 2010

25 Hype Cycle

26 Issues with Surgical Safety Checklist Windsor. ANZ J Surg 2009

27 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

28 Study design Confirmation required Only intended as a pilot study Longitudinal observational design A clustered RCT with random allocation to intervention group or control group (no checklist) should be considered to remove confounders and bias Has NEJM study removed equipoise?

29 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

30 One small hospital One rural hospital No private hospitals One developing, three transitional and three developed nations Note only one district rural hospital

31 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

32 SURPASS checklist

33 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

34 Composition Selection criteria for the 19 items were not given, nor the evidence base, and just agreed to be a committee Authors considered that 6 of the 19 items contributed to effect Was it mainly the Hawthorne effect? What is best composition of checklist?

35 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

36 Adherence markedly differed between centres Site 1 (94% before and after) Site 5 (0% before and after) Site 7 (47% before and 92% after)

37 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

38 Counterproductive if SSC duplicated or replaced existing systems, but did not do them as well.

39 Issues with Surgical Safety Checklist Design Representation Scope Composition Compliance Counterproductive Cultural resistance

40 Leading Indian surgeon this will never work in Indian culture surgeons will not introduce themselves to everyone in the theatre they know who I am there is a subservience culture with unquestioning obedience and real fear of insubordination We need heirarchy, and checklist will undermine authority and autonomy

41 Hell, there are ain t no rules around here, we re trying to accomplish something Thomas Edison

42 we have celebrated cowboys, but what we need is more pit crews

43 Atul Gawande Checklists are often met with hostility, because they challenge doctors cherished notions about status, autonomy and expertise. Good clinicians still need expert audacity, but should be ready to accept the virtues of regimentation and standardisation.

44 Professor Alan Merry, author the introduction of the team by name and role results in the activation phenomenon which allows all members of the team to feel free to speak up and question, to wave a flag if something is not right

45 View of the press Ruth Laugeson, journalist one answer is that the gods of medicine have to submit to a simple and unexpectedly powerful discipline: the humble checklist - the real magic is that it disrupts medical heirarchies and promotes teamwork

46 Surgical Safety Checklist The NEJM study is a landmark and it has rightfully generated significant interest. The question posed, one year on, is whether the SSC is being adopted, adapted and applied as envisaged? Has there been an impact?

47 WHO statement There is no standardized way of measuring the impact of the SSC There is an ongoing challenge to create buy-in There is no clear idea about how to sustain the proper use of it WHO SSSL Newsletter April 2010

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49 Technology is easy to develop, but changing a culture is the difficult part. People do not like change. Dean Kamen Segway inventor The Economist 2010

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51 Crossing the chasm Leadership and research

52 Research on Checklist Design elements Elements Simplicity to reduce work and cost Practicality for ease of use Paper vs electronic vs verbal format Strategies To incentivise and change culture To ensure sustainability Impact of checklist on outcome

53 The future of SSC? It has been widely promoted and implemented, but questions remain about whether it will become part of the culture Questions remain about composition, compliance and impact Further research is needed Surgeons have a significant leadership role to play, otherwise...

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56 Hype Cycle

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58 What contributes to effect? Is there a cause - effect relationship? Or could it be due to the fact that the clinical teams were fully aware of being studied (an unblinded study) the Hawthorne effect, as noted by authors McCambridge et al. NEJM 2009

59 The utility of formal protocols varies with the nature of the activity They can disrupt focus and undermine success They can take away the authority to use own judgement, freedom to be responsible, innovate, and solve problems

60 Minnesota

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62 Critique of the checklist Composition There are 19 items in the checklist Selection criteria for items not stated Are all items required or useful? Authors speculated that the positive findings were due to only 6 of 19 items Further studies are required to optimise best composition of the checklist

63 Critique of the checklist Consistency between centres Lack of consistency and adherence differed markedly between centres, e.g. Site 1 (94% adherence before and after) Site 5 (0% before and after) Site 7 (47% before and 92% after)

64 Critique of the checklist Confinement to the OR Safety issues can occur from admission to discharge, raising the question whether the checklist should be confined to OR? Half of all deviations occur outside the OR de Vries et al. Lancet 2008 Dutch Study SURPASS, A to D, but has 100 items, and maybe too cumbersome

65 Critique of the checklist Counterproductive Claiming a 30% reduction in mortality on extrapolation maybe misleading NB MR actually increased in one hospital Result not likely in developed countries when checklist implemented as MR already lower than the published result This might adversely affect credibility of approach and long-term compliance. Martin et al. NEJM 2009: 2373

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68 Dismantling Cultural Barriers Deep-seated believe that surgeon autonomy is crucial to quality care, having freedom to lead and make decisions as patient s primary advocate Other cultural barriers include resistance to being measured, resistance to criticizing colleagues resistance to teamwork

69 Are surgeons ready for checklists and vice versa? Checklists, although not optimised, are being widely implemented. There must be a commitment to continuous improvement of this approach by further research. Surgeons are not all ready for checklists, but those not using it are creating a medico-legal risk, because it is now rapidly becoming standard of care

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73 Dimensions of quality with organizational layers of healthcare Ministry of Health (NZ) 2003

74 Airline Crash Video or Tenerife photograph

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77 Types of checklists

78 Error happens

79 Error in Healthcare Existence recognized since Hippocrates Often caused by the process of healthcare rather than by the underlying disease itself Extent of problem only recognized recently The watershed publication by Institute of Medicine (USA) in 2000: To err is human: building a safer health system

80 Tony Ryall a strong focus on teamwork and communication in the operating room, the main role of the checklist is simply to ensure throughness and consistency, that necessary steps are completed, all the time

81 WHO initiated projected because of Previously underestimated importance of surgery to the overall health of a nation Concern over the on-going problem of iatrogenic harm, particularly in surgery Teamwork identified as the pivotal issue for safer surgery checklist aims for a team conversation It is not just about ticking boxes, but about embracing a culture of teamwork and discipline. 2 minute WHO checklist is just a

82 The hard question, still unaswered, is whether medical culture can seize the opporutnity AG Good clinicians will not be able to dispense with expert audacity, yet we should be ready to accept the virtues of regimentation. The resistance is perhaps and inevitable response

83 Another bestseller?

84 Contribution might be by establishing relationships, forming a team, and instigating three pause points

85 Change in Death and Complications by Income Classification Change in Complications Change in Death High Income 10.3% 7.1%* 0.9% 0.6% Low / Middle Income 11.7% 6.8%* 2.1% 1.0%* Haynes et al. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. New England Journal of Medicine 360: (2009) * p<0.05

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87 Critique of the checklist Cost Authors claimed that the checklist is neither costly nor lengthy No data is provided on either aspect There are additional costs (theatre time, equipment, antibiotics) that have not been accounted for, and maybe prohibitive But WHO has stated that these required for safe surgery Sanders et al. NEJM 2009: 2373

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91 Has it? What impact has the SSC had in your hospital? How would you know?

92 ANZ Launch of Checklist Australia launch in Canberra on 19 August 2009 by Hon. Nicola Roxon, Federal Minister for Health and Aging. New Zealand launch in Wellington on 27 August 2009 by Hon Tony Ryall, Minister of Health. An opportunity to undertake a review, after the first year.

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97 Responsibility of the surgeon

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100 Aviations response to error Mandatory simulation training from 1955

101 Aviations response to error Mandatory simulation training from 1955 Voluntary error reporting from 1977 Anonymous and non-discoverable Non-punitive

102 Aviations response to error Mandatory simulation training from 1955 Voluntary error reporting from 1977 A systems approach to human error system is analyzed to find cause of error operator not named, blamed, shamed

103 Aviations response to error Mandatory simulation training from 1955 Voluntary error reporting from 1977 A systems approach to human error system is analyzed to find cause of error operator not named, blamed, shamed defenses were created to reduce risk of error and adverse outcome one of the defenses is the CHECKLIST

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105 How should we respond? Acknowledge the significance of the study But recognize that success with a single study is not an enduring reduction in M&M Adopt the checklist philosophy Register your hospital with WHO and participate in ongoing developments Adapt the checklist to India and evaluate with a better designed study in India, possibly a strategic role for IASG

106 Do we need a checklist for the checklist? Great concept in theory Preliminary pilot study evidence insufficient, needs confirmation on a regular basis in each institution (it is not a magic bullet)

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108 10 OBJECTIVES for Safe Surgery The team will operate on the correct patient at the correct site. The team will use methods known to prevent harm from administration of anaesthetics, while protecting the patient from pain. The team will recognize and effectively prepare for life-threatening loss of airway or respiratory function. The team will recognize and effectively prepare for risk of high blood loss. The team will avoid inducing an allergic or adverse drug reaction for which the patient is known to be at significant risk.

109 10 OBJECTIVES for Safe Surgery The team will consistently use methods known to minimize the risk for surgical site infection. The team will prevent inadvertent retention of instruments or sponges in surgical wounds. The team will secure and accurately identify all surgical specimens. The team will effectively communicate and exchange critical information for the safe conduct of the operation. Hospitals and public health systems will establish routine surveillance of surgical capacity, volume and results.

110 What can you do? Register on the WHO website as a participating hospital Implement the Surgical Safety Checklist in your hospital Measure results such as deaths and complications and give feedback on checklist implementation based on your personal experience

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112 Deaths Complications

113 Deaths Complications Near Misses

114 Support for implementation WHO Guidelines for Safe Surgery Additional resources available online at Web-based community of hospitals, organizations, and clinicians participating in this program Safe Surgery Saves Lives Program Team based in Geneva and Boston

115 Why should you get involved? Save lives and prevent complications Reduce medical costs related to errors Become a part of a supportive international online network of providers and hospitals using the checklist Participate in a program that identifies your hospital as a leader in patient safety

116 Why delayed recognition of the importance of medical error? Semantics innocuous-labelling of the problem sequelae, adverse events, complications Complacency - accepted as inevitable and expected part of operative surgery Fatalism the price to be paid for the great benefits of modern healthcare Rare and dispersed events that has not been systematically measured

117 Surgical safety is a rapidly becoming understood as a critical issue Checklist study has helped to promote this, although it is neither the first nor necessarily the best approach. Major issues exist (list the C s), and further work is required Checklists are not ready for surgeons and I do not think surgeons are ready for checklists

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121 Medicines response to error Personal approach to human error

122 Medicine: response to error Personal approach to human error

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124 Medicine: response to error Emphasis on human error Poor reporting of error (clinical audit)

125 ? Leave this out Fig 1.1 Dimensions of quality and organizational layers of healthcare Safety is just one dimension to consider The focus of this presentation is confined to this area but clearly cannot consider this in isolation.

126 Surgeons and pilots operate in complex environments where teams interact with technology

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128 Epidemic of error

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141 Deaths per year (USA) Number Civil AVIATION 334 National Transportation Safety Board 2007

142 Deaths per year in USA Number Civil AVIATION 334 MEDICINE 323,993

143 Deaths per year in USA due to medical error Number Civil AVIATION 334 MEDICINE 195,000

144 The number of iatrogenic deaths in the USA was equivalent to 2 jumbo jets full of passengers crashing every 3 days. Leape. Error in Medicine. JAMA 1994

145 There is an epidemic of error in healthcare

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