What’s New in the Patient Safety World


October 2009


·        Complications – Prevent Them or Manage Them Better?

·        Warfarin for Atrial Fibrillation – Too Much? Or Just the Wrong Patients?

·        A Cautious View on CPOE

·        Unintended Events in the ED

·        A Better Tool for Predicting ICU Need in Community-Acquired Pneumonia?

·        Joint Commission Activities




Complications – Prevent Them or Manage Them Better?


Last week’s New England Journal of Medicine had a real wake-up call in it. The article “Variation In Hospital Mortality Associated With Inpatient Surgery” (Ghaferi et al 2009) had some stunning revelations. They demonstrated, using data from the National Surgical Care Improvement Project (SCIP), that the two-fold variation in surgical mortality rates amongst hospitals is not explained by the characteristics of the patients or by the occurrence of complications. Complication rates, in fact, were quite similar at high-mortality hospitals and low-mortality hospitals. What differed, however, were the mortality rates in those cases where major complications occurred. The study thus lends credence to the concept raised by Silber et al (Silber 1992) of “failure to rescue” as the major explanation for differences in mortality across hospitals. Essentially what it implies is that the variation in mortality rates is due to differences in the way hospitals react to and manage complications. Though the current study just looked at surgical mortality rates, we’d bet the findings would be similar if a number of medical conditions were studied.


We have long looked at some of the public “quality” report cards on hospitals and been skeptical about inferring anything about quality based on the mortality rates or complication rates in those databases. They have largely been based on administrative data (submitted for reimbursement purposes) rather than clinical data. The severity adjustments in those have been questionable. And when you see hospitals with low complication rates but long average lengths of stay, you can be pretty sure the hospital is probably underreporting complications. But the new study by Ghaferi et al. is different. It did not rely on administrative data. Rather it used the clinical data from the SCIP project that was well risk-adjusted, clinically detailed, and identified complications accurately.


So does this mean we should no longer spend our efforts trying to prevent complications? Of course not. Patient safety efforts to prevent complications are still critical from both quality and cost-effectiveness standpoints. But it does tell us we need to re-examine how we identify complications and how we respond to them. Ghaferi et al. speculate that studies showing improved quality with better nurse:patient ratios may be one of those factors. Staffing and processes in the ICU may be another area of difference. This may also stimulate further research efforts into computer surveillance programs that, for example, can identify sepsis earlier than even the most skilled clinicians can.


What is clear is that we are going to hear a lot more about this phenomenon over the next year.





Ghaferi AA, Birkmeyer JD, DimickJB. Variation in Hospital Mortality Associated with Inpatient Surgery. The New England Journal of Medicine 2009; 361:1368-1375




Silber JH, Williams SV, Krakauer H, Schwartz JS. Hospital and patient characteristics associated with death after surgery: a study of adverse occurrence and failure to rescue. Med Care 1992; 30: 615-29





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Warfarin for Atrial Fibrillation – Too Much? Or Just the Wrong Patients?


For years we have heard over and over that anticoagulation with warfarin is underutilized in patients with atrial fibrillation. We’ve heard that most patients with atrial fibrillation other than those with uncomplicated atrial fibrillation should be fully anticoagulated unless contraindications were present. We’ve even had complex calculations tell us the number needed to treat and the financial implications of strokes that could have been avoided by use of warfarin.


Now a new study (Singer 2009) has challenged conventional wisdom by looking at a new risk stratification of patients with atrial fibrillation and showing the benefit of warfarin is not uniform in patients with atrial fibrillation. The study used data from a large healthplan database (the ATRIA study cohort) to look at outcomes in patients with atrial fibrillation who were stratified by the CHAD2 score. The CHAD2 score assigns one point for CHF, diabetes, hypertension, age 75 or older and two points for a history of prior stroke or TIA. It also utilized an outcome formula that included not only the outcomes of ischemic stroke and systemic emboli but also the risk of intracranial hemorrhages attributable to anticoagulation (thus the net benefit).


As expected there was a net clinical benefit for the whole group on warfarin. But the subgroup analysis revealed some surprising findings. The net benefit was greatest for those patients having a history of prior stroke and those age 85 and older. The latter group, of course, is one in which the argument of increased risk for intracranial hemorrhage has often used to justify not anticoagulating.


There was a clearcut benefit for warfarin in patients with the highest CHAD2 score (4-6) but there was no net benefit in those with a CHAD2 score of 0-1. Clinical benefit began for those with a CHAD2 score of 2. Overall, almost half of the patients anticoagulated with warfarin had no clinical benefit. Though the study was retrospective and used administrative data to determine outcomes, it confirmed the value of using CHAD2 scores to stratify patients and confirmed the benefit of anticoagulation in the very elderly that had also been seen in the BAFTA trial.


Lessons from this study?

1)      Don’t ignore the very elderly with atrial fibrillation. They have the most to gain from anticoagulation.

2)      Patients with prior stroke or TIA also have the most to gain from anticoagulation.

3)      Patients with few clinical risk factors (CHAD2 score of 0-1) are not likely to have a net benefit from anticoagulation.


So not only have we probably been anticoagulating many patients in whom there is no net benefit, we have probably also been ignoring the group in which the most net benefit is seen.





Singer DE, Chang Y, Fang MC, et al. The Net Clinical Benefit of Warfarin Anticoagulation in Atrial Fibrillation. Ann Intern Med 2009; 151(5): 297-305




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A Cautious View on CPOE


Though we have always been and continue to be strong advocates of CPOE (computerized physician order entry), we have always also been wary that data showing a reduction in serious medication errors and adverse outcomes has been scant. We’ve also pointed out the many unintended consequences of CPOE, BMV (bedside medication verification) and electronic medical records:


A new systematic review published in this month’s JAMIA (Reckmann 2009) also concludes that the evidence showing a reduction in medication errors by CPOE, particularly serious medication errors, is scant. The few studies that did demonstrate positive results either had very focused outcomes (i.e. only certain types of medication errors in select populations were studied) or the study populations were very small or there were methodological problems.


On the positive side, another study (Weingart 2009) looked at the Massachusetts experience on the effect of alerts on electronic prescribing in ambulatory care. Applying a modeling technique, it showed what most other studies have shown, i.e. that the vast majority of computerized alerts are ignored by physicians. But it did show that about 10% of the alerts accounted for 60% of the adverse drug events possibly avoided and 78% of the projected cost savings. This reinforces previous recommendations to focus on a relatively few alerts that pertain to the most serious events and avoid the problem of alert fatigue.


These studies should not dissuade you from implementing CPOE with clinical decision support in your organizations. But they serve as a reminder that you should not do so with blind faith. You need to look at the benefits and the risks, anticipate unintended consequences, and focus your efforts in those areas where the evidence base supports the biggest impact.





Reckmann MH, Westbrook JI, Koh Y, Lo C, Day RO. Does Computerized Provider Order Entry Reduce Prescribing Errors for Hospital Inpatients? A Systematic Review.
 J Am Med Inform Assoc 2009; 16: 613-623




Weingart SN, Simchowitz B, Padolsky H, et al. An Empirical Model to Estimate the Potential Impact of Medication Safety Alerts on Patient Safety, Health Care Utilization, and Cost in Ambulatory Care. Arch Intern Med. 2009;169(16):1465-1473





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Unintended Events in the ED


A study from the Netherlands (Smits et al 2009) looked at the occurrence of unintended events in 10 emergency departments and performed root cause analyses to identify many of the causes. Not surprisingly, problems in communication were major causes identified and these especially pertained to collaboration with departments outside the ED.


Of factors internal to the ED, human ones predominate. This would include things like failure to record when a medication was administered or failure to plug the battery of a medical device into an outlet. But organizational errors were also common (eg. incomplete protocols, failure to replace outdated medical equipment, etc.).


But factors external to the ED were especially important, whether they were human factors or organizational ones. These often involved the laboratory or radiology or consultants from medical specialty services or surgical services.


Some limitations of this study may have been a bias toward reporting of less serious unintended events and the fact that most events were reported by nursing rather than medical staff.


The key lesson from this study is that emergency departments need to focus on their communications and collaboration with other departments (especially radiology and the laboratory) and with those services frequently consulting on emergency department patients, such as medical specialists. The authors stress the importance of joint efforts between the emergency department and the outside departments to identify the causes and potential solutions.





Smits M, Groenewegen PP, Timmermans DRM, van der Wal G, Wagner C. The nature and causes of unintended events reported at ten emergency departments. BMC Emergency Medicine 2009, 9: 16




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A Better Tool for Predicting ICU Need in Community-Acquired Pneumonia?



Most of you are familiar with the variety of calculators and tools that have been used in the evaluation and management of patient with community-acquired pneumonia (CAP). The Pneumonia Severity Index (PSI) and the CRB-65/CURB-65 tools have been useful in predicting outcomes and helping physicians make decisions about the most appropriate level of care in which to manage the patient (outpatient, inpatient, ICU).


The American Thoracic Society developed its own prediction model in 2001 and this was updated in 2007 by the Infectious Diseases Society of American and the American Thoracic Society. These tools were developed to help predict ICU admission in patients with CAP. A new study (Kontou et al. 2009) demonstrates their usefulness in predicting ICU admission with high sensitivity and a high negative predictive value in patients with CAP caused by Streptococcus pneumoniae. Mortality was still best predicted by the PSI score. The 2007 IDSA/ATS tool was not better than the older one in predicting ICU admission and the older one is slightly simpler so expect the latter to be adopted as a tool to predict ICU admission.






Fine MJ, Auble TE, Yealy DM, Hanusa BH, Weissfeld LA, Singer DE, et al. A prediction rule to identify low-risk

patients with community-acquired pneumonia. N Engl J Med. 1997; 336: 243-250




British Thoracic Society Pneumonia Guidelines Committee. BTS guidelines for the management of

community-acquired pneumonia in adults – 2004 update.




Niederman MS, Mandell LA, Anzueto A, Bass JB, Broughton WA, Campbell GD, et al. American Thoracic

Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment

of severity, antimicrobial therapy, and prevention. Am J Respir Crit Care Med. 2001;163:1730-1754




Kontou P, Kuti JL, Nicolau DP. Validation of the Infectious Diseases Society of America/American Thoracic Society criteria to predict severe community-acquired pneumonia caused by Streptococcus pneumoniae. American Journal of Emergency Medicine 2009; 27(8): 968-974





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Joint Commission Activities


The Joint Commission has issued a new sentinel event alert: “Leadership Committed to Safety” and has also formally issued the 2010 National Patient Safety Goals (NPSGs). There are no new NPSG’s for 2010 but several of the old ones have been converted to Standards, many have had revisions and clarifications, and others have parts that have now become fully implemented.




The Joint Commission. Sentinel Event Alert. Issue 43. August 27, 2009 (Revised September 8, 2009) Leadership committed to safety.




The Joint Commission. 2010 National Patient Safety Goals (NPSGs)




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Print “October 2009 What's New in the Patient Safety World (full column)

Print “October 2009 Complications – Prevent Them or Manage Them Better?

Print “October 2009 Warfarin for Atrial Fibrillation – Too Much? Or Just the Wrong Patients?

Print “October 2009 A Cautious View on CPOE

Print “October 2009 Unintended Events in the ED

Print “October 2009 A Better Tool for Predicting ICU Need in Community-Acquired Pneumonia?

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