What’s New in the Patient Safety World

December 2010


·        Bad Bundle? Or Not?

·        The ABCDE Bundle

·        Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units

·        ISMP Updates Tall Man Lettering List






Bad Bundle? Or Not?


Most healthcare organizations have considerable experience now implemented care “bundles”, groups of evidence-based interventions that have individually demonstrated efficacy in well-designed clinical studies. Most are familiar with IHI’s VAP Bundle (see our September 2, 2008 Patient Safety Tip of the Week “Updates on VAP Prevention”) or various “Bladder Bundles” (see our June 24, 2008 Patient Safety Tip of the Week “Urinary Catheter-Related UTI’s: Bladder Bundles”). Many also consider the SCIP (Surgical Care Improvement Project) interventions as a “bundle”.


One of the problems when we implement a bundle and see improvement is that we are never quite sure which of the components of that bundle was most responsible for the improvement. But we have usually documented that implementation of the bundles improved the outcomes we were measuring.


But now a new study showed a care bundle paradoxically worsened the very outcomes it was intended to improve. Anthony et al. (Anthony 2010) did a randomized controlled trial of a bundle of interventions in colorectal surgery. Their bundle consisted of 5 interventions that had been shown to reduce surgical site infections in studies where they were evaluated individually. These interventions included: (1) omission of mechanical bowel preparation (2) pre- and intra-operative warming (3) supplemental oxygenation (4) intraoperative fluid restriction and (5) use of a surgical wound edge protector. Rather than reducing the rate of SSI’s (surgical site infections), their intervention group actually had a significant increase in SSI’s.


But there were some other differences between their control group and the intervention group. The average surgical duration was 20 minutes longer in the intervention group. We previously discussed the relationship between SSI’s and surgical procedure duration in our March 10, 2009 Patient Safety Tip of the Week “Prolonged Surgical Duration and Time Awareness” and our January 2010 What’s New in the Patient Safety World column “Operative Duration and Infection”. Each half-hour extra is associated with a 2.5% higher SSI rate. So a 20-minute average difference in surgical duration is unlikely to explain the almost 2-fold difference in infections rates seen in the Anthony study. It would, however, be of interest to see whether implementation of the bundle in any way contributed to the longer surgical durations.


The vast majority of the SSI’s seen were superficial wound infections and there were no mortality differences between the two groups. By the way, the relatively high rate of SSI’s in this study is instructive in that many were diagnosed after discharge from the hospital. SSI rates in most studies have just included cases identified prior to discharge and may underestimate the true incidence.


The authors also postulate that maybe the evidence base for some of the interventions is not so strong. The authors of the current study also just published a companion article reviewing the evidence base for nonpharmacologic interventions designed to prevent SSI’s in colorectal surgery (Murray 2010).



But we agree with the authors’ main lesson: don’t assume that interventions which are combined will necessarily produce more improvement. They went into their study expecting to see at least an additive and perhaps synergistic effect of combining interventions. It is counterintuitive to think that combining interventions that proven efficacy individually would actually lead to worse outcomes. But that is exactly what they saw in this study.


The study comes on the heels of the recent report of a mixed impact of SCIP (Surgical Care Improvement Project) on actual outcomes (Stulberg 2010) that some found to be disappointing. That study showed that adherence to the individual infection prevention measures did not result in a significant reduction in infection rates. However, performance on the global composite score (a measure of adherence to all the individual measures) did correlate with a reduction in infection rates. In fact, demonstrated adherence to SCIP measures through the all-or-none global composite SCIP scores was associated with a reduction from 14.2 to 6.8 postoperative infections per 1,000 discharges. One could actually probably argue that this study did show a synergistic effect of the “bundle”. One factor that is very hard to cull out from studies like this is the impact of “culture”. Organizations that implement full bundles as opposed to a few individual interventions are more likely to have a “culture of safety”, which in the end may be more important than the individual interventions.


More importantly, it is a reminder that use of process measures or other surrogate measures (eg. adherence to a practice) rather than actual outcome measures may give rise to misleading impressions.







Anthony T,  Murray BW, Sum-Ping JT, et al. Evaluating an Evidence-Based Bundle for Preventing Surgical Site Infection. A Randomized Trial.

Arch Surg. Published online November 15, 2010. doi:10.1001/archsurg.2010.249




Murray BW, Huerra S, Dineen S, Anthony T. Surgical Site Infection in Colorectal Surgery: A Review of Nonpharmacologic Tools of Prevention. J Am Coll Surg 2010; 211(6): 812-822




Stulberg JJ, Delaney CP, Neuhauser DV, et al. Adherence to Surgical Care Improvement Project Measures and the Association With Postoperative Infections. JAMA. 2010; 303(24): 2479-2485







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The ABCDE Bundle



Despite this month’s column “Bad Bundle? Or Not?”, we still like bundles. And there is a new bundle being promoted, the “ABCDE bundle” (Vasilevskis 2010). This really focuses on prevention of two very common and very serious iatrogenic problems seen in our ICU’s: delirium and ICU-acquired weakness. The ABCDE acronym stands for “Awakening and Breathing Coordination”, “Delirium monitoring”, and “Exercise/Early mobility”.


ICU delirium and ICU-acquired weakness are associated with significant morbidity and mortality, excessive lengths of ICU and hospital stay, and excessive costs. Both are potentially preventable. The authors of the paper describe the risk factors and contributing factors for both complications and suggest the ABCDE bundle as a way to reduce the risk of patients developing either or both complications. The individual components of the bundle are well-accepted interventions in most ICU’s.


Awakening the patient daily is the first component. Daily sedation “vacations” are a key component of the IHI VAP Bundle and other bundles designed to prevent ventilator-associated pneumonia. Minimizing sedation also helps reduce the incidence of delirium in the intubated, mechanically-ventilated patient. We all recognize there is a tendency to oversedate ICU patients on ventilators. We even reported in our March 2010 What’s New in the Patient Safety World column “If Sedation Vacations Work, Why Not Eliminate Sedation All Together?” a study by a group of Danish clinical researchers (Strem 2010) who did a randomized controlled trial in which ICU patients on mechanical ventilation were randomized to receive either no sedation or daily interrupted sedation. They found that patients who received no sedation had significantly fewer days on ventilators, shorter ICU stays, and shorter total hospital LOS. There was no difference in accidental extubations or VAP, though more patients in the no sedation group had agitated delirium.


The B component Breathing refers to daily interruptions of mechanical ventilation. The authors stress that use of protocolized management by nonphysicians in the ICU have been shown to be safe and effective.


The C component is Coordination of daily awakening and daily breathing. Coordinating these two interventions has been shown to produce better outcomes than either intervention alone. The ABC trial (Awakening and Breathing Controlled trial) (Girard et al 2008), which we discussed in our June 23, 2009 Patient Safety Tip of the Week “More on Delirium in the ICU” was a multicenter prospective controlled trial that paired the use of spontaneous breathing trials (SBT’s) with spontaneous awakening trials (SAT’s) in comparison to a usual care group in mechanically ventilated ICU patients. Results demonstrated patients in the intervention group had more ventilator-free days, shorter ICU and total hospital lengths of stay, and a 32% better survival at one year.


The D component, Delirium monitoring, has been the topic of many of our own columns. They discuss many of the validated tools, such as the CAM-ICU and the Intensive Care Delirium Screening Checklist, plus sedation scales like the Richmond Agitation-Sedation Score (RASS) and how these objective measures lead to reduction in complications.


The E component, Exercise/Early Mobility is based in multiple studies that have demonstrated early mobilization and early physical therapy contributing to improved outcomes in mechanically ventilated ICU patients.


They then go on to provide statistics about the relative frequency (actually infrequency is the better term!) each of these components is used in typical ICU care and gaps that exist between evidence-based principles and actual clinical care. Their section on using members of the entire ICU team, interdisciplinary care, and good communication are critical in developing a culture of safety in the ICU. They also note use of some of our other favorite tools, checklists and ICU daily goals, are helpful during implementation of the ABCDE bundle.


This is a very good paper posing use of a very logical bundle. Getting some actual outcome measurements after implementation of the full ABCDE bundle should further solidify more widespread use of this bundle. The paper also has excellent references to the individual components of the bundle.







Eduard E. Vasilevskis EE, Ely EW,  Speroff T, et al. Reducing Iatrogenic Risks: ICU-Acquired Delirium and Weakness—Crossing the Quality Chasm. Chest 2010; 138: 1224-1233   November 2010




Strem T, Martinussen T, Toft P. A protocol of no sedation for critically ill patients receiving mechanical ventilation: a randomised trial. The Lancet 2010; 375: 475 - 480




Girard TD, Kress JP, Fuchs BD, et al. Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. The Lancet 2008; 371: 126 - 134, 12 January 2008







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Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units



The Joint Commission has issued a new Sentinel Event Alert on preventing suicide. It is really an update to a previous Sentinel Event Alert on preventing suicide (TJC 1998). The focus of the new alert is on units other than behavioral health units, i.e. medical/surgical units and the emergency department.


They provide statistics about suicide on various units, places the suicides take place, and means used. They point out that there are 2 types of patients who commit suicide on med/surg units: (1) those admitted after a suicide attempt and (2) those with no known psychiatric disorder or know suicide intent. They detail the many risk factors for suicide plus the potential warning signs. Suicide on med/surg units also tends to occur earlier after admission than those occurring on behavioral health units.


They discuss many of the environmental items, usually not available on psychiatric units but readily available on med/surg units, that may be used in suicides. These include items such as bell cords, sheets, restraint belts, various types of tubing, bandages, etc.


But key contributing factors are lack of screening, failure to identify risk or recognize warning signs, lack of appropriate training, poor communication, and lack of appropriate staffing for proper observation.


They make a number of recommendations regarding screening for depression and suicide risk (both inpatient and emergency department) and watching for behaviors that are potential warning signs of impending suicide attempts. They then offer tips about engaging the patient and family or others capable of providing peer support. And they stress the importance of communication at all levels of care.


We have previously done Patient Safety Tips of the Week on January 6, 2009 “Preventing Inpatient Suicides” and February 9, 2010 “More on Preventing Inpatient Suicides”. We encourage you to read those columns since they have many practical considerations. You need to be especially cognizant of the risks when patients go elsewhere in your facility. An AHRQ WebM&M Case & Commentary several years ago noted a suicide attempt occurred in a bathroom in the radiology suite. We wonder how many hospitals would have inspected that bathroom for potential suicide risk. We’ve done that in several hospitals and uniformly found that not only do those bathrooms have numerous “loopable” items that could be used for hanging but also that they can be locked from the inside and there is typically no one readily available with a key to get in. In fact, that is one of the items we added to our patient safety scavenger hunt list (see our March 16, 2010 Patient Safety Tip of the Week “A Patient Safety Scavenger Hunt”). Bathrooms on non-psychiatric floors may be especially problem prone. Not only are they seldom assessed for tools and implements that could be used for suicide, but some also allow the door to be locked from the inside. So observation protocols for potentially suicidal patients on such units should ensure that doors are not locked (or, if they can be locked, that the “observer” has keys to access the bathroom). Having observers of the same gender as the patient also is recommended.


You also need to consider areas you often do not consider accessible. We heard of a case recently where locked doors automatically opened when the fire alarm went off and a patient then got access to a rooftop. So during your environmental safety rounds you need to say to yourself “what could happen if those doors were to become unlocked?”.


Communication to all parties is particularly important during transports within the hospital (such as going to the radiology suite). We’ve talked about the “Ticket to Ride” communication tool for hospital transports. That useful tool needs to also be used to properly prepare for potentially suicidal patients.


Suicide risk assessments are often incomplete or not done and the 1998 Joint Commission alert especially noted a dearth of suicide reassessments. Sound familiar? How often have we noted that other key assessments in healthcare, such as fall risk or DVT risk assessment, are done on admission but are not repeated even though clinical circumstances have changed during the hospital course? Another issue is that even though the reason for admission may have been related to a suicide attempt, the patient on admission may be unable to cooperate with a suicide risk assessment (eg. the patient may be comatose or obtunded because of a drug overdose). Sometimes many days pass where the patient physically would have been incapable of another suicide attempt but, ironically, as they begin to improve medically the suicide risk reappears.


Several articles have noted that the “sitters” commonly utilized to monitor the potentially suicidal patient on the non-psychiatric unit are often not specifically trained in assessment of the environment or management of the suicidal patient. The AHRQ article noted above has a good discussion on this.


Our February 9, 2010 Patient Safety Tip of the Week “More on Preventing Inpatient Suicides” has some good descriptions of the types of patients on med/surg units prone to suicides. Especially vulnerable are those with delirium or dementia. That column also discusses the availability of several great tool kits for education and management of suicide risk.


Since it is very difficult to predict suicides, careful attention to environmental factors that could facilitate suicide is critical. Appropriate assessment and reassessment for suicide risk are important. Similarly, for those patients identified as at-risk for suicide, it is essential that appropriate monitoring with appropriately trained staff be used. Transitions of care are especially vulnerable and suicide risk should be considered in all handoffs and other communications.


Suicide on one of your inpatient services, whether psychiatric or med/surg, is a devastating event for families, your other patients, your staff, your community, and your reputation. You need to get a better understanding of your vulnerabilities and take action to mitigate the risks of potentially avoidable events.










The Joint Commission. A follow-up report on preventing suicide:  Focus on medical/surgical units and the emergency department. Sentinel Event Alert 2010; 46: 1-5 November 17, 2010




The Joint Commission. Inpatient Suicides: Recommendations for Prevention. Sentinel Event Alert 1998; 7: 1-2   November 6, 1998




Gibson J, Taylor DH. AHRQ Web M&M Case & Commentary “The Dangerous Detour.” June 2003







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ISMP Updates Tall Man Lettering List



Mixups involving look-alike/sound-alike (LASA) drugs continue to be problematic. Most facilities use tall man lettering as a tool to help reduce the likelihood of such mixups. Most facilities we’ve worked with have utilized either ISMP’s list or the FDA list of look-alike drug sets with recommended tall man lettering, though some simply use the preconfigured ones built into their pharmacy or CPOE systems.


ISMP (Institute for Safe Medication Practices) has just updated its list of drug name pairs with TALL man letters. They provide an excellent description of several potential ways to highlight parts of drug names to help avoid confusion with other drug names. Those include not only use of tall man lettering but also use of color, bolding, italicizing, etc. Tall man lettering can even be combined with one of those other methods as well, for example using color with the tall man lettering. They updated their list after receiving responses to a survey they recently sent out. The survey sought information about what systems (eg. CPOE, ADM’s, pharmacy IT, etc.) tall man lettering is currently utilized in and how use of tall man lettering is communicated to staff. But they also suggested some new additions to their list and sought further suggestions. As a result, they have now have multiple new drug name pairs added to the list with the suggested tall man lettering conventions.


IMSP Canada had also just recently published a safety bulletin on use of tall man lettering in oncology. The ISMP Canada project was a collaborative process involving numerous oncology organizations and individual oncology practitioners across Canada. They also utilized experts in human factors engineering and psycholinguistics. They sent out a survey to help determine problematic drug pairs and then compared those suggested ones to the ISMP and FDA lists. They found 3 new drug pairs that did not yet have tall man lettering conventions. Their recommendations for two drug pairs have also been incorporated into the updated ISMP list.


We’ve highlighted issues with LASA drugs in numerous columns on our site, most recently in our Patient Safety Tips of the Week for September 21, 2010 “Dilaudid Dangers” and November 2, 2010 “Insulin: Truly a High-Risk Medication”. We also had a more extensive discussion in our August 14, 2007 Patient Safety Tip of the Week “More Medication-Related Issues in Ambulatory Surgery”.








FDA and ISMP Lists of Look-Alike Drug Name Sets With Recommended Tall Man Letters.




ISMP (Institute for Safe Medication Practices). ISMP updates its list of drug name pairs with TALL man letters. ISMP Medication Safety Alert Acute Care Edition. November 18, 2010




ISMP Canada. Application of TALLman Lettering for Drugs Used in Oncology. ISMP Canada Safety Bulletin 2010; 10(8): 1-4  November 11, 2010





Print “December 2010 ISMP Updates Tall Man Lettering List






Print “December 2010 What's New in the Patient Safety World (full column)

Print “December 2010 Bad Bundle? Or Not?

Print “December 2010 The ABCDE Bundle

Print “December 2010 Joint Commission Sentinel Event Alert on Suicide Risk Outside Psych Units

Print “December 2010 ISMP Updates Tall Man Lettering List
















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