What’s New in the Patient Safety World

April 2014



·         Insulin-Induced Hypoglycemia Rising

·         Checklists Don’t Always Lead to Improvement

·         Surgical Complications and Cost

·         Insulin Pens - Again

·         Another Rap on the VTE Prophylaxis Measure





Insulin-Induced Hypoglycemia Rising



Flying under the radar in the last few decades have been an epidemic of emergency department visits and hospitalization related to insulin-related hypoglycemia. But recently researchers (Geller 2014), using 2 large national data sources, found that there were an estimated 97,648 ED visits annually related to insulin-related hypoglycemia. Moreover, almost one-third (29.3%) resulted in hospitalization and severe neurological sequelae were estimated to occur in 60%. Insulin-treated patients 80 years or older were more than twice as likely to visit the ED and nearly 5 times as likely to be subsequently hospitalized.


Geller et al. note that the number of patients in the US taking insulin has increased 50% over the last decade. When they looked at reasons for the hypoglycemia, the most commonly identified precipitants were reduced food intake and administration of the wrong insulin product. While almost half of the cases noted a meal-related misadventure, 22% involved the patient taking a wrong insulin product and 12% a wrong dose. One of the biggest problems was the patient taking a rapid-acting insulin rather than the intended long-acting one.


They recommend focusing efforts on education of patients on several aspects of insulin use, including having patients demonstrate to providers their understanding and simulation. They also call for continued efforts to better differentiate the various insulin products. They also note a trend in recent diabetes treatment guidelines to relax targets in patients with advanced age, short life expectancies, and high risk of hypoglycemia.


In an accompanying commentary Sei J. Lee (Lee 2014) puts this trend in perspective, noting that the 100,000 ED visits annually for hypoglycemia have gotten far less attention than the 715,000 annual MI’s despite the fact that most hypoglycemia is caused by the health care system. Lee also points a finger at the pharmaceutical industry for its role in driving guidelines to aim for tighter glucose control and lower HbA1c levels. Lee notes that the ACCORD trial in type II diabetics showed increased mortality when patients are treated to an overly aggressive HbA1c target (mean HbA1c 6.4%). Lee recommends that rather than prescribing a target for HbA1c, specifying a range might be more likely to remind us not to overtreat. Also we need to be very careful that widely-used quality metrics do not inadvertently drive overtreatment. Lastly, Lee raises the question of avoiding insulin all together in patients age 80 years and older.







Geller AI, Shehab N, Lovegrove MC, et al. National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations. JAMA Intern Med 2014; Published online March 10, 2014




Lee SJ. So Much Insulin, So Much Hypoglycemia. JAMA Intern Med 2014; Published online March 10, 2014




The Action to Control Cardiovascular Risk in Diabetes Study Group. Effects of Intensive Glucose Lowering in Type 2 Diabetes. N Engl J Med 2008; 358: 2545-2559





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Checklists Don’t Always Lead to Improvement



Among our numerous columns dealing with use of checklists in healthcare and other industries the WHO Surgical Safety Checklist has probably attracted the most attention. Our July 1, 2008 Patient Safety Tip of the Week “WHO’s New Surgical Safety Checklist” described the tool and provided the link to download the checklist tool and instructions how to use it.  We also discussed checklist design and use in our September 23, 2008 Patient Safety Tip of the Week “Checklists and Wrong Site Surgery”.


In our January 20, 2009 Patient Safety Tip of the Week “The WHO Surgical Safety Checklist Delivers the Outcomes” we discussed the striking improvements in patient outcomes following implementation of the WHO Surgical Safety Checklist at hospitals in eight different countries. Haynes and colleagues (Haynes 2009) demonstrated that mortality at 30-days post-op decreased from 1.5% before introduction of the checklist to 0.8% after. Rate of any complication decreased from 11% to 7%. Both these outcomes were highly statistically significant. That’s a relative risk reduction of approximately 36% for mortality and major morbidity!


That striking improvement in outcomes occurred even without complete adherence to all items on the checklist. We discussed the debate as to whether the striking improvement was attributable to use of the checklist per se or to the change in “culture” that accompanied use of the checklist.


But recent widespread adoption of a surgical checklist in over 100 hospitals in Ontario, Canada failed to demonstrate significant reductions in adjusted rates for mortality or complications (Urbach 2014). The rate of any complication decreased from 3.86% to 3.82% and mortality at 30-days post-op decreased from 0.71% to 0.65% in Canadian study, neither being statistically significant. There was also no significant changes in rates of hospital readmission and emergency department visits within 30 days after discharge. This result was surprising, especially since self-reported compliance with the checklist was over 90% at almost all participating hospitals.


In an accompanying editorial Lucian Leape discusses potential reasons for lack of evidence of improvement in Ontario hospitals after implementation of the checklist (Leape 2014). He suspects the most likely reason was that the checklist was not accurately used, despite the reported 98% compliance in the study. He also notes that since the checklist was adopted unmodified in 90% of hospitals the local buy-in and team building that are needed for true adoption were likely lacking. He also feels that the 3-month period was probably far too short for significant improvement to have occurred.


We have several of our own thoughts on why the Ontario study failed to show improvement after implementation of the checklist and, thus, differed from the prior studies. One is that the results of the original study (Haynes 2009) were almost too good to be true. The school of thought popularized by John Ioannidis says that “if it sounds too good to be true, it probably is not true” (Ioannidis 2005, Pereira 2012) and might apply here. That school concludes that most large treatment effects emerge from small studies, and when additional trials are performed, the effect sizes become typically much smaller. That is a distinct possibility here, given that the Ontario study was so much bigger than any of the other studies.


But the Haynes study was not the only one to demonstrate striking improvement in outcomes after implementation of a surgical checklist. Improvements of a similar magnitude were seen after implementation of the SURPASS checklist (de Vries 2010). That checklist is a very comprehensive checklist that deals with the entire surgical pathway, including pre- and post-operative care as well as events within the OR (see our November 30, 2010 Patient Safety Tip of the Week “SURPASS: The Mother of All Checklists”). After implementation of SURPASS the number of complications per 100 patients dropped from 27.3 to 16.7 and in-hospital mortality dropped from 1.5% to 0.8%. Note that outcomes at several comparable hospitals considered “control” hospitals did not change. And no other significant programs were introduced at the time, further suggesting that the improvements were due to implementation of the checklist. Moreover, complication rates were significantly lower in those patients for whom 80% or more of the checklist items were completed. But the authors are quick to note that the benefits of the checklist implementation are not just due to the checklist but also due to the development of a “culture of safety” that results from such implementation. Also of note was that these improvements occurred at hospitals which already had relatively high levels of quality of care.


Another study (van Klei 2012) demonstrated a 15% reduction in adjusted mortality rates after implementation of WHO’s Surgical Safety Checklist and showed outcomes were better in those with full checklist completion compared to those with partial completion or noncompliance.


Another group implemented both team training and a comprehensive surgical checklist and demonstrated significant reduction of 30-day morbidity (Bliss 2012). Overall adverse event rates decreased from 23.60% for historical control cases and 15.90% in cases with only team training, to 8.20% in cases with checklist use.


A recent systematic review of the impact of surgical checklists (Treadwell 2014) noted that 10 of 21 studies on implementation of surgical checklists included data on outcomes. Outcomes from those reporting were generally favorable, showing decreases in both inhospital mortality and complication rates.


So did all these prior studies overestimate the impact of checklist implementation on patient outcomes? Only time will tell.


Another possible reason for the difference between the Ontario study and the other studies has to do with difference in the baseline (historical) levels of mortality and complications. While it’s not clear that exactly the same things were being measured across studies, the rate of any complication decreased from 11% to 7% in Haynes study compared to 3.86% to 3.82% in Ontario study. Mortality at 30-days post-op decreased from 1.5% before introduction of the checklist to 0.8% after in Haynes study compared to 0.71% to 0.65% in Ontario study. So was it that the Ontario hospitals were already performing at a relatively high level and had less room to improve? The study on the SURPASS checklist outcomes (de Vries 2010) showed improvements comparable to those in the Haynes study and was done at hospitals said to be already performing at high levels (note, however, that the mortality rates in the Ontario study were lower than that in the SURPASS study even after the latter showed improvement).


Another consideration is whether the 3-month measurement timeframe (both before and after implementation) in the Ontario study was simply too short to demonstrate improved outcomes. Well, that was the same timeframe used in the SURPASS study and they demonstrated striking improvement.


Our last consideration has to do with Lucian Leape’s comments about the fact that the checklist was seldom modified at the local level in the Ontario hospitals. That suggests that the “culture” aspect of using checklists never developed. In fact, the Ontario hospitals were basically mandated to use a checklist. We all know that our medical staffs don’t like to have anything “foisted upon them” from the outside. So there may well have been a difference compared to the hospitals that voluntarily (and usually enthusiastically) adopted the checklists in some of the other studies.


The systematic review by Treadwell et al. (Treadwell 2014) cautions that the association between checklists and improved outcomes does not necessarily imply causation. First, they note that checklists are often implemented as part of a multifaceted strategy to improve care. They also note there may be reporting bias (i.e. perhaps only those with positive outcomes reported outcome data). And, third, it’s possible that not all surgical checklists are beneficial.


It’s important to keep in mind that none of these studies was a randomized controlled trial (RCT) and there are several practical barriers to doing such an RCT. They all have before/after observational designs and it is conceivable that factors other than just the checklist are important. Indeed, we strongly suspect that the change in culture is probably more important that the checklist per se. Developing checklists is not enough. You need to involve your staff in development of those checklists and educate all staff in their importance and implementation. You need to audit the use of and adherence to the checklists you develop. The audit should be done for anything you develop a checklist for, not just a safe surgery checklist.


Don’t let the Ontario study dissuade you on the importance of checklists. Checklists are some of the most valuable tools we have available in quality improvement and patient safety. They are simple and save time in the long run. Most take only minutes to complete. They are also the least expensive of all tools. All the items in the WHO Surgical Safety Checklist have negligible financial costs. None of the favorable studies above published the likely financial savings resulting from the improvements but they would obviously be substantial. The ROI on checklists is incredibly high, both in human terms and financial terms.




Some of our prior columns on checklists:







Haynes AB, Weiser TG, Berry WR, et al. for the Safe Surgery Saves Lives Study Group. A Surgical Safety Checklist to Reduce Morbidity and Mortality in a Global Population. N Engl J Med. Online First January 14, 2009 (DOI: 10.1056/NEJMsa0810119), in Print January 29, 2009




WHO Surgical Safety Checklist




Urbach DR, Govindarajan A, Saskin R, et al. Introduction of Surgical Safety Checklists in Ontario, Canada. N Engl J Med 2014; 370: 1029-1038




Leape LL. The Checklist Conundrum (editorial). N Engl J Med 2014; 370:1063-1064




Ioannidis JP. Why most published research findings are false. PLoS Med 2005; 2(8): e124




Pereira TV, Horwitz RI, Ioannidis JPA. Empirical Evaluation of Very Large Treatment Effects of Medical Interventions. JAMA 2012; 308(16): 1676-1684




de Vries EN,  Prins HA, Crolla RMPH, et al. for the SURPASS Collaborative Group. Effect of a Comprehensive Surgical Safety System on Patient Outcomes. N Engl J Med 2010; 363: 1928-1937




van Klei WA, Hoff RG van Aarnhem EEH et al. Effects of the Introduction of the WHO “Surgical Safety Checklist” on In-Hospital Mortality: A Cohort Study. Ann Surg 2012; 255: 44-49




Bliss LA, Ross-Richardson CB, Sanzar LJ, et al. Thirty-Day Outcomes Support Implementation of a Surgical Safety Checklist. J Am Coll Surg 2012; 215: 766-776




Urbach DR, Govindarajan A, Saskin R, et al. Introduction of Surgical Safety Checklists in Ontario, Canada. N Engl J Med 2014; 370: 1029-1038




Leape LL. The Checklist Conundrum (editorial). N Engl J Med 2014; 370:1063-1064




Treadwell JR, Lucas S, Tsou ay. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf 2014; 23: 299-31






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Surgical Complications and Cost



Cases with surgical complications cost more. Duh. Sounds like an oxymoron. Of course they cost more. But who is really paying attention?


An analysis of patients undergoing elective colorectal surgery showed 35% of patients developed at least one complication (Zoucas 2014). Complications increased hospital costs at least 2-fold, primarily due to increased length of stay and ICU costs. Largest costs were related to wound dehiscence and suture line failure requiring reoperation. In addition, if a patient required readmission because of a complication, costs were further substantially increased. Factors that increased complication rates were obesity, complexity of surgery, and factors related to the surgeon.


A study of surgical complications in cancer patients demonstrated a significant financial cost attributable to surgical complications (Short 2014). The researchers looked at the AHRQ PSI’s (patient safety indicators) in patients having 6 cancer surgeries: colectomy, rectal resection, esophagectomy, pancreatic resection, pneumonectomy, and pulmonary lobectomy. They found that the occurrence of one PSI increased the hospital cost by 20% for most types of surgery but for respiratory failure the costs increased 53-77%.


The authors note that, whether justified or not, there seems to be a higher tolerance for complications in patients with cancer undergoing surgery compared to patients with benign conditions. However, many complications in cancer patients may in fact be preventable or avoidable.


Post-op DVT or pulmonary embolism increased costs 28-37%. Certainly cancer is a significant risk factor for DVT/PE but that makes it even more imperative that appropriate prophylaxis be used in such patients. A decubitus increased costs 28-60%. Malnutrition or other factors related to cancer might make render such patients at greater risk for decubiti. But that just increases the need for appropriate surveillance and preventive measures.


Of course, in the current reimbursement system hospitals have little financial incentive to avoid surgical complications. Yes, such cases cost hospitals more but they also bill more in most cases. Researchers have demonstrated that for patients with Medicare and private insurance, hospitals actually reap higher contribution margins for cases with surgical complications (Eappen 2013). However, as we move to different reimbursement models (eg. accountable care organizations, bundled payments, global budgets, capitation and others) any savings from avoiding surgical complications should begin to accrue to someone other than the payors. So the financial incentive will be added to the moral imperative to improve care and avoid complications.








Zoucas E, Marie-Louise Lydrup M-L. Hospital costs associated with surgical morbidity after elective colorectal procedures: a retrospective observational cohort study in 530 patients. Patient Safety in Surgery 2014; 8: 2 (3 January 2014)




Short MN, Aloia TA, Ho V. The influence of complications on the costs of complex cancer surgery. Cancer 2014; 120(7): 1035–1041




Eappen S, Lane BH, Rosenberg B, et al. Relationship Between Occurrence of Surgical Complications and Hospital Finances. JAMA 2013; 309(15): 1599-1606






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Insulin Pens - Again



Just a little over a year ago (see our February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?”) we highlighted reports of the occurrence in Western New York of insulin pens being used on multiple patients, potentially causing cross-contamination of patients with blood-borne pathogens. The focus of our column was as much on how organizations are made aware of unsafe practices discovered elsewhere as it was on the insulin pens themselves. The above episodes occurred despite several warnings from ISMP, the FDA, and CDC as referenced in our column. We provided recommendations and referred readers to several articles by ISMP. Both ISMP and the VA Health System have discouraged use of insulin pens (or multi-dose pen injectors for other drugs) in hospitals.


Last month another hospital alerted more than 4,200 patients who may have received insulin from an insulin pen reservoir of possible exposure to hepatitis viruses and human immunodeficiency virus (HIV) due to possible blood contamination (Reuters 2014).


Shortly after the Western New York insulin pen incidents were reported ISMP issued a call for removal of insulin pens from use in inpatient settings (ISMP 2013). They cited similar incidents occurring at multiple hospitals since 2009. Many of those instances have occurred despite warnings from ISMP, the FDA, and CDC. And they cited evidence that blood and other materials have been found in such pens after use. They note that such pens were originally introduced for use in ambulatory care. They note that placing a label on the pen for a single patient has its difficulties and that other problems are seen, such as using the pens as multi-dose vials, risk of needlesticks, etc. They note that the VA National Center for Patient Safety has now prohibited use of multi-dose pen devices on patient care units in VA facilities with certain exceptions (VA 2013).


ISMP went on to note the ease with which such errors are likely to occur when providers not fully familiar with the safety issues around such pens are now confronted with such pens. They note that we cannot reasonably expect education and inservicing to reach all necessary parties and that punishment of those who never learned the correct use of such devices is not appropriate. Hence, they suggest the best solution is removal of such devices from the inpatient setting (with the exception of those circumstances identified by the VA NCPS and outlined in the ISMP article).


Please refer to our February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?” and our April 2013 What’s New in the Patient Safety World column “More Tips on Insulin Pen Safety” for our recommendations for hospitals and for links to the important ISMP, VA, FDA and CDC communications on insulin pen safety.


If testing is done on the 4000+ patients in the current episode we can pretty much guarantee that several will test positive for some of the pathogens even if none were actually contaminated at that hospital through use of the insulin pens on multiple patients. Testing on about 500 of the 716 patients who could have been exposed to hepatitis or HIV because of the misuse of insulin pens on diabetic patients in the Western New York episode showed that at least fourteen tested positive for hepatitis B and at least six others tested positive for hepatitis C (Zremski 2013). And if the human toll and quality and patient safety issues are not enough to get you to ensure such episodes don’t occur at your facility, your CFO might let you know that the cost of one full course of hepatitis C with the newer drugs just on the market is about $84,000 (Pollack 2014).


Don’t you think you better act now?







Reuters staff. New York hospital warns patients of possible HIV, hepatitis exposure. Reuters March 13, 2014




ISMP (Institute for Safe Medication Practices). Ongoing concern about insulin pen reuse shows hospitals need to consider transitioning away from them. ISMP Medication Safety Alert. Acute Care Edition. February 7, 2013




VA Patient Safety Alert. Multi-dose pen injectors. January 17, 2013




Zremski J. 20 Buffalo VA patients test positive for hepatitis. The Buffalo News. May 9, 2013




Pollack A. Lawmakers Attack Cost of New Hepatitis Drug. New York Times. March 21, 2014






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Another Rap on the VTE Prophylaxis Measure



No one questions the importance of prophylaxis against deep venous thrombosis and pulmonary embolism (collectively known as venous thrombembolsim or VTE) in patients at high risk for such occurrences. But we’ve done several columns that have called into question the use of the VTE prophylaxis measure as a measure of quality because of biases and other flaws.


In our November 2013 What’s New in the Patient Safety World column “Are VTE Measures Flawed as Quality Measures?” we highlighted a study (Bilimoria 2013) that looked at almost a million surgical patients in almost 3000 hospitals for VTE prophylaxis rates, VTE event rates, and use of imaging in VTE screening. They found that greater hospital VTE prophylaxis adherence rates were weakly associated with worse risk-adjusted VTE event rates. When they looked at hospitals with higher “structural” quality scores (based on 8 factors commonly thought to be associated with higher commitment to quality) they found higher VTE prophylaxis adherence rates but worse risk-adjusted VTE rates. Risk-adjusted VTE rates increased significantly with VTE imaging use rates in a stepwise fashion, leading to their conclusion that surveillance bias limits the usefulness of the VTE quality measure for hospitals.


In our February 15, 2011 Patient Safety Tip of the Week “Controversies in VTE Prophylaxis” we highlighted a study by some very respected investigators in the surgical quality improvement field (Qadan 2011) that questioned the current recommendations on venous thrombembolism (VTE) prophylaxis in elective major surgery. The authors collected data on DVT and PE in patients electively undergoing 4 major surgical procedures (colorectal resection, total knee replacement, total hip replacement, and hysterectomy) from a large database from a consortium of academic medical centers for two periods of time (2003-2004 vs. 2007-2008). The study demonstrated a substantial increase in the use of pharmacologic DVT prophylaxis between the two time periods. Yet the rates of DVT and PE were not significantly impacted by this increased use of such prophylaxis. Moreover, the overall rates of DVT and PE were actually quite low and the rates in patients who did not receive pharmacoprophylaxis actually decreased between the two time periods. The authors concluded that this may show that clinical judgment of physicians in choosing which patients need pharmacoprophylaxis is remarkable.


Now another study has questioned the utility of the VTE prophylaxis measure (JohnBull 2014). The authors used publicly reported data from CMS to see if there was a correlation between VTE prophylaxis rates and outcome rates and found no correlation. They found that VTE rates at hospitals reporting 100% compliance with VTE prophylaxis were no different than those at hospitals in the bottom quintile of prophylaxis rates. Though the authors note that meeting the minimal standards to comply with the SCIP VTE measure may play a role, they concur with the previous authors also that surveillance bias may be a contributing factor.


Has the time finally come to move on from the VTE prophylaxis process measures to other measures that are less subject to biases and are better matched with actual patient outcomes?







Bilimoria KY, Chung J, Ju MH, et al. Evaluation of Surveillance Bias and the Validity of the Venous Thromboembolism Quality Measure. JAMA 2013; 310(14): 1482-1489




Qadan M, Polk HC, Hohmann SF, Fry DE. A reassessment of needs and practice patterns in pharmacologic prophylaxis of venous thromboembolism following elective major surgery. Ann Surg 2011; 253(2): 215-220




JohnBull EA, Lau BD, Schneider EB, et al. No Association Between Hospital-Reported Perioperative Venous Thromboembolism Prophylaxis and Outcome Rates in Publicly Reported Data (Research Letter). JAMA Surgery 2014; online first February 5, 2014






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Print “April 2014 Insulin-Induced Hypoglycemia Rising

Print “April 2014 Checklists Don’t Always Lead to Improvement

Print “April 2014 Surgical Complications and Cost

Print “April 2014 Insulin Pens - Again

Print “April 2014 Another Rap on the VTE Prophylaxis Measure




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