What’s New in the Patient Safety World

October 2013



·        HAI’s: Costs, WHO Hand Hygiene, etc.

·        Opioid Safety Actions and Resources

·        Challenging the 39-Week Campaign

·        How Many Deaths Result from Medical Errors?

·        New AHRQ Toolkit: Improving Your Office Testing Process





HAI’s: Costs, WHO Hand Hygiene, etc.



Healthcare-associated infections (HAI’s) have been a major focus of quality improvement and patient safety initiatives as well as pay-for-performance initiatives over the last decade. Recently, a study sought to quantify the financial impact of HAI’s (Zimlichman 2013). Many prior publications on the financial impact of HAI’s have looked at total costs. The current study looked at costs attributable to the HAI’s (that is, costs that would not have been incurred had the HAI not occurred). They found that the average cost for HAI’s was as follows:


CLABSI (central line–associated bloodstream infections)          $45,814

VAP (ventilator-associated pneumonia)                         $40,144

SSI (surgical site infections)                                                       $20,785

C. diff (Clostridium difficile infection)                             $11,285

CAUTI (catheter-associated urinary tract infections)                  $     896


Taking into account the frequency of the various HAI’s they estimate the total annual costs for the 5 major HAI’s to be $9.8 billion, with SSI’s and VAP each accounting for almost a third of that.


But who is currently footing that bill? In some cases in the current reimbursement world there is actually little incentive to improve. A recent study (Hsu 2013) evaluated the impact of a central line–associated bloodstream infection (CLABSI) initiative on costs, reimbursements, and margins for a hospital and its payers. They concluded that hospitals reduce costs by preventing CLABSIs but also decrease their margins by preventing CLABSI’s, creating a perverse incentive.


The trend for Medicare and other payors to no longer reimburse hospitals for potentially preventable complications has not yet had a significant impact on HAI rates. However, over the next several years value-based purchasing programs and penalties under the Affordable Care Act will begin to include more weight to HAI’s and should serve as an incentive for hospitals to prevent HAI’s.


One of the interventions usually touted to reduce HAI’s is handwashing. There have been a variety of programs designed to improve compliance of healthcare workers with handwashing (see our Patient Safety Tips of the Week for January 5, 2010 “How’s Your Hand Hygiene?” and May 24, 2011 “Hand Hygiene Resources”). One of the more widely known initiatives has been that espoused by the World Health Organization (WHO). Recently results of a study on the WHO hand hygiene program at six pilot sites in Costa Rica, Italy, Mali, Pakistan, and Saudi Arabia was published (Allegranzi 2013). Implementation had a major effect on compliance of health-care workers across all sites and healthcare workers’ knowledge of microbial transmission and hand hygiene principles improved as well. The positive results have been sustained over time. However, what is still missing is data on the actual impact of these improvements on the rates of various HAI’s.







Zimlichman E, Henderson D, Tamir O, et al. Health Care–Associated InfectionsA Meta-analysis of Costs and Financial Impact on the US Health Care System. JAMA Intern Med 2013;  Published online September 02, 2013 doi:10.1001/jamainternmed.2013.9763




Hsu E, Lin D, Evans SJ, et al. Doing Well by Doing Good: Assessing the Cost Savings of an Intervention to Reduce Central Line–Associated Bloodstream Infections in a Hawaii Hospital. American Journal of Medical Quality 2013; 1062860613486173, first published on May 7, 2013 as doi:10.1177/1062860613486173




Allegranzi B, Gayet-Ageron A, Damani N, et al. Global implementation of WHO's multimodal strategy for improvement of hand hygiene: a quasi-experimental study. The Lancet Infectious Diseases 2013; Early Online Publication, 23 August 2013 doi:10.1016/S1473-3099(13)70163-4







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Opioid Safety Actions and Resources



We’ve written often about the safety hazards of long-acting or extended release opioid products, including fentanyl patches. Our September 13, 2011 Patient Safety Tip of the Week “Do You Use Fentanyl Transdermal Patches Safely?” and our May 2012 What’s New in the Patient Safety World column “Another Fentanyl Patch Warning from FDA” had numerous recommendations regarding what you should be doing to improve safety of fentanyl patches. Last month we noted ISMP’s recent outreach for everyone to play a role in helping to avert accidental exposure to fentanyl patches (see our September 2013 What’s New in the Patient Safety World columnISMP Outreach on Fentanyl Patch Safety”).


The FDA (FDA 2013a) has also just announced new required changes in the labeling on fentanyl patches (Duragesic and generic patches). The label must print the name and strength of the drug in long-lasting ink, in a color clearly visible to patients and caregivers. The announcement also emphasizes that patients should be aware that patches that are not stuck to the skin tightly enough may accidentally fall off a patient and stick to someone in close contact, such as a child. Used fentanyl patches require proper disposal after use ― fold the patch, sticky sides together, and flush it down the toilet right away. (Note that this disposal recommendation applies to consumers. See the update in our May 2012 What’s New in the Patient Safety World column “Another Fentanyl Patch Warning from FDA” for comments on disposal in hospitals.)


The FDA also recently announced labeling changes and postmarket study requirements for extended-release and long-acting (ER/LA) opioid analgesics (FDA 2013b). The indication is updated to make it clear these drugs are intended for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The latter include non-opioid analgesics and short-acting opioid analgesics. It emphasizes that LA/ER opioids are not intended to be used on a “prn” basis nor should they be used for acute pain. The FDA also will require a boxed warning on these LA/ER opioids that use during pregnancy may cause neonatal opioid withdrawal syndromes.


There have been increased efforts at local, regional, state and national levels to deal with the growing problem of accidental overdose with prescription opioids. The prescription rate for opioids for non-cancer pain has almost doubled in the last decade (from 11.3% in 2000 to 19.6% in 2010) while the prescription rates for non-opioid pain-relieving drugs have remained unchanged (Medical News Today 2013).


A recent study in Canada (ISMP Canada 2013) on deaths associated with medication incidents showed that five of the top seven medications involved were opioids (HYDROmorphone, morphine, fentanyl, oxycodone, and methadone). In some of the cases early signs or symptoms of opioid overdose were noted by family or healthcare workers but intervention opportunities were not recognized. Deaths related to fentanyl patches involved wrong patches (fentanyl instead of nitroglycerine patch), concurrent use of fentanyl patches with other opioids, and use of high-dose fentanyl patches in opioid-naïve patients. Their analysis of the opioid-related deaths revealed three key causes of death: overdoses, overlapping toxicities with other medications, and administration to people who should not have been receiving them. ISMP Canada developed a video for consumers to emphasize the safety issues of opioids.


In the US, SAMSHA has just published its Opioid Overdose Prevention Toolkit. The toolkit includes not only recommendations for physicians regarding opioid prescribing and management but also resources for patients and families, first responders, and community members. It even has resources for survivors of opioid overdose and family members.


The SAMSHA toolkit for prescribers has good sections on patient selection and evaluation and selection of an appropriate medication, patient education and informed consent, checking state prescribing databases, the prescription itself, monitoring the patient’s response, and deciding whether and when to end opioid treatment. It discusses consideration of prescribing a naloxone kit (for emergency treatment of overdose) at the time the opioid prescription is made. It also has good discussions about recognizing signs and symptoms of opioid overdose and treating overdoses. It has good references and links to other resources.


The toolkit emphasizes that state prescription drug monitoring programs have emerged as a key strategy for addressing misuse and abuse of prescription opioids, thus preventing overdoses and deaths. Such databases tell whether the patient is filling his/her prescriptions and whether he/she might be receiving the same or similar drugs from other prescribers. In New York State our program is called I-STOP. The NY Chapter of the American College of Physicians nicely describes the program (NYACP 2013) and the state has an FAQ document for the program (NYSPMP 2013).




Some of our other Patient Safety Tips of the Week regarding fentanyl and fentanyl patches:


·        April 2010                    RCA: Epidural Solution Infused Intravenously

·        July 13, 2010               Postoperative Opioid-Induced Respiraatory Depression

·        January 18, 2011          More on Medication Errors in Long Term Care

·        April 12, 2011 Medication Issues in the Ambulatory Setting

·        June 28, 2011              Long-Acting and Extended-Release Opioid Dangers

·        September 13, 2011     Do You Use Fentanyl Transdermal Patches Safely?

·        November 8, 2011       WHO’s Multi-Professional Patient Safety Curriculum Guide

·        May 2012                    Another Fentanyl Patch Warning from FDA

·        July 24, 2012               FDA and Extended-Release/Long-Acting Opioids

·        September 2012           Joint Commission Sentinel Event Alert on Opioids

·        March 2013                 Try Googling Fentanyl Accidents

·        September 2013           ISMP Outreach on Fentanyl Patch Safety







FDA. Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure. FDA News Release September 23, 2014




FDA. FDA announces safety labeling changes and postmarket study requirements for extended-release and long-acting opioid analgesics. FDA News Release September 10, 2013




ISMP Canada. Deaths Associated with Medication Incidents: Learning from Collaborative Work with Provincial Offi­ces of the Chief Coroner and Chief Medical Examiner. ISMP Canada Safety Bulletin 2013; 13(8): 1-5




ISMP Canada. Consumers Can Help Prevent Harm from Opioid Use! (YouTube video on opioid safety).




Medical News Today. Huge increase in prescriptions for opioid drugs for non-cancer pain. Medical News Today 2013; 18 Sept. 2013




SAMSHA (Substance Abuse & Mental Health Services Administration).

Opioid Overdose Prevention Toolkit. August 2013




NYACP (New York Chapter of the Amercian College of Physicians). Effect of the Internet System for Tracking Over-Prescribing (I-STOP) Act on Physicians. Last updated September 19, 2013




NYSPMP. FAQ’s for the New York State Prescription Monitoring Program (NYSPMP). Revised July 2013






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Challenging the 39-Week Campaign



For several years now there has been a campaign to reduce non-medically indicated labor inductions prior to 39 weeks of gestation (see our February 8, 2011 Patient Safety Tip of the Week “Inducing Too Early”). That campaign, originally sponsored by the March of Dimes, Leapfrog Group, California Maternal Quality Care Collaborative and the California Department of Public Health; Maternal, Child and Adolescent Health Divisions, and later adopted by the American College of Obstetricians and Gynecologists (ACOG) highlighted the risks to newborns delivered prior to 39 weeks of gestation and provided tools to help avoid “elective” inductions prior to 39 weeks. We’ve been on board for that campaign.


We and others have also speculated that those early inductions might also be leading to more cesarean sections (see our September 7, 2010 Patient Safety Tip of the Week “Patient Safety in Ob/Gyn Settings” and our September 2013 What’s New in the Patient Safety World column “Full-Time Laborists Reduce C-Section Rates”).


Now a new study challenges both concepts. Researchers at the Oregon Health & Science University (Darney 2013) reviewed data on all the deliveries in the state of California in 2006 and applied better methods to identify cases in which inductions lacked medical indications and then compared maternal and neonatal outcomes between those with non-medical inductions vs. expectant management. They found that the odds of cesarean section was actually significantly lower in women having inductions without medical indication at weeks 37, 38, 39, and 40 among both multiparous and nulliparous women.


Moreover, there was no difference in the risk for severe lacerations, operative vaginal delivery, perinatal death, NICU admission, respiratory distress, or macrosomia between the groups at any week studied. There was an increased risk of hyperbilirubinemia in infants with inductions lacking medical indication at 37 and 38 weeks of gestation and an increased risk of shoulder dystocia at week 39.


Note that another study published about a year ago (Stock 2012) had found that elective induction of labor between weeks 37 and 40 was associated with decreased odds of perinatal mortality compared to expectant management and did not increase the risk of cesarean sections. Admissions to a neonatal unit were, however, increased in those cases having elective induction prior to 41 weeks.


The Darney study highlights the difficulties in interpreting conclusions that come from retrospective analysis of data (on which most prior recommendations have been based). The authors note that efforts to reduce induction of labor without medical indication before 39 weeks of gestation (or to reduce induction without an indication overall) are based on a relatively limited literature. They caution that focus on induction of labor as a quality metric in obstetrics must be evidence-based. Use of a standard method to classify induction without medical indication would be critical for prospective studies to further answer these important questions.







Darney BG, Snowden JM, Cheng YW, et al. Elective Induction of Labor at Term Compared With Expectant Management: Maternal and Neonatal Outcomes. Obstetrics & Gynecology 2013; published ahed of print 6 September 2013




Stock SJ, Ferguson E, Duffy A, et al. Outcomes of elective induction of labour compared with expectant management: population based study. BMJ 2012; 344: e2838 Published 10 May 2012






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How Many Deaths Result from Medical Errors?



The 1999 Institute of Medicine (IOM) report “To Err is Human: Building a Safer Health System” has widely been recognized as opening the eyes of the public and the medical profession about the enormity of the issue of medical errors. It estimated that up to 98,000 patients might die each year as the result of their medical care rather than from their underlying medical conditions. While some criticized the study as overestimating the numbers or noted many of the patients may have died anyway, most of us who have been hospital medical directors or been involved in quality improvement and patient safety felt the numbers were likely underestimates.


Then in 2011 (see our May 2011 What’s New in the Patient Safety World column “Just How Frequent Are Hospital Medical Errors?”) we noted a study (Classen 2011), using IHI’s Global Trigger Tool to identify hospital adverse events, that found that the numbers may be 10-fold higher than what was noted in the IOM report. Potentially avoidable adverse events occurred in a third of hospital admissions. In our January 2011 What’s New in the Patient Safety World column “No Improvement in Patient Safety: Why Not?” we noted a study (Landrigan 2010) that showed there has been little improvement in hospital adverse events overall over a long time frame. That study, done on data from 10 North Carolina hospitals, used IHI’s Global Trigger Tool to estimate rates of patient harm and preventable harm over a 6-year period. They found essentially no reduction in harm over that period.


The IHI Global Trigger Tool clearly identifies more adverse events than are found either via chart review or voluntary reporting or using administrative data tools like AHRQ’s PSI indicators. While the IHI Global Trigger Tool measures events somewhat differently than in the studies that formed the basis of the IOM report, the global trigger tool methodology is “doable” with limited resources and provides a more reliable comparison over time. See our October 30, 2007 Patient Safety Tip of the Week “Using IHI's Global Trigger Tool” and our April 15, 2008 Patient Safety Tip of the Week Computerizing Trigger Tools” for more details on how to use it.


Now a new study (James 2013) provides a new evidence-based estimate of patient harms associated with hospital care. It’s “evidence-based” because it analyzed those published studies which utilized the Global Trigger Tool (GTT) methodology to identify cases of potentially preventable medical errors. Using a weighted average of 4 studies utilizing the GTT, James estimates that the lower limit of deaths per year associated with preventable harms in hospitals is 210,000 deaths per year. And, given the limitations of the GTT and fact that these studies do not include deaths related to diagnostic errors which may not show up for years, James further estimates that the number of deaths associated with preventable harm may be more than 400,000 per year. He also notes that the frequency of serious harm may be 10- to 20-fold higher than that for lethal harm.


This is a well-done analysis and James has a good discussion of the difficulties involved in accurately assessing the frequency of adverse events related to medical care.


But we’ll come back to a point we’ve made frequently. You’ve often heard us use the phrase “Stories, Not Statistics” (see our December 2009 What’s New in the Patient Safety World column “Stories, Not Statistics”). When we first began doing presentations on patient safety in the early 1990’s we often began with some of the statistics on medical error from Lucien Leape’s work. But we began to notice physicians and medical students begin to zone out when we talked about statistics on medical error. What they liked were the anecdotes we would tell about cases that really happened. So we changed our focus. While we still often show statistics on medical error to put things in context, we no longer highlight them. Instead, we really rely on the stories. That’s what gets people’s attention. That’s what makes people say “I wonder if that could happen here?” and what makes them go back to look at the systems in their health care systems. It is those stories that hit home hard and make people remember. Who cannot remember their own reactions when they first heard the Josie King story, or the story about the nurse who administered Bicillin intravascularly, or the little boy who died from concentrated epinephrine injection during a simple surgical procedure, or any nurse who inadvertently administered concentrated potassium solutions? We could even begin with the story of the death of the son of the author of the most recent study. In his book “A Sea of Broken Hearts” (James 2007) James writes about his son, who died while running, and a variety of issues related not only to prolonged QT interval syndrome but also to multiple other problems in our healthcare system (communication breakdowns, fragmented care, unnecessary tesing, regulatory boondoggles, etc.).


In fact, the lack of compelling stories is one of the reasons we feel IOM’s “To Err is Human: Building a Safer Health System” failed to gain traction despite considerable initial media attention. Everyone focused on the statistics from that report. It lacked the stories about real people you need to tell in order to get people and systems to change.


Yes, the new study further clarifies the magnitude of the problem. But telling stories about real people experiencing such problems is what will get your healthcare colleagues to perk up and take notice that many of those problems could happen in their hospital or their practice. And, by the way, you’ve probably also noticed in your state that legislators are also more likely to enact patient safety legislation in response to personal stories rather than statistics! So use the statistics as background information but lead with the stories.







Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999




Classen D, Resar R, Griffin F, et al. ‘Global Trigger Tool’ Shows That Adverse Events In Hospitals May Be Ten Times Greater Than Previously Measured. Health Affairs 2011; 30(4): 581-589




Landrigan CP, Parry GJ, Bones CB, et al. Temporal Trends in Rates of Patient Harm Resulting from Medical Care. N Engl J Med 2010; 363: 2124-2134




James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care. Journal of Patient Safety 2013; 9(3): 122–128




James JT. A Sea of Broken Hearts—Patient Rights in a Dangerous, Profit-Driven Health Care System. Bloomington, IN: AuthorHouse; 2007







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New AHRQ Toolkit: Improving Your Office Testing Process



AHRQ has just put out a new toolkit “Improving Your Office Testing Process”, aimed at helping offices track and follow up on tests ordered during office visits. Failure to follow up on test results is one of our most frequent topics and one of the most frequent causes for malpractice claims in outpatient medicine.


The toolkit provides step-by-step instructions on how to evaluate your office processes for tests and use rapid-cycle quality improvement techniques to make them safer and more reliable. It provides tools for assessing your testing practices and for planning your improvement project. For each step you map out it asks practical questions like who usually performs this step and who does it if that person is absent. It explains how to use a scoring tool to identify those areas most in need of improvement.


In addition, there is a patient handout and tools for assessing office readiness and patient engagement, and tools for chart audits and electronic record evaluations.


Gurdev Singh, BScEngg, MScEng PhD, Co-Director of the University of Buffalo Patient Safety Research Center and a coauthor of the AHRQ Toolkit notes “it is a proactive tool that empowers stakeholders at the point of care. It helps create teams that inculcate mutual respect, trust, collaboration and cooperation that leads to prioritization of hazards in the system and design of feasible interventions to reduce harm to all. As each setting is unique the tool is adaptable to fit its needs. The most important feature is that it promotes bottom-up approach designed to educate, engage and empower providers and patients with a mission to create high reliability organization.” 


We think most offices and outpatient clinics will find this toolkit easy to use and very valuable in improving one of the most important facets of ambulatory medicine.



See also our other columns on communicating significant results:


Some of our other columns on errors related to laboratory studies:







AHRQ Toolkit. Improving Your Office Testing Process. A Toolkit for Rapid-Cycle Patient Safety and Quality Improvement. AHRQ 2013



patient handout



office readiness survey



patient engagement survey



chart audit tool



electronic record evaluation tool







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Print “October 2013 What's New in the Patient Safety World (full column)

Print “October 2013 HAI’s: Costs, WHO Hand Hygiene, etc.

Print “October 2013 Opioid Safety Actions and Resources

Print “October 2013 Challenging the 39-Week Campaign

Print “October 2013 How Many Deaths Result from Medical Errors?

Print “October 2013 New AHRQ Toolkit: Improving Your Office Testing Process







Print “October 2013 What's New in the Patient Safety World (full column in PDF version)











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