What’s New in the Patient Safety World

July 2013



·        I COUGH

·        “Bad Apples” Back In?

·        Flu Vaccine Controversy

·        More on the CT/Cancer Debate







There is a fairly substantial literature on interventions to reduce complications in intubated, mechanically ventilated patients. However, there is a much less robust literature on best practices to prevent pulmonary complications in non-ventilated patients.


Now a new multicomponent intervention bundle has been demonstrated to reduce post-operative pulmonary complications (Cassidy 2013). The “I COUGH” program was associated with a reduction in the incidence of post-op pneumonia from 2.6% to 1.6% and unplanned intubations from 2.0% to 1.2%. The acronym “I COUGH” stands for the components of the intervention bundle use:

I           Incentive spirometry

C         Coughing and deep breathing

O         Oral care (brushing teeth and using mouthwash twice daily)

U         Understanding (patient and family education)

G         Getting out of bed frequently (at least 3 times daily)

H         Head-of-bed elevation


The authors also note that postoperative pain control was a key element of the bundle. The educational piece involved not only patients and families but also physicians and nurses. They developed a standardized order set to incorporate all the key interventions. Unit-specific audit of nursing practice changes probably also played an important role.


The authors also felt that the composition of the workgroup that developed and implemented the program was extremely important. That mulitidisciplinary workgroup consisted of surgeons, nurses, internal medicine representatives, respiratory therapists, physical therapists, infection control, and quality improvement personnel. They also felt that nurse managers were especially crucial to the success of the program. The catchy acronym ICOUGH also helped staff and patients and families remember the key intervention components.






Cassidy MR, Rosenkranz P, McCabe K, Rosen JE, McAneny D. I COUGH. Reducing Postoperative Pulmonary Complications With a Multidisciplinary Patient Care Program. JAMA Surg. 2013; (): 1-6 Published online first June 5, 2013






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“Bad Apples” Back In?



One of the slides we still show on occasion dates back to the work of Lucian Leape and colleagues from the Harvard Medical Practice Study (Leape 1991, Brennan 1991, Leape 1994) noting that “bad apples” accounted for only 2% of errors encountered in their study. Since that seminal work we have always focused on the “systems” nature of errors that lead to adverse events.


But in recent years we have begun to focus more on the effects that disruptive physicians (and other disruptive healthcare workers) have on quality and patient safety. In 2008 Joint Commission issued Sentinel Event Alert #40 “Behaviors That Undermine a Culture of Safety” and most hospitals have taken steps to identify egregious behaviors and deal with them appropriately. The “Just Culture” philosophy has always recognized that there are some behaviors that are not tolerable. Even Lucian Leape has begun to rethink some of our underlying root causes in adverse outcomes. Our July 2012 What’s New in the Patient Safety World column “A Culture of Disrespect” summarized what he considers to be the number one problem in patient safety today: we have a culture of disrespect. His argument is that our pervasive culture of disrespect is what is blocking our ability to move to a culture of safety. While he includes the classic disruptive physician type behaviors in his 2-part series on the culture of disrespect (Leape 2012a, Leape 2012b) and related video “Lucian Leape on Key Lessons in Patient Safety”, he emphasizes the much more subtle behaviors we exhibit that undermine the safety culture.


But the “bad apple” theme won’t go away. This month’s issue of BMJ Quality and Safety has a provocative study on complaints about physicians in Australia (Bismark 2013) and three accompanying editorials (Gallagher 2013, Paterson 2013, Shojania 2013).


The study by Bismark et al. found that 3% of Australia’s medical workforce accounted for 49% of all complaints by patients and 1% accounted for 25% of the complaints. Moreover, there was a striking dose-response relationship, i.e. the more complaints about a physician the higher the likelihood that there would be yet further complaints. For example, a doctor with a third complaint had a 38% chance of a further complaint within a year and 57% chance of another complaint within 2 years. For one with a fifth complaint, the chance of another complaint within 1 and 2 years, respectively, was 59% and 79%. The authors point out that we are often too late to respond to physicians who have attracted multiple complaints and that we should really look at complaints as sentinel events. The hope is that early response may result in changes in physician behaviors.


So is the recent emergence of a focus on “bad apples” really in conflict with our more global “systems” view of patient safety? Shojania and Dixon-Woods (Shojania 2013), in an editorial accompanying the Bismark study, argue that it really is a systems problem and that we need to focus our resources on identifying such individuals and dealing with them. They also note that, in some cases, there may be multiple system problems that lead to a physician attracting multiple complaints (eg. understaffing in a clinical area).


In another accompanying editorial Paterson (Paterson 2013) notes that patient complaints are the “canaries in the coal mine” that should alert us to deeper problems and should not be ignored.


The third editorial (Gallagher 2013) focuses on the need to end our silence and speak up and tell our colleagues about ways they can improve their care and communicate better. They argue we need to do a much better job acting locally (at the departmental, medical staff, academic unit, and clinical unit levels) to address these behaviors before they need to go to higher levels. They also note the need to develop better metrics for incorporating measures of patient satisfaction.


Of course, it is not just patient complaints we need to consider. Complaints from staff are equally important and it should come as no surprise that the same physicians who attract patient complaints likely have had multiple staff complaints as well. Our January 2011 What’s New in the Patient Safety World column “No Improvement in Patient Safety: Why Not?” and our March 29, 2011 Patient Safety Tip of the Week “The Silent Treatment: A Dose of Reality” discuss failure to change the culture as barriers to patient safety and good healthcare. Turning a blind eye or deaf ear to such problems just continues to make the working environment worse for all parties involved. We’ve seen numerous occasions where staff had previously stepped forward to report such behaviors, only to be ignored or, worse yet, suffer retribution for their actions. So the organization as a whole needs to ensure a supportive environment is present so that staff do not feel uncomfortable in confronting such individuals or in addressing such threats to patient safety. You can have all the policies and procedures in the world but if your culture is not conducive to eliminating these hazards we will never move patient safety to that next level.







Brennan TA, Leape LL, Laird NM, et al.  Incidence of Adverse Events and Negligence in Hospitalized Patients: Results of the Harvard Medical Practice Study I.  N Engl J Med, 1991; 324(6): 370-376




Leape LL, Brennan TA, Laird NM, et al.  The Nature of Adverse Events in Hospitalized Patients: Results of the Harvard Medical Practice Study II.  N Engl J Med, 1991; 324(6): 377-384




Leape LL.  Error in Medicine. JAMA 1994; 272(23): 1851-1857




Leape LL, Shore MF, Dienstag JL, et al. Perspective: a culture of respect, part 1: the nature and causes of disrespectful behavior by physicians. Acad Med. [Epub ahead of print, May 22, 2012] 2012; 87: 1-8. http://journals.lww.com/academicmedicine/Abstract/publishahead/PerspectiveACultureofRespect,Part1The.99620.aspx



Leape LL, Shore MF, Dienstag JL, et al. Perspective: a culture of respect, part 2: creating a culture of respect. [Epub ahead of print, May 22, 2012] Acad Med. 2012; 87: 1-6. http://journals.lww.com/academicmedicine/Abstract/publishahead/PerspectiveACultureofRespect,Part2.99622.aspx



"Lucian Leape on Key Lessons in Patient Safety" (video)



Bismark MM, Spittal MJ, Gurrin LC, et al. Identification of doctors at risk of recurrent complaints: a national study of healthcare complaints in Australia. BMJ Qual Saf 2013; 22: 532-540 Published Online First: 10 April 2013 doi:10.1136/bmjqs-2012-001691




Shojania KG, Dixon-Woods M. ‘Bad apples’: time to redefine as a type of systems problem? BMJ Qual Saf 2013; 22: 528-531 Published Online First: 6 June 2013 doi:10.1136/bmjqs-2013-002138




Paterson R. Not so random: patient complaints and ‘frequent flier’ doctors. BMJ Qual Saf 2013;22:525-527 Published Online First: 10 April 2013 doi:10.1136/bmjqs-2013-001902




Gallagher TH, Levinson W. Physicians with multiple patient complaints: ending our silence. BMJ Qual Saf 2013; 22: 521-524 Published Online First: 10 April 2013 doi:10.1136/bmjqs-2013-001880








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Flu Vaccine Controversy



Back in the late 1970’s this author was assembling a large database on patients with Guillain-Barre Sydrome (GBS) treated at the Massachusetts General Hospital (Ropper 1991). Because a small percentage of cases of GBS follow a variety of immunizations this author declined to get vaccinated against the “swine flu” which was touted at the time to be a major healthcare threat. (The controversy over whether swine flu vaccine caused GBS swirled for several years. At most there may have been a very small increase in GBS attributed to swine flu vaccine over that associated with traditional flu vaccine.) But it certainly raised the issue of vaccine efficacy vs. untoward consequences.


Similarly, when this author turned 50 years old and was offered the influenza vaccine, I looked to the literature. There really was no good evidence of a net benefit at a personal level to influenza vaccination of a healthy 50 year-old without chronic diseases.


But in recent years, there has been a broadening of the population for which influenza vaccination is recommended. Basically, it is now recommended for everyone above the age of 6 months who does not have a contraindication. Moreover, for healthcare workers there has been a real push for flu immunization in order to protect the patients whom we care for. The percentage of healthcare workers who get the flu vaccine has become a metric in value-based purchasing programs for hospitals and will become a publicly-reported statistic. In New York State the Department of Health has had a big push to increase the number of healthcare workers immunized against the flu. So the author has acquiesced in recent years and has received influenza immunization, primarily to serve as an example for other healthcare workers. We understand the concept of herd immunization.


But now a researcher from Johns Hopkins has challenged the evidence base for widespread influenza immunization (Doshi 2013). Doshi points out that most of the studies supporting influenza immunization have been retrospective observational studies, not randomized controlled trials. Hence, they may be subject to the “healthy user” bias (i.e. that people getting the flu vaccine may be, in general, more health conscious and more likely to get the vaccine). He also notes that some of the statistics purporting all-cause mortality benefits of 27-30% (one even as high as 48%) seem implausible.  He states “If true, these statistics indicate that influenza vaccines can save more lives than any other single licensed medicine on the planet.” Overall, Doshi suggests that the efficacy of the influenza vaccine has probably been oversold and the potential side effects underplayed.


Shortly after Doshi’s article appeared in the British Medical Journal, another article from CDC appeared describing the magnitude of influenza-related illness and hospitalizations averted in the US by influenza vaccination from 2005 to 2011 (Kostova 2013). Applying modeling to statistics from various databases, the authors estimate that from one million to 5 million cases of influenza illnesses are averted annually and from 7700 to 40,400 hospitalizations are averted in the US annually by the influenza vaccine.


So how do we reconcile these disparate pictures of the effectiveness of the influenza vaccine? We don’t purport to know the answer. We’ll just point out that there are numerous examples in healthcare where practice have been adopted on the basis of observational studies, only to be refuted once randomized controlled trials were done. We’ve heard too many times that it would be “unethical” to do a randomized controlled trial for “a treatment we already know works”. We think randomized controlled trials should be the basis for interventions, particularly those impacting such a huge portion of the population.


In the interim, hospitals are pretty much stuck with complying with recommendations of the regulatory bodies. It is possible to get close to 100% compliance with staff immunization in hospitals. An abstract presented at the recent APIC (Association for Professionals in Infection Control and Epidemiology) meeting highlighted Loyola University Medical Center that took its rate from 65% to 99% (APIC 2013). This was achieved without significant loss of the healthcare workforce there.


Many hospitals still deal with significant staff opposition to mandatory immunization. Let’s hope that someday we can reassure them that there is a sound evidence base for the recommendation of mass immunization for influenza.






Ropper AH, Wijdicks EFM, Truax BT: Guillain-Barre Syndrome. FA Davis: Philadelphia 1991




Doshi P. Influenza: marketing vaccine by marketing disease. BMJ 2013; 346: f3037 (Published 16 May 2013)


(Doshi 2013)



Kostova D, Reed C, Finelli L, et al. Influenza Illness and Hospitalizations Averted by Influenza Vaccination in the United States, 2005–2011. PLoS ONE 8(6): e66312. doi:10.1371/journal.pone.0066312, published online June 19, 2013




APIC. Mandatory flu vaccination of healthcare personnel does not lead to worker exodus. APIC News Release June 7, 2013 regarding Oral Abstract #012 at the 40th Annual Conference of APIC “Four-Year Experience with Mandatory Seasonal Influenza Immunization for All Personnel in a University Medical Center”, Sunday, June 9, 2013







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More on the CT/Cancer Debate



Since our April 2013 What’s New in the Patient Safety World column “Radiation Risk of CT Scans: Debate Continues” and our June 4, 2013 Patient Safety Tip of the Week Reducing Unnecessary CT Scans” another key study highlighting the risks of cancer related to CT scanning in the pediatric population has been reported (Miglioretti 2013). This was rapidly followed by a statement from the American College of Radiology that cautioned parents not to overreact to that study (ACR 2013). And while the headlines would make you suspect that the two “camps” were diametrically opposed on the issue, they really are aligned when you read the details.


The Miglioretti study, published online in JAMA Pediatrics, looked at CT scans done in children younger than 15 years old between 1996 and 2010. They looked at frequency and type of CT exams done, radiation doses, and then projected the number of cases of potential lifetime cancer using a model based upon the Life Span Study (on Japanese A-bomb survivors). They found that overall use of CT scans increased 2-3 times in this population over this time span, though the rates plateaued in 2006-2007 and then decreased slightly since then. They estimated that that the over 4 million CT scans done on patients in this age group annually would result in 4870 future cancers.


Risks of future cancer were projected to be higher in girls and children younger than 5 years and higher for those undergoing CT scans of the abdomen/pelvis or spine.


The authors estimate that reducing the dose of radiation in the highest 25% of cases down to the median dose could prevent 43% of projected cancers (this would be under the control of the radiologist), compared to a 33% reduction of projected cancers if fewer CT scans were ordered (this would be mostly under control of the ordering physicians).


The same day the Miglioretti study was published the American College of Radiology released a statement on the raditation risks from pediatric CT scans (ACR 2013). The message was that parents should not forgo necessary imaging scans for their children. It pointed out that the risk of children developing cancer after a CT scan was actually very low and, while it encouraged parents to ask all the right questions, noted that CT scans in many cases are the diagnostic test of choice and parents should not preclude their child from getting that most appropriate test. It discourages parents from saying no to a CT scan that might be life-saving for their child. And while you might look at the ACR statement as a blatant attempt to preserve their “turf”, the gist of their statements are very similar to that of the Miglioretti paper.


The ACR statement encourages parents to ask how the scan would improve their child’s care, whether there are alternatives that might be equally effective without radiation exposure, whether “child-sized” radiation doses will be used, and whether the facility is accredited. It recommends using ACR Appropriateness Criteria in deciding whether a CT scan is appropriate or not. It points out that modern CT scanners use up to 90% lower doses than those done just 10 years ago. It points out that the ACR has participated in the Imaging Gently and Imaging Wisely campaigns and the Choosing Wisely project that have probably helped reduce the number of pediatric CT scans since 2007.


The editorial accompanying the Miglioretti study (Schroeder 2013) has a small table with examples of how and when alternative studies not utilizing ionizing radiation might be used instead of CT scans. One example is use of ultrasound as a first test for suspected appendicitis. Another is use of clinical prediction “rules” to help decide when observation for mild head trauma may be sufficient. We’ve discussed use of such rules in several of our previous columns. They also note that there may be downsides to CT scans other than the radiation dose. These include financial costs, possible need for sedation in some cases, overdiagnosis and need for additional testing for false positive results. They also attribute much of the recent decrease in CT scanning in children to the Imaging Gently and Choosing Wisely campaigns. Both this editorial and the ACR statement encourage parents to track the number of radiology studies and radiation dosages for their children.


We’ve noted previously that sometimes both the circumstances and the urgency of the situation may dictate what study gets done. For example, some rural hospitals may lack nighttime ultrasound coverage or might not have an MRI scanner. In such cases, one must weigh the risks associated with transfer of the patient to another facility having these resources against the small lifetime risk of a CT scan. There might also be circumstances where sedation might be required in a young child and a CT scan might be considerably faster than an MRI, reducing the duration of sedation and its attendant risks.


Our June 4, 2013 Patient Safety Tip of the Week Reducing Unnecessary CT Scans” had a good discussion of ways to reduce overall utilization of CT scans.



The message of both the Miglioretti study and the ACR statement is clear: eliminate those CT scans that are not necessary and use the lowest possible radiation dose for those CT scans that are necessary. Neither paper suggests not doing CT scans when the clinical information likely to be gained is important and other alternatives are not as good.




Some of our previous columns on the issue of radiation risk:


·        February 2, 2010         The Hazards of Radiation

·        November 23, 2010     Focus on Cumulative Radiation Exposure

·        March 2010                 More on Radiation Safety

·        June 2011                    Progress in Reducing Radiation from CT Scans

·        April 2013                    Radiation Risk of CT Scans: Debate Continues

·        June 4, 2013                Reducing Unnecessary CT Scans







Miglioretti D, Johnson E, Williams A, et al. The Use of Computed Tomography in Pediatrics and the Associated Radiation Exposure and Estimated Cancer Risk. JAMA Pediatr. 2013; (): 1-8. Published online June 10, 2013




Schroeder AR, Redberg RF. The Harm in Looking. (Editorial) JAMA Pediatr. 2013; ():1-3. Published online June 10, 2013




ACR (American College of Radiology). Press release. ACR Statement on JAMA Pediatrics Study on Radiation Risk from Pediatric CT Scans. Parents Should Not Forgo Necessary Imaging Scans for Their Children. June 10, 2013






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