What’s New in the Patient Safety World

August 2018


·       Thromboembolism: Another Downside of Transfusions

·       Burnout and Medical Errors

·       Pediatric Adverse Events

·       IHI on Safety of Care in the Home




Thromboembolism: Another Downside of Transfusions



The move in recent years toward more restrictive transfusion policies and practices has been fueled by increased recognition of untoward side effects of transfusions and controlled clinical trials demonstrating as good or better outcomes with the more restrictive practices in most cases (see the list of our prior columns at the end of today’s column).


Now, an additional risk associated with transfusion has been identified: venous thromboembolism. Goel and colleagues (Goel 2018) analyzed data from the American College of Surgery National Surgical Quality Improvement Program (ACS-NSQIP) database, They found that perioperative RBC transfusion was associated with higher odds of venous thromboembolism  (adjusted odds ratio 2.1), deep venous thrombosis (aOR 2.2), and pulmonary embolism (aOR 1.9), independent of various putative risk factors.


Moreover, they found a significant dose-response effect, with increased odds of VTE as the number of intraoperative and/or postoperative RBC transfusion events increased. The adjusted odds ratios were 2.1 for one event, 3.1 for 2 events, and 4.5 for 3 or more events compared to no intraoperative or postoperative RBC transfusion.


And the association between any perioperative RBC transfusion and postoperative VTE was statistically significant across all surgical subspecialties.


The Goel article goes on to discuss the putative mechanisms by which RBC transfusions might increase the risk of venous thromboembolism.


So the new study provides even more evidence to support restrictive transfusion practices in most cases. You’ll recall the AABB (American Association of Blood Banks) updated its guidelines in 2016 (see our November 2016 What's New in the Patient Safety World column “AABB Updates Transfusion Guidelines Again”) and recommended two tiers of hemoglobin level transfusion triggers (Carson 2016):


But even the recommendation for orthopedic surgery has been challenged. Researchers at Johns Hopkins Bayview Medical Center looked at outcomes in orthopedic surgery patients before and after implementation of a blood management program (Gupta 2017). The program consisted of provider education, tranexamic acid, a new surgical blood order schedule, electronic best practice advisories, a “Why Give 2 When 1 Will Do?” campaign advocating single unit RBC transfusions, and audits with provider feedback for guideline compliance. They found, after implementation of the new program, a 38% decrease in percent of patients transfused, and a 25% decrease in mean RBC units per patient. Median length of stay was one day shorter in the post blood-management group with a statistically significant decrease in 30-day readmission rate and no difference in adverse outcomes. (Note that we discussed the Hopkins program (Sadana 2017) in our December 2017 What's New in the Patient Safety World column “Study Confirms Safety of Restrictive Transfusion Policy”.)


Increasing evidence suggests that more restrictive transfusion practices improve patient safety and outcomes and can lead to considerable financial savings, not only from reduced blood product costs but also from the savings seen with fewer complications, shorter lengths of stay, etc.




Prior columns on potential detrimental effects related to red blood cell transfusions:







Goel R, Patel EU, Cushing MM, et al. Association of Perioperative Red Blood Cell Transfusions with Venous Thromboembolism in a North American Registry. JAMA Surgery 2018; Published online June 13, 2018




Gupta PB, Scher LJ, Yang WW, et al. Impact of a Patient Blood Management Program on Blood Utilization and Clinical Outcomes in Orthopedic Surgery. ANESTHESIOLOGY 2017 Abstract A3101.




Carson JL, Guyatt G, Heddle NM, et al. Clinical Practice Guidelines from the AABB. Red Blood Cell Transfusion Thresholds and Storage. JAMA 2016; Published online October 12, 2016




Sadana D, Pratzer A, Scher LJ, et al. Promoting High-Value Practice by Reducing Unnecessary Transfusions with a Patient Blood Management Program. JAMA Intern Med 2017; Published online November 20, 2017







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Burnout and Medical Errors



We’ve done numerous columns on the impact of fatigue on medical errors. A recent study published in the Mayo Clinic Proceedings (Tawfik 2018) showed that physicians reporting excessive fatigue were almost 40% more likely to have reported a major medical error in the prior 3 months. But, more surprisingly, the study showed that physicians reporting symptoms of burnout were more than twice as likely to have reported a major medical error in the prior 3 months.


The study was based upon physicians in the American Medical Association Physician Masterfile invited to respond to an anonymous survey. The survey was completed by 19% of those who opened the request for participation. Note that the term “burnout” was not used in the survey. Rather, questions included symptoms commonly related to burnout.


54.3% of respondents reported symptoms of burnout, 32.8% reported excessive fatigue, and 6.5% reported recent suicidal ideation. One other factor assessed was a poor or failing patient safety grade in their primary work area and this was reported by 3.9% of respondents. Overall, 10.5% of respondents reported making a major medical error in the prior 3 months. Error in judgment (39%), diagnoses (20%), and technical mistakes (13%) were the most commonly reported errors.


Physicians reporting errors were more likely to have symptoms of burnout (77.6% vs 51.5%;), fatigue (46.6% vs 31.2%), and recent suicidal ideation (12.7% vs 5.8%).


In multivariate modeling, odds ratios (OR) for association with errors were 2.22 for burnout, and 1.38 for excessive fatigue.


As you’d expect, errors were more likely to be reported as the safety grade for their primary work unit worsened. For safety grades B, C, D, and F the respective odds ratios for errors were 1.70, 1.92, 3.12, and 4.37 compared to safety grade A. In a press release about the study (White 2018), co-author Tait Shanafelt said, “This indicates both the burnout level as well as work unit safety characteristics are independently related to the risk of errors.” Lead author Danial Tawfik noted the study also showed that rates of medical errors actually tripled in medical work units, even those ranked as extremely safe, if physicians working on that unit had high levels of burnout. He felt this indicates that burnout may be an even a bigger cause of medical error than a poor safety environment.


As with any study based on responses to a survey, there may well be some degree of selection bias and the results show an association but not necessarily causality. But, while there may be some inaccuracy in the actual statistics, we believe the overall message of the study: burnout is a real problem and it contributes to medical errors and untoward patient outcomes.


We, thus, need better ways to recognize physician burnout and interventions to offer support when we recognize it. Other industries have recognized job burnout and developed approaches to address it. We need to borrow from those industries and apply their approaches to healthcare. An excellent review on physician burnout also recently appeared in the Mayo Clinic Proceedings (Olson 2017).


Also of interest is another recent study that showed physician burnout symptoms were fewer in small independent primary care practices (Blechter 2018). Over 70% of those physicians were solo practitioners so the authors propose one explanation could be the autonomy (ie, control of work environment) associated with owning one's own practice as opposed to working in an integrated health system or Federally Qualified Health Center where providers are subject to greater administrative regulations. They also found that higher “adaptive reserve” scores were associated with lower levels of burnout. They suggest that interventions to reduce burnout in primary care practices should focus on strengthening factors that support organizational capacity for change (ie, strong communication, leadership supports, innovation).







Tawfik DS, Profit J, Morgenthaler TI, et al. Physician Burnout, Well-being, and Work Unit Safety Grades in Relationship to Reported Medical Errors. Mayo Clinic Proceedings 2018; Published online: July 9, 2018




White T. Medical errors may stem more from physician burnout than unsafe health care settings. Stanford Medicine Press Release. July 8, 2018




Olson KD. Physician Burnout—A Leading Indicator of Health System Performance? Mayo Clinic Procedings 2017; 92(11): 1608-1611




Blechter B, Jiang N, Cleland C, et al. Correlates of Burnout in Small Independent Primary Care Practices in an Urban Setting. J Am Board Fam Med 2018; 31(4): 529-536





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Pediatric Adverse Events



Trigger tools have provided a good way to identify adverse events in hospitalized patients and in other healthcare settings (see our prior columns on trigger tools listed below). Most of the early work on trigger tools was done in adult patients but Stockwell et al. (Stockwell 2015) developed and tested a trigger tool that would identify the most common causes of harm in pediatric inpatient environments. Expanding upon that, the safety surveillance tool GAPPS (Global Assessment of Pediatric Patient Safety) has been validated and now studied in multiple children’s hospitals.


A new study shows that adverse event (AE) rates remain high in hospitalized pediatric patients and have not substantially improved over time (Stockwell 2018). Researchers used the GAPPS tool to measure temporal trends in AE rates among hospitalized children from 2007 to 2012. They randomly selected pediatric inpatient records from 16 teaching and nonteaching hospitals.


Among 3790 records reviewed, they found 414 AEs (19.1 AEs per 1000 patient days) and 210 preventable AEs (9.5 AEs per 1000 patient days). On average, teaching hospitals had higher AE rates than nonteaching hospitals (26.2 vs 5.1 AEs per 1000 patient days). The most frequently identified AE’s were hospital-acquired infections, intravenous line complications, gastrointestinal events, respiratory-related events, and “other”. As we’d expect, chronically ill children had higher AE rates than patients without chronic conditions (33.9 vs 14.0 AEs per 1000 patient days). They found that neither teaching nor nonteaching hospitals experienced significant variations in AE rate over the time of the study.


In terms of severity, 1.2% of AEs resulted in permanent harm, 10.1% were potentially life-threatening, 0.7% were fatal or contributed to a patient's death. Perhaps most striking is that 50.7% were considered potentially preventable.


In the accompanying editorial, Quinonez and Schroeder (Quinonez 2018) noted some prior studies had suggested AE rates were decreasing but that the GAPPS tool is better at identifying AE’s. But they also note that GAPPS may miss some harms, such as those related to the “diagnostic cascade” that results from overtesting.


Though the analysis did not look at trends after 2012, the findings suggest that adverse events in pediatric patients remain at high levels and that many are potentially preventable. Use of trigger tools like GAPPS can help with identification of such adverse events and help hospitals and health systems identify areas in need of improvement.




Some of our prior columns on trigger tool methodology:







Stockwell DC, Bisarya H, Classen DC, et al. A Trigger Tool to Detect Harm in Pediatric Inpatient Settings. Pediatrics 2015; Published online ahead of print May 18, 2015




Stockwell DC, Landrigan CP, ToomeySL, et al. for the GAPPS Study Group

Adverse Events in Hospitalized Pediatric Patients. Pediatrics Jul 2018, e20173360




Quinonez RA, Schroeder AR. “GAPPS” in Patient Safety. Pediatrics Jul 2018, e20180954






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IHI on Safety of Care in the Home



IHI (Institute for Healthcare Improvement) just published an excellent report/monograph “No Place Like Home: Advancing the Safety of Care in the Home” (IHI 2018). It identifies some of the unique issues that apply to care in the home setting. Much is based on a previous IHI report “Patient Safety in the Home: Assessment of Issues, Challenges, and Opportunities” (Carpenter 2017).


They identify the following factors that make safe care in the home especially challenging:

  1. The provision of care outside the controlled environment of the health care system
  2. Issues with communication and care coordination among the care team, the care recipient, and the family caregiver
  3. The need to balance autonomy and risk
  4. The closeness of the link between the care recipient and those providing care
  5. The limited health literacy of the care recipient and the family caregiver
  6. Variable availability of data
  7. Social and physical isolation
  8. The variety of needs and populations


They identify risks specific to care in the home and the potential harms associated with those risks, which often have underlying causes that are interrelated:

  1. Adverse events related to medication and other forms of treatment
  2. Injuries due to physical hazards in the home (e.g., falls)
  3. Injuries related to equipment and technology
  4. Pressure injuries
  5. Infections
  6. Conditions related to poor nutrition
  7. Adverse effects on family caregivers
  8. Adverse effects on home care workers
  9. Potential neglect and abuse of care recipients


The report provides recommendations, strategies, and tools for realizing five guiding principles:


We encourage you to go to the IHI website and download the full report(s). As usual, IHI has done an excellent job of summarizing some of the challenges in yet another healthcare setting.


We also hope you’ll go back to our August 13, 2013 Patient Safety Tip of the Week “Adverse Events in Home Care” that summarized the findings of several excellent Canadian studies on patient safety issues in the home setting.



Some of our prior columns on patient safety issues in the home:






IHI (Institute for Healthcare Improvement). No Place Like Home: Advancing the Safety of Care in the Home. IHI 2018




Carpenter D, Famolaro T, Hassell S, et al. Patient Safety in the Home: Assessment of Issues, Challenges, and Opportunities. Cambridge, Massachusetts: Institute for Healthcare Improvement; August 2017





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Print “August 2018 Thromboembolism: Another Downside of Transfusions

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