What’s New in the Patient Safety World

February 2014



·        SHEA’s New Recommendations for Hospital Attire

·        New Studies on Delirium

·        Helping Promote Disclosure and Apology

·        Medicare Adverse Event Trends

·        OSHA Worker Safety in Hospitals




SHEA’s New Recommendations for Hospital Attire



The Society for Healthcare Epidemiology of America (SHEA) has just published in the February 2014 issue of Infection Control and Hospital Epidemiology a guidance statement for hospital attire outside the OR (Bearman 2014). The guidance attempts to balance professional considerations against the potential risk of transmission of pathogens to patients. The authors make it clear that the actual role of hospital attire in causing infections in patients remains unclear at this time. Nevertheless, the guidance has recommendations that are based on practical, theoretical and biologically plausible considerations to reduce the likelihood of transmission of pathogens to patients. The guidance reviews the laboratory evidence of contamination of various pieces of healthcare worker’s attire with pathogens, including multi-drug resistant pathogens.


One recommendation is “bare below the elbows (BBE)”. This means healthcare workers should wear short sleeves during patient contact and have no wristwatch, rings or other jewelry below the elbows. Note that BBE has been utilized in the UK now for many years.


There are multiple recommendations regarding the traditional white coats worn by healthcare workers. Workers should have at least 2 white coats available and a convenient and economical way of laundering them. The institution should provide onsite laundering at no cost or low cost when possible. The institution should also provide coat hooks for healthcare workers to remove their white coat (or other long-sleeved outerwear) prior to patient contact. While they note that attire worn in patient contact should be laundered after daily use, they recommend that white coats worn during patient care should be laundered at a minimum once a week or when visibly soiled. While they did not take a firm stance on whether attire should be laundered at home or professionally, they do recommend that if attire is laundered at home a hot-water wash cycle with bleach be used, followed by a cycle in the dryer.


Specific recommendations on footwear are that all footwear should have closed toes, low heels, and nonskid soles. These basically echo AORN recommendations for shoes in the OR.


Equipment that is shared between patients (eg. stethoscopes) should be cleaned between patients.


SHEA did not take a specific stance on issues related to neckties, lanyards, cell phones, pagers, other jewelry but noted that when such come in contact with patients or the patient environment they should be disinfected, replaced or eliminated.


The paper nicely describes the literature on all facets of hospital attire and potential for infection. It notes that while, in general, patients prefer more formal attire and white coats in their clinicians, they are okay with the newer attire once the potential for cross contamination is explained to them.


The paper does include the background studies on the laboratory evidence of pathogens on attire and body parts but emphasizes that there is a paucity of data that links the contamination of attire to actual patient infections. Nevertheless, the new SHEA recommendations are practical and economical and biologically plausible so we would hope that hospitals begin to adopt them.


There is, however, a huge gap between hospital attire policies and their enforcement. The SHEA paper notes that enforcement of hospital attire policies may be as low as 11%. Given the number of healthcare workers we see in scrubs in hospital cafeterias, other parts of the hospital, and even shopping alongside us in our local grocery stores, we know it will take much more than a policy to foster true change.






Bearman G, Bryant K, Leekha S, et al. SHEA Expert Guidance. Healthcare Personnel Attire in Non-Operating-Room Settings. Infect Control Hosp Epidemiol 2014; 35(2): 107-121  February 2014 electronically published January 16, 2014





Print “February 2014 SHEA’s New Recommendations for Hospital Attire





New Studies on Delirium



We’ve done multiple columns on delirium, its assessment, and its management (see list at the end of today’s column). But the etiology and pathophysiology of delirium has remained largely speculative. But a new study from researchers at Vanderbilt, which is well known for its work on delirium, has some good insights into the pathophysiology (Hughes 2014). The researchers looked at biomarkers of blood-brain barrier dysfunction and endothelial dysfunction in 134 ICU patients with respiratory failure or shock. They assessed patients for delirium with the CAM-ICU and RASS tools. They found that delirium-free days and coma-free days were reduced in patients with higher levels of the biomarkers for both blood-brain barrier dysfunction and endothelial dysfunction, even after adjustment for confounding variables. Further adjustment suggested that the endothelial dysfunction is not simply mediated via the blood-brain barrier dysfunction.


The study results suggest possible targets for new therapies to prevent delirium. For example, statins might be a potential therapy. In fact, another study just published (Page 2014) showed that continued use of statins, in ICU patients previously taking statins, is associated with a lower daily risk of delirium. They attribute the effect to the anti-inflammatory effect of statins. These findings should be considered preliminary and the authors note an ongoing clinical trial is investigating if statins are a potential therapy for delirium in the critically ill.


A recent systematic review of screening for delirium in the emergency department (LaMantia 2014) found that several delirium screening tools have been used in investigations in the ED but validation of these instruments for this particular environment has been minimal to date. Moreover, the ideal interval(s) during which a delirium screening process should take place has yet to be determined. You’ll recall that fluctuation is a critical component in detecting delirium. It is repeat assessments over time that helps us identify delirium in other settings, such as ICU’s and post-op recovery areas. The authors call for development of better tools to screen for delirium in the ED and determination of the optimum intervals for such screening.


Meanwhile, another abstract presented at the Society of Critical Care Medicine (SCCM) 43rd Critical Care Congress in January seems to challenge the traditional concept that ICU delirium is related to long-term mortality and poorer quality of life. While their data showed greater mortality and greater declines in a quality of life measure in patients who experienced ICU delirium, after adjustment for confounders the differences were no longer statistically significant. The study did, however, demonstrate that the risk of mild cognitive dysfunction in survivors was increased more than two-fold.


Lastly, just as we came to press, a review article appeared in NEJM (Reade 2014). Though it does not contain any new information, it does have a good review of previous work related to the dual concepts of sedation and delirium.




Delirium remains common in multiple hospital settings and many patients are undiagnosed. We hope that studies on the pathophysiology of delirium will lead to development of appropriate treatments. In the interim, we still need to be on the lookout for delirium and institute the preventive and ameliorating measures we’ve discussed in our prior columns on delirium.



Some of our prior columns on delirium assessment and management:

·        October 21, 2008 “Preventing Delirium

·        October 14, 2009 “Managing Delirium

·        February 10, 2009 “Sedation in the ICU: The Dexmedetomidine Study

·        March 31, 2009 “Screening Patients for Risk of Delirium

·        June 23, 2009  More on Delirium in the ICU

·        January 26, 2010 “Preventing Postoperative Delirium

·        August 31, 2010 “Postoperative Delirium

·        September 2011 “Modified HELP Helps Outcomes in Elderly Undergoing Abdominal Surgery”)

·        December 2010 “The ABCDE Bundle

·        February 28, 2012AACN Practice Alert on Delirium in Critical Care

·        April 3, 2012 “New Risk for Postoperative Delirium: Obstructive Sleep Apnea

·        August 7, 2012 “Cognition, Post-Op Delirium, and Post-Op Outcomes

·        September 2013 “Disappointing Results in Delirium

·        October 29, 2013 “PAD: The Pain, Agitation, and Delirium Care Bundle







Hughes C, Girard T, Thompson J, et al. Role of Endothelial Dysfunction and Blood-Brain Barrier Injury in Acute Brain Dysfunction. Society of Critical Care Medicine (SCCM) 43rd Critical Care Congress: Abstract 595. Presented January 10, 2014



Page VJ, Daniel Davis D, Zhao XB, et al. Statin Use and Risk of Delirium in the Critically Ill. American Journal of Respiratory and Critical Care Medicine 2014; Posted online on 13 Jan 2014




LaMantia MA, Messina FC, Hobgood CD, Miller DK. Screening for Delirium in the Emergency Department: A Systematic Review. Annals of Emergency Medicine 2014; Review article (In Press Corrected Proof) 18 December 2013





Wolters A, van Dijk D, Pasma W, et al. Long-Term Outcome of Delirium During ICU Admission in Survivors of Critical Illness. Society of Critical Care Medicine (SCCM) 43rd Critical Care Congress: Abstract 50. Presented January 2014



Reade MC, Finfer S. Sedation and Delirium in the Intensive Care Unit. N Engl J Med 2014; 370: 444-454






Print “February 2014 New Studies on Delirium





Helping Promote Disclosure and Apology



The theme of the January 2014 issue of Health Affairs is “Exploring Alternatives to Malpractice Litigation”. Included in this issue are 5 useful articles that deal with disclosure and apology (to patients and families) after medical errors. The term “disclosure and apology” is now also competing with the term “communication and resolution” which, though accurate, sounds a little too legalese for our taste. The “resolution” part includes compensation to the patient or family when the standard of care was not met. Several studies have now shown that the ultimate costs of such programs are less than one would see with historical malpractice settlements. More importantly, it’s the right thing to do!


We’ve been advocates of disclosure and apology since the early 1990’s. But despite the evidence base in the literature supporting the trend to disclose medical errors and apologize to patients and families, physicians and hospitals and administrators (often based on legal counsel) have been slow to adopt this approach.


Hendrich and colleagues (Hendrich 2014) describe how one health system, Ascension Health, implemented a full disclosure policy beginning with demonstration projects in 5 of their labor and delivery units. It is an excellent account of the barriers they met during implementation and how they were able to increase the rate of full disclosure by 221% in 2 years. Key success factors included insurers’ acceptance of the full disclosure protocol, consistent and ongoing leadership by local practitioners and hospitals, the establishment of a well-trained local investigation and disclosure team, and disclosure training for practitioners. The article and an accompanying blog (Henkel 2014) discuss how the concept of disclosure and apology fits in with the Ethical and Religious Directives for Catholic Healthcare Services, 5th ed. as well as Just Culture, the AMA Code of Ethics, Joint Commission standards, etc. They learned from their experience that disclosure is a healing process, both for mothers involved and the healthcare individuals involved (see also our December 17, 2013 Patient Safety Tip of the Week “The Second Victim”).


One “communication and resolution” program implemented in general surgery at 5 New York City hospitals (Mello 2014a) was able to improve rates of disclosure and surveillance for adverse events within about 2 years but had difficulty implementing the program’s compensation component. Like the experience at Ascension Health, strong support from top leadership at the hospital, support from insurers, and adequate staff resources were critical success factors. Educating clinical staff about how the program can benefit them is important. Very important, however, is that the hospital and its leadership be able to tolerate risk and support the “communication and resolution” concepts.


A related paper (Mello 2014b) studied communication and resolution programs implemented by six early adopters. The participants interviewed identified several factors that contributed to their programs’ success: the presence of a strong institutional champion, investing in building and marketing the program to skeptical clinicians, and making it clear that the results of such transformative change will take time.


Yet another paper (Etchegaray 2014) focused on the role that patients and families might have in participating in the analysis of events following an adverse event. Results from interviews with patients, family members, clinicians, and administrators were subsequently discussed at a one-day national conference. Conference participants concluded that increasing the involvement of patients and their families in the event analysis process was desirable but needed to be structured in a patient-centered way to be successful. They provide suggestions on how that might be accomplished.


Lastly, Sage and colleagues offer recommendations from many of those who have been involved in developing and implementing communication and resolution programs (Sage 2014). They discuss the importance of the legal system supporting such programs and many of the legal aspects, such as allaying providers’ fears by protecting apologies from use in court, facilitating patient participation by ensuring legal representation, and discussing how such programs may affect providers’ reputation and economic concerns.



Overall, the papers in this issue of Health Affairs are both useful and provocative and should be very helpful to you if you have not yet become and adopter of “disclosure and apology” or “communication and resolution”.




Some of our prior columns on Disclosure & Apology:

July 24, 2007               Serious Incident Response Checklist

June 16, 2009              Disclosing Errors That Affect Multiple Patients

June 22, 2010              Disclosure and Apology: How to Do It

September 2010           Followup to Our Disclosure and Apology Tip of the Week

November 2010           IHI: Respectful Management of Serious Clinical Adverse Events

April 2012                    Error Disclosure by Surgeons

June 2012                    Oregon Adverse Event Disclosure Guide

December 17, 2013     The Second Victim



Other very valuable resources on disclosure and apology:


·        IHI’s “Respectful Management of Serious Clinical Adverse Events” (Conway 2010)

·        The Canadian Disclosure Guidelines (Canadian Patient Safety Institute 2008)

·        The Harvard Disclosure Guidelines (Massachusetts Coalition for the Prevention of Medical Errors 2006)

·        The ACPE Toolkit (American College of Physician Executives)

·        Oregon Patient Safety Commission Oregon Adverse Event Disclosure Guide.







Hendrich A, McCoy CK, Gale J, et al. Ascension Health’s Demonstration Of Full Disclosure Protocol For Unexpected Events During Labor And Delivery Shows Promise.

Health Affairs 2014; 33: 39-45




Henkel R, Slosar JP, Haydar Z, Hendrich A, Santos P. The Moral Imperative to Disclose Medical Error: Doing the Right Thing. Health Affairs Blog January 7, 2014




Mello MM, Senecal SK, Kuznetsov Y, Cohn JS. Implementing Hospital-Based Communication-and-Resolution Programs: Lessons Learned in New York City. Health Affairs 2014; 33: 30-38




Mello MM, Boothman RC, McDonald T, et al. Communication-and-Resolution Programs: The Challenges and Lessons Learned From Six Early Adopters. Health Affairs 2014; 33: 20-29




Etchegaray JM, Ottosen MJ, Burress L, et al. Structuring Patient and Family Involvement in Medical Error Event Disclosure and Analysis. Health Affairs 2014; 33: 46-52




Sage WM, Gallagher TH, Armstrong S, et al. How Policy Makers Can Smooth The Way For Communication-And- Resolution Programs. Health Affairs 2014; 33: 11-19






Print “February 2014 Helping Promote Disclosure and Apology





Medicare Adverse Event Trends



In the last couple decades during which the patient safety movement has gained momentum, we have struggled to demonstrate that outcomes have improved as a result of our efforts.


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. They had chosen North Carolina because many hospitals there had participated in patient safety collaboratives and North Carolina had a much higher percentage of hospitals participating in IHI’s patient safety programs.


In our May 2011 What’s New in the Patient Safety World column “Just How Frequent Are Hospital Medical Errors? we noted another study (Classen 2011), using IHI’s Global Trigger Tool to identify hospital adverse events, found that the numbers may be 10-fold higher than what was noted in the 1999 IOM report “To Err is Human…”. Potentially avoidable adverse events occurred in a third of hospital admissions. In addition to the human cost of iatrogenic adverse events, the financial costs are huge.


The IHI Global Trigger Tool clearly identifies more adverse events than are found either via voluntary reporting or using administrative data tools like AHRQ’s PSI indicators.


Now a new study has attempted to track and trend adverse events in the hospitalized Medicare population over time using yet a different methodology (Wang 2014). Wang and colleagues looked at data from the Medicare Patient Safety Monitoring System (MPSMS) from 2005 to 2011. This system contains data abstracted from the medical records of a random sample of hospitalized Medicare patients, with 21 adverse events currently measured. Though the MPSMS was established in 2002, data on all the current 21 adverse events became available in 2005. The authors analyzed the trends in those adverse events for patients with four diagnoses: acute MI, CHF, pneumonia, and conditions requiring surgery. They used 3 separate measures of adverse events (rate of adverse events per patient at risk for such events, rate of patients with one or more adverse events, and rate of adverse events per 1000 hospitalizations). Generally, but not always, those 3 measures trended the same direction. Their results showed that adverse events rates for patients with acute MI and CHF declined significantly over the study period. However, for patients with pneumonia or conditions requiring surgery the rate of adverse events did not change. The authors conclude “Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing.”


Frankly, while the study was done by respected researchers from places like Hopkins, Harvard and Yale and under the auspices of AHRQ, we’re really not sure what it means!


First, you can’t compare total adverse events rates across the four conditions because the individual events are not the same for all the conditions, though that may not matter as much if we are simply looking for trends. Secondly, it is difficult to understand differences in some adverse event rates without taking into account the context, which may influence adverse event rates (for example, the indications for anticoagulants may differ across the four condition categories). Third, it’s not clear whether some adverse events are double counted in conditions requiring surgery. For example, CAUTI’s appear as adverse events under events associated with knee and hip replacements and under a separate category.


But the study does raise some interesting questions. For example, why was there a statistically significant decrease in inpatient falls for patients with AMI but not the other conditions? Why were there significant decreases in adverse events associated with IV heparin and events associated with LMW heparin or factor Xa inhibitors for those with AMI but not with any of the other conditions?


The study did confirm previous observations that patients experiencing adverse events are more likely to die during the hospitalization and to have longer lengths of stay.



The bottom line: there are simply too many questions about this methodology and this study to come to any really useful conclusions. Nevertheless, it does add to our frustration that so many patient safety efforts are not leading to measurable improvements in patient care.







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




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




Wang Y, Eldridge N, Metersky ML, et al. National Trends in Patient Safety for Four Common Conditions, 2005–2011. N Engl J Med 2014; 370: 341-351





Print “February 2014 Medicare Adverse Event Trends





OSHA Worker Safety in Hospitals



Several studies have shown that healthcare worker safety and patient safety are interrelated and that hospitals having good worker safety records also tend to have good patient safety records.


OSHA (Occupational Safety & Health Administration) has just launched some new worker and patient safety resources on its website “Worker Safety in Hospitals”. You’ve heard us say often that hospitals are dangerous places for patients. Well, hospitals are also dangerous places for workers. In fact, injuries and illnesses resulting in days away from work are more frequent in hospital workers and almost 50% more than in manufacturing or private industry.


The OSHA website has fact books and self-assessment tools for hospitals. It also has a host of tools for implementing best practices in activities such as patient handling, equipment handling, lifting, etc. It also has links to other good worker resources.


Good worker safety programs may improve job satisfaction and morale, reduce staff turnover, improve patient outcomes, and also improve the hospital’s financial bottom line.


This is a good resource.






OSHA (Occupational Safety & Health Administration). Worker Safety in Hospitals.





Print “February 2014 OSHA Worker Safety in Hospitals





Print “February 2014 What's New in the Patient Safety World (full column)

Print “February 2014 SHEA’s New Recommendations for Hospital Attire

Print “February 2014 New Studies on Delirium

Print “February 2014 Helping Promote Disclosure and Apology

Print “February 2014 Medicare Adverse Event Trends

Print “February 2014 OSHA Worker Safety in Hospitals



Print “February 2014 What's New in the Patient Safety World (full column in PDF version)











Tip of the Week Archive


What’s New in the Patient Safety World Archive