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June 28, 2016
Culture of Safety and Catheter-Associated Infections
A study recently published garnered lots of national headlines implying that we don’t need to change our culture to improve outcomes. While we can’t speak for the authors of that study, we don’t think the headlines generated were what they intended.
University of Michigan researchers (Meddings 2016) looked at responses on the Hospital Survey on Patient Safety Culture (HSOPS) survey at hospitals participating in two prospective cohort studies from acute-care intensive care units (ICUs) and non-ICUs participating in the AHRQ CLABSI and CAUTI collaboratives, including one (Saint 2016) we’ve highlighted in our July 2016 What's New in the Patient Safety World column “Holy Moly, My Patient has a Foley!”. Among responding units, infection rates declined over the project periods, by 47% for CLABSI and 23% for CAUTI. But Meddings and colleagues found no correlation between the CLABSI and CAUTI rates at these units and the HSOPS measures either at baseline or at one year. Those results were contrary to the authors’ hypothesis that the improvements seen would correlate with scores indicating a culture of safety as measured by HSOPS.
Meddings et al. conclude their results show one of two possible things:
The implications are significant. If the former is true, many projects could be streamlined by eliminating many of the time and other resources put into developing a culture of safety. If the latter is true, time could also be saved by eliminating a measure that is also time-consuming and adds little value.
Yes, you can use constraints or forcing functions to promote use of standardized techniques and procedures (for example, requiring completion of a checklist before a central venous catheter kit can be opened). But if you don’t get buy-in from most physician and nursing staff that the standardized techniques and procedures are the right thing to do to improve patient safety, your likelihood of success will be diminished.
Note that we have stressed over and over that, in our opinion, the primary reason we’ve failed to significantly improve patient safety has been our inability to develop a culture of safety in our organizations. You’ve heard us use the phrase “culture trumps ________” (fill in the blank with words like policy, procedure, strategy, tactics, vision, etc). In fact, “Culture trumps…Everything!”. When we do root cause analyses (RCA’s) on cases with adverse outcomes we very often find that the culture of the unit tolerated workarounds or shortcuts or was such that it discouraged healthcare workers from speaking up when they knew something was wrong. We have wholeheartedly agreed with John Nance’s view that the reason healthcare has not achieved the results that the aviation industry has attained in safety is that healthcare has failed to change our culture (see our June 2, 2009 Patient Safety Tip of the Week “Why Hospitals Should Fly...John Nance Nails It!” and our January 2011 What's New in the Patient Safety World column “No Improvement in Patient Safety: Why Not?”).
And “failure to embrace a culture of safety” made the most recent ECRI Institute’s Top Ten Patient Safety Concerns for 2016 (see our May 2016 What's New in the Patient Safety World column “ECRI Institute’s Top Ten Patient Safety Concerns for 2016”).
And all the good work done at Johns Hopkins and the Michigan Keystone Collaborative utilizing CUSP’s (Comprehensive Unit-based Safety Programs) has emphasized the importance of culture at the unit level (see our March 2011 What's New in the Patient Safety World column “Michigan ICU Collaborative Wins Big”). In fact, CUSP principles were a key component of the two national collaboratives in the current Meddings study.
So does the recent Michigan study really mean you don’t have to change organizational culture to effect improvement and you should abandon your efforts to develop a culture of safety? Or does it just mean that the tools used to “measure” culture are not very useful. We’ll opt for the latter explanation. We’ve never been fans of the variety of “culture” surveys that are widely used. When applied to assess the “culture” of an organization as a whole they can be terribly misleading. Culture at the unit level is much more important. All the surveys out there tend to show the same thing: physicians and administrators all have a more positive view of the “organizational culture” than do nurses and other frontline personnel. And the culture often varies dramatically from unit to unit. And people often respond to such surveys with the answers they think you want to hear rather than what they actually think, even when the surveys are “anonymous”.
We’ve always found that you get a much better feel for the “culture” of a unit on your Patient Safety Walk Rounds than you get from any formal survey. When you have direct interaction with frontline staff in an informal and non-punitive fashion, they are more likely to be forthcoming and point out potential vulnerabilities that they might not when responding to a formal survey or questionnaire. Our October 7, 2014 Patient Safety Tip of the Week “Our Take on Patient Safety Walk Rounds” discusses in detail how you can make such rounds valuable and help improve your culture of safety (and also warns how you can misuse such rounds to be detrimental in promoting a culture of safety!).
Where we do concur with Meddings et al. is that using HSOPS responses in large quality improvement collaboratives is time-consuming and may add little value. It should be noted that in the Meddings study HSOPS response rates were low overall, 24% for the CLABSI collaborative and 43% for the CAUTI collaborative. Those low rates of response may well reflect that participants found HSOPS to be time-consuming and they gave little importance to its inclusion in the projects. We really doubt that the authors would recommend eliminating use of the CUSP principles from such projects. Rather, we concur with the second theory espoused by Meddings et al. that HSOPS was not designed to provide a valid measure of safety culture impacting care at the bedside. Meddings et al. also point out that safety culture can be very difficult to measure over time, particularly since changes in staffing and resources and competing priorities commonly occur during the timeframes of such measurement. If you are going to eliminate anything from such quality improvement projects, take out the culture surveys.
So beware of media headlines that seem to imply that safety culture may not be so important.
Some of our prior columns related to the “culture of safety”:
April 2009 “New Patient Safety Culture Assessments”
June 2, 2009 “Why Hospitals Should Fly...John Nance Nails It!”
January 2011 “No Improvement in Patient Safety: Why Not?”
March 2011 “Michigan ICU Collaborative Wins Big”).
March 29, 2011 “The Silent Treatment: A Dose of Reality”
May 24, 2011 “Hand Hygiene Resources”
March 2012 “Human Factors and Operating Room Safety”
July 2012 “A Culture of Disrespect”
July 2013 “"Bad Apples" Back In?”
July 22, 2014 “More on Operating Room Briefings and Debriefings”
October 7, 2014 “Our Take on Patient Safety Walk Rounds”
July 7, 2015 “Medical Staff Risk Issues”
September 22, 2015 “The Cost of Being Rude”
Meddings J, Reichert H, Greene MT, et al. Evaluation of the association between Hospital Survey on Patient Safety Culture (HSOPS) measures and catheter-associated infections: results of two national collaboratives. BMJ Qual Saf 2016; Published Online First 24 May 2016
Saint S, Greene MT, Krein SL, et al. A Program to Prevent Catheter-Associated Urinary Tract Infection in Acute Care. N Engl J Med 2016; 374: 2111-2119
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In our December 1, 2015 Patient Safety Tip of the Week “TALLman Lettering: Does It Work?” we noted some recent publications that had questioned the effectiveness of TALLman lettering in preventing LASA drug pair errors. We’ve long been fans of TALLman lettering and we’ve recommended its use (eg. HYDROmorphone) in our numerous columns on the dangers of Dilaudid. In fact, we’ve even sometimes suggested our own TALLman lettering schemes for certain LASA drug pairs (see our prior columns “Ophthalmology: Blue Dye Mixup” and “Another Blue Dye Eye Mixup”). So we weren’t about to conclude that TALLman lettering should be abandoned. But the two publications noted in our December column (Zhong 2015, ISMP Canada 2015) suggested that we need a systematic review of the impact of TALLman lettering in multiple other venues. While we doubt TALLman lettering causes harm, it makes sense we find out which drug pairs benefit the most from TALLman lettering and whether there have been any unintended consequences noted. Therefore, we recommended that, while waiting for such future studies, it is probably wisest to reserve your TALLman lettering conventions for those LASA drug pairs with the most potential to have serious patient safety consequences in your organizations.
ISMP (US) has now responded to the issues raised, reported results of a survey it has done with multiple hospitals, and updated its List of Drug Names with Tall Man Letters (ISMP 2016).
The new ISMP survey found that the vast majority of responding hospitals use TALLman lettering in some fashion and almost all find it useful. Some recalled specific examples where TALLman lettering helped avoid dangerous errors.
Interestingly, the survey also found some problems with implementation of TALLman lettering conventions, particularly integrating it into some electronic medical records and/or CPOE systems. For example, some such systems listed drugs in all capital letters and did not allow case changes. Others do not allow mixing of upper and lower case letters in names and many do not allow part of a name to be bolded (remember: part of the format for TALLman names suggested by ISMP is bolding or use of a different color or contrast as a further way to visually highlight part of the name and alert users that there might be a potential LASA issue).
ISMP also asked for potential new drug pair additions from survey respondents and 16 such pairs were recommended. Of those 16, ISMP opted to add 13 to its List of Drug Names with Tall Man Letters.
Though ISMP has added to its list, it acknowledges the ISMP Canada observation that overuse of tall man lettering may reduce effectiveness since names no longer appear novel. ISMP took into consideration keeping the list short enough to avoid diluting the effectiveness of the list.
The ISMP article also has nice descriptions from survey respondents as to how TALLman lettering really works as an alert system. It visually captures the attention of the user and makes them refocus or slow down and ensure they are ordering the correct drug.
The same June 2, 2016 special issue of ISMP Medication Safety Alert! Acute Care Edition also has a companion article with a review of the evidence for tall man lettering.
You can access the FDA and ISMP Lists of Look-Alike Drug Name Sets with Recommended Tall Man Letters with the updates at the ISMP website at the following address: http://www.ismp.org/tools/tallmanletters.pdf.
Should you be considering using tall man lettering for a drug pair you have identified as risky at your own institution, the ISMP article also recommends following the “CD3 rule” as a methodology for capitalizing and promoting consistency and standardization. See the ISMP article for details.
Zhong W, Feinstein JA, Patel NS, et al. Tall Man lettering and potential prescription errors: a time series analysis of 42 children's hospitals in the USA over 9 years. BMJ Qual Saf 2015; published online first November 3, 2015
ISMP Canada. Application of TALLman Lettering for Selected High-Alert Drugs in Canada. ISMP Canada Safety Bulletin 2015; 15(10): 1-3 October 30, 2015
ISMP (Institute for Safe Medication Practices). Special Edition: Tall Man Lettering. ISMP updates its list of drug names with tall man letters. ISMP Medication Safety Alert! Acute Care Edition 2016; June 2, 2016
ISMP (Institute for Safe Medication Practices). FDA and ISMP Lists of Look-Alike Drug Name Sets with Recommended Tall Man Letters. 2016
The race is on for a simple test to diagnose delirium. In our August 2014 What’s New in the Patient Safety World column “A New Rapid Screen for Delirium in the Elderly” we discussed the importance of recognizing delirium but that delirium goes unrecognized or undiagnosed in up to 72% of cases in hospitalized patients (Collins 2010). One of the reasons may be that commonly used screening tests for delirium may not be brief enough or may require specific training for administration. We noted a new screening tool, the 4 ‘A’s’ Test (4AT) to help improve screening for delirium and its validation in a population other than that in which it was developed (Bellelli 2014).
Then in our November 2014 What's New in the Patient Safety World column “The 3D-CAM for Delirium” we discussed another brief diagnostic tool for delirium, the 3D-CAM, that had been derived and validated (Marcantonio 2014). The assessment takes only about 3 minutes to administer and can be administered by a wide variety of healthcare workers. It takes less than an hour to train someone to administer the tool.
In the validation study, the 3D-CAM had a sensitivity of 95% and specificity of 94% and performed almost equally well in patients with and without dementia (specificity in patients with dementia was slightly less at 86% but sensitivity was 96%). Importantly, the vast majority of patients identified as having delirium had either the hypoactive variety or normal psychomotor activity. That is the population in which delirium is often undiagnosed, compared to those with the hyperactive variety.
Then in late 2015 yet another simple screening tool for delirium was introduced by the team that had developed the 3D-CAM (Fick 2015). Fick and colleagues used subsets of the 3D-CAM to develop an ultrabrief two-item bedside test for delirium. They found that the best 2-item screen was the combination of “months of the year backwards” and “what is the day of the week?” Those two items had a sensitivity of 93% and specificity of 64%. Even the single item “months of the year backwards” had a sensitivity of 83% and specificity of 69% for diagnosing delirium. The median time it took to administer the screening was 36.5 seconds. The authors emphasize that this should not be considered a diagnostic test but rather a screening tool. When positive, it could be followed with a more comprehensive test like the 3D-CAM. This 2-item tool still needs validation in other populations.
And now an even newer test, the Stanford Proxy Test for Delirium (S-PTD), is being touted as a rapid, simple screening test for delirium that may have the additional desirable feature of not requiring direct patient participation (Maldonado 2016). This test also took less than a minute for nurses to complete. It would completed it at the end of each shift and it is based purely on nursing observations. The researchers found the S-PTD had a sensitivity of 79% for identifying delirium, specificity 91%, positive predictive value 70%, and negative predictive value 94%.
And, finally, another study noted that delirium assessments that can be reliably and quickly performed by nonphysicians are lacking in the emergency department setting (Han 2016). The authors evaluated the diagnostic performance of the modified Brief Confusion Assessment Method (modified bCAM) in ED patients 65 years or older. The original bCAM was a brief (<2 minutes) delirium assessment that assessed for inattention by asking the patient to recite the months backward from December to July. It was modified by adding the Vigilance A (“squeeze my hand when you hear the letter ‘A’”) to the inattention assessment. The elements of the modified bCAM were performed by a research assistant (RA) and emergency physician. Delirium was found in 12% of the 406 patients enrolled in their study. The modified bCAM had a sensitivity of 82.0% and specificity of 96.1% when performed by the RA. The emergency physician's modified bCAM exhibited similar diagnostic performance. Use of the modified bCAM needs to be validated in other sites and settings but nevertheless is promising as a screening tool that can be easily administered.
While traditional validated tools like the CAM and CAM-ICU remain key components of any programs addressing delirium, we wholeheartedly support the exploration of tools that can be administered briefly and by those without extensive training. We agree that such tools will likely greatly increase the detection of delirium so that appropriate management strategies can be put in place.
Some of our prior columns on delirium assessment and management:
Collins N, Blanchard MR, Tookman A, Sampson EL. Detection of delirium in the acute hospital. Age Ageing 2010; 39 (1): 131-135
The 4 ‘A’s Test: screening instrument for delirium and cognitive impairment
Bellelli G, Morandi A, Davis DHJ, et al. Validation of the 4AT, a new instrument for rapid delirium screening: a study in 234 hospitalised older people. Age Ageing 2014; 43(4): 496-502
Marcantonio ER, Ngo LH, O'Connor M, et al. 3D-CAM: Derivation and Validation of a 3-Minute Diagnostic Interview for CAM-Defined Delirium: A Cross-sectional Diagnostic Test Study. Ann Intern Med 2014; 161(8): 554-561
3D-CAM (3 minute diagnostic assessment). The Hospital Elder Life Program 2014.
Fick DM, Inouye SK, Guess J, et al. Preliminary development of an ultrabrief two-item bedside test for delirium. Journal of Hospital Medicine 2015; 10(10): 645-650
Maldonado JR. The Proxy Test for Delirium (PTD): A New Tool for the Screening of Delirium Based on DSM-5 and ICD-10 Criteria. American Psychiatric Association (APA) 2016 Annual Meeting. SCR-Measurements and Scales, no. 3. Presented May 17, 2016
As discussed in Brooks M. New Delirium Test May Be Simpler, More Accurate. Medscape Medical News 2016; May 25, 2016
Han JH, Wilson A, Graves AJ, et al. A quick and easy delirium assessment for nonphysician research personnel. Am J Emerg Med 2016; 34(6): 1031-1036
In our many columns on avoiding unnecessary use of Foley catheters we’ve often noted that posters or screensavers are helpful tools in achieving reduction of Foley catheter use. At the recent American Geriatrics Society (AGS) 2016 Annual Scientific Meeting one of the poster presentations highlighted a program on a Canadian acute geriatrics unit that successfully reduced urinary catheter use by almost half (Sinha 2016). One of the keys to success was use of a poster that had the headline “Holy Moly, My Patient has a Foley!”. Way back in our May 8, 2007 Patient Safety Tip of the Week “Doctor, when do I get this red rubber hose removed?” (and our many other columns on avoiding CAUTI’s) we’ve talked about how often physicians are surprised to find that their patient had a Foley catheter in place.
Variations of that phrase have been used elsewhere, such as “Holy Moley, Take Out That Foley!” (Ghanem 2015) or “Holey Moley, What About That Foley?” (Steinmann 2012). But what was unique in the Canadian program was that they apparently placed the posters in bathroom stalls “where all staff had ample time to review indications for catheters, associated risks, and ways they could take action to remove them”. What a great concept! We’ve seen that with posters elsewhere or computer screensavers staff tend to block them out after they’ve seen a few. But we like the idea of using the bathroom stall where you have a “captive audience”!
It’s creative programs like this that every healthcare organization can learn from. There are many evidence-based interventions and best practices that we try to disseminate in our organizations. But dissemination of some are more successful than others. It’s often in the way you communicate. And use of a catchy phrase and an even catchier place to put it might really help spread the message. Kudos to Sinha and colleagues for this program!
We’d, of course, be remiss if we failed to mention the results of a recently published, AHRQ-sponsored national project to reduce unnecessary urinary catheter use and CAUTI’s (Saint 2016). Led by Sanjay Saint, whose work on CAUTI reduction we’ve noted in many of our prior columns on CAUTI prevention such as the Michigan Health and Hospital Association (MHA) Keystone Center’s Bladder Bundle Initiative, the national Comprehensive Unit-based Safety Program included dissemination of information to sponsor organizations and hospitals, data collection, and guidance on key technical and socioadaptive factors in the prevention of catheter-associated UTI. Principles from CUSP (Comprehensive Unit-Based Safety Program) programs were utilized in understanding some of those sociaoadaptive factors (we discussed CUSP principles in our March 2011 What's New in the Patient Safety World column “Michigan ICU Collaborative Wins Big”).
Data were obtained between March 2011 and November 2013 from over 900 units before and after implementation and again at 12 months to assess sustainability. Adjusted CAUTI rates overall fell 14%. For non-ICU units CAUTI rates fell 32%. Catheter use decreased 7% in non-ICU units. Results of both were sustainable over the 12 months of data collection.
Interestingly, neither catheter use nor CAUTI rates fell in ICU’s. The reason for the lack of improvement in ICU’s is not clear, though the authors speculate the need for monitoring urinary output may justify more use of urinary catheters in the ICU setting and several other factors in ICU patients may lead to higher CAUTI rates.
Our December 2015 What's New in the Patient Safety World column “CAUTI Prevention Tools” discussed AHRQ’s “Toolkit for Reducing CAUTI in Hospitals” (AHRQ 2015). The toolkit was developed as part of a multi-hospital project in which CUSP (Comprehensive Unit-based Safety Program) principles were used along with evidence-based CAUTI prevention measures. The toolkit includes multiple tools, including:
It also has links to a host of prior AHRQ webinars on preventing CAUTI’s and using CUSP principles. It also has multiple resources for sustaining change and improvement.
Our other columns on urinary catheter-associated UTI’s:
Sinha S, et al. American Geriatrics Society (AGS) 2016 Annual Scientific Meeting: Abstract P2. Presented May 19, 2016
As presented by Harrison L. Geriatrics Unit Reduces Catheter Use, Reports Fewer Deaths. Medscape Medical News 2016; May 25, 2016
Ghanem A, Artime C, Moser M, et al. Holy Moley! Take out that Foley! Measuring Compliance with a Nurse Driven Protocol for Foley Catheter Removal to Decrease Utilization. Amer J Infect Control 2015; 43(6): Supplement, Page S51
Steinmann K. Holey Moley! What About That Foley?! PowerPoint presentation. Hennepin County Medical Center. September 7, 2012
Saint S, Greene MT, Krein SL, et al. A Program to Prevent Catheter-Associated Urinary Tract Infection in Acute Care. N Engl J Med 2016; 374: 2111-2119
AHRQ (Agency for Healthcare Research and Quality). Toolkit for Reducing CAUTI in Hospitals. 2015
With the continued emergence of pathogens resistant to multiple antibiotics there is a renewed urgency to optimize use of antibiotics. The latest CDC report notes that 20-50 percent of antibiotics prescribed in hospitals are unnecessary or inappropriate (CDC 2016). Antibiotic stewardship programs have proven to be successful in hospitals at reducing antibiotic resistance (see or October 14, 2014 Patient Safety Tip of the Week “Antibiotic Stewardship”). And we also discussed antibiotic stewardship in ambulatory and long-term care settings in our November 2015 What's New in the Patient Safety World column “Medications Most Likely to Harm the Elderly Are…”.
Despite the push to get antibiotic stewardship programs functioning at high levels, a recent study found that among 4,184 U.S. hospitals, 39% reported having an antibiotic stewardship program that met all seven CDC-defined core elements (Pollack 2016). 59% of hospitals with greater than 200 beds had such programs but only 25% of hospitals with less than 50 beds reported achieving all seven CDC-defined core elements of a comprehensive ASP.
In our November 2015 What's New in the Patient Safety World column “Medications Most Likely to Harm the Elderly Are…” we mentioned that the National Quality Forum had recently announced a new initiative on antibiotic stewardship. That resource is now available. Antibiotic Stewardship in Acute Care: A Practical Playbook is produced by the NQF and numerous partner organizations, including the CDC (NQF 2016).
For each of the CDC core elements the Playbook includes a brief rationale and overview, examples for implementation, potential barriers and suggested solutions, and suggested tools and resources. The seven CDC-defined core elements (CDC 2016) of a comprehensive antibiotic stewardship program are:
The Playbook does a very good job of identifying potential barriers and suggesting solutions. For each core element it also provides links to resources available to help with that element. Such resources include not only those pertinent to patient safety but also those involved in making the business case for a good antibiotic stewardship program. It also provides examples of potential interventions (system interventions, patient-specific interventions, and diagnosis- and infection-specific interventions). It offers suggestions on tracking both process and outcome measures and antibiotic use.
You’ll find the Playbook a very valuable tool, both for getting your antibiotic stewardship program up to snuff (meeting the 7 CDC-defined elements) and taking it to the next level. It will also help you get ready to meet The Joint Commission’s proposed new standards on antibiotic stewardship (TJC 2015).
Other excellent resources on antibiotic stewardship are available for free from the Pennsylvania Patient Safety Authority (Adkins 2015, Bradley 2015), The Joint Commission, the CDC, and Johns Hopkins Hospital. The CDC core elements document has a nice checklist for you to see if your organization is meeting the core elements of a good antibiotic stewardship program.
And, as we were getting ready to publish this column, CMS has announced that hospitals will be required to have antibiotic stewardship programs and demonstrate that they have reduced inappropriate antibiotic usage (CMS 2016).
Some of our prior columns on antibiotic stewardship:
CDC (Centers for Disease Control and Prevention). Core Elements of Hospital Antibiotic Stewardship Programs. Page last updated: May 25, 2016
Pollack LA, van Santen KL, Weiner LM, et al. Antibiotic stewardship programs in U.S. acute care hospitals: findings from the 2014 National Healthcare Safety Network (NHSN) Annual Hospital Survey. Clin Infect Dis 2016; First published online: May 19, 2016
NQF (National Quality Forum) National Quality Partners Antibiotic Stewardship Action Team. Antibiotic Stewardship in Acute Care: A Practical Playbook. May 2016
TJC (The Joint Commission). Proposed Standard for Antimicrobial Stewardship in AHC, CAH, HAP, NCC, and OBS. The Joint Commission 2015; November 2015
Adkins J, Bradley S, Finley E. Strategies to Turn the Tide against Inappropriate Antibiotic Utilization. Pa Patient Saf Advis 2015; 12(4):149-157
Bradley S. Antibiotic Stewardship in Hospitals and Long-Term Care Facilities: Building an Effective Program. Pa Patient Saf Advis 2015; 12(2): 71-78
CDC (Centers for Disease Control and Prevention). Get smart for healthcare website. Page last updated: January 13, 2016
The Joint Commission. Antimicrobial Stewardship Toolkit.
Johns Hopkins Medicine. JHH Antibiotic Management Guidelines (updated annually).
CMS (Centers for Medicare & Medicaid Services). CMS Issues Proposed Rule that Prohibits Discrimination, Reduces Hospital-Acquired Conditions, and Promotes Antibiotic Stewardship in Hospitals. June 13, 2016
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