Patient Safety Tip of the Week Archive

What’s New in the Patient Safety World

February 2013

· More Evidence Favoring Restriction of Transfusions

· Joint Commission Proposes New 2014 National Patient Safety Goal

· Checklists for Surgical Crises

· The ABCDE Bundle in Action

More Evidence Favoring Restriction of Transfusions

We’ve done several columns (see list at the end of this column) highlighting some of the detrimental effects related to red blood cell transfusions and the trend toward more restrictive transfusion strategies in many different scenarios.

Several more recent studies have given further credence to the approach of more restrictive transfusion practices. One randomized controlled trial compared the safety and efficacy of a restrictive transfusion strategy to a liberal one in patients with GI bleeding (Villanueva 2013). They found the probability of survival at 6 weeks was higher in the restrictive-strategy group than in the liberal-strategy group. Moreover, the frequency of further bleeding and the frequency of adverse events were lower in the restrictive transfusion strategy group.

A somewhat more controversial topic is that of transfusion in patients with acute MI or acute coronary syndromes and anemia. It is fairly well known that acute MI patients with anemia have poorer outcomes. Another recent systematic review and meta-analysis showed that anemia is independently associated with a significantly increased risk of early and late mortality in acute coronary syndromes (Lawler 2013). That might make one logically imply that interventions to correct anemia (like transfusions) ought to improve mortality. But is that the case? Previous studies have had conflicting conclusions. So Chatterjee and colleagues just did a meta-analysis of studies on the effect of transfusions on mortality in patients with acute MI (Chatterjee 2013). They concluded that blood transfusion or a liberal blood transfusion strategy compared with no blood transfusion or a restricted blood transfusion strategy is associated with higher all-cause mortality rates. The all-cause mortality rate for transfusion during acute MI was 18.2% compared to 10.2% for a no transfusion strategy. But there are numerous limitations in the Chatterjee meta-analysis, as pointed out in the accompanying editorial (Carson 2013). Most importantly, most of the patients in the meta-analysis came from observational studies rather than from randomized controlled trials. A lack of patient level data to provide reasons for transfusion also makes it highly likely that there were multiple confounding factors.

In our April 2012 What’s New in the Patient Safety World column “New Transfusion Guidelines from the AABB” we noted that the AABB (formerly the American Association of Blood Banks) had just come out with new clinical guidelines for red blood cell transfusion (Carson 2012). While those guidelines generally call for adhering to a restrictive transfusion strategy (7 to 8 g/dL threshold) for many patients, they could not recommend for or against a liberal or restrictive transfusion threshold for hospitalized, hemodynamically stable patients with the acute coronary syndrome. Bottom line: until we have a large randomized controlled trial we are unlikely to have a definitive answer as to the best transfusion strategy in acute coronary syndromes.

On the other hand, a new study suggests that transfusions may reduce mortality in patients with sever sepsis and septic shock (Park 2012). The authors did a propensity-matched analysis of a prospective observational database in twenty-two medical and surgical intensive care units in 12 teaching hospitals in Korea. Transfused patients had a lower risk of 7-day, 28-day, and in-hospital mortality rates than those not transfused even after adjustment for other variables.

The newly updated Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock (Dellinger 2013) do mention use of transfusion in early goal-directed resuscitation protocols that use a target hematocrit of 30% in patients with low Scvo2 during the first 6 hrs of resuscitation of septic shock. But once tissue hypoperfusion has resolved and in the absence of extenuating circumstances, such as myocardial ischemia, severe hypoxemia, acute hemorrhage, or ischemic coronary artery disease, they recommend that red blood cell transfusion occur when the hemoglobin concentration decreases to < 7.0 g/dL to target a hemoglobin concentration of 7.0 to 9.0 g/dL in adults

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

· March 2011 “Downside of Transfusions in Surgery”

· February 2012 “More Bad News on Transfusions”

· January 2012 “Need for New Transfusion Criteria?”

· April 2012 “New Transfusion Guidelines from the AABB”

References:

Villanueva C, Colomo A, Bosch A, et al. Transfusion Strategies for Acute Upper Gastrointestinal Bleeding. N Engl J Med 2013; 368: 11-21

http://www.nejm.org/doi/full/10.1056/NEJMoa1211801?query=featured_home

Lawler PR, Filion KB, Dourian T, Atallah R, et al. Anemia and mortality in acute coronary syndromes: A systematic review and meta-analysis. Am Heart J 2013; 165(2): 143-153.e5

http://download.journals.elsevierhealth.com/pdfs/journals/0002-8703/PIIS000287031200734X.pdf

Chatterjee S, Wetterslev J, Sharma A, et al. Association of Blood Transfusion With Increased Mortality in Myocardial InfarctionA Meta-analysis and Diversity-Adjusted Study Sequential Analysis. JAMA Intern Med. 2013; 173(2): 132-139

http://archinte.jamanetwork.com/article.aspx?articleid=1485987

Carson JL, Hébert PC. Here We Go Again—Blood Transfusion Kills Patients? Comment on “Association of Blood Transfusion With Increased Mortality in Myocardial Infarction: A Meta-analysis and Diversity-Adjusted Study Sequential Analysis”. JAMA Intern Med. 2013; 173(2): 139-141

http://archinte.jamanetwork.com/article.aspx?articleid=1485995

Carson JL, Grossman BJ, Kleinman S, et al. for the Clinical Transfusion Medicine Committee of the AABB. Clinical Guidelines.Red Blood Cell Transfusion: A Clinical Practice Guideline From the AABB. Ann Intern Med 2012; E-429 published ahead of print March 26, 2012

http://www.annals.org/content/early/2012/03/26/0003-4819-156-12-201206190-00429?aimhp

Park DW, Chun B-C, Kwon S-S, et al. Red blood cell transfusions are associated with lower mortality in patients with severe sepsis and septic shock: A propensity-matched analysis. Critical Care Medicine 2012; 40(12): 3140-3145

http://journals.lww.com/ccmjournal/Abstract/2012/12000/Red_blood_cell_transfusions_are_associated_with.4.aspx

Dellinger RP, Levy MM, Rhodes A, et al. Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2012. Crit Care Med 2013; 41(2): 580-637

http://www.sccm.org/Documents/SSC-Guidelines.pdf

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Joint Commission Proposes New 2014 National Patient Safety Goal

The Joint Commission had no new National Patient Safety Goals (NPSG’s) for 2013 other than some enhancements to the CAUTI NPSG and a renewed focus on medication reconciliation (TJC 2012). But they have already proposed a new NPSG for 2014. This one is a much needed NPSG that deals with the safety of alarm management (TJC 2013). The proposed NPSG is open for public comment until February 26, 2013.

The proposed new alarm NPSG has several elements. First, leadership must make focus on alarm safety a priority. Second, each organization must do an annual inventory of all systems having alarms and identify default alarm settings for each. Then, from the inventory, they need to identify which alarms are most important to manage. Lastly, policies and procedures for managing those alarms must be developed and implemented. These include things regarding managing alarm parameters, disabling alarms, responding to alarms, and how you monitor alarms. The latter would include the ways you check those alarms for accuracy, operation, audibility, etc. Also, deciding which alarms are really needed is required. And, of course, there must be educational programs on all those policies and procedures.

Alarm issues are one of our favorite topics and we’ve mentioned before that we often make amicable bets with CEO’s when we enter their facilities that we will find within a specified timeframe some alarms that have been disabled or otherwise manipulated.

Checking alarms should be a regular component of your Patient Safety Walk Rounds. More importantly, it should be something your staff does daily on every unit that utilizes alarms of any type. Some units even do it on every shift. You should at least include alarm status as part of your structured handoff tool used at changes of shift. We also strongly recommend that any time you set up a new piece of equipment on a patient you use a checklist specific to that piece of equipment that forces you to verify that all alarms are appropriately set and functional and that parameters chosen are appropriate. We also recommend you review some of the useful tips we’ve included in our February 23, 2010 Patient Safety Tip of the Week “Alarm Issues in the News Again” and the several other columns noted below.

We’ve mentioned several times a provocative article (Lynn 2011) on alarms and why they fail to identify deteriorating patients early. The authors discuss the flaws in current threshold-based alarm systems and the need for true “smart” alarms that integrate multiple physiological parameters and respond to patterns of changes in these. Alarm safety is also always a good topic for a FMEA (Failure Mode and Effects Analysis). For FMEA’s an excellent resource is “Fault Tree Analysis of Clinical Alarms” (Hyman 2008). This is a great way of looking at the potential things that can go wrong, both technical and human, in each of multiple facets of any alarm system.

Prior Patient Safety Tips of the Week pertaining to alarm-related issues:

March 5, 2007 “Disabled Alarms”
March 26, 2007 “Alarms Should Point to the Problem”
April 2, 2007 “More Alarm Issues”
June 19, 2007 “Unintended Consequences of Technological Solutons”
April 1, 2008 “Pennsylvania PSA’s FMEA on Telemetry Alarm Interventions”
February 23, 2010 “Alarm Issues in the News Again”
March 2, 2010 “Alarm Sensitivity: Early Detection vs. Alarm Fatigue”
March 16, 2010 “A Patient Safety Scavenger Hunt”
November 2010 “Alarms in the Operating Room”
February 22, 2011 “Rethinking Alarms”

References:

The Joint Commission. Hospital: 2013 National Patient Safety Goals. October 22, 2012

http://www.jointcommission.org/assets/1/6/2013_HAP_NPSG_final_10-23.pdf

The Joint Commission. Proposed 2014 National Patient Safety Goal on Alarm Management. January 15, 2013

http://www.jointcommission.org/assets/1/6/Field_Review_NPSG_Alarms_20130109.pdf

Lynn LA, Curry JP. Patterns of unexpected in-hospital deaths: a root cause analysis. Patient Safety in Surgery 2011, 5:3 (11 February 2011)

http://www.pssjournal.com/content/pdf/1754-9493-5-3.pdf

Hyman WA, Johnson E. Fault Tree Analysis of Clinical Alarms. Journal of Clinical Engineering 2008; 33(2) 85-94

http://journals.lww.com/jcejournal/Abstract/2008/04000/Fault_Tree_Analysis_of_Clinical_Alarms.23.aspx

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Checklists for Surgical Crises

There are some emergency situations that are so rare that it is hard to prepare for them, yet your actions during such situations may determine life or death. Pilots prepare for such emergencies (for example, they all have to simulate an aerodynamic “stall” so they know what steps to immediately take to right the aircraft). And pilots have standard operating procedures in their myriad of manuals pertaining to a whole host of seldom-encountered emergency situations. Often those standard operating procedures use checklists so that the crew can rapidly go through all the steps required in such emergencies.

Our August 16, 2011 Patient Safety Tip of the Week “Crisis Checklists for the OR” highlighted the work done by Atul Gawande and colleagues (Ziewacz 2011) on use of checklists for various crises that might be encountered in the OR. They had developed a series of “crisis checklists” for 12 of the most frequently occurring operating room crises and tested their use in a high-fidelity surgical simulator. They had OR teams in the surgical simulator address 4 crisis situations with checklists and 4 without. In simulated crises without checklists, the teams’ failure rate to perform critical steps was 24%. When using checklist, the failure rate was only 4%. Surveys of the participating OR teams found that the crisis checklists were very well-received, usable, and likely to prepare the teams well for real crises.

Gawande and colleagues have now expanded on that experience and tested the crises checklists in multiple settings with multiple teams in simulated scenarios (Arriaga 2013). They had 17 teams in one academic and two community hospital settings participate in the scenarios, randomized to either using the checklists or dealing with the crises simply by memory. There were a total of 106 simulated crisis scenarios in all. They found that 6% of necessary steps were missed when the checklists were used, compared to 23% of steps missed when memory alone was used. That translates to a 75% improvement! Those numbers are similar to those found in their initial 2011 study. Virtually every team performed better when using the checklists. And 97% of respondents to a survey stated that they would want checklists used if they were a patient undergoing surgery.

The appendices to the 2011 article (Ziewacz 2011) contain the actual checklists they developed and, for each “crisis” a list of the key processes and steps identified as being important. The conditions for which this group developed crisis checklists include malignant hyperthermia, surgical fires, air embolism, anaphylaxis, unstable bradycardia, unstable tachycardia, cardiac arrest (asystolic and VF/VT), failed airway, unexpected hemorrhage, hypotension and hypoxia.

The authors do acknowledge that good performance in simulation is no guarantee that outcomes will be good in real-life OR crises and that there are no definitive studies in aviation or nuclear power that demonstrate simulation exercises improve safety, though simulation is widely accepted. But even if you don’t have access to a surgical simulator, it would be well worth your while having your OR teams become familiar with these tools and run “drills” on each of these. Especially if you combine these with other team training programs, such as TeamSTEPPS™, your OR teams will likely be better prepared to handle these relatively rare but critical scenarios.

References:

Ziewacz JE, Arriaga AF, Bader AM, Berry WR, et al. Crisis Checklis ts for the Operating Room: Development and Pilot Testing. J Am Coll Surg 2011; 213(2): 212-219

http://www.journalacs.org/article/S1072-7515%2811%2900343-7/abstract

Arriaga AF, Bader AM, Wong JM, et al. Simulation-Based Trial of Surgical-Crisis Checklists. N Engl J Med 2013; 368: 246-253

http://www.nejm.org/doi/full/10.1056/NEJMsa1204720

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The ABCDE Bundle in Action

Our December 2010 What’s New in the Patient Safety World column “The ABCDE Bundle” described a very logical bundle for ICU care (Vasilevskis 2010). We noted that getting some actual outcome measurements after implementation of the full ABCDE bundle should further solidify more widespread use of this bundle. Some of that outcome data was just presented January 20, 2013 in an abstract at the Society of Critical Care Medicine 42^nd Critical Care Congress (Balas 2013).

The ABCDE acronym stands for “Awakening and Breathing Coordination”, “Delirium monitoring”, and “Exercise/Early mobility” and focuses on prevention of two very common and very serious iatrogenic problems seen in our ICU’s: delirium and ICU-acquired weakness. ICU delirium and ICU-acquired weakness are associated with significant morbidity and mortality, excessive lengths of ICU and hospital stay, and excessive costs.

The individual components of the bundle are well-accepted interventions in most ICU’s and are described in our December 2010 column. But they also note that using members of the entire ICU team, interdisciplinary care, good communication, and developing a culture of safety in the ICU, as well as use of tools like checklists and ICU daily goals, are helpful during implementation of the ABCDE bundle.

The new study (Balas 2013) was a prospective, cohort, before-after study of the ABCDE bundle at a large, tertiary medical center, involving patients from multiple ICU’s (93 prior to implementation of the bundle and 94 after implementation of the ABCDE bundle). They found patients treated with the ABCDE bundle experience more days breathing without assistance and a shorter duration of ICU delirium. But there were no significant differences in the time to ICU or hospital discharge, incidence or duration of coma, or change in residence between groups. Mortality was lower in those receiving the ABCDE bundle but this did not achieve statistical significance.

This is a very promising bundle of interventions and perhaps studies on a larger patient population in the future may also demonstrate improvement in the important clinical outcomes like mortality and ICU/hospital LOS. However, it remains difficult to sort out what improvements were the result of specific bundle interventions vs. what impact came from the more general improvement in culture of safety that the project obviously fostered. Nevertheless, the early outcomes are promising.

References:

Vasilevskis EE, Ely EW, Speroff T, et al. Reducing Iatrogenic Risks: ICU-Acquired Delirium and Weakness—Crossing the Quality Chasm. Chest 2010; 138: 1224-1233 November 2010

http://chestjournal.chestpubs.org/content/138/5/1224.abstract

Balas M, Olsen K, Gannon D, et al. Safety And Efficacy Of The ABCDE Bundle In Critically-Ill Patients Receiving Mechanical Ventilation. Abstract at Society of Critical Care Medicine 42^nd Critical Care Congress. Presented January 20, 2013. Crit Care Med 2012; 40(12) (Suppl.): 1

http://www.sccm.org/SiteCollectionDocuments/2013CongressAbstracts.pdf

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