What’s New in the Patient Safety World

April 2012



·        Tubing Misconnections

·        Operating Room Briefings and Debriefings

·        Specimen Labeling Errors

·        New Transfusion Guidelines from the AABB

·        Problems with “Ketofol”








Tubing Misconnections



Catheter/tubing misconnections are among the most devastating patient events we have seen, since many result in patient death. See our previous columns on this topic:


July 10, 2007               Catheter Connection Errors/Wrong Route Errors

November 2007           More Patient Deaths from Luer Misconnections

August 2009                 Catheter Misconnections Continue to Occur

August 2010                 ISMP Advice on Catheter Misconnections

August 23, 2011           Catheter Misconnections Back in the News



A couple new resources to help prevent such accidents are now available. ISMP (ISMP 2012), in collaboration with Baxter Healthcare’s Clinical Center of Excellence, has developed a tubing misconnections self assessment for healthcare facilities. A brief tutorial can be accessed from ISMP’s website and the full assessment and tutorial can be accessed from Baxter’s Clinical Center of Excellence website.


The winter issue of the APSF newsletter has an article on preventing epidural catheter misconnections (Block 2012). It emphasizes the need for device redesign to prevent such errors. It has a good bibliography regarding incidents specifically related to injection of incorrect substances into the epidural space.


The general concepts of catheter misconnections and wrong route incidents were discussed in our previous columns noted above and in the 2006 Joint Commission Sentinel Event Alert #36, the UK NPSA, the WHO/Joint Commission Collaborating Center for Patient Safety Solutions, the October 2007 issue of FDA Patient Safety News and multiple ISMP articles.







ISMP (Institute for Safe Medication Practices). ISMP Medication Safety Alert! Acute Care Edition 2012; Tubing Misconnections Self Assessment for Healthcare Facilities.

March 8, 2012


Brief tutorial


Full assessment and tutorial www.baxter.com/healthcare_professionals/clinical_center_of_excellence/connections_portfolio/programs/tubing_misconnection_index.html



Block M, Horn RJ, Schlesinger MD. Reducing Risk of Epidural-Intravenous Misconnections. APSF Newsletter 2012; 26(3): 63-66 Winter 2012




The Joint Commission. Tubing misconnections—a persistent and potentially deadly occurrence. Sentinel Event Alert 2006; Issue 36  April 3, 2006




World Health Organization, The Joint Comission, Joint Commission International: WHO Collaborating Centre for Patient Safety Solutions. Avoiding catheter and tubing mis-connections. Patient Saf Solut. 2007; Volume 1. Solution 7. May 2007




National Patient Safety Agency (UK). Patient Safety Alert “Promoting safer measurement and administration of liquid medicines via oral and other enteral routes” March 28, 2007 http://www.npsa.nhs.uk/site/media/documents/2463_Oral_Liquid_Medicines_PSA_FINAL.pdf



FDA. More Patient Deaths from Luer Misconnections FDA Patient Safety News: Show #68, October 2007




ISMP. Collection of all their catheter misconnection articles.






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Operating Room Briefings and Debriefings



A new study (Bandari 2012) demonstrates how structured tools for OR briefings and debriefings can identify a whole host of patient safety issues. They used simple checklist-style tools for briefing before and debriefing after cases in their OR and found 141 “defects” per month, the detection rates about equally divided between the briefings and debriefings. They used standard categories to group defects identified. Equipment issues were the most commonly identified defects but communication issues were also common. Equipment issues ranged from identifying equipment that needed repair or replacement, issues on cleaning and sterility, setting up for cases, to training staff on use of certain equipment. They also noted how often staff were pulled away from or interrupted in their tasks to deal with such issues. The online version of the article provides copies of the tools used.


Other examples of such checklists for the preoperative briefings may be found on either the NHS Patient Safety First website or the VA website. Video examples of preoperative briefings may also be found at the NHS website or the VA website.


Preoperative briefings (sometimes called “huddles”) and postoperative debriefings are tools we have strongly recommended since we first began talking about the TeamSTEPPS™  training program back in 2007 (see our our May 22, 2007 Patient Safety Tip of the Week “More on TeamSTEPPS™” and our March 2009 What’s New in the Patient Safety World column “Surgical Team Training”). Briefings and debriefings are also core components of many of the crew resource management programs such as the VA’s Medical Team Training Program (see our January 11, 2011 Patient Safety Tip of the Week “NPSA (UK) ‘How to Guide’: Five Steps to Safer Surgery”).


Basically, in the debriefings you are asking “What went well?”, “What didn’t go well?” and “What could we do better next time?”. As above, you’ll often identify the need to fix broken equipment or ensure the availability of appropriate backup instruments. Sometimes it’s something simple like tray set-ups or equipment set-ups that interfered with the surgeon’s movements during the procedure.


Checklists have been utilized more often for the preoperative briefings or huddles. We previously noted a study by Lingard et al (Lingard 2008) that used a checklist to structure short team briefings and documented reduction in the number of communication failures. Another group (Paull 2010) demonstrated that implementation of preoperative checklist-driven briefings was associated with increased compliance with antibiotic prophylaxis and DVT prophylaxis.


Checklists that are too complicated are not good. We do have a tendency to add too many things to the checklists. Generally you should keep checklists to fewer than 10 items. Checklists should also be reviewed and revised as needed. Items that are not providing useful information can be deleted. Our December 9, 2008 Patient Safety Tip of the Week “Huddles in Healthcare” discussed an article by Nundy and colleagues at Johns Hopkins (Nundy 2008). They used a very simple format for pre-operative briefings that led to a 31% reduction in unexpected delays in the OR and a 19% reduction in communication breakdowns that lead to delays. The tool they used was simple and consisted of 5 key items:


But one of the unsaid messages in the Nundy paper is the KISS (“Keep It Simple, Stupid”) principle. Anticipate things and try to discuss the most serious things that might happen, but don’t make the process so complex and long that team members lose their attention. A typical pre-op huddle or briefing ordinarily takes no more than 3-4 minutes.


Some of the issues that might be discussed in a pre-op briefing/huddle are:


While each checklist should be kept short and simple, you can use “cascading” checklists (akin to the examples used in industry provided by Atul Gawande in his book “The Checklist Manifesto”). The best medical example of the cascading checklist is that for surgical fires. Our January 2011 What’s New in the Patient Safety World column Surgical Fires Not Just in High-Risk Casesnoted an effort to promote fire safety in the OR (Murphy 2010) in which the San Francisco VA developed a checklist “The Surgical Fire Assessment Protocol”. This checklist/protocol is actually printed on the reverse side of their larger preoperative briefing checklist. It’s a good example of how you can use “cascading” checklists to avoid putting too many items on a single checklist.


Importantly, the mere performance of the briefings and debriefings fosters a sense of belonging to teams, empowerment for all members, and better communication. These lead not only to a culture of safety but they also significantly improve job satisfaction for all involved.


And don’t forget: huddles are not just for the OR! Our December 9, 2008 Patient Safety Tip of the Week “Huddles in Healthcare” also discussed how huddles and briefings can be useful in a variety of healthcare situations, not just the preoperative one.







Bandari J, Schumacher K, Simon M, et al. Surfacing Safety Hazards Using Standardized Operating Room Briefings and Debriefings at a Large Regional Medical Center. The Joint Commission Journal on Quality and Patient Safety 2012; 38(4): 154-160




NHS Patient Safety First. video demonstrating sample pre-op briefings




NHS Patient Safety First. Quick guide to briefing and debriefing.




Veterans Health Administration. Preoperative Briefing Guide for Use in the Operating Room.




Veterans Health Administration. Postoperative Briefing Guide for Use in the Operating Room.




Veterans Health Administration. Preoperative Briefing Video.




Lingard L, Regehr G, Orser B, et al. Evaluation of a Preoperative Checklist and Team Briefing Among Surgeons, Nurses, and Anesthesiologists to Reduce Failures in Communication. Arch Surg, Jan 2008; 143: 12-17




Paull DE, Mazzia LM, Wood SD, et al. Briefing guide study: preoperative briefing and postoperative debriefing checklists in the Veterans Health Administration medical team training program. Am J Surg 2010; 200(5): 620-623




Nundy S, Mukherjee A, Sexton JB, et al. Impact of Preoperative Briefings on Operating Room Delays: A Preliminary Report. Arch Surg 2008; 143(11): 1068-1072




Murphy J. A New Effort to Promote Fire Safety in the OR. Topics In Patient Safety (TIPS) 2010; 10(6): 3




SF VAMC Surgical Fire Risk Assessment Protocol








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Specimen Labeling Errors




A recent article on the OutpatientSurgey.net website highlighted a $1 million malpractice award in a case of switched pathology specimens (Paige 2012). A patient underwent a robotic prostatectomy and no cancer was found. It was later discovered that his original biopsy specimen had been switched with that of another patient. Where and how the swtich occurred could not be resolved and both the laboratory and the center where the original biopsy had been done were held liable in the case.


In our March 6, 2012 Patient Safety Tip of the Week ““Lab” Error” we noted that the vast majority of “lab”errors really occur in the pre-analytical and post-analytical phases of laboratory evaluation.


A recent report on laboratory errors collected from 30 healthcare organizations (Snydman 2012) notes that the top 2 errors were specimen not labeled (18.7%) and specimen mislabeled (16.3%) and concludes many “lab” errors occur before the specimen ever reaches the lab and could be prevented by better labeling.


A paper from the Mayo Clinic (Francis 2009) discusses changes made after their gastrointestinal and colorectal surgery endoscopy units had experienced mislabeling or no labeling of specimens. They initiated a new specimen-labeling system that uses RFID technology, a paperless requisition process, and confirmation of the correct site and correct patient by 2 healthcare providers. They were able to document a substantial decrease in errors as a result of the new processes.


But labeling errors may occur with the lab itself. Another paper identified errors in specimen labeling within a surgical pathology laboratory (Layfield 2010). They found labeling errors occurred at a rate of 0.25% of cases and could involve either patient name or site of the specimen. The majority of the mislabelings occurred in the gross room. One theme they noted was that more errors occurred with small specimens that were similar in appearance and were batch processed. They also noted that batch processing had been previously identified in the literature as a root cause of labeling errors in the laboratory.


See our Patient Safety Tips of the Week for October 9, 2007 “Errors in the Laboratory“ and November 16, 2010 “Lost Lab Specimens” for discussions on specimen identification, labeling, etc. And our October 11, 2011 Patient Safety Tip of the Week “LEAN in the Lab” describes use of LEAN principles to improve lab safety and efficiency.



Some of our other columns on errors related to laboratory studies:








Paige L. Switched Pathology Specimen Results in Errant Prostate Surgery, $1 Million Settlement. Both urology clinic and pathology lab denied liability, so they shared payment of damages. Outpatientsurgery.net Published: March 6, 2012




Snydman LK, Harubin B, Kumar S, et al. Voluntary Electronic Reporting of Laboratory Errors: An Analysis of 37 532 Laboratory Event Reports From 30 Health Care Organizations. American Journal of Medical Quality March/April 2012 27: 147-153, first published on September 14, 2011




Francis DL, Prabhakar S, Sanderson SO. A Quality Initiative to Decrease Pathology Specimen–Labeling Errors Using Radiofrequency Identification in a High-Volume Endoscopy Center. Am J Gastroenterol 2009; 104: 972–975




Layfield LJ. Anderson GM. Specimen labeling errors in surgical pathology: an 18-month experience. American Journal of Clinical Pathology 2010. 134(3): 466-70, 2010 Sep.






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New Transfusion Guidelines from the AABB



We’ve done several columns highlighting some of the detrimental effects related to red blood cell transfusions (see our What’s New in the Patient Safety World columns for March 2011 “Downside of Transfusions in Surgery”, February 2012 “February 2012 More Bad News on Transfusions”, and January 2012 “Need for New Transfusion Criteria?”).


Add to that a paper just presented at the Annual Meeting of  the Society of Thoracic Surgeons (Horvath 2012). They found that transfusions were associated with a significant risk of infection in cardiac procedures. And while there seemed to be a threshold in the 2-4 unit range above which the risk really seemed to increase, there was an additional infection risk even with the first unit of blood transfused. A variety of infections were associated with these transfusions in a dose-dependent manner. The crude risk of infection increased an average 29% with each unit of packed RBC’s transfused.


And as we implied in our January 2012 What’s New in the Patient Safety World column “Need for New Transfusion Criteria?”, the AABB (formerly the American Association of Blood Banks) has just come out with new clinical guidelines for red blood cell transfusion (Carson 2012). The main recommendation is adhering to a restrictive transfusion strategy (7 to 8 g/dL threshold) in hospitalized, stable patients (Grade: strong recommendation; high-quality evidence). They also recommend adhering to a restrictive strategy in hospitalized patients with preexisting cardiovascular disease and considering transfusion for patients with symptoms or a hemoglobin level of 8 g/dL or less (Grade: weak recommendation; moderate-quality evidence). They could not recommend for or against a liberal or restrictive transfusion threshold for hospitalized, hemodynamically stable patients with the acute coronary syndrome. Lastly, they suggest that transfusion decisions be influenced by symptoms as well as hemoglobin concentration, as most previous guidelines have recommended.


Undoubtedly these new guidelines will kindle some debate, as highlighted in the editorial accompanying the guideline publication (Vincent 2012). His argument centers around the need to balance the risks and benefits of transfusion against the risks and benefits associated with anemia management.


The debate may continue but the new AABB guidelines set a new standard and emphasize the need to carefully weigh both the potential benefits and risks each time you are faced with a decision about whether to transfuse or not.







Horvath KA et al. Do Blood Transfusions Affect the Risk of Infections After Cardiac Surgery? Experience of the NIH/CIHR Cardiothoracic Surgical Trials Network. Abstract presented at the 2012 Annual Meeting of  the Society of Thoracic Surgeons as summarized in Wachter K. Cardiac Surgical Transfusions Linked to Infection Risk. Hospitalist News Digital Network. March 15, 2012




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




Vincent J-L. Editorial. Indications for Blood Transfusions: Too Complex to Base on a Single Number? Ann Intern Med 2012; published ahead of print March 26, 2012






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Problems with “Ketofol”



The increasingly popular practice of mixing ketamine and propofol together for use in patient procedures has come under fire recently. The practice stems from the idea that using lower doses of both agents together can provide adequate patient sedation with less toxicity. The May 2011 issue of The Annals of Emergency Medicine had several articles addressing the use of this combination for procedural sedation/analgesia. The article by Green et al. (Green 2011) nicely summarizes the pros and cons of use of this combination.


But ISMP has recently warned about some safety issues associated with this practice (ISMP 2012). They are especially concerned about sterility, since the mixing of these two drugs often takes place in the emergency room under less-than-ideal circumstances for sterility. They caution against puncturing single-dose vials multiple times, ensuring that the proper expiration date is included on the syringe label, and that the medication is appropriately disposed of after use. They also note that there is no standardized concentration or volume of each drug in the combination and that there is little literature on the compatibility of these two agents. Moreover, look-alike/sound-alike issues may occur. Because “ketofol” does not appear in standard drug dictionaries or CPOE lists it would be easy to choose the wrong drug from a list. Similarly, a syringe filled with “ketofol” might be mistaken for a syringe filled with just propofol. ISMP recommends that, if you use “ketofol”, you conduct a FMEA (failure mode and effects analysis) to determine your vulnerabilities.


A second paper (Andolfatto 2010) has also raised safety issues about ketofol. Contrary to the widely-held view that the combination is safer than individual drugs, the authors found in a randomized controlled trial that “ketofol” does not result in a reduced incidence of adverse respiratory events compared to propofol alone. In an emergency department setting they found that “ketofol” resulted in adverse respiratory events in 30% of patients, compared to 32% of patients receiving propofol alone. Deep levels of sedation were common and several patients required bag/mask ventilation. Moreover, several patients receiving “ketofol” developed recovery agitation, the side effect that had largely displaced ketamine from frequent use in the past.


So evidence has raised significant safety concerns to the use of this combination. Be very wary. You may not even know what areas of your organization may be using this potentially dangerous combination. Use your pharmacy IT systems to identify patients in whom both agents were used but bear in mind that many ED’s, OR’s, and radiology suites (the 3 areas most likely to use this combination) are not connected to the main hospital IT systems so you may need to do some good old detective work to find out who is using it.






Green SM, Andolfatto G, Krauss B. Ketofol for Procedural Sedation? Pro and Con. Ann Emerg Med 2011; 57(5): 444-448




ISMP (Institute for Safe Medication Practices). What’s wrong with “ketofol”? In a word, plenty! ISMP Medication Safety Alert. Nurse Advise-ERR edition 2012; 10(3): 1,4 March 2012






Andolfatto G, Abu-Laban RB,, Zed PJ, Staniforth SM, et al. Ketamine-Propofol Combination (Ketofol) Versus Propofol Alone for Emergency Department Procedural Sedation and Analgesia: A Randomized Double-Blind Trial. Ann Emerg Med 2012; article in press March 9, 2012





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