What’s New in the Patient Safety World

April 2010

·        Update on C. diff

·        Medication Events Related to Cancer Chemotherapy

·        RCA: Epidural Solution Infused Intravenously

·        Medication Issues in the Emergency Department



Update on C. diff


C. diff has overtaken MRSA as the leading hospital-associated infection and has been becoming more prevalent in the community as well and more virulent strains have emerged. But even as the Society for Healthcare Epidemiology (SHEA) and the Infectious Diseases Society of America (IDSA) have issued new guidelines for C. diff, new studies are showing promising measures to control this serious threat.


The new SHEA/IDSA guideline on C. diff appears online on the Infection Control and Hospital Epidemiology website (to be published in print in May 2010). The guideline does a good job of letting healthcare workers not only know what to do, but also what not to do. Importantly, testing for C. diff or its toxins should only be performed on diarrheal stools (unless ileus due to C. diff is suspected). Specifically, you should not test asymptomatic individuals for C. diff nor should you test to see if you’ve cured the infection and you should not perform routine environmental screening for C. diff. Stool culture remains the most sensitive test but is a slow method of detection. Testing for toxins A and B are more rapid but less sensitive. A 2-step method of testing (using enzyme immunoassay for C. diff glutamate dehydrogenase (GDH) first, followed by cell cytotoxic assay or toxigenic culture if the GDH is positive) may be the best strategy. Ultimately, PCR testing will likely become the best test. Repeat testing during the same bout of diarrhea is not recommended.


Prevention remains the best strategy for reducing the impact of C. diff infections. Good hand hygiene compliance is critical. Washing hands with soap (or antimicrobial soap) and water is important for both healhcare workers and visitors after coming in contact with infected patients. Contact precautions should be used as long as the patient has diarrhea and patients should be kept in private rooms (or cohorted if private rooms are not available).


Identification and removal of environmental sources should be undertaken. Electronic thermometers should be replaced with disposable ones. Chlorine-containing cleaning agents or other sporocidal agents should be used on the environment. Most important is minimizing the use of antimicrobial agents. A good antibiotic stewardship program is recommended but use of probiotics is not recommended at this time.


Cessation of antibiotics that may have facilitate development of C. diff infection is usually the first step in treatment of infected patients. Treatment should be guided by stratifying patients into mild-to-moderate and severe categories. Though there has been some development of resistance, metronidazole remains the usual drug for initial cases of mild-to-moderate disease. Vancomycin is used in initial cases of severe disease and both drugs may be considered in cases of severe complicated disease. Doses and route and duration are described in the guideline. Recurrent bouts are common and the guideline has recommendations for the best approaches, again stratifying by disease severity. Colectomy may be required in severe cases and serum lactate or peripheral white blood count may be useful in making a decision for colectomy. The guideline provides extensive documentation of the evidence base and bibliographic resources.


In the meantime, researchers at the Mayo Clinic demonstrated a significant reduction in the rate of hospital-acquired C. diff by consistent daily cleaning of high-touch surfaces with a sporocidal bleach disinfectant wipe for all patients in high epidemic areas.





Stobbe M. Study: Lesser-known bug a bigger hospital threat. Associated Press March 20, 2010




Cohen SH, Gerding DN, Johnson S, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA)

Infection Control and Hospital Epidemiology 2010; 31(5): 000-000 online first March 22, 2010 http://www.journals.uchicago.edu/doi/pdf/10.1086/651706



Clostridium Difficile Infection Nears Zero: Intervention Drops Hospital Infection Rate By 1/3. Medical News Today. March 22, 2010.





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Medication Events Related to Cancer Chemotherapy



Good timing related to our Patient Safety Tip of the Week for April 6, 2010 “Cancer Chemotherapy Accidents” – there is a good summary article just published that adds to our understanding of some of the patient safety dangers involved in cancer chemotherapy.


ISMP Canada has done a safety bulletin on Medication Incidents Involving Cancer Chemotherapy Agents, based on over 500 reports they received over a seven year period. They categorize them into seven main themes and provide brief examples for each theme and key contributing factors for each subtheme.


Under the theme “Scheduling the Patient’s Visit to Clinic for Treatment” they note that many chemotherapy regimens and protocols are multiphase and the timing of one cycle affects the timing of the next cycle. They caution that sometimes the scheduling is done in advance and when there are delays in one cycle, staff may forget to reschedule the next visit with the appropriate delay. As a result, patients may get the next cycle at an inappropriately early time.


Under the theme “Prescribing” they cite multiple subthemes and contributing factors such as miscalculation of body surface area, inconsistent documentation of past reactions to chemotherapy, complexity of chemotherapy protocols, and look-alike/sound-alike protocol names (like “FOLFOX/FOLFIRI” or “Hyper-CVAD 2A/Hyper-CVAD 2B”).


Under the theme “Order Entry or Transcription” they cite use of dangerous abbreviations, look-alike/sound-alike medication names, lack of knowledge about chemotherapy agents, and duplicate therapies as issues.


The theme “Clinical Assessment and Communication of Treatment Changes” includes numerous examples of chemotherapy inadvertently given when it should have been postponed because of laboratory results (usually failure to verify such results before administering chemotherapy or assessing the wrong set of lab results or lack of a system for independent checks of lab work).


Under the theme “Dispensing” many of the typical medication errors are noted (wrong concentrations, incorrect rate because of incorrect pump selection, look-alike/sound-alike drug names or packaging similarities, etc.


The theme “Administration of Medication” includes incorrect patient, frequency, route, rate and omission of dose. Pump programming errors and other problems with pumps are a major factor in these.


The last theme “Monitoring” includes things like extravasation and leak of medication during infusion and such things as lack of patient education or understanding of risks and actions required.





ISMP Canada Safety Bulletin. Medication Incidents Involving Cancer Chemotherapy Agents. ISMP Canada Safety Bulletin 2010; 10(1): 1-4 March 16, 2010




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RCA: Epidural Solution Infused Intravenously



Another well-time article, related to our recent Patient Safety Tip of the Week for March 30, 2010 “Publicly Released RCA’s: Everyone Learns from Them” is from the Joint Commission Journal on Quality and Patient Safety on a root cause analysis and the lessons learned in a fatal incident where an infusion intended for the epidural route was inadvertently given intravenously (Smetzer et al 2010). This case was actually previously described briefly in a 2006 ISMP Canada Safety Bulletin but the current article goes much more into the details of the case and the lessons learned. We’re willing to bet that many of the contributing factors in this case occur at your facilities today. This case also really hits home because a nurse involved in this case had to endure criminal proceedings and subsequent licensure issues. We would not want organizational cultural issues and system gaps to put our nurses in similar jeopardy nor would we want to put our patients at risk. So read this one carefully because it has lots of good lessons.


Basically, a young expectant mother arrived for induction of labor. The admitting nurse completed the admission evaluation and anticipated that epidural pain management would be used in this case. So in addition to the usual equipment, supplies and medications for induction of labor, she brought into the patient’s room a bag of the mixture of fentanyl and bupivacaine that is used for the epidural infusion. As she was entering the patient room, a colleague also handed her the intravenous penicillin that the patient was ordered to be given for strep infection. The patient’s identification bracelet (for barcoding) had not yet been applied to the patient. The nurse planned to start the IV, start an educational video for the patient, and then scan the infusion bag to document the administration (presumably the penicillin).  But within minutes of infusion the patient had a seizure and then cardiopulmonary collapse. The team immediately suspected an allergic reaction to penicillin. While attempting to rescuscitate the patient they also moved her to the OR and delivered a healthy infant via C-section. However, attempts to rescuscitate the mother were unsuccessful. It was then they found a partially infused bag of the epidural solution and an unspiked bag of penicillin and realized that the mixup had occurred.


Though bringing the epidural infusion mixture into the patient’s room before it was needed was a proximate cause, there were multiple root causes and contributing factors to this. The obstetricians apparently did not routinely document their plans of care and the decision to use early epidurals was often made when the nurses suggested it to the obstetricians. Dissatisfaction on the part of anesthesiologists about the patient’s state of readiness for the epidural on their arrival also contributed to the practice of bringing the epidural mixture to the room before it was needed.


But a second proximate cause was that the nurse picked up the wrong medication, failed to read the label carefully and gave the wrong medication IV. The RCA focused on similarities of the IV bags, “faded” perception of the risk (she thought she was hanging penicillin, which she does many times daily), and may have had “inattentional blindness” where she failed to see the plainly visible sticker that said “for epidural use only”. There were other contributory factors such as fatigue (she had worked two shifts the previous day and slept in the hospital overnight) and perhaps distractions because of tensions within the patient’s family. They also mention the lack of a physical constraint that could have prevented any solution intended for epidural use from being connected to IV tubing. To this we would add the “two in a box” phenomenon (see our April 23, 2007 Patient Safety Tip of the Week “Predictable Errors“) where having two of almost anything at the same time increases the likelihood you will select the wrong object.


The third and fourth proximate causes were failure to place the identification band on the patient and failure to use the bar-coding system in the intended fashion. It had become the norm on the unit not to place these bands before the mothers were taken to the birthing suite. The bar-coding system had recently been implemented and not all staff were yet comfortable with it. There apparently were some problems such as scanning labels on IV bags and many workarounds had popped up on the unit, similar to those described in our June 17, 2008 Patient Safety Tip of the Week “Technology Workarounds Defeat Safety Intent”.


It is well worth your while to read through the recommendations in this paper. They include things like adding a pink epidural warning label over the infusion port on epidural bags and specifically requiring a physician order before nursing may remove an epidural bag, The 2006 ISMP Canada Safety Bulletin had some other good recommendations such as storing epidural solutions in a separate area and keeping them sequestered until specifically needed, retrieving the epidural solutions at a different time than IV solutions, using distinctly colored epidural tubing to differentiate it from other tubing, using independent double checks, and others.


Even if you don’t do obstetrics, the lessons learned here are valuable. The section on auditing compliance with barcoding and doing exception reporting applies to all facilities doing barcoding.





Smetzer J, Baker C, Byrne FD, Cohen MR. Root Cause Analysis. Shaping Systems for Better Behavioral Choices: Lessons Learned from a Fatal Medication Error.
The Joint Commission Journal on Quality and Patient Safety 2010; 36(4): 152-163 April 2010




ISMP Canada. Epidural Medications Given Intravenously May Result in Death. ISMP Canada Safety Bulletin 2006; 6(7): 1-2. October 5, 2006




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Medication Issues in the Emergency Department


We do a lot of patient safety initiatives on medication safety. However, one area that often is overlooked on medication safety is the emergency department. Perhaps that is because fewer drugs are ordered or prescribed there than in most other settings. Yet the ED is extremely important in terms of continuity of care. Medication reconciliation typically starts in the ED. And the ED must convey back to the next practitioner any additions or changes made in the patient’s medications.


Two recent papers address medication issues in the ED. The first documented that ED crowding is associated with an increased frequency of medication errors (Kulstad et al 2010). This was a prospective observational study in a large community emergency department. They performed a sampling of patients seen in the ED and identified various medication errors. They then evaluated frequency of those errors against the Emergency Department Work Index (EDWIN) score. Not surprisingly, there was a positive correlation between medication error frequency and the daily EDWIN score. Errors ran the gamut of medication errors and included medication name confusion, wrong route, incorrect dosing, and others. They discuss various predisposing factors that occur in most ED’s such as high volume, high acuity, clinical uncertainty, multiple handoffs, and staff shortages. To that we would add that in many ED’s the health information technology systems have not been integrated with the rest of the hospital IT systems.


The second paper looked at prescribing of potentially inappropriate medications (from Beer’s List) to older adults in the ED (Meurer et al 2010). Using a large national ambulatory database, they determined that 16.8% of ED visits were associated with prescription or administration of at least one potentially inappropriate medication to elderly adults. The five most commonly prescribed PIM’s were promethazine, ketorolac, propoxyphene, meperidine and diphenhydramine. There was a correlation between PIM’s and total number of medications prescribed or administered. There was also a higher frequency in rural locations outside the Northeast and being seen by a staff physician only  (as opposed to a resident or intern).


Our January 15, 2008 Patient Safety Tip of the Week “Managing Dangerous Medications in the Elderly “ focused on prescribing of medications on Beer’s List that may be potentially inappropriate in the elderly, as did our June 2008 What’s New in the Patient Safety World column “Potentially Inappropriate Medication Use in Elderly Hospitalized Patients”. Many hospitals and ambulatory settings have integrated CPOE alerts for drugs on Beer’s List. Unfortunately, many or even most ED’s do not currently use CPOE for ordering medications.





Kulstad EB, Sikka R, Sweis RT, Kelley KM, Rzechula KH. ED overcrowding is associated with an increased frequency of medication errors. American Journal of Emergency Medicine 2010; 28: 304-309




Meurer WJ, Potti TA, Kerber KA, Sasson C, et al. Potentially Inappropriate Medication Utilization in the Emergency Department Visits by Older Adults: Analysis From a Nationally Representative Sample.

Academic Emergency Medicine 2010; 17: 231–237




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Print “April 2010 What's New in the Patient Safety World (full column)

Print “April 2010 Update on C. diff

Print “April 2010 Medication Incidents Related to Cancer Chemotherapy

Print “April 2010 RCA: Epidural Solution Infused Intravenously

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