What’s New in the Patient Safety World

July 2014

·         Joint Commission Sentinel Event Alert: Don’t Misuse Vials

·         Wrong-Sided Thoracenteses

·         Issues on Timing of Beta Blockers in MI

·         New MRI Risks: for Staff!





Joint Commission Sentinel Event Alert: Don’t Misuse Vials



We’ve done several columns in the past year about patients being potentially exposed to blood-borne pathogens from misuse of insulin pens in hospitals (see February 26, 2013 Patient Safety Tip of the Week “Insulin Pen Re-Use Incidents: How Do You Monitor Alerts?” and our What’s New in the Patient Safety World columns for April 2013 “More Tips on Insulin Pen Safety” and April 2014 “Insulin Pens - Again”).


But a far more common risk is exposing patients to infection by misuse of single-use vials and even multi-dose vials. So much so that the Joint Commission has just issued a sentinel event alert on preventing infection from misuse of vials. The sentinel event alert notes that vials intended for single use do not have preservatives so they are especially prone to bacterial contamination and spread of infection.


Occurrences and outbreaks of blood-borne pathogens and associated infections, including hepatitis B and C virus, meningitis, and epidural abscesses. Adverse events caused by this misuse have occurred in both inpatient and outpatient settings but 2 outpatient settings seem to be especially vulnerable: pain management clinics and cancer clinics.


The biggest contributing factor is failure to adhere to safe injection practices and aseptic techniques. Joint Commission cites statistics that 6% of healthcare providers surveyed admitted using single-dose or single-use vials on multiple patients and 15% using multiple-dose vials used the same syringe to re-enter the vial numerous times for the same patient or used the vial for multiple patients.


The sentinel event alert focuses heavily on CDC’s recommendations for injection safety and CDC’s One & Only Campaign. The latter emphasizes “ONE needle, ONE syringe, ONLY ONE time”.


The alert goes on to provide recommendations for standardized policies pertaining to single-dose/single-use, multi-dose, and all vials. It also recommends doing audits looking for open vials on various units. That’s an important recommendation. In addition to formal audits, we’d recommend you add this to the activities you do on your Patient Safety Walk Rounds. And the alert discusses the importance of training and education, safety culture and reporting.


Call us skeptics. You can do all the education and training in the world. But if you have vials and syringes in patient care areas it is inevitable that someone will at some time misuse those vials. The fewer people that have access to vials, the lower the likelihood that such misuse will occur. Absent some changes in product design at the manufacturer/supplier level, the best way to reduce the risk would be to have the pharmacy prepare all such doses and provide them to the patient care areas in pre-filled syringes. That solution might work in hospitals and hospital-based outpatient clinics but is problematic in those office and clinic settings that do not have access to a pharmacy.


We know that sometimes the misuse of vials is done with the good intention of cost containment. There is no question that our suggestion above or a change at the manufacturer/supplier level would increase supply costs (and perhaps personnel costs). But you have to weigh that against the costs (both financial and PR) you’d incur if you have to notify many patients of potential exposure, do testing for pathogen exposure, and cover costs for treatment of such exposure. In our April 2014 What’s New in the Patient Safety World column “Insulin Pens - Again” we noted that the cost of one full course of hepatitis C treatment with the newer drugs just on the market is about $84,000.


This is a real problem. It deserves an industry-wide solution. We only solved the unintentional lethal KCl injection problem by taking vials of concentrated KCl off patient care units. We similarly need to avoid enabling well-intentioned healthcare workers from unintentionally exposing patients to infection through misuse of vials.






The Joint Commission. Sentinel Event Alert. Preventing infection from the misuse of vials. Sentinel Event Alert 2014; 52: 1-6  June 16, 2014




CDC. Injection Safety.




CDC. One & Only Campaign.






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Wrong-Sided Thoracenteses



We’ve long known that wrong-site procedures outside the OR are frequent. We discussed them in our Patient Safety Tips of the Week for December 6, 2010 “More Tips to Prevent Wrong-Site Surgery” and June 6, 2011 “Timeouts Outside the OR” and our August 2011 What’s New in the Patient Safety World column “New Wrong-Site Surgery Resources”. These included links to some excellent resources (Neily 2011, Stahel 2010).


In our Patient Safety Tip of the Week November 25, 2008 “Wrong-Site Neurosurgery” we noted that chest tube inserted on the wrong side was the most frequent wrong-site occurrence in New York State in the past. Wrong-side chest tube insertions and wrong-side thoracenteses continue to occur. Now a new study (Miller 2014) has analyzed factors associated with wrong-side thoracenteses. The researchers searched the VA’s extensive root cause analysis database from 2004 through 2011 and found 14 cases of thoracenteses performed on the wrong side outside the OR setting. These were complicated by pneumothorax in 4 cases, bleeding in 3, and attributable death in 2. Length of stay was increased for 8 cases where reported (by an average of 2.6 days, including 1.9 ICU days).


A resident performed the procedure in 10 of the cases and an attending performed 2. An attending was present in 6 cases and a nurse was present in just 3 cases.


The most frequent associated factor was failure to perform a timeout (12 of the 14 cases). Laterality was missing from the consent form in 10 cases and the site was not marked in 12 cases. Medical image verification was not done in 7 of the 10 cases where information was available.


They found 30 root causes in the 14 cases (average 2.1 root causes per event). These most often included communication issues, failure to follow policy or procedures, and equipment issues. In several cases, the images were not available at the time of the procedure. That is particularly problematic in today’s computerized environment. If the PACS system is down you may not have immediate access to the images. In the old days we’d bring the actual films with us to the bedside. Today there are no films, only the images on the computer system.


Of interest, most of the wrong-side thoracenteses were performed on the patient’s right side when the pleural effusion was on the left. The authors note that right-left confusion is a common human error in many scenarios. They note one resident knew the pleural effusion was on the left side on the x-ray but when he went behind the patient the x-ray image in his mind reversed.


Miller et al. note a number of strategies that are helpful in preventing such events. First is formal standardization of Universal Protocol and timeouts for invasive procedures anywhere, not just in the OR. Checklists, site marking, and ultrasound localization are also useful. Learning and practicing the procedures in a simulation environment is also encouraged. Development of a culture of patient safety and good communication is also critical.


We prefer to use forcing functions or constraints as actions whenever possible (see our March 27, 2012 Patient Safety Tip of the Week “Action Plan Strength in RCA’s” including our illustrative slides of strong vs. weak actions). Particularly for thoracenteses, there are two good ways to ensure that a timeout gets done and force all the appropriate elements to prevent a wrong-site, wrong-side, or wrong-patient procedure. One is to prevent a physician from accessing a thoracentesis tray all alone. That is best done by requiring an order for the tray, which would require a nurse to access the tray and accompany the physician to the patient’s room (or other site where the thoracentesis will be performed) and participate in the procedure. Second is to include on the outside of the sterile tray a checklist that must be completed prior to opening the sterile tray. That checklist, of course, would include the items typically in the Universal Protocol and timeouts (things like consent, verification of the patient, procedure, laterality including review of relevant imaging studies, etc.).



The Miller paper is a reminder that wrong-site procedures continue to occur and that we must put in place system interventions to help reduce the risk of their occurrence, not only in the OR but everywhere in our facilities.



Some of our prior columns related to wrong-site surgery:


Patient Safety Tip of the Week columns:

  September 23, 2008 “Checklists and Wrong Site Surgery”

  June 5, 2007 “Patient Safety in Ambulatory Surgery”

  March 11, 2008 “Lessons from Ophthalmology”

  July 1, 2008 “WHO’s New Surgical Safety Checklist”

  January 20, 2009 “The WHO Surgical Safety Checklist Delivers the Outcomes”  

  September 14, 2010 “Wrong-Site Craniotomy: Lessons Learned”

  November 25, 2008 “Wrong-Site Neurosurgery”

  January 19, 2010 “Timeouts and Safe Surgery”

  June 8, 2010 “Surgical Safety Checklist for Cataract Surgery”

  December 6, 2010 “More Tips to Prevent Wrong-Site Surgery”

  June 6, 2011 “Timeouts Outside the OR”

  October 30, 2012 “Surgical Scheduling Errors”

  January 1, 2013 “Don’t Throw Away Those View Boxes Yet”

  August 27, 2013 “Lessons on Wrong-Site Surgery”

  September 10, 2013 “Informed Consent and Wrong-Site Surgery”


What’s New in the Patient Safety World columns:

  July 2007 “Pennsylvania PSA: Preventing Wrong-Site Surgery”

  August 2011 “New Wrong-Site Surgery Resources”

  December 2011 “Novel Technique to Prevent Wrong Level Spine Surgery”

  January 2013 “How Frequent are Surgical Never Events?”







Neily J, Mills PD, Eldridge N, et al. Incorrect Surgical Procedures Within and Outside of the Operating Room. A Follow-up Report. Arch Surg 2011; Published online July 18, 2011




Stahel PF, Sabel AL, Victoroff MS, et al. Wrong-Site and Wrong-Patient Procedures in the Universal Protocol Era. Analysis of a Prospective Database of Physician Self-reported Occurrences. Arch Surg. 2010; 145(10): 978-984




Miller KE, Mims M, Paull DE, et al. Wrong-Side Thoracentesis. Lessons Learned From Root Cause Analysis. JAMA Surg 2014;  Published online June 11, 2014







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Issues on Timing of Beta Blockers in MI



We’ve done many columns on the controversy over use of beta blockers in patients undergoing surgery. On the other hand, beta blockers have been a mainstay of treatment in patients who have had an MI. Studies have clearly demonstrated the long-term benefit of chronic beta blockers in patients with a history of MI. But recently questions have been raised about the acute short-term benefits of beta blockers, noting that prior studies demonstrating an acute benefit were largely done in the era before coronary reperfusion strategies became widespread.


A new analysis of data (Park 2014) from the large Global Registry of Acute Coronary Events (GRACE) has raised issues regarding the timing and route of administration of beta blockers in patients with ST-segment elevation MI (STEMI). It must be kept in mind that this is a retrospective analysis of data from a registry, not a randomized controlled trial. In such analyses it is always impossible to determine whether there were confounding factors (eg. the patient may have had clinical factors that led to certain decisions about the use, route, and timing of beta blockers) that may have impacted outcomes.


Nevertheless, the new analysis raises interesting questions. They classified patients as receiving early (within the first 24 hours) or delayed (after 24 hours) beta blocker therapy and further differentiated IV from oral early beta blocker therapy. Early IV beta blockers and delayed beta blockers were associated with higher rates of some adverse outcomes (cardiogenic shock, ventricular arrhythmias, acute heart failure). But in-hospital mortality was significantly increased with IV beta blockers but reduced with delayed beta blockers. On the other hand, early oral beta blocker therapy was associated with reduced rates of cardiogenic shock, ventricular arrhythmias, acute heart failure but was associated with higher in-hospital mortality rates.


Again, it is difficult to use data from registries to conclusively change practice recommendations. What the analysis really tells us is that we need further randomized trials to answer the question about optimal timing of beta blocker therapy in patients with acute MI.








Park KL, Goldberg RJ, Anderson FA, et al. Beta-blocker Use in ST-segment Elevation Myocardial Infarction in the Reperfusion Era (GRACE). The American Journal of Medicine 2014; 127(6): 503–511






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New MRI Risks: for Staff!



We’ve done lots of columns on adverse effects on patients in the Radiology suite and MRI suite (see the list at the end of today’s column). But we’ve never before done one on adverse effects on MRI staff! And it turns out that there are symptoms that staff may develop after exposure to MRI.


A pilot study done on Swedish nurses exposed to MRI (Wilιn 2011) showed that 15% of nurses responding to a survey reported regularly experiencing at least one health complaint attributed to arise or be aggravated by their presence in the MRI scanning room.


Now researchers in The Netherlands (Schaap 2014) reviewed diaries from 361 employees of 14 clinical and research MRI facilities and attempted to correlate reported symptoms with exposure and scanner strength. Symptoms were reported in 16-39% of MRI shifts worked. They found a positive association between scanner strength and reported symptoms among healthcare and research staff working with closed-bore MRI scanners of 1.5 Tesla(T) and higher. This finding was mainly driven by reporting of vertigo and a metallic taste. Other symptoms included nausea, tinnitus, seeing light spots or light flashes, tingling sensations, and a host of more general symptoms. They conclude that there is an exposure-response association between exposure to strong static magnetic fields and reporting of transient symptoms on the same day of exposure. But the authors do postulate that there may be a possible underlying trait of personal sensitivity that may influence whether a person develops symptoms on exposure to a static magnetic field.


While the study does not report on any permanent sequellae to exposure to MRI fields and the transient symptoms do not appear to be particularly debilitating, we suspect it may lead to further research on the effects of working in MRI suites. It is a reminder that we need to consider staff as well as patients in our patient safety efforts.




Some of our prior columns on patient safety issues in the radiology suite:


Some of our prior columns on the “Ticket to Ride” concept:


Some of our previous columns on the issue of radiation risk:









Wilιn J, De Vocht F. Health complaints among nurses working near MRI

Scanners - a descriptive pilot study. Eur J Radiol 2011; 80: 510-513




Schaap K, Christopher-de Vries Y, Mason CK, et al. Occupational exposure of healthcare and research staff to static magnetic stray fields from 1.5–7 Tesla MRI scanners is associated with reporting of transient symptoms. Occup Environ Med 2014; published online April 8, 2014 doi:10.1136/oemed-2013-101890






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Print “July 2014 Joint Commission Sentinel Event Alert: Don’t Misuse Vials”

Print “July 2014 Wrong-Sided Thoracenteses”

Print “July 2014 Issues on Timing of Beta Blockers in MI”

Print “July 2014 New MRI Risks: for Staff!”






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