The OR is a setting at risk for medication errors for a variety of reasons (and note that when we use the term “OR” here we also include all the other areas collectively making up the perioperative setting). These reasons include the complexity of the cases, the increasing number of comorbidities, the pace of activity, the distractions and interruptions, the changing of personnel at various times, hand-printed labels that can get smudged, multiple patient IV lines and catheters of various types, and fact that many high-alert drugs and look-alike/sound-alike (LASA) drugs are used in the OR. In addition, many of the safety checks and balances we use in other parts of the hospital are often absent in the OR. We often have one person (the anesthesiologist) obtaining, mixing or preparing, administering, documenting in the record, and monitoring the effects of the medications. So the double checks we use elsewhere (eg. by pharmacists or nurses or the patient himself) are often not used in the OR. Similarly, many OR’s do not yet have IT integration with the hospital’s other IT systems so safety measures such as bedside medication verification (BMV aka barcoding) may not be usable in the OR. In addition, the physical constraints of the OR often result in syringes, medication vials, basins with fluids, etc. being in a position that someone could inadvertently use the wrong item in the midst of a rapidly progressing situation. Clutter (ever looked at an anesthesiologist’s work station!) is often a contributing factor to errors. Add to that the multi-tasking that the anesthesiologist must do and you can see how our systems make this setting so potentially prone to errors.
In fact, medication errors do occur frequently in the OR. In malpractice claims against anesthesiologists, medication errors are considered the most “preventable” and tend to lead to higher payouts than other types of claims.
This month two new valuable resources on medication errors in the OR became available: a medication safety video from the Anesthesia Patient Safety Foundation (APSF 2012) and the 2012 edition of the Perioperative Standards and Recommended Practice from the Association of periOperative Registered Nurses (AORN 2012).
The new AORN standards address medication safety at each of the phases of medication use (procuring, prescribing, transcribing, dispensing, administering, monitoring, and disposal). They really focus on a multidisciplinary approach and note that monitoring compliance with medication safety practices is critical, yet seldom done in a rigorous fashion in most OR’s,
One of their key new recommendations is not to use multidose vials. While most facilities use multidose vials, primarily as a cost-saving measure, they give rise to two problems. First, they introduce the risk of cross-contamination. Second, they increase the risk that a patient may be given too much of a medication. Another recommendation that has caused some controversy is to puncture intravenous solution containers as close to time of use as possible. In some OR’s, to improve efficiency, multiple medications and solutions that are expected to be used are prepared in advance. While that may improve efficiency the tradeoff is on the safety side (see our September 15, 2009 Patient Safety Tip of the Week “ETTO’s: Efficiency-Thoroughness Trade-Offs”). They also stress the importance of maintaining sterility. That is important not only when transferring newly prepared medications to the sterile field but also when one syringe might be used for incremental injections. Another key recommendation is to include a pharmacist in perioperative medication management, if not physically during actual cases at least being involved in the planning and oversight of OR medication safety programs.
The APSF medication safety video (APSF 2012) is about 15 minutes long and includes some clips you may have previously seen in ISMP videos highlighting testimonials from some providers at the “sharp end” of unfortunate medication incidents in the OR. It is largely based on “STPC” paradigm published in their Spring 2010 Newsletter (APSF 2010). STPC stands for:
The video begins with the oft-quoted statistic that a significant medication error will occur in one of every 133 cases where anesthesia is administered and that 4% of closed malpractice claims for anesthesiologists involve medication errors. It points out many of the high-risk drugs used in the OR. That includes not only the “usual suspects” we see in other parts of the hospital (eg. opiates, anticoagulants, insulin, benzodiazepines) but also drugs more unique to the OR such as neuromuscular blocking agents (NMBA’s) and epinephrine or vasopressors. They point out a variety of the common errors in the OR, including syringe swaps, labeling errors, substitution errors, and injection into wrong ports. A full quarter of the errors involved in the claims involve substituting the wrong drug for an intended drug (eg. giving a NMBA instead of epinephrine or vice versa) and almost a third are due to giving incorrect doses.
Recurrent themes in OR cases with medication errors are lack of standardization and lack of protocols in the setting of production pressures and other distractions. Drug labeling errors and syringe swaps are often implicated as causes of OR medication errors.
The video highlights the importance of labeling all medications and syringes and reading those labels before administering the drugs. They also talk about making drug labels distinctive. They mention color-coding of labels to help recognition of high-alert drugs (though this remains somewhat controversial where statewide or national standards for color-coding have not been established). But they note that APSF says this is not enough and has failed to prevent medication errors so more is needed.
Standardization is a fundamental patient safety concept. This applies not only to things like drug dosages and drug concentrations but also to drug preparation, workplace design, equipment models, and clinical protocols. They describe all the Joint Commisssion requirements for appropriate labeling for all drugs and syringes (and don’t forget you need to also label any liquids you put in sterile containers or basins on the sterile field). Having drugs in standardized concentrations prevents someone from inadvertently giving a patient a dose that is 100- or 1000-times higher than the intended dose. That is especially important with high-alert drugs like epinephrine, phenylephrine, heparin, etc. Lots of anesthesiologists like to have “their room” in the OR and not have to switch from room to room. If you standardize the workspace in each room that becomes less a barrier at the same time it helps prevent errors. Admittedly, the medication needs are quite different for cardiac and intracranial cases than, say, for orthopedic cases. So sometimes the “standardized” items need to be standardized by case type. If you don’t have some of the technology safeguards mentioned below, consider requiring verification of high-risk medications by a second person prior to administration. And use “read-back” and “hear-back” to facilitate understanding in all your OR communications.
Pharmacy/Premixed/Prefilled refers not only to having pharmacists involved in your program but also to using premixed solutions and prefilled syringes so that your anesthesiologist is not trying to prepare those things while attending to multiple other things. Let someone else do that preparation, whether it is a pharmacist in an OR satellite pharmacy or pre-packaged drugs and solutions purchased from commercial vendors. As in the AORN resource, they strongly recommend a pharmacist being physically part of the OR but, if that is not feasible, at least being involved in the planning and oversight of OR medication safety programs.
Technology is a key component of patient safety systems in preventing medication errors in most other parts of the hospital and should also be used in the OR. Barcoding (BMV) is a critical component of that but feedback and clinical decision support tools are also important. Ideally, your OR computer systems should be integrated with your hospital electronic health record so that information exchange is facilitated in both directions. Documentation of drug administration on EHR’s theoretically should improve efficiency, though the “clunkiness” of some current user interfaces may actually detract from OR efficiencies. Undoubtedly these will improve in the future. The video optimistically looks to voice recognition technology to help with that efficiency. And use of standardized infusion pumps with standardized drug libraries (“smart pumps”) are used in other parts of the hospital and should be used in the OR and perioperative area as well. Make sure that the pumps and the concentrations of the drugs used are standardized so that these pumps can go with the patient when they go from the PACU to the ICU, etc.
Culture, of course, refers to developing the culture characteristics that are hallmarks of the culture of patient safety. This includes adoption of a “Just Culture” approach, recognition that most bad outcomes typically involve multiple system errors rather just human error, having a non-punitive system for reporting errors and near-misses, and learning from adverse events or near-misses and sharing those lessons learned. In the APSF video, Michael Cohen from ISMP stresses that “good people make errors” and points out that there is usually a cascade of multiple errors or contributing factors in every case where there is a bad outcome. Focusing on fixing systems rather than people leads to more success in safety in any industry (not to mention that systems are easier to fix than people!).
Changing some aspects of “culture” can be difficult, particularly since so many anesthesiologists have prided themselves in their autonomy and independence and abilities to think fast and improvise. So getting them to buy into standardization, use of protocols, checklists, etc. may be met with some resistance. Using the technique of “stories, not statistics” (see our December 2009 What’s New in the Patient Safety World column “Stories, Not Statistics”) may be helpful. The APSF video does include reference to the well-known unfortunate case in which a young boy died after inadvertent injection of concentrated epinephrine. In the consensus conference that led to development of the “STPC” paradigm, multiple speakers provided such real-life examples of errors that led to deaths or other serious outcomes. Those included cases of injection of wrong drugs or injection of drugs into the wrong (eg. epidural) catheters or other injection ports. Using such “stories” or real-life examples, particularly if you can also tell the story from the point of “the second victim” (the provider involved) is a very useful way to get buy-in from not just your anesthesiologists, but every one involved in perioperative care (including administrators and especially CFO’s!).
The APSF video should be part of mandatory training for all your personnel involved in perioperative care. It’s short but to the point and makes a compelling case for the need to change our ways and our culture in the OR. That video and the Spring 2010 APSF Newsletter plus the new AORN standards are very valuable resources to help you ensure medication safety in your OR and perioperative environment. For those of you who happen to be in Canada, ISMP Canada has a collaborative that uses their Operating Room Medication Safety Checklist© (ISMP Canada 2009), another very valuable tool. At least the last time we checked its use is still restricted to the Canadian hospitals participating in the collaborative but we expect it will be further refined and eventually made available to everyone.
If you haven’t yet adopted the recommendations from these resources, we expect that you will soon. But don’t forget the other critical piece: you need to audit and monitor compliance with any of these safety interventions you put in place. Make it part of your Patient Safety Walk Rounds, part of your regular OR Committee agenda and part of your Medication Safety Committee or Patient Safety Committee agenda.
APSF (Anesthesia Patient Safety Foundation). Medication Safety In The Operating Room: Time For A New Paradigm (video). 2012
AORN (Association of periOperative Registered Nurses). Perioperative Standards and Recommended Practice. 2012
APSF (Anesthesia Patient Safety Foundation). APSF Newsletter. Spring 2010
ISMP Canada. Operating Room Medication Safety Checklist©. Version 2. 2009