A 43-year-old woman was admitted for open reduction and internal fixation of a forearm fracture. She was overweight but otherwise healthy and was not taking any medications prior to admission.
The procedure was staffed by a resident who had been rotating from another specialty for approximately 3 months and was being supervised by a consultant anesthesiologist. The consultant happened to also be working as an intensivist, so after inducing anesthesia and maintaining the patient on inhalational anesthesia, the consultant stepped out to tend to another patient in the intensive care unit (ICU). In the operating room, the patient's heart rate dropped below 50 beats per minute, and the resident asked the anesthesia technician to draw up 0.5 mg of atropine. The technician returned with an unlabeled 2 mL syringe without the original ampule. The resident was reluctant to administer the drug without verifying the product, but the anesthesia technician insisted it was atropine so a double check was not performed.
As the resident injected the drug, the consultant returned to the operating room. Over the next few minutes, the patient's blood pressure skyrocketed to 250/135 mm Hg. The consultant emergently administered labetalol, glycopyrrolate, and high-concentration sevoflurane to antagonize the effect of the drug, which he assumed was some kind of vasoconstrictor.
Upon further investigation, it was discovered that the ampule the technologist used to make the 2 mL syringe actually contained 10 mg of phenylephrine instead of 0.5 mg of atropine. The patient was observed in the ICU overnight and did not experience any lasting harm from the incident.
by Audrey Lyndon, PhD, RN, and Stephanie Lim, MD
Anesthesia as a field has been a leader in patient safety for decades. Advances include practice guidelines, newer and shorter acting medications, new equipment for airway management, development of simulation, and early adoption of high reliability principles and critical resource management. Yet, anesthesia is also uniquely vulnerable to medication errors—in that perioperative medications are typically ordered, prepared, and administered without pharmacist review, computerized decision support, or other systematic checks that are standard in other areas.(1) While perioperative medication errors are believed to be fairly rare, there are relatively few recent studies in this area. Most studies are also either retrospective or rely on self-reporting or incident reporting, mechanisms that tend to grossly underreport errors when compared with prospective observation.(2,3)
A literature review of medication errors in anesthesia from 1950–2012 found the consistent leading factor in anesthetic medication errors to be misreading or failing to check vials and labels.(4) In a more recent prospective study (3) using direct observation of 277 surgeries as well as chart review to identify medication errors, investigators determined that 44% of cases involved at least one medication error or adverse drug event. The medications most frequently involved included propofol, phenylephrine, and fentanyl, and errors occurred most commonly in labeling (24%), wrong dose (23%), and omission or failure to respond (18%).(3) Efforts to decrease perioperative medication errors have focused primarily on standardization strategies for medications, syringes, and work areas, as well as use of technology and cultivating a culture of reporting and learning from errors.(1,4) Organizations that have implemented barcode labeling and other forms of standardization have reduced perioperative medication errors (1,3), but these technologies are not yet widely distributed.
Use of prefilled, manufacturer-labeled syringes and a standardized workspace would have reduced the opportunity for error in this case.(1) However, underappreciated contributors to error in the current case are situational and likely include organizational culture and social pressure. Close analyses of hospital environments have (i) documented variability in the quality of interpersonal relationships (ii); identified negative effects of hierarchy, intimidation, and bullying on raising safety concerns; and (iii) described a tendency toward self-doubt in novel or ambiguous situations.(5-8) In this case, the resident involved was not practicing in their primary area of specialization, was relatively new to the anesthesia environment, and was without the immediate support of the attending. These factors may have encouraged greater timidity in the resident or caused the resident to redefine the situation as a mistake in understanding, as opposed to a clear safety threat.
Studies with surgical and anesthesia residents have shown that a resident's willingness to raise and pursue safety concerns is affected by system, supervisor, trainee, and clinical factors including local culture, perceptions of autonomy and collegiality, trainee personality, and impressions of potential for harm.(5,6) Residents are quite sensitive to hierarchy and unspoken rules.(5,6,9) They may experience a great deal of variability between institutions and attendings regarding expectations for their autonomy and communication styles. Thus, residents are particularly susceptible to the effects of organizational culture and may quickly suppress concerns when met with resistance, as the resident was in this case.
Most research on the effects of hierarchy involves challenging formal authority, such as in the resident–attending physician relationship. However, exposure to strict hierarchies inhibits communication and assertiveness in contexts that extend beyond the resident–attending dyad. A narrative synthesis of studies on challenging authority in the operating room found that intimidation, fear of conflict and reprisal, and concern for longer term impact on relationships with team members are commonly reported barriers to speaking up about safety concerns. The paper concludes that education on communication without attention to changing organizational culture is ineffective.(8) Furthermore, a recent in-depth case study demonstrated that even organizations that are considered leaders in patient safety may have toxic cultures that inhibit communication and assertion of concerns and that exert deep and pervasive pressure to "stay in your box."(10) While it is unclear what the nature of the organizational culture was in this case, the technician committed a clear rule violation by not labeling the medication and resisted the resident questioning the contents of the syringe. Neither behavior is consistent with a strong safety culture nor an environment of mutual support, cross-checking, and acceptance of feedback. The appropriate action would have been to hand the medication vial directly to the resident. Second, one should not resist requests for confirmation.
A final factor in this case was the absence of the attending. This is a common situation, as attending anesthesiologists may cover multiple cases simultaneously and may at times have responsibilities in units that are floors apart. This is again a question of resources, organizational culture, and prioritization. It is important to have procedures in place to ensure that trainees demonstrate competency before leaving them in rooms alone, that the attending is physically accessible for consultation at all times, and that the involved learner or other staff are not too intimidated to ask for help or to question decisions in the operating room. The perioperative "time out" is one place to set this tone with introductions, clear statement of roles, and expression of humility and openness to questions by the attending surgeon and anesthesiologist.
- Improper labeling and misreading of vials remain leading sources of perioperative medication error.
- Prefilled, prelabeled syringes from the manufacturer or pharmacy can reduce perioperative errors.
- Opportunities remain for improved point-of-care technological support for the perioperative medication process.
- Organizational culture has a very strong effect on willingness of health care providers to be assertive about safety concerns, regardless of their role. Educating junior or less powerful staff on how to speak up cannot overcome an organizational culture that allows intimidation or otherwise punishes expression of concern.
- Everyone in the operating room should have a clear understanding of the roles and responsibility of each member of the perioperative team.
Audrey Lyndon, PhD, RN
Professor and Assistant Dean for Clinical Research
NYU Rory Meyers College of Nursing
New York, NY
Stephanie Lim, MD
Assistant Professor of Anesthesia
University of California, San Francisco
San Francisco, CA
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