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The authors develop a typology of clinicians' workarounds when using barcoded medication administration (BCMA) systems. Authors then identify the causes and possible consequences of each workaround. The BCMAs usually consist of handheld devices for scanning machine-readable barcodes on patients and medications. They also interface with electronic medication administration records. Ideally, BCMAs help confirm the five “rights” of medication administration: right patient, drug, dose, route, and time. While BCMAs are reported to reduce medication administration errors—the least likely medication error to be intercepted— these claims have not been clearly demonstrated. The authors studied BCMA use at five hospitals by: (1) observing and shadowing nurses using BCMAs at two hospitals, (2) interviewing staff and hospital leaders at five hospitals, (3) participating in BCMA staff meetings, (4) participating in one hospital's failure-mode-and-effects analyses, (5) analyzing BCMA override log data. The authors identified 15 types of workarounds, including, for example, affixing patient identification barcodes to computer carts, scanners, doorjambs, or nurses' belt rings; carrying several patients' prescanned medications on carts. The authors identified 31 types of causes of workarounds, such as unreadable medication barcodes (crinkled, smudged, torn, missing, covered by another label); malfunctioning scanners; unreadable or missing patient identification wristbands (chewed, soaked, missing); nonbarcoded medications; failing batteries; uncertain wireless connectivity; emergencies. The authors found nurses overrode BCMA alerts for 4.2% of patients charted and for 10.3% of medications charted. Possible consequences of the workarounds include wrong administration of medications, wrong doses, wrong times, and wrong formulations. Shortcomings in BCMAs' design, implementation, and workflow integration encourage workarounds. Integrating BCMAs within real-world clinical workflows requires attention to in situ use to ensure safety features' correct use.
The authors herein identify and examine clinicians' workarounds when using barcoded medication administration (BCMA) systems. We then develop a typology of workarounds, their causes, and the implications of workarounds to BCMA processes. We also endeavor to document workflows, procedures, and system designs that likely engender workarounds and the medication errors potentially facilitated by them. We delineate the causes of these adaptations, and present staff's explanations for their actions. Finally, building on these findings, we suggest methods to systematically find, examine, and correct BCMA work and design processes that engender workarounds.
The Institute of Medicine (IOM) estimates that, on average, a hospitalized patient is subject to one medication administration error per day, and deems medication administration error a priority for patient safety intervention. 1 In hospitals, the medication administration stage accounts for 26% to 32% of adult patient medication errors 2,3 and 4% to 60% of pediatric patient medication errors. 4 Errors in this latter stage of the medication process are far less likely to be intercepted and far more likely to reach patients than in any previous stage. 2,3,5 It is because medication administration errors are so prevalent, so seldom intercepted, and so final that BCMAs have been strongly recommended for all hospitals. 1,6,7
There is evidence that BCMA systems can reduce pharmacy dispensing errors, 8 and there are reports that BCMA systems can reduce administration errors, 9-11 although the latter claims have not been clearly demonstrated. 1 What has been demonstrated is that some users deviate from written BCMA-use protocols. 12-15 These deviations, called violations or workarounds, are staff actions that do not follow explicit or implicit rules, assumptions, workflow regulations, or intentions of system designers. 16 They are nonstandard procedures typically used because of deficiencies in system or workflow design. 17 Although several BCMA workarounds have been documented, no systematic evaluation of BCMA workarounds' causes and possible outcomes has been previously reported.
The BCMAs are designed to enhance patient safety by: (1) integrating the patient's medication administration record (MAR) with the medication administration process; (2) confirming the five “rights” of medication administration: right patient, drug, dose, route, and time; and (3) helping to ensure that users, most often nurses, follow medication use and equipment use protocols.
The authors could not identify any preexisting comprehensive lists of BCMA workarounds, perhaps because so much of the literature has focused on BCMA's many and important advantages, and perhaps because of the complexity of studying the entwined processes of workarounds' causes and often sub-rosa characteristics, BCMA's evolving status (with evolving work rules), and BCMA's intricate linkages with other information technologies (ITs) (e.g., computerized physician order entry, MARs, and pharmacy IT systems and databases). As a result, this research required a multidisciplinary approach with on-the-floor observations; careful interviews conducted in situ or through detailed discussion to interpret actions taken; and analysis of BCMA-related failures. Last, because all of these elements are related to the sensitive issues of medication errors and personal actions, they are difficult to uncover via a single research approach.
We conducted a mixed-method study of BCMA use at a 470-bed Midwestern academic tertiary-care hospital and a four-hospital, 929-bed East Coast health care system during 2003 to 2006.
Individually, we were studying BCMA use at our respective institutions or study sites (TW and B-TK: Midwest hospital; JLT: four suburban East Coast hospitals.) Upon discussing our analyses, we discovered we had been witnessing aspects of the same phenomenon: BCMA workarounds. Building on our separate research work, we combined five methods into a triangulated research effort to generate the initial workaround categories and the list of probable causes of workarounds: (1) observation of BCMA use and shadowing of staff administering medication, (2) interviews with staff and with hospital leaders involved in medication administration, (3) researcher participation in staff meetings about BCMA use, (4) a failure modes and effects analysis (FMEA) of BCMA use, and (5) analysis of BCMA override log data reflecting over 300,000 medication administrations and indicating each drug, dose, patient, and reason for overrides. (e.g., medication barcode is torn and thus unreadable by the scanner, or pharmacy sent two 20-mg tablets but the scanner will accept only one 40-mg tablet barcode).
The integration of the five methods proceeded as follows. First, observations were used to watch the BCMA work sequence leading to each workaround. Staff comments sometimes cued observers to workaround causes. Second, because the BCMA system requires the user to explain each override in a text box or pull-down menu on the BCMA's computer, the user records the perceived causes and his or her actions. These entries provided explanations that were not verbalized or seen in the observations. The other three methods—committee meetings to discuss BCMA use and override data, interviews with users to capture information not necessarily evident from the observations and BCMA data logs, and data from the FMEA about BCMA use—provided discussions and insights about workarounds by persons knowledgeable about the technology and work processes. Each of the five methods alone would provide only a subset of workarounds and causes. By using all methods and a grounded theory approach, each possible category was iteratively expanded, reduced, or eliminated. The methods and strategies are discussed in detail herein, and are reflected in .
After collecting and examining all available occurrences of apparent workarounds from each of the respective data sources, we reached an agreed-upon definition of each workaround. We examined hospital policies to ensure the occurrences were workarounds. Then we re-examined each workaround and its sources in an iterative fashion; combining the data into an overall final list of workaround types. The iterative and multiple methods helped validate each category. 20-22 When possible, subsequent interviews and our participation in meetings for FMEA, morbidity and mortality conferences, and BCMA implementation also helped validate the candidate workarounds and their causes. Only workarounds and their causes that were actually observed, reported, or documented are included in this analysis. Workaround causes were classified according to the work system model for Systems Engineering in Patient Safety (SEIPS). 23 Potential patient safety consequences of workarounds were determined by the researchers using the five rights of medication administration and associated FMEA findings.
We analyzed 307,698 medication administrations, of which 274,550 (89.2%) generated no alerts or alerts leading to cancellation or changing the medication. Of the remaining 33,148 alerts that were overridden, 1,376 were excluded from this analysis because the override reasons were ambiguous, or because of back-charting of medication administration, or documentation alerts. Thus there were 31,772 medication administration overrides that had listed reasons for being overridden that we could code as to cause of the override. Taking 31,772 as a percentage of the total administered and documented medication administrations equals 10.3%. In other words, 10.3% of all documented BCMA medication administrations were overridden.
We analyzed 142,203 instances of one or more medications administered to patients. Of those, there were no alerts or alerts leading to cancellation or changing the patient 135,328 times (95.2%). Of the remaining 3,785 alerts that were overridden, 837 were excluded from this analysis because the override reasons were ambiguous or for back-charting of medication administration. Thus there were 6,035 overrides that had reasons we could code as to the cause of the patient override. Taking 6,035 as a percentage of the total patient medication administrations equals overrides of 4.2% of administrations to patients.
This study was approved by each researcher's facility's internal review board. The BCMA vendors made hardware and software modifications in response to some of our reported findings, but no researcher was paid by them and no researcher has financial arrangements with BCMA companies.
The BCMAs usually consist of tethered or wireless handheld devices for scanning machine-readable barcodes on patients and medications, and are interfaced with electronic medication administration records (eMARs) displayed on handheld devices or computers on carts (computers-on-wheels, COWs).
BCMAs require that users: (1) scan their ID badges to access BCMAs, (2) obtain medications from supply areas, (3) check medication labels against the BCMA eMAR—a part of most BCMA systems, (4) scan medication barcodes, (5) scan the patient's ID wristband barcode, (6) administer medications, and (7) document (chart) medication administration. 12 If BCMAs detect mismatches between patient and medication or medication and medication order, audible and/or visual alerts are triggered. In response to alerts, users either change their actions (e.g., find correct patient or medications), or override alerts and document their reasons for overriding the alerts (e.g., “Gave 1/2 20-mg tab that was sent [by pharmacy] for a 10-mg order”). Similarly, if patients or medication barcodes cannot be scanned because of missing barcodes or scanning failures, users can override the scanning function to administer medications. Every BCMA alert, override, and medication administration is logged in a central computer database. In some hospitals, visual double-checks by another provider are documented for high-risk medications; in many hospitals physicians also use BCMAs to review eMARs.
The BCMAs studied were Siemens Medication Administration Check using medication Admin Check version 23.4.1, InfoLogix SL series wheeled two- and four-drawer medication carts with UL2601 300-W 28-amp medical batteries, 17-inch computer monitors, and wireless HHP ImageTeam Linear scanners (implementation 6/2004–6/2005) and McKesson Corporation Horizon Admin-Rx version 4.8 point-of-care barcoding system using handheld devices to scan and display eMARs (implementation 12/2001–9/2004; upgraded to version 6.3.2 in 8/2004; upgraded to version 6.6.2 in 11/2006.) Siemens and McKesson comprise approximately 30% of the nongovernmental market of hospital BCMAs (Kelly J, Entropy Research, personal communication, February 14, 2007).
We identify 15 types of BCMA-related workarounds and 31 separate probable causes of the identified workarounds. We then present the relationships among workarounds, probable causes, and potential errors as a result of workaround occurrence.
We found 15 workaround types, which we placed into three broad categories (). We also indicated 6 types of linked potential errors with each workaround. The three workaround categories are as follows.
This category reflects workarounds in which a typical process step is omitted, for example, failure to scan medication or patient ID barcodes, failure to review BCMA system computer screens or alerts, or failure to perform visual checks of medications and the eMAR.
The workaround may manifest itself in many different manners. To avoid scanning the patient's actual ID wristband, users were found to affix extra copies of patient ID barcodes on desks, scanner carts, doorjambs, supply closets, or clipboards, or to wear extra copies themselves on belt loops or their own arms. Other examples are scanning one medication barcode twice when administering two doses on the (possibly false) assumption that tablets or vials are identical, or scanning barcodes from discarded medication packaging. Medications also are not scanned when barcodes are missing or damaged (crinkled, blurred, covered by another label reminding them to scan the label, or torn).
This workaround group denotes documenting medications as administered before actually administering the medication or observing patient ingestion or administering medications and documenting it much later.
This category describes workarounds that change how a process step is performed or that add new steps. Disabling audio alarms on BCMA devices that signal alerts or separating the scanning device from the COW are workarounds that preclude alerts from being heard or seen, thus disabling the technology's safety features.
lists the categories of workarounds' probable causes and defines and illustrates each cause. The last column lists data sources and any supportive data from the BCMA override logs. The probable cause categories are as follows.
These include problems with BCMA software or hardware as they are used in practice, e.g., failing batteries of handheld scanners or linked computers, difficult-to-read or navigate screens, and alert beeps that sound like confirmation beeps. In addition to hardware and software limitations, these reasons include both negative and positive perceptions of the technology, i.e., resistance to BCMA use (negative), or overreliance on BCMA's ability to catch all errors (positive).
These include aspects of BCMA protocols with which users are unfamiliar or believed slow performance, e.g., nurses speed their work and circumvent BCMA protections by carrying several patients' medications on one tray or by not scanning medication IDs or patient IDs. Staff may also believe circumstances justify circumventing BCMAs, e.g., giving emergency medications. In other instances, they administer medications without scanning, discard the packaging, and retroactively chart (back-chart), precluding any mismatch alert.
These are linked with most of our identified workarounds, and generally involve organizational policies incompatible with safety. Examples of these include patients or medications without barcodes (due to organizational or workflow flaws), medication barcodes covered by a label reminding users to scan barcodes, and pharmacies sending only partial doses. Hospital policy may not fit with BCMA procedures, e.g., barcodes should be placed on home-brought medications but are not. Workarounds are also enabled by inadequate technology-use training, inadequate staffing, and staff misunderstanding of BCMA's role in patient safety.
These comprise staff decisions regarding patients' special circumstances, e.g., patients refusing medications, vomiting medications, sleeping, agitated, receiving central lines, or in contact isolation. Staff may therefore not scan patient IDs or document administrations before medications are ingested. For hospitals permitting home-brought medications, these medications are often not barcoded and scanned.
These result from the hospital's physical structure and from locations of persons, medications, and related technologies, e.g., some hospital areas lack wireless BCMA connectivity (operating rooms, laboratories). Some doorways and patient room configurations hinder bedside access of the BCMA COWs. Also, medications stored remote from the scanner (e.g., those that require refrigeration) necessitate multiple trips to scan, dispense, and return. Loud ambient noise in rooms or hallways may prevent nurses from hearing scanner warning alarms.
In , we show the relationships among workarounds, their probable causes, and the potential medication errors associated with each workaround. In the table, checked cells indicate which causes are associated with which workarounds; the row beneath the workarounds reflects the errors that may result from workarounds.
Although some causes might generate errors directly (e.g., loud ambient noise obscuring BCMA alarms, resulting in an administration error), our listed causes generally lead to workarounds, and those workarounds subsequently increase risks of errors.
Key to the impact and persistence of the workarounds is the multiplicity of relationships among causes and workarounds. In other words, workarounds may result from one or more causes and a cause may be associated with multiple workarounds. Organization-related and technology-related causes are associated with all 15 of the identified workarounds. Task-related causes, the smallest grouping, are nevertheless linked to 14 of the 15 workarounds, as most workarounds are a result of time-saving efforts. Patient issues and environmental causes each contribute to seven workarounds.
The structure and organization of clinical hospital work are factors for all 15 workarounds. For example, workarounds 6 and 7 are efforts to administer medications when confronting problematic patient or medication barcodes and/or when scanners fail. Workaround 9, affixing extra copies of patients' ID barcodes to other locations (e.g., nursing stations, clipboards, COWs, supply rooms, doorjambs, bangles around nurses' sleeves) is a time- and effort-saver allowing required computer documentation of medication and patient barcodes without the necessity (or protections) of bedside patient scanning. Not visually inspecting medication lists or medications before scanning (workaround 1) reflects confidence in the technology and saves time but increases wrong-medication and wrong-dose risks.
can be read from several perspectives. Focusing on the probable causes, each of the 31 causes facilitates multiple workarounds, without simple one-to-one cause-and-effect relationships. For example, slow or difficult BCMA procedures (row 13) are associated with 14 workarounds. Medications without readable barcodes (row 18) are associated with only two categories (workarounds 7 and 12), but link to almost all potential error categories—wrong patient, medication, dose, route, and/or time.
Focusing on workarounds, we see that each workaround can result from many causes, e.g., administering medications without scanning them (workaround 7) is linked to 19 of the 31 probable causes, including almost all organizational- and task-related causes, along with many technology-related causes (in addition to risks of wrong medication, dose, and time).
We set out to examine BCMA workarounds and their causes. We found that many workarounds were engendered by difficulties with the technology and by interactions between BCMA technologies and other environmental, technical, work processes, workloads, training, and policies. In doing so, we have documented and categorized types of workarounds during BCMA use. We identified 15 BCMA-related workarounds in three categories: omitted steps, incorrect sequence, and unauthorized steps. We find these workarounds are associated with 31 probable causes, categorized as technology-related, organizational, task-related, patient-related, and environmental. These causes include obvious difficulties in using BCMAs (e.g., unreadable or missing barcodes, large/bulky COWs, medication packages not matching prescribed doses, battery failures) along with staff-perceived limitations of BCMAs and staff overestimation of BCMA's risk-elimination abilities. Many of these causes have never been examined in this context; some are new to the barcode literature, e.g., role of refrigerated medications and distance from patients, hallway-dwelling COWS with noise-obscuring alarms, special BCMA problems of contact isolation and patient refusals.
These data show that as with all health care technologies, 24-29 suboptimal design and implementation of BCMAs can facilitate new medication administration hazards, 13-15,30-32 lead clinicians to deviate from required safe-use protocols, reduce the technology's safety benefits, 12-15 and enhance the probability of medication errors. None of these identified workarounds were malicious, and many were engendered by system design deficiencies. Although individuals are often blamed for circumventing safety rules, these rules might be viewed as inappropriate in some circumstances, e.g., waking patients to scan their IDs to administer intravenous medications. Thus, workarounds perceived as necessary by the user for patient care, efficiency, 33 or safety, 34 may be beneficial, neutral, or dangerous for patients' safety 33,35-37 Some workarounds are clearly intentional tradeoffs, e.g., providing urgently needed medications without taking the time to scan the patient or medication. Therefore, reiterating existing rules or enacting more rules may not reduce workarounds. 38-44 BCMA patient safety is best served by improving system design, workflow integration, and implementation, 27,44-46 especially BCMA-specific impediments. 47-49
Despite these difficulties, our data also suggest that BCMAs offer many valuable benefits. We have presented the number and percent of overrides, but BCMAs have an important role in alerting users to drug–patient mismatches. Unpublished data for 1 year (June 2006–May 2007) from the four East Coast hospitals indicate there were 23,828 BCMA alerts of drug or patient mismatches that apparently led users to change their action instead of overriding an alert, e.g., change the medication or patient. That is nearly four for every 1,000 times a medication was administered or patient identified. Moreover, continuing modifications to BCMAs and to hospital policies reduced several workarounds and addressed some of the software screen issues in our study hospitals. Focused educational efforts based on interim findings helped providers use the equipment more efficiently (see Recommendations section)
Although staff frequently blame the technology, and many problems are indeed due to hardware or software design, a significant source of difficulties is not malfunctioning technology but rather barriers generated by how the technology is designed for and used in organizations, and how staff respond to its use. 29,50,51 Each organization must evaluate its social, technological, and physical contexts when selecting and implementing IT, 52-56 e.g., BCMAs.
These causes (and related workarounds) are neither rare nor secret. They are hiding in plain sight, 50 obscured by faith in technology, clinicians' need to focus on patients, the medical ethos of getting the job done, limited communication among hospitals with similar systems, and dispersed oversight of BCMAs used across many clinical services and units. Persistent workarounds and their causes are reported frequently by hospital staff. Vendors know of many. Workarounds are discussed routinely by committees overseeing BCMA use. They are the focus of educational campaigns and appear in the literature. 12-14
The evolving and encompassing nature of BCMA requires direct observation of technology use, user interviews, realistic review of override data, and proactive process change. All of this information should be applied to make protocol compliance user friendly and intuitive. With rare exceptions, it should be easier to follow policy than work around it. When it is not, stressing the patient safety reasons for the protocol becomes essential, as does continual coaching of staff on protocols (in contrast to punishing for not following).
There are several limitations to our data and to generalizability. Our data undoubtedly do not enumerate all possible workarounds or causes, even though we found similar workarounds and causes across multiple hospital sites. Nurses were aware that they were being observed administering medications using BCMA. This awareness may have affected their behavior. However, the expected change in behavior would have been in favor of their greater compliance with BCMA use protocols, not in the direction of the commission of additional workarounds. Some actions originally considered workarounds may have become institutionalized as “best practices.” Our observations and data would therefore not capture these.
We studied two widely used, state-of-the-art systems, thoroughly integrated into highly regarded hospitals with considerable IT implementation resources. It is therefore likely that other institutions will find additional types of causes, workarounds, and outcomes. Upgraded BCMA versions and differing patient-load profiles will inevitably engender new and potentially unforeseeable workarounds and causes (see Recommendations section). Additionally, there are functions in advanced BCMAs (e.g., daily and lifetime limits, look-alike–sound-alike warnings, drug reconciliation) that we have not examined. These functions might offer additional protections, although we predict they would probably also offer more workaround opportunities.
Some of our causes are unequivocally linked to specific workarounds (medications that are missing barcodes cannot be scanned), and some are less tightly coupled, e.g., confusion caused by multiple barcodes on medication packages does not automatically imply that nurses will seek workarounds (and one of those multiple barcodes is probably correct). We do not infer from our data which probable causes and/or workarounds generate the most or least medication errors, or the severity of errors that may occur. This is not a study of specific errors or patient harm, so we list only types of potential errors that are facilitated by each workaround. Similarly, the override data do not directly reflect workarounds' or causes' frequencies; they are staff explanations for BCMA overrides.
This combination of research methods and data sources does not offer the same level of certainty afforded by randomized clinical trials. But the complexity of the user–machine–patient–environment–policy interface necessitates use of our multimodal and qualitative methods for gaining a deeper understanding of BCMA use in situ.
The research presented here provides an initial but critical step to understanding how BCMA systems are actually used in the challenging reality of hospital practice, why BCMA workarounds are so common, and what hospitals can do to find them and then to address their causes and unintended consequences. Although BCMA systems are intended to advance medication safety, our data reveal that integrating BCMAs within real-world clinical workflows requires critical attention to ensure that technology safety features are used as intended and that systems are designed to support this use. As with any technology in complex organizations, workarounds will occur.
Compliance with patient safety protocols is best achieved by configuring BCMAs for efficient as well as safe patient care. It is not enough to tell staff to “do it right.” Instead, repeated examinations and corrections of BCMAs' actual uses are needed to optimize their role in preventing medication errors. This research provides the groundwork and suggested methods to help health care organizations, clinicians, and BCMA vendors realize their patient safety and efficiency goals.
These issues must all be considered together and not independently.
The authors thank the following for their suggestions and comments on earlier drafts: Pascale Carayon, PhD, Thomas McCarter, MD, Gordon Schiff, MD, Christine Sinsky, MD, Scot Silverstein, MD, Frank Sites, RN, Sara Martin, RN, Edmund Weisberg, MS.
Supported in part by a grant from the Agency for Healthcare Research and Quality (AHRQ), P01 HS11530-01, Improving Patient Safety Through Reduction in Medication Errors (RK), AHRQ Grant 1-UC1 HS014253-01 (TW) and a Clinical Research Scholar Award from the National Institutes of Health (1 K12-RR01764-01) (TW).