Intravenous Chemotherapy Compounding Errors in a Follow-Up Pan-Canadian Observational Study.

PURPOSE: Intravenous (IV) compounding safety has garnered recent attention as a result of high-profile incidents, awareness efforts from the safety community, and increasingly stringent practice standards. New research with more-sensitive error detection techniques continues to reinforce that error rates with manual IV compounding are unacceptably high. In 2014, our team published an observational study that described three types of previously unrecognized and potentially catastrophic latent chemotherapy preparation errors in Canadian oncology pharmacies that would otherwise be undetectable. We expand on this research and explore whether additional potential human failures are yet to be addressed by practice standards. METHODS: Field observations were conducted in four cancer center pharmacies in four Canadian provinces from January 2013 to February 2015. Human factors specialists observed and interviewed pharmacy managers, oncology pharmacists, pharmacy technicians, and pharmacy assistants as they carried out their work. Emphasis was on latent errors (potential human failures) that could lead to outcomes such as wrong drug, dose, or diluent. RESULTS: Given the relatively short observational period, no active failures or actual errors were observed. However, 11 latent errors in chemotherapy compounding were identified. In terms of severity, all 11 errors create the potential for a patient to receive the wrong drug or dose, which in the context of cancer care, could lead to death or permanent loss of function. Three of the 11 practices were observed in our previous study, but eight were new. Applicable Canadian and international standards and guidelines do not explicitly address many of the potentially error-prone practices observed. CONCLUSION: We observed a significant degree of risk for error in manual mixing practice. These latent errors may exist in other regions where manual compounding of IV chemotherapy takes place. Continued efforts to advance standards, guidelines, technological innovation, and chemical quality testing are needed.

Effects of Nested Interruptions on Task Resumption: A Laboratory Study With Intensive Care Nurses.

OBJECTIVE: Interruptions to secondary tasks resulting in multiple tasks to resume may tax working memory. The objective of this research is to study such interruptions experienced by intensive care unit (ICU) nurses. BACKGROUND: ICU nurses are frequently interrupted, resulting in a switch from primary to secondary tasks. In two recent studies, we observed that some of these secondary tasks also get interrupted, resulting in multiple tasks that have to be resumed, a phenomenon we refer to as nested interruptions. Although completing multiple secondary tasks in a serial fashion during an interruption period can create context-switching costs, we hypothesize that nested interruptions tax the working memory even more than just performing multiple secondary tasks sequentially because the nurse would have to encode in working memory the resumption goals for both the primary and the interrupted secondary tasks. METHOD: We conducted a laboratory study with 30 ICU nurses, who performed an electronic order-entry task under three interruption conditions: (a) baseline-no secondary task during the interruption period; (2) serial-performance of two tasks one after the other during the interruption period; and (3) nested-performance of two tasks during the interruption period, one of which was also interrupted. RESULTS: Nested interruptions resulted in significantly longer primary-task resumption lag and less accurate task resumption compared with both the serial interruption and baseline conditions. CONCLUSION: The nested nature of interruptions adds to the resumption lag and diminishes resumption accuracy by likely populating the working memory with goals associated with interrupted secondary tasks.

The relationship between interruption content and interrupted task severity in intensive care nursing: an observational study.

BACKGROUND: In a previous study, we observed that the majority of interruptions experienced by nurses in a cardiovascular intensive care unit (CVICU) carried information directly related to their patient or other aspects of work affecting other patients or indirectly affecting their patient. Further, the proportion of interruptions with personal content was significantly higher during low-severity (in case of an error as defined by nurses) tasks compared to medium- and high-severity tasks suggesting that other personnel may have evaluated the criticality of the nurses' tasks before interrupting. However, this earlier study only collected data when an interruption happened and thus could not investigate interruption rate as a function of primary task type and severity while controlling for primary task duration as an exposure variable. OBJECTIVES: We addressed this methodological limitation in a second observational study that was conducted to further study interruptions and also to evaluate an interruption mitigation tool. The data from the baseline condition (i.e., no tool) is analyzed in this paper to validate the results of our previous study and to report interruption rates observed during tasks of varying severities (low, medium, high), with a particular focus on comparing different interruption contents. DESIGN AND SETTING: The study was conducted in a 24-bed closed CVICU at a Canadian hospital, during day shifts. PARTICIPANTS: The baseline condition involved thirteen nurses. METHODS: Over a 3-week period, three researchers observed these nurses 46-120 min each, with an average of 89 min. Data were collected in real time, using a tablet computer and software designed for this purpose. The rate of interruptions with different content was compared across varying task severity levels as defined by CVICU nurses. RESULTS: Nurses spent about 50% of their time conducting medium-severity tasks (e.g., documentation), 35% conducting high-severity tasks (e.g., procedure), and 14% conducting low-severity tasks (e.g., general care). The rate of interruptions with personal content observed during low-severity tasks was 1.97 (95% confidence interval, CI: 1.04, 3.74) and 3.23 (95% CI: 1.51, 6.89) times the rate of interruptions with personal content observed during high- and medium-severity tasks, respectively. CONCLUSIONS: Interrupters might have evaluated task severity before interrupting. Increasing the transparency of the nature and severity of the task being performed may help others further modulate when and how they interrupt a nurse. Overall, rather than try to eliminate all interruptions, mitigation strategies should consider the relevance of interruptions to a task or patient as well as their urgency.

Mitigating nonurgent interruptions during high-severity intensive care unit tasks using a task-severity awareness tool: A quasi-controlled observational study.

PURPOSE: In a previous study of interruptions to intensive care unit (ICU) nurses, we found that other personnel tend to regulate their interruptions based on nurses' tasks. However, nurses' tasks are not always immediately visible to an interrupter. This article evaluates a task-severity awareness tool (TAT) designed for nurses to inform others when they are performing high-severity tasks. When a nurse engages the tool within an ICU room, a "do not disturb please!" message is displayed outside the room. METHODS: Task-severity awareness tool was installed in a cardiovascular ICU room at a Canadian hospital. Fifteen nurses assigned to the TAT room and 13 nurses assigned to 11 other rooms were observed, approximately 2 hours each, over a 3-week period. Data were collected in real time, using a tablet computer. RESULTS: Interruption rate during high-severity tasks in the TAT room was significantly lower than in other rooms; interruptions with personal content were entirely mitigated during high-severity tasks. Furthermore, interruptions from nurses and medical doctors were also entirely mitigated during high-severity tasks but happened more frequently during non-high-severity tasks compared with rooms with no TAT. CONCLUSIONS: Task-severity awareness tool proved to be effective in mitigating unnecessary interruptions to critical tasks. Future research should assess its long-term effectiveness.

The effects of interruptions on oncologists' patient assessment and medication ordering practices.

Interruptions are causal factors in medication errors. Although researchers have assessed the nature and frequency of interruptions during medication administration, there has been little focus on understanding their effects during medication ordering. The goal of this research was to examine the nature, frequency, and impact of interruptions on oncologists' ordering practices. Direct observations were conducted at a Canadian cancer treatment facility to (1) document the nature, frequency, and timing of interruptions during medication ordering, and (2) quantify the use of coping mechanisms by oncologists. On average, oncologists were interrupted 17 % of their time, and were frequently interrupted during safety-critical stages of medication ordering. When confronted with interruptions, oncologists engaged/multitasked more often than resorting to deferring/blocking. While some interruptions are necessary forms of communication, efforts must be made to reduce unnecessary interruptions during safety-critical tasks, and to develop interventions that increase oncologists' resiliency to inevitable interruptions.

Implementation and optimization of smart infusion systems: are we reaping the safety benefits?

To address the high incidence of infusion errors, manufacturers have replaced the development of standard infusion pumps with smart pump systems. The implementation and ongoing optimization processes for smart pumps are more complex, as they require larger coordinated efforts with stakeholders throughout the medication process. If improper implementation/optimization processes are followed, hospitals invest in this technology while extracting minimal benefit. We assessed the processes hospitals employed when migrating from standard to smart infusion systems, and the extent to which they leveraged their investments from both a systems and resource perspective. Twenty-nine hospitals in Ontario, Canada, were surveyed that had either implemented smart pump systems or were in the process of implementing, representing a response rate of 69%. Results demonstrated that hospitals purchased smart pumps for reasons other than safety, did not involve a multidisciplinary team during implementation, made little effort to standardize drug concentrations or develop drug libraries and dosing limits, seldom monitored how nurses use the pumps, and failed to ensure wireless connectivity to upgrade protocols and download use data. Consequently, they are failing to realize the safety benefits these systems can provide.

Optimizing the design of preprinted orders for ambulatory chemotherapy: combining oncology, human factors, and graphic design.

PURPOSE: To establish a set of guidelines for developing ambulatory chemotherapy preprinted orders. METHODS: Multiple methods were used to develop the preprinted order guidelines. These included (A) a comprehensive literature review and an environmental scan; (B) analyses of field study observations and incident reports; (C) critical review of evidence from the literature and the field study observation analyses; (D) review of the draft guidelines by a clinical advisory group; and (E) collaboration with graphic designers to develop sample preprinted orders, refine the design guidelines, and format the resulting content. RESULTS: The Guidelines for Developing Ambulatory Chemotherapy Preprinted Orders, which consist of guidance on the design process, content, and graphic design elements of ambulatory chemotherapy preprinted orders, have been established. CONCLUSION: Health care is a safety critical, dynamic, and complex sociotechnical system. Identifying safety risks in such a system and effectively addressing them often require the expertise of multiple disciplines. This study illustrates how human factors professionals, clinicians, and designers can leverage each other's expertise to uncover commonly overlooked patient safety hazards and to provide health care professionals with innovative, practical, and user-centered tools to minimize those hazards.

Order sets in health care: a systematic review of their effects.

OBJECTIVES: Order sets are widely used in hospitals to enter diagnosis and treatment orders. To determine the effectiveness of order sets in improving guideline adherence, treatment outcomes, processes of care, efficiency, and cost, we conducted a systematic review of the literature. METHODS: A comprehensive literature search was performed in various databases for studies published between January 1, 1990, and April 18, 2009. A total of eighteen studies met inclusion criteria. No randomized controlled trials were found. RESULTS: Outcomes of the included studies were summarized qualitatively due to variations in study population, intervention type, and outcome measures. There were no important inconsistencies between the results reported by studies involving different types of order sets. While the studies generally suggested positive outcomes, they were typically of low quality, with simple before-after designs and other methodological limitations. CONCLUSIONS: The benefits of order sets remain eminently plausible, but given the paucity of high quality evidence, further investigations to formally evaluate the effectiveness of order sets would be highly valuable.

Applying usability heuristics to radiotherapy systems.

BACKGROUND AND PURPOSE: Heuristic evaluations have been used to evaluate safety of medical devices by identifying and assessing usability issues. Since radiotherapy treatment delivery systems often consist of multiple complex user-interfaces, a heuristic evaluation was conducted to assess the potential safety issues of such a system. MATERIAL AND METHODS: A heuristic evaluation was conducted to evaluate the treatment delivery system at Princess Margaret Hospital (Toronto, Canada). Two independent evaluators identified usability issues with the user-interfaces and rated the severity of each issue. RESULTS: The evaluators identified 75 usability issues in total. Eighteen of them were rated as high severity, indicating the potential to have a major impact on patient safety. A majority of issues were found on the record and verify system, and many were associated with the patient setup process. While the hospital has processes in place to ensure patient safety, recommendations were developed to further mitigate the risks of potential consequences. CONCLUSIONS: Heuristic evaluation is an efficient and inexpensive method that can be successfully applied to radiotherapy delivery systems to identify usability issues and improve patient safety. Although this study was conducted only at one site, the findings may have broad implications for the design of these systems.

Usability evaluation of order sets in a computerised provider order entry system.

BACKGROUND: Computerised provider order entry (CPOE) is an important patient safety intervention that has encountered significant barriers to implementation. The usability of a CPOE system plays a significant role in its acceptance. The authors conducted a heuristic evaluation of a CPOE order set system to uncover existing usability issues prior to implementation. METHODS: A heuristic evaluation methodology was used to evaluate the usability of a CPOE test order set system. There are 10 heuristic principles, such as error prevention, to help users identify and recover from errors. Evaluators included a staff physician with extensive clinical experience, and three engineers with expertise in heuristic evaluation methodology. The results of the heuristic evaluation were used to create a user centred design prototype. RESULTS: 92 unique heuristic violations were found for the CPOE test order set system, including 35 identified by the clinician and at least one engineer, and 57 of the 92 violations (62%) found only by the clinician. All evaluators identified at least one violation of each of the 10 usability heuristics in their analysis of the CPOE system. A user centred design prototype was created to demonstrate changes that could improve usability. INTERPRETATION: The CPOE test order set system had many usability heuristic violations. Many violations were found by a clinician with knowledge of the heuristic evaluation process. Implementation of the CPOE system was deferred and a new user centred design prototype was developed for future study. The authors recommend conducting heuristic evaluations early in the process of designing, selecting and implementing CPOE systems.

Does user-centred design affect the efficiency, usability and safety of CPOE order sets?

BACKGROUND: Application of user-centred design principles to Computerized provider order entry (CPOE) systems may improve task efficiency, usability or safety, but there is limited evaluative research of its impact on CPOE systems. OBJECTIVE: We evaluated the task efficiency, usability, and safety of three order set formats: our hospital's planned CPOE order sets (CPOE Test), computer order sets based on user-centred design principles (User Centred Design), and existing pre-printed paper order sets (Paper). PARTICIPANTS: 27 staff physicians, residents and medical students. SETTING: Sunnybrook Health Sciences Centre, an academic hospital in Toronto, Canada. Methods Participants completed four simulated order set tasks with three order set formats (two CPOE Test tasks, one User Centred Design, and one Paper). Order of presentation of order set formats and tasks was randomized. Users received individual training for the CPOE Test format only. MAIN MEASURES: Completion time (efficiency), requests for assistance (usability), and errors in the submitted orders (safety). RESULTS: 27 study participants completed 108 order sets. Mean task times were: User Centred Design format 273 s, Paper format 293 s (p=0.73 compared to UCD format), and CPOE Test format 637 s (p<0.0001 compared to UCD format). Users requested assistance in 31% of the CPOE Test format tasks, whereas no assistance was needed for the other formats (p<0.01). There were no significant differences in number of errors between formats. CONCLUSIONS: The User Centred Design format was more efficient and usable than the CPOE Test format even though training was provided for the latter. We conclude that application of user-centred design principles can enhance task efficiency and usability, increasing the likelihood of successful implementation.

The use of human factors methods to identify and mitigate safety issues in radiation therapy.

BACKGROUND AND PURPOSE: New radiation therapy technologies can enhance the quality of treatment and reduce error. However, the treatment process has become more complex, and radiation dose is not always delivered as intended. Using human factors methods, a radiotherapy treatment delivery process was evaluated, and a redesign was undertaken to determine the effect on system safety. MATERIAL AND METHODS: An ethnographic field study and workflow analysis was conducted to identify human factors issues of the treatment delivery process. To address specific issues, components of the user interface were redesigned through a user-centered approach. Sixteen radiation therapy students were then used to experimentally evaluate the redesigned system through a usability test to determine the effectiveness in mitigating use errors. RESULTS: According to findings from the usability test, the redesigned system successfully reduced the error rates of two common errors (p<.04 and p<.01). It also improved the mean task completion time by 5.5% (p<.02) and achieved a higher level of user satisfaction. CONCLUSIONS: These findings demonstrated the importance and benefits of applying human factors methods in the design of radiation therapy systems. Many other opportunities still exist to improve patient safety in this area using human factors methods.

Patient perceptions of remote monitoring for nocturnal home hemodialysis.

Adoption of nocturnal home hemodialysis (NHHD) has been slow, due in part to patient-perceived barriers, such as anxiety and lack of self-efficacy. This study investigates patient perception of remote monitoring in addressing these barriers. Perceptions of remote patient monitoring (RPM) were studied through a quantitative survey and qualitative interviews. The NHHD and conventional hemodialysis (CHD) were included in the survey (209 in total). Twenty semistructured interviews were conducted as well as a focus group that included NHHD patients and family caregivers. The CHD patients had greater interest in adopting NHHD with RPM than without (1.90±1.37 vs. 1.71±1.28, P<0.002), with the negative intensity ratio declining from 10.50 to 5.56. Interest in RPM was correlated with interest in NHHD (r=0.768, P<0.001). Other significant factors correlated with interest in NHHD include the belief that remote monitoring will ease the performing of NHHD (r=0.452, P=0.001) and the belief that RPM should be mandatory (r=0.541, P=0.000). Qualitative findings supported three themes: (1) There is an expectation for the use of RPM, (2) RPM should be used at a minimum transitionally, and (3) RPM acts as a surrogate support of family-caregivers. The RPM may lower perceived barriers to the adoption of NHHD, in part through its surrogate support of family caregivers. However, RPM alone is likely insufficient to alter patients' attitudes to undergo NHHD. RPM is a common expectation of CHD patients considering the therapy, at a minimum during the transitional phase.

Checking it twice: an evaluation of checklists for detecting medication errors at the bedside using a chemotherapy model.

OBJECTIVE: To determine what components of a checklist contribute to effective detection of medication errors at the bedside. DESIGN: High-fidelity simulation study of outpatient chemotherapy administration. SETTING: Usability laboratory. PARTICIPANTS: Nurses from an outpatient chemotherapy unit, who used two different checklists to identify four categories of medication administration errors. MAIN OUTCOME MEASURES: Rates of specified types of errors related to medication administration. RESULTS: As few as 0% and as many as 90% of each type of error were detected. Error detection varied as a function of error type and checklist used. Specific step-by-step instructions were more effective than abstract general reminders in helping nurses to detect errors. Adding a specific instruction to check the patient's identification improved error detection in this category by 65 percentage points. Matching the sequence of items on the checklist with nurses' workflow had a positive impact on the ease of use and efficiency of the checklist. CONCLUSIONS: Checklists designed with explicit step-by-step instructions are useful for detecting specific errors when a care provider is required to perform a long series of mechanistic tasks under a high cognitive load. Further research is needed to determine how best to assist clinicians in switching between mechanistic tasks and abstract clinical problem solving.

Human factors perspectives on a systemic approach to ensuring a safer medication delivery process.

The current, prevailing approach to addressing medication delivery safety issues has been to apply solutions at the point of failure with direct, local remediation. These include computerized physician order entry to address transcription and prescribing problems, tall man lettering for label clarity and smart pump systems to address programming use errors. We discuss the lack of a systemic, holistic approach to addressing medication delivery issues that has led to fragmented solutions that do not address the problem as intended and introduce new, unintended patient safety issues. We use recent case studies in addition to our own experimental data from human factors investigations to show how a comprehensive human factors approach can be applied to address systemic error in medication delivery. Only by identifying how (1) subsystems interconnect, (2) information flows, (3) care providers communicate and (4) users are impacted will healthcare organizations and system vendors be able to fully address error in medication delivery. Much of what is required from organizations is to transcend the organizational boundaries of medicine, pharmacy and nursing to produce a delivery system that ensures an integrated approach that addresses all stakeholders' needs.

The user-centered approach in the development of a complex hospital-at-home intervention.

We discuss the development of a comprehensive remote patient monitoring system that facilitates the self-care of patients undergoing nocturnal home hemodialysis (NHHD), a complex hospital-at-home therapy. The use of a continuous, iterative approach with user involvement for the validation of assumptions can avoid situations where the system serves a patient poorly. An ethnographic analysis was used to determine specific design principles, which were reviewed with the patients prior to development of the system. Iterative designs were tested through usability testing and further validation was done with a member-checking exercise. Patients expressed concern about the physical obtrusiveness of monitoring which, consequently, led to a lack of adherence. The need for monitoring the integrity of the bloodlines was identified as important because one of the most significant fears among patients was potential blood loss. Patients expressed a need for immediate human intervention in response to an alert. The use of ethnography, usability testing, and member-checking methods in a user-centered approach to design can result in systems that better meet the needs of the patients and caregivers alike.

Patient-perceived barriers to the adoption of nocturnal home hemodialysis.

BACKGROUND AND OBJECTIVES: Nocturnal home hemodialysis (NHHD) has been shown to improve clinical outcomes, although adoption has been limited. Given the known benefits, an understanding of the barriers to adoption is needed. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Patient-perceived barriers were studied through a cross-sectional survey of prevalent hemodialysis patients using validated instruments, study-specific questions, and ethnographic interviews. Fifty-six of 66 NHHD patients and 153 of 199 conventional hemodialysis (CHD) patients were included in the survey. Twenty interviews were conducted with NHHD, CHD, and predialysis patients. RESULTS: Compared with CHD patients, NHHD patients had higher perceived physical health scores (Short Form 12 [SF-12]: 41.47 +/- 10.9 versus 34.73 +/- 10.6, P < 0.0001), but had similar mental health scores (47.30 +/- 11.1[NHHD] versus 45.27 +/- 11.3[CHD]), P = 0.25). Despite having similar measures of education and perceived social support as NHHD patients, CHD patients had a low interest (1.68 [out of 5] +/- 1.26) in adopting NHHD. The major barriers perceived by CHD patients were lack of self-efficacy in performing the therapy, lack of confidence in self-cannulation, and length of time on current therapy. Similar themes emerged from the qualitative analysis as well as: burden on family members and fear of a catastrophic event. CONCLUSIONS: Patient-perceived barriers are primarily fears of self-cannulation, a catastrophic event, and the burden on family. These findings should form the basis of screening patients for interest in NHHD and serve to mitigate these concerns.

A mobile phone based remote patient monitoring system for chronic disease management.

Rising concern over the poor state of chronic disease management led to the user-informed design and development of a home tele-monitoring system. Focus groups with patients and primary care providers guided the research team towards a design that would accommodate the workflow and concerns of the healthcare providers and the low use and comfort with technology found among the patient population. The system was trialed in a before-and-after pilot study of 34 patients with diabetes and hypertension. Findings demonstrate a significant improvement in systolic and diastolic blood pressure. An RCT beginning in 2007 is being conducted to confirm these findings. It is hypothesized that this user-centred approach, utilizing focus groups, iterative design and human factors methods of evaluation, will lead to the next-generation of home tele-monitoring applications that are more intuitive, less cumbersome, and ultimately bring about greater patient compliance and better physician management.

Electromagnetic interference in critical care.

Mobile communication and wireless data transmission are playing an increasing role in health care. Reports describing medical device malfunction related to cellular phones have raised awareness about the problem of electromagnetic interference. Although initial institutional responses were to ban cellular devices in hospitals, these restrictions are relaxing as the knowledge base in this area expands. Medical device malfunction is extremely rare if the distance from the transmitting device is greater than 1 m. This article reviews the current understanding of electromagnetic interference as it applies to the technology-rich critical care environment.

Image quality assurance of soft copy display systems.

Image quality assurance has traditionally been a high priority in medical imaging departments. Recently, it has often been neglected with the transition from hard copy (film) to soft copy (computer) display systems, which could potentially result in difficulty in reading images or even misdiagnosis. This transition therefore requires careful management such that comparable image quality is achieved at a minimum. It is particularly difficult to maintain appropriate image quality in the clinical settings outside of medical imaging departments because of the volume of display systems and the financial restraints that prohibit the widespread use of dedicated computers and high-quality monitors. In this study, a protocol to test and calibrate display systems was developed and validated by using an inexpensive calibration tool. Using this protocol, monitors were identified in a hospital in which image quality was found to be inadequate for medical image viewing. It was also found that most monitors could achieve a substantial increase in image quality after calibration. For example, the 0 and 5% luminance difference was discernable on 30% of the piloted display systems before calibration, but it was discernable on 100% post calibration. In addition, about 50% of the piloted display systems did not have the maximum luminance (white level) suitably set, and 35% of them did not have the minimum luminance (dark level) suitably set. The results indicate that medical display systems must be carefully selected and strictly monitored, maintained, and calibrated to ensure adequate image quality.