A dataset of 827 incidents were received from the hospital and included in the analysis. Incidents not concerning direct patient care were then excluded (n=73). (Details of the 827 incidents are given in Additional file 2 and elsewhere (37)). In the analysis of the incidents, the CPOE appeared to be both a mechanism for safety and a contributing factor for incidents.
Twenty interviews were conducted with 19 participants (Table 1). Interviews lasted about 30 minutes.
We integrated results from interviews and incidents analysis and structured these around interdependencies and risks to medication safety, strategies to deal with these risks, and the role of the CPOE for each strategy. We identified quotes from interview transcripts by interview number (idX), but do not provide details on interviewees’ roles to protect their anonymity. We refer to incident reports by their row in the dataset (iX).
Interdependencies and risks to safety with chemotherapy
Work practices related to paediatric chemotherapy treatments were rich in interdependencies. Across interviews and incidents, we identified two interrelated overarching types of interdependencies that characterised chemotherapy prescribing and administration: first, those related to the organisation of clinical activities, in particular the medication workflow involving doctors, nurses and pharmacy staff, and its interplay with a variety of hospital services (e.g. intensive care, pathology, imaging, as well as other hospitals), and second, interdependencies inherent to chemotherapy regimens that dictated combinations of medications and tests. Time dependencies were especially apparent, such as precise time gaps between administration of successive doses.
Both types of interdependencies (organisational and regimen-related) were identified in incident reports and often involved CPOE. For example, an incorrect date in a CPOE prescription and a delay in documentation of the patient being ‘ready for chemotherapy’ (organisational dependency-medication workflow) delayed administration due to the medication requiring pre-medication (a regimen dependency), which further cascaded into requiring monitoring of the patient ‘after hours’, leading to increased risks for the patient and costs to the hospital (organisational dependency).
[...] Patient due rituximab and MTX [methotrexate] today, date for chemotherapy was incorrect and not ‘ready for chemotherapy’ documented [in the CPOE]. This delayed chemotherapy administration until 11am. [...] [medications] will need to be reordered. The first medication requires premedication and the patient is at risk of anaphylaxis with this drug (needs to be given in business hours) and MTX requires blood monitoring levels and if given outside set hours adds significant cost [...] [i150]
Ultra-safe risk strategies applied to chemotherapy processes
Chemotherapy safety risks were reported to be managed through a range of strategies based on the application of rules and multiple safety checks. These appeared more typical of the ultra-safe model of safety (3) than the HRO model.
Specifically, participants spoke of rigid rules regarding who was authorised to prescribe chemotherapy (on CPOE) and the content of medication orders as per chemotherapy protocols. Continuing with a regimen (e.g. progressing to the next cycle) was organised around the principle of withholding treatment until the patient recovers (comparable to ‘Plan A’ in the ultra-safe model).
Participants reported multiple checks during the medication process. In particular, nurses were tasked with checking each dose against the protocol to alert doctors to any discrepancy. This was ‘aninstitution specific practice’ (id16) that was maintained after CPOE implementation, despite the use of pre-set CPOE templates that would (or should) support doctors to produce orders matching the corresponding protocol.
...when I am ordering it [on CPOE], it looks fine to me. [But] The nurses [would] say, “Well, can’t do that because it is out of sequence,” or, “you have pushed this onto that.” [...] Or they will say, “The protocol mandates 120% of this and you are giving 110% or 150%.” And they are just simply saying, “Is this what you want me to do?” ... (id16)
Sometimes the patient’s condition led to clinicians deciding to deviate from the protocol – such as when ‘this child has such a high-risk disease that no matter what I’m going to go ahead’ (id16) despite test results not reaching the threshold indicated by the protocol. This kind of judgement – highly dependent on individual clinical expertise - typically belongs to the ultra-adaptive model of safety. However, in this context – where the doctor had to communicate the decision to the nurses and to other doctors in order to act on it – it is perhaps suggestive of a HRO approach to dealing with risks.
Does CPOE support an ultra-safe model of safety with chemotherapy?
CPOE supported strategies typical of the ultra-safe model through hard and soft mechanisms, namely through automation, access to information and standardisation of the semantics of protocols (disambiguation) (Table 2).
In terms of automation, the CPOE provided clinicians with all required medications pre-built in templates, to reduce the possibility of medications being omitted by mistake, which were also linked with appropriate time dependencies (if doctors delayed one, the others would be automatically delayed for a corresponding period). The CPOE provided automatic dose calculations and warnings based on embedded rules, and ‘exposed’ unreliable patient weight and height data used for dose calculation, by displaying trends and normal ranges.
... you can see patients with a weight here and a height up here [on the CPOE chart] [...] three months for a baby of four kilos you can go to eight kilos, you can change dramatically the dose. [...]. Now, in paper land [...] [doctors] might go six months without checking the height and weight. It happened before, but here it’s exposing it. (id1)
CPOE automation also limited prescribing and administration rights through different users’ profiles; the embedded workflow management system automatically routed the orders to the authorised person. The CPOE paused the workflow proceeding forward to administration until the system had been notified via a checkbox that the patient was ‘ready for chemo’.
However, these CPOE contributions towards an ultra-safe approach to chemotherapy were challenged by the perceived complexity of operating the system (especially when protocol templates were not available in the system to prescribe a patient’s regimen), and difficulties in identifying ‘where the patient is at’ in the protocol.
In terms of ‘soft’ mechanisms, we identified two aspects of CPOE that supported use of ultra-safe risk strategies. All clinicians had access both to patient information and the relevant chemotherapy protocol; previously, paper-based protocols were kept in drawers and not easily accessible across place and time. In addition, the process of converting paper-based protocols into electronic versions brought to the surface previously invisible ambiguities in their rules. To automate these rules, these had to be clarified and uniquely defined so that all clinicians would interpret the protocol in the same way.
HRO strategies - Management of uncertainties and ‘usual hazards’ through adaptation and different time horizons
The application of the principle of withholding treatment until the patient recovers (‘plan A’) meant that planned doses or cycles often needed to be rescheduled. Thus, for any patient there would be uncertainty about when exactly the treatment would be given. This scheduling – or rescheduling - of the treatment must also take into account the constraints posed by the hospital’s resources (organisational interdependencies), for example ‘our general anaesthetic days are Monday and Thursday’ (id16), or over holidays, ‘services aren’t working quite as well’ (id1). The patient and family may also pose constraints on suitable dates – such as wanting to avoid school photo day.
Clinicians reported that it was challenging to plan cycles, tests and doses much in advance. Although the CPOE theoretically allowed clinicians to prescribe a whole regimen in advance, given these uncertainties, interviewees indicated that they would only schedule about a month ahead in practice.
Researcher: the doctors might schedule the entire one year of treatment in advance?
Participant: [...] they probably wouldn’t. [...] we would chart chemotherapy, kind of, a month out, because [children] can grow so much in such a short time, the doses need to change. Other things can happen as well that they may start to not recover as well, so we need to modify the dose, it was too big for them, so we need to back off [...]. (id7)
Doctors therefore made use of time as a risk management strategy (25) to deal with the uncertainties. More specifically, we identified three time horizons used to approach a patient’s chemotherapy regimen – a life-long view, the whole regimen view, and the ‘here and now’. CPOE automation better supported the ‘here and now’ than the longer time views (Table 3). For example, clinicians reported difficulties with finding and collating information to calculate a patient cumulative dose (a life-long view), and with the fragmented electronic display of the whole regimen.
Sensitivity to operations and CPOE
We found that a combination of situation awareness, organisational awareness and CPOE awareness was perceived as essential for safe and efficient CPOE use (Figure 2). Clinicians had to maintain (and act on) situational awareness to understand ‘where is the patient at’ in their specific regimen and with respect to the corresponding protocol. Several interviewees referred to this information need – ‘where patients are up to’ (id1, id5, id7, id8-12). Clinicians also had to maintain (and act on) organisational awareness. For example, they had to act on the system with awareness of self and others ‘down the line’ (Table 4). They had to be aware of CPOE, learning to be watchful of its automated behaviour such as automated recording of times and dates. With use, clinicians learned that, for a variety of reasons, time and dates in the system may not accurately reflect the times when medication activities took place. This had repercussions for regimen time dependencies, which were also encoded in the templates.
...sometimes when [the CPOE] says, it’s the start date, it’s not really been the start date, because it’s been delayed [...]. That stays as the estimated start date [...] when you come to [prescribe], they’re due next week, for example, but if you look at the chemotherapy, [...], they’re due in two weeks. [...] just [automatically] ticks over [...] (id3)
CPOE = Computerized Provider Order Entry system. We refer to Endsley’s definition of situation awareness (38) as “the perception of the elements in the environment within a volume of time and space, the comprehension of their meaning and the projection of their status in the near future”, applied to a patient. With organisation awareness we refer to the understanding of how roles and services fit within the organisational structure, institutional practices and rules, and how to operate within these practices to achieve desired effects. This definition includes individual awareness of local teams and workflows, or of the wider hospital organisation, within or beyond individual’s control. CPOE awareness is knowledge on how the technology works/how to make it work/the effects it produces and acting on this knowledge. We take sensitivity to operations (at individual or collective level) as any and all of the three types of awareness at any one time.