Objectives To evaluate the implementation and adoption of the NHS detailed care records service in “early adopter” hospitals in England.Design Theoretically informed, longitudinal qualitative evaluation based on case studies.Setting 12 “early adopter” NHS acute hospitals and specialist care settings studied over two and a half years.Data sources Data were collected through in depth interviews, observations, and relevant documents relating directly to case study sites and to wider national developments that were perceived to impact on the implementation strategy. Data were thematically analysed, initially within and then across cases. The dataset consisted of 431 semistructured interviews with key stakeholders, including hospital staff, developers, and governmental stakeholders; 590 hours of observations of strategic meetings and use of the software in context; 334 sets of notes from observations, researchers’ field notes, and notes from national conferences; 809 NHS documents; and 58 regional and national documents.Results Implementation has proceeded more slowly, with a narrower scope and substantially less clinical functionality than was originally planned. The national strategy had considerable local consequences (summarised under five key themes), and wider national developments impacted heavily on implementation and adoption. More specifically, delays related to unrealistic expectations about the capabilities of systems; the time needed to build, configure, and customise the software; the work needed to ensure that systems were supporting provision of care; and the needs of end users for training and support. Other factors hampering progress included the changing milieu of NHS policy and priorities; repeatedly renegotiated national contracts; different stages of development of diverse NHS care records service systems; and a complex communication process between different stakeholders, along with contractual arrangements that largely excluded NHS providers. There was early evidence that deploying systems resulted in important learning within and between organisations and the development of relevant competencies within NHS hospitals.Conclusions Implementation of the NHS Care Records Service in “early adopter” sites proved time consuming and challenging, with as yet limited discernible benefits for clinicians and no clear advantages for patients. Although our results might not be directly transferable to later adopting sites because the functionalities we evaluated were new and untried in the English context, they shed light on the processes involved in implementing major new systems. The move to increased local decision making that we advocated based on our interim analysis has been pursued and welcomed by the NHS, but it is important that policymakers do not lose sight of the overall goal of an integrated interoperable solution.

Objectives To describe and evaluate the implementation and adoption of detailed electronic health records in secondary care in England and thereby provide early feedback for the ongoing local and national rollout of the NHS Care Records Service. Design A mixed methods, longitudinal, multisite, sociotechnical case study. Setting Five NHS acute hospital and mental health trusts that have been the focus of early implementation efforts and at which interim data collection and analysis are complete. Data sources and analysis Dataset for the evaluation consists of semi-structured interviews, documents and field notes, observations, and quantitative data. Qualitative data were analysed thematically with a sociotechnical coding matrix, combined with additional themes that emerged from the data. Main results Hospital electronic health record applications are being developed and implemented far more slowly than was originally envisioned; the topdown, standardised approach has needed to evolve to admit more variation and greater local choice, which hospital trusts want in order to support local activity. Despite considerable delays and frustrations, support for electronic health records remains strong, including from NHS clinicians. Political and financial factors are now perceived to threaten nationwide implementation of electronic health records. Interviewees identified a range of consequences of long term, centrally negotiated contracts to deliver the NHS Care Records Service in secondary care, particularly as NHS trusts themselves are not party to these contracts. These include convoluted communication channels between different stakeholders, unrealistic deployment timelines, delays, and applications that could not quickly respond to changing national and local NHS priorities. Our data suggest support for a "middle-out" approach to implementing hospital electronic health records, combining government direction with increased local autonomy, and for restricting detailed electronic health record sharing to local health communities.Conclusions Experiences from the early implementation sites, which have received considerable attention, financial investment and support, indicate that delivering improved healthcare through nationwide electronic health records will be a long, complex, and iterative process requiring flexibility and local adaptability both with respect to the systems and the implementation strategy. The more tailored, responsive approach that is emerging is becoming better aligned with NHS organisations' perceived needs and is, if pursued, likely to deliver clinically useful electronic health record systems.

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Regular multilaboratory surveys of laboratories derived primarily from Australia, New Zealand, and Southeast Asia have been conducted during the last 8 years to evaluate testing proficiency in the diagnosis of von Willebrand disease (vWD). We summarize and update the findings of these surveys with a particular emphasis on diagnostic errors and error rates associated with particular tests or test panel limitations. A total of 43 plasma samples have been dispatched to survey participants. These have included 13 normal samples, five type 1 vWD samples, eight type 2 vWD samples (three 2A, three 2B, one 2M, and one 2N), and four type 3 vWD samples. In addition to numerical test results, participant laboratories (currently, n = 49) were asked to provide diagnostic interpretations regarding results, and whether or not vWD was suggested, and if so, a probable subtype. Although laboratories usually provided correct interpretative responses, diagnostic errors occurred in a substantial number of cases. On average, type 1 vWD plasma was misidentified as type 2 vWD in 13.3% of cases, and laboratories performing von Willebrand factor (vWF):ristocetin cofactor activity (RCo) without vWF:collagen-binding activity (CB) were seven times more likely to make such an error compared with those performing vWF:CB. Similarly, type 2 vWD plasma was misidentified as type 1 or type 3 vWD in an average of 20.1% of cases, and laboratories performing vWF:RCo without vWF:CB were three times more likely to make such an error compared with those performing vWF:CB. Finally, normal plasma was misidentified as vWD in an average of 6.7% of cases, and laboratories performing vWF:RCo without vWF:CB were four times more likely to make such an error compared with those performing vWF:CB. We conclude that although laboratories are generally proficient in tests for vWD, diagnostic errors do occur and error rates are substantially reduced when test panels are more comprehensive and include the vWF:CB.

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The laboratory has a key role in the initial detection of factor inhibitors and an ongoing role in the measurement of inhibitor titres during the course of inhibitor eradication therapy. The most commonly seen factor inhibitors are those directed against factor VIII (FVIII), usually detected either using the original or Nijmegen-modified Bethesda assay. In view of previously demonstrated high variability in laboratory results for inhibitor assays, we have more extensively examined laboratory performance in the identification of FVIII inhibitors. Over the past 3 years, we conducted two questionnaire-based surveys and two wet-challenge surveys utilizing eight samples comprising no FVIII inhibitor (n = 1), or low-titre (n = 2), medium-titre (n = 3) or high-titre (n = 2) FVIII inhibitor. Four samples were tested by 42 laboratories in 2007, and four by 52 laboratories in 2009. High inter-laboratory variation was evident, with CVs around 50% not uncommon, and some 10% of all laboratories (or around 15% of laboratories using Bethesda method) failed to detect low-level inhibitors of around 1 BU mL(-1). Laboratories using the Nijmegen method appeared to perform better than those using a standard Bethesda assay, with lower evident assay variation and no false negatives. There was a wide variety of laboratory practice, with no two laboratories using exactly the same process for testing and interpretation of factor inhibitor findings. In conclusion, our study indicates that there is still much need for standardization and improvement in factor inhibitor detection, and we hope that our findings provide a basis for future improvements in this area.