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The impact of electronic records on patient safety: a qualitative study
© The Author(s). 2016
Received: 26 February 2016
Accepted: 29 May 2016
Published: 4 June 2016
Our aim was to explore NHS staff perceptions and experiences of the impact on patient safety of introducing a maternity system.
Qualitative semi-structured interviews were conducted with 19 members of NHS staff who represented a variety of staff groups (doctors, midwives, health care assistants), staff grades (consultant and midwife grades) and wards within a maternity unit. Participants represented a single maternity unit at a NHS teaching hospital in the North of England. Interviews were conducted during the first 12 months of the system being implemented and were analysed thematically.
Participants perceived there to be an elevated risk to patient safety during the system’s implementation. The perceived risks were attributed to a range of social and technical factors. For example, poor system design and human error which resulted in an increased potential for missing information and inputting error.
The first 12 months of introducing the maternity system was perceived to and in some cases had already caused actual risk to patient safety. Trusts throughout the NHS are facing increasing pressure to become paperless and should be aware of the potential adverse impacts on patient safety that can occur when introducing electronic systems. Given the potential for increased risk identified, recommendations for further research and for NHS trusts introducing electronic systems are proposed.
Electronic records are being introduced into many healthcare organisations around the world  and contain patient information; personal, diagnosis, condition and treatment details . In the UK, electronic records are seen as one mechanism by which the NHS can become safer and more efficient. For example, NHS IT policy claims that electronic records have the potential to ‘improve health and transform the quality and cost of healthcare’ . The goal of ‘electronic records for all’ was proposed in 1998 by the NHS IT strategy ‘Information for Health’  but remains an ambition of the NHS, with recent IT strategies (2013, 2014) calling for a paperless NHS by 2020 [3, 4]. However, despite an estimated £10 billion being invested since 2002 [4, 5], progress has been slow.
Policy and financial support for NHS trusts to implement electronic records implies a strong evidence base supporting the idea that these systems can improve health outcomes and quality of care. In reality, the literature is limited, as demonstrated in a recent systematic review  of eHealth technologies and their impact on the quality and safety of healthcare, which concluded that there is a gap between the proposed and empirically evidenced benefits of eHealth technologies. In addition, there is little consideration given in existing literature to potential negative effects of these systems on patient safety, with existing evidence under-cited and predominately from the U.S whose health service has different economic, organisational and structural foundations from the UK [7–11]. In their review , Black et al provided some discussion into this and suggested that the lack of evidence may be due to publication bias, with potential conflicts of interest making it particularly difficult to publish negative findings .
Given policy pressures on hospitals to implement electronic records it is crucial that potential risks and safety implications are examined, not just potential benefits. NHS IT policy is often criticised for not evidencing its aims, however to do so, evaluations of not only the positive, but negative impacts of implementing electronic records are essential . In the NHS there is not a good culture of error reporting as it often leads to blame allocation rather than process improvement. Risks are under-reported  and so exploring perceptions and experiences was considered a good way of understanding current risks to patient safety, as opposed to incident reports or observations. This study explored perceptions and experiences of staff regarding the impact upon patient safety of implementing a maternity system. Implementing an electronic system into a maternity unit differs from other specialties, as since the introduction of the ‘co-operation card’ in 1956, which made paper hand-held records integral to maternity shared care , women in the UK have been responsible for their own records throughout pregnancy.
The study explored the implementation of a maternity system in a Women’s and Newborn unit in a teaching hospital in the North of England. The trust offers care to approximately 6,000 women and families annually. To protect the anonymity and confidentiality of the participating trust and the maternity system’s supplier it has not been named and is referred to as ‘the system’ hereafter. The system which can be integrated into a broader hospital wide Electronic Patient Record has been implemented as a departmental system to allow obstetric journeys to be electronically recorded. When fully implemented, it will be used for a range of care activities: antenatal, delivery, postnatal and community. Data collection took place between April and November (2014) during the first year of the system's implementation. Ethical approval was obtained by the University of York Health Sciences Research Governance Committee in January 2014. NHS R&D approval from the study site was also obtained in April 2014.
We drew upon socio-technical thinking , which aims to determine how social influences affect the performance of technical systems . This approach challenges the idea that IT projects fail due to technological reasons alone  by giving equal weight to social and technical issues affecting the implementation and adoption of technology in healthcare . Socio-technical thinking has been applied to studies evaluating the implementation of electronic records  based on the premise that these systems do not merely store information, but influence care. The approach assumes ‘people and technologies are linked within complex, dynamic, socio-technical networks that enable and inhibit what is possible within certain situations and contexts’ . This study used socio-technical thinking when analysing interview data to establish themes illustrating clinician’s perceptions and experiences of how the system has impacted patient safety .
Recruitment and sampling strategy
As the system was implemented in stages and interviews were conducted during the first year of the system's implementation, the amount of time that staff had been using the system when interviewed varied. It was anticipated that staff and wards across the maternity unit would be using the system differently because of their varying roles and responsibilities. To try and reflect this variation, a purposive sampling frame was used to recruit from a range of staff groups and grades to understand their perceptions and experiences of the system’s impact on patient safety across a range of usage. Staff from the unit who were directly involved in the implementation of the system were recruited as key informants, their perceptions and experiences of the system potentially differing from those not actively involved in supporting the system’s implementation.
Participants were recruited via telephone, email and a junior doctors’ WhatsApp group. The purposive sampling frame was used until a sample that qualitatively represented a range of specialities and professions throughout the maternity unit was achieved.
Of the 29 members of staff invited to take part in the study, 19 individuals consented and were interviewed. The sample comprised 11 midwives (grade 5 to 7), 7 doctors (Senior House Officers to Consultant) and 1 health care assistant. Participants were recruited from a range of different wards throughout the maternity unit including; maternity assessment centre, community, birth centre, labour and the antenatal day unit and had between 5 and 28 years professional experience. 4 participants were members of the system support team whose role was to champion the system and assist staff users.
Interview design and content
Interviews were conducted face-to-face, were semi-structured and followed a topic guide (Additional file 1) which was informed by the literature and prior discussion with key informants. Findings presented here are part of a wider study and so following informed consent, interviewees were asked about their perceptions and experiences of the benefits and barriers to the implementation of the system as well as the impact of the system upon their practice and patient safety.
Interviews were transcribed verbatim and analysed thematically in five stages: transcription, familiarisation, coding, theme development and data reporting . The research team were consulted throughout code and theme development. Following each interview, reflexive notes  were taken with personal and methodological changes or challenges noted and considered during analysis.
During interviews, NHS staff described how they perceived, and in some instances experienced, an increased risk to patient safety. Significantly more challenges were reported (and with more emotion) than benefits of the system. A concerted effort to maintain balance was made during interviews; however it became clear that challenges to patient safety outweighed perceived benefits and so these concerns were allowed to emerge unconstrained by the interviewer. From the analysis the two key themes emerging for perceived increased risk related to social (e.g. computer literacy) and technical factors (e.g. system design).
Social factors affecting the safe use of the system
Midwife 062712: it’s my legal documents and I’m not the quickest typist in the world, I’m not a trained typist, so the amount of time it took me to make sure that you’ve got everything spelt right and…written down because our documents follow us for 25 years (41-44).
Consultant 180703: in the olden days if somebody had a full blood count on their notes was a little box to say they had it done so if I saw patient and did a full blood count there would be a little box and hopefully that would prompt the next person when they see the patient to say ‘she has a box from last time so let me check that full blood count’ whereas I am not sure we are highlighting that adequately in the way we are using it (158–162).
Technical factors affecting the safe use of the system
Midwife 133002: I think we will miss something because we don’t know where to look for the information or we’ll miss a problem and an alert and it will lead to a baby becoming septic or a mother becoming unwell (107–108).
Consultant 042202: people were picking up from the down select button they were going to the minimum, easiest quickest route so every operations looked exactly the same…all caesarean sections looked exactly the same…and as a clinician for 15–20 years I know that not every caesarean section is the same (169–171)
Midwife 091203: my main concern would be that we would miss women that come in and whether they are MRSA positive and it’s stuck to the front of the notes and it won’t be any more… simple things like that to a HIV positive and we are not going to know that until we get to a computer and we might not have time to get to a computer which…could really affect the delivery… of the baby so that would be the biggest issue is not knowing if they come in and they do it quickly not being able to access the computer its potentially putting them at risk and we can be putting us at risk (87–95).
Midwife 051602: I’ve recently had a case where I couldn’t get a signal….and …this was a very high risk pregnancy, I did know the patient very well…the high risk issue poses a risk to us as well as to her and if I’d have gone out and say she had delivered at home unprepared….and no access to any records I think is a massive risk to this organisation and to the midwives and the woman, there was no signal…it was in the city center…I’m quite scared by it to be honest (55–60).
Doctor 111609: It would be nice to look at somebody’s notes on a laptop or something outside the room and see what you are talking about rather than go into a room cold with a patient and then say ‘who are you? Why are you here? How many times have you been pregnant?’ and they say ‘three times’ and you say ‘oh how are your three children?’ and they go ‘well actually one of them died’ (154–160).
Midwife 081203: the implications could be the wrong information is down, the wrong date of birth, or the wrong NHS number, It can cause problems further down the line and I guess the problem is that from a midwife point of view people might not actually be aware of what those implications might be if the baby doesn’t have an NHS number or it hasn’t been registered properly they turn up to the registrar’s office to get a birth certificate and they’ve put the wrong gender down. I mean that’s quite a common mistake that people make and it’s not because they don’t know if it’s a boy or a girl it’s just they’re tired or the cursor just flips from female to male or there’s contradictory information (151–159).
Midwife 091203: it wouldn’t let us save this new baby because it didn’t believe that she’d had another pregnancy and it wouldn’t not let us do it at all and we’d tried all sorts but this was the documentation for the parents to take home that I just couldn’t give them because the system wouldn’t let me finish it and that was on the Saturday and nobody was in till the Tuesday (183–186).
Interviews revealed that NHS staff perceived there to be an increased risk to patient safety during the first 12 months of the system’s implementation. Some staff were able to give specific examples of where they thought use of the system had put patient safety at risk. The social and technical factors identified here, were largely a result of human factors and system design which were felt to have increased the risk of inputting errors and of missing patient information.
Our study has identified perceived constraints and limitations of new electronic records. It is surprising that there has been so little research into the potential harms of implementing electronic systems into the NHS on patient safety. Previous research has focused on potential benefits of these systems, such as reducing inputting errors and adverse drug events [22–26]. This study’s findings correspond with a limited and predominately U.S evidence base, which has identified human errors and technical issues associated with Health Information Technology [8–12, 27–33] and which have the potential to increase the risks for patient safety. Sittig and Singh’s  framework for the development of electronic record specific patient safety goals can be used to help conceptualise the findings within this study and those within the existing literature. The framework, suggests a 3-phase approach for measuring and monitoring safety concerns, categorising concerns as those which are specific to technology (e.g., issues with the system crashing or an insufficient number of computers available), or which result from the incorrect use of technology (e.g., inputting error due to poor computer literacy). In its final phase, the framework considers the use of technology to monitor risks, healthcare processes and outcomes for identifying concerns before a patient is harmed. The framework may therefore provide a useful mechanism for raising awareness of the potential risks associated with electronic records. The third phase of the framework may also prove useful for highlighting the limited evidence surrounding the use of technology to monitor patient safety risks.
The study adds to an emerging but limited evidence base that has reported potential negative impacts of electronic systems upon patient safety. The purposive sampling frame enabled a more comprehensive representation of the way that the system is perceived and experienced to of impacted patient safety to emerge. Additionally, the use of socio-technical thinking during the interpretation of the study’s findings allowed a more in-depth interpretation of the data that went beyond a descriptive list of themes to be obtained. The study’s main limitation was that it was undertaken with NHS staff within a single maternity unit at a NHS trust. A number of the issues identified within this study were the result of the particular systems’ design and implementation. For instance, the system did not have the capacity for diagrams and there were insufficient computers stationed in inappropriate places. These issues, that had potential ramifications for patient safety, may not necessarily be experienced by other trusts implementing different electronic systems. However, it is likely that many of these factors would be transferable to other similar large hospital trusts and other clinical specialties.
It has been suggested that to effectively evaluate technology and its impact on safety, evaluation needs to occur continuously prior to, during and following implementation . In this study, interviews took place at just one point in time-during the first year of the system’s implementation’. It is therefore possible that participants’ views may have changed or be representative of only that stage of implementation. Although it would have been preferable to conduct interviews throughout the ‘evaluation lifecycle’  this was not possible due to significant delays to the system’s implementation restricting the time available for interviews to be conducted.
Recommendations for implementing technology into healthcare organisations
Engagement of front line staff and feedback
Hospitals should not underestimate and should acknowledge the potential risks by providing regular opportunities for front line staff to voice their concerns. Trusts should also work closely with clinicians to increase their vigilance and preparedness for potential errors in the early phases of implementation.
Technology and hardware
Prior to introducing systems, hospitals should ensure that sufficient hardware is placed in appropriate locations to prevent delays to clinics and risks in emergency situations.
Where technologically and financially possible, mobile devices or computers on wheels may help to alleviate situations where staff are choosing between accessing information and staying with acutely unwell patients.
During system down times or failures, back up or well communicated procedures and policies should be incorporated and understood by all staff. For instance, if paper is to be reverted to then it should be a mandatory requirement that any information recorded on paper during these periods should then be inserted onto the system once it is ‘up and running’ to prevent important information from being lost or missed in future.
Training and support
Training should be provided on an on-going basis so that those finding using the system difficult can gain extra support with basic IT training sessions advisable. IT support teams should be available 24/7 to reflect the 24/7 provision of clinical care in hospitals. To ensure that those with poor computer literacy are supported, basic IT training, including typing skills should be made available, particularly during initial implementation. Hospitals should also be responsible for ensuring that all staff are computer literate.
This study identified that during the first year of implementation there may be a period of increased risk to patient safety, as staff become accustomed to using the system. Given the global focus on digitising health, it is important that organisations are aware of and do not underestimate the potential risks. This study has identified perceptions and so further research is needed to determine the actual level and scale of the risk during early implementation of electronic systems. This could be achieved by quantifying errors and harm using robust case note review or through linking qualitative findings around increased risk with standardised hospital reporting procedures such as incident reports which would help to ascertain and validate perceptions and experiences of risk. Additionally, research that seeks to determine the impact upon patient safety during initial implementation should aim to study a number of different electronic systems across different trusts to identify common risk factors.
IT, Information Technology; NHS, National Health Service; UK, United Kingdom; US, United States.
The authors would like to thank the staff at the study site for their participation.
This project was part of a PhD studentship funded by the University of York and The Bradford Institute for Health Research, funded by the NIHR. JA, PC, LS, IW, JW received no support from any organisation for their contribution to this study.
Availability of data and materials
The data-set which we have acquired will not be shared as a supplementary file. Our ethical approval does not permit the sharing of the entire dataset which we have acquired.
AC drafted the manuscript, undertook recruitment, data collection and analysis, conceived the study and conducted the design of the study. JA: participated in the design of the study, conceived of the study and helped to draft the manuscript. IW: participated in the design of the study, conceived of the study and helped to draft the manuscript LS: assisted with the thematic analysis and participated with the design of the study PC: assisted with the thematic analysis and participated with the design of the study JW: conceived of the study, participated with the design of the study and helped to draft the manuscript. All authors read and approved the final manuscript.
The authors declare no competing interests
Ethics approval and consent to participate
Ethical approval was obtained by the University of York Health Sciences Research Governance Committee in January 2014. NHS R&D approval from the study site was obtained in April 2014. All participants provided written informed consent prior to interviews. Interviews also provided their consent for publication of the study’s findings.
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