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Implementation challenges The investigation highlighted the main implementation challenges. This includes: National consistency in drug libraries – smart infusion pumps have an inbuilt dose error reduction system (DERS) which requires the use of a drug library. The investigation found that drug libraries were developed ‘locally’ and that there is no agreed national drug library for use in NHS. They also found that there is no national guidelines or standards on how to implement the libraries. Significant changes in processes – introducing the technology requires significant changes to prescribing and administration processes in trusts. The investigation found that procedure and guidance documents often needed updating, and variations in medication practice were ‘locally managed’ and were rarely shared within and between hospitals. Provision of specialist IT support and infrastructure – substantial IT infrastructure is needed to support the integration of smart pump technology. Software is needed to upload the drug library to smart pumps, download data logs (including any errors detected) and monitor the status of each smart pump. The investigation highlighted that maintaining the required IT infrastructure required specialist staff roles and often a new skill set. The investigation found that the implementation of smart pump functionality would benefit from the use of risk management practices, as requirements are complex and similar to the introduction of a new IT system. Existing NHS Clinical risk standards could provide a basis for both manufacturers and trusts to work together to manage risks.

Developing the FRAS In January 2017, I read a tragic story in Outpatient Surgery involving an elderly patient in the US who suffered multiple burns following the use of chlorohexidine bottled alcoholic prep. I'd also read that in the US there are over 600 surgical fires every year. As the Practice Development Lead for my theatre department at the time, I decided to design a Fire Risk Assessment Score (FRAS). I discussed the FRAS with my manager and my suggestion to add the FRAS to the 'Time Out' of our WHO Surgical Safety Checklist. To further develop my ideas, I attended one of the Association for Perioperative Practice (AFPP) study days. All the delegates were asked to discuss and write a plan to make an immediate change in practice on return to their theatre department. I planned the FRAS. My manager who had originally agreed to my idea in January left in March, but I persevered with the idea and in July 2017 I made copies of the FRAS, discussed the score with senior staff, laminated the copies and placed one in each theatre. It was used as part of the WHO Surgical Safety Checklist Time Out. One month later I moved on and started bank shifts as a scrub practitioner in theatres. Fast forward 3 years Imagine my delight on a bank shift in August 2020 to see the FRAS as part of the patient profile on the hospital computer system – which meant it was in all six hospitals! So have fires decreased in theatres? Research shows that fires are still occurring in some UK theatres, and around the world, where a score is not part of the 'Time Out'; where bottled alcoholic prep is still used and not allowed to dry for 3 minutes before draping; and where lighted cables are sometimes allowed to rest on paper drapes. All perioperative staff need to have an awareness of surgical fires – where each flammable item used for the procedure is counted as 1 risk, and the score highlighted to the team and also documented before the start of the surgery. In doing this we can be reassured that we have taken all the necessary fire safety precautions for patients in our care, for the perioperative surgical team and also the preservation and the reputation of the hospital. Further reading The FRAS tool Kathy implemented Yardley IE, Donaldson LJ. Surgical fires, a clear and present danger. The Surgeon 2010; 8(2):87-92. Alani H et al. Prevention of surgical fires in facial plastic surgery. Australas J Plast Surg 2019; 28:40-9. Vogel L. Surgical fires: nightmarish “never events” persist. CMAJ 2018;190(4): E120. Cowles Jr CE, Culp Jr WC. Prevention of and response to surgical fires. BJA 2019; 8:261-266.

In July, the PHSO submitted a report to the Public Administration and Constitutional Affairs Select Committee exploring the state of local complaints handling across the NHS and UK Government Departments. Drawing on evidence from a wide range of individuals and organisations, Making Complaints Count identified three core weaknesses in the existing complaints system: There is no single vision for how staff are expected to handle and resolve complaints. Staff do not get consistent access to complaints handling training. Public bodies too often see complaints negatively, not as a learning tool that can be used to improve service.[1] The PHSO stated in this report its intention to consult on a new Complaint Standards Framework for the NHS, aiming to “help create a stronger culture in which complaints are genuinely learned from”.[2] Patient Safety Learning believes that having an effective complaints process in healthcare is vital to improving patient safety, and in this blog we will set out our response to the consultation on this new Framework. Complaints: an untapped patient safety resource Too often complaints processes in healthcare are viewed in a negative light and patients and their families are not recognised as being a “primary source of learning for safety”.[3] Having an effective complaints system provides an important opportunity to learn from incidents of unsafe care. Patients experiences can be used to help identify patient safety problems, ascertain the causes of these issues and put in place remedial measures to prevent them from recurring. The absence of an effective system has often been cited in patient safety scandals as contributing towards the persistence of unsafe care. Robert Francis identified this in the Public Inquiry into the Mid Staffordshire NHS Foundation Trust, noting that complaints “were not given a high enough priority in identifying issues and learning lessons”.[4] More recently, the Independent Medicines and Medical Devices Safety Review stated that the current complaints system is “both too complex and too diffuse” to promptly identify safety issues arising from a medication or device.[5] It has also been long acknowledged that the complaints system in the NHS requires significant improvements, in terms of both the processes and finding an effective way of learning from complaints to bring about improvements. In the wake of the Mid Staffordshire Inquiry, a review of NHS hospital complaints, co-chaired by Ann Clwyd MP and Tricia Hart, made a number of recommendations for change in complaints handling and procedures.[6] More recently, a report from Healthwatch England which focused on how hospitals report on and communicate their work on complaints highlighted concerns about inconsistency in reporting and a focus on counting complaints rather than learning from them.[7] The consultation process for the PHSO’s Complaint Standards Framework was composed of a survey with several questions and a section in which to add any additional comments. Below is the response provided by Patient Safety Learning in the additional comments section. Consultation response Patient Safety Learning welcomes the PHSO’s Complaint Standards Framework and its recognition of the need to reform the NHS complaints system. From a perspective of making improvements for patient safety, we welcome: The statement that organisations should “have clear processes in place to show how they capture learning from complaints, report on it, and use it to improve services”. Its acknowledgement of the importance of sharing learning and complaints widely with other organisations in healthcare. The identification of the need for clear complaints governance structures, ensuring the feedback is regularly reviewed by staff at a senior level. Its recognition that an effective complaints system is intrinsically linked with promoting a Just Culture in healthcare, one that is less focused on blame and encourages transparency and accountability when mistakes occur. Implementation We note that this Framework is focused on providing “a shared vision for NHS complaints handling” rather than looking in more detail at how this would be put into practice.[8] While we welcome many of the aspirations set out in this, its implementation will ultimately determine its effectiveness in reforming the NHS complaints system. Too often, there exists a gap between learning and implementation in healthcare. We may know what improves patient safety, but in practice such measures can often remain siloed in specific organisations, resulting in patients continuing to experience harm from problems that have already been addressed. If this Framework is to create a more effective complaints process, one which contributes to improving patient safety, we feel that there are several issues that will need to be addressed prior to its implementation: It will need to be clear how organisations report on their progress in implementing the Framework. There will need to be guidance on how organisations report on their implementation of the Framework and a level of transparency and consistency to allow for monitoring and comparison. It needs to be made clear who is responsible for ensuring that organisations will design this approach to complaints into their governance structures. There is also the question of how this change will be monitored. In the consultation survey, the PHSO pose a question related to this, asking whether they “should be given legislative powers to set and enforce national complaint standards for the organisations it investigates”. At Patient Safety Learning, we think that it is vital that this process is monitored. However, we question whether the PHSO, specifically, can do this, in terms of whether it has both the legislative remit and the resources for this undertaking. In practice, we suggest that this role would sit better within the remit of the Care Quality Commission and its existing inspections regime. We feel this issue needs further consideration. Public reporting As mentioned previously, we believe a key question that needs to be addressed before implementing the Framework is how it will be reported on by organisations, and whether reporting will be consistent to allow for monitoring and comparison. A recent report from Healthwatch earlier this year looking at hospital complaints highlighted the difficulties around this. It noted significant variations amongst different hospitals regarding how they reported on complaints (in terms of the data provided publicly) and, in some cases, whether they did actually report on these complaints.[7] It stated “because the regulations don’t require trusts to publish their annual complaint reports, we can’t know for sure how many of them are fully compliant with the regulations”.[9] Achieving the goals of the Framework may encounter similar challenges, not providing clear indications of how its suggestions should be implemented. For example, the Framework states that organisations should “report on the feedback they have received and how they have used that feedback to improve their services”.[10] We believe that this needs to be accompanied by clear guidance, for instance, stating that feedback should be publicly reported on a quarterly basis. Sharing good practice We welcome the strong emphasis that the Framework places on the need to learn from complaints, and to share this learning widely. We believe that complaints too often remain an untapped resource for making patient safety improvements; a negative view of these processes present a barrier to effectively utilising the insights they can provide. In our report, A Blueprint For Action, we note that “healthcare is systematically poor at learning from harm”.[3] This has also been recognised in the CQC’s report, Opening the door to change, stating that “there is no clear system for staff to learn from each other at a national level. Local reporting systems are often poor quality and do not support staff well”.[11] How we achieve this ambition of sharing learning from patient complaints widely between NHS organisations requires further consideration. Organisations need the means to be able to share learning from complaints widely and effectively with other organisations in the NHS, without this getting lost in “the avalanche of other information that bombards organisations daily”.[3] Patient Safety Learning welcomes the opportunity to collaborate with PHSO on this issue and to promote and share good practice on the hub. References PHSO, Making Complaints Count: Supporting complaints handling in the NHS and UK Government Departments, July 2020. Ibid. Patient Safety Learning, The Patient-Safe Future: A Blueprint For Action, 2019. Robert Francis QC, Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry, February 2013. The Independent Medicines and Medical Devices Safety Review, First Do No Harm, 8 July 2020; Patient Safety Learning, Findings of the Cumberlege Review: patient complaints, 30 July 2020. Rt Hon. Ann Clwyd MP and Professor Tricia Hart, A Review of the NHS Complaints System: Putting Patients Back in the Picture, October 2013. Healthwatch, Shifting the mindset: A closer look at hospital complains, January 2020; You can find further reading on complaints in healthcare on the hub. PHSO, Have your say in shaping the future of NHS complaints handling, Last Accessed 18 September 2020. Ibid. PHSO, Complaint Standards Framework: Summary of core expectations for NHS organisations and staff, July 2020. CQC, Opening the door to change: NHS safety culture and the need for transformation, 2018.

In this book the authors set out two key areas for attention if audit is to play a part in bringing about real improvements in quality of care. First, efforts must be made to ensure that the NHS creates the local environment for audit. Second, the NHS needs to make sure that it uses audit methods that are most likely to lead to audit projects that result in real improvements.

A simple visual display that outlines and logically connects: An improvement aim that quantifies what better will look like, for who and by when. A small number of Primary drivers that focus on the key components of the system/main areas of influence that need to change to achieve the aim. These are often associated with process, infrastructure, norms (culture) and people. Secondary drivers that break primary drivers down in to natural subsections or processes. They provide more detail on where interventions to positively influence the primary drivers are required. Change ideas – these are the specific ideas that teams can test to see if they influence the secondary drivers and ultimately the aim.