Pathology

Establish the Clean Framework as the governing ethos, overarching quality framework, and basis of pathology accreditation throughout the healthcare system. a UK Accreditation Service (UKAS) to work with the pathology community to redevelop accreditation using the Clean Framework as the basis of engagement with the ISO standard, with oversight from the National Pathology Board (NPB). b To deliver action 1a, labs and PNs to lead in setting up mechanisms for engaging with all teams to embed the Clean Framework across the end-to-end pathway, starting with primary care and emergency departments (EDs). c Labs, PNs and PCNs to develop a plan to: • apply this approach consistently to all settings, including Point of Care Testing (POCT); • ensure all POCT is supported by an accredited lab in line with Medicines and Healthcare products Regulatory Agency (MHRA) guidance.

Establish network-wide standards, and where useful agree at national level. a Labs and PNs to share peer-to-peer learnings on best practice in implementing the Clean Framework, and use these to establish and monitor network standards to establish end-to-end quality, including: • Care Sets; • diagnostic pathways; • decision support; • test specifications, to include: – reference intervals; – action limits; – turnaround times; – strategy for dealing with specialist tests; – stabilisation requirements; – sample quality requirements; • guidance for patients.

Establish electronic requesting and messaging as standard in all labs and with all requestors. a Labs to work with PCNs to ensure that electronic requesting is standard for all primary care requesting, where the percentage of requests received electronically from PCNs is below 80%, in line with the NHS Long Term Plan (NHS LTP). b Labs, trusts and PNs to have agreed plan and timescale for introducing electronic requesting in other areas, where current percentage of requests received electronically is below 80%, in line with the NHS LTP. c Labs, PNs and PCNs to continuously monitor and update electronic requesting system to reflect feedback and guidance changes and to improve decision support.

Future-proof pathology by developing a national roadmap for data interoperability and end-to-end paperless pathology. a The NPB to co-ordinate with NHSX to establish a roadmap for common data standards (and a realistic national commitment to drive this forwards), with clear aims of: • integrating results from any setting, including POCT and Community Diagnostic Hubs, and delivering results to any setting; • ensuring data supports patient-focused pathology, including support for innovations such as wearables; • ensuring data supports clinicians via improved decision support/AI, better interpretation and display, and automated reminders. b Once the roadmap is established, the NPB to ensure that all subsequent initiatives use the data standards. c The NPB to commission a data repository to enable analysis and comparison of local, network and national data.

Create flexible pathology networks that reflect local needs, feed into national testing needs, and that are primarily engines of quality. a PNs to develop a plan to suit local needs, which could include assigning network centres of excellence, or sharing with other networks. b The NPB to ensure there are enough national centres of excellence to give sufficient specialist testing coverage across the country. c PNs to: • develop network training plans, collecting data and identifying gaps; • where a gap cannot be resolved locally, raise these nationally; • ensure the workforce can flow around the network to improve resourcing and enhance career progression; • ensure staff can access training, mentoring and tutoring within the network. d PNs to use the NHS Clinical leadership framework to improve leadership in pathology networks.

Interrogate all tests to ensure all are: • based on a valid clinical question; • necessary, appropriate and sufficient to answer that question. a PNs to: • develop network-wide Care Sets, in all possible areas, including primary care, ED and specialty; • ensure guidance available as decision support; • continually monitor, benchmark and review Care Sets. Labs to implement these Care Sets and promote their use to all requestors. b PNs to: • within Care Sets, disaggregate common testing profiles as a network, as much as possible, working closely with primary care colleagues; • remove urea and chloride from primary care testing profiles; • eliminate routine co-ordering of C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) tests; • identify and remove all other tests of limited clinical value; • ensure requestors can still request these tests if they have a specific reason to do so. Labs to implement in line with above. c PNs to: • check all minimum retest intervals are aligned to RCPath guidance; • build intervals into decision support and electronic requesting; where this is not possible, impose lab limits; • educate requestors on the proper use of minimum retest intervals. Labs to implement in line with above.

Reconfigure transport and sample collection services to ensure that samples reach the lab in the best possible condition. a Labs, trusts and PNs to monitor non-numeric potassium levels, and, if 5% or greater, intervene urgently to address issues identified. b Labs, trusts, PNs and PCNs to identify where there is a difference between summer and winter potassium levels of 0.5mmol/L at individual collection point level (for example an individual surgery), and wherever this occurs, intervene urgently to address issues identified. c Labs, trusts, PNs and PCNs to audit processes for collection of urine, and address issues identified. d Labs, trusts, PNs and PCNs to improve current monitoring of time of critical events along the end-to-end pathway, for example time of collection, and audit and address all identified issues. e UKAS to link portering and transport quality to accreditation. f Labs, trusts and PNs to ensure portering and transport arrangements are fit for purpose in line with anticipated UKAS approach to accreditation.

Ensure all requestors are using NHS numbers consistently (apart from known exceptions). a Labs, trusts, PNs and PCNs to identify barriers to use of NHS number, and address with requestors, aiming for a minimum of 90% of requests using the NHS number, starting with primary care and ED.

Urgently investigate acute kidney injury (AKI) flags to understand variation. a The NPB, in conjunction with the Renal Association and UK Renal Registry, to commission research to identify and, if appropriate, address causes of variation.

Audit and overhaul approach to action limits, including out-of-hours protocols. a Labs and PNs to audit results communicated out of hours, working with primary care colleagues, and change strategy where the numbers are causing problems for users or patients.

Ensure appropriate turnaround times, and address identified issues. a Labs and PNs to identify pathways where turnaround times are impacting on patient care, and address issues. b Labs and PNs to report potassium from ED within one hour of collection. c Labs and PNs to ensure blood cultures are loaded onto analysers within four hours of collection. d Labs and PNs to ensure neonatal blood cultures are reported within 36 hours of the sample being taken, in line with NICE guidance.

Develop an integrated venous thromboembolism (VTE) pathway for network use. a Trusts, PNs and PCNs to establish an agreed pathway for VTE diagnosis and management.

Make better use of EQA information at national level. a The NPB and NEQAS to work together to establish national co-ordination and to ensure fuller use of the available information, also engaging with manufacturers to achieve greater consistency. b The RCPath EQA Oversight Board to: • use EQA data to ensure methodologies are of an acceptable quality, with harmonisation where possible; • set performance standards that manufacturers must meet for tests supplied to the NHS, ensuring that a manufacturer's method is fit for purpose.

Establish a proactive, integrated approach to ensure new technology can be adopted at speed. a The NPB to co-ordinate implementation of rapid technology framework.

Improve regulation of in-vitro diagnostic (IVD) devices. a MHRA to work with the pathology community to develop a structured and risk-based UKCA governance framework.

Full addressee: MHRA

Increase diversity of staff involved in the accreditation process. a Labs and PNs to make it easier for working pathologists to become quality leads, by allocating time for practitioners to develop quality initiatives and participate as assessors, and funding this as part of Continuous Professional Development (CPD).

Embrace and support innovation in pathology, including digital pathology and improved decision support. a The NPB to work with NHSX and NHS Digital to drive further development of digital pathology, including remote reporting, improved decision support, and artificial intelligence (AI) assistance, in line with the NHS LTP. b Labs, trusts and networks to plan for implementing digital pathology, as a means to address workforce challenges and improve patient experience.

Interrogate usage and wastage data for blood products, and address identified problems. a Using Blood Stocks Management Scheme data, trusts to benchmark performance against other trusts and work to understand and address issues identified.

Identify and close workforce gaps at a national level. a Building on network-level metrics identifying gaps, the NPB to work with training bodies and Health Education England (HEE) to ensure a wide range of intake and increase the number of training positions available, to meet anticipated future demand. b Labs, trusts and PNs to allocate time for biomedical scientists to mentor and tutor colleagues to higher levels to fill gaps in the medical workforce in all relevant specialties.

Review funding models for pathology. a NHS England and NHS Improvement to explore ways to incentivise effectiveness in pathology alongside continuing the drive for efficiency.

Reduce litigation costs by application of the GIRFT programme's five-point plan. a Clinicians and trust management to assess their litigation claims covered under Clinical Negligence Scheme for Trust (CNST) notified to the trust over the last five years. b Clinicians and trust management to discuss with the legal department or claims handler the claims submitted to NHS Resolution to confirm correct coding to that department. Inform NHS Resolution of any claims which are not coded correctly to the appropriate specialty via CNST.Helpline@resolution.nhs.uk c Once claims have been verified, clinicians and trust management to further review claims in detail including expert witness statements, panel firm reports and counsel advice as well as medical records to determine where patient care or documentation could be improved. If the legal department or claims handler needs additional assistance with this, each trust's panel firm should be able to provide support. d Claims should be triangulated with learning themes from complaints, inquests and serious untoward incidents (SUI)/serious incidents (SI)/Patient Safety Incidents (PSI) and where a claim has not already been reviewed as SUI/SI/PSI we would recommend that this is carried out to ensure no opportunity for learning is missed. The findings from this learning should be shared with all staff in a structured format at departmental/directorate meetings (including multidisciplinary team meetings, Morbidity and Mortality meetings where appropriate). e GIRFT clinical leads and regional teams to share with trusts examples of good practice where it would be of benefit.