Athina Lockyer, Programme Manager, Kent Surrey Sussex Academic Health Science Network, shares her experience of supporting implementation of a blood test designed to support diagnosis of pre-eclampsia in pregnant women.
Over the last 18 months, I have had the privilege of working with suppliers, clinicians and labs across Kent, Surrey and Sussex (KSS) to facilitate the adoption and implementation of an innovative blood test, designed to support with the clinical diagnosis of pre-eclampsia in pregnant women.
The Placental Growth Factor test (PlGF) offered by both Quidel and Roche Diagnostics, can be used to highlight women who are likely to develop pre-eclampsia within 7-14 days. The blood test can be taken as part of routine bloods when women present at maternity triage or day assessment units and who are between 20 weeks and 34 weeks-plus-6-days pregnant.
The PlGF test is well placed to support clinicians feeling confident in their decision-making by providing an objective measurement to combine with other clinical symptoms and signs, such as high blood pressure, blurred vision, or high protein in urine. PlGF-based testing has a high negative predictive value (rule-out) for pre-eclampsia, meaning women who receive a negative diagnosis can be safely sent home.
Innovation Technology Payment programme
Under NHS England’s Innovation Technology Payment programme, from April 2019 providers of maternity services were able to adopt and implement either the Quidel or Roche test fully funded, as NHSE centrally reimbursed the suppliers directly.
Within KSS, East Sussex were the first trust to implement the Roche sFLT/PlGF ratio test in August 2019, with trusts in Kent and Medway (Darent Valley, Medway Maritime, East Kent, and Maidstone and Tunbridge Wells) implementing during 2020. In Surrey, the Berkshire and Surrey Pathology Services, serving Ashford and St Peter’s and Royal Surrey trusts, implemented the Quidel test in 2020.
Stop start challenges
COVID threw into stark relief the requirement for safe and effective care, and reducing the need to admit pregnant women who were at increased risk of contracting the virus. However, for each site, traversing the pressure of COVID, pausing and then restarting services, changing priorities and implementing a new pathway has raised significant challenges. The dedication of the laboratory staff across our region to continue to deliver agreed turnaround times, the perseverance of clinicians to support raising awareness of the test in their departments and ensure their colleagues access training and the specialist support provided by Roche and Quidel have been humbling to witness.
AHSNs, including ourselves in KSS AHSN, have provided guidance to the clinicians and laboratories with navigating implementation, ensuring appropriate data is collected to measure local impact, supporting with SOP development, facilitating discussions between key stakeholders, sharing best practice and escalating concerns to our national ITP product lead for the AHSN Network, Guy Checketts, Interim Director of Strategic and Industry Partnerships, Oxford AHSN.
MedTech Funding Mandate
More recently, the ITP programme came to an end on 31st March 2021, however PlGF testing will continue to be supported by local funding mechanisms under the MedTech Funding Mandate (MTFM), and NHS Standard Contract from 1st April 2021.
This has given clinicians and laboratories the opportunity to revisit their local pathways and all sites who have adopted the test within the KSS region have chosen to increase the availability of the test to 37 weeks gestation, to prevent unnecessary early inductions and twice weekly outpatient monitoring. Under the ITP programme, whilst the test is validated to use up to 37 weeks gestation, NICE guidance DG23 demonstrates the greatest cost savings across the health care system can be realised between 20 weeks and 34 weeks + 6 days and as such under the ITP programme this gestational range was used.
The change in policy from ITP to MTFM has resulted in collaborative work with trust finance departments and local commissioners, to ensure the transition between programmes has a minimal impact on patient safety and accessibility. Through the development of local business cases, Kent and Medway clinicians and pathologists have recognised a need to share best practice, pathways and service models between the four trusts and have agreed to the development of a collaborative network to explore pre-eclampsia service standardisation across the region.
As I am starting maternity leave to welcome our first baby (the irony!) I feel confident in the knowledge that the collaborative partnership that has developed between the clinicians and pathologists with their chosen supplier will continue, and help to look after other women like me in KSS, ensuring we can work towards safer pregnancy experiences and better outcomes for growing families.
Athina Lockyer, Programme Manager (on maternity leave), KSS AHSN
For more information or for support to implement PlGF, please email firstname.lastname@example.org