NHS England is actively preparing to deliver CAR-T cell therapies to patients in England from the last quarter of 2018. Given the high toxicity associated with these therapies, NHS England has devoted considerable time to maximising patient safety aspects and mitigating risks. Aside from national service specifications for centres who will provide these therapies, NHS England also require that they hold JACIE accreditation for administration of Immune Effector Cells (IEC) under edition 6.1 of the FACT-JACIE Standards.
17 centres responded to the NHS England call for Expressions of Interest (EoI) in May 2018. A scoring system for the EoIs was devised based on factors such as ICU access, apheresis, pharmacy, IEC storage, experience with CAR-Ts and/or CART trials/studies participation, the latter two scoring highest. All EoIs were reviewed by the JACIE Committee (minus UK members) and based on geographical distribution and highest scoring, nine were selected for the next stage. Those nine centres then underwent on-site inspection, effectively constituting a technical assessment on behalf of NHSE on aspects related to patient safety, team competency, facilities and process set-up to deliver therapies associated with high-risks.
The JACIE inspectors were almost all from outside the UK to minimise any conflicts of interest. A bespoke Inspection Checklist was created of around 40 items from the clinical standards. Inspectors were also supplied with access to online educational materials obtained from FACT and required to complete a short exam before they could undertake an inspection. Based on the checklist, inspectors were asked to assure the experience and training of the teams with IECs, the provision of ICU and neurological support for patients receiving these novel therapies and the pharmacy role in overseeing the delivery of care. Storage of the products on receipt from the manufacturers before infusion was also checked.
It has been necessary to move quickly in order to make this potentially transformational new treatment available to patients as soon as possible, but despite these challenges, both the centres and inspectors responded amazingly well to the process. This effort has been noted and appreciated by NHS England.
The remaining steps are to shortly distribute the inspection reports to the centres and to award accreditation to centres that demonstrate compliance. Beyond this technical assessment, JACIE has no other role in designating centres as service providers, this being NHS England’s area of responsibility.
NHS England has recognised the value of JACIE accreditation for over 14 years, pinning service commissioning to accreditation and so it was very satisfying that they approached JACIE with the request for a technical assessment. This recognition of professionally-driven standards and assessment in the context of delivering advanced therapies is a significant further endorsement from one of the largest national health systems in Europe.
There is no doubt that this process represented a particular challenge for JACIE. The summer months and the deadline set made team search and inspection scheduling more intense than normal. The process included several changes from a normal inspection that made demands on the inspectors’ organisational skills. Nonetheless, the centres and the 17 clinical and quality management inspectors from 8 countries (including the UK) rose to this challenge showing high levels of professional rigour and efficiency. Particular thanks go to Rob Wosley (Plymouth) who remarkably undertook two IEC inspections in September.
JACIE will review the process carried out in England towards the end of this year to learn what worked well and what could be improved. Inspectors, centres and NHSE will be invited to contribute. The model described above could be of interest to other healthcare systems preparing to deliver these therapies at pace and seeking mechanisms to mitigate safety and risks to deliver this treatment to patients.