The High Court has ruled on four outstanding issues in a revised protocol for handling and releasing CervicalCheck cytology slides to independent experts in litigation. Ms Justice Reynolds delivered the ruling on 1 November 2023 in proceedings brought by T.M. against the Health Service Executive (HSE), with Medlab Pathology Limited named as a third party.
The ruling concerns the protocol’s terms, not the merits or outcome of T.M.’s clinical negligence proceedings, which had been compromised. The court said its focus in revisiting the protocol was the security and integrity of patient slides and their availability during litigation.
The court retained the practice under which the plaintiff or their legal representatives organise and pay for the return courier after an expert review. The judge concluded that involving the National Screening Service (NSS) or its contracted laboratory in arranging the return could add coordination challenges and increase the risk of slides being lost.
The court also rejected a proposal for a shared live document to record the release and return of slides. The judgment says all parties had conceded that a shared Google document was inappropriate, citing GDPR and other “insurmountable issues”. It records general agreement that the detailed chain-of-custody provisions in the revised protocol would reduce the risk of slides going missing.
Whole slide imaging is to be the default where available. However, the judge retained the existing arrangement under which digital images are held by the contracted laboratory as a fail-safe and released only if physical slides are lost, damaged in transit or otherwise cannot be located. The judgment notes that physical slides were considered the best available evidence and that digital review could differ materially from the conditions under which the original screener examined a slide.
The NSS had sought a provision allowing it, subject to the court, to refuse further slide releases where it identified material non-compliance or had reasonable cause for concern about obligations under the protocol. The judge found that proposal disproportionate and unnecessary in light of revised provisions setting a limited review period and allowing an aggrieved party to apply to the court.
The ruling directs that the proposed enforcement provision be removed. It does not describe a broader final approval or implementation order for the revised protocol.