CL-2022-000676 - [2025] EWHC 2486 (Comm)

Over the course of 2022, DHSC procured sterility testing on 120 gowns from Swann-Morton (Microbiological Laboratory Services) Limited (“Swann-Morton”) and 20 of the gowns from Synergy Health Ireland trading as Steris Laboratory Tullamore (“Steris”).

On 27 April 2022, 6, 15 and 22 June 2022, as well as 12 and 22 September 2022, Swann-Morton test result certificates for the anaerobic sterility testing were obtained. Further test certificates were obtained by Swann-Morton on 6 (on which date there were two) and 13 October 2022. On 30 May 2022, DHSC sent a further letter to Medpro explaining that “As part of broader testing of PPE products that DHSC has been unable to use, DHSC commissioned sterility testing of a sample of PPE Medpro gowns by Swann-Morton (Microbiological Laboratory Services) Limited”. The letter set out some preliminary test findings showing that 26/30 gowns were not sterile. The letter identified further breaches of the Contract in light of that evidence.

The first tranche of 60 gowns tested by Swann-Morton between April and June 2022 resulted in 26 out of 30 gowns failing the aerobic test and 29 out of 30 gowns failing the anaerobic test. The second tranche of 60 gowns tested between August and October 2022 resulted in 26 out of 30 gowns failing the aerobic test and 22 out of 30 gowns failing the anaerobic test.

Microbes were isolated from these tests and sent to another laboratory (“Charles River”) for detailed microbiological identification. On 11 July 2022, Charles River Associated provided the first tranche of the results of their microbiological testing, and on 13 October the second tranche.

A third lab, Steris, also carried out (less detailed) microbiological identification between 23 and 30 November 2022. Their certificate was issued on 15 December 2022. The sample for the microbiological identification test report was received on 22 December 2022, and approved on 13 January 2023. Of those 20 gowns, 19 were found to be not sterile.