SUMMARY OF LETTER SENT TO THE RCP REQUESTING INVESTIGATION OF
ANOMALOUS TESTING PRACTICES UNDERTAKEN AT THE
LYME BORRELIOSIS UNIT SOUTHAMPTON
In April 2016 the following letter was sent to the UK Royal College of Pathologists (RCP) requesting they respond to the 22 concerns relating to testing undertaken by the Lyme Borreliosis Unit, Southampton (LBU). The RCP failed to respond.
Between 2010 and 2012 a patient led group undertook an analytical review of over 100 patient tests performed at the LBU. Careful consideration was give to the prevailing manufacturer test kit instructions also the Clinical Pathology Accreditation (CPA) and Health Protections Agency (HPA) guidelines which determined good laboratory practice at the time; all standards were founded on ISO 15189.
Consequently in 2012 two patients complained to Public Health England (PHE). However following PHE’s protracted and unsatisfactory responses complaints were submitted to a higher body, the Parliamentary Health Services Ombudsman (PHSO). It took until 2015 for the PHSO to produce a draft report confirming all the anomalous non-validated testing practices at LBU and 2016 for the final report to adjudge there had not been ‘serious maladministration’.
Over a significant number of years the LBU did not inform patients or their clinicians of altered testing procedures that were never validated; confirmed by both PHE & PHSO in their responses to the complainants. To this day LBU test results remain on all those patients’ records undertaken until LBU’s closure in 2012.
The following concerns were identified and raised with PHE, PHSO & RCP:
The LBU
§ Used a test certified (qualified) only for use with human serum with cerebrospinal fluid (CSF) (off label use)
§ Used a test certified only for human serum with CSF without validation of accuracy in accordance with the prevailing guidelines and reported those results to exclude infection
§ Failed to follow the test kit manufacturer’s instructions
§ Modified the incubation times of the Western Blot tests from 30 minutes to 60 minutes without validating for sensitivity or accuracy (off label use)
§ Did not use the recording sheets supplied by the manufacturer for the complex task of determining whether a band was a scoring band and if it was dense enough to be recorded. Instead LBU used a visual judgment system that was not validated
§ Did not use the band calibration sheet supplied (unique to each specific test kit lot number) in accordance with the manufacturer instructions. Evidence exists that lots were mixed; the calibration sheets were destroyed and instead a non-validated visual judgement deployed
§ Failed to validate altered test kit procedures. This was in contravention of the guidelines and at odds with their published website which stated ‘the antibody test kits routinely used in the LBU have been fully validated’
§ Supplied results to clinicians from tests that appeared to fail the quality criteria defined by the manufacturer. Subjective evidence exists of damaged strips, with high background density, smearing, missing control bands, ‘weakly reactive control’ bands that were overly dense; all evidencing incorrect interpretation of Western Blot test results
§ Failed to notify clinicians that the tests were used off-label and/or non-validated in accordance with the prevailing guidance
§ Failed to notify patients ahead of testing that the test was used off-label defying the prevailing guidance which stated ‘the patient must be fully informed during the consent procedure and a note made in the patient's records’
§ The LBU laboratory recording system was so poor it resulted in misinterpretation by the PHE and erroneous results submitted to the patient throughout the complaint process
[i] Lyme Borreliosis: the challenge of accuracy S. O’Connell Lyme Borreliosis Unit, Health Protection Agency, Public Health Laboratory, Southampton General Hospital 2012
See full text of the letter on the pdf file below.