Harm is inevitable


When the inspectors come, one of their stock phrases is that the inspection is “just a sampling exercise” and cannot assure that absolutely everything is correct.  I never thought otherwise, though probably some do.  The disclaimer is important to their liability.  They don’t want to be seen having accredited something that is then found to go wrong.  It would damage the credibility of their brand.  The legally-protected brand is what accreditation rests on.  The responsibility for errors will rightly remain yours.  Their expertise is in the procedures of inspection; what they mean by “sampling exercise”, in medical terms, is that inspection is a screening test.

Margaret McCartney points out a healthcare company that

“- are offering are a raft of mainly non evidence based screening tests, some of which are intimate examinations.  The NHS Screening portal contains information about which screening tests are recommended for use in the UK.  The problem is that screening tests come with strings attached; harm is inevitable.  Screening tests require to be properly validated before they can be recommended, and informed consent is required because of the risk of overdiagnosis, investigative harm and overtreatment screening can lead to.”

Pathologists know this well for assays, but don’t seem to realise that accreditation by inspection has similar limitations to patient screening tests.  Unlike the tests, it has no evidence base at all.

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