When it’s a double standard.
Inspectors accredit private laboratories to an ISO standard in a less rigorous way than they do EC Official Control Laboratories or National Reference Laboratories.
Private laboratories can be cheap because they pay for poorly trained and qualified staff. That’s what the ISO standard expects.
The inspection body needs cash flow from a large number of customers to stay in business. But it is also used as a proxy by bodies like the Food Standards Agency to enforce aspects of EC legislation on its behalf. It therefore holds private and official labs to different standards of the ISO standard.
Samples sent to reference labs often find out-of-specification results that private labs have missed (false negatives). When inspectors meet well-qualified staff they treat them the same as less knowledgeable staff they have met elsewhere. This is inherent in the ISO standard because it is sold as the source of quality. According to the standard, professional staff are not the source of quality; accreditation is.
The evidence does not support this. Private labs often send reference labs impure or inappropriate samples because of lack of skills to investigate a sample fully or using simplified methods.
A business or clinician can be misled by poor results and fail to recognise this because they believe the accredition marks assure equality in quality.
Clinicians are particularly at risk of accepting the multitude of quality certificates at face value. Do they realise how much time the pathology staff spend keeping the paperwork correct when they could have been analysing the samples more carefully?
One standard…but really, two standards.