Cartel and regulatory failures in the quality of diagnostic tests


For years Oxoid had been covering up erratic quality in the antibiotic testing discs they produced.  These were reference materials that accredited laboratories relied upon to measure microbial resistance and the correct antimicrobial dose to prescribe.  These actions would have led to wrong results in microbiology labs testing the antimicrobial sensitivity of pathogens.  In some cases this would have resulted in treatment failure; in others, inappropriate treatment of patients.  In all cases, epidemiological analysis of susceptibility data will be inaccurate.

Maybe there will turn out to be a bankster connection in this fraud since Oxoid were bought by US giant, Thermo Fisher Scientific.

Quality cartel members and government regulatory bodies in the UK, USA and Germany all failed to act decisively on data provided by whistleblowers.  Their audits failed to identify the problems.   Through the company’s deception regarding reference materials the market failed to correct the problem too.  Read the story here:

Laboratories and regulator misled over antibiotic susceptibility test discs. BMJ 2013; 346 doi: (Published 13 February 2013) Cite this as: BMJ 2013;346:f837.

While laboratory accreditation delivers confidence that all is as good as it can be, the BMJ editorial casts doubt by pointing out that European regulation of in vitro dignostic devices is fallible:

Assuring the quality of diagnostic tests BMJ 2013; 346 doi: (Published 13 February 2013) Cite this as: BMJ 2013;346:f836.

If situations like this can be allowed to go on for years, what is the “confidence” delivered by UKAS and CPA actually worth?  Perhaps it is delusional like the bogus system of assurance itself.  It’s something many want to believe against the evidence.

Nothing is more rewarding to cartel members than their public failure.  Failure, they will say, is proof that we need even more regulation rather than a better approach to quality and safety.

More tax, more petty tasks, more inefficiency…inspectors are worth it.

This entry was posted in Bureaucracy, Cartel, Laboratory medicine, Medicine, NHS, Practical problems and tagged , , , , , , , . Bookmark the permalink.

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