An uninvestigated pandemic


Why are accreditation bodies treated with less suspicion than pharmaceutical companies?  Laboratory accreditation is promoted as source of confidence and quality by accreditation organisations.  These exist in an international quality cartel which prevents the price competition between members that normally destroys cartels.  It does this through mutual recognition of singly-appointed national bodies.

The monopoly providers in the UK are the United Kingdom Accreditation Service (UKAS) and its subsidiary, Clinical Pathology Accreditation (CPA).  Their inspection-based approach requires quality to be defined as compliance with protocols based on the ISO 17025, ISO 15189 and associated laboratory standards.  Quality is difficult to define but this definition is one that few others would choose.

It is critical to distinguish ISO technical standards that promote standardised products from ISO management standards that promote social control.  The latter are derived from the flawed ISO 9000 series whose growth has relied on international marketplace coercion.[1]  It shows that specified management records are kept but says nothing about the quality of the product.  The laboratory standards attempt to address technical competence.  This inflexible and inefficient approach originated in the continued employment of factory inspectors.  It currently affects laboratories but UKAS plans to apply it to all areas of clinical measurement and beyond.

Accreditation is characterised by the compiling and exhaustive recording of prescribed practices to assuage inspectors’ requirement that every detail is verified.  Inspectors consider items to be untrue unless recorded, but evade their own accreditation ideology being subjected to verification.  Perfection in procedures and measurements is expected of laboratories, but in return UKAS delivers only the emotional and non-numerical value of “confidence”.

UKAS’s assertions are strongly voiced and the system has a plausibility reminiscent of the alleged millennium computer bug.

But plausibility alone is the absence of any argument that justifies accreditation’s use.  Evidence for accreditation’s effectiveness is negligible and very weak.  Only a few anecdotal post hoc ergo propter hoc reports exist.  No strong assessment of accreditation’s efficacy or value has been published despite these “voluntary consensus standards” being enforced by law in some cases.  Accreditation’s widespread acceptance by medical and scientific professionals is surprising since use of a new drug or procedure would not be considered ethical without strong evidence from sufficiently powered clinical trials.

This is part of a broader problem of command and control management and the related condition of probophilia has been described.  This syndrome involves mis-measurement done to assuage the system’s pathological need for verification.  It occurs when certain character traits are facilitated by organisational dysfunction.

Substantiating the requirement for evidence, Walshe has stated of quality improvement (QI) initiatives generally that, “Our expectations of the evidence base for QI methodologies should be on a par with our expectations in relation to other forms of healthcare interventions.”  He observed that the pseudo-innovation of most quality improvement schemes shows neither novelty nor health improvement.  Similar ideas are repackaged with a different emphasis and sold again by management consultancies.  Repeated sequential changes result in the cumulative deterioration of organisational performance.  His bibliometric analysis graphically reveals the faddish nature of QI schemes. 

It has also been observed of quality programmes that, not only do they “consume more resources than any treatment” but, ”Seeking evidence for evidence based policy is either impossible or premature at this stage.” But it is the ability to test that distinguishes science from ideology.

There are technical reasons that make evaluation difficult, but potentially the international quality cartel may benefit while services to patients suffer.  It is contrary to the principle of equality that the cartel should be treated more leniently than a pharmaceutical company.  Accreditation should be rejected before it spreads more widely unless there is strong evidence for its use.

Just as clinical tests need controls, ideologies need a devil’s advocate to prevent serious errors being promulgated.  The placebo effect is common and needs to be excluded by properly-designed trials of management fads as well as medicines.  Those who supported accreditation because of its laudable aims may yet turn to oppose it when they study the evidence more fully.

A high sensitivity, low specificity test kit would be rejected for general use because of the number of false-positives, unnecessary work and alarm it creates.  However, it has not been recognised that inspection for conformance has similar performance characteristics to such a test kit.  It detects errors (“non-compliances”) that may be irrelevant to technical results but does not allow freedom to interpret their significance except by the precautionary principle.

Increasing the dosage of an effective drug beyond an optimal range does not increase its effect or benefit proportionately.  Above a certain level it becomes toxic and counterproductive.  UKAS lacks a clinical or economic understanding and each year focuses on new aspects of the ISO standards to tighten.  This delivers continual improvement in the quantity of bureaucracy, not the quality of result and service.

Accreditation is very expensive but seldom costed.  Those involved estimate an increase of perhaps a third over previous laboratory costs.  If it is to be ethical and worth paying for it must produce measureable improvements in health outcomes.  These must exceed the benefits of other options on which the cost could otherwise have been spent.

Accreditation is a metaphor for quality rather than a measure of it.  It may also seem metaphorical to identify the requirements of the ISO management system with diagnostic psychiatric criteria.  However, accreditation seeks security in trivial, fetishistic list-making.  The ISO management system is persistently maladaptive and works against the efficient running of the accredited organisation.  It so closely mirrors the characteristics of Obsessive Compulsive Personality Disorder (OCPD) that the parallels need to be highlighted, recognised, and either verified or rejected.

Organisations are recognised in the Corporate Manslaughter Act 2007 as being capable of manslaughter.  Institutions have been described as institutionally racist.  Accepting in law the transposition of the mens rea from the individual to the group, it cannot be denied that an organisation may be corporately deranged also.  Once this is understood it becomes clear why working an accreditation system feels rather like living out someone else’s personality disorder – because the ISO standard is simply the codification of OCPD.  Any doubts about the relationship between OCPD’s symptoms and the ISO accreditation standards must be less than questions about the nature of OCPD itself.

Marketplace coercion, groupthink and EC legislation have made a pandemic of accreditation’s wasteful obsession.  This should be widely recognised.  It can be stopped by an emphasis on professional relationships rather than standards, records and targets.  A time of enforced efficiency improvement is a good opportunity to restore freedom to professionals, allowing them to exceed compliance.  This should enable them to use appropriate measures to deliver the qualities required by patients rather than compliance to the inspection bodies.


[1] Seddon J.  The Case Against ISO 9000.  2nd ed.  Dublin: Oak Tree Press; 2000.

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