This paper is an example of the very small number of peer-reviewed publications that appear to validate ISO management standards. The detailed descriptions may obscure the fact that they are descriptions only. The paper describes the management of a science but is not scientific in its method. There is no testing of accreditation’s efficacy. This is assumed. It is assumed because the project was EU-funded. Funding skews the outcome of clinical trials towards the organisation providing the money. Unsurprisingly, the paper appears to offer support for the EU policy of compelling compliance. If fact, it demonstrates the power of preconceptions and funding to bias conclusions.
Most professionals are victims of accreditation groupthink which justifies worthless legislation and inspection. It has no competition because no other inspection system would make a worthwhile improvement in quality either. Quality is assured by professional staff, not collecting paper to facilitate inspectors.
European Journal of Human Genetics 18, S1-S19 (September 2010) | doi:10.1038/ejhg.2010.104
Approaches to quality management and accreditation in a genetic testing laboratory
Sarah Berwouts, Michael A Morris and Elisabeth Dequeker
Medical laboratories, and specifically genetic testing laboratories, provide vital medical services to different clients: clinicians requesting a test, patients from whom the sample was collected, public health and medical-legal instances, referral laboratories and authoritative bodies. All expect results that are accurate and obtained in an efficient and effective manner, within a suitable time frame and at acceptable cost. There are different ways of achieving the end results, but compliance with International Organization for Standardization (ISO) 15189, the international standard for the accreditation of medical laboratories, is becoming progressively accepted as the optimal approach to assuring quality in medical testing. We present recommendations and strategies designed to aid genetic testing laboratories with the implementation of a quality management system, including key aspects such as document control, external quality assessment, internal quality control, internal audit, management review, validation, as well as managing the human side of change. The focus is on pragmatic approaches to attain the levels of quality management and quality assurance required for accreditation according to ISO 15189, within the context of genetic testing. Attention is also given to implementing efficient and effective quality improvement.
Why has accreditation eluded testing for so many years?
If it works, why has this not been clearly proven?
If it has not been proven to work, how is it ethical to enforce it?
Accreditation will continue to escape ethical principles unless it is subjected to the verification it demands of its victims.
No similarly expensive intervention in medicine would have been allowed this privilege and protectionism.