The forensic work of Randox Testing Services was compromised by rogue employees they had taken on. Police money was needed to bail the service out.
More recently Eurofins Scientific and Eurofins Forensic Services have been hit by a ransomware attack. Eurofins analyse half of the UK’s forensic cases. Court work has had to cease but UKAS accreditation continues.
UKAS’s list of sanctions still omits these companies. Their customers have worked out what to do even if UKAS hasn’t.
Criminals have no regard for UKAS certificates. But UKAS has regard for its fee income. UKAS spreads its warm, yet strangely unquantifiable, feelings of confidence while the police and courts have lost confidence and gone elsewhere.
The police don’t do much about online fraud and cybercrime anyway, so can this attack have been to interfere with evidence?
A knowledgeable commentator opined,
“Supply chain attacks are often coordinated, so relying on one company for a significant portion of your operations demands an effort to validate the defences they have in place before awarding a contract, and ideally on a regular ongoing basis,” said Mimecast’s Sloshberg. “Otherwise, the knock-on effect of a successful attack can expose serious risks for your organisation.”
Relying on a monopoly provider of ISO accreditation provided assurance rather than protection. This fact is being ignored here.
Truthfully, it’s the ISO accreditation certificates that never mattered. The police and courts can work out the implications for themselves.
Worried about your cholesterol? Ravnskov et al. say, don’t be.
They allege decades of misleading statistics and selective reviews to sustain the hypothesis that high cholesterol is the major cause of CVD.
The idea that high cholesterol levels in the blood are the main
cause of CVD is impossible because people with low levels
become just as atherosclerotic as people with high levels and
their risk of suffering from CVD is the same or higher. The
cholesterol hypothesis has been kept alive for decades by
reviewers who have used misleading statistics, excluded the
results from unsuccessful trials and ignored numerous contradictory
What difference would it make if your bloods had been analysed in a lab accredited to ISO 15189?
When someone conducts a critical review of the literature supporting ISO accreditation, will we see similar dishonesty to sustain the inspection cartel’s power?
Read the paper here:
Uffe Ravnskov, Michel de Lorgeril, David M Diamond, Rokuro Hama, Tomohito Hamazaki, Björn Hammarskjöld, Niamh Hynes, Malcolm Kendrick, Peter H Langsjoen, Luca Mascitelli, Kilmer S McCully, Harumi Okuyama, Paul J Rosch, Tore Schersten, Sherif Sultan & Ralf Sundberg (2018) LDL-C does not cause cardiovascular disease: a comprehensive review of the current literature, Expert Review of Clinical Pharmacology, 11:10, 959-970, DOI: 10.1080/17512433.2018.1519391.
Burnout of clinicians is the wrong term, argue Dean et al. Instead they liken the phenomenon to “gaslighting” – the act of psychologically manipulating someone to question their own sanity, in order to gain some advantage.
We believe that clinicians are not burned out; instead, they are suffering moral injury. Moral injury occurs when we perpetrate, bear witness to, or fail to prevent an act that transgresses our deeply held moral beliefs. In the healthcare context, this transgression is caused by the need to accomplish the impossible task of satisfying the patient, hospital, insurer, and ourselves all at once. Moral injury locates the source of the distress, appropriately, external to the physician and within the business framework of healthcare itself.
Healthcare systems have looked for easy fixes for physician distress, focusing on wellness (yoga, retreats, and self-care lessons), but this is misguided. Finding solutions requires that we address the problem for what it really is: a challenge inherent in the structure of the healthcare industry. Telling clinicians that they are “burned out” without acknowledging the cause of their distress is gaslighting.
Wendy Dean, Austin Charles Dean, Simon G. Talbot. Why ‘Burnout’ Is the Wrong Term for Physician Suffering – Medscape – Jul 23, 2019.
Their earlier description of moral injury is here.
Accreditation does rely on gaslighting. Year by year, assessors ramp up allegations of potential incompetence and lack of “quality” if more and more records aren’t kept for them to inspect. Where’s the evidence that it’s true? Numbers, please. With calculations for uncertainty of measurement and trends. Why should the inspection gang get away with cosy assessments of each other?
Gaslighting has always been part of how inspectionism works. And it’s increased laboratory costs by a third.
ISO accreditation doesn’t feature in the article’s causes of “burnout” for this large group of US doctors who have little exposure to it. However, staff groups that live under it do experience similar effects from the demands of accreditors. Cognitive dissonance may never kick in since many staff fail to realize that accreditation is mostly a scam.
The feelings can also be mistaken for hypocrisy by those whose for whom accreditation has become central to their jobs. That’s only true if they’re extolling it rather than doing their jobs of complying. It’s the price for living in the parallel universe where accreditation does what it claims in spite of the increasing numbers of ISO-accredited disasters and deaths.
Professional bodies and top management get taken for a second ride: they say that marketing elements of eastern religions as commercialized personal worship hobbies provides a solution.
Mindfulness is not the solution.
Neither are the various brands of yoga.
These layers of gullibility show the organisations don’t know what they’re talking about.
No, the solution is to stop the ISO accreditation scam and various similar waste-generating bureaucracies.
Spend some of the money saved on a prize for anyone who identifies a difference.
et al reviewed over 3000 randomized controlled clinical trials in leading medical journals. They found 396 reversals of practice were indicated.
While medical leaders increasingly put their trust in ISO 15189 and ISO 17025 there remains a lack of evidence in the peer-reviewed journals whether it leads to improvement or harm.
The evidence is in the popular news and at Oxebridge that accreditation is no security against harm and is often a source of it.
It looks like there may be a long delay before the ISO accreditation fad has to be reversed.
The ability to identify medical reversals and other low-value medical practices is an essential prerequisite for efforts to reduce spending on such practices. Through an analysis of more than 3000 randomized controlled trials (RCTs) published in three leading medical journals (the Journal of the American Medical Association, the Lancet, and the New England Journal of Medicine), we have identified 396 medical reversals. Most of the studies (92%) were conducted on populations in high-income countries, cardiovascular disease was the most common medical category (20%), and medication was the most common type of intervention (33%).
Low-value medical practices are medical practices that are either ineffective or that cost more than other options but only offer similar effectiveness (Prasad et al., 2013; Prasad et al., 2011; Schpero, 2014). Such practices can result in physical and emotional harm, undermine public trust in medicine, and have both an opportunity cost (Korenstein et al., 2018) and a financial cost (Reid et al., 2016; Beaudin-Seiler, 2016). Identifying and eliminating low-value medical practices will, therefore, reduce costs and improve care.
Medical reversals are a subset of low-value medical practices and are defined as practices that have been found, through randomized controlled trials, to be no better than a prior or lesser standard of care (Prasad et al., 2013; Prasad et al., 2011). It can, however, be difficult to identify medical reversals. For example, Cochrane reviews provide high-quality evidence on medical practices (Garner et al., 2013), but each review focuses on only one practice and many practices have not been reviewed by Cochrane. The Choosing Wisely initiative in the US maintains a list of low-value medical practices, but it relies on medical organizations to report such practices and often includes only those practices where there is a high degree of consensus (Beaudin-Seiler, 2016).
Here we report how a systematic search of randomized controlled trials in three leading medical journals – the Journal of the American Medical Association (JAMA), the Lancet, and the New England Journal of Medicine (NEJM) – identified 396 medical reversals. It is our hope that, by building on previous efforts in this area (Prasad et al., 2013), this list will help others to eliminate the use of these practices…
Randox Testing Services found that UKAS accreditation was no security against deceitful employees. Why would it be? Massive numbers of British forensic tests are having to be repeated.
UK court cases will be further delayed with a cyberattack on Eurofins Scientific which is also accredited by UKAS because the accreditation body has persuaded the government and the market that ISO accreditation ensures quality. More fool them. How could it?
ISO 17025 requires its marks to protect data from unauthorized access, safeguard against tampering and loss, operate in suitable environment, maintain integrity of data, record system failures and corrective actions.
UKAS has accredited Eurofins. The hackers have made fools of both.
Paying the UKAS tax was of no help against the malicious.
Putting more effort into internal security would have been more useful.
Let us be thankful that the failures of UKAS are being recorded for all to see.
Why should only its accreditees have to record failures?
Are UKAS’s peer assessor bodies counting the accredited disasters or just keeping the bandwagon rolling?
Dr Melvyn Langford explains how the US Department of Defense (DoD) invented the 5×5 risk matrix in the 1980s.
The methodology uses ordinal numbers (which are only for ranking) as if they are suitable for calculations. It is misleading, meaningless and gives erroneous risk ratings that result in great waste.
In 2003 the DoD issued new guidance acknowledging this. IEC/ISO 31010 began to cash in with improvements in 2009. However the 5×5 matrix is still in widespread use, including in the NHS.
By using uncalibrated rankings as if they had a linear relationship, the matrix badly over-estimates potential problems. This leads to major financial waste.
What do UKAS have to say about the matrix?
“When assessing risks, are UKAS expecting to see a risk matrix of likelihood and impact similar to how health and safety risks are assessed?
o ISO/IEC 17011:2017 and UKAS are not prescriptive of how risks are documented.”
To see the tables and graphs read the article on p39-45 of Health Estates Journal, May 2019.
The French court ordered TUV Rheinland was ordered to pay compensation to victims of defective PIP breast implants. The French regulator, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), probably regrets delegating this task to them in the first place.
Here’s one British assessment of the situation from 2013, before the French court ruling.
Martindale V, Menache A. The PIP scandal: an analysis of the process of quality control that failed to safeguard women from the health risks. J R Soc Med. 2013;106(5):173-7.
The Implant Files reveal that parliamentarians in France aren’t happy with the medical devices market.
The two-person commission, French parliamentarians Julien Borowczyk and Pierre Dharréville, offered particularly scathing criticism of device-approval controls now in place across Europe and the potential conflicts of interest in the device approval process, which relies on so-called Notified Bodies, mostly private firms that are paid by device manufacturers themselves.
“The essential place entrusted to these audit bodies … has led to a complete bankruptcy of the health control system for placing [devices] on the market,” the report said.
The commissioners said that the current regulatory regime has never been robust enough to resist the influence of profit-driven device manufacturers intent on speeding products to market even in cases where testing could have been more robust.
“This balance between the manufacturer’s … impulse and the ability of the regulator to counter it, where it poses health safety risks, is probably at the root of the now well-known failures of the control system,” the report said, adding that the current regime “has not undergone a fundamental change, despite successive reforms.”
As a solution, the Commission produced a range of options, including transferring responsibility for assessing high-risk devices, including implants, to a new department within the European Medicines Agency “on an equal footing” with the EMA’s work regulating drugs.
Such a centralized agency, which echoes the system in the United States in which the Food and Drug Administration is the sole authority over device approval, has been proposed over the years by reform advocates both at the European Commission and the European Parliament. As the International Consortium of Investigative Journalists reported, the idea was strenuously opposed by industry lobbyists, sometimes using misleading claims, and ultimately defeated.
Their solution is likely to involve turning from CE marks to much more demanding ISO accreditation that has also failed in many industries. What else have they got?
We’re going to have to wait and see how that works out.