Hard times for policing

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.

 

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Cholesterol and atherosclerosis deception

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.

9. Conclusion

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

observations.

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.

 

 

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Gaslighting, not burnout

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.

The Mindful Path, LLC – Empowering women with mindfulness skills ...

Mindfulness is not the solution.

What is Mindfulness? - Mindful

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.

 

 

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Hundreds more medical reversals. But not ISO accreditation

Herrera-Perez 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.

Meta-Research: A comprehensive review of randomized clinical trials in three medical journals reveals 396 medical reversals

Feature Article
Cite this article as: eLife 2019;8:e45183 doi: 10.7554/eLife.45183

 

Abstract

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%).

https://doi.org/10.7554/eLife.45183.001

Introduction

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., 2011Schpero, 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…

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Another UKAS-accredited forensic meltdown

Raising Awareness of Drink and Drug Drive Limits in the UK ...

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.

Eurofins Scientific has offices in Cambridgeshire, Oxfordshire and Derbyshire. A court has been told it is still in 'cyber crime lockdown'

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?

The Bandwagon Effect & Influencer Marketing - Conversion ...

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.

Oops.

UKAS has accredited Eurofins.  The hackers have made fools of both.

Paying the UKAS tax was of no help against the malicious.

He fooled me but now I'm only fooling myself..empty ...

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?

 

 

 

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Current ISO body-count

Yep, we’re countin’:

To date, Oxebridge has found that over 220 people have died in accidents caused by companies certified by ISO certification bodies accredited by ANAB, with almost 1700 killed in accidents related to all IAF member Accreditation Bodies.

The graphic above shows the damage caused by the fire and those who perished on each floor during the blaze

Enter a caption

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Police forensics contractor ‘sent phones to Fone Fun Shop’ – Sytech suspended

UKAS suspends a number of its customers each quarter.  This proves it’s doing its job while limiting its financial losses.

The Guardian reports the story of one of them:

Police forensics contractor ‘sent phones to Fone Fun Shop’

Sytech holds major contracts with more than a dozen police forces. Photograph: Alamy

One of the country’s largest digital forensics laboratories has been stripped of its accreditation after a former employee reported concerns about the handling of evidence at the business.

It was found that the company, Sytech, had inadequate vetting procedures for new staff and police exhibits were being transported in private vehicles at a recent inspection.

The Guardian has heard of further concerns from former staff who said that broken phones had been unsealed from evidence bags and sent to a consumer repair shop called Fone Fun Shop. On other occasions phones were sent abroad to be decrypted without the knowledge of the police, a former staff member said.

Sytech, based in Stoke-on-Trent, holds major contracts with more than a dozen police forces, and during a period when police spending on forensics science has fallen precipitously, it is one of the few companies to have expanded. However, concerns have been raised about the chain of custody of evidence entrusted to the company and the case raises broader questions about the outsourcing of forensic work to private labs.

“What made me report them to the forensic services regulator was because I couldn’t get it out of my head [that] any doubt in a case can get a case overturned or thrown out or even an appeal on a previous conviction,” the former Sytech analyst said.

When asked whether phones had been sent to the repair shop, Sytech said in an email: “We have carried out all mobile phone repairs in-house for over 12 months.”

The company said it was not aware of any cases in which the failure to maintain a chain of custody could risk undermining criminal evidence.

A second former employee, who also did not wish to be named, said a police force, understood to be Greater Manchester police, raised concerns with Sytech last year after learning that phones had been sent abroad to be unlocked by the Israeli-founded, Japanese-owned company Cellebrite.

When asked to confirm this, Emily Burton, the head of forensic services at Greater Manchester police, said: “In October 2018, we became aware of potential issues with the data extraction service provided to us by an external digital forensics company. When this potential issue became apparent, we raised this with the national policing leads for forensics, immediately reviewed current investigations and made alternate arrangements for our data extraction needs whilst the matter was resolved.”

Currently no investigations had been significantly affected, Burton said.

In an email, Sytech said the findings of the recent inspection by the UK Accreditation Service (UKAS) “make no reference to our handling of phones requiring pin-decryption”. Currently phones were not sent abroad, the company said, adding that all exhibits sent to external labs for unlocking were transported by a driver with police security clearance in a secure van.

Gillian Tully, the government’s forensic science regulator, declined to comment on specific concerns about Sytech. In general, she said, establishing a continuous chain of custody for evidence was a cornerstone of forensic science. “All organisations engaged in work for the criminal justice system should be well aware of those requirements and of adhering to them,” she said. “If the continuity can’t be established … it could compromise cases.”

Tully said it would be of concern if private labs were subcontracting “outside of the quality chain”.

Nick Baker, the national police lead on digital forensics and deputy chief constable of Staffordshire police, said his force had placed outsourcing to Sytech temporarily on hold while a risk assessment was carried out. “We’re going through a process of understanding what the issues are and understanding what our own exposure and risk is and obviously [we’ll] make a decision based on that,” he said.

Sytech said it had made police aware of its loss of accreditation “fully and frankly”.

It said the company completed “internal authentication of staff” and arranged for the police online application to be completed immediately when staff joined the company. “All new employees go through a period of training and strict supervision during their probationary period,” Sytech said.

In response to the UKAS findings Sytech said it had ceased using privately owned vehicles for the transport of exhibits.

As seen previously with Randox Testing Services, UKAS weren’t quick to spot they’d been accrediting services that fell short of the standards they claim to enforce.

Ergo, “takes one to know one” is disproved.

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Risk-based thinking – it’s risky not to understand the mathematics of risk (and randomness)

Dr Melvyn Langford explains how the US Department of Defense (DoD) invented the 5×5 risk matrix in the 1980s.

Risk Assessment Guide & Template Collection

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.

 

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Oxebridge whistleblower hotline launched

Tired of griping about the problems UKAS manufactures while the real problems of the ISO gang go on killing people?  Now you can do something about it.

Whistleblow to Oxebridge’s hotline.

Fill in the form, let the experts investigate and apply legal pressure.  You may be protected by whistleblowing laws in your region, but you can “prefer not to say”.

“If you are reporting a crime, contact law enforcement first.”

Oxebridge Launches ISO Whistleblower Hotline
A new way to report problems

Pushing forth on the “third phase” of the path to improve the ISO certification scheme — that’s the one where we file reports with law enforcement agencies, government regulatory bodies and legislative panels — I’m happy to announce we have launched a new ISO Whistleblower Hotline reporting tool, on our brand new website at whistleblower.oxebridge.com.

Now ISO 9001, AS9100 and other management system certification stakeholders can file reports of complaints, conflicts of interest, lawbreaking and other issues to an independent third party (Oxebridge), with the option of doing so with complete anonymity. We will then sort and analyze the entries, and forward them to the appropriate oversight bodies or law enforcement agencies around the world. We will collect the aggregate data on the nature of the issues to help bolster the information we are currently providing to US government legislative committees, as well as to ministries in other countries.

With the latest Boeing 737MAX crashes, the Equifax hack, the Texas chemical plant fires and other scandals impacting on the ISO and AS schemes, it’s no longer up for discussion that the various certification bodies, accreditation bodies and IAF are incapable and unwilling to do their jobs and ensure the validity of ISO certificates. Now it’s a question of how many people are going to have to lose their lives due to defective products and services that would have never reached the market had these companies not been granted drive-by ISO certificates.

I want to pause on that last note: if the IAF-matrixed CBs and ABs done their jobs properly, in many cases these companies would have been denied ISO certification, which would have then denied them access to the contracts which allowed them to build and release defective products and services. So the IAF and its cronies are complicit in these disasters, whether tangentially or directly. They also have tools at their disposal, right now, which can help prevent such things from happening again, and are willfully refusing to use them, in order to protect corrupt CBs and their incompetent auditor pools.

I’m not willing to wait for more people to be harmed. I am asking stakeholders from around the world to report their stories and concerns with the various certification schemes and standards development bodies, so this data can be used to fix these problems once and for all.

To file your report, visit the ISO Whistleblower Hotline webpage. You will not be added to any lists, and your information is not used for any other purposes.

— Christopher Paris

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PIP implants – from CE marks to ISO accreditation?

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.

Insight: In PIP implant scandal, a ragged safety net exposed | Reuters

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.

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