UKAS now “a partner to Government”

In a BMTA interview with retired chief executive of UKAS, Paul Stennett MBE,
we learn,
UKAS and the Government are now able to use each other to avoid the parliamentary scrutiny that legislation ought to be subjected to.
ISOs are done in-house and the inspection cartel don’t answer questions.
They’re much more detailed and less reasonable than legislation.
ISOs are inspected rigorously at the expense of those accredited.  Who could pay for a police presence every time a crime is committed?
The enforcement of ISOs versus the law is horribly imbalanced.
We also learn that all pathology laboratories are now paying their dues to UKAS:
Are those diagnoses and treatments any better than in 2003?  Or has not-for-profit UKAS just won a big diversion of NHS money from its lobbying government?
But he’s not telling us how pathologists in Scotland have quickly found accreditation to be a waste of money and have told this to the Scottish Parliament.
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Randox Testing Services blew the whistle on rogue employees -and on UKAS

Randox Testing Services (RTS) were hit by employees manipulating forensic results.  So far, it may affect 10,500 specimens.  It’s going to cost RTS £2.5M to retest specimens the police sent them.  That’s on top of what they paid to UKAS to provide accreditation “assuring” the quality of their services.  

Signs and Red Flags a Business Is an MLM Scam

A company like Randox might think of extending its own QC services to compete with the sham ISO 17025 scheme.  If only it could get past the other gang members in the ISO, IAF and co.  

RTS’s statement says,

“RTS are new to the forensic arena and in establishing their capability employed staff with employment history from other accredited laboratories, the Forensic Science Service and UKAS.  RTS complied fully with all UKAS accreditation requirements and in numerous inspections by UKAS, when it appears manipulation was underway, nothing untoward was found.”

What’s next?  Will the Fraud Squad being investigating UKAS for its part in an international Multi-Level Marketing scheme?

The UKAS logo is the product

Perhaps the police never heard the UKAS assessors assuring RTS that their inspection is only a sampling exercise and can’t assure anything they didn’t inspect.  

This is something the ISO should insist goes on every report form.  Right next to the logo UKAS want placed there as free advertising.  

Who’s promoting whom?

The logo is the product.

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Failed regulation of medical devices

The BMJ is asking Why aren’t medical devices regulated like drugs?  

“How much do you know about the safety and effectiveness of the implanted devices your patients are offered? You may assume that pacemakers, neurostimulators, joint prostheses, and breast implants have been tested rigorously before being licensed for widespread use. But this week a major international investigation, involving 59 organisations and including The BMJ, finds device regulation unfit to protect patients from harm (https://www.icij.org/investigations/implant-files; doi:10.1136/bmj.k4999, doi:10.1136/bmj.k5010, doi:10.1136/bmj.k4917, doi:10.1136/bmj.k5026).”

This is part of a wider investigation by the International Consortium of Investigative Journalists into medical implant scandals.  There’s lots of informaton on the Implant Files website.  Contact them if you’ve a story to tell. 

We’ve been watching the evidence accumulate that shows most disasters are ISO-certified disasters.  Oxebridge reports on them often.  While paying the ISO 9001 tax may be declining (why else would ISO fudge the figures?), agri-food and bioscience remain big growth area for UKAS accreditation. 

In the next phase people are going to find out the role of the ISO cartel in making everyone think these devices were safe.

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Statistical pitfalls of accreditation

While doctors who experience UKAS assessments are becoming increasingly cynical about them, few have yet called out accreditation and stopped it.

Stephen Senn’s comment in Nature,

Statistical pitfalls of personalized medicine.  Misleading terminology and arbitrary divisions stymie drug trials and can give false hope about the potential of tailoring drugs to individuals, warns Stephen Senn.

explains why expectations should be lowered for personalized medicine.  If you’ve waited weeks for a GP appointment you may already be questioning the potential of personalized medicine.  Is it just a wheeze to boost academic careers?  How often will it make a difference for ordinary patients?

Hardly any work has been done to investigate how the imposition of ISO 15189 on pathology labs has improved patients’ lives.  Is the “quality” achieving faster or more certain diagnoses?  Is it curing more patients or reducing suffering?  Why is nobody measuring this when so much effort and money is being poured into supporting the inspectorate that cannot prove its worth? 

To think about it, replace “patient” in Senn’s diagram with “lab” and “drug” with “accreditation”.


Why are no evaluations available for the effect of accreditation on laboratory improvements? 

Why do labs have to do endless measurements of limited value while there is no similarly demanding measurement of inter-assessor variation? 

Why are assessment between assessment bodies kept secret?  Labs need to know if they’ve paying money to a body that’s got lots of non-compliances – because they’re precluded from choosing one from a different country. 

Read Senn’s article to see why it is so difficult to reach firm conclusions about the effects of treatments.  Many clinical studies get it wrong.

For ISO accreditation, no studies get done.  It would be challenging to test accreditation meaningfully.  Yet still the confidence trick remains widely-accepted.

Chris Paris is correct to relate it to Multi-Level Marketing rackets like Amway

Maybe one day the inspection cartel will suffer a similar judgemt to Amway.

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Police question third forensic scientist in ISO-accredited lab

The Daily Mail has reported police investigation of another forensic scientist employed by Randox Testing Services.  

You can see that accreditation is still in force for the company so UKAS can keep invoicing them every year.

“This is just a sampling exercise” the assessors have to warn in case they create the impression that UKAS might have legal liability for what they approve.  

More than 10,000 forensic samples may be affected.  This is one more large public crisis presided over by ISO accreditation.  How much longer will UKAS be able to claim it is 

It’s arguably not the fault of Randox – or even the fault of UKAS.  However it does demonstrate clearly that ISO accreditation can give little assurance against human dishonesty.  

Let’s hope this one gets the legal scrutiny it deserves. 

Police question third forensic scientist on suspicion of tampering with test results amid fears more than 10,000 blood test results were doctored

  • A lab worker has been questioned by detectives investigating sample tampering
  • More than 10,000 blood sample results may have been potentially doctored 
  • The Mail on Sunday revealed last year that 10,000 cases were being re-examined due to fears about the reliability of Randox tests 

By Martin Beckford Home Affairs Editor For The Mail On Sunday

Published: 00:33, 25 November 2018 | Updated: 00:37, 25 November 2018

Britain’s biggest ever forensics scandal has deepened with a third scientist now under suspicion of tampering with test results.

The laboratory worker has been questioned by detectives investigating the potential doctoring of more than 10,000 blood sample results.

It has led to innocent motorists losing their licences after being wrongly convicted of drink and drug driving and may have resulted in children being wrongly removed from their parents.

The laboratory worker has been questioned by detectives investigating the potential doctoring of more than 10,000 blood sample results [File photo] 

The laboratory worker has been questioned by detectives investigating the potential doctoring of more than 10,000 blood sample results [File photo] 

Like the two previous men arrested, the latest suspect worked for both Trimega and Randox Testing Services where the alleged manipulation of toxicology tests for police and social services is believed to have taken place over many years.

The widening of Operation Churchill – the codename for the criminal investigation – was revealed last week by Justice Minister Lucy Frazer. 

‘Greater Manchester Police are undertaking an ongoing, expansive criminal investigation into alleged manipulation of toxicology results now by three individuals who were employed at Trimega and later Randox Testing Services after Trimega’s liquidation in 2014 and this matter is being treated with the utmost seriousness,’ she said.

‘As the police are now treating all results obtained by Trimega between 2010 and 2014 as unreliable, and because Trimega provided toxicology testing for civil and family court cases, it is possible that some civil cases may have been affected by manipulation.’

Mrs Frazer said that at least one family court case has been reopened because it was based on a fabricated Trimega test. The Mail on Sunday has established that it involves a father forced to undergo a hair alcohol test in 2011 as part of divorce proceedings.

It has led to innocent motorists losing their licences after being wrongly convicted of drink and drug driving [File photo]

It has led to innocent motorists losing their licences after being wrongly convicted of drink and drug driving [File photo]

Due to the inaccurate findings, he was ordered not to drink when he saw his child. But when the forensics scandal emerged and the sample retested, the order was altered at Worcester County Court in June.

The Mail on Sunday revealed last year that 10,000 cases were being re-examined due to fears about the reliability of Randox tests. The firm is having to pay the estimated £2.5 million cost for other forensics firms to retest samples that are considered unreliable.

The Crown Prosecution Service has informed a number of motorists over the past year that their convictions have been set aside or that they will not have to face trial.

Britain’s biggest ever forensics scandal has deepened with a third scientist now under suspicion of tampering with test results [File photo]

A spokesman for Richard Silver Solicitors in Manchester said it was handling several Randox cases. ‘Following retesting, one of these cases has just been dropped by the prosecution,’ he said. ‘Had we not spotted the issue, the motorist would have been disqualified from driving and faced a heavy fine.’

Greater Manchester Police confirmed that the third man had been interviewed under caution in February and that the two previous suspects, aged 47 and 31, remained on police bail.

Randox said it was unable to comment on an ongoing police investigation, but added that it had agreed to cover the cost of retesting ‘as a matter of good faith’.

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Uncertainty of hypocrisy

When the assessors visit they want to see that masses of statistical work has been done to demonstrate the uncertainty of your measurements.  ISO 17025 requires it.  Assessment gang members have additional guides on it.  Customers who just wanted test reports find uncertainty confusing.

Oxebridge reports the IAF’s claim that 93% of its customers have transitioned to its 2015 standards.

iaf93percent.jpg

Click and read the analysis of data that shows they’re lying.

isosurveyscreenshot-768x351.jpg

There’s nothing new in their numerical fabrications.  Remember John Seddon’s open letter to Stephan Breeze at the BSI when customers were rubber-stamped into the latest standard overnight in order to meet the transition deadline?

The panic transitioning looked better than simply lying about the figures as they do now.

While UKAS demands calculations of uncertainty of measurement that are often time-wasting and unnecessary, none of the cartel members are being pressed to deal honestly with the corrupted statistics they use to promote their publishing and inspection businesses.

 

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Getting Rid of Stupid Stuff

Melinda Ashton wrote in Getting Rid of Stupid Stuff 

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ISO standards – the backlash

Nuclear safety guy, Martin Wakeman, summarises the backlash against malpractice using ISO standards in cartoons:

IMG_2991

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Accreditation of US hospitals did not improve patient outcomes

The BMJ published

Association between patient outcomes and accreditation in US hospitals: observational study by Lam et al. BMJ 2018;363:k4011  http://dx.doi.org/10.1136/bmj.k4011

The Boston doctors investigated over 4 million patient outcomes in this retrospective observational study.

Their conclusions?

“US hospital accreditation by independent organizations is not associated with lower mortality, and is only slightly associated with reduced readmission rates for the 15 common medical conditions selected in this study. There was no evidence in this study to indicate that patients choosing a hospital accredited by The Joint Commission confer any healthcare benefits over choosing a hospital accredited by another independent accrediting organization.”

It’s not run by the ISO gang but the idea is similar.  The Joint Commission dominates the marketplace and its inspections focus on structural factors and processes rather than the outcomes that matter.

Let’s hope for more studies like this exposing multimillion dollar rip-offs.

No time to read the paper?  Medscape has a shorter summary here.

 

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Six Sigma Is Draining Employees’ Creativity

Should your organization decide that ISOs are inadequate and add Six Sigma, consider Andrew Smart’s explanation and click through to read more fully or to order his book:

The single most important goal of the Six Sigma is to reduce varia­tion in organizational processes by using disease vectors to spread throughout the company. These vectors are improve­ment specialists, a structured method, and performance metrics.

This is similar to what the underlying disease in epilepsy does to neurons. During a seizure, the variations in the neu­rons are reduced. Reducing variation in the brain is devastating.

Applied to an entire company, the Six Sigma process is analo­gous to an organizational epileptic seizure….

The only system we know of in the universe that can be innovative is the human brain. But the brain seems to need things like freedom, long periods of idleness, positive emo­tions, low stress, randomness, noise, and a group of friends with tea in the garden to be creative. The truth is that we can’t have it both ways. Until we figure out how to give robots a “creative mode,” humans are going to be the only source of innovation for the foreseeable future.

The human brain actually seeks out and thrives on its own variation. With each new experience we have, our brain is irre­versibly changed. These changes become more profound and stable if we rest between new experiences. This allows our brain to consolidate what it has absorbed and integrate it into our own sense of self, therefore making meaning out of experience.

The process is different for each experience and different for each person. Neuroscience is discovering that a crucial part of this process is to allow the brain’s default mode network time to be active. A resting brain is necessary for this to happen.

To get the message even better, click to play his Autopilot text adventure.

Chill, man.

 

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