Randox rogues show ISO doesn’t balance

We saw before that Randox Testing Services paid UKAS for ISO accreditation of forensic testing.  Accreditation couldn’t stop employees rendering the results unreliable by falsifying QC results.  Randox called in the police.

The Daily Mail reports on the continuing investigation,

Dr Tully also raised the possibility that the problem may spread wider than just Randox.

She said: ‘The organisation concerned held accreditation to the appropriate quality standard, but the malpractice was not discovered by the usual quality checks. 

‘This raises a number of questions, including: a, whether or not malpractice is more widespread than at one organisation; and b, whether or not the quality standards need to be strengthened.’

But she went on: ‘No reasonable set of quality standards could guarantee to prevent determined malpractice by skilled but corrupt personnel and the inevitable cost of adding additional safeguards should be balanced against risk.’

Randox said last night it is paying for the retesting to be carried out in independent labs. (emphasis added)

Dr Tully is correct: balance safeguards against risks.  ISO doesn’t balance.

Once again, accreditation isn’t paying for the increase in costs its obsessive collection of evidence demands.

Maybe we need a new ISO standard that’s more oppressive.  Maybe the inspectors should be fired because they didn’t do their jobs well enough (though nobody is asking).  Maybe the RTS needs to improve its management to get the best out of its staff.  Maybe without accreditation, staff would have not felt so oppressed that they had to resort to deception.  Time will tell.

The ISO is catching up again by putting anti-corruption and risk assessment into its latest version of ISO 17025.  Will anyone assess the risks from wasting resources on accreditation?  It’s just to provide fodder for keeping the cartel running and inspectors employed, as jobs in real science vanish.

Randox: you run your own EQA scheme; take up the challenge – produce a simpler, better system of quality assurance that lets labs dump UKAS.

 

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ISO 9001: in need of further compulsion

ISO 9001 is slowly withering.  ISO 17025 is popular among science managers and legislators.  Therefore the new revision of ISO 17025 contains a mandatory nudge towards ISO 9001 to inject a bit of vigour into it.

UKAS explains:

» ISO/IEC 17025 Standard Revision Update

» ISO/IEC 17025 Standard Revision Update

–>12 January, 2017

The Draft BS EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is now available on the BSI website for public comment.

For the past couple of years, ISO/CASCO Working Group 44 have been busy preparing this new version of ISO/IEC 17025.

This standard, first produced from EN 45001 and ISO Guide 25 back in 1999, underwent just a minor revision in 2005.

The present revision addresses the need to align it with the other more recent ISO 17000 series standards, as required by ISO CASCO and to modernise the standard, recognising advances in technology and business practices.

There are no significant technical changes and presently compliant laboratories are unlikely to have any significant issues with the new standard. The biggest difference is in the structure of the Standard, which is completely revised, having distinguished “resource” from “process” and acknowledging the possible role of an ISO 9001 based management system.

Work in the UK on the revision is being undertaken by BSI’s UK WG44 Mirror Group, the secretary is sarra.cheyne@bsigroup.com. It is chaired by Trevor Thompson from UKAS and contains representatives of laboratories and stakeholders.

Trevor would be pleased to receive any comments for consideration by the UK mirror group, or you may comment direct to BSI as instructed on their website. UKAS has set up a mailbox 17025.review@ukas.com if you wish to contact the UK mirror group.

Please bear in mind that the restructuring of the standard is mandatory, as is the inclusion of the ISO 9001 option. Please make any comments only on the online form, and only when suggesting replacement text on the form. BSI have set a public comment closing date of 22 February 2017.

It is presently expected that the Standard will be published at the end of 2017 and it shall have a three year implementation period. We shall, of course, be in touch with affected customers, later in the year.

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Compliance audit fails again. And again…

Potential food safety breaches uncovered at UK’s largest supermarket chicken supplier in ITV News/Guardian investigation

Investigations have alleged a major chicken processor has been guilty of numerous offences including repackaging out-of-date chicken and destroying traceability evidence.

stream_imgThe company replies,

“We also successfully operate in one of the most tightly-controlled and highly regulated food sectors in the world.

“We are subject to multiple and frequent unannounced audits from the FSA, BRC, Red Tractor, independent auditors as well as our customers. By example, our facility in the West Midlands under investigation received nine audits (five unannounced) in the months of July and August alone.”

These weren’t ISO compliance audits monopolized by UKAS.  However, audits by government and independent auditors failed to pick up multiple malpractices that were detected on camera by ITV News/Guardian investigators.

So what does compliance audit, which is the foundation of inspection businesses, really assure?  It’s not keeping business owners honest and it’s not protecting consumers from fraud and hazards.

Will making audit bigger and better through ISO 19011:2011 Guidelines for auditing management systems prevent practices such as those above that we can see on camera?

As usual, the ISO is attempting to catch up with superior management practices and trying to convince its victims of its relevance.

Even rotten meat doesn’t go to waste in some sections of the meat industry; why must the inspection industry create waste everywhere else?

 

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No gain without pain

A profile of child branding cases in Kashmir valley

Rashid, AF et al. 

Journal of Forensic and Legal Medicine Volume 49, July 2017, Pages 50–53.

https://doi.org/10.1016/j.jflm.2017.05.001

https://s100.copyright.com/AppDispatchServlet?publisherName=ELS&contentID=S1752928X1730046X&orderBeanReset=true

________________________________________

Highlights

•The article is a two year study on Child branding practices in Kashmir valley practiced by faith healers [quacks].

•These healers possibly relieve the initial stigmata of the disease by playing with body’s “pain gating mechanisms”.

•The mistreated disease condition continues to fester undiagnosed which increases its morbidity and mortality.

•The study aims to establish a pattern between child branding and its medical; social and economic correlations.

•A positive outcome of this study is educating people to shun such practices and follow proper treatment regimens.

________________________________________

Abstract

The article deals with child branding cases that were researched over a period of two years. Child branding practice is a common occurrence in the rural areas of the Kashmir valley where it is often practiced by faith healers [quacks] having no knowledge of underlying disease processes or the possible differentials of the same; leaving treatment protocols a distant possibility for the same. These illiterate so called healers possibly relieve the initial stigmata of the disease process that is pain by many procedures including burning the affected population with hot coals; embers; and various other pain inducing processes. In this way cutting a painful condition by stimulating another painful condition by possible intervention of body’s “pain gating mechanisms” bring a somewhat temporary relief to the sufferer. This undiagnosed and mistreated underlying disease condition meanwhile continues to linger on with increasing severity often causing morbid relapses and ultimately resulting in a highly mortal course when the patient is actually brought for tertiary hospitalization. The present study aims to establish a pattern between child branding and its medical; social and economic correlations. Among these correlations the study will focus on disease related morbidity and mortality; role of community based faith healers [“quacks”]; poverty and illiteracy. The study will also reveal how bits and pieces of scientific information have been used to misdiagnose and mistreat a significant population belonging to pediatric age group. It will further try to evaluate the role of “pain gating” mechanisms as a means of pain relief and the partial success in motivating a significant population by these healers to be part of such practices. A positive outcome of this study is educating a significant part of affected population to shun such practices and follow proper treatment regimens.

At least somebody is investigating the Kashmiri quackery.  In the West we have better PR. 

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Inside the minds of pathology reformers

Reforms to pathology services according to the Carter Report are still doing poorly.  The cover-up of the failures is working better:

Pathology Networks

The morning session provided attendees with different perspectives on Pathology Networks; appropriately titled ‘Networks – a blessing or a curse’.

Dr Cathy Street, Consultant Clinical Biochemist, offered a unique personal insight into Pathology Services in England. She outlined the key themes of the Carter Independent Reviews (both 2005/2008) based on consolidation of Pathology services in England. The aim of this consolidation of Pathology services was to provide improved service quality, responsiveness and cost effectiveness.

She indicated how the transformation of pathology services has moved quite slowly with issues surrounding; differentiation of ‘hot’ and ‘cold’ work, logistics between the ‘hub and spoke’ laboratories, underestimation of costs associated with development/reconfiguration of Pathology Networks, and the unrealistic models for delivery of Pathology services which have been devised. These issues have impacted on staff morale within laboratories leading to the loss of many experienced staff members.

Dr Street also highlighted the pathology related concerns raised by Royal College of Pathologists in their response to Lord Carter’s independent report, ‘Operational productivity and performance in English NHS acute hospitals: Unwarranted Variations’. The RCPath had indicated that the instruction to consolidate is ‘unlikely to save money and is likely to cost more in the long-term, put the lives and well-being of patients at risk and increase litigation’.

She questioned if the transformation of Pathology services has truly been clinically led and asserted that the establishment of managed Pathology Networks has resulted in greater losses than gains with a diminished quality of service providing no tangible benefit to patients and staff.

Dr Chris Fourie, of LTS Consulting, provided a very different perspective, as a consultant supporting consolidation and transformation of Pathology Services in England. LTS works with NHS Improvement for a number of Trusts and private Pathology service providers. LTS are supporting the NHSI to define the roadmap for Pathology through a summary of the current state of Pathology services and by setting a clear set of benchmarks. He suggested that finance and clinical input can be the key enablers or constraints to service delivery with major opportunities in the operational aspects of Pathology service delivery.

He outlined the recipe for success in terms of Pathology Service Consolidation which includes; Clinical Leadership, which plays a key role, Executive Participation, Logistics, Integration of Technology and Change Management Support. He also introduced PinpointBPS which is a performance management system that provides Laboratory Management with detailed analytics and structured process documentation.

Dr Pat Twomey, Consultant Chemical Pathologist (in the absence of Dr David James, Clinical Director, Southwest Pathology Services, SPS), provided a succinct overview of how Pathology services can be delivered through a public private partnership. SPS, formed in 2012, is a joint venture between Taunton and Somerset NHS Foundation Trust, Yeovil District Hospital NHS Foundation Trust and Integrated Pathology Partnerships (iPP). SPS delivers full laboratory services to a population of 500,000 patients and over 100 GP practices in Somerset. Dr Twomey outlined the key ingredients for a successful Pathology Network and the co-operation that can be achieved in a public-private partnership.

Dr Mike Ryan, Consultant Chemical Pathologist, Northern HSC Trust, completed the session with a highly engaging overview of Pathology Networking in Northern Ireland and its progress to date. He outlined the challenges that laboratories face such as rapid advances in technology, the changes in the QA and regulatory environment, unnecessary risks associated with variation in practice, the clinical demand for more effective ICT and constrained resources.

He was firm in his belief that information technology is the key to transforming pathology services and that many of the challenges are now drivers for the modernisation of the Pathology Service.

He presented the three proposals for modernising Pathology services in Northern Ireland currently in the public consultation domain. They include; consolidation of ‘cold’ testing activity, infrastructure development in terms of IT and logistics and an integrated management structure. He asserted that a ‘root and branch’ change is required to the way the Pathology Service is delivered and stressed that ‘there is no right answer but there is a wrong answer: that we do not change!’

http://www.acb.org.uk/docs/default-source/publications/acb-news/2017/june.pdf

35.

‘there is no right answer but there is a wrong answer: that we do not change!’ – a logical statement or a desperate rhetorical flourish in the face of contradictory evidence?

Change will come anyway; it doesn’t have to be the big, bad change brought to other hospitals by the command and control management that pays your salary.

Read more about how bad management survives common sense in this brilliant post from Thinkpurpose who really knows his onions: The secret management model that must not be named…

He even explains to NHS managers where performance management comes from.

 

Lessons from recent history

The collapse of UKAS-accredited, ISO-compliant pathology partnerships brought about by supposedly inevitable change should be more widely known.  Labs were doing so much more with so much less that they couldn’t function any more.  Leading to expensive waste when a functional service had to be re-established.

UKAS won’t do much that might upset the inflow of cash from public services that will pay for whatever UKAS demands.  Nobody blames them for blessing the mistakes of others.

Here is an expensive management failure, accredited but not caused by UKAS, passed off as restructuring:

https://thepathologypartnership.info/our-services/

Wikipedia explains the multi-million pound deficit a little more fully:

https://en.wikipedia.org/wiki/Pathology_Partnership

The HSJ explains in more detail for those with a subscription,

Host trust quits financially ‘fragile’ NHS pathology venture

https://www.hsj.co.uk/newsletter/topics/finance-and-efficiency/host-trust-quits-financially-fragile-nhs-pathology-venture/7006069.article

Blair-appointed life peer, Lord Carter’s promised savings from lab mergers have turned into wastes.  Some predicted these events.  Many just went along for the ride.

On Boss Level Podcast, watch John Seddon explain the creation of failure demand because in “a contingent relationship – ‘do this to get that’, we focus on ‘get that’.”

 

polluted-water-popsicles-taiwan-8

Clearly foreseeable

 

http://www.boredpanda.com/polluted-water-popsicles-taiwan/

 

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Validation and verification guesswork

Dr Bignardi has done a lot of work with validation and verification required by ISO 15189 for just one laboratory device.

Validation and verification of automated urine particle analysers.   http://jcp.bmj.com.sci-hub.io/lookup/doi/10.1136/jclinpath-2016-203958.

He reports it more simply in the Royal College of Pathologists Bulletin,

v&v

Note: the standards are lacking in detail to give free reign the imagination of UKAS inspectors.

As we have explained previously, the ISO managements standards are designed with a hypocritical vagueness because of the symbiotic relationship they have with the inspection side of the quality cartel.

Dr Bignardi has tried to make it more simple and sensible.  Professionals rise to the challenge of complying.  Will this approach work with all the non-standardised inspectors?

It remains to be seen whether the years of work in this one aspect of meeting the ISO standard will make much difference to patient outcomes.

 

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Resistance from academia to Chartered Scientist registration popular in the NHS

Another bureaucratic body seeks to expand its membership by coercion rather than proven virtue:

Drive to register all UK scientists: benchmark or bureaucracy?

Critics call proposal for world-first professional recognition system ‘demented’

April 20, 2017 https://www.timeshighereducation.com/news/drive-register-all-uk-scientists-benchmark-or-bureaucracy

A drive has been launched to make the UK the world’s first country where all scientists are professionally recognised, to help benchmark standards in academia.

The Science Council, which has previously worked closely with researchers from industry, wants more academics and university technicians to become registered or achieve chartered status.

The membership organisation argues that, at a time when there is growing concern about the reproducibility of scientific evidence, professional registration will help to make academics’ research credible, as they will be signing up to a code of professional ethics.

But university-based researchers have spoken out against the idea. One said it was “utterly demented” and could “regulate creativity”, and others questioned the scheme’s usefulness and potential bureaucratic burden.

While other countries have forms of registration for specific disciplines, such as chemistry or geology, the council said that the UK is the first country to look at registering scientists as one group.

The Science Council, a membership organisation for professional bodies and learned societies in science, currently has no power to enforce registration upon scientists. It sets the standards for professional registration of scientists and science technicians and licenses its members to accredit their individual members.

However, the organisation is working with the research councils, which are exploring a registration requirement for science technicians. It is also working with the Government Science and Engineering profession – the professional community for scientists and engineers in the Civil Service, which provides evidence for policy – to roll out registration and raise the profile of the process with key ministers.

Becoming a registered or chartered scientist has previously been popular in industry, and the Science Council hopes to extend this to academia.

The council’s new chair, David Croisdale-Appleby, who is also a visiting professor at Durham University Business School, told Times Higher Education that the introduction of tuition fees and the advent of the teaching excellence framework in England mean that measures of scientific career progression are changing.

“It won’t be enough that an academic is able to get published; she or he will have to also demonstrate that they are an able professional, with skills and experience in applying them that registration publicly recognises,” he said.

He added that “registration is an external mark of competence awarded and recognised outside your institution”, which will help academics hoping to move between universities and industry. “Academic pedigree alone will not be enough to secure jobs in the future,” he said.

But Tony Barrett, director of the Wolfson Centre for Organic Chemistry in Medical Science at Imperial College London, was not convinced of the idea’s merits.

“This is an utterly demented idea by some functionary or functionaries who have far too much spare time, little imagination, and the desire to thwart the progress of science and regulate creativity,” he said. “If I had wanted chartered status, I would have become an accountant or surveyor.”

In order to become registered or chartered, scientists have to apply in writing outlining their skills and experience and provide evidence to the Science Council or a licensed professional body, such as the Institute of Physics or the Royal Society of Chemistry, for example. Some bodies require a face-to-face assessment as well.

Professor Barrett said that no scientists at any stage of their career would benefit from “yet another layer of pointless paperwork”. But he added that the idea could appeal to “third rate scientists” who may see it as a way “to overcome feelings of inadequacy or ineffectiveness”.

Philip Moriarty, professor of physics at the University of Nottingham, said that the key advantage of the scheme was that it would provide “much needed recognition” for technicians. “They’re the lifeblood of universities but too often this is forgotten,” he said.

The move could also “potentially lead to more rigorous standards with regard to publication ethics”, he said. But he added that it was not clear how this could be enforced.

Professor Moriarty added that the process could potentially involve “a massive bureaucratic workload”.

“I’d be concerned that some generic, jargon-ridden commitment to the principles of the scheme will need to be written up and evidence provided to demonstrate that those principles have been followed,” he said.

David Fernig, professor of biological chemistry at the University of Liverpool, said that he could not see how it would be useful for academia and doubted that registering all scientists would be achievable.

He added that the idea of chartered scientists “goes against the growing trend of ‘citizen scientists’ in their many different guises”.

“The status would most likely be used as a lever to protect the few against criticism. Critical thinking is in short enough supply already,” Professor Fernig said.

holly.else@timeshighereducation.com

Reader’s comments (1)

#1 Submitted by Jaswinder007 on April 20, 2017 – 10:15am

Great, who will pay for the registration? As in case I am SMIEEE (paying £150 per year), FHEA (luckily free). I have not applied for CENg because I cannot afford another £100 per year, not that I won’t be granted CEng if i apply because I do qualify. Where do we stop and what do we want to prove…?

(emphasis added)

 

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EU 2017/625 recognizes expense of ISO accreditation. But still requires it.

Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation)Text with EEA relevance.

recognizes that accrediting labs to ISO 17025 is costly,

(50)

Laboratories designated by the competent authorities to carry out analyses, tests and diagnoses on samples taken in the context of official controls and other official activities should possess the expertise, equipment, infrastructure and staff to carry out such tasks to the highest standards. To ensure sound and reliable results, those laboratories should be accredited for the use of these methods according to standard EN ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’. The accreditation should be delivered by a national accreditation body operating in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (16).

(51)

While accreditation is the instrument of choice to ensure high performance by official laboratories, it is also a complex and costly process, which would result in a disproportionate burden for the laboratory in cases where the method of laboratory analysis, test or diagnosis is particularly simple to perform and does not require specialised procedures or equipment, as is the case for the detection of Trichinella in the context of the inspection and, under certain conditions, in cases where the laboratory only carries out analyses, tests or diagnoses in the context of other official activities and not of official controls.

(52)

In order to ensure the flexibility and proportionality of the approach, in particular for animal health or plant health laboratories, provision should be made for the adoption of derogations aimed at allowing certain laboratories not to be accredited for all the methods they use. That happens in particular where validated methods for detecting particular pests of plants are not available. Moreover, accreditation of a laboratory for all the methods that it should use as an official laboratory might not be immediately available in cases where new or recently modified methods are to be used, in cases of emerging risks or in emergency situations. Under certain conditions, official laboratories should therefore be allowed to carry out analyses, tests and diagnoses for the competent authorities before they obtain the relevant accreditation.

(emphasis added)

It’s good to see the flow of revenue to waste and the inspection industry is now recognized.  Maybe in future years it will be understood that inspection does not guarantee quality and that no study has been done to check.  Oops!

Or maybe not, because revealing that EU officials don’t know the effectiveness of accreditation, or whether results from “official” labs are always perfect, would undermine several bureaucratic regimes.

Paragraph 52 also recognizes the slowness of the ISO and accreditation bodies to respond to new scientific developments.  It allows labs to investigate new hazards without accreditation for a year or so.  So will accreditation later make a difference to the quality of results?

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ISO/IEC quality coercion doesn’t work for software either

ISO 9000 doesn’t create quality for general management and ISO 17025 and 15189 don’t work for labs.  The authors below “conclude that ISO/IEC 9126 is not suitable for measuring design quality of software products.”

The use and usefulness of the ISO/IEC 9126 quality standard

Hiyam Al-Kilidar, Karl Cox, Barbara A. Kitchenham

This paper reports an evaluation the utility of ISO/IEC 9126. ISO/IEC 9126 is an international standard intended to ensure the quality of all software-intensive products including safety-critical systems where lives are at risk if software components fail. Our evaluation exercise arose from an experiment that required a quality assessment of outputs of the design process. Although ISO/IEC 9126 is intended to support evaluation of intermediate software products, both the experimental subjects (158 final year computer science and engineering student) and experimenters found the standard was ambiguous in meaning, incomplete with respect to quality characteristics and overlapping with respect to measured properties. We conclude that ISO/IEC 9126 is not suitable for measuring design quality of software products. This casts serious doubts as to the validity of the standard as a whole.

DOI: 10.1109/ISESE.2005.1541821
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Exciting developments in healthcare

UKAS says Brexit will require more accreditation.  HM Government seems inclined to believe this. 

The Royal College of Physicians (RCP), NHS England, the Institute of Physics and Engineering in Medicine (IPEM), the Royal College of Radiologists (RCR) and the Society and College of Radiographers (SCoR) are the latest organisations of healthcare professionals to give themselves over to supporting accreditation by UKAS.

You can read these stories from UKAS here.

Are the profit-hungry US companies that want to use the NHS brand going to continue to pay for inspections by the quality cartel?

 

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