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.
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.
» 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 email@example.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 firstname.lastname@example.org 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.
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.
The 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?
Reforms to pathology services according to the Carter Report are still doing poorly. The cover-up of the failures is working better:
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!’
‘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:
Wikipedia explains the multi-million pound deficit a little more fully:
The HSJ explains in more detail for those with a subscription,
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’.”
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,
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.
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,
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).
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.
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.
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?
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.
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?