The muddled mind of a UKAS assessor

UKAS’s latest technical bulletin gives further insight into the muddled thinking that lies behind the ISO scheme.

Medical Royal College examinations, Continuing Professional Development, GMC registration, revalidation etc. etc. are all unable to render doctors competent any more.

And UKAS want their cut of the bureaucratic profit through ISO 15189:2012.

“As shown by the range of indicators that might contribute to the assessment of competence, good performance in EQA/iEQA does not automatically demonstrate competence and equally, poor performance does not automatically mean lack of competence.”

So, even though performance in EQA schemes proves little, doctors must still submit to UKAS assessing them through a method they admit confirms nothing.

The old BSI strategy is to maximize the potential points of failure and pretend this is meaningful or helpful.

This self-contradiction will protect UKAS from being sued for defective pathology.

Though note that BSI is in trouble again for continuing with its deceptive advertising when the Advertising Standards Agency told it not to.

UKAS will play its part in squeezing the life out of healthcare purely for its own profit.

The bulletin in full:

» Technical Bulletin – UKAS Position Paper: Assessment of a Medical Laboratory’s approach to the assurance of clinical staff competence and use of EQA

28 November, 2017


This paper is intended to clarify requirements of ISO 15189:2012 and UKAS’ expectations of how a medical laboratory demonstrates the competence of its clinical staff. This paper also includes information on the use of External Quality Assurance (EQA) programmes.

This paper has been developed by the UKAS Medical Laboratory Technical Advisory Committee following some questions concerning the approach to the assessment of clinical staff competence and seeks to provide clarification to laboratories of the information that a laboratory needs to provide to UKAS as part of its assessments.

UKAS accreditation provides independent confirmation of a laboratory’s competence to carry out specified activities. UKAS assessments are conducted to gather objective evidence that a laboratory is competent; assessing the competence of a laboratory will include the competence of the personnel, the validity of test methodologies and the validity of outcomes/test results.

It follows that UKAS must assess the procedures a laboratory has in place to evaluate the on-going competence of all staff and the associated evidence and records that demonstrate implementation. As with all areas of assessment, this will be assessed through a sampling exercise on assessment visits. As stated in previous guidance in this area (Assessor Update April 2015), competence in the provision of clinical advice/opinion is likely to be based on multiple components.

UKAS considers that EQA provides valuable information for laboratories and accreditation bodies that gives assurance about the medical laboratory service, including assurance on clinical interpretations. Participation in EQA is not a compulsory component of the assessment of the competence of clinical staff, however, as evidence of conformity to good medical and scientific practice and continuing professional development, where appropriate schemes exist, laboratories might reasonably expect their clinical staff to participate.

The Assessment

It is the laboratory’s responsibility to define the criteria that it uses to determine the competence of its staff. UKAS uses competent peer assessors that have the demonstrable knowledge, skills and experience to evaluate the laboratory’s approach and assess examples of records to determine that the approach is followed and is effective.

ISO 15189 provides some examples (Clause 5.1.6 Note 1) of how a laboratory can assess the competence of its staff, both initially and on an ongoing basis. A laboratory may choose to use different mechanisms to provide information about the ongoing competence of its staff and this might include the use of EQA where it exists and is appropriate. UKAS understands that there are some limitations to the use of EQA in this way, particularly ’interpretive’ EQA schemes (see below).

ISO 15189 clause 5.1.9 specifies the content of the records to be held for all personnel and requires that the records are readily available. The laboratory should consider carefully how it will retain access to this information, taking into account that some competence information may be held as part of confidential appraisal records or performance reviews. The assessment team needs to assess the evidence that is used to demonstrate competence and the laboratory should seek to provide this without compromising confidential information that is not relevant to the assessment.

The assessment of the laboratory’s approach to evaluating clinical staff competence may include assessment of, but not necessarily be limited to, the following:

  • Qualification records, experience, knowledge, appointment process, induction, training sign off
  • Records of EQA participation
  • Mechanisms to monitor on-going competency internally and associated records
    • Any competency assessment programme would have defined acceptance criteria, including for clinical staff. It would be expected that such an on-going programme is suitably robust to cover all of the staff member’s scope of activity, at sufficient frequency.
  • Records of knowledge sharing, for example MDT involvement, case review discussions, case handovers, on call involvement
  • Suitability of competency programme acceptance criteria
  • CPD (e.g. College CPD, external meetings, course evaluations, iEQA)
  • Review of test reports
  • Coverage of all areas by internal audit
  • Minutes of meetings aimed at service improvement

It is acknowledged that information relating to a doctor’s competence is essential for the GMC revalidation process and will be gathered and reviewed as part of the regular appraisal process. Competence records held by the laboratory may be used by clinical staff to generate evidence for appraisal and vice versa. This should be conducted in such a way to preserve the confidentiality of information that is not relevant to the assessment.

UKAS Position on External Quality Assurance Participation

Technical EQA schemes

ISO 15189:2012 (clause requires the laboratory to participate in interlaboratory comparison programmes (such as EQA or proficiency testing) appropriate to the examination and interpretation of results. UKAS Publication TPS 47 Policy on participation in proficiency testing contains more information to support the implementation of ISO 15189 and recognises that it is for the laboratory to judge the suitability of an EQA scheme to meet their needs. A laboratory may be able justify non-participation in an available scheme based on its suitability and/or other factors. The laboratory can also consider alternative approaches to providing assurance. It may be necessary to look beyond the UK for EQA scheme availability and laboratories may refer to the EPTIS database to assist with this process [].

Interpretive EQA Schemes

UKAS understands that not all interpretive EQA (iEQA) schemes are suitable for use in demonstrating the performance of the laboratory and/or individuals, and that participation may solely be for the purpose of CPD. It is for the laboratory to determine which schemes it will participate in and for what purpose. Where a laboratory is not participating in an existing scheme there needs to be justification for this; where a valid justification is not provided, a suitable finding will be raised.

Where individual staff participate in iEQA for the purposes of their own CPD, evidence should be included in their CPD records.


Assessment and Reporting

UKAS understands that participation in EQA/iEQA is primarily to provide information to develop and improve processes, knowledge and understanding, and to assure outcomes, and does not simply aim to achieve a specific result or answer. However, where unexpected results are encountered and any necessary action is identified, this should be progressed through the laboratory’s own governance system to consider opportunities for improvement.

While participation in EQA/iEQA may provide evidence of a positive approach to quality assurance, it is recognised that there is a strong educational component and EQA/iEQA scheme reports will often contain advisory and educational components to achieve this aim. As shown by the range of indicators that might contribute to the assessment of competence, good performance in EQA/iEQA does not automatically demonstrate competence and equally, poor performance does not automatically mean lack of competence.

Where UKAS identifies nonconformities, it is the responsibility of the laboratory to specify its improvement/corrective action, this is not something that is specified by the assessment team. It is usual for the laboratory to discuss its proposals with the assessor(s) and there is usually some discussion about the possible routes to take and the impact of each. Should the laboratory reconsider its original proposal and develop an alternative solution to an agreed improvement that addresses the finding, such evidence can be submitted and would be considered by UKAS.  

Download printable version of this Technical Bulletin


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Accredited forensic fakery – how assured are you feeling?

Herbert Edelhertz defined white-collar crime as: any illegal act or series of illegal acts committed by nonphysical means and by concealment or guile, to obtain money or property, to avoid the payment or loss of money or property, or to obtain business or personal advantages. Gilbert Geis defined upperworld crime as: a label designed to call attention to the violation of a variety of criminal statutes by persons who at the moment are generally not considered, in connection with such violations, to be the ‘usual’ kind of underworld and/or psychologically aberrant offenders.

We have seen previously how Randox was fleeced by UKAS in paying for the false assurance of accreditation to ISO 17025.  It didn’t stop “rogue scientists” altering forensic results.

Another forensic company has been drawn into the investigation.  Trimega Laboratories boasted of the prestigious UKAS accreditation it gained in 2013.  Here’s the press release in case it disappears in embarrassment:


Trimega Labs Drug and Alcohol Analysis

Since the acquisition of Trimega Laboratories last year, Ingemino have invested more than £1 million in developing our new laboratory

Trimega Laboratories, specialists in testing for illegal drugs, alcohol and DNA, are pleased to announce that hair drug testing analysis at its newly enlarged Manchester laboratory, has been accredited to the ISO/IEC 17025:2005 international standard by the United Kingdom Accreditation Service (UKAS). The accreditation was granted on July 10th. 

“This is great news and a credit to the hard work of the new management team. Since the acquisition of Trimega Laboratories last year, Ingemino have invested more than £1 million in developing our new laboratory and the supporting systems that go with it. As part of this process, we have developed an improved quality system and the UKAS accreditation is the ultimate seal of approval” says Fiona Begley, Director of Trimega Laboratories, and Executive Chairman of the Ingemino Group.

UKAS themselves explain the significance of accreditation on their website: 
“Accreditation is the only mechanism that determines the technical competence and integrity of the organisations offering testing services. ISO/IEC 17025 not only contains requirements for the quality management system of the organisation but they also include detailed and specific technical criteria for the operation of the technical service including ensuring the competence of personnel.”

The accreditation schedule for the testing of hair samples comprises the confirmation and quantitation of a total of 10 analytes and metabolites: Amphetamine, Methylenedioxymethylamphetamine (MDMA),
Cannabis: Delta 9-THC, Cocaine, Benzoylecgonine, Methadone, EDDP, Opiates: Codeine, 6 Monoacetylmorphine and Morphine. Trimega’s schedule of accreditation is published on the UKAS website. 

Frank Whitfield, recently appointed as the Trimega Laboratory Operations Manager following fours year with Roche Diagnostics, in describing the process of accreditation, said: “To gain accreditation, Trimega Laboratories had to undergo independent, rigorous audits by UKAS to establish not only that the analytical processes meet the standards, but that those standards are sustainable. We have rigorous checks in place at every stage of the testing process. Each sample that enters the laboratory can be traced via a chain of custody audit trail and can be tracked from the moment it enters the laboratory through to the issuing of the result.” 

As with all accredited laboratories, the processes will now be regularly audited by UKAS to ensure Trimega continues to meet the ISO 17025 standard. 

This latest accreditation adds to the ISO 14001 ‘environmental management system standard’ already awarded to the company and the ISO 9001 quality assurance certification awarded to the Client Services department based in Germany.

The prestigious ISO 17025 accreditation reflects the laboratory’s rigorous approach to testing and laboratory processes, to help ensure consistent calibrated, accurate results. By analysing a sample of hair from a donor, Trimega is able to develop a picture of the habit underpinning harmful substance misuse for up to a year prior to the date of the test. 


Editor’s Notes
Perfectly Picked communications
Tel: +44 (0) 1491 636262

About Trimega Laboratories

Established in London in 2005, Trimega Laboratories is a specialist in the legal testing for substance misuse and in paternity testing. Its core business is laboratory-based analysis of hair samples that provide accurate historical records of alcohol or drugs dependency over a one to 12 month period. In the UK, Trimega’s clients include: family law specialists, law courts, and social services.

Trimega Laboratories was acquired by the Ingemino Group in 2012 and since then the business has undergone a complete overhaul with new management and investment. Fiona Begley, Director of Trimega,Laboratories and Executive Chairman of the Ingemino Group is a renowned expert in this industry and former CEO of Concateno plc, the owner of Trichotech laboratories.

UKAS Accreditation:…
Confirmation and Quantitation of:
• Amphetamine
• Methylenedioxymethylamphetamine (MDMA)
• Cannabis: Delta 9-THC
• Cocaine
• Benzoylecgonine
• Methadone
• Opiates
• Codeine
• 6 Monoacetylmorphine
• Morphine

ISO accreditation is no security against false results.  Maybe the “rogue scientists” are solely to blame.  Maybe the unnecessary pressure it creates drives staff to faking results.  Either way, accreditation provides no assurance.  It is merely a confidence trick.

Let’s hope the solicitors of those falsely-convicted are gearing up to include UKAS in the writ.

The scientists will be prosecuted.  The UKAS senior managers will continue to walk free – the get-out clause is, “our assessment is only a sampling exercise.”

These events show their accreditation is as worthless as it is expensive.

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Essential Services Laboratories

If you’ve read John Seddon you will know that the front office – back office arrangement will be a disaster.  It may have been sold promising economies of scale and a new computer system, neither of which will work out well.  Workers need to be able to help customers solve their problem from beginning to end, not pass it on to someone who doesn’t understand.

Telemarketing Outsourcing

Lord Carter of Coles gave the NHS a version of front office – back office for pathology labs.  It’s called the Hub and Spoke model:

An external file that holds a picture, illustration, etc.Object name is cbr29_1p7f1.jpg

Illustration of the hub and spoke or disseminated laboratory medicine network. Numbers 1 to 5 represent laboratories on different sites that share common equipment, reference ranges and quality management system. All laboratories provide a common core service and specialised laboratory services are rationalised in line with clinical services. Small black circles represent centres outside the laboratory where laboratory testing is performed using point of care testing.


You can read Graham Beastall’s description of the plans here:  The Modernisation of Pathology and Laboratory Medicine in the UK: Networking into the FutureClin Biochem Rev. 2008 Feb; 29(1): 3–10.

It separates patients from the pathologists equipped to solve their problems.  You can work out some of the consequences of the misunderstandings and delays that are inevitable.

Professionals and their organisations largely went along with it because they didn’t have more persuasive ideas, quality had to be improved (though there was little evidence of problems) and the war cries of management that shut down critical discussion – “economies of scale”, “not fit for purpose”, “the status quo is not an option!” etc.

Some of these network management schemes have failed on a large scale.  Now the Royal College of Pathologists has released this document, Essential Services Laboratories – NHSI Oct 2017.  It is much better than some earlier professional opinions which mostly accepted the authority of the Carter proposals.  The College paper draws on experience of the destruction of services that will be brought about by the new arrangements when the labs of hospitals in England are reduced to 29 networks of “Essential Services Laboratories”.

Take note or watch the next disaster unfold…

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ISO – in the swamp

Oxebridge try to make ISO 9001 workable and would like to save it.  The ISO management standards are inadequate, a fraud and facilitate corruption.  We say, let them die.

Oxebridge have a sense of humour that’s unusual in those having to deal with the ISO.

ISO knows it can’t sue when its logo is used for purposes of editorial parody, but we still expect Wrigley candy company to sue for having their brand tainted by proximity to ISO.

More helpfully, they give a sample list of major scandals that ISO certification has been implicated in.

The Final Step to Saving ISO 9001

The problems facing the ISO 9001 and AS9100 certification schemes are many, and complicated. While auditing bodies and standards developers deny such problems, the evidence is irrefutable: ISO 9001 is not providing confidence in the quality of companies that adopt it, and the both the certification scheme and standards development process is dominated by a handful of private consultants who use their positions to enrich themselves. ISO’s customers – the users of ISO 9001 – have little to no say in developing the content of the standard, nor in how certifications are issued and accredited. The CBs and their oversight Accreditation Bodies have abdicated their duties in enforcing the rules, and allow routine bad behavior, the most egregious of which is overt consulting by certification auditors. After Enron, the finance world learned of the problems this arrangement poses, and took action; in the ISO certification arena, those lessons are being ignored or fought outright, even as similar scandals loom on the horizon.

In the United States, Oxebridge estimates the ISO 9001 industry in the United States to be between $1.5 to $2 billion dollars annually, much of which is flowed down to consumers and taxpayers. This does not include lost productivity and expenses associated with implementation and audit support efforts. In addition, the impact on a poorly run ISO certification industry has a direct impact on the public health and safety. We have since learned that the companies involved in the Takata airbag scandal and the DeepWater Horizon oil spill were certified by accredited ISO 9001 certification bodies. Likewise, well-publicized fiascoes related to the production of the F-35 Joint Strike Fighter, the doomed Shuttle Columbia, the 787 Dreamliner battery fires, the PIP breast implant scandal and the Volkswagen/Bosch emissions defeat scandal involved ISO certified supply chain actors.

Within the US, a single entity holds sway over both standards development and the certification scheme: the American National Standards Institute (ANSI).Yet for the past few years, ANSI representatives and executive management have ignored or resisted outright all calls for improvement, reform or even informal internal introspection. In short, they deny there are any problems. As an entity that derives revenue from the sale of standards and through certification activities, this is not unexpected.

In 2012, the CEO of ANSI – Joe Bhatia – testified before the US Congress, and promised the Federal government that all was well regarding ANSI, the ISO 9001 development process, and the ISO certification scheme. The testimony included statements that have since been proven to be untrue, and were likely untrue when the testimony was given.

Given the impact of the failures of ISO 9001, it is imperative that the Congress and American people have equal access to true and current information, including the dangers and costs the current system presents, as well as ANSI’s failures to adhere to its responsibilities. Congress must then take suitable steps to demand explanations from ANSI, and – if it deems it appropriate – investigate thoroughly. The goal should be to restore the trust in third party ISO 9001 certifications, and the standard itself, for the purposes of reducing waste and fraud, and reducing the risks to public health and safety…

Make sure you click through and read the testimony of ANSI’s CEO .

“If a legal case can be made that Bhatia misled the government, then it could be argued that both ANSI and ANAB are involved in a literal conspiracy to defraud the United States government.

Are things any better with BSI, UKAS and other cartel members who lobby politicians outside the USA?

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Kobe Steel – ISO 9001 certification of corruption



Kobe Steel.  You can download their recent ISO 9001 certificate here.

UKAS.  IAF.  Lloyd’s Register LRQA.  It’s got all the jealously-protected logos.

Yet the company has been falsifying quality data for its products for over a decade.  Kobe even have memos on how far deviations are permissible from the stated tolerances.

The Japanese automakers say the metals are actually OK.  Were certified standards too tight in the first place or are all the companies lying?

Certification obfuscates.  For all the talk from the inspection cartel about anti-corruption, it cannot prevent it.  Maybe it obliges deception because its standards are so impractical to meet.

Why should the industrial companies be more at risk than the quality cartel’s well-protected branding?

The Bank of Japan protects the corporate deceivers (they made political campaign donations).  It buys Kobe’s corporate bonds and spreads the losses to the taxpayers and pensioners.

Just like the cartel’s inspectors are never to blame and never experience the consequences of their failures.

Read more here:

The hidden chapter of Atlas Shrugged

and here:

Japan’s automakers issue reassurances as global bodies urge freeze on Kobe Steel products 




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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 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 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.



•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.



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!’


‘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,

Host trust quits financially ‘fragile’ NHS pathology venture

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’.”



Clearly foreseeable


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