Going where no ISO has gone before


As the inadequacy of ISO 15189 is increasingly recognised, CPA and UKAS have persuaded the Royal College of Pathologists that the answer lies in extending the inspectors’ remit to important areas outside the current ISO: 

Clinical Pathology Accreditation
The Royal College of Pathologists actively encourages its members to engage positively with Clinical Pathology Accreditation, which is now owned by the United Kingdom Accreditation Service. However the limitations and restrictions of CPA, as currently based on the international standard (ISO 15189), have been widely discussed. Specifically, CPA accreditation concentrates heavily on evaluating processes within the laboratory, but does not adequately cover the crucial interfaces between patients, clinicians and the laboratory. As Lord Carter’s reports pointed out, quality evaluatiuon (sic) must cover ‘the end-to-end process’.
Within the United Kingdom Accreditation Service (UKAS) there is an acknowledged need for the profession to define standards and how they should be measured so that the remit of CPA in accrediting pathology services can be widened to include the measurement of performance against these standards.
These suggestions are made to assist this process.
Suggested CPA standards beyond ISO 15189:
Test repertoire
Turnaround times
Critical results communication
Point of care testing
Laboratory professional direction
Professional qualifications
Cover and handover
Primary identifier
Prospective monitoring of outstanding histopathology cases
Laboratory EQA analytical scheme membership
Histopathology EQA interpretive scheme membership
User and patient satisfaction surveys
EQA scheme professional direction

(Emphasis added to highlight this deliciously self-serving statement by the inspectors.) 

This is gravely disappointing, but it can still be avoided.

CPA and UKAS are more or less admitting that the ISO standard doesn’t do what it claims.  Their answer is the traditional fall-back position of bureaucrats – more bureaucracy.  This response is diagnostic of the bureaucratic mentality.  Even without clinical trials evidence, history tells us this will not work. 

It’s a pity that the College has not appreciated the difference between the antiquated ISO approach and other indicators of quality, many of which are probably valid, that the ISO forgot.  The ISO lacked the knowledge of clinical systems because ISO 15189 is derived from ISO 9001 which is based on BS 5750 which originated in defence manufacturing standards for a different type of work.  The Royal College also is making an  error in accepting UKAS’s authority on quality: UKAS’s expertise is in inspection, which is an outdated concept of quality

Hopefully the College can shake off the influence of UKAS’s evidence-free alternative medicine.  The answer is not to hand new parameters over to CPA for inspection.  Checking records for an even wider range of factors will not work.  The quality cartel’s system is flawed too fundamentally for this to work.  Its record-keeping-for-inspection destroys the purpose of pathology which is providing prompt and useful information to doctors and patients – not inspectors.  The non-technical ISO standards such as this control human actions, but not quality.  Now UKAS wants to use the standards’ failure to assure quality as a springboard for its own expansion through inspection beyond the ISO standards themselves.

UKAS attempts to embrace, extend and extinguish ideas superior to its own.  We are entering the extend phase.  Quality that customers want still exists. 

Yum, liver.

In due course the recent Key Performance Indicators may be written into a revised ISO and the UKAS monster will have more and more to feed its expansion.  This is part of the UKAS corporate growth plan – parasitically to bring all clinical measurement under its remit. 

Read the full College comment here.  You don’t ask the barber if you need a haircut.  You don’t have your car MOT’d because you’re worried about its quality or safety.  However, accreditation is a tax that is largely avoidable. 

The College should just say to UKAS, No, we can organise meaningful quality without you.

Learn from the economy the virtue of sometimes doing nothing.  Bill Bonner says:

“Having learned nothing, The Economist gives more bad advice:

“…[Republicans] main plank is that the federal government slash spending.

“ Families are tightening their belts and sticking to a budget – and Washington should too,” said Eric Cantor, the Republican majority leader in the House.

Maybe so, but spending less when households are in no shape to pick up the slack seems a sure-fire way to keep an anaemic recovery off-colour.

Yeah. Spend, spend, spend… borrow, borrow, borrow. That’s worked great so far. Yeah.

The trouble with The Economist, the Financial Times, the US government and most mainstream economists is not that they don’t know what is going on but that they don’t want to know.

Nobody gets a Nobel Prize for letting the chips fall where they may. Nobody attracts readers by telling them that there is nothing that can be done. And nobody gets elected by promising to do nothing.

So they continue giving bad advice… and following dead-end, counter-productive, zombie-feeding policies.

Usually, the economy is robust enough to recover despite their efforts. Not, apparently, this time.

So, we give you a new definition:

A Great Correction: when an economy is so weak it can’t overcome the feds’ efforts to fix it.”

And nobody sells inspections by saying they don’t bring any benefit.

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This entry was posted in Bureaucracy, Cartel, Laboratory medicine, Management, Medicine, NHS and tagged , , , , , , . Bookmark the permalink.

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