WHAT’S WRONG WITH EQA? Dr David James

FOCUS 2019

WHO AM I?

Chemical Pathologist in Somerset

CMO for SYNLAB in the UK Current Chair of the RCPath Joint Working Group on

Quality Assessment

DEFINING WHAT WE MEAN BY

EQA

Good to start by defining what we want to moan about!

DEFINING WHAT WE MEAN BY

EQA

Good to start by defining what we want to moan about!

Why do we do it? One part of QA process

To give us, our users and the patient an assurance that the test results are of a standard fit for purpose

DIFFERENCES BETWEEN PT AND EQA External Quality Assessment Best Practice James D, Ames D, Lopez B et al J Clin Pathol 2014;67:651-655

WHAT DOES GOOD LOOK

LIKE?

Range of providers available, meeting requirements of laboratories for EQA (what are requirements?) Good engagement between laboratories and EQA providers An effective oversight process with mechanisms to “correct” when things go wrong

DO WE PROACTIVELY CHOOSE OUR EQA SCHEMES? - Finance make us choose the cheapest

- I don’t want lab disrupted by too many samples

- It’s nobody’s business but ours

HOW DO WE PERFORM EQA IN OUR LABS?

HOW DO WE PERFORM EQA IN OUR LABS?

NOW TO THE TITLE OF THE TALK…..WHAT’S WRONG WITH EQA We seem to have a framework for good practice……………….

PQAR…………JANUARY 2014

4.27. “The membership, role and function of the JWGQA should be revised and expanded. It should set consistent standards and performance criteria for all schemes across pathology and work with UKAS to ensure their implementation in the scheme accreditation process. The JWGQA should advise on publication of performance data. The National Medical Director has confirmed that he will ask the RCPath to lead this work.”

4.28. “Further consideration must be given to the ways in which individual performance can be assessed, monitored and competence-assured. The National Medical Director will ask the professional bodies, led by RCPath, to review these issues and report back within twelve months on their findings.”

PQAR…………JANUARY 2014

PQAR…………JANUARY 2014

DEFINING STANDARDS

The frequency of distributions, number of samples in a distribution and range covered can vary significantly between providers (EQALM Survey 2009)

Conflict between UKAS and PQAR – ISO17043 says scheme should define poor performance…….yet across Europe there are definitions applied by “national bodies”

Poor performance should be reported through Panels/JWG yet some providers do not see the need…………

TAKE PARACETAMOL

At least 5 EQA providers used within the UK

Is there any certainty that what is deemed poor performance in one scheme will also be flagged in any of the others?

Do all 5 have the same “sensitivity and specificity” to detect poor performance?

WHEN LABS GO BAD…………….

What happens – what sanctions can be brought to bear?

Currently, only professionalism applies

JWG/Panels have had frustration of poorly performing lab manipulating legal entity so as to avoid issues………..but very little teeth with JWG/Panels at that time

WHEN METHODS GO BAD…………….

“The FDA have no issue with the method”

**** the FDA

MHRA – improving communications with MHRA, BUT if you have a method related problem, REPORT IT ON THE YELLOW CARD SYSTEM TO MHRA regardless.

SO, WHAT NOW OF PQAR

College have appointed a Clinical Director of Safety and Quality (Dr Berenice Lopez)

Restructured “stakeholder” group

Investment (hopefully!) in infrastructure and support for the Panels

Engagement with broad group of stakeholders including CQC

Creating a framework to move things forward

INTERPRETIVE EQA……….

PQAR move to individual interpretive EQA to form part of competency framework

UKAS interpretation vs RCPath guidance

Are any fit for purpose?

MY PERSONAL VIEWS ON INTERPRETIVE EQA

Need to move to personal IEQA which forms part of professional “revalidation/appraisal”

IEQA needs to be fit for purpose Assessed on a non-subjective basis

Able to discriminate between super expert in field and generalist appropriately

Learn lessons from histopath IEQA – the good and the bad

Needs to be guidance on what is expected from IEQA providers

IN SUMMARY

Lots of good things in place – guidance, new structure evolving, engagement

Not there yet

Can we answer the question that was the cause of the PQAR – “do we have in place adequate QA processes to identify when patients may suffer harm, or preferably prevent it from happening?” Sadly, no………………..but perhaps I see a glimmer of hope