In his last posting Roger Ekins wrote:
"Given that manufacturers seem unable or unwilling to guarantee
the long term stability of their kits, it is perhaps worth considering
whether an independent body should undertake the detailed
monitoring of kit performance, to which, inter alia, representations
and complaints might be made by users."
In response to Roger's question, a great deal of 'method monitoring'
is undertaken by EQA schemes, some of which are able to provide
reference values and perform 'validation' exercises which illuminate
issues of calibration and specificity. Changes are made to
methods because of these findings. Schemes often act as
clearing houses for complaints about methods and are frequently
consulted by MDA following complaints.
EQA schemes are completely independent, but are generally
without the kind 'policing power' that is probably being suggested
here. Manufacturers do, however, take EQA data very seriously
indeed and are known to take action to correct identified problems.
The NQAAPs (Advisory Panels) have executive authority in the UK
to deal with persistently poor performing laboratories and are also
prepared to take action against poorly performing methods.
CPA do not have a direct role with manufacturers, but expect
laboratories to have an effective Quality Management System
which embraces quality specification of methods and proper
method evaluation and internal quality control.
The MDA (the UK Notified Body for the IVD Directive) are also
interested in method problems and can take action under their
rules for adverse incidents.
Government / DH devolved responsibility for the quality of laboratory
investigations to the professions many years ago, and individuals
from the professions populate CPA / JWG / NQAAP / EQA
schemes and their Steering Committees etc
So are we considering something like and arm of NICE for IVD's?
Would the Government or DH wish to take back responsibility for
laboratory quality and would the professional bodies accept this?
(They might change the names of the committees and oversight
bodies, but it would probably have to be the same people that
would sit on them!)
Are we looking at a 'watchdog' quango (OFPATH) with powers to
investigate complaints and call manufacturers to account or does
MDA fulfil this role already?
And how would manufacturers be expected to respond given that
most are non-UK based? If the method passes FDA approval and
the USA is happy, why should a method be changed if the UK is
'unhappy'?
All interesting questions!
Up to now we have taken a co-operative and collaborative
approach, working in a 'partnership' between manufacturers, EQA
schemes and laboratory professionals to investigate and correct
problems. Appropriately undertaken in a spirit of willingness to
make things better, this should allow a quality improvement cycle
to turn. Is it time to re-evaluate this 'cosy' arrangement?
I say 'NO' because (being an optimist) I feel there is still a great
deal that can be done to improve communication between
manufacturers, laboratories, EQAS, expert groups etc, which
would improve understanding of problems and encourage
improvement.
In my experience, the very best way of dealing with this (bottom up
approach) is through company user group meetings, where EQA
data can be presented and full and frank exchanges of views can
be made.
Hope this helps
Jonathan Middle
Jonathan Middle, UK NEQAS Birmingham
tel 0121 414 7300 fax 0121 414 1179
The content of this message is intended only for the above addressee(s).
The opinions expressed are mine alone and do not necessarily represent
those of UK NEQAS Birmingham or the UK NEQAS Organisation
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