Let me state from the get-go that in my opinion, the
jump-start in medical laboratory Quality around the world in the last 10 years
can be directly attributed to the International Organization for Standardization
and its creation of its landmark standard ISO15189, requirements for quality and competence.
Many countries had dabbled with medical laboratory
accreditation since the 1970’s most of their documents were created by cherry
picking good ideas from a broad variety of processes, some from credible
organizations, others developed from local opinion makers. Some countries, like the United States
created federal legislation on minimum requirements, and others, like Australia
adapted other documents, such as Guide 25 which became ISO17025. But the reality was that issues of Quality
monitoring, and Quality improvement remained by and large a combination of minimal
Quality Control and Lip Service.
With the increasing awareness of the dangers imposed by
healthcare (IOM’s To Err is Human) and a voluntary standard ISO15189:2003 many
medical laboratories around the world started to focus on implementing Quality
Management Systems.
It has been an impressive change in mind-set. That is not to say that the task is done and now we can
go on to the next thing. In my opinion
medical laboratory Quality still has a long way to go.
Take for example the principle of Satisfaction. This is not a new concept. Japanese engineers, having benefited from giants
like Deming and Juran and wrote early about customer expectations and “customer
driven” Quality. Crosby reinforced and
popularized the recognition of Quality as meeting requirements.
Business learned that waiting upon receipt of complaints
was a poor way of assessing satisfaction; much more active approaches are needed
to garner information. Many have taken
to doing customer satisfaction surveys, often by internet. Unfortunately many are poorly designed and
don’t create much useful information, but I have written about that before.
ISO15189:2012 talks about customers and complaints and
suggestions, but the word “satisfaction” does not appear in the document. It does not suggest or imply that surveys can
or should be done, which is interesting since the concept of surveys was
included in the previous versions. There
are so many steps along the way that can through simple and inexpensive
measures improve service and efficiency from the specimen ordering form,
through the process of sample collection, and transport to accessioning and on
through reporting. They require some
attention to detail, but they would reduce the risk of error that result in
delayed results or worse.
Most docs and patients don’t bother to complain because
it is not worth the bother. That is
common everywhere. Many organizations
have realized that most people do not complain, and that when one is received
that represents perhaps 10 others that were felt but not entered. Actively pursuing information to learn how laboratory
workers are functioning, through the eyes of the users is a valuable way to
gather information. (Note: not the only
way; direct observation through internal audit is also invaluable)
So entering into a third iteration of the document and
stepping further back from actively pursuing information, in my opinion is a
step backwards.
In Canada, where nearly all healthcare is public, the
absence of an active process to define opinion is really lacking. One might interpret this as “who cares”. Government is very interested in reducing
costs, and I suspect strongly believes that asking opinions of how to meet
“customer driven” requirements would increase the costs, not lower them. But from Juran a long time ago it was clear
that small improvements can result in substantial decreases in total costs
associated with poor quality.
(As a side note, recently I was a customer of our health
care system. Most of the experience was
excellent, but there were also significant problems that could and should be
addressed. If I want to bring these to
people’s attention, I would be required to write a formal letter. I am not averse to writing, but I have to
decide if it is worth the energy.)
The private sector of health care in Canada, the US, and
the Caribbean are embracing 15189 more aggressively than the public sector; I
suspect that is because they see the financial and business advantage that
Quality and Satisfaction can bring. I trust that these organizations have the smarts to
recognize that defining and meeting customer driven requirements is where
Quality should begin, and not where it should end.
ISO15189:2012 is a valuable part of the Quality movement,
but the crafters need to focus on gathering better information if they want laboratory
Quality to get to the next step..