Sunday, January 27, 2013

Customer Satisfaction and the Medical Laboratory - again

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..


  1. I am not sure that trying to be guided by customer satisfaction would up the costs. If the never-quite-good-enough service becomes part of a bad scenario, you have no idea how that can send things skyrocketing. An elderly relative of mine spent five weeks in hospital with a fractured pelvis, due to a fall that happened because a hospital demied him timely lab service, and he had to go down the street and use a private lab that was 'closing in half an hour'. The added stress was just too much. And I am sure there are myriad examples out there!

  2. There are lots of sad stories about patient consequences resulting from laboratory error. I would like to think that laboratorians understand this.

    In the laboratory in Bugando Medical Center in Tanzania, there are pictures of patients up on the walls as a reminder that the samples all come from patients.

    I suspect that there would be a thousand reasons why laboratories in North America could not do this because of patient confidentiality concerns. But I thought it was a very good and personal reminder.


Comments, thoughts...