ISO: 28 Years of Improving the Quality of Medical Laboratories:

 

In 1994 the medical laboratory world changed.  At the request of an organization in the United States a meeting was convened in Philadelphia, under the authority of the International Organization for Standardization (ISO) to explore the need of a new committee to meet the needs of medical laboratories around the world, with a primary interest in laboratory quality.  While many countries in Europe, North America and Asia had already been developing some national standards for medical laboratory practices, this was (I think I am right on this) the first time that the collective international community of medical laboratory organizations came together for the single purpose of developing a comprehensive document for laboratory quality and competence. 

This was a challenging task and took near 10 years to complete, but in the end ISO15189:2003 Medical Laboratories:  particular requirements for quality and competence was published in 2003.  Over the years the document has gone through a series of revisions, with the next one to come out either at the end of 2022 or early 2023.   I was one of the attenders at the Philadelphia meeting.

The ISO process is one of working in technical committees which include members from participating (P) countries and others from observing (O) countries. The working committee responsible for ISO15189 is enumerated as ISO TC 212 .  The countries that participate tend to grow in number.  When ISO TC 212 started it had about 20 “P” countries.  Today that number has increased to 44 and they are joined by another “O”s.   Some of the P member participants have been attending meetings from the very start, although new people come in all the time, while others leave.  (I personally was very active for about 20 years.  While I am still involved, it is to a lesser extent.)

ISO 15189 is now used all over the world.  In many countries medical laboratorians and accreditation bodies know the number (15189) as synonymous with laboratory quality. 

But what few people know is that ISO TCs are not “one-trick ponies”.  Technical committees, through various Working Groups are constantly creating new revisions and new documents all the time.  ISO TC 212 has now created 47 documents completed and another 17 on the way.  Most are NOT used for accreditation purposes, but all relate to laboratory quality in one way or another.  The most recently published document is ISO/TS 5798 which provides recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) using nucleic acid amplification.

Unfortunately, many of these documents are  barely known about at all, which is a shame, because they can all be value in improving medical laboratory services. You can go to the ISO TC 212 website (https://www.iso.org/committee/54916.html) and see the list. Your laboratory will benefit.

It would be wonderful to read them all and figure out which ones would work in your laboratory.  You might be able to get access to the documents through your national standards body.  In Canada we have Standards Council of Canada (SCC) in the US they have American National Standards Institute (ANSI) and in the UK they have British Standards Institute (BSI).  I suspect that all countries have such a body. It would be well worth your while to connect with yours.

A warning… ISO standards are not for free; some might say they are expensive, maybe very expensive.  To get access to all the output of ISO TC 212 would cost about $8000… plus.

Maybe you can strike a deal through your National Standards Organization. 

Even SDOs have customers.

It has been a while since I have felt the need to vent in this space, but the events of today lead to exasperation and venting here in public/private seems like a good way of dealing with it.  

I will tell you that I have spent nearly my whole career in and around standards development, some at the very local level, some provincial, and some national, and a lot international.  In the beginning, I think my major motivating driver was ego, that I was in a space where I could “impose” my ideas on a larger professional group.  After a short while this wears off, and the driver gets replaced by being motivated to have your profession steered by sound principles that come in large part from understanding customer needs.  By listening to what other laboratorians tell me, I am told that I am competent at translating those needs into requirements that work well in standards at all levels.  

For example, when working with laboratories in developing countries it was pretty obvious that the best way to introduce quality management principles was to break a sophisticated document like ISO 15189 (medical laboratories – requirements for quality and competence) into bite size pieces and introduce them on chunk at a time, along with mentorship assistance until they have worked through a series of implementation and gap analyses until they are ready for international accreditation. 

That is now a very common and popular model for success.

I have had my successes and I have had my failures, perhaps the largest being my inability to get the measurement of uncertainty removed as a requirement from biology based laboratories.  From what I can see, after 20 years of experimenting with uncertainty, few laboratories get it, and the consequence is that they throw some numbers into a formula and get a number which they then ignore, as quite rightly they should.  

I will say that from the laboratorians that I talk with, and increasingly the number of accreditation bodies that have to work with the standard, I see that the tide is slowly turning, and in time I will be vindicated.  Sooner or later, the customer is always right.

But today was not about MU, it was about a clearly and shining arrogance displayed when some standards developers are intent on pointing out how smart they are and how dumb are the people that are going to be required to use the documents they are creating.  

One person actually relayed a story about how he went to talk with a significant user and asked why he was concerned about a new standard version being created and was told that the new version was not going to work well with his peers.  He felt the new version deviated substantially from the existing version.  

As he recounted his story his response was along the lines of “this fellow is a nice guy and I consider him a friend, but in this case he was dead wrong and his opinion was garbage.”  Good way of listening to the document users.  

Then he went on to say that the document that was being created was complicated by including definitions of terms when they could be equally found in another document.  The solution was simple.  Take them out of the new document and require users to buy two documents, one with the standard, and another with the definitions.  “When you buy a book, if you don’t understand the words then you go out a buy a dictionary.”  Good attitude towards addressing customer needs.  

What was interesting that this group also thought it was be a good idea to go through a document validation process before making a decision on next steps.  For those unfamiliar with the concept, document validation means going to a group of users and asking them if they understand the document and discover if their understanding is consistent and compatible with what the crafters intend.  It actually is a good idea, but can be a lengthy and complex process, and requires an open mind and the ability to accept criticism.  It is the Check step of PDCA.  

With what I heard today I think we have all the makings of a new PDCA – Plan, Do, Check, and Argue that the customer is a jerk and just doesn’t appreciate how much smarter we are than they.

Deming would be livid.

So am I.