Sunday, May 29, 2022

Celebrating World Accreditation Day – 2022 (Plus…..!)


Celebrating World Accreditation Day – 2022 (Plus…..!)

When I first started this blog in June 2012, one of the topics that we said that we would discuss was Quality Partners.  I made a rookie mistake by using the phrase but didn’t define it.  We had been using the term in our Certificate Course as far back as 2008, but that was a closed system that few readers would have an opportunity to read.

What we described in the course and later here was that Quality Partners were organizations that worked with and around medical laboratories with the sole intent of helping laboratories develop and maintain their Quality Management Systems with the goals being error reduction and quality improvement. 

As best as I can tell we were the first and only to use this phrase in this context, and maybe still am.  The point is that the laboratory is surrounded by organizations intent of keeping Quality front of mind.  We include in this list:

  • Standards Development Bodies
  • Accreditation Bodies
  • Proficiency Testing Bodies
  • Educators
  • Professional Organizations
  • Equipment and Reagent Suppliers.


I return to this concept because every year at this time the International Laboratory Accreditation Cooperation (ILAC) recognizes and celebrates the importance of Accreditation in the process to improve laboratories and protect the public.

Having spent most of my career being involved in Quality Partnership (Standards Development, Accreditation, Proficiency Testing, Educator) I am aware that most laboratorians, even today, still think of Quality Partners more as adversaries.  They tend to see us and generally appreciate us as grudgingly helpful but more often as picky and intrusive.  The over-riding thought is “we don’t make mistakes”. 

And for the most part, they are right… most laboratories do a good job most of the time.  Until they don’t. 

What we have seen over the last few years has been all sorts of false positive and false negative COVID-19 testing errors.  (see:  We see concerning errors in Proficiency Testing in Gram Staining and in Pre-examination knowledge (see:   The problem is that  wrong information goes out and can impact on patients and their healthcare workers when faulty decisions are made.

Without going into details, last year we saw an organization with little experience in proficiency sample put staff at considerable risk and harm from inappropriate use of the samples.  Had they thought to contact us rather than go directly to harm, we may have reduced anguish and concern.  We are there to prevent bad things from happening.

So from my perspective, I congratulate ALL our Quality Partner colleagues with particular reference to our Accreditation colleagues for remaining committed and helping laboratorians help themselves and protect the public. 

And ILAC, many thanks for shining the light.

But here is a thought.  Maybe the time has come to acknowledge not only the standards development organizations, and the laboratory accreditation organizations, but to formally recognize ALL the laboratory Quality Partners for their contributions for making healthcare safer.


Monday, May 23, 2022

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 ( 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.