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Laboratory Quality in the Research Laboratory

  It was only 8 years ago when John Ioannidis wrote about "increasing value and reducing waste in research design, conduct, and ana...

Monday, July 11, 2022

Laboratory Quality in the Research Laboratory

 

It was only 8 years ago when John Ioannidis wrote about "increasing value and reducing waste in research design, conduct, and analysis" as a way to improve the disappointing results of all too much of what universities and other institutions euphemistically call “research” (see: Lancet. 2014 Jan 11;383(9912):166-75)

He pointed out pretty egregious failures including but not limited to  absence of detailed written protocols, poor documentation, doubtful statistical precision or power often too low or used misleadingly. He pointed out insufficient consideration to previous or continuing studies. He highlighted problems of the research workforce from poor knowledge of statistics, poor training failure of clinical researchers and laboratory scientists in research methods and design, and the involvement of stakeholders with conflicts of interest. Most damning was what he described as reward systems that incentivise “quantity more than quality”, and “novelty more than reliability”.

It reminded me of a presentation that I once gave to researchers in my university department,   I suggested that there were some five simple things that could be implemented to catch and reduce error, such as quality control monitoring for the use of equipment and procedures on some form of regular basis.  developing quality indicators to monitor for error, participating in some form of round robin proficiency testing, recording opportunities for improvement.  When I finished I was thanked for my thoughts, but it was clear that no one was doing any of these and more importantly there was no appetite to start.

Pretty disappointing.

But it appears, at least in some circumstances change is coming.  The European Union developed in 2021 and launched in 2022, the Enhancing Quality In Preclinical Data (EQIPD) program  (see: https://quality-preclinical-data.eu/about-eqipd/eqipd-quality-system/), essentially an application of Deming and the PDCA cycle as an approach to allow research laboratories to improve process without damaging innovation and freedom of research).  For those involved in Laboratory Quality Management that would be an easy and intuitively obvious place to start, but for those unaware, it is a major opportunity to step forward. 

Not unexpected there is always room for improvement.   

Published just a couple months ago, Holst et al  published the results of a survey of 38 medical centres in Germany which looked for markers of institutional policies that would require or encourage robust and transparent research process (Holst MR et al. Health Res Policy Syst. 2022 Apr 12;20(1):39), but no such policies were mentioned in over 90% of were mentioned in documents reviewed.  Odds are, if there are policies in place some, perhaps many of the centres and investigators would adhere.  In the 90 percent plus where there are no such policies, the chances of anything happening would approximate zero.

But to end on a POSITIVE note, harkening back to my presentation on the 5 simple things you can do to assist laboratory quality improvement, recently one of my colleagues in my university department, a person with considerable research knowledge and experience wrote an article on LinkedIn entitled “Mistakes can happen - but failing to take responsibility or be accountable really should not.”

So that is a good thing.

M

PS:  I have decided to put my money where my mouth is and will be creating a program to incentivize residents in medical laboratory disciplines and graduate students in medical laboratory related research to focus attention on Quality Improvement.  More on this soon.

 

 

 

 

 

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:  https://cmpt.ca/covid-19-proficiency-testing-one-year-later/)  We see concerning errors in Proficiency Testing in Gram Staining and in Pre-examination knowledge (see: https://cmpt.ca/publications-newsletter/annual-report/).   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 (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.