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:, 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.


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.