Keeping Proficiency Testing Relevant (Team 2)

 

Understanding the Laboratory Proficiency Testing Cycle
(External Quality Assessment – EQA)

This presentation is part 4 of a series highlighting 
Proficiency Testing as a Laboratory Quality Partner.

This series is put together by Dr. Michael A Noble BA MD FRCP the material founder and now retired chair of CMPT – Canadian (formerly Clinical) Microbiology Proficiency Testing Program.  It is based on his national and international experience and expertise in Proficiency Testing (PT/EQA).  Dr Noble continues on the advisory committee of CMPT and collaborates with other EQA programs including Oneworld Accuracy

 

In the previous missive (https://www.medicallaboratoryquality.com/2022/10/understanding-laboratory-proficiency.html) I introduced my version of the PT/EQA cycle and the Teams that work through the cycle, talked about the importance of starting and closing every cycle and event with Quality.  It is hard for PT/EQA providers to promote laboratory quality if they are not prepared to run their own Quality-Committed-Program (QCP). 

For this reason it made sense to designate the Quality Team as Team 1.  But let it be clear this is first in sequence, in the creation of an effective PT/EQA program ALL the teams are of equal and first priority.  A failure in any step along the way results in a failure for all.

This entry is on Team 2: the Organizer, the Planner, the Research and Development and Production team, which I think is the most fun.  Team 2 is all about planning and introducing new and changing challenges that are of high quality and relevant to what is happening today... and tomorrow!

Medical laboratories change all the time.  New analytes get introduced as do new equipment and reagents.  When Sunderman was looking at laboratories he created challenges for Glucose, Calcium, Salt, Urea, Protein and Hemoglobin.  Today the battery of tests is in the hundreds.   To ensure that laboratories are performing all these tests correctly PT/EQA has be change and adopt all the time.

Consider for the moment just one analyte that has consumed medical laboratories, everywhere in the world… looking for laboratory diagnostic evidence for carriage or infection with COVID 19.  In the last 3 years there have been billions of tests performed, with millions near every month. I suspect that no other laboratory test has exploded onto the world stage in as short a time ever before.

As the demand for test results rapidly increased, the number of laboratories testing for COVID around the world rapidly expanded, with many of the laboratories having little prior experience.  Laboratories performing assays at super-human capacity, all over-stretched and exhausted.  The chance that all the tests results were correct and accurate was zero. 

What was so interesting was how rapidly people at large just accepted getting their COVID test done and assumed that is was always right.  The number of positive tests was reported on a daily basis through television and internet.  Companies and institutions and governments predicated all sorts of decisions based on the results they received. With little or no consideration about accuracy or relevance. 

For those interested, here is a short presentation on what happens when tests get introduced too quickly, before sufficient training can be implemented.

https://cmpt.ca/covid-19-proficiency-testing-one-year-later/

Fortunately many countries appreciated that quality assessment of performance was essential if anything constructive  was going to come from the testing.  The PT/EQA providers need to generate new ways to measure testing performance.  They needed to get access of COVID RNA or COVID spike protein, and other materials.  They needed to figure out how much material was needed for each sample, dilutions, how long the material would be stable, whether the samples should be pure or were essential additives required.  Would the samples travel, how long would the last, and many more questions.  And they needed to do that all in a very short time in order to reduce the impact of poor performance.  Research and Development in PT/EQA was the cornerstone of protecting laboratories, patients, families, friends, and the community.  

Putting that together requires a team of laboratory folk; the ones who see and envision the challenge, those who plan the strategy to keep relevant and move forward, the scientists who work through the R&D details, and the ones to take the products of R&D and create it into a program challenge production.  That is the group that I call Team 2. 

 

Personally I love being part of that team; without it the PT/EQA program loses its relevance and  performance falls apart;  and worse, without relevant monitoring of performance, the whole of the laboratory exercise goes will slip back to what Sunderman was railing against 80 years ago. 

More on Team 3 next.

The Wrights and Wrongs of Vaccination.

 

 

I am reading a brilliant book recently written (2020)  by Matt Ridley entitled How Innovation Works in which he makes the point big changes in real life do not occur as they do through the back mirror of romantic history.  Invention and Innovation are two separate events.   Change is never linear and is always impacted by opportunity, trial and error, and a big dose of luck and circumstance.  The drivers of new ideas often toil for years, borrowing off the ideas of others, and rarely see the fruits of their vision.  Change, even life altering change is incremental.

He tells the story of Alexander Fleming working in his laboratory at St. Mary’s Hospital when he noted an interesting gap between the cultured colonies of Staphylococcus aureus and a contaminating colony of Penicillium.  That he noticed it was a moment of curiosity (and maybe brilliance) but points to how much luck and circumstance affected his (and our collective) fate and  future.  (Devine Intervention?)  If there had not been a fluctuating heat wave in London and if there was not floating fungus in the air which happened to land on a culture plate, then the  Penicillium would not have been there and would not have grown on the plate, and would not have exuded a compound that prevented the Staphylococci from growing onto the Penicillium.   But it did happen and Fleming did see it, and the world changed accordingly.

But there is another part to the story.   Fleming was working at the laboratory headed by Sir Almroth Wright, a brilliant mind who had involved in the development of typhoid vaccine for near 25 years.  Wright was absolutely convinced of the powers of vaccination.  In 1904 he studied how bacteria stimulated phagocytes with opsonins.  Unfortunately, so powerful was his passion for vaccines, he was totally resistant to the idea that any other approach such as medication would or could impact infections diseases, so much so that he discouraged Fleming’s interest in the pursuit of his Penicillin mould for more than 12 years.   

If was not by accident that many of Wright’s colleagues nicknamed him Sir Almost Right or Sir Always Wrong.  (George Bernard Shaw mocked and immortalized Wright in his plays The Doctor’s Dilemma, How These Doctors Love One Another! and Too True to Be Good).

Without the surreptitious efforts of  Fleming and friends like Florey and Chain in pursuing penicillin and the many many others, we might never had entered the era of survival of infections and the benefits of interventions like surgery, implants, transplants, or chemotherapy. 

It seems that today our lives are again being impacted by a new slew of Almoth Wrights.  Today we have people who are so convinced of the powers of vaccines, that they deeply and truly believe vaccine induced protection is better than natural immunity through infection.  Today we have people who measure “herd immunity” not by mass spread of infection, but by mass immunization, which includes the vast majority of healthy people under the age of 70 or 60 with virtually no risk or concern from infection from COVID-19 (including kids of school age and university.   

I am sure they are sure there is sound justification for requiring all people show proof of immunization regardless of prior infection, mild, moderate or severe, but I am less convinced.

Of personal interest, I am comforted by the knowledge that I am not alone in my concern.   For those with the time and facility I encourage you to read, the just published “Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections” written by

Sivan Gazit and colleagues.  It was just published recently (August 24, 2021) in the journal medRxiv (pronounced Med Archive) preprint doi: https://doi.org/10.1101/2021.08.24.21262415; 
You can find it on PubMed (National Library of Medicine).

For those who will trust my reading and interpretation, the study looked at 3 groups of people (1) no infection, but protected by two doses of vaccine (2) evidence of prior infection and no vaccine and (3) evidence of infection but who also received one dose of vaccine. 

Regardless of age or underlying “comorbidities” the people with infection and no vaccine had a strongly significant reduction in break through infections (ie natural infection imparts better protection than vaccine). 

People with infection and one dose of vaccine had a marginal (but statistically significant) improvement compared to those with infection but no vaccine.   

The study did NOT look at side effects associated with vaccine in either the those with prior infection or not.

 

 

Almost Eighteen Months In...

 

A colleague of mine experienced  a recent death in his near-extended family.  The person was young and despondent, and unfortunately successfully suicidal.  Regardless of all the factors involved, it is always a tragedy when a young person takes their own life.

We are now nearly 18 months into this life-altering, society-altering event that is impacting people and their societies world wide.  Tragedy is a good word to describe what is happening.  Whether this was an accident of nature, or an accident of science may never get resolved.  But there are some things that are apparent, the first of which is how much harm has been done.  And by harm I do not mean viral.

The rise in suicide rate and overdose deaths has been disturbingly high and both linked to the pandemic ^(1,2) neither a consequence of being infected by the virus, but rather, as being a victim of the societal consequences that have been created in the attempt to reduce the risk being infected.  In the words of the current day vernacular, the rise in suicides and overdoses seems to be a result of our perpetual challenge to “keep safe” and “flatten the curve” by creating a society of “shut-ins”, closing schools, closing businesses, creating financial damage, closing recreation, closing exercise, and closing social gatherings of spiritual purpose.

There has been much work over the last near eighteen months, much with the goal of making life better, with the best of intent, trying to sustain some sense of normalcy, all while trying very hard to make this virus go away.  There has been hard work of creativity, invention and innovation and monumental personal effort, and some with regulatory force. But despite all that the virus has gone through “waves” coming and going, waxing and waning, regardless of our actions.   

In a science based, learning society, we have to be able to stand back and look at what we have accomplished (or not) and then either go forward or recalibrate.  So far it seems there has been a lot of non-success and very little recalibrating.  There have been meetings (many, many meetings), public health people "public-healthing",  politicians being political, journalists "journalizing", to little avail.  The restrictions and proscriptions escalate.  Science types are creating more and better tests, and more treatments, and more preventions, but to date with little evidence that the virus is going away.

 There has been lots of money spent, many pronouncements and predictions made, all with questionable or little impact.   

It would be difficult to call this any sort of success. 

I would like to think that with all that active human brain power we would have been able to effectively outsmart or out-strategize the virus, especially since the virus has NO brain, NO brain power, NO thinking and NO strategizing.  The virus just is.

But with regret the opposite is true. I don't want to say we are still at Virus 1 - Human Brain Power No score, but it is hard to see in what way we are winning.

Thanks to the epidemiologists in our province our experience over the last 18 months.  We can look our society in three groups of people. 

	People 30 years or younger “education group”	People over 30 years but under 70 years  “adult worker group”	People 70 years or older. “senior and elder group”
In our province	1.7 million	2.8 million	0.67 million
People test positive	43,000	62,000	9,300
Got sick	363	2,200	2,300
Died	2	212	1300
Percent COVID illness in the province	0.02% 20 per 100,000	0.008% 80 per 100,000	0.343% 343 per 100,000
Percent COVID deaths in their age group	0.0001% ~1 per 1,000,000	0.007% ~100 per 1,000,000	0.194% ~2,000 per 1,000,000

 

These proportions have remained faithful and consistent through the whole of this experience.  And they are essentially the same in every jurisdiction in every country in the world.  The young are largely, near completely unaffected, the adults are marginally affected, and the brunt of illness is carried by our seniors and elders.   Our elder care in nursing homes has been a travesty. 

To put this into perspective, we have, over the last 100 years done much better with far worse; Smallpox, Yellow Fever, Malaria, Tuberculosis, Syphilis, Typhoid, Ebola, Lassa, Zika, Meningitis and Influenza.  Dealing with this virus should not be this hard.    

Maybe it is time to acknowledge that perhaps our approach is part of the problem.  We have over-thought, and over strategized, and at least in my opinion what has been done has made things worse rather than better.   If young people are killing themselves through drugs and other means at a disturbingly high rate, almost at the same rate as the virus (if not higher), then it is time to pull back.

We are smarter than what we are doing now.   If we keep creating harm while trying to find a solution, then what we are doing is not working out.  

Regardless of profession, can we all agree that Hippocrates, near 2500 years ago stated a universal truth: First, Do No Harm.

1.       1.  McIntyre RS, Lee Y. Projected increases in suicide in Canada as a consequence of COVID-19. Psychiatry Res. 2020;290:113104. doi:10.1016/j.psychres.2020.113104

2.     2.  https://calgaryherald.com/news/postpandemic/canadas-hidden-crisis-how-covid-19-overshadowed-the-worst-year-on-record-for-overdose-deaths.  Dated March 29,2021.  Visited April 23, 2021