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Wednesday, September 30, 2020

Unintended Consequences

 

The other day I attended yet another Zoom meeting.  

In my province the Ministry of Health acknowledged from the beginning that there while there may be an outbreak of viral infection (COVID-19)  in the province and that the province believed that the province may be required to take some action, there was the probability that some "unintended consequences" may occur, and the province had an obligation to monitor  them and their potential impact.

One can take this at face value or consider it as some obscene rye joke.  To be fair and give credit where credit is due, I think you have to give them points for good intention and for having the foresight to acknowledge that there may be some negative (and maybe some positive) unanticipated outcomes when you decide to shut down a jurisdiction of some 5 million peoples. 

So we are now into the ninth month of this outbreak, and it has spawned what I think many would call the most egregious Satan’s baby of all times.  

Public Health folks and the Politicians and the media decided to focus on the weakest of all catchphrases of all times, clearly not understanding what any of it meant.  Flatten the Curve.  Surely someone understood that “Flattening the Curve” means “don’t let the caseload  peak, even if we have to extent the period of activity”. I know with absolute certainty that the docs understood this.   Probably so did some of the politicians.  But for politicians it is easier to sound wise that to actually be wise, and so off they ran with “Let’s Flatten the Curve… We’re all in this together” and not bother to know, explain or understand the downside risk of pushing too early.

So I argue the First Unintended Consequences of trying to Flatten the Curve, was the tragic shutting down the province, killing business and community spirit, all the while ensuring, indeed  guaranteeing that the outbreak would stay on and on. 

And what about Unintended Consequence number 2?  How about when you try to pretend that you can treat the whole province like a big hospital and use precautions (the other catchphrase that politicians love - PPE) that are intended for intensive care units.  By using them in all shops and in the streets of all the villages and cities, you end up finding that, just as they barely work  in the hospital, they don’t work at all in the street. 

What the public is apparently unaware is the tragic reality that every intensive care unit (ICU) in the world bounces from one outbreak to the next.  Despite all the gowns and gloves and masks and booties and caps, the secondary infections happen in ICUs all the time.  Infection spreads all the time.  They never stop.    C. difficile, MRSA, VRE, Klebsiella, Pseudomonas, pneumonia, diarrhea, …. over and over and over.  

So if all this protective gear barely works when used by knowledgeable, experienced healthcare professionals in confined specific spaces of single purpose, why would anybody think they would work just fine in the hands of uninformed amateurs?  

As for Unintended Consequence number 3, when you shut down businesses, and travel, and communities, and religious gatherings, people become isolated and scared, and angry and depressed.  Some people get into bad activities like drinking too much alcohol, taking too many drugs, watch too much television, get into fights, harm themselves, harm others, over-eat, don’t exercise, gain weight, don’t take care of their health.   And children (of ALL age groups)  stop learning. 

Did our leaders really think this through at all, or are all these just more unintended consequences?

So here is where we are now.  In this province of 5 million and 9 months in, we had about 8500 people who tested positive of which 880 ended up in hospital and 229 people died, most of who were elders living in nursing homes (another place where society has NEVER been able to contain outbreaks).   

Of the people who died the median age was 85(!) with a range of 44 to 104 years.  This is sad but the number is no greater than other years.  If they had not died from COVID-19, many would have died from strokes, or falls, or common colds, or influenza, or depression, or senescence because it was their time.   

To put the 229 number into context, over the same period we have had 1600 deaths by drug overdose, and 600 deaths by motor vehicle accidents.  And then there are some 23 deaths from avalanches and about the same for swimming pools deaths.  Maybe our leaders should require all people going into swimming pools wear goggles and water wings.  Probably as effective as wear an N95 mask.

So here is what we have learned. 

1.    People LOVE catchphrases, like superbug, flatten the curve, PPE and second wave and LOVE to scare themselves tragic.  Catchphrases allow people to sound so learned without actually having to know anything

2.    Leaders love to show how much they are in charge and how forcefully they can use their catchphrases, seemingly to no positive avail.

3.    People who are terrorized and traumatized by fear can be driven to show how compliant they can be,  but seemingly without much positive benefit.

4.    Pandemics can and do considerable harm to elderly vulnerable people, but no where in the scope of the damage that people  do to everything and everybody else with all their good intentions and forceful actions. 

5.    Hopefully we have learned that whatever we do the next time, let’s NOT do this again.

So I wonder if the first question is NOT what were the Unintended Consequences of our COVID actions, but rather, what were the INTENDED consequences and why did they fail so badly?

 

 

Thursday, July 2, 2020

Training Laboratory Quality Managers for 2021 and beyond



In 2003 two things happened.  In that year the first version of the standard ISO15189:2003 medical laboratories – particular requirements for quality and competence was published.  One of the requirements in the new standard was that medical laboratories were required to have a person in a position referred to as the Laboratory Quality Manager.   
In the same year a new and unique course was started at the University of British Columbia to provide education for those seeking information and insight on what is required and expected for a person interested in becoming a Laboratory Quality Manager. 

That course has continued every year, training people around the world.  Because it is a certificate, non-credit course, people with a variety of backgrounds can take the course and gain the knowledge required.  Over the years we have had laboratory physicians, laboratory doctorate scientists, graduate students, physicians-in-training, research laboratory managers, clinical laboratory supervisors, laboratory technologists, all participate.  

What we require is an understanding of laboratories through 3 years of work experience, and a capability to take and actively participate in an on-line course in English.  (Actually we put on the course in a country where English was neither the first or second language, and it worked remarkably well.)

The course has been immensely successful.  It has attracted people from around the world.  We have had a successful certification rate of about 90 percent.   We have had people who have taken the course, continue to work in laboratory quality and return to the course and become mentors, replacing others who have retired.

There are reasons for our success.
  •     It is on-line and accessible.
  •    The course takes advantage of text, pictures, audio, video multimedia
  • Because it is delivered across many time zones, the access and delivery is primarily asynchronous, meaning that people can work at their time in their time zone, but still have an active and flowing conversation.
  • The course does focus a lot of time on ISO and ISO standards (including ISO15189).  But it also looks at other laboratory quality systems for clinical and research laboratories that are NOT ISO based.
  • It demands active participation by the course planners, and staff, and mentors and participants.  We call it VCOLE: Virtual Classroom On-Line Education.  People’s activity is monitored and if they are away, they are contacted to make sure that remain active.  This is NOT a course where you sit in front of your computer and do a quiz and get your certificate.
  • The course takes 22 weeks to complete (January to June).    It is long enough to gather a lot of knowledge and experience, but short enough that people can continue to work while taking the course.
  • The course provides large group discussion, small group discussion, group projects, individual quizzes and a final examination.  People describe the course as busy, active, demanding and very very positive.  (When people finish the course, they tend to remain in touch with their small group peers who often function as peer Quality colleagues.
  • The course works is developed and delivered using the studied principles of Knowles Andragogy (adult learning).
  • The course is updated and revised every year to ensure that the information is always relevant to the current understanding of laboratory quality. 
  • The course has a “holistic” approach to Quality in that addresses Customers requirements, Testing and Service and Management, and Staff Culture expectations.
     
We have just finished the 2020 session and are preparing for 2021.
For more information go to:  https://polqm.med.ubc.ca
Registration starts in September 2020
Registration is limited.

PS:  Many Laboratory Directors see value in paying the registration fees for their staff because they understand the value of having a Quality Manager who is knowledgeable, informed, and connected to peers and mentors across their country and around the world.
For what they pay, they get back 10 fold from the savings they derive from reduced expenses due to Poor Quality.



Tuesday, May 26, 2020

Real Science


REAL Science.

I think I have made clear my personal opinion of the past 5 months of covid panic-demic; most of this has been an extreme over-reaction to create an atmosphere of anxiety and fear with benefit to some.  Some of the winners are obvious – shy types who have found more than a small amount of limelight, expressing opinion as fact, creating a new set of codified language for the newly self defined Cognoscenti, happy to get their two minutes (or more) on television or social media.  All we hear about is distancing, sheltering, testing and antibodies and now contact tracing.

If only they could take a few minutes to actually read and understand the actual literature, rather than kinda-sorta quoting what they think they heard on CNN or FOX or CBC yesterday or the day before.  

What would be nice would be for at least some them to understand that having a positive nose swab does not prove infection, and having measurable antibodies does not signify immunity.   

And for those who are think that a fast vaccine is a really good idea, I suggest they read about Swine Flu (H1N1) in 1976- one (1) person died from the flu but 450 got ascending paralysis  from the vaccine. That is what we call a BAD outcome.

For those interested in the origins of the term social distance,  it was  created in 1963 by  Edward T Hall, a cultural anthropologist interested in how we interact with each other in space.  In his study of animals and space (proxemics) he defined the concepts of intimate space, personal space, social space (near) and social space (far), and social distance.  Social space (far) was 7-12 feet separation which would allow two workers to be close enough to chat, but far enough away that they could work uninterrupted.  In the animal kingdom social space (far) was about the distance that a crab could shed its shell and still survive being eaten by other crab (shell intact).  None of this has anything  to do with infections.  Hall was more intrigued in the notion of wanting unwanted people to stay outside our intimate and private spaces.  You can read his work in his books The Silent Language (1973) or the Hidden Dimension (1991).

The one person who did more study of respiratory virus transmission than anyone ever was Jack Gwaltney Jr who studied a very closely related virus called rhinovirus.  Jack Gwaltney was what you call a real scientist.  Over a decade he put people in various rooms and conditions and studied and carefully documented person to person transmission of virus that he painted on people’s fingers.  He didn’t depend upon newly developed swab tests or serology tests that result in more questions and answers.  Instead he actually measured the actual virus as it went from an actual person to another actual person.   I strongly refer you his summary article (Mechanisms of Transmission of Rhinovirus Infections.  1988 J.O. Hendley and  J.M. Gwaltney, Jr.   Epidemiologic Reviews Vol. 10.  pp242-258). 

While I would prefer you read the article yourself, but in case you don’t have access to PubMed, what he found was spread is hugely through hands, some through sneezes and nasal secretions, very little by cough (detection of virus in coughs as measured at 10 cm ( 4 inches) from the nose or mouth was less than 10%).   Viruses can be detected and spread by air transmission, but ONLY when an aerosol generating machine was used.  Machine generated aerosols and air spread?…yes.  Human generated aerosols and air spread?…NO.  (Most of what you think you know about the general truth of spread is NOT the product of studied human based experiments.  It is the product of artificial manikin machines studies that try to simulate the human condition.  

Whether you want to believe this or not is up to you, but real study by real scientists using real viruses and real people make one thing clear…  human to human transmission of virus can and does occur, but almost always it has a huge amount to do with hands and noses and objects that we touch, and little with coughs and nothing with social distance, or anything close.  Want to effectively spread virus?... sneeze into your hands and then touch someone or something.   

If you want to spread the virus further, go buy an aerosol generating machine or a manikin.  

PS: There are some other winners; the light on their feet, innovative entrepreneurs who found opportunity, turning their shut down restaurants into grocery stores and those capitalizing on video meeting equipment, and on-line teachers.  Even the personalized mask makers.  Congratulations.  Your success has that special taste of success and reward.