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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.


Tuesday, April 28, 2020

We are ALL GOING TO DIE!!!


A LONG RANT

I have been around Infectious Diseases, Microbiology, Eldercare, Infection Control and “pandemics” and other crises for near 50 years.  So maybe that allows me to have my own perspective.

I was not born in time for the Spanish Flu pandemic of 1918 which killed millions and millions.  My first influenza pandemic was in 1957-8 followed in 1968 with  the “Asian Flu (H2N2).  I don’t remember much about getting sick with either and obviously I didn’t die, so it is fair to say I survived my first pandemics without any problems.  

In 1976, when I first became a trainee (resident) to become an Infectious Diseases physician was a special year.  First there was the H3N2 pandemic and then suddenly there was a second outbreak in an army camp in New Jersey (Fort Dix) that spread quickly.  This second one (the Swine Flu) scared everyone because it was an (H1N1) just the Spanish Flu.    

Everyone (well almost everyone) agreed.  This is it!!  I was TOTALLY convinced.

The US President at the time (Gerald Ford) created a “gold medal advisory panel” which some real superstars, like Jonas Salk, and Albert Sabin, the creators of the  polio vaccines.  The politicians decided that the only solution was to create a new vaccine and immunize everyone immediately.  Have to be seen to be leading.  Sabin, both brilliant and bold (he tested his oral polio vaccine on himself) was never happy with the hurry up vaccine.  In a New York Times editorial, he said that while he agreed with the decision to create the vaccine and thought preparedness for an outbreak was good, he criticized the "scare tactics" used by Washington to promote mass vaccination (“scare tactics”… sounding familiar?). He suggested stockpiling and waiting to see what might happen.  

Sabin lost the battle and the mass immunization started, but he turned out to be right and the charge-aheads were wrong.  Some 450 people were paralyzed with a vaccine related syndrome called Guillain-BarrĂ© syndrome.  The government relented and stopped the ill fated hurry-up  vaccine program.   

Despite the absence of vaccination, the outbreak burned itself out, and the sun rose.  Despite the absence of vaccine, (and no “social distancing”) the world survived. 

Over the next bunch of decades leaders have repeated this same exercise.  Most times it was influenza, other times HIV or West Nile Virus, or St. Louis Encephalitis, or other coronaviruses (SARS, MERS).   Occasionally they decided to go extreme because of bacteria - C. difficile diarrhea or antibiotic resistance (MRSA).  The message was always  the same.  We are all unsafe… the world is coming to an end… we are all going to DIE!!!!!

Today is just the latest version; “experts” who know exactly what to do,  and politicians and the media all prepared to run with them.  They run their SCARE TACTICS, and spout stuff that sounds like science instead of opinion.   

This time has had its own twist: Shelter-in-place, snitch on your neighbours, hide in your basement. “socially distance”, keeping count of “cases” on an hourly basis.    If Hippocrates was around, he would remind us "First, Do NO Harm"

We will forever remember this as the great panic-demic of 2020.

This time it will be just like the Spanish Flu of 1918.   But think about it…  1918 was the last year of World War 1.  Europe was a mess.  Food was not plentiful.  Most homes did not have running water or indoor plumbing.  There was no refrigeration, no food storage.  Intravenous rehydration was in its infancy (no disposable needles).   There were no antibiotics.  Therapeutic oxygen was only being experimented with for poison gas in 1916-17  (Modern use of oxygen didn’t start until 1962).  The “modern medical and nursing care” of the time in NO way resembled the care we have available today.  There were NO laboratories to help diagnose diabetes, infection, sepsis, kidney failure, or strands of viral RNA.  
 So how exactly is this “just like 1918”? 

This panic-demic speaks more about the nature of us as a species.  We have these great brains, but we seem to prefer to use them to experience horror movies like Rosemary’s Baby and The Exorcist and The Night of the Living Dead.  We love virus movies like Andromeda Strain and Outbreak and Contagion.  We construct fear stories and convince ourselves of the dangers solar eclipse and the boogeyman under the bed, and witchcraft and devil worship and changing clocks (remember Y2K).  Each time it is the same: “… well sure before it was shameless hype and hysteria, but this time, THIS TIME, IT’S REAL!

 “Fool me once, shame on you; fool me twice, shame on me.”