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. 

Moving Forward

2022 is a major changing career point for me… I am now 75 years “young”, soon to be 76. I am not sure when that number will cease to grow. 

I have worked as a physician and teacher and leader in the arenas of laboratory medicine since 1978. I have focused on microbiology, infection control, elder care, and most recently and most actively in quality teaching, quality assessment and quality improvement.  I am pretty pleased with my career. 

But this is a good time for a change. I am well and healthy now, but who knows about tomorrow. This is a good time for me to turn over the reins to someone younger and with as much enthusiasm as I have had, but importantly with more room to grow. I am confident we have found that person, and so I am comfortable with making the transition. I was able to find a generous sponsor who has provided professorship support to keep the program going and growing for another 10 years, at least, so what we have created can continue and improve and prosper. 

What to do next… I love my wife and children and grand children and I plan to focus a lot of my energies there. I also have old hobbies for which I will now have more . 

But to be clear, I fully anticipate continuing with my professional career, with some adjustment on focus. I am setting up a consulting platform from which I can continue to teach and advise. Through this site (and some others) I will try to continue as a thought leader and perhaps a bit of a provocateur contrarian, as long as I think I have new ideas to contribute. 

So Making Medical Lab Quality Relevant is not ending now. I just extended my ownership of the domain for another 3 years. 

Many thanks for your continuing readership and support.

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.