Showing posts with label Canadian Blood Services. Show all posts
Showing posts with label Canadian Blood Services. Show all posts

Wednesday, November 14, 2018

Nessun dorma (Musings on anti-paid plasma blogs over the years)

Updated: 14 Nov. 2018

Below is a list of the blogs I've written so far on paid plasma: 23 blogs over 6 years as of 14 Nov. 2018. Some blogs focus on it entirely, others touch upon it along with related issues. In total 2004-2018 I've written 174 blogs, and paid plasma constitute about 13% of them. This blog's sequence is different than others. The main content (list of earlier blogs) will come at the end.

INTRODUCTION
The blog's title comes from a famous aria for tenors in Puccini's opera Turandot, which premiered at La Scala in Milan in 1926 after Puccini's death. Like many, I love the classic for many reasons. One is my spouse and I heard Pavarotti sing it in person in Edmonton in 1995. The face of every person on the LRT ride home from the concert radiated with joy.

I chose Nessun Dorma for several reasons. The title and first lines translate as 'None shall sleep' and builds to the final, victorious cry of 'Vincero!' (I will win!). In the battle over paid plasma in Canada, and it is a battle, I'm against paid plasma, as explained in the 23 blogs below. We don't know who will win and what the win will look like.

I hope the eventual winners (Vincero!) will be
  • Patients who need plasma derivatives and are prescribed products like intravenous immune globulin (IVIG) for evidence-based reasons, not because Big Pharma promotes it relentlessly to physicians. VERSUS patients being scared into panic by BIG Pharma, which supports their associations financially and is not beyond creating fear the world will end if paid plasma clinics cease to grow exponentially. 
  • Blood donors in financial need, who will no longer be exploited at the risk of their health by Big Pharma, which makes $billions off their body tissue. Yes, not all see themselves as being exploited, but many, if not all, are exploited and it's unethical.
  • Volunteer blood donor sector, which will recruit and be able to retain young donors, instead of having them slowly siphoned off to paid plasma, from which they are unlikely to return as they age.
  • Canada's blood supplier CBS (outside Quebec), which can concentrate on ways to encourage more volunteer young donors, perhaps with token incentives as happens in the USA system, or maybe not. Hope that CBS gets funding to open plasma collection clinics to get Canada closer to meeting its plasma needs.
  • Canada's government funders of the blood system, which should fund CBS plasma clinics, encourage voluntary donation, VERSUS now needing to spend megabucks to regulate ('police') the use of IVIG due its ever-increasing usage, as done by the BC PBCO and others, including for primary immunodeficiency
  • Health Canada should do its duty to regulate blood safety as a win-win strategy for patients and blood donors, VERSUS encouraging Big Pharma to promote endless iffy uses of plasma derivatives by supporting its exploitative paid plasma growth in Canada. 
FOR FUN
PAST PAID PLASMA BLOGS (n=23)
2018
The sound of silence (More musings on paid plasma pros and cons) 
The Boxer (Musings on HC's Expert Panel Report on immune globulin and paid plasma)
2017
Look what they done to my song (Musings on how paid plasma mirrors Rumpelstiltskin) 
Always on my mind (Musings on lack of transparency in Canada's blood system) 
The Sound of Silence (Musings on Health Canada's Expert Panel on Immune Globulin Product Supply) 
While my guitar gently weeps (Musings on recent transfusion-related news) 
We are the world (Musings on the humanitarianism of selling body tissues) 
The Boxer (Musings on lies & jests in the blood industry)
2016
Simply the best (Musings on paid plasma  and TM colleagues I've know) 
Sweet Dreams (Musings on a recent transfusion-related nightmare) 
Heart of Gold (Musings on donating the gift of life)
2015
Heart of Gold (Musings on sucking $ from body tissues)
2014
Don't worry, be happy (Musings on the safety of our blood supply) 
If you could read my mind (Musings on hard-to-believe TM news) 
C'est si bon (Musings on TM news that is so good and not so good) 
Hey Jude (Musings on why paid plasma makes it worse, not better) 
I heard it through the grapevine (Musings on paid plasma's PR campaign) 
Bridge over troubled water (Musings on what to be thankful for as TM professionals)
2013
Day tripper (Musings on HC's instructions to the jury on paid plasma) 
Heart of Gold (Musings on pimping for paid plasma) 
Stop children, what's that sound (Musings on commercialization of our blood supply) 
We are the world (More musings on commercialization of the blood supply) 
Still my guitar gently weeps (Yet more musings on commercialization of our blood supply)

Sunday, October 28, 2018

I will remember you (Musings on all those who died in tainted blood tragedies)

Updated: 5 Nov. 2018 
Canada's blood scandal, Further Reading
Responses to a Comments

Haven't written a blog for awhile and this one will be short. For October I'll  briefly comment on the ongoing attack on national blood suppliers like Canadian Blood Services and many others by gay activists. In Canada the designation is lesbian, gay, bisexual, transgender, queer, and two-spirit (LGBTQ2).

The blog was stimulated by two items at the AABB 2018 and the current UK Infected Blood Inquiry (Further Reading), both featured in TraQ's October newsletter under General and UK, respectively.

Recently, I've seen many attacks on Twitter accusing  CBS of discrimination. Almost all activists claim there never was a reason to ban or defer male homosexuals. When I've defended CBS by reporting the history of transfusion-associated HIV transmission in Canada, the blood supplier's perspective and its ongoing research, I've often been accused of being homophobic. Quite scary for an oldster but it won't ever stop me from voicing my opinions on controversial issues.

My take is that gays have suffered horrific discrimination over the years and many cannot differentiate blood supplier caution from larger societal historical wrongs. And most are too young to appreciate blood supplier's perspective and the need for nation-specific evidence-based policies. Suspect I'm being too generous here but won't elaborate. What the hell, I will. Could be dead wrong but sometimes when you've been unfairly repeatedly victimized, you see oppressors everywhere.

The blog's title derives from a 1995 song by Canadian Sarah McLachlan.

BACKGROUND
Activists worldwide see even a temporary ban of men who have sex with men (MSM) as discriminatory. Over the years in Canada the deferral has gone from permanent deferral to a 5 year deferral without MSM to a one year deferral without MSM and likely will soon become a 3 month deferral without MSM.

Gays see any deferral, no matter how short, as a holdover from an era of panic over AIDS in the early 1980s (Further Reading, NBC):
"They are just the latest chapter in a narrative that casts gay men as untrustworthy, promiscuous vectors of disease. We know scientifically we pose no greater threat than anyone else, but fear is a really powerful thing — especially fear of HIV."
I'll provide only this one news item but also see Google search for "gay blood donation discriminatory" in Further Reading, which yields 5,630,000 hits.

In Canada, Prime Minister Justin Trudeau was foolish to promise a change in CBS's MSM policy because it's not a political decision, it's science-based. Sadly, his error fueled much of the outrage by the gay community against CBS. The last thing our blood system needs is a political-based decision. We've been there, done that at the beginning of Canada's HIV/AIDS 'tainted blood scandal'.

BOTTOM LINE: As lifelong worker in transfusion as front-line medical laboratory technologist/scientist, supervisor-manager, educator, and consultant (54 yrs - Yikes!)  I've experienced the best of times and the worst of times. I firmly believe our blood supplier CBS is right to be cautious and base blood safety policies on evidence gathered in Canada (CBS MSM deferral policies, Further Reading).

As always, comments are most welcome. Please see the 4 comments below and my response to one (added Nov. 1, 2018).

ADDED Nov.1, 2018
Please see comments below. My reply to Shanta is as follows:

About your first point: If my comment that victimized LGBTQ2 see oppressors everywhere is true, it is probably because homophobia IS everywhere and doesn't magically stop at the front door of institutions because they reflect the values of the society that created them.

I'll grant that homophobia still exists everywhere in society, including in Canada as opposed to nations in which homosexuality is criminalised, including some nations where the death penalty applies. Source: Gay relationships are still criminalised in 72 countries, report finds. (The Guardian, 2017)

But I see it as more nuanced. Having worked for its predecessor Canadian Red Cross for 13 years, and for CBS over many years, mainly as a consultant with a brief stint as 'assman' managing CBS Edmonton's patient services laboratory, I do not believe Canadian Blood Services is a homophobic institution. I don't think CBS institutionalized policies of homophobia, including the ever decreasing ban on gay MSM donations. Individuals within any organization may be homophobic but I don't think there's evidence CBS per se is. Reasonable people can disagree on this point and I'll give my reasons below.

Shanta's second point relates to evidence-based policy-making. If the CBS MSM policy is purely based on evidence, we should be able to correlate each change over 30 years -- from permanent to 5-year to 1-year to the now anticipated 3-month deferral without MSM -- to the evidence that triggered each decision. If we can't do that, it's possible to conclude that policy-makers are influenced by more than just the evidence.

My view is that evidence-based policy-making on HIV and MSM is complex and affected by many factors including risk-modelling research, which is way above my pay grade (comprehension). For the record like many countries Canada moved from an indefinite deferral for any MSM to a five-year deferral in 2013, and to a 12-month deferral in 2016. Source: HIV donor testing. I believe the initial permanent deferral was justified and I've been labelled a homophobe on Twitter for it by  gay activists.

To be clear, national blood suppliers need to take into account many variables, including national HIV rates, data accumulated over many years because of the low prevalence of HIV, and the need to be cautious because of the incredible screw-ups that cost thousands of lives in what Canada refers to as the 'tainted blood tragedy,' the biggest PREVENTABLE public health disaster in our history.

CBS recognizes that 'MSM deferral is one of the most controversial deferral policies, and while blood safety remains paramount, issues of social justice and inclusivity highlight the need for its modernization.' See Developing more inclusive deferral policies for blood and plasma donors,

To Shanta's point, it's impossible for CBS to present clear cut evidence for each decision to decrease the deferral without MSM. The variables are too numerous. My view is that, yes, 'policy-makers are influenced by more than just the evidence.' But the elephant in the room is NOT homophobic discrimination, it's CBS's desire to err on the side of safety and caution to prevent a massive catastrophe of the 1980s (HIV) and 1990s (HCV) which resulted in Canada's blood supplier Canadian Red Cross Blood Transfusion Service being axed.

And let's face it, the emphasis on evidence-based medicine is relatively new.  Example: Choosing Wisely Canada launched on April 2, 2014.

FOR FUN
I chose a song by Canadian Sarah McLachlan to honour all those thousands who died and suffered from infected blood tragedies worldwide. Having lived through it in 1980s and 1990s I can never forget them. In early days of my career, I knew folks with hemophilia who came to blood centre to pick up their cryoprecipitate, then FVIII concentrate that killed so many. Two were Barry and Ed Kubin mentioned in Vic Parsons' book below.
FURTHER READING
It's still a ban': Gay blood deferrals still discriminatory, LGBTQ advocates say (NBC, 29 Nov. 2017)

Google search: "gay blood donation discriminatory"

AABB 2018
CBS on MSM Deferral Policies
Canada's Blood Scandal
UK Infected Blood Inquiry: October 2018 News

Sunday, February 25, 2018

Musings on review of CBS as an employer by a Donor Care Associate

Updated: 26 Feb. 2018 (expanded the ending)
Decided to write shorter blogs, perhaps one each week. We'll see how it goes.

I've always known shorter blogs were the way to go, because transfusion professionals, like most folks these days, are busy. Busy in their work lives, family lives, and often overwhelmed by the onslaught of digital input, whether via texting, e-mail or social media.

But I credit the motivation to write shorter blogs to a UK transfusion professional who tweeted about the blogs of Mary Beard: A Don's Life. Somehow I'd missed them.

So the first short blog is about a review of Canadian Blood Services by a 'Donor Care Associate" which I came across on my @transfusionnews twitter account. I'll begin with my tweets.

If you click on the review and get 'sign in with'...just click on the text outside the request or access the review here.
Now we can choose to dismiss such reviews because they're anonymous. For interest, many folks I know hesitate to critique employers until they retire and are no longer subject to a backlash.

Several points the reviewer made peaked my curiosity. First:

Second:
Note that the reviewer worked at CBS part-time for 3 years and included several pros about working for them. Frankly, I cannot dismiss her Cons as outright lies. In general, criticism works best if it contains helpful and specific suggestions for positive change.

In my teaching career, I'd explain to students that feedback is an indispensable tool to help both instructor and learner improve and, when given feedback, model appropriate responses such as, "Thanks for telling me that."  When MLS students entered their clinical internship year, I'd explain that they can improve only if supervisory staff tell them when they are doing something wrong or doing something that needs to be improved.

Can CBS take criticism in the same vein? (no pun intended)

As always comments are most welcome.

Thursday, November 24, 2016

Don't stop (Musings on government regulation as a TM disruptive force)

Updated: 25 Nov. 2016
November's blog was stimulated by a Dark Report about an Australian conference on medical laboratory professionals exploring disruptive forces in healthcare (Further Reading). 

This will be the first in a series exploring disruptive forces that have and still affect, or will affect, the practice of transfusion medicine (TM) and its diverse practitioners. Each blog will deal with one disruptive force and its related aftermaths.

What is this blog about and why might you want to read it? It requires more than the cursory scan you no doubt give most of the info overload you receive daily. But if you want to understand, truly 'dig' current transfusion realities, please consider giving it a read.

Executive version (over the long haul of all the blogs in the series):
  • At heart, the blogs are designed to combat 'BS baffles brains';
  • Because disruption affects all transfusion professionals, I hope you see its relevance to your practice;
  • Sub-aims include being able to 
    • Differentiate disruptive forces from normal progress;
    • Identify beneficial forces from those worth resisting;
    • Make the most of positive disruptive forces to improve patient care and safety.
In the 'management speak' ubiquitous in blood supplier annual reports, the last aim would be to leverage disruption and create a centre that drives not just leading or bleeding edge innovation but innovation that leads to transformative change.  

The blog's title derives from a 1977 ditty by the Brit-US rock band, Fleetwood Mac.

INTRODUCTION
Disruption has been in the news a lot lately given the unexpected UK Brexit vote and Donald Trump's election as US President. A recent search of Google news stories for ''disruptive forces'' yielded 8,830 hits.

For decades now we've seen disruption in many aspects of our daily lives. A few examples, and I bet you can name even more:
  • Personal computers disrupt mainframes;
  • Apple's Macintosh WYSIWYG OS disrupts command-driven MS DOS; 
  • Internet disrupts everything;
  • Cable TV disrupts the networks;
  • Google disrupts libraries and the publishing industry;
  • Streaming services like Netflix disrupt DVD rental stores;
  • Apple's iPod disrupts music industry;
  • Uber disrupts taxis;
  • Airbnb disrupts hotels.
The list is endless. Disruption is big in the business world too, witness a new McKinsey Global Institute (management consulting firm) report, Ordinary Disruption: The Four Forces Breaking All the Trends: (Further Reading).

No doubt disruption is now established as the next big thing. But it's not new. Disruptive forces have affected clinical laboratories for decades. 

DISRUPTIVE FORCES
So what the heck are disruptive forces? The OED defines disruptive as 'innovative or ground-breaking'.

According to the UK consulting firm, Tomorrow Today Global:
A disruptive forces is not a force that results in incremental changes, improving products or services one step at a time. Rather disruptive forces result in a breakthrough or a step change that transforms society forever. Sometimes the disruption is complete and swift. 
The key here is a true disruptive force does not affect change in baby-steps but rather consists of a big step (innovation) that changes things forever. 

DISRUPTIVE FORCE #1: Tainted Blood Massive Screw-up
Being a medical laboratory technologist who became a transfusion science educator, I found it so tempting to begin with - you guessed it -  either laboratory automation or its latest iteration, molecular typing of red cell antigens and its kissin' cousin, personalized medicine. But I've resisted. 

The first blog will discuss the worldwide 'tainted blood' tragedy of the 1980s and '90s, which resulted in the related disruptive forces of 
  • Krever Inquiry (Royal Commission of Inquiry on the Blood System in Canada);
  • Vein-to-vein responsibility for blood transfusion;
  • Government regulation migrating from blood supplier to hospital transfusion services.
The focus will be on Canada because that's what I know best. But I suspect the transmogrification of blood suppliers and hospital transfusion services was similar in other countries, albeit some progressing faster, some slower than Canada. 

Note that I am an oldster (see 'Life as a blood eater' in Further Reading) and my recall is not perfect. If I inadvertently omit significant events or get things wrong, please comment below or e-mail me. My personal take on the highlights of these disruptive forces follows.

BLOOD SUPPLIERS
In Canada, the Krever Inquiry - 1993-1997 (Further Reading) -  resulting from the HIV and HCV 'tainted blood' scandals, had a huge impact on the blood supplier, the Canadian Red Cross Blood Transfusion Service (CRC-BTS). Krever was an earth-shaking disruptive force that eventually resulted in Canada creating two new blood suppliers in 1998

Goodbye CRC-BTS, hello CBS and H-Q!
THE FALL GUY
Think about it. The blood supplier that had managed Canada's blood system from the get-go in the 1940s was to disappear under a cloud of suspicion. 

In exchange for not bringing the case of Canada's tainted blood scandal to trial, the Red Cross pleaded guilty to violating the Food and Drug Regulation Act by distributing a contaminated, drug (Factor VIII concentrate). The $5,000 fine was the maximum penalty for that charge under the Act. 

Other court cases proceeded against individuals but with no convictions:
In effect,the CRC-BTS was the fall guy (not its complicit government paymasters) for the entire tragedy. Two factors at work were the typical physician sin of paternalism and government secrecy. The panacea was to create new organizations at arms-length from government that would be more transparent. 

Only something NEW could restore the faith of Canadians in the blood system. 

The reality was that the new blood suppliers had many of the same transfusion professionals serving as leaders (medical directors), and the trench workers were the same, mainly medical lab technologists performing blood donor testing.  It's not like experienced, skilled personnel were hanging around like low-lying fruit waiting to be picked.

Regulatory Compliance Project
Meanwhile, in the mid-1990s the Canadian Red Cross initiated a Regulatory Compliance Project whereby standard operating procedures (SOPs) to encompass all operations were to be written and used in all CRC-BTS centres. To implement the SOPs and to maintain the system, a training component was included. SOPs were to comply with current Good Manufacturing Practices (cGMP). 

During this time I taught at University of Alberta, but after hours participated as an external consultant in developing training materials. 

It's worth noting that the transition to SOPs and training - a huge undertaking - happened on the 'disgraced' soon-to-disappear Canadian Red Cross's watch.  

HOSPITAL TRANSFUSION SERVICES
Despite the long history of Quality Systemsthe first I became acutely aware of QSE (Further Reading) and their implications for hospital transfusion laboratories was at the CSTM 2000 annual conference in Quebec City. 

The Canadian province of Quebec had created transfusion safety officers (TSO), initially with both a medical technologist and nurse for 20 designated centres.  [Right click and select 'Translate to English']:
In 1999, following the report of the Krever Commission, a complete reorganization in transfusion medicine was initiated in the province of Quebec. To improve transfusion practice, roles and responsibilities were established for the professionals involved in the management of blood products from blood donor to recipient
Ontario, particularly at the McMaster University Medical Centre in Hamilton, had a few TSOs (CSTM blog - Gagliardi: Further Reading) who had become specialists in QSEs and writing standard operating procedures (SOP). 
And it was at this CSTM meeting I learned of the existence of the BC Provincial Blood Coordinating Office (PBCO), Canada's first PBCO, which had been created ~1998. 

A friend (CSTM blog - Chambers: Further Reading) introduced me to its then medical director as a 'geek' who could potentially manage and coordinate resources for its TraQ program (one of the luckiest days of my life).  

Soon I became aware of the extensive help the PBCO gave to transfusion services throughout BC to help with writing SOPs and training materials. The BC PBCO was ahead of the curve - way ahead of the curve. 
It's fair to say that these BC manuals served as templates for transfusion service SOPS written across Canada and perhaps beyond, particularly in developing nations since they were generously shared online.

Then in 2004 - a huge disruption - The Canadian Standards Association (CSA) published its Standards for “Blood and blood components” (also known as Z902-04). I wrote about it for the BC PBCO's Blood Matters newsletter:
INTERNATIONAL ASPECTS
It's worth noting that the UK's blood system, while not having a Krever-style commission until much later, was quite active and early in producing guidelines for transfusion services via the Red Book.

And the UK and Australia were leaders in creating transfusion safety officers: 
In the USA the AABB had its excellent Technical Standards but being AABB accredited was voluntary. Nonetheless, the AABB Standards served as best practice.

As in Canada, the government (FDA) regulated blood suppliers. I'm unaware about the U.S. situation, but in Canada, until the Krever Inquiry report on the tainted blood tragedy, inspections, if they occurred, lacked rigour. That's the politically correct way of saying government oversight of the blood supplier was a joke. For example, in my 13 years at CRC-BTS in Winnipeg, I cannot recall one inspection having happened. Maybe they did but I doubt it. These days, every staff member in a blood centre is ultra-aware when inspections and audits are to occur.

U.S. regulation and accreditation of blood transfusion labs is a quagmire of multiple bodies, e.g., AABB, FDA, CAP, CLIA, The Joint Commission, ISO 15189, COLA, and many others. Perhaps unfair but my best guess of the on-the-ground situation in U.S. hospital labs in the 20th C comes from graduates of the University of Alberta Med Lab Sci program, when so many went to work in the USA in the 1990s due to no jobs in Canada. 

First, U.S. employers loved them, probably because of their solid experience rotating in clinical labs, generally significantly more time than U.S. grads received. Second, I'll never forget their often humorous transfusion anecdotes. One example: 
  • 'My gawd, Pat they don't even label the test tubes for pretransfusion testing.' 
No doubt the situation is much improved today. Also worth noting is that the USA never had an inquiry into tainted blood scandals similar to Krever. And the U.S. was also late to adopt TSOs and hemovigilance.

SO WHAT DISRUPTION OCCURRED?
First, be aware that before Krever even blood suppliers in Canada did not have SOPS or follow cGMPs. I worked for the CRC-BTS for 13 years as a bench technologist, supervisor, and clinical instructor and the methods used to test donated blood were unwritten. Methods used to crossmatch blood for patient transfusion were also unwritten. New staff learned as surgeons traditionally did: 
  • See one, do one, teach one (Further Reading)
  • Sidebar: After 6 months in Jamaica more or less goofing off, and longing for cooler climes, I wanted to return to CRC-Winnipeg but had to first substitute for a vacationing staff member in CRC-Calgary returning to her family in South America for an extended vacation. 
  • Spent one day watching a technologist perform pretransfusion testing (method was quite different than Winnipeg's) and was asked to do one. Afterwards the lab manager asked my supervisor if I could do the job and her reply was, 
    • 'She's good to go.' That was it. I was now the sole night technologist for CRC-Calgary.
The Winnipeg CRC-BTS also performed pretransfusion testing for all city hospitals (unique in Canada) and many rural ones in Manitoba and NW Ontario. 

Re-SOPs, once I became a clinical instructor for Winnipeg CRC-BTS I spent an entire summer holiday writing SOPs for the transfusion lab. None existed and it seemed a good thing to do, not only for staff but also for students during their clinical rotation in the one transfusion service lab in town. 

What follows focuses on the disruptive impact to hospital transfusion services due to vein-to-vein responsibility for transfusion safety.

SOPs and Competency Training - Med Lab Technologists
As noted post-Krever Canada's blood supplier underwent a tremendous disruptive transformation to cGMPs and training. To those who worked pre-Krever, post-Krever was a different universe. 

The disruptive requirement in transfusion services to have written SOPS and related competency training at first, at least in Canada, applied mainly to medical laboratory technologists. This spawned an entire industry, first via government-funded PBCOs and their equivalents and soon by the need for hospitals or health regions to hire TSOs to educate and train the 'trench workers', whether technologists or the nurses who administered blood transfusions.   

The cost to the public purse was huge (new PBCOs and TSOs), as was the disruption to the daily lives of affected professionals. But having SOPs and training was wonderful because 
  1. They standardized lab methods - learning no longer depended on who taught you.
  2. Your competency - knowledge and practical skills - were documented;
  3. The system became much safer.
Some, like the USA's talented Lucie Berte capitalized and built a successful career around QSEs and SOP development with diverse global clients.

SOPs and Competency Training - Nurses
Soon nurses - those who administer blood transfusion - were affected by the disruption of regulatory requirements. Indeed, hemovigilance programs (also a disruptive force) such as the UK's SHOT show that many errors continue to be clinically related due to human error failing to ensure 'right blood to right patient' at the bedside. 

Checklists and clinical audits of administering blood transfusions are now the norm in many locales. But SOPs and checklists only work if humans follow them.

SOPs and Competency Training - Physicians
The one profession seemingly least affected by the disruption of regulatory requirements are the clinicians (physicians) who prescribe blood transfusion. Blood supplier medical directors, and especially transfusion service medical directors, are affected because they are ultimately responsible for ensuring patient safety. 

Physicians continue to receive minimal education in transfusion medicine (typically a few hours as medical students). Ordering practices may be somewhat controlled and monitored by computerized test-order-entry systems requiring laboratory data to justify ordering blood products and hospital transfusion committees. But do physicians actually do this or do they often leave an order for ward staff to perform? 

In some jurisdictions, more rigorous monitoring of expensive blood products such as IVIg exists. 

But from all I know, despite such monitoring, if physicians want a blood product, they usually get it despite poor clinical indications, especially if they are 'grand poo-bahs' in their hospital. 

That said, blood education is ongoing and jurisdictions such as the NHSBT's Patient Blood Management program report good progress.

SAY WHAT?
I've heard from colleagues that transfusion-related SOPS may have run amok in some locations. Specifically, they now include so many steps and documentation requirements that medical laboratory technologists can get lost in the trees and lose sight of the forest. It's complicated by centralized laboratories in which even staff in the main lab automatically default to asking the transfusion specialist to handle any problem, large or small. But that's a topic for another blog. 

Main point is that too much of a good thing can quickly go wrong.

SUMMARY
In Canada the tainted blood scandal was a disruptive force that led to the Krever Inquiry and the creation of two new blood suppliers as well as the related disruptive force of government regulation, resulting in vein-to-vein monitoring of the entire blood system and the creation of SOPs and competency training for most involved in blood transfusion. 

I say for most because the one profession that's been least affected are the physicians who order blood components and products. They've been affected, more or less so, depending on their locale, but 'least' is the operative word. Correct me if I'm wrong. Why do physicians largely merit a get-out-of-jail-free pass on blood transfusion? 

Medical laboratory technologists and nurses receive SOP training and must show competency before they can perform tasks independently. Every aspect of their technical and clinical job performance is regularly audited. Physicians not so much...

Canadian Blood Services has a great resource, its Clinical Guide to Transfusion. The first chapter explains everyone's responsibilities:
The ordering clinician's first duty is 'To carefully assessing the clinical need for each order'. How effectively is this monitored, I wonder? 

Because of a tragedy that killed 1000s, life as transfusion professionals changed forever in the 1990s. In Canada, the Krever Inquiry led to government regulation requiring SOPs and competency training, which eventually extended to vein-to-vein monitoring of the blood system.

These disruptions were good for all concerned and promoted patient safety, because that's what it's ultimately all about. 

As always, comments are most welcome.

FOR FUN
Couldn't resist this 1977 song by Fleetwood Mac, written by Christine McVie, which became the campaign song of Bill Clinton in the1992 US Presidential election. 
Don't stop, thinking about tomorrow,
Don't stop, it'll soon be here,
It'll be, better than before,
Yesterday's gone, yesterday's gone.
Don't you look back.

FURTHER READING

Dark Daily: In Sydney, Australia, Medical Laboratory Professionals Gather to Explore Disruptive Forces in Healthcare and How Labs Are Using Innovation and New Leadership Approaches to Successfully Transition to Value-Based Care

CSTM blogs - I will remember you:
Canada's Krever Inquiry

Life as a blood eater

Quality System Essentials (in brief)

Kotsis SV, Chung KC. Application of the "see one, do one, teach one" concept in surgical training. Plast Reconstr Surg. 2013 May;131(5):1194-201. 

Friday, February 19, 2016

Sweet Dreams (Musings on a recent transfusion-related nightmare)

Updated: 28 Feb. 2015 (see CBS's Dr. Sher audio clip at end)
February's blog derives from news items in TraQ's monthly newsletter that resulted in my dreaming from a 'what if' perspective.

The title derives from a Eurythmics ditty that I've used several times before. Was reminded of it again from this Twitter post from 
@SantaCruzbio:



For links to news items and resources, see Further Reading at the blog's end.


I HAD A DREAM 
Dreamt I was a Canadian who had a blood transfusion in 2018 and contacted a debilitating, deadly disease. Turns out 1000s of folks around the globe got the same transfusion-associated disease and many died within a few years before they discovered a treatment that works for many, but not all, and not forever. 

THE DISEASE
The disease I contacted was named 
  • Arrogant Scientific Syndrome by Highly Analytical Tossers after those who allowed it to happen (ASSHAT for short)
At first ASSHAT appeared in homosexual and bisexual males, so was deemed sexually transmitted and soon it showed up in IV drug abusers, presumably via contaminated needles. 

Hence, the perspective developed that it was the victim's fault - THEM - and wouldn't affect WE- those of us outside those groups. In other words, the typical WE-THEY bigotry. 

I DREAMT THE NEWS TODAY, OH BOY...
In my dream, here are but 6 things that happened in Canada, and no doubt occurred elsewhere, given that government bureaucrats, medical administrators, and physicians (sometimes the same individuals wearing different hats) are similar the world over.

1. The transfusion medicine community naturally denied ASSHAT was transfusion-transmitted until the evidence was overwhelming. They knew the blood supply was safe, so much safer than before. After all, the new transmissible disease test for hepatitis B had been implemented ~10 years ago. We felt safe.

2. At first the blood supplier chose not to screen out high-risk donors for fear of blood shortages, aided by interest group lobbying.

3. The blood supplier and its government funders were so concerned about saving money that they cut corners, in secret, of course. Specifically, they chose
  • Not to purchase a safer blood product for hemophiliacs in order to use up contaminated inventory, apparently thinking they were likely already infected, so what the hey! Or perhaps they thought better to give contaminated products than none at all, given the dangers of severe bleeding? Maybe they thought they were leveraging existing inventory to save money. Who knows?
  • To delay implementing a test for ASSHAT because money was tight.
4. Someone, who knows who or how, destroyed key documents, minutes of meetings) of the Canadian Blood Committee. This group influenced, if not outright decided, most of the above decisions.

5. At an individual level, a paternalistic physician chose not to tell an older man's wife that her husband was ASSHAT-positive because the physician was sure they were not having sex. No doubt he thought he was being kind. Wrong! The wife came down with ASSHAT and sued the physician, which is how we found out about it.

6. Ultimately, police laid 32 criminal charges against senior scientists at Health Canada, the Canadian Red Cross Society and Armour Pharmaceutical Co. Guess how many were convicted?

OUTCOME
In Canada a commission of inquiry was set up ~12 years later in 2030 and completed its report in 2034. That was 16 years after I contacted ASSHAT. 

But I was one of the 'lucky ones' who was still alive. And I benefited because the federal government  offered $120K in 'humanitarian assistance' in exchange for a promise we would not sue. The provinces later offered $30K/year for life. 

Those who got variant ASSHAT, resulting from the blood supplier failing to use surrogate tests used in the USA, threatened to sue for equal treatment and the government paid out millions of dollars. 

Many of those affected by both diseases died before compensation was available. Sometimes I suspect maybe that was the idea.

Then I dreamt that I was British and had a worse nightmare. The inquiry into ASSHAT offered only one wimpy recommendation after 6 years of inquiry, held more than 25 years after the ASSHAT tragedy. I had died by then.

LEARNING POINTS
Think what happened in my horrific dream couldn't happen, that it's just too far out, too sci-fi? Think again. It already has. Think it couldn't happen again? Why? The physicians and blood administrators who made the decisions decades ago were smart, caring people. But not infallible when confronted with financial constraints, interest group lobbying, and political pressure.

Canada was one of the few, maybe only, countries that held an extensive legitimate inquiry into what is typically called in the media, the tainted blood scandal

Canada's Krever Commission had 50 recommendations. The first was to compensate victims. Recommendation 2:
    • Blood is a public resource.
    • Donors should not be paid.
    • Sufficient blood should be collected so that importation from other countries is unnecessary.
    • Access to blood and blood products should be free and universal.
    • Safety of the blood supply system is paramount.
But apparently paying blood donors is now okay, at least for plasma, because we are so much smarter today and our technology is so much better. Sure it is. 

As always the views are mine alone and comments are most welcome.

FOR FUN
I chose Sweet Dreams as the music for the blog because it's ironic. My dream was not a Sweet Dream but rather a nightmare. Nonetheless, I love this ditty:
  • Sweet Dreams [are made of this] (Annie Lennox, Live 8, Hyde Park, London, 2005)
Sweet dreams are made of this.
Who am I to disagree?
I travel the world and the seven seas
Everybody's looking for something.

Some of them want to use you.
Some of them want to get used by you.
Some of them want to abuse you.
Some of them want to be abused.


Thanks to Anonymous (see Comments below) for link to this video by CBS CEO Dr. Graham Sher:





Also thanks to Anonymous for 

  • Audio clip (~10 mins): CBS CEO Graham Sher's interview (CBC, The Current, 25 Feb. 2016) 
    • Transcript of interview
    • Apparently, the manufacturing process for plasma derivatives kills anything and everything. Why even test plasma collected for fractionated products? Maybe the price of IVIg would come down?
FURTHER READING
Canada
UK