Showing posts with label Krever. Show all posts
Showing posts with label Krever. Show all posts

Tuesday, February 26, 2019

Always on my mind (Musings on infected blood inquiries)

Stay tuned - Updates likely to occur

The idea for this blog has roots in the UK Infected Blood Inquiry now in the news and the CBC's Unspeakable, an 8-part television series (Jan. 9-Feb. 27) about Canada's 'tainted blood scandal' of the 1980s-90s.

I will not go into too much detail as some topics discussed are emotional minefields for folks, eliciting strong opinions. The purpose is to offer food for thought and leave it to you, the reader, to think about the issues, according to your background and experience.

The title derives from a 1969 ditty that Willie Nelson covered with much success in 1982.

As you read, please monitor your reactions, since what we think and how we react to events largely depends on the emotional baggage we each carry. As one example of many, my reaction to blood inquiries is shaped by having worked for Canada's first blood supplier (Canadian Red Cross) for 13 years and for decades as a transfusion science educator. Also my views are shaped by being a bit of a contrarian who tends to challenge orthodox opinions of transfusion medicine's 'biggies' (thought leaders).

PURPOSE/PRINCIPLES OF INQUIRIES
First, inquiries into infected blood tragedies are not concerned with criminal or civil liability. Supreme Court Decision of Canada (Attorney General) v. Canada (Commission of Inquiry on the Blood System) specifies
Second, the same Supreme Court decision specifies
Note that inquiries can make findings of misconduct if they fall within the inquiry's terms of reference. If the same is true for the UK's inquiry, then folks looking for criminal and civil blame to be assigned will be disappointed. But misconduct that occurred or actions that failed standards of conduct will be identified and open to further investigation by the justice system.

Given that memories fail and records disappear over time, especially sensitive ones, and self-interest makes few reveal their errors, based on Canada's experience, criminal prosecution is next to impossible. But civil suits, requiring a lower standard of proof beyond a reasonable doubt, may succeed.

As in most legal matters, credibility of witnesses is crucial where no hard evidence exists. It's complicated because of self-interest. Few,if any, admit, 'I screwed up and made a bad decision, I'm partly to blame. Forgive me.' Those involved are far more likely to say, ' I did the best I could under difficult conditions. I didn't know all the facts or what would happen. No one did. Hindsight is 20-20.'

From Canada's experience, an added key factor is that so many different players are involved, sometimes operating in silos, with no one ultimately responsible, that it's easy to claim, 'Not my responsibility.' All very convenient and I suspect Canada's blood system still has this fatal flaw despite its transmogrification, post-Krever.

PURPOSE/PRINCIPLES OF CRIMINAL JUSTICE SYSTEM
Not being a lawyer, I hesitate to include this section but include it as food for thought. Here's how I see Canada's justice system, its purpose and principles. Note: My opinions may well differ with those of many Canadians, particularly regarding incarceration and punishment.
  • Ensures public safety by protecting society from those who violate the law. Defines unacceptable behaviours and the nature and severity of punishment for a given offence. 
  • Presumes innocent until proven guilty and those charged have the right to legal representation and a fair trial. Burden of proof is on the prosecution and defendant must be proven guilty beyond a reasonable doubt. 
  • Acts as a deterrent to criminals, with incarceration being the last resort, reserved for the most serious offenses and where mitigating factors do not exist.
  • Purpose is not to punish offenders but to act with compassion and rehabilitate, if possible. Fact: Most people who come in contact with criminal justice system are vulnerable or marginalized individuals who struggle with mental health and addiction issues, poverty, homelessness, and prior victimization. (See 'What we heard - Transforming Canada's criminal justice system,' Further Reading)
TIDBIT: When I read news items or information on the UK Blood Inquiry, it's my impression, rightly or wrongly, that, as in Canada, many victims and their families are out for blood so to speak. They clearly want those whose professional misconduct and negligence  - unproven but it's how they see it - led to loved ones being infected brought to justice and punished. In other words, the NHS and its medical professionals and officials seem to have been prejudged as guilty. (Further Reading)

ANALOGIES
Analogies are offered to stimulate thought.

#1. Tragic Humboldt bus crash (Further Reading)
On April 6, 2018 sixteen people were killed and thirteen injured when a bus carrying members of the Humboldt Broncos, a Canadian junior hockey team, struck a semi-trailer truck. The driver passed four signs warning about the upcoming intersection yet the semi-trailer went through a large stop sign with a flashing red light.

The driver of the semi-trailer, 29-year-old Jaskirat Singh Sidhu was charged with 16 counts of dangerous operation of a motor vehicle causing death and 13 counts of dangerous operation of a motor vehicle causing bodily injury.On January 8, 2019, Sidhu pleaded guilty to all charges.

The Crown is asking for a sentence of 10 years with a 10-year driving prohibition. Sentencing is March 22, 2019. It's possible Sidhu could be deported after serving his sentence.

Sidhu followed his girlfriend to Canada in 2013 and is now a permanent resident. He's a newlywed who grew up on a farm in India and earned a commerce degree. He worked at a Calgary liquor store before he started driving a truck. He started work at a small trucking company only three weeks before the crash, after undergoing a week of training and spent two weeks driving a double-trailer with the owner before driving on his own.

Canada and its provinces, except for Ontario, have no compulsory training for new 'class 1' truck drivers and no mandatory training standards.

TIDBIT: Sad but it seems Sidhu will take the full blame for his horrific error, despite mitigating circumstances, namely the entire trucking driver safety system failed. Trucking companies and governments now say they'll do better, but they suffer no consequences, only the ill-trained driver of the truck. Sidhu is the scapegoat.

Reminds me that Canadian Red Cross was the scapegoat of Canada's 'tainted blood tragedy.' The newly created CBC and Héma-Québec operated with many of the same transfusion professionals because you cannot educate and train new experts overnight.

Truck companies can save money by offering minimal training and put unsafe drivers of large semi-trailers behind the wheel. Only one provincial government required mandatory training or considered standardized training. Of course, now some provincial governments have but it will be a pathetic patchwork, ignoring that semis regularly drive across provincial borders.

Did the justice system provide a deterrent to prevent a tragedy like the Humboldt bus crash from happening? If a similar tragedy occurs, will it all fall on the driver again?  Will the justice system rehabilitate the dysfunction system that played a key role in the crash?

#2. Sexual abuse by Roman Catholic clergy (Further Reading)
Happened globally in 20th and 21st centuries, and likely for centuries before that. Scandal is so well exposed it needs no documentation, though see Further Reading. Clearly a systemic problem, yet who is held accountable?

Bishops transferred known offending priests to other jurisdictions to abuse more children. Everyone in the Church worked to protect the Church at the expense of children, and now it turns out, even nuns were abused.

Who is ever held accountable other than the odd defrocked clergyman? Who in the Catholic Church's patriarchal hierarchy should be held accountable and what would justice for victims, providing a deterrent to future crimes, and making the public and society safe entail?

Does 'We did the best we could in difficult circumstances, wanting to protect both the perpetrators and victims equally' cut it, because there's good people on both sides (to use a Trumpism)?

BLAME GAME
Healthcare, including transfusion medicine, supposedly has adopted a quality system that promotes a blame-free culture where individuals are able to report errors or near misses without fear of reprimand or punishment. (Further Reading, Culture of Safety)
"The culture of individual blame still dominant and traditional in health care undoubtedly impairs the advancement of a safety culture. One issue is that, while "no blame" is the appropriate stance for many errors, certain errors do seem blameworthy and demand accountability. In an effort to reconcile the twin needs for no-blame and appropriate accountability, the concept of just culture is now widely used.  
A just culture focuses on identifying and addressing systems issues that lead individuals to engage in unsafe behaviors, while maintaining individual accountability by establishing zero tolerance for reckless behavior. It distinguishes between human error (e.g., slips), at-risk behavior (e.g., taking shortcuts), and reckless behavior (e.g., ignoring required safety steps), in contrast to an overarching "no-blame" approach still favored by some. " 
Yet the blame game still exists in medicine, as exemplified by the Dr. Bawa Garba case in the UK (Further Reading), although the injustice was ultimately rectified.

A key part of human nature is to want to know and understand why things happen. Humans (we Homo sapiens) have done it since we emerged as Great Apes, along with orangutans, gorillas, and chimpanzees. Later in our history it's one reason astrology emerged.

If bad things happen, it's natural to assign blame. Take footie (soccer in NA). If a team loses 1-0 because of a goal from a penalty kick due to the referee penalizing our player, many fans see it as the refs fault, it wasn't a penalty, the opponent dived. Definitely not that our club couldn't score even one goal.

And it's much more satisfying and easy to grasp if we can assign blame to fellow humans as opposed to some amorphous system failure. Another factor at play: if we look for something, we often find it. For example, can be as simple as being a new VW Beetle owner and suddenly noticing them everywhere. Or more relevantly, if I suspect that a person is a misogynist, I may interpret their perhaps innocent words and actions as misogynistic.

REVENGE 
When I told a good pal that I considered writing this blog, she encouraged me (as she always does) and suggested I include what a desire for revenge does to a person.

Good example exists in the CBC's Unspeakable series, in the character Ben Landry, to me a fictionalized version of one of two book authors (along with Krever Report) the series is based on: Vic Parson, who wrote Bad Blood: The Tragedy of the Canadian Tainted Blood Scandal. In the fictionalized version, Landry's behaviour drives away his wife and son with hemophilia and misses out on celebrating the birth of his grandson.

It's a given that hatred and the desire for revenge eats away at people and can destroy their lives if left unchecked. Know this from personal experience of a relative who physically abused his wife and sexually abused many children. Revenge seldom, if ever, gives the solace we need.

LEARNING POINTS
Just want folks to think about what would constitute justice for victims of infected blood scandals around the globe. Are thousands of deaths from HIV and HCV the fault of no one, just a system failure that no one could prevent? No one can be faulted for decisions because they didn't know enough? If preventable errors were made, what does justice look like?

 FOR FUN
Chose this ditty because it fits how I feel about the blog's issue. To me, transfusion professionals always had patient well-being on their minds yet they failed them, as the lover admits in this song:
COMMENTS: As always, your comments are appreciated and welcome. See below.

 FURTHER READING
Canada's blood scandal 
If you view only one resource, make it this one. From Canada's blood tragedy: Tragedy of Factor VIII concentrate (19:14 mins. well worth watching. See Randy Conners words at 18 min. mark)
Criminal Justice System Purpose
UK Infected Blood Inquiry News 
Humboldt Broncos bus crash
Catholic Church Sexual Abuse
No Blame Culture
Bawa-Garba Case
Posted by Blut at 6:09 PM 2 comments
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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 Systems, the 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. 
Posted by Blut at 5:36 PM 4 comments
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Saturday, August 09, 2014

The way we were (Musings on TM history and its lessons for today)

Updated: 11 Aug. 2014
This month's blog discusses 3 recent news items (and associated scientific papers) related to men who have sex with men (MSM), HIV risks, and blood donation, plus a paper written by Canadian transfusion medicine experts on Canada's perspective on donor criteria for MSM.

The blog's title is from a 1975 Barbra Streisand classic (one of my favorites) and theme from an eponymous movie starring her and Robert Redford.

Please read the news items and papers as they provide fascinating, useful details beyond the brief reports presented in the blog. Although the specifics involve North America, the content and learning points apply everywhere.

1. USA: HIV positive man arrested and charged after donating plasma for $30
A man admitted to police that he donated plasma at BioLife in Elkhart, Indiana even though he knew he was HIV positive. He'd lost his job and needed money. 
Biolife pays $30 for plasma via a debit card and is a division of Baxter Healthcare. 
The plasma donor was charged with three counts of attempting to transfer contaminated body fluids and one count of transferring contaminated body fluids.
2. USA: Activists fight MSM policy (lifetime deferral if even once since 1977) with National Gay Blood Drive on 11 July, 2014.
The blood drive involves gay and bisexual men who want to donate bringing proxy donors who are eligible to donate and publicizes what activists believe is an outdated discriminatory and unscientific policy. 
The news item outlines the key issues on both sides of the argument with quotes from Paul Strengers, medical director at the Dutch Sanquin Blood Supply Foundation (anti-changing the policy) and the American Medical Association (pro-change). 
Related: AABB, ABC, ARC Joint statement on National Gay Blood Drive
Among other things, the US organizations were concerned that the event might disrupt blood center operations but support "rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities."
3. USA: 5 reasons HIV is on the rise among young gay and bisexual men
In brief, according to HIV researchers at CDC, the reasons include young gay and bisexual men's partners are more likely to
  • Have and transmit HIV
  • Engage in risky sexual practices
  • Use drugs
  • HIV's stigma could make people less likely to get tested
  • Younger men weren't around for worst of the HIV/AIDS epidemic and are less likely to know the dangers
Related: Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in the United States, 2002-2011. JAMA 2014;312(4):432-4.

4. Goldman M, Lapierre D, Lemay L, Devine D, Sher G. Donor criteria for men who have sex with men: a Canadian perspective. (Commentary) Transfusion 2014 Jul;54(7):1887-92.
With other jurisdictions considering a change in MSM policies, this paper was written by Canadian blood experts who thought it might be of value to share Canada's experience. It outlines CBS and Héma-Québec's extensive processes to consult interest groups / stake holders to achieve a consensus to support Canada changing its long-standing permanent deferral for MSM to a 5-year deferral from last MSM contact. 
The 'Commentary' begins by outlining the history of the HIV/AIDS/HCV 'tainted blood' disaster in Canada, which led to the Krever Royal Commission of Inquiry into Canada's blood system and its 'damning' (my word) 1997 report.  
As a result, in 1998 CBS and Héma-Québec were created; blood was regulated as a drug with blood centres considered biologics manufacturers, with more stringent regulatory oversight by Health Canada. 
I'll present only a few key highlights of the paper, those selected through my biased eyes. Also note [my Comments].
HISTORY: [One of the most explicit mea culpas I've seen from Canadian TM experts]:
* There was a lag between implementing measures to reduce transmission of AIDS/HIV in Canada compared to the US and others, including donor deferral criteria, HIV antibody testing, and sole use of adequately virus-inactivated factor concentrates.

* Delays contributed to infection of many transfused patients, with the hemophilia population particularly devastated by HIV. Delays also occurred in adopting measures to reduce HCV transmission. 
* Anger and bitterness over the (mis)management of HIV and HCV risk by the blood system cast a long shadow over the new organizations, CBS and H-Q. 
[Why did the delays occur? What's the root cause? A focus on cost over safety? A belief in evidence-based science that failed to consider what experts did NOT know? Or?]
STATISTICS: As of 2011 PHAC reports there were ~71,000 prevalent and 2250-4100 annual incident cases of HIV in Canada. MSM risk was high for prevalent and incident infections, accounting for about half of new infections.
* Large MSM studies demonstrate seroprevalence rates from 10% to 20% but generally recruit participants in gay venues and focus on currently sexually active MSM, often with frequent partner change (not those in longstanding monogamous relationships or those sexually inactive for a long time).

[Incidence of HIV seroprevalence in gays in long monogamous relationships is unknown.]

* With sensitive antibody detection assays and minipool nucleic acid testing (NAT), the window period for HIV is estimated at 9 to 11 days. 
* Residual risk for HIV is estimated at less than 1 in 8 million units at CBS and in the USA is 1 in 1.5 million units, due to higher rates of HIV+ donors. 
[FYI, residual risk is the risk of an infectious donation being present in the blood supply after all donor and donation screening activities occur and unsuitable donations are removed and discarded.  See Current information on the infectious risks of allogeneic blood transfusion - Residual risk. Put another way, it's the OOPS! factor.]
RISKS
* Risk modeling in Canada found the incremental risk of a 5-year deferral for MSM was less than 1 infected HIV unit entering the blood supply in 1000 years. 
* A 5-year deferral for MSM would not substantially increase transfusion-associated HIV in Canada. Similar modeling studies were done in France, UK, and USA. 
[Sounds great, eh? Almost as if we can crow, 'Don't worry, be happy'. But the fly in the ointment...] 
* 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where data are often sparse. Additionally, they do not provide information on novel or emerging threats.' 
[Modeling involves many assumptions based on minimal data – so much for evidence-based. Plus, obviously new and emerging threats (unknown) are absent from modeling studies.]
MUSINGS
I'm not going to report the guts of the Canadian paper, which outlines the processes used in Canada in 2001, 2006, 2008, 2009, 2011, and 2012 except to mention the Kyle Freeman court case.

But please read the paper if you have access because it explains the science and politics of MSM and blood donation as few resources have and the emotions and tension that marked the debate historically and still do.

In brief, the Freeman case involved a gay man who informed CBS via an anonymous e-mail that he donated and lied about his MSM status. To trace the anonymous e-mail and apply the appropriate deferral code, CBS sued for negligent misrepresentation as a way to obtain his identity from his e-mail service provider. He counter-sued, claiming CBS violated his rights under the Canadian Charter of Rights and Freedoms.

Freeman lost. Key elements of the judgment in favor of CBS were that blood donation is a gift and not a right and that MSM policy is not discriminatory based on sexual orientation.
Relevant reading:
LEARNING POINTS
MSM, HIV, and blood donation continue to be controversial and political. To me, key points from the Transfusion paper and related news items include 

#1. Goldman paper: 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where evidence is lacking. As well, they do not provide information on new or emerging threats.

In other words, models of HIV and other infectious disease risks to the blood supply are based on assumptions backed up with more or less zero data and do NOT consider new threats. So much for evidence-based decisions touted by TM experts.

#2. The role that student and gay rights activists play in changing blood safety policy is pure politics.

They claim discrimination (and a case can be made based on MSM vs engaging in risky behaviors regardless of gender) but ignore that HIV-prevalence of MSM presents a real risk to the blood supply. Moreover, HIV is on the rise among young gay and bisexual men, current HIV tests have a window period of 9 to 11 days, and donors may lie on blood donor screening questionnaires.

#3. Goldman paper: 'For patient groups, many of whom are chronic users of the blood supply, the change meant putting aside their fears of the past, assessing the available scientific information, and trusting in the system.'

To me, this is 'Don't worry, be happy' time (see earlier blog). Trust us. We've got your back covered based on science. Oh yah!

#4. All this aside, blood suppliers worldwide will cave to the political pressure of activist interest groups, claim it's evidence-based, and it won't affect blood safety until it does.

UK PERSPECTIVE
For interest, the UK's NHSBT donor policy on MSM:
The change means that only men who have had anal or oral sex with another man in the past 12 months, with or without a condom, are asked not to donate blood. 
Men whose last sexual contact with another man was more than 12 months ago are eligible to donate, subject to meeting the other donor selection criteria.
Other nations have permanent (indefinite) deferral or a 5 year deferral.              
FOR FUN
The blog's topic is not funny. The 'for fun' bit is just for enjoying the song. Looking back on the HIV tragedy and its impact on blood transfusion, I'm reminded of the innocent way we were before HIV appeared.
Mem'ries,
Light the corners of my mind
Misty water-colored memories
Of the way we were. 
Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were.
Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? Could we? 
Mem'ries, may be beautiful and yet
What's too painful to remember
We simply choose to forget.
So it's the laughter
We will remember
Whenever we remember...
The way we were...
As always the views are mine and mine alone and feedback is most welcome.


Posted by Blut at 6:59 PM 0 comments
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Sunday, January 11, 2009

Dr. Strangeblood or How I learned to start worrying and hate the numbers

As we enter a new year, money and the economy are on the minds of many people. Certainly economics is an obsession in the developed world. Accordingly, I could not resist a money-themed blog. Like it or not, money, money, money makes the world go round.

THE PAPER
As it happens there is a recent publication involving economics and transfusion medicine (TM):


Brian Custer, lead author, is with the Blood Systems Research Institute.
-->This blog examines the issue of cost effectiveness analysis and its role in influencing blood safety policies. As always, ideas are presented as food for thought.

The authors discuss cost-effectiveness analysis (CEA) in TM, with a focus on blood safety and infectious diseases. For example:
The paper's so-what statement:
"Blood safety may be different, but the economic concept of efficiency does apply. It is better to pay $10,000,000 to save 1,000 people than to pay 10 times that amount to save 1 person, and it is surely better to reach this decision after looking at the costs and the benefits rather than before."

With economics, like statistics, many people’s eyes glaze over. But read on – it’s fascinating stuff. Below are but a few of the paper's key points.

ECONOMIC CONCEPTS
Economics is about the efficient use of scarce resources and a CEA is one tool that can help decision makers decide which new blood safety test or process to implement.

CEA involves 3 key concepts:
  1. Since there are insufficient resources to support all possible activities, we must make choices.
  2. We must decide whether or not to adopt a given intervention and how to allocate resources between competing alternatives.
  3. In choosing, we must factor in the "opportunity cost", i.e., the value of forgone benefits. In other words, the true cost of something ("A") is not just what "A" costs but also the value of what we did without (the lost opportunity, "B") because we chose "A".
Quality-Adjusted Life Year
CEAs range from narrow (impact on the budget) to broad (factoring in the cost of human life and the quality of life). The latter analysis is termed cost utility analysis (CUA). CUA results are often given as a ratio of cost to health benefits and are reported as cost per quality-adjusted life year (QALY).

The cost per QUALY is a tool that allows for comparisons of health benefits across diseases. The value of what is considered a cost- effective QALY varies greatly between developed and undeveloped countries, as well as among disciplines.

In general, a cost-effective QALY is considered to be
  • Clinical medicine: $50,000 to $100,000/QALY
  • WHO: up to 3 times the GDP per person = ~$94,000 in USA & Canada and $72,000 in Europe (in year 2000 $)
QALY & blood safety
Larger QALY ratios are accepted in some areas such as blood safety because of several factors:
  • First, do no harm implies a high priority to prevent outcomes such as diseases caused by contaminated blood.
  • Society places a relatively high value on preventing low-probability risks with serious consequences.
  • Society is willing to support interventions that target identifiable individuals e.g., blood recipients.
As a result, blood safety policy makers in developed countries consider and accept interventions that cost well more than $1 million/QALY. As a rule, tests become more cost-effective if the disease being screened for has a higher prevalence in the donor population and if it cannot be detected to some extent by existing tests and screening procedures.

For example:
  • Anti-HIV screening when first adopted: $3600/QALY (due to higher HIV prevalence in donors & limited use of donor selection strategies)
  • HIV p24 antigen testing (since abandoned): $2.0 million/QALY
  • HIV NAT: $2.0 million/QALY (even using a NAT minipool, multiplex format with HCV and even with HBV too)
  • HCV NAT: >$1.8 million/QALY (minipool)
  • WNV NAT: $500,000/QALY (2003 - highest outbreak year)
  • HBV NAT: additional $1 million/QALY or more (in multiplex format with HIV and HCV)
  • HBV NAT: $66 million/QALY (separate test without HIV and HCV)
Since the AIDS tragedy of the 1980s, safety has focused on preventing transfusion-transmitted infectious diseases and more common transfusion life-threatening risks have taken a back seat even though preventing them is more cost-effective, e.g.,

  • Mechanical barriers to prevent misidentification errors leading to transfusing the wrong ABO group: $197,000/QALY
MUSINGS

The following ideas are not particularly profound or original but seem worth stating.

1. Statistics can be used to prove anything.

If you want to inspire confidence, give plenty of statistics. It does not matter that they should be accurate, or even intelligible, as long as there is enough of them.
- Lewis Carroll, mathematician, clergyman, author (1832 – 1898)
Don’t get me wrong, I love statistics. However, as we know, CEAs and their sub-type CUA generate many statistics and, depending on the assumptions chosen, can be used to justify just about anything.

This is especially true when decisions involve costs or benefits whose price is unclear or varies, which limits the generalizability of many studies. For example, consider this paper and its assumptions:

AuBuchon JP, Littenberg B. A cost-effectiveness analysis of the use of a mechanical barrier system to reduce the risk of mistransfusion. Transfusion. 1996 Mar;36(3):222-6.
Note that costs could change dramatically if the study's few assumptions changed. As a result economic studies have to be assessed carefully and taken with a huge block of salt.

Unfortunately, critical assessment of economic papers is often beyond the grasp many health practitioners.
  • Whenever statistics are tossed about, the potential for Taurus excreta cerebrum vincit exists. (Latin is incorrect, but you get the idea.)
2. Desire for zero risk

Undoubtedly, the history of the "tainted blood" scandals of the 1980s and 1990s involving HIV and HCV have influenced society's willingness to accept interventions that are not cost effective when compared with other areas of medicine. As has been noted so often by the TM community, citizens have come away from the HIV/AIDS tragedy with the impossible desire for a zero-risk blood supply.

Regrettably, in attempting to achieve zero risk, with tests for infectious diseases with common risk factors, we run into the law of diminishing returns. Because each test or intervention is layered upon previous ones, we inevitably spend more and more to detect fewer and fewer infections until the "bang for the buck" is minimal and the QALY cost is prohibitive.

3. Legal concerns

The threat of legal action remains influential in TM policy decisions, as in all of health care, and contributes to higher costs. As quoted by Custer and Hoch, regarding the decision to implement leukoreduction in Belgium:

The core problem proved to be legal. The blood banks are legally accountable for blood safety. This accountability is absolute, based on avoidance of all possible risks, regardless of costs. This strategy leads to inefficiencies in health care (i) blood safety management is guided by available rather than cost-effective technology, and (ii) private insurance premiums for civil liability are sharply increasing, while they are in no way related to the expected returns and the high and increasing [cost of] blood safety.
Source: Cleemput I, Leys M, Ramaekers D, et al: Balancing evidence and public opinion in health technology assessments: The case of leukoreduction. Int J Technol Assess Health Care 22: 403-407, 2006.

Government settlements to victims of transfusion-related diseases have been substantial, for example:
TM organizations continue to fight and present a unified front to those attempting to sue:
4. CUA versus the precautionary principle

Cost utility analysis (CUA) is about allocating resources between competing alternatives. CUA calculates a ratio of cost to health benefits that is reported as cost per quality-adjusted life year or QALY.

Custer and Hoch write:
  • It is better to pay $10,000,000 to save 1,000 people than to pay 10 times that amount to save 1 person….
This assumes that the options are framed as an either / or choice within a specific field such as TM. Such clear cut choices become relatively easy. Opting for cost-effectiveness under such circumstances is like being for Mom and apple pie.

Unfortunately, real world choices are almost always much messier. Then there is the precautionary principle, which was extensively reviewed in an earlier blog:
This CMAJ commentary (The Krever Commission – 10 years later) discusses Canada’s approach to the precautionary principle:
  • The tainted blood tragedy was arguably the worst public health catastrophe in Canada's history.
  • Guided by the Krever Commission findings, Canada's reformed blood system has restored public confidence in blood safety by proactively addressing infectious risks.
  • Two influential concepts from the Krever Commission have contributed to the reformed blood system's success: the adoption of precautionary measures and the creation of a governance system with clearer roles and responsibilities, including the separation of funding from decision-making concerning safety.
The author further notes:

The adoption of the precautionary approach has partly contributed to a mentality that is highly averse to risk that has led to the introduction of some safety measures considered to be cost-ineffective, with costs per quality-adjusted life-years sometimes in the millions…. Now that Canada has distanced itself from the tainted blood tragedy, and that public confidence in the blood system has been re-established, officials have the luxury of re-examining safety priorities and the correct balance between safety and cost.
I interpret the author as saying that we in Canada went overboard with the precautionary principle - now let’s get with the correct balance, whatever that is.

5. History as prologue

I cannot help but recall a few quotations about history:
  • Those who cannot learn from history are doomed to repeat it. (George Santayana)
  • History repeats itself, first as tragedy, second as farce. (Karl Marx)
  • The charm of history and its enigmatic lesson consist in the fact that, from age to age, nothing changes and yet everything is completely different. (Aldous Huxley)
  • History will be kind to me for I intend to write it. (Winston Churchill)
The history of transfusion-related HCV in Canada is instructive.

From 1986 to 1990 Canada, like many other countries, did not implement surrogate tests for what was then called non-A, non-B hepatitis. If an extensive CEA had been done of surrogate tests, the results would probably have been that the tests (anti-HBc and ALT screening) were not cost-effective. Regardless of the sensitivity and specificity of both screens (poor), the CEA's key assumptions would likely have been wrong. They would have underestimated the extent of the disease and its eventual health consequences. Regardless, such a CEA was not done.
How many infections the surrogates could have prevented is also impossible to tell. That’s because other screening measures during 1986–90 may have coincidentally also contributed to a reduction in HCV transmission. Nothing evolves in a vacuum and blood safety improvements, like many diseases, are multifactorial.

BOTTOM LINES

1. GIGO. One of the main challenges with CEA and CUA is, as the computer nerds say, GIGO, Garbage in, garbage out or more likely where computer-generated statistics are concerned, Garbage in, Gospel out.

2. QALY. Statistical gobbledegook involving numbers, poorly understood concepts, and loads of money can baffle even the most astute among us. Fess up – do you really understand QALY?

“The idea of QALY is to put a value on treatments that may not save lives but improve them. For example, if a blind person’s quality of life is “worth” 0.75 points per year, a treatment that would restore him to perfect vision — and raise his quality of life to 1 per year — is worth 0.25 per year of life. If the person lived another 30 years, the treatment would be worth 7.5 QALYs, or 30 times 0.25.”

Source: Berenson A. Pinning down the value of a person’s life (see Further Reading)
Say what? QALY, schmally, this type of creative number crunching is perverse even without all the iffy assumptions that go into producing the final numbers.

3. Dr. Strangeblood. Perhaps it’s because the transfusion-associated AIDS tragedy seems very recent to me, but whenever people start to promote cost effectiveness studies for blood safety measures, I get nervous.

Judicious use of public money is only common sense given that the money pot is finite. But, inevitably, when suits with calculators take control, even Dr. Strangebloods in suits with stethoscopes around their necks, humanity seems to fade.

People become numbers, money becomes paramount, and medicine becomes just another business. Is that what will protect the blood supply from another HIV tragedy?

Maybe I’m just a bleeding heart but I’m starting to worry and hate the numbers. I cannot get around the concern for love nor money. Take your pick:
ADDENDUM: Statistical tidbits (see paper's references for sources):

Infectious disease risks (USA)
HIV:1 per 2.3 million donations
HCV: 1 per 1.8 million donations
HBV: between 1 per 63,000 to 205,000

Non-infectious risks (examples of interventions)
TRALI from plasma:1 per 100,000 (male-only plasma)
Fatal septic transfusion reaction from platelets: 1 per 140,000 (mandatory testing)
Major mismatch of ABO type:1 per 600,000 (mechanical barriers, bar coding, RFID)
FURTHER READING

Government of Canada. Hepatitis C - Compensation for Tainted Blood Victims

Krever H. The blood supply system in Canada: systemic problems in the 1980s. Commission of Inquiry on the Blood System in Canada. Final report. Ottawa: Canadian Government Publishing; 1997;989.

(click "continue to the document")
Krever - Vol. 1: The background
Krever - Vol. 2: Where much of the "nitty-gritty" controversy is investigated and discussed
Of particular interest and relevance:
#24 - Canada's rejection of surrogate testing
Krever - Vol. 3 - International responses to the risk of HIV in the blood supply
Hill B. Zero risk at all cost in blood transfusion. Biomed Scientist, April 2005. (PDF)

Berenson A. Pinning down the value of a person’s life. New York Times, June 11, 2007.

Staginnus U. Health economics research on blood transfusion safety measures - an introductory primer. In Peterson BR.ed. New Development in blood transfusion research. Nova Science Publishers, 2006.

Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 
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