Monday, October 13, 2014

Bridge over troubled water (Musings on what to be thankful for as TM professionals)

Updated: 14 Oct. 2014

Apparently being thankful can improve your life. A professor of psychology at the University of California says so. It must be true (she wrote with tongue in cheek). Actually (and I hate writing or saying 'actually' after hearing a news reporter begin every sentence with it), I suspect it's true in most circumstances. Not necessarily when linked to being obsequious, though.

I had earlier written another blog for October on a topic I often blog about (two guesses - see below) but rethought it, especially since it's Canada's Thanksgiving today. Accordingly, this month's blog is about three things I feel thankful about it in the world of transfusion medicine and two that I don't.

Despite the Canadian references, transfusion professionals worldwide should be able to relate. As you read, I encourage you to think about your career and assess if any of my musings agree with yours.  Please feel free to comment.

The blog's title derives from 1970 Simon and Garfunkel classic, one of my favorites.

TOP THREE 'THANKFULS'

#1. Career in Transfusion Medicine
My life in TM began by accident and I never should have been hired. I was a high school teacher who wanted to work in Winnipeg but jobs were hard to come by for a 21 year old with a year's experience teaching in a rural Manitoba 4-room high school.

Lo and behold - a friend said, 'Pat, Canadian Red Cross Blood Transfusion Service hires BSc grads because most med lab tech grads from Red River Community College are scared to work there.' Say, what? I later learned the fear was largely because the clinical rotation was pathetic. Students spending most time labelling tubes and similar scut work in between being told by technologists to get the ABO group right or they could kill a patient. Did I mention the clinical rotation was only 2 weeks then? 

Soon I started work in a large combined blood centre and transfusion lab, the latter doing compatibility testing for all city hospitals and beyond, plus prenatal testing for northwestern Ontario. At first, I did not even know what the yellow stuff was when the red cells settled. True story. Could never happen today, a good thing.

I'm so thankful for the mentoring of generous colleagues. And for wanting and needing to read the 'bibles' of TM from front to back (every word). The books were penned by such icons as Issitt and Mollison, and included the AABB Technical Manual and a 'little red book' written for Red Cross staff by Dr. B.P.L. (Paddy) Moore (and others), National Director of the Red Cross Blood Group Reference Laboratory, who died in 2011. I wrote about Dr. Moore in a 2007 blog, 'My life as a blood eater.'

I worked in Winnipeg for 13 years, got Subject certification in Transfusion Science (no longer offered) from what is now CSMLS. My last 3 years were as the clinical instructor for new laboratory staff, RRCC students, and medical residents doing a transfusion medicine rotation in the only show in town. How crazy is that?

Looking back, I'm thankful that I worked in a busy laboratory where you never knew what to expect. Besides the routine of pretransfusion testing for scheduled surgery and anemic patients, at any time 24/7 patients might need massive amounts of blood in a hurry from a ruptured aneurysm to a GI bleed to a placenta previa during delivery. Often the lab was chaotic but it was organized chaos, even if that's an oxymoron.

Moreover, I'm thankful that in those days work was mostly hands-on and issues arose daily that required problem solving. For example, I worked with Dr. John Bowman when he did the first trials of antenatal Rh immune globulin and was involved in the work that led to this paper (I'm the Pat):












Eventually the blood donor side of the laboratory got an autoanalyzer, the Technicon BG-15. We called it 'Big George' and two staff (probably closet chemistry technologists at heart) opted to become 'specialists in automation'. Can you see the irony?
For an absolute hoot, when you have some time for 'mindfulness' reading, see these articles from 45 years ago by Canadian Red Cross staff, including Dr. B.P.L. Moore. The second includes, 'The possible future role of automated tests on blood donations is briefly discussed.' (Emphasis is mine.)
As to my career, the rest is history.... I'm thankful that I lucked out getting a teaching job in Medical Laboratory Science, University of Alberta, where I had the privilege of again working with generous, talented colleagues and teaching 100s of bright, inquisitive students, who kept me on my toes and forced me to keep learning. To be honest, at MLS I believe I had the best job teaching blood bank in the entire world.

Thinking about a career, particularly in later years, makes you realize how lucky you have been. I'm thankful to have worked in the trenches of blood banking doing work that made a difference and then to have gotten a job where that knowledge and skill could be passed to others. I hope that's true for you too.

As an aside, I'm thankful that I learned how to create web sites before it was easy (and you needed to know html code), which has stood me in good stead over the years, especially after I left real work. 

#2. Living in Canada
The good points of living in Canada are obvious, but that's not where I want to go. I imagine residents of many countries feel privileged for various reasons.

Instead, in keeping with the transfusion theme, I'm thankful that today Canadians are free to criticize CBS and our blood system leaders. Goodness knows, I do plenty of that and live to write another day.

October's TraQ newsletter has examples of criticism and responses to it:
In olden days, medicine was so paternalistic that physicians had god complexes. Some still do but times have changed, not just among health professionals but between doctors and patients, as in this 2011 Maureen Dowd column in the NY Times:
In many countries criticism of perceived authority is not allowed. And in some democracies health care workplaces exist where questioning prevailing orthodoxy, especially by those lower in the pecking order, is discouraged, even risky, career-wise. I'm grateful that's not true in Canada's transfusion medicine community, at least not the one I've been fortunate to work in.
#3. UK's SHOT
The UK's haemovigilance scheme (why is everything in UK TM a 'scheme'?), known universally as SHOT (Serious Hazards of Transfusion), is a world leader in hemovigilance.
Note, I've dropped the 'ae' diphthong, which still rears its ugly head in Canada, a carryover from transplanted Brits running our blood system. (big grin).
I'm thankful for SHOT, a godsend to TM professionals globally and one of the best tools for education and quality improvement ever. As an educator, I use it repeatedly to make instruction real to students and professionals alike.

The prior blog discussed an example from the 2013 SHOT report on how errors occur and touted it as a great CE resource. 
  • Stand by me (Musings on effects of errors on transfusion professionals)
I've mentioned SHOT again in order to emphasize one of the 'Bottom Two' issues below that I'm NOT thankful for.

One of the best parts of SHOT's reports are its case studies, which detail exactly what went wrong and provide learning points. As but one example from SHOT 2013:
  • Case 3: ABO incompatible transfusion despite a robust system of warning alerts on the laboratory information management system (LIMS)
  • Search for 'Case 3' (without the quotation marks)
Excerpt:
" An ABO incompatible red cell unit was transfused resulting in a haemolytic transfusion reaction. The blood was issued using an emergency protocol on the LIMS, which was not appropriate for the non-urgent clinical situation, and the computer warning flag stating that the units were incompatible was overridden several times by the biomedical scientist (BMS).

This incompatibility was not noted at the bedside and when the patient reacted to the transfusion, the doctor who was consulted advised that the transfusion should continue without reviewing the patient. The patient developed acute and delayed haemolysis, but no long-term sequelae."
Good stuff, no?

TWO NOT-THANKFULS
To give the blog a dash of hard cold reality and move from 'Kumbaya' territory, two TM realities I'm not grateful for:

NOT Thankful For #1
Canada's lack of a hemovigilance reporting similar to SHOT, where TM practitioners and educators alike, can see how our TM system is doing. Oh wait! Instead of the usual archived SILENCE, all of a sudden, TTISS is online with  - wait for it - summary tables:
Okay, I guess we should be thankful for small mercies. We're keeping statistics, so will be able to measure improvement. And finally a public report on all the data that's been collected, even though no news media have picked it up, hence no citizens will even know. Plus, no real details, no analysis. Baby steps...

For interest, I blogged about Canada's lack of hemovigilance reporting in 2011:
NOT Thankful For #2
Health Canada's stonewalling on Ontario's paid plasma clinics. I've blogged about this many times. HC's public consultation from April 2013 has transmogrified into SILENCE as 2015 approaches. Hmmm...

The one thing perhaps to be grateful for is the hope that 'no news is good news.' Not holding my breath.

LEARNING POINTS
1. I hope all readers can say they love their careers as I love mine. In some ways the 20th C was a golden age, especially for those of us who love immunohematology.

Work is something we do, first to provide essentials like shelter and food, second to be able to appreciate the good things in life that aren't free, and third, to make a difference in the world - to make life better for each other.

TM professionals are truly fortunate to love going to work each day and to be able to question authority. For so many on the planet that's not true. Best of all is knowing we make a difference, each in our small way. It's captured by Mary Oliver in her poem, The Summer Day:
'Tell me, what is it you plan to do
with your one wild and precious life?'
2. Where we live is an accident of birth. We in the industrialized west are so fortunate. Search Google's images for 'children garbage dumps' for  1000s of examples. Or people who say homosexuality should be accepted or places where female genital mutilation commonly occurs.

3. Some national blood systems spend time, energy, and money on improving transfusion practice and generously share it with the rest of us. The best example is SHOT, funded by the UK Blood Services. Kudos to NHSBT. Wish Canada and the USA would do more of the same. Hope springs eternal...

FOR FUN
What was my original Oct. blog's topic? Two guesses (my favorite 'hobby horses'):
A. Paid plasma clinics
B. HIV/AIDS
For  clue, look at TraQ's Oct. newsletter.
Now, on to the fun music selections. On the two TM issues I'm NOT grateful for, the song that comes to mind is Simon and Garfunkel's 1964 classic, 'The Sound of Silence,' #156 on Rolling Stone's list of the 500 Greatest Songs of All Time and one of the most covered songs of the 20th C.
On the three TM realities I am grateful for, the chosen song is another Simon and Garfunkel classic, 'Bridge Over Troubled Water' released in 1970, ranked #48 on Rolling Stone's list of the 500 Greatest Songs of All Time.

Why? Mainly because I'm grateful for this song and appreciate its lyrics.
Also, because one of the best things in life is to be grateful for our friends.
When you're weary, feeling small,
When tears are in your eyes, I will dry them all.
I'm on your side. When times get rough
And friends just can't be found,
Like a bridge over troubled water
I will lay me down.
As always the views are mine alone and comments are most welcome. Does any of this ring true? What are you grateful for these days?

Sunday, September 07, 2014

Stand by me (Musings on effects of errors on transfusion professionals)

Updated: 9 Sept. 2014
Recently, I browsed the Speaker abstracts and Poster abstracts for the BBTS annual conference to be held 24-26 Sept. in Harrogate, UK. The abstracts were published online 26 August 2014 as free full text. At the same time, I happened to be reading the UK's 2013 SHOT Report published in July. One abstract and a section of the 2013 SHOT coalesced to form the idea for this blog.

September's theme relates to all transfusion professionals, whether lab technologist/scientist, nurse, or physician. The blog’s title derives from a 1961 song by Ben E. King, covered more than 400 times and featured in a 1986 movie of the same name.

Of all the fascinating BBTS abstracts, the one chosen to build a blog around is under 'Clinical Audit/Service Improvement Short Paper Orals':
  • SI27. An exploratory research study into the effects of staff feelings and perceptions following a transfusion incident investigation. Transfus Med 2014;24 (Suppl. 2):19. 
    • By D. Creighton (SNBTS Edinburgh) and M. Wright (Glasgow Caledonian University, Glasgow)
The reason this abstract resonates is that in a long career as a lab technologist, supervisor, and educator I've been involved with and privy to many serious transfusion errors and their effects on the professionals involved.

What follows are my musings on the BBTS abstract and related personal memories, as well as what the 2013 SHOT Report says about causes of human error. The focus is on the effects that errors have on those who make them, realizing that it is patients who suffer irrevocable, sometimes fatal, consequences.

As an aside, with a background as a medical laboratory technologist (biomedical scientist) and transfusion science educator, what I like about the 2014 BBTS meeting is how many talks and posters directly relate to transfusion professionals who work in the laboratory.

2014 BBTS MEETING ABSTRACT
As noted, the abstract that stimulated the blog is by D. Creighton and M. Wright of the SNBTS Edinburgh, and Glasgow Caledonian University, Glasgow, respectively. Please read the complete abstract (Further Reading). My précis of it is as follows:
  • Most research on transfusion errors focusses on procedural errors, not human factors or staff emotions. This research examined the emotional impact of errors and contributing factors.
  • Researchers recruited and interviewed staff involved in a transfusion error and analysed results.
  • Of 12 staff, five agreed. The main human factors acknowledged by four participants were distraction and a busy work environment when the error occurred. 
  • All five expressed disbelief they had been involved.
  • Four were affected emotionally, experiencing insomnia and decreased confidence. 
  • Most worried about confidentiality and other staff knowing they’d made an error. 
  • Support was mainly positive but two participants experienced negative reactions from colleagues. 
  • All learned lessons which they would carry forward and share with colleagues. 
  • Participants’ reactions directly correlated to error severity and potential patient outcome.
The authors conclude that human factors need to be included in training packages. Reactions and feelings of staff involved in errors can be overwhelming and support is crucial.

MUSINGS
With the advent of quality systems and hemovigilance, transfusion medicine has long had a no-blame culture (at least in theory), as have health care systems in general. For example,
A no-blame culture is critical for patient safety. Health professionals must feel comfortable with reporting errors, including their own, so that hemovigilance and quality improvement programs can detect, analyse, and help prevent them in future. In an effort to encourage error reporting, we use blame-free terms such as events, incidents, and occurrences. Despite the talk, 'walking the talk' of no-blame attached to individuals who make errors is a tough slog.

PERSONAL MEMORIES
Below are two memories of transfusion-related errors I was involved in with serious consequences.

Memory #1 
Years ago when working in a combined centralized transfusion service/blood centre, one weekend when on shift by myself, I crossmatched a group AB patient for several RBC. The following Monday I was also working when the call for more blood came through. We had to order a new specimen as there was no more patient serum. (Yes, in olden days we routinely used clotted blood samples for pretransfusion tests and even patients without clinically significant antibodies were crossmatched by indirect antiglobulin test and more.)

Much to my horror the patient now typed as group O. I’m sure my entire insides shook as a colleague redid the patient’s ABO on the earlier sample. Absolute personal relief when it typed as group AB.

The transfusion service did the usual follow-ups. Called to stop any transfusions, asked how many RBC had been transfused and if patient was experiencing any signs and symptoms of a hemolytic transfusion reaction, requested new blood specimens, etc.

The patient experienced a severe hemolytic transfusion reaction but survived.  It’s amazing how resilient the human body is, even for those ill enough to be transfused:
We later learned that a hospital nurse had drawn the blood specimen from the wrong patient. Both the group AB and O samples came from patients in the same hospital room. And the RN in question was the highly respected liaison we dealt with at that hospital, the one who drew many of the blood samples and maintained the onsite ‘blood bank’ (refrigerator and associated request forms and records).

The effect on the implicated RN is unknown. Was the patient's family told what had happened? I doubt it. The effect on me - I’ll never forget it. 

If I had mistyped the first specimen, would I have been fired, even though it was the first ‘critical incident’ (or any error) I’d been involved in? Perhaps. That was a long time ago, pre-quality systems, when the concept of ‘system error’ was unheard of in health care. We were not unionized and worked long (indeed outrageous) hours without time off.

But before being fired, I suspect that I’d have resigned from the guilt and shame of having made the biggest error a lab technologist can make, mistyping a patient’s ABO group and putting a patient's life at risk. Because ABO errors can cause death, they require 100% accuracy, no room for error. Could counselling have helped? Maybe. Even more important would be the support, understanding, and ongoing respect of colleagues.

Of interest, the 2013 Annual SHOT Report reports 9 ABO incompatible red cell transfusions in 2013 and one patient death with the incompatible transfusion as a contributory factor.

Memory #2 
Much later, while employed as a university professor and clinical instructor for the transfusion service at a tertiary care hospital, one of my students made an error that caused a patient’s premature death. The error per se did not cause death but hastened it.

What was the error? Something so simple. Something that can happen if concentration wanders, or strategies are not in place to prevent them, or practitioners don’t follow procedures.

While performing antibody screens, the student mis-pipetted one patient’s serum into another patient’s tests. As a result the patient was transfused with incompatible red cells and subsequently died. I documented the error as a TraQ case study for the BC Provincial Blood Coordinating Office.

Although not directly involved with the error (the student was supervised by an experienced, exemplary technologist), I observed the aftermath first hand. The main effect was that the experienced, supervising technologist, one of the best, with great potential, soon left the lab for a career outside health care. Could this have been prevented? With proper support, I believe so.
  • TraQ's Case A8: Severe Hemolytic Transfusion Reaction Involving a Student (see Further Reading)
MAKING MISTAKES
When we make mistakes, our first reaction is to deny them. For example, as an instructor I noticed that students who made pipetting and other mistakes would invariably claim something like, “I KNOW I added the right things’, where ‘things’ could be patient serum, reagent red cells, etc. My response was always,
  • ‘Of course, you thought you were adding the right things to the tests. If you knew you were adding the wrong things, you’d stop and would not add them.’ 
Fortunately, because such errors are often easy to demonstrate, students could accept their errors, learn from them, and move on.

Sometimes, especially as students, we progress to blaming circumstances for our errors. And sometimes circumstances do play a role as when staff are overworked, morale is poor, and training and competency assessment are inadequate. These are the so-called system errors where the system is faulty and affects all involved.

2013 SHOT REPORT
A fascinating feature in the 2013 Report is the inclusion of the MHRA hemovigilance team's analysis of serious adverse events (SAEs) reported to Serious Adverse Blood Reactions & Events (SABRE).
  • Medicines and Healthcare products Regulatory Agency (MHRA) Report on Blood Safety and Quality Regulation in 2013 (See pp. 27-41)
In 2013, 2.9 million blood components were issued in the UK with only 705 SAE reports submitted. Human error accounted for 689 (97.8%) of the SAEs, where an SAEs is defined as
‘Any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.’
In brief, reports to SABRE showed that those making errors were aware of their local SOPs, which were complete and current. Individuals were either busy with urgent work when the error occurred (especially during out of hours shifts), or were otherwise distracted. In either case the result was an error due to a lapse in concentration.

Of all reported human errors, a lapse in concentration was the largest single cause, accounting for 35.6% (245/689) of errors. The next largest category related to omitting procedural steps or not following the correct procedure. About two thirds of all SAEs could have been prevented had correct procedures been followed.

The advice that especially caught my attention in the MHRA report:
  • Formal re-training is often proposed as a corrective measure but is usually only appropriate if the individual did not understand their initial training. If a trained, competent member of staff makes an error, the root cause will seldom, if ever, be addressed by re-training. 
  • Look for other reasons for the error, e.g., for an error due to loss of concentration when rushing, investigate why the staff member was rushing. Possible causes include a busy workload due to an emergency, poor planning, staff shortages due to lack of resources, or poor staff management
Being rushed is a reality for health professionals, now more so than ever. A major complicating factor has long been staff shortages and under-staffing caused by repeated health care restructuring, ongoing cutbacks to postsecondary education and health care, and more.

LEARNING POINTS
When errors happen, we in the TM community espouse a ‘no blame culture’. Sometimes it’s real, sometimes it’s pretence, in that, despite the nice words, staff are blamed and stigmatized.

But as the BBTS meeting abstract shows, we typically don’t consider the emotional effects of making errors on those involved. It’s all cool root cause analysis, perhaps targeting ‘system error’ as the culprit, but more often resulting in ‘training issue’ as the catchall for whatever goes wrong.

How the staff involved feel is seldom considered and, besides re-training, their emotional well being is largely ignored. At most a caring colleague might ask, 'Are you okay?' with the individual involved seldom replying honestly.

No-blame culture aside, making errors devastates health professionals and undermines confidence.  In some ways, that’s preferable to brushing off errors with, ‘Oh well, sh*t happens’. But without support, a serious error can have long-lasting negative effects on individuals and co-workers alike. Even well meaning colleagues may be critical, never overtly express it to those involved, thinking it could never happen to them, or secretly thinking, ‘Thank gawd that wasn't me!’

A critical issue is that we acknowledged making errors as human. If we haven’t made one yet in the lab or on the wards, we likely haven’t worked long enough. Or is it that we are perfect? Hmmm…. Tempted to say, ‘Let he who is without sin [error], cast the first stone.'

In that vein, I love this BMJ piece:
As an instructor I tried to model these words to show students it’s okay not to know. Who can know everything with today’s rate of knowledge turnover and technological advances? Don't know? Let’s find out.

Maybe we should add, ‘I made a mistake’ as three words we acknowledge but don’t let define or destroy us.

FOR FUN
We’re all in this world together and must support each other, especially when the going gets tough. As health professionals, any one of us is capable of making a devastating error. Support and compassion are not only kind but validate our humanity.

Think of this song the next time a colleague screws up. Could be you, yes it could.
I'll end by asking you to find 19 minutes to watch Dr. Brian Goldman's TED talk on physician error. That may seem a lot of time in our busy lives but think of all the time we waste on the Internet and television each day. You won't be disappointed with Goldman's talk. His message applies to all of us. Perhaps you can listen to it on your next walk or jog or over lunch?
As always the views are mine alone and comments are most welcome.
FURTHER READING
Meeting abstracts and resources like SHOT reports and TraQ's case studies are free continuing education and a great way to keep abreast of new developments and what’s trending. They make great bathroom (toilet/loo) reading to while the time away so that life’s baser functions serve a higher purpose.

Why not skim them online and then print content of most interest for later reading? Or print for discussing at staff meeting or journal clubs. Do journal clubs even exist any  more?

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.


Sunday, July 27, 2014

Don't worry, be happy (Musings on the safety of our blood supply)

Updated: 1 Aug. 2014 (If you've visited before, refresh your browser)

Below is a copy of a Comment made to the earlier bog, Turn,Turn, Turn. and my reply to it. I decided to write a separate blog because Turn was getting too long and the Comment stimulated other aspects of the paid plasma issue, most noteworthy, safety.

The safety aspects I'll touch upon include 
  • Foolproofing. Our blood experts assume blood safety is now foolproofed (no longer susceptible to human incompetence, error, or misuse) because the blood tragedies of the 80s and 90s are of historical interest only. 
    • Put another way, many blood experts (thought leaders) developed an arrogance that exudes, 'We're so much smarter now.' 
    • They base it on implementing quality systems, improved blood screening tests, and more stringent government regulation
  • Cost constraints, mainly affecting the nature and number of staff.
    • Despite the best foolproofing tools (see Further Reading below), not all facilities can afford them.
    • And humans working short-staffed and under pressure, and those with less formal education, are more prone to human error, especially if the system itself is flawed due to cost constraints. 
The blog's title derives from a Bobby McFerrin ditty from 1988.

First, Anonymous's comment from the Turn blog:
Anonymous wrote: Two quotes from G. Sher that appear 4 days apart in the media. PLEASE include this in a future blog!
“Canadian Blood Services has successfully managed the blood and blood products supply for Ontarians for more than 15 years. We are confident in the safety and sustainability of the current blood and blood products system in Canada, and we recognize Ontario’s role in preserving voluntary blood and plasma donation in this province.”
Dr. Graham Sher
CEO, Canadian Blood Services
Ontario official press release July 22, 2014
Anonymous: A quote from Friday just four days prior:
Dr. Graham Sher, CEO of Canadian Blood Services, is concerned about “the mischaracterization of this as a safety issue, as opposed to a public policy issue.” 
“People are caught in a paradigm from 30 years ago and are saying that paid plasma donors are unsafe and therefore we shouldn’t be allowing a paid facility in Canada because it’s an unsafe thing to do and people are going to die as a result. That, to me, is fear-mongering and it’s inaccurate.” 
Equating paid donors with an unsafe product would mean 80 per cent of the plasma drugs in Canada aren’t safe. And that’s simply not true, says Sher, calling them “extraordinarily safe.” 
“We may have moral objections and philosophical objections to paying,” he says. “But let’s not make it an issue about safety when it’s not about safety.”Sher says that as long as Canadian Plasma Resources operates safely and doesn’t impact the voluntary donor base, it would have “no objection to existing side by side with this company.” 
Toronto Star, Isabel Teotonio
Anonymous: To say that transfusion medicine with [is] totally safe is to believe in a perfect product. That is arrogant and dangerous. I want CBS to understand the ever present risk and be vigilant and consistently working to minimize this risk. To do less will lead down the dark road of the Red Cross and unknown catastrophes.
My response to Anonymous

To be fair, CBS CEO Sher called plasma derivatives 'extraordinarily safe' but I agree the impression he creates is that they are 'totally safe'.

And I suspect that his carefully crafted public comments inadvertently create mixed messages. Dr. Sher likely thinks he's been perfectly clear:
  • CBS supports a voluntary blood donor system.
  • CBS supports Ontario's right to protect a voluntary donor system.
  • Paid plasma is safe (as safe as voluntary donor plasma).
  • Object to it on moral and philosophical grounds, but not safety.
  • If a paid plasma company operates safely and doesn't adversely affect voluntary donation, CBS would not object to existing side by side with it.
That last bit is a tad weaselly. We may not know if paid plasma centres or manufacturers of plasma derivatives or non-profit blood suppliers like CBS operate safely until an inspection or 'tainted blood' disaster shows they didn't. Sure, they all must meet stringent government regulations and be periodically audited, but errors happen all the time. And not just historically.

Mistakes (systematic and individual) regularly occur today. For example:

#1. In 2012 the USA's FDA fined the American Red Cross $9.59 million for violating blood safety rules. Note this is 2012, not 1982 or 1992.

Sometimes audit findings seem trivial, i.e, nitpicking that's unlikely to translate to patient harm. But ARC violations were serious, not trivial. All of the violations merit discussing but I'll choose just one, one that health professionals, indeed everyone, can relate to:
  • Most of the regional operating centres of the Red Cross were seriously understaffed.
Understaffing has long been a reality in health care. Why? Cost constraints and cutbacks. The powers that be usually opt to cut staff or substitute more highly educated, and therefore more expensive, staff with less educated, cheaper staff that are trained on the job and supervised by fewer well educated, expensive staff.

A classic example is CBS's 'donor care associates' mentioned in my blog of Nov. 2013:
  • Lest we forget (Musings on accountability of national blood suppliers)
The blog dealt with CBS's 2013 Report to Canadians, which mentioned cost a whopping 747 times.  
Cost savings apparently applies to worker bees, not top CBS executives. In 2012-13 CBS executives earned $283,000 to $342,000, with the CEO Sher earning $560,000. No doubt all well earned. To get top talent, you must pay top dollar. Just odd how cost savings seldom translate to executives.
As a joke I created a cartoon about possible other CBS 'care associates':

Understaffing played a role in ARC's blood safety violations. Staffing levels invariably adversely affect blood safety. We often get away with it, until we don't.

#2. Another example of systematic and individual staffing issues and ineffective government regulation  is shown by this news item:
Note this happened in 2014 in Hazelton, PA, USA, not a third world nation. Besides inadequate staffing, among many findings the state Department of Health concluded:
  •  The governing body was ineffective in carrying out their responsibilities to approve, implement and enforce standards of quality management and improvement for the hospital by failing to ensure the chief executive officer provided a safe setting for patients receiving blood.
In Canada, our current government's commitment to science versus saving money (in the run-up to a 2015 election) is suspect. Not wanting to become too political, but our government has cancelled Statistics Canada's long-form census and been accused of muzzling scientists, even to the point of investigation by Canada's Information Commissioner

I wonder if Health Canada, the government body charged with regulating and protecting our blood supply, has been adversely effected by staff cuts due to the government's desire to balance the budget prior to an election. 

They've taken a long time to rule on Canada's paid plasma collection centres, having first held a round table (closed to the public) in April, 2013. In July 2013 I wrote a blog about it:
  • Day tripper (Musings on HC's instructions to the jury on paid plasma)
Still no answer a year later. Why?

#3.  A key part of expert certainty of the safety of our blood supply is all the pre-donation screening questions, post-donation tests and manufacturing processes used, especially for plasma derivatives like IVIg. The blood supply in developed countries is safe today, much safer than in the past. 

But the blood supply not totally safe. Many things can go wrong:
Seems foolproof, no? Except it isn't. The system only works for transfusion-transmitted infections we know about.

For example, in 1994 it was discovered that the plasma derivative Rh immune globulin in Ireland had been contaminated with HCV in 1977-78 from a singe donor. Plasma derivatives are made from 1000s of donors and it only takes one to escape detection.
  • HCV wasn't discovered until the late 1980s. 
  • At least 390 Irish women were shown to be infected with HCV-RNA. 
  • By 1998, 206 million (~$300 million CDN in today's money) was paid to these women and others infected with HCV via transfusion.
In Canada, at least 30,000 Canadians were infected with HCV between 1986 and 1990. And all because  Canada's experts failed to use surrogate tests for non-A, non-B hepatitis (as was done in the USA) because they judged the tests to be unscientific. Compensation to Canadians infected with HCV during this time totaled over $1 billion.

BOTTOM LINE
I dig that the blood supply in developed nations like Canada is exceedingly safe compared to 20-30 years ago. But I prefer to be skeptical vs championing, 'Don't worry, be happy,' as CBS CEO Graham Sher does.

ADDED 31 JULY (amended 1 Aug. 2014)
In reply to the Comment below from Anonymous (Curtis), whose main points were:

1. AnonymousYou state that he [Dr. Sher] inadvertently sends mixed messages. I contend that he rides the fence on purpose. I have it from reliable sources that CBS wants of offload the cost of collecting plasma. They are just not efficient at it and look to the US model as a way to achieve this. 
My reply: You're likely right that CBS CEO Sher tries to have it both ways, given how CBS closed Thunder Bay's plasma collection facility in 2012. I blogged about it, noting that CBS obfuscated its real reason for closing the centre: Operating a Canadian plasma centre is more expensive than buying surplus plasma from the USA.
2. Anonymous: This is why Ian Mumford of CBS was part of the Dublin Consensus Statement that everyone points to as a paper that outlines the successful co-existence of the private sector and the public sector in the plasma industry. 
My reply: The Dublin consensus is like politics in which we all agree on motherhood and apple pie:
  • Dublin Consensus Statement on vital issues relating to the collection of blood and plasma and the manufacture of plasma products
Reality is often different:
For interest, according to LinkedIn, Mumford is responsible for ensuring CBS consistently provides high quality transfusable, plasma protein and stem cell products to customers at the right time, at the right place, and at the right cost. Likely the last is most important, given CBS's focus on cutting costs to satisfy provincial pay masters. 
3. Anonymous: I contend that Dr Sher when asked by his employer... the government of Ontario he does what a loyal employee does and that is make them look good. 
My reply: CBS is funded by all Canada's provinces and territories except Quebec (which operates Héma-Québec), not just Ontario. According to CBS's website, Canada's Health Ministers are responsible for the overall expenditure of public funds but do not have the power to direct operational decisions of the Board of Directors or Canadian Blood Services staff.
But your point has merit. Sher's pronouncement on the Ontario government's proposed legislation to ban paid plasma was to be expected, in that there was no way he could be political and publicly contradict a provincial government's policies. 
4. Anonymous: However, I also know that he has been privately petitioning for the Ont Govt to let CPR open.
My reply: Assume you have it on good sources, but I can't give such an accusation credence without confirmation. All  can say is, if true, it would not surprise me. It fits with Sher's public statements:
FOR FUN
Love this song with the reggae beat I learned in Jamaica, circa 1969.
As always, the opinions are mine alone and feedback is most welcome.

FURTHER READING
These resources are for those who want to explore some of the issues affecting blood safety in-depth.

Plasma derivative safety
Foolproofing (Applies mainly to hospital based transfusion where computers are seen as answer to human error.)
Staffing
It's hard to find reports on inadequate staffing, mainly because overworked professionals, especially those in the laboratory, fear that, by speaking out, they'll suffer repercussions, not just to their current job but in their careers.



Saturday, July 12, 2014

Turn! Turn! Turn! (Musings on how the TM community now puts cost above all)

Updated: 27 July 2014 
Dearly beloved,

We are gathered here today because a change is happening, one that we in the transfusion medicine (TM) community should all be aware of, the death of the precautionary principle in transfusion medicine (TM). But life goes on, and now we see the birth of risk-based decision making (RBDM), which is probably at the toddler stage.

Lean and Sigma Six was the flavour of the decade in blood centres and transfusion services. I can only imagine how much money consultants made and still make off this cash cow. Now the new cash motherload for consultants is RBDM.

The blog's title derives from a Pete Seeger classic of the 1950s.

I decided to blog about RBDM because it was featured in the June issue of AABB News in the form of a report on the 2014 National Blood Foundation (NBF) Leadership Forum in Washington, DC on 28 April.

Although AABB News is 'news lite' compared to the full strength journal,Transfusion, I wonder how many working professionals (technologists, nurses, physicians) read the NBF forum report. I suspect few.

But here's the thing. It's worth reading on several levels, including the ability to pass top executives in the hallways of power and quip,
  • 'Hey, Graham. How's our transformational innovation going? And do we have any adjacent initiatives on the burner? 
Read on to discover more. The NBF leadership forum highlighted
  • Appropriate Use of Medical Resources, Risk-Based Decision Making and Strategies for Innovation
Leach Bennett's presentation (I searched for it on the web and found it and took the liberty of lifting a few diagrams from it. If inappropriate, let me know):
RBDM - A PARADIGM SHIFT?
RBDM is a major initiative of the The Alliance of Blood Operators (ABO). ABO is international, at least for developed countries. ABO would not make sense for poor countries, which have little or no money to prevent kids dying from diarrhea, let alone effectively prevent risks to the blood supply.

From what I can tell, RBDM is a process for high level leadership dudes to decide things like whether to implement new blood safety measures or not. Its ascendancy signals that the precautionary principle is truly dead. As Thomas Kuhn may have said, there's been a paradigm shift, folks.

Sorry, I know using 'paradigm shift' to describe abandoning the precautionary principle for RBDM is an abuse of what Kuhn meant, but the phrase is one of the most abused ever.

By paradigm, Kuhn meant a 'set of assumptions, definitions, laws and techniques that are shared by the members of a scientific community.' That has since been expanded to relate to members of any community, including the transfusion medicine community and is used in the 2014 paper by Menitove, et al., cited below.

BTW, if you've never read The Structure of Scientific Revolutions, give it a try. It's accessible and fascinating:
By examining history, Kuhn explained why incorrect scientific ideas persist and how they're finally rejected. Because people believe what they know, science is inherently conservative. A current scientific theory ('paradigm') is hard to dislodge and takes much evidence or a powerful single piece of evidence to overturn. When this occurs, Kuhn called it a 'paradigm shift'.

So let's look at RBDM to see if it's a TM paradigm shift.

RBDM takes off
RBDM has been around for a few years but is now gaining steam in NA and all developed nations. For example, in Oct. 2010 a consensus conference was held in Toronto, Canada:
And now this 2014 paper
As Judie Leach Bennett, LLB, LLM, director of CBS's Centre for Innovation explains,
The goal is to optimize the safety of the blood supply by enabling the proportional allocation of finite resources to mitigate the most serious risks, recognizing that the elimination of all risk is not possible.
Leach Bennett is a lawyer whose earlier jobs at CBS included Executive Director, Legal and Risk Management, and Legal Counsel. (LLB is a Bachelor of Laws, LLM a Master of Laws.) The well respected Leach Bennett is also the Chair of The Alliance of Blood Operators (ABO) RBDM Steering Committee.

SMOKE AND MIRRORS?
How did the supposed 'zero-risk paradigm' in transfusion medicine evolve to a paradigm of risk-based decision making (RBDM)? First, there never was a zero-risk paradigm in TM. The public may have wanted zero-risk but TM professionals knew it was impossible. If anything, what ruled after the HIV/HCV transfusion-related tragedies was a precautionary principle paradigm.

Discussing the nuances of the precautionary principle and the pros and cons of applying it (whatever 'it' means) is beyond the scope of this blog and my competence. To me it always meant
  • If there was considerable evidence that a serious risk existed, we should try to prevent it, even if it wasn't proven beyond a shadow of a doubt. 
And providing we can afford to do so, given that health resources are finite and priorities are necessary. And forgetting that the cost of wars fought since 9/ll have been huge for many countries, most of all the USA:
That said, 2 papers on the precautionary principle:
But back to the Menitove paper. Let's assume zero-risk was a TM paradigm. Was it a paradigm shift in the Kuhn sense, meaning zero-risk was dislodged over time by a preponderance of evidence or a single powerful piece of evidence? Not really.

Papers on RBDM suggest the paradigm has changed because the COST of preventing some risks is too expensive. For example the opening sentence of
Health care costs have risen to 17.4% of US gross domestic product, and health care economists urge a reversal of this unsustainable trend.
Leach Bennett in her presentation to the NBF's 2014 leadership conference, under 'Impetus for Change', references the precautionary principle as the TM response to the 1980s blood tragedies but then states:
  • [It's] Clear that pursuit of 'precaution at all costs' is unsustainable
  • Blood safety decision-making is increasingly complex: science,ethics, social values, economics, public expectations, context
Note how science is placed first, with economics in the middle. This graphic on 'health economics and outcomes' from her presentation is enlightening:

Instead of cost and effectiveness, many risk assessment models put safety first, i.e., consider the severity of a risk and its probability of happening:

Leach Bennett's NBF presentation is well worth reading because it explains where we are going. The science part ('Risk Intelligence'):
Comprehensive patient outcome and quality data, including hemovigilance, will guide decision-making and help define acceptable risk.
The 'Effectiveness and Cost' part:
Reliable information and tools will be readily available to balance risks, costs and benefits in a manner which optimizes donor safety and patient outcomes.
The entire RBDM Change Agenda: Source: Judie Leach Bennet's 2014 NFB presentation, Risk-Based Decision Making for Blood Safety


And note what's third on the Change Agenda: Blood operators will take an expanded leadership role in vein-to-vein blood safety. In Canada, that would be our national blood suppliers, CBS and Héma-Québec.

Sounds a wee bit like a unilateral power grab, no? And there's that word innovation again.

GESTALT SWITCH
TM's abandoning the precautionary principle to protect blood safety, and now championing RBDM, is not a true paradigm shift, but could be called a 'gestalt switch'.

OMG, you say, not more jargon! Bear with me. I'm just 'tarting up' the RBDM movement to assess cost vs benefit in blood safety with bafflegab that's an alternative to 'paradigm shift'.

Gestalt is a German concept meaning the whole is greater than the sum of its parts. Gestalt means shape (or form) in English. Gestalt is used in psychology to describe an approach which aims to see something as a whole rather than its individual parts.

A gestalt switch requires an emotional and intellectual switch to think differently. For example, what do you see? A white vase? Or 2 black profiles facing each other? To see one or the other requires us to make a gestalt switch.


That's what our TM 'thought leaders' are doing with RBDM. Because of cost constraints, they've designed a completely different way of conceptualizing risks to blood safety and how to prevent them.
  • Zero risk is impossible (something we've long known).
  • Safety isn't paramount because it's too expensive. Safety is shades of grey.
  • Let's promote the change to RBDM as safety first, because that's what the (somewhat deluded) public wants.
  • Moreover, let's associate the cost-saving movement with a sexy name like innovation to make it more palatable. For example:
Judie Leach Bennett, once Director of CBS's 'Legal and Risk Management', now heads the CBS 'Centre for Innovation'.
Title of the AABB News report: Appropriate Use of Medical Resources, Risk-Based Decision Making and Strategies for Innovation. 
INNOVATION BAFFLEGAB
Another speaker at the NBF leadership conference was Brian Quinn, employed by a company owned by Deloitte Consulting, Chicago.

Quinn highlighted innovation in his closing talk, describing three types:
  • Core: existing products
  • Adjacent: new business areas adjacent to existing core strengths
  • Transformational: inventing products and creating new markets
I love the last, transformational. It's one of the words banned by the UK's Local Government Association in 2009. Yet it's a favorite of CBS leaders and usually features prominently in CBS's annual reports to Canadians.

 To read more about this new consulting bafflegab on innovation, see
Looks like Monitor Deloitte has moved from consulting for Libya's Muammar Gaddafi to the world's TM community, among others.

BOTTOM LINE
The RBDM movement means we've truly jettisoned the precautionary principle (whose application to TM has been flawed at times) for cost uber alles. It's reality and well foreshadowed.

If RBDM prevailed earlier, it's possible that much of what the TM community did since 1981* to protect the blood supply would never have been done. [*When the CDC's MMWR published a report describing cases of a rare lung infection, Pneumocystis carinii pneumonia, in 5 young, previously healthy, gay men in LA.]

Perhaps a good thing in some cases, but a quasi-cost-effectiveness approach was used decades ago and caused harm, e.g., Canada's decision not to implement surrogate tests for non-A, non-B hepatitis (hepatitis C) because they were too 'unscientific'/ineffective (poor sensitivity and specificity) and too expensive. This decision led to many thousands of Canadians being infected with HCV.

Or the blood supplier (then Canadian Red Cross), clinicians, and government deciding that most hemophiliacs were probably already infected with what became known as HIV, so should continue to receive non-heat treated factor VIII concentrate derived from tens of 1000s of blood donors. Gotta use up that expensive, paid-for stock on the shelves? Seems likely but we'll never know because minutes of crucial meetings were mysteriously shredded.

All of which identifies the flies in the RBDM ointment:
1. TM professionals don't always know what measures are more or less effective to enhance blood safety. Sometimes measures that seem costly at the time and are deemed flawed (ineffective) can save the health care system mega-bucks in the long run, to say nothing of human suffering, as in Canada's hepatitis C debacle.
2. Just like the public in general, health professionals sometimes get caught up in mob psychology. If thought leaders religiously proselytise a particular policy, it's hard for acolytes to dissent and be designated heretics. Definitely not a good career move. 
To everything there is a season. The old blood safety season (new season):
  • 'Above all, do no harm' (Only do no harm if it's cheap and effective.) Note: Doing harm can result from acts of omission.
  • 'If harm is suggested, but not proven beyond a shadow of a doubt, we should try to prevent it.' (If harm is possible, don't prevent it unless the measure is cheap and effective.)
Because the health care money pot is finite, it's now all about risk vs benefit, similar to return on investment (ROI) in the financial world.
  • Soon we will spend money only on cheap, effective blood safety measures. All else is no or maybe.
Of course, the RBDM model was developed by smart, well meaning transfusion professionals and is more complex than I've focused on here. Among other aspects, RBDM includes assessing science, ethics, social values, economics, public expectations, and context.

But it's human nature to go for the simplest tool and, because  economics fits the bill and is a driver for RBDM, it will likely carry more weight.
Updated 16 July 2014
In reply to Roger (see comment below): Invariably those making decisions promote safety above all but, when you examine what they say, often a different picture emerges. 

Note the words used to soothe the public that all is well, you can trust us. For example:

1) The goal is to optimize the safety of the blood supply by enabling the proportional allocation of finite resources to mitigate the most serious risks, recognizing that the elimination of all risk is not possible.
means, 'We'll spend $ only on the MOST SERIOUS RISKS and only if it's INEXPENSIVE because there's not enough $ to go around.' The other points are background noise to obfuscate the main point.
Key words to soothe the public: optimize, safety

2) Comprehensive patient outcome and quality data, including hemovigilance, will guide decision-making and help define acceptable risk.

means, 'We don't have a clue how to decide what acceptable risk is, but, trust us, because we'll use comprehensive, quality data and muddle our way through.'
Key words to soothe the public: comprehensive, quality, acceptable

3) Reliable information and tools will be readily available to balance risks, costs and benefits in a manner which optimizes donor safety and patient outcomes.

means, 'You can trust us to decide what's safe. '
Key words to soothe the public: reliable, readily, balance, optimize, safety

The soothing words didn't appear by accident but were carefully crafted. They're not quite weasel words to mislead readers into thinking that a meaningful, specific statement was made. But they do aim to mislead in that they're designed to create the overwhelming impression that RBDM leaders are on top of things, have all bases covered, and put safety first, not saving money.

They make the case that, by not spending money on ineffective, costly measures, blood safety will be enhanced. Hard to argue against that, assuming we know ahead of time what's ineffective (we didn't with surrogate tests for HCV). The rest is sheer 'trust us' territory and, if past is prologue, why would we?

Update #1 (17 July 2014)
In reply to Anonymous who wrote on the reality of scarce resources (see Comments below):

I agree the health care system must prioritize as funds are finite. That's a given. But you set up a false hypothetical in that everyone can agree not to fund your example.

It's the heavy emphasis on costly (cost is easy to determine) prevention measures where things can go awry, especially as history shows experts don't always know what's effective, or even true prevalence, witness HCV when it was non-A, non-B hepatitis.

In Canada, governments have long tried to curb the cost of transfusions, particularly plasma derivatives like IV immune globulin, which have many off-label uses, e.g., the BC PBCO's utilization management program.

Then there's looking at larger priorities for tax dollars in terms of $ spent on the Afghan war, fighter jets we don't even have yet, Canada's Senate, and on and on.

How to spend health resources effectively and fairly is challenging. That's why our TM experts should be challenged on their plans, especially when they choose to wrap it in quasi-weasel-language like transformational innovation.

Update #2 (17 July 2014)
In reply to Anonymous, who wrote, 'We seem to be getting arrogant again in thinking the science alone can manage risk':

My gut reaction is to quip, 'Getting arrogant again? Nope. We never stopped being arrogant.' But you make a point worth discussing.

Today's health professionals, including TM experts, stress evidence-based medicine (EBM), most recently CBS CEO Graham Sher on the issue of paid plasma collection in Canada:
We have created a safe and secure system that today is the envy of much of the world, and we did this using science, evidence and risk-based decision making as our core principles. It is important that these principles continue to be the driving force behind public policy and the blood system.
But EBM is not without its flaws, as explained in this 2011 Boston Globe op ed:
As the author notes, “Evidence-based medicine is only as strong as the evidence used to support it. The stark reality is that evidence can be weak, biased, or even fraudulent.” Amen.

For a comprehensive, straightforward, balanced look at the issues facing blood safety, one not into the current group-speak lingo propagated in many of the other cited papers, see:
Updated 23 July 2014
In reply Anonymous (x2), about latest news on Ontario's plan to ban paid plasma clinics in Canada:
Intriguing part is ON Dept of Health inspectors 'swooped in to seize records'. Those operating Canadian Plasma Resources clinics said the raid virtually halted operations.

Why a raid to seize records? Can't wait for more details. Stay tuned.

Updated 27 July 2014
In response to the Comment below about two quotes by CBS CEO Graham Sher, I've decided to write a new, separate blog. This one is getting a bit long.

FOR FUN
The theme made me think of Pete Seeger's Turn! Turn! Turn! The lyrics and final verse are adapted word-for-word from Chapter 3 of the Book of Ecclesiastes:
And here's the man himself, age 93:
To everything, turn, turn, turn.
There is a season, turn, turn, turn.

And a time to every purpose under heaven.
A time to be born, a time to die.
A time to plant, a time to reap.
A time to kill, a time to heal.
A time to laugh, a time to weep.
 
As always, the opinions are mine alone and feedback is most welcome.