Saturday, February 08, 2014

We are the world (Musings on sharing TM resources)

Updated: 10 Feb. 2014
February's blog is on transfusion medicine resources, including blogs and twitter. [Like all blogs, please check again as revisions invariably occur.]

The blog's title derives from a 1985 song written by Michael Jackson and Lionel Ritchie for 'USA for Africa.'

The blog's theme was triggered by discovering that CBS had removed the Vein to Vein section of its transfusionmedicine.ca website, a site that Kathy Chambers and I developed for CBS in 2001-2003. CBS assessed that some content had become outdated and some was now well covered by other resources. Both true.

The V2V site went up in 2004, ~10 years ago, a long time in transfusion medicine. It's possible that some elements may be revised based on community needs and re-published on the site, but that's just a maybe.

You can still see snapshots of the V2V site because organizations exist that archive websites. This link is the archived site from Sept. 2012.
[Note: Literature references and other external links are still active but don't work on web archives.] 
But that got me thinking about TM resources and who uses them. As explained in January's blog - 'Mommas don't let your babies grow up to be lab techs' -  in reply to Robina's comment (#2 in Addenda), fewer and fewer medical laboratory technologists read TM journals. The same may be true for physicians and nurses.

About online TM resources, I encourage you to ask and answer these questions for yourselves:
  • What resources exist? Who created them and why?
  • Who uses them and why? 
  • Are they useful in your practice?
Perhaps most importantly, should industrialized nations share resources with those in the developing world? In a way, it's similar to whether we in the West should focus on 'Charity begins at home' and give less or nil in foreign aid to poorer nations. And what's the right balance on that continuum?

What follows is my take and I've selected only a few of many useful online resources. Many more exist and your choices may differ from mine.

Please let me know if I've missed an exceptional resource and specify why.

Criteria I use to assess online TM resources:
  • Is content created by credible health professionals, preferably acknowledged experts?
  • Are references to scientific literature included?
  • Is content current and, if older, still relevant today?
  • Even if country specific, is content generalizable to other locales?
  • Who's behind the site? [Usually in About Us] 
  • Who funds the site? Do they have an agenda? If yes, what is it?
  • Does the site follow the entire Swiss HON 'Code of Conduct'?
 A few useful TM resources, in no particular order:

WEBSITES 

CANADA
Canada has many websites that share incredible resources that took much time, expertise, and funding to create. In each case, developers could have hogged the resources, kept them secret on an organization's intranet.

But, like Australia, the UK, and others, they bravely and generously decided to make them public via the Internet so all could see, share, offer feedback on, perhaps even criticize.

For those who know these sites, bear with me. I'll try to feature a few goodies that may be new to you.

1. BC PBCO 

BC's Provincial Blood Coordinating Office was the first PBCO created in Canada (1997). Among other things, that's reflected in them having the vision to snap up the generic domain name, pbco.ca. [Couldn't resist the joke.]
Sorry!
Sorry, PBCO pals!
Seventeen years later, BC PBCO remains a leader in blood utilization management, information management, and quality management, as well as in sharing educational and other resources via its site and TraQ's (see below). For example:
2. TraQ
Disclosure: I'm TraQ's content coordinator and webmaster.

TraQ has several unique strengths, including:
3. ORBCoN

Among its many exceptional resources, ORBCoN hosts
AUSTRALIA
Australia has long been a leader in developing and sharing blood safety educational resources. Some examples:
UK
The UK too has always generously shared its TM resources and they've led in many key areas. For example:
USA
The best transfusion resources in the USA are the AABB's. I've been a member since 1975 (Yikes!). Please consider that when I criticize the organization. It must be doing something right.

Many of AABB's best resources are restricted to members. But some are available to all, e.g.,

SOCIAL MEDIA
Many of today's 'mature' health professionals diss social media as being sound and fury, signifying nothing, as Shakespeare had Macbeth say about life:
Life's but a walking shadow, a poor player
That struts and frets his hour upon the stage
And then is heard no more: it is a tale
Told by an idiot, full of sound and fury,
Signifying nothing. 
Still, I recommend blogs and Twitter, if they meet criteria as above, as being worthwhile resources for TM professionals.

Social media are democratic, meaning anyone can spout off (I'm a prime example). But health professional bloggers and tweeps shouldn't, and do not, get an audience without earning the respect of peers for the content of the offerings.

Unless they're celebs like Justin Bieber and Katy Perry, who each have over 46 million followers on Twitter. Celebs can be total ______ (fill in the blank with an appropriate word) and still have millions of followers eagerly gobbling up their drivel.

A significant characteristic of social media is that, unlike the websites mentioned above, individual blogs and twitter accounts can be created by anyone for free. The only cost is the time and effort of the people (bloggers and tweeps) who participate and contribute.

BLOGS
1. Musings on transfusion medicine (You are here)
Granted, it's shameless self-promotion to include my own blog. This blog began in 2004 and will have its 10th year anniversary in October. This entry is the 119th individual blog. [As is obvious, I'm long-winded with many rants inside just waiting to be released.]

Many blogs exist (although, not many on TM). Blogs should be taken with a huge grain of salt because they represent one person's biased perspective. Blogs can be thought of as short compositions on a single subject written from the author's personal perspective.

In essence blogs are like newspaper editorials, which represent an individual or group's opinion, e.g., that of the owner, publisher, editor, or editorial board.

Musings on TM represents my opinions alone. A natural tendency is to go against prevailing orthodoxy. To me so much of what people believe, including transfusion professionals, results from speaking to the same people, perhaps a few dozen, day in and day out.

What inevitably results is 'group think'. Spending time in an echo chamber, where you constantly hear your views parrotted back to you, leads to believing your views are conventional wisdom, i.e., Doesn't everyone think that?

In revolt, I'm an iconoclast and this blog provides the medium to oppose what most of us accept as 'truth'.

Still, I hope the blog's ideas are more than a 'nutball sounding off' and represent
  • Constructive criticism
  • Fresh perspective
  • Sound reasoning (Well, mostly...)
If not, the Comments section of the blog (~ Letters to the Editor in newspapers) allows readers to counterbalance my often biased views.

2. A few other transfusion blogs exist but they don't turn my crank using the criteria above. If you know of a good one, please let me know.

TWITTER
Created in 2006, Twitter is a late comer to social media and initially was much ridiculed for its limit of 140 characters and some users tweeting trivialities, e.g., what they ate for breakfast, etc.

But gradually people realized the power of Twitter and saw how it could changed media, politics, business, and more.

I love Twitter for its ability to share news and resources. If you're curious about the world and an information junkie, beware! It's addictive.

1. Cyber Bloodbanker @transfusionnews

Again, forgive the self-promotion. I've 7 Twitter accounts, 4 of them serious (well, relatively so), especially the one above, and 3 spoof accounts strictly for fun. Two are transfusion-related with few followers (only tweet when CBS actions warrant a humorous response):
For transfusion news judged useful or interesting to others, I'll immediately put a link to it on @transfusionnews.

For those new to Twitter, you can register and never tweet, just follow others. Or, if that's too much, a simple approach is to bookmark the account's page and visit it when the mood strikes.

2. Other Twitter accounts
Many of the major TM players tweet and are worth following. Some examples:
LEARNING POINTS
  1. Did you notice that most recommended websites were from countries with publicly funded health care and blood systems? Sharing is good.
  2. All resources on TM websites in Australia, Canada, and UK are available to anyone with Internet access. In a way, it's a version of foreign aid.
  3. Social media is in its infancy but will become ever more powerful as it transmogrifies who controls the message.
FOR FUN

No one says World Wide Web anymore but the web allows us in the West to share resources with those less fortunate around the globe.

Which led me to this month's music choice:
Also see
As always, comments are most welcome.


Saturday, January 11, 2014

Mommas, don't let your babies grow up to be lab techs (Musings on what TM journals imply about med lab technologists/scientists)

Last updated: 3 Feb. 2014 ('Tweeks' +ADDENDA below)
Happy New Year, everyone. January's blog is a crude attempt to identify the state of transfusion medicine in developed nations in 2014 and, particularly, where my medical laboratory colleagues (vs nurses and physicians) fit in the grand scheme according to TM journals.

The title is a take-off on a song covered and made famous by Waylon Jennings and Willie Nelson.

To be clear, I and most of my cohort had wonderful careers as medical laboratory technologists working in transfusion medicine. We experienced the glory years where our specialty, immunohematology (blood group serology) was exciting and rewarding. But, my friends, the times they are a changin', and have been for a long time.

At the start of a new year, I wondered if transfusion medicine journals had become more relevant to working medical laboratory technologists / scientists and decided to use the January 2014 issue of the AABB journal Transfusion as an indicator.

The same challenge faces TM nurses and physicians - of all the knowledge needed to keep current, how many papers are truly useful? (What RNs and MDs would read of direct relevance won't be dealt with here, mostly because it's beyond my pay grade.)

Also, I wondered if the New Year issue would identify what's hot, and not hot, in TM.

It's a thought game I play with every issue of the TM journals I read. With a background as a medical laboratory technologist and educator, what would I read? Frankly, I read many papers just for fun, out of curiosity and as bathroom reading. (Easily beats People magazine and edges Canada's Macleans.)

But most adult learners, including busy TM professionals, want immediate usefulness. They tend to take time to read resources that they can apply instantly and directly in their jobs.

So, specifically, what would I read in January's Transfusion that is of immediate relevance to me, assuming I still worked as a frontline worker, instead of playing around on the Internet, looking for resources to share with all involved in transfusion medicine?

My assessment for practical relevance includes several factors:
  • How closely does the author's locale fit my situation?
  • Do I know the authors personally or by reputation as thought leaders?
    • Love this buzz word, meaning influential. 
    • How many colleagues would you name as thought leaders?
  • Does the paper deal with something I have some control over and can evaluate and implement?
  • Who funded the research? 
  • Which competing interests do authors identify?
CUTTING DOWN TREES FOR WHAT?
As an aside, one thing I noted in the Jan. issue was how only the editorials (10 pp.) and letters (3pp.), i.e., 5% (13 of 258 pp.) of Transfusion's January pages, were new. The rest were published and available online mainly in April-June, 6-8 months earlier.

Does Transfusion's publisher, Wiley, need to continue to cut down trees for 5% of new content? How about asking AABB members and other subscribers if online access suffices?
After all, how many TM professionals exist who cannot access the Internet? No doubt some in developing nations, but even there, electronic copies may be easier to access than paper ones.
MY WINNERS (Transfusion, Jan. 2014)

1. The 'Transitions' editorial, only because the title is irresistible. Transitions of what? AABB, the journal's focus, or even TM itself? I had to know.
Turns out the editorial was about changes to Transfusion's editors.Of special note to me was the retirement of George Garratty, PhD as associate editor of the Immunohematology section after 31 years of service promoting papers on red blood cell serology. His successor is Connie Westhoff, SBB, PhD, who also handles Blood Group Genomics. Garratty will continue to serve Transfusion as a member of the editorial board.
George is an icon to TM medical technologists - see this interview, similar to these 'dudes' and others:
Over the years I've noticed how some physicians, at best, patronize PhDs and, at worst, denigrate them for their lack of clinical expertise (usually among fellow physicians, almost never to their face). Which is why this sentence on George Garratty from the Transfusion editorial struck me:
'Even though he is not a clinician, he demonstrated a remarkable ability to marry the serologic aspects of manuscripts with clinical implications, adding value to this section for laboratory technologists, immunohematology researchers, and laboratory directors who supervised technical activities and who are required to interpret these findings for practicing clinicians.'
Patronizing? I can only imagine what the author thinks of medical laboratory technologists. Can we ever have 'remarkable ability to marry the serologic aspects of manuscripts with clinical implications' or marry anything to the be-all and end-all supremacy of clinical? And if not, are we lesser beings in the TM pecking order?

And what about nurses? They're clinical but do they cut it with docs for their clinical expertise or are they forever designated as handmaidens to physicians? Just asking, you do your own answering.

2. Transfusion Medicine Illustrated. Who doesn't love neat photos?
An unusual cause of red plasma: Due to concern for cyanide exposure, a burn patient was treated with hydroxocobalamin. Red discoloration was subsequently seen in her plasma, urine, and wound dressing. 
Many causes of discolored body fluids exist (e.g., ingesting food coloring, rapid hemolysis), but in this case the clinical scenario suggested it was due to the dark red color of hydroxocobalamin.
 Is it similar to red pee after eating beets? <;-)

3. 'Hospital-based transfusion error tracking from 2005 to 2010: identifying the key errors threatening patient transfusion safety' and not just because its authors are Canadians but because we all need to know what errors are made in order to prevent them. From the abstract:

During 5 years at Sunnybrook in Toronto, errors occurred at every point in the transfusion process, with the greatest potential risk of patient harm resulting from inappropriate ordering of blood products and errors in sample labelling. Specifically:
  • 15,134 errors were reported, a median of 215 errors/mth:
    • 9083 (60%) on the transfusion service (TS) 
    • 6051 (40%) on the clinical services 
  • 23 errors resulted in patient harm:
    • 21 on clinical services and two on the TS 
    • 21 of 23 harm events involved inappropriate use of blood 
  • Errors with no harm were 657x more common than events that caused harm 
  • Most common high-severity clinical errors:
    • Sample labeling (37.5%) 
    • Inappropriate ordering of blood (28.8%)
  • Most common high-severity error in TS: 
    • Sample accepted despite not meeting acceptance criteria (18.3%) 
  • Cost of product and component loss due to errors: $593,337
4. 'Record fragmentation due to transfusion at multiple health care facilities: a risk factor for delayed hemolytic transfusion reactions.' 
The paper deals with errors due to record fragmentation, a risk that exists whenever people are treated in regions without a common information system for patient records. With increasing mobility of the workforce, the risk is ever-present and widespread.
From the abstract:

Multisite transfusions were common. For patients seen at both of two nearby hospitals, antibody records were frequently discrepant. Findings support the need for interfacility sharing of transfusion records, particularly at the regional level. More specifically:
  • Antibody discrepancies occurred in 64.3% (27/42) of cases 
  • Most common discrepancy was failure of one facility to detect an antibody
5. 'Successful management of severe hemolytic disease of the fetus due to anti-Jsb using intrauterine transfusions with serial maternal blood donations: a case report and a review of the literature.'
The authors are from Muscat, Oman but a case report dealing with HDFN is a magnet to most techies because some immunohematology and other laboratory data are sure to be present.

The case was notable because anti-Jsb is an extremely rare antibody. 100% of Caucasians and 99% of blacks are Js(b+) and maternal blood was used for 4 intrauterine transfusions.

LEARNING POINTS
#1. Besides the editorial and TM illustration, as a busy medical laboratory technologists/scientist who worked in a large tertiary care facility and earlier in a combined transfusion service-blood centre, I would probably have read three papers comprising 19 useful pages of 258 (~7%) of January's Transfusion.

Keep in mind I would have read more out of curiosity as a bench technologist and because, after becoming an educator, I wanted to be at least familiar with all aspects of TM, even if it was in the purview of nurses and physicians.

WHO READS JOURNALS?
Think for a moment: How many of today's med lab techs in the transfusion service, especially cross-trained ones who rotate in the blood bank, hematology, and clinical chemistry - but also TM specialists - would read any of these papers?
First, even specialists would lack access to Transfusion unless they were AABB members or had journal clubs that discussed published research or were at university hospitals where staff were given access. Not many.  
Experiment: Ask your TM colleagues (medical technologists, nurses, physicians):
  • How many read Transfusion (or the equivalent specialty journal in your country)?
  • If a medical technologist, assuming they're members and receive a journal as part of membership, how many read even a few articles in their general professional journal? Ex:
    • AJMS in Australia
    • CJMLS in Canada
    • IBMS Newsletter in UK 
    • Lab Medicine or Clin Lab Science in USA
2. Transfusion complications and errors continue to be a concern. Besides papers 3 and 4 above, three other papers deal with transfusion complications and risks (See TOC below).
To Ben Franklin's famous quote, 'In this world nothing can be said to be certain, except death and taxes,' we can surely add, 
Nothing is more certain that transfusion errors and complications will occur despite our best efforts. [See UK's SHOT]
3. What's hot? Looking at the Table of Contents (TOC), Transplantation and Cellular Engineering and Transfusion Practice have the most papers (6 each).

The first section (sounds oh so important - love use of engineering) fits with AABB's attempt, and transfusion medicine in general, to move from blood transfusion (waning in an era of transfusion complications and blood conservation) to a more viable, emerging field like stem cell transplantation.

Kinda like dentists expanding their practices by promoting teeth whitening for all and braces for more and more kids?

The second (Transfusion Practice) validates AABB and transfusion MEDICINE in general as mainly in the control of physicians. Doh!

4. What's not hot? Immunohematology and Immune Hematologic Disease (the anti-Jsb case study) has the fewest papers (1 each). And even there, I wouldn't read the Immunohematology paper as it deals with basic research using mouse red cells ('Transfusion of murine red blood cells expressing the human KEL glycoprotein induces clinically significant alloantibodies').

All I can say on what's hot, what's not, is Plus ça change, plus c'est la même chose. [If needed, a translation]

BOTTOM LINE
You may disagree with my assessment of read-worthy papers for medical lab technologists/scientists in Transfusion's Jan. 2014 issue. If you agree or disagree, please let me know in Comments section or by private e-mail.

As noted, I cannot evaluate the articles from the perspective of busy TM nurses and physicians. Decide for yourself (Transfusion TOC in Further Reading below) which of the papers' titles would motivate you to read them.

ADDENDA
#1. (12 Jan. 2014) In reply to Roger (see Comments below): Thank gawd for ARC's journal, Immunohematology. One place where those of us in the lab can still enjoy and learn about blood group serology, a dying art.

#2. (13 Jan. 2014) In reply to Robina (see Comments below):

Robina, I agree that a significant reason for so few 'serological studies' being published is that routine blood group serology is not as innovative and ground-breaking the way it was, especially in the 1960-80s.

Soon thereafter, and extending into the 21st C, red cell serology papers were often comparisons of various automated systems with manual techniques and then with each other.

Other factors abound, including:

EVOLUTION OF TESTING
1. Waning of serologic studies as pretransfusion testing became assessed for clinical relevance. Ex:
2. With the invention of PCR and DNA sequencing, blood group discoveries began to focus on DNA analysis to determine blood group inheritance. For example, see Willy Flegel's
  • Rhesus site at the University of Ulm (static since 2009)
3. Molecular genotyping. Applying DNA analysis to typing blood group antigens started in the early 1990s and continues to make inroads into routine use. I blogged about this in 2010:
4. Shifting priorities.
-As labs became more automated
-As regulation extended beyond blood centres to transfusion services
-As governments instituted cutbacks on health care funding,
research into the following became higher priorities:
  • Competency training, assessment, and audits for compliance
  • Reducing errors in patient identity, blood administration and blood ordering
  • Improving blood utilization, especially for plasma derivatives like IVIg 
As well, the funding of transfusion safety officers to help with the above meant that blood group serology all but disappeared from the research radar.

HUMAN RESOURCES
Besides the above factors, secondary causes for the paucity (sorry, cannot resist the word) of published papers on red cell serology include the nature of the TM workforce. The following are my views and I could be wrong.

Olden Days vs Today
1. Once medical directors of transfusion services and blood centres had sufficient budgets and staffing to allow a lab technologist to work part-time on a research project under supervision and with support.

Today, this is generally untrue. Staffing is stretched to the max just to get the real work done.

Research projects exist in a few places but typically dealing with new priorities and where the medical director has access to research funding or to students in a local university CLS/MLS program. And also where, because of affiliation with a university, medical directors have an incentive to publish papers as it earns prestige, promotion and salary increases, no matter how minimal. 

2. With the advent of regionalization, centralized testing and automation, it's possible to operate transfusion services with fewer staff, and less well trained ones. The few existing transfusion specialists are swamped with administrative, education, human resources, and management issues.

As for the 'trench workers', regardless of education and training, they often feel less valued by employers (knowing they are disposable if the right technology comes along) or, in the case of blood centres, if the right 'care associate' can be trained to do their job. See my joke on the practice.

Hence, many have evolved into 9-5ers, taking pride in their daily job, but unlikely to put in the extra hours that goes invariably with research. Of course, some do want to excel and go above and beyond, but the numbers are small.

Well, these are a few stream-of conscious ideas for why blood group serology papers are increasingly rare in major TM journals.

Please see Robina's follow-up comment below about the situation in the UK.

#3. (3 Feb. 2014) In reply to Anonymous(see Comments below):

Yes, the Globe & Mail article on paid plasma clinics in Canada is interesting. Health Canada is into its second year of deliberating whether to license the clinics and notes that each province can decide to allow paid plasma clinics (or not).

The CBS quotes are interesting. Most notably, Graham Sher, CBS's CEO seems to have shifted ever so slightly in how he presents the CBS position.

For example in a commentary he authored in the Toronto Star in March 2013 ('Prohibiting pay-for-plasma would harm patients'), Dr. Sher wrote (summarized by me):
  • On Safety
    • Manufacturers must be licensed and meet stringent quality and safety standards.
    • Safety procedures built into fractionation are extensive, and include donor screening and testing, plasma quarantine, technology that inactivates viruses, and purification steps. 
    • These products are extraordinarily safe. 
    • Many studies show plasma products from paid donors are as safe as those manufactured from volunteer donors.
  • On Security of Supply
  • A safe system must ensure security of supply. 
  • 1000s of patients depend on life-saving fractionated products (plasma derivatives).
  • Prohibiting paying donors for plasma would deny patients access to these products, both here in Canada and around the globe. 
In the Globe and Mail piece, Marc Plante (CBS Communications Specialist) reiterates Dr. Sher's March 2013 commentary, whereas Sher is quoted as telling a panel audience at an October 2013 production of Tainted:
  • “Would I be happy if they [paid plasma clinics] never opened their doors here? Never did business here? Absolutely.”
Perhaps an attempt to modify his earlier statements where he seemed to to come across as an advocate for paid plasma?

I also thought it interesting that the Globe and Mail quoted Janet Conners. Also see
Comments are most welcome.

FOR FUN
And just because I'm in a 'Willie Nelson frame of mind':
FURTHER READING


Thursday, December 12, 2013

The long and winding road (Musings on 30 years of transfusion-associated AIDS)

Updated: 13 Dec. 2013
AABB's Transfusion for October 2013 is a themed issue.
Since few transfusion professional will probably read, let alone scan, all 238 pages, this blog will review the two items (among several gems) that I found most interesting, a commentary and a letter to the editor from authors in Brazil.    
  • Dubin C, Francis D. Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic. Transfusion 2013 Oct;53(10 Pt 2):2359-64. (Commentary)   
  • Salles NA, Levi JE, Barreto CC, Sampaio LP, Romano CM, Sabino EC, Júnior AM. Human immunodeficiency virus transfusion transmission despite nucleic acid testing. Transfusion 2013 Oct;53(10 Pt 2):2593-5. (Letter)  
The blog's title derives from a 1970 Beatles tune. But why blog about an old transfusion issue like HIV/AIDS? I can see some of you yawning. After all, our blood supply in developed nations is the safest it's ever been.

We in the transfusion medicine community can congratulate ourselves on how safe we have made blood from viruses like HIV, HBV, HCV, and WNV. Fact is, we often do. 


Now the main threats for fortunate us exist elsewhere. As but two examples, transfusing an incorrect blood group (due to patient misidentification) and transfusing the wrong blood product (perhaps due to clinician lack of knowledge or communication errors between hospital departments).

Why blog on HIV/AIDS?

1. Because AIDS was in the news 30 years ago, it follows that health professionals age 45 or younger were children at the time and unlikely to be aware of HIV and AIDS.

2. We're told by transfusion experts that the era of transfusion transmitted infections is all but over due to these reasons:

  • Better pre-donation screening
  • Almost foolproof donor testing for infectious diseases
  • Manufacturing processes such as viral inactivation and filtration
But it's not. Besides the situation in the 'third world' in which governments cannot afford expensive tests and do not have the infrastructure to support them, human and systemic errors happen, infectious disease tests are not 100% sensitive, and donors may lie about risky behavior on predonation screening questions.

3. Significant historical events should be acknowledged as a sign of respect.

4. George Santayana got it right: Those who cannot remember the past are condemned to repeat it.

DISCLOSURE: Be aware, what follows is not always politically correct. I mean no disrespect but will call 'em as I see 'em (or recall 'em). Also, the content is highly selective based on my biases. Lastly, there's more than a few 'tacky' aspects to the so-called tainted blood tragedy. Have barf bags handy.

For interest, the Transfusion special issue features 6 papers on HIV (from China, Hong Kong, Germany, South Africa, Zimbabwe, and the International NAT study Group). Also included are 7 papers on hepatitis, 4 on NAT, and 4 on other viruses.

BACKGROUND
A brief trip down memory lane... My early days at Canadian Red Cross were pre-AIDS. Then we screened blood donors only for syphilis and later the hepatitis B surface antigen (HBsAg). The 'good old days' of farcical government regulation, no SOPs. Training was sort of like the long-standing medical school model:

  •  See one, Do one, Teach one.
Early infectious disease tests were far from perfect. For example, I have fond memories (nightmares at the time) of trying to visualize the white precipitin lines of positive HBsAg reactions between donor serum and anti-HBs wells after counterimmunoelectropheresis (CIEP). CIEP was a  'second generation' test that was the first test used to mass screen blood donors for hepatitis. To say such tests were subjective is an understatement.

HIV / AIDS ERA
A few historical highlights / lowlights:


1981: Then came AIDS, first reported as 'gay-related immune deficiency' (GRID) in 1981, and soon identified in sex workers, Haitians in the USA, and IV drug users. Cause unknown.

1982: The term AIDS first appeared when it was used by the CDC to describe a disease affecting the immune system. Cause unknown.

1982: Evidence for a blood-borne pathogen transmitted by transfusion emerged when reports of AIDS were reported in 3 hemophilia A patients who were heterosexual, had no other known risk factors, and were frequently transfused with Factor VIII concentrate. Cause unknown.

1984: The US government held a press conference to announce that Robert Gallo, a National Cancer Institute scientist, had discovered the cause of AIDS, which he named HTLV-III, and had invented a screening test worth mega-bucks.

1983: In truth the French research team of Luc Montagnier (who later delved into quackery) discovered HIV a year earlier and had sent Gallo a sample to investigate. They called it lymphadenopathy-associated virus (LAV). 


1984: Gaëtan Dugas dies. He was a French Canadian flight attendant linked by CDC to 40 of the first 248 reported cases of AIDS in USA, purported to be 'patient zero', a claim later disputed.

1985: Once it became known that Ryan White, a hemophiliac, had contracted AIDS from a blood transfusion, school officials banned him from classes. Ryan died of AIDS at age 18 in 1990.

1985: US President Reagan, he of 'win one for the Gipper' fame, first used the word AIDS, expressing skepticism in allowing children with AIDS to continue in school although he supported their right to do so.

1985: Blood donor tests for HIV began in USA, Canada and elsewhere.

1985: The Pasteur Institute filed a lawsuit against the National Cancer Institute to claim a share of the royalties from the NCI's patented AIDS test.

1986: HIV is adopted as name of the virus that causes AIDS.

1994: The battle for patent rights to the HIV test lasted for more than a decade and ultimately favored the French claim, although all decided to play nicey-nicey in the end.

2008: Montagnier and Françoise Barré-Sinoussi shared the 2008 Nobel Prize in Medicine and Physiology for the discovery of HIV (along with  Harald zur Hausen, who discovered that human papilloma viruses can cause cervical cancer). Gallo was frozen out.

See amfAR for an interesting review of AIDS, 1981-2011.

TRANSFUSION'S SPECIAL ISSUE

My take on this commentary, written from a USA perspective, but applicable everywhere:

Dubin C, Francis D. Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic. Transfusion 2013 Oct;53(10 Pt 2):2359-64.  (Commentary) 

I love that AABB included a commentary by Cory Dubin and Dr. Donald Francis. Kudos!

A few selected excerpts from Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic (which I've condensed):
AIDS devastated 4 generations of families with hemophilia. But the real story predates HIV/AIDS. Pharmaceutical firms are required to manufacture safe biologics, yet the blood community remained indifferent to the presence of hepatitis in the blood supply for decades.

That indifference set the stage for the HIV/AIDS catastrophe. It was as if a 'collective denial' spread through the blood community. Despite warning signals, the system allowed dangerous practices such as collecting plasma from prisoners and importing plasma from undeveloped countries. Plasma collection in prisons did not end until 1993. 
In hemophilia, factor concentrates were the 'Golden Goose' that revolutionized treatment. Concentrates brought independence from hospitals and convenient treatment. 
Widespread denial blinded the entire blood system. The CDC warned the blood community, but inertia prevailed. What followed was one of the worst medical disasters in history.
Authors' take home message
In 2013, 30 years after transfusion-associated HIV/AIDS was confirmed, we must not become complacent due to improved regulations and scientific gains. We must resist the influence of conflict of interest while rejecting the scientific and medical arrogance that contributed to the AIDS/blood epidemic. We must never forget the human cost. We must prepare for the unexpected and unforeseen.

MUSINGS

* Because Factor VIII concentrates were a god-send to patients with hemophilia, physicians kept transfusing the product, even realizing the danger, because they

(1) Thought most hemophiliacs were already infected (2) Believed the alternative was patients potentially bleeding to death
* Physicians were in denial about HIV / AIDS in the blood system, illustrated in this interview with Dr. Noel Buskard of Canadian Red Cross (Sorry about the short ads). Quote: Physicians and hemophiliacs must weight the cost benefit ratio in every therapy - If I give you an aspirin there is a risk...

* Canada's Krever Report makes it clear that transfusion experts, however well motivated, screwed up, big time.

The slowness in taking appropriate measures to prevent the contamination of the blood supply was largely due to experts rejecting, or at least not accepting, an important tenet of the precautionary principle.
When there was reasonable evidence that serious infectious diseases could be transmitted by blood, the principal actors in the blood supply system in Canada refrained from taking essential preventive measures until causation had been proved with scientific certainty. The result was a national public health disaster.
Best line from the Dubin and Francis commentary:
We must resist the influence of conflict of interest while rejecting the scientific and medical arrogance that contributed to the AIDS/blood epidemic.

Now to the themed issue's letter to the editor in Transfusion:

* Salles NA, Levi JE, Barreto CC, Sampaio LP, Romano CM, Sabino EC, Júnior AM. Human immunodeficiency virus transfusion transmission despite nucleic acid testing. Transfusion 2013 Oct;53(10 Pt 2):2593-5.     

Key facts:
* The risk of HIV transmission by blood transfusion in a blood center in São Paulo, Brazil was estimated to be 0.68 per 100,000 donations [6.8/million] using nucleic acid testing (NAT) on minipools of six donations. 
[For reference, in Canada the residual risk of HIV is 1 per 8 million donations, where residual risk is estimated as the incidence multiplied by the window period.]
* In November 2012, a leukemia patient became HIV-positive after 47 transfusions of RBCs and platelets. Upon follow-up, one donor was found to be HIV positive, with a pattern that suggested he likely donated a few days after becoming infected.

* The donor had denied all risk factors in the interview when donating and continued to deny high-risk behavior in 3 subsequent visits to the blood bank, even after his HIV status was disclosed to him. He also did not self-defer by confidential unit exclusion before the implicated donation.

* The literature has several reports of transfusion-transmitted HIV in the NAT-negative window period, although this case may have the lowest documented viral load.

* This case shows that even individual NAT (not pools of 6 donors) by the most sensitive methods available might not detect HIV. Thus, we must to continue to understand motivations for blood donation and publicize the risk of donating shortly after risky behaviors.

MUSINGS
Blood donors lie and infectious disease screening test are not perfect. HIV windows of negativity still exist no matter how short. Transfusion-associated HIV is extremely rare. But if it's you or a loved one who becomes infected, you don't care how rare it is.

Transfusion professionals must resist becoming blasé
 about how protected the blood supply in developed countries is from HIV and other infectious agents. Unfortunately, many are blasé.

For example, in Canada we have Health Canada and the CEO of CBS saying that paid plasma donation is no big deal because infectious disease screening tests and manufacturing processes used to produce plasma derivatives like IVIg are foolproof.

As an aside, on a related issue in 2013 Health Canada decided to allow men to donate blood if they haven't had sex with a man in the last five years. 


For years the gay community has campaigned to drop the permanent ban on blood donation for MSM donors on the grounds the ban is unscientific and discriminates. 

CBS's Public Affairs put out an interview with Dr. Dana Devine, Vice President, Medical, Scientific & Research Affairs on the changed MSM policy.  She noted that it will take years to gather valid data set to evaluate impact of changed policy on blood safety as incidence of HIV+ donors is extremely low. 

The geek in me wants to suggest it's a matter of statistical power: The ability of a study to detect a real difference, if one exists. Power is affected by how big the difference is and sample size. If a difference is big, it's easier to detect. And large sample sizes make a real difference easier to detect .
I'll end on a personal note with a newspaper article that appeared in the Toronto Star, Feb. 18, 2006 but is no longer online. I hope the Star doesn't mind that I've reproduced it. 
When I worked at Canadian Red Cross in Winnipeg, Barry and Ed Kubin would drop by periodically to pick up cryoprecipitate and, later, Factor VIII concentrate.

FOR FUN
Admittedly, it's hard to say 'for fun' on an issue that has devastated so many. But please enjoy this 1970 ditty by The Beatles, the last one released shortly after they broke up and while all 4 were alive. 


* The Long and winding road (Paul McCartney and The Beatles)

As always, comments are welcome.

Monday, November 11, 2013

Lest we forget (Musings on accountability of national blood suppliers)

Updated 12 Nov. 2013
This month's blog was completed on November 11, 2013, known as Remembrance Day in Commonwealth countries and commemorated on this day because the Great War ended in 1918 at the '11th hour of the 11th day of the 11th month'. Hence its title, Lest we forget. 

I started a draft of the blog after reading CBS's 2013 Report to Canadians (published 4 Oct.). Like issues of AABB's Transfusion, it became bathroom reading.  Initially the blog was going to be a few miscellaneous musings and questions on tidbits that struck me. As usual, I hoped a theme would magically emerge by publication date. 

Then on Oct. 28, 2013 independent performance review of CBS by Ernst & Young was released, which answered some questions. CBS also posted a management response to the performance review.

That's when the blog's focus became clear. The annual report and performance review were about accountability, something we should never forget.  It's self-evident that organizations and health professionals on the public payroll need to be accountable. To whom and for what is the stuff of cliches and open to discussion, if not debate.

So.....If you're 'into' transfusion medicine and blood banking, these reports are loaded with goodies worth reading. 
Even if 'you're not just that into blood suppliers,' the CBS report and performance review provide a banquet of food for thought.

I hope it relates no matter where you live. For comparison to other nations with publicly funded blood suppliers, see

What follows are my musings on a few selected aspects of the CBS report and performance review, the 'goodies' I find most fascinating or amusing (she said with an evil grin). Read on if you too are curious about 
  • How it's efficiencies über alles when it comes to reducing staff costs by consolidating testing and production, outsourcing, decreasing staff and hiring less qualified ones
  • Not so much emphasis on efficiency when it comes to executive compensation
  • How much it costs to produce transfusable products 
  • Cost and trends for plasma-derived products such as immunoglobulins
Before beginning, as the review notes, kudos to CBS, which has successfully:
  • Regained public and stakeholder trust in the blood supply 
  • Implemented safety procedures and tests resulting in a blood system where safety aligns with international leading practices 
  • Increased stakeholder engagement and transparency through open Board meetings, national and regional liaison committees
Transparency remains an issue but, compared to others, CBS bares its inner goings-on admirably. We are the champions...

SMALL POTATOES NIT-PICKING
First, as a webmaster I can't help but notice that when you go to the CBS website, it takes 4 clicks to get to the Report's entry page. And, unless you notice the menu at the top, it's a whopping 15 more 'Next' clicks to get to the Financial Report entry page, where you can select several versions of the 'nitty-gritty' such as
Wow, that was hard work! Didn't see the menu the first go-round. 

CBS BACKGROUND FACTS
Canada is the world's second largest country by land mass with a population of ~ 35 million, mostly concentrated near the USA border.

To serve this population and geographical area (excluding Quebec), CBS currently has (graphic, p.30 of annual report)

  • 42 permanent collection sites
  • 2 blood testing facilities 
  • 10 manufacturing facilities (4 were axed - 'consolidated' - in 2012-13 with more scheduled to close in the future)
CBS
  • Operates with ~4,700 staff and 17,000 volunteers
  • Collects ~ 1 million units of whole blood and apheresis donations annually
  • Has a budget of ~$1 billion paid for by Canadian tax payers
BUSINESS LINES
CBS has these business lines:

  • Transfusable Products (RBC, platelets, plasma)
  • Plasma Protein Products (also transfusable, but what the hey)
  • Diagnostic Services
  • Stem Cells
  • Organs and Tissues
Only the first three will be mentioned in the blog. 

Now the good stuff, an 'executive version' through the filter of my biases.

1. STAFFING, EFFICIENCIES, COSTS, PRODUCTIVITY

Staff
Full-time equivalent positions (FTEs) decreased by ~124 FTEs, within the Transfusable Products program, which contributed to $22 million of efficiencies. 

CBS reports staff costs as $276,824,000 or ~58% of total costs.
Presumably this does not include executive compensation. 

Staff costs are often cited as higher than 58% but it's hard to compare workplaces. Regardless, staffing usually constitutes the highest cost, so employers continue to eliminate well educated staff and look for cheaper, invariably less well trained, workers. 

Efficiencies
Under the umbrella of efficiencies, every year CBS decreases the number of staff, hires less trained, cheaper staff, and considers outsourcing. It's a big deal. For example, the CBS performance review mentioned 
  • Efficiency 93x, efficiencies 25x, efficient 8x. Total=126
In its response to the performance review, CBS mentioned 
  • Efficiency 50x, efficiencies 43x, efficient 5x. Total=98
In fairness, the review mentioned the motherhood issue of safety 226 times. 

Cost
Of course, cost is closely related to efficiency. The performance review mentioned it 747 times. Which more or less reveals the performance review's priority, decreasing government costs. Judging by mentions ('hits' in search term parlance), cost is more than 3 times as important as safety.

The review's Recommendation #23: 
'CBS should continue to explore opportunities to optimize staff mix by implementing the use of donor care associates.'

The CBS response
CSB acknowledges that the largest cost driver in the collections function is staff costs.....CBS will continue to review its staff mix and optimize where viable. 
The Donor Care Associates role has been piloted ....and Health Canada approved this role in April 2013. The organization is planning to further implement the Donor Care Associates role over the coming fiscal years.
The CBS website explains the purpose of hiring 'donor care associates' and training them: The strategy is to better align skills and knowledge of staff to the requirements of the clinic functions. 

Oh yah. Aligning staff skills and knowledge to functions is what it's all about, meaning hiring cheaper staff, similar to right sizing, biz jargon for layoffs, firings, or, less toxic, not filling vacant positions when staff leave or retire. But not less toxic to remaining staff who must do more with less and suffer burnout as a result.

Productivity
The review claims that, while CBS has improved its productivity, measured by labour hours per unit, by 5% since 2008-09:
CBS remains less productive than comparable blood services organizations in donor recruitment and production and distribution processes. 
Higher staff costs account for most of the difference in whole blood clinic costs compared to 2 of the 3 other blood service organizations reviewed. 
Approximately 75% of CBS employees are unionized.
The 3 comparable blood organizations reviewed remain a mystery, but surely one is Canada's Héma-Québec, perhaps the one with equally 'high staff costs.' 

My read is that Ernst & Young are suggesting CBS should increase productivity by paying staff less. Hard to do in unionized setting unless you replace well paid staff by less educated ones. For example:
  • 6 staff work 3 hours to produce outcome. If average wage is $20/hr cost is $360 (6x3x20) 
  • If staff paid $10/hr, cost is only $180. 
Hey, immediately we're 100% more productive. Viva CBS! We are the champions...

2. DIAGNOSTIC SERVICES 
Besides aligning skills to function, apparently CBS can also decrease costs by divesting some or all of its Diagnostic Services business line. 

For interest, CBS's Diagnostic Services includes many things but mostly it's the patient side of CBS: prenatal testing, pretransfusion testing, and antibody investigations (patients and donors). In other words, Diagnostic Services is largely staffed by medical technologists who love red cell serology. 

My ears perked because for a short time in 1999-2000 I was 'assman' in the diagnostic services lab at the CBS Edmonton Centre. (assman, how the Quality Dept. addressed mail to the assistant lab manager). 

Diagnostic Services is an ongoing interest, having worked in one in Winnipeg for 13 years at the Canadian Red Cross Blood Transfusion Service - a large combined blood centre and regional crossmatch and prenatal testing facility  - that morphed into CBS, post-Krever Commission. 

And the lab in Edmonton is currently managed by a graduate of the first Med Lab Science class I taught from start to finish at the University of Alberta, one of my original 'kids'.

With that history, any mention of divesting Diagnostic Services gets immediate attention. The review's Recommendation #32: 
The provincial and territorial governments should work with CBS to investigate opportunities to decrease costs.  
Decreasing costs may be achieved through centralization of testing or divesting testing services performed by CBS to local hospitals. 
Transferring prenatal and pretransfusion testing from CBS to local hospitals has long been discussed in Canada's transfusion community. 

The irony is that CBS's pretransfusion testing lab in Winnipeg is already a cost-effective, centralized testing service. Same with prenatal testing in Alberta. So transferring these functions to local hospitals would mean significant increased cost to health regions. 

Since the money all comes from the same pot (the provinces and territories), it may actually cost more to transfer testing to hospitals, to say nothing of the changes they would need to make and adapt to. 

Or perhaps CBS will have a go at further centralizing diagnostic services as they have donor testing and component production. 

Before entering the morass of  executive compensation at CBS, two items that should be 'ho hum'...

3. COST PER UNIT
CPU is the ratio of total expenses to shipments of all products. According to the CBS annual report

  • Cost per unit for 2012-13 was $386
Although cost comparisons are impossible, given differences in how they are calculated, in bathroom reading I noticed that the UK NHSBT reports the costs of a unit of RBC  in 2012-13 as £123/unit ($204 CDN).

So raw data show the UK blood supplier as ~50% more efficient than Canada. An unfair comparison since CBS data include all products, not just RBC, and we're a huge country compared to them. Still interesting....


4. PLASMA DERIVED PRODUCTS
As a percentage share of total expenses, CBS reports transfusable products and plasma-derived ones as almost equal. 

  • 47.2% Transfusable Products
  • 46.3% Plasma Protein Products* 
* Plasma protein products include plasma-derived and recombinant therapeutic products, e.g., immunoglobulin (Ig), albumin, hyperimmunes, and clotting factors (factor IX, factor VIII, factor VIIa).

Plasma protein products such as Ig continue to be those with high continued growth.

CBS reports that, since self-sufficiency for plasma protein products  is not operationally or economically feasible in a volunteer, non-remunerated model, they try to maintain a sufficiency of 30% for Ig. 

To meet demand for Ig, CBS buys surplus recovered plasma from voluntary donations from the USA for fractionation.

It's debatable that CBS has ever seriously tried to get more plasma from volunteers. In March 2013 it closed a plasma collection centre in Thunder Bay, effectively exporting jobs to the USA.

My take on the plasma collection closure:

Seems that CBS buying plasma from USA to produce Canada's plasma protein products is cheaper than collecting plasma ourselves. Fair enough, but why not be transparent? 

Which is why I'm skeptical of CBS's statement in the 2013 report:

  • Self-sufficiency for plasma protein products  is not operationally or economically feasible in a volunteer, non-remunerated model.
Have they ever seriously tried? If paid plasma donors are heroes, wouldn't volunteers be even more heroic?
Then there's the matter of paid plasma collection sites coming to Canada, seemingly supported by Health Canada and CBS CEO Sher.
  • Day tripper (Musings on HC's instructions to the jury on paid plasma)
5. EXECUTIVE COMPENSATION
CBS executive compensation (pp. 62-3 of annual report) includes several elements:

  • Base salary
  • Annual pay-at-risk, long-term incentives
  • Pension, benefits and perquisites
In 2012-13 CBS executives earned $283,000 to $342,000, with the CEO Graham Sher earning $560,000. 'Compensation at risk' as a percentage of base pay was 25% for the CEO and 20% for most executives.

'Compensation at risk' is tied to performance measures and means the percentage of base salary that executives could lose if they don't achieve defined performance measures. Using the figures above, it means the CEO could earn between $420K and $560K depending on performance.

It's not public knowledge but I wonder if the CBS CEO, or any executives, have ever lost any 'compensation at risk.' It would also be more transparent if specific performance measure criteria were public, given that Canadian tax payers foot the bill.

If not, 'compensation at risk' sounds good but may be a bit of a scam, which is why the performance review on executive compensation is informative. The review notes that 

  • Compensation of CBS leadership team is positioned at the high end or exceeds the range against other comparable national publicly funded organizations.
  • The analysis found that the low end of CBS executive compensation is positioned slightly higher than the average for comparators, while its high end is 20% to 30% higher than comparators.
Also, the review assesses that, while CBS has a formal process in place, as well as processes to support their continuous professional development,
  • The review of the process found that there is a lack of clarity in how and which performance indicators and outcomes are linked to executive management compensation.
So like much of what CBS spouts, it sounds good, but is not transparent and may be total bafflegab. Or not. We don't know, which is the problem.

Speaking of bafflegab, or annoying, pompous jargon that consultants dream up, the CBS management response to the performance review has 10 'hits' for best practice, 16 for leverage, and 47 for strategic. 

At least they weren't thinking outside the box or proposing a paradigm shift.   

SUMMARY
Lest we forget, all players in publicly funded health care need to be accountable, including governments, health institutions, service providers, clients, health professionals, and patients. 

To whom is CBS MAINLY accountable? 
To governments (provincial and federal) on whose dime it operates and to whom cost is king? To its customers, hospital transfusion services and their clients (patients) to whom safety is paramount? 

My take: The priority of governments today is cost-efficiency. Yes, lip service to safety but the CBS performance review referenced safety 226 times versus cost 747 times and efficiency (meaning cost efficiency) 126 times.

And accountable for what?
For improving and maintaining blood safety? For saving tax payers money? My take: Both with cost the priority. 

Nothing has changed from the '80s and '90s when Canada's blood experts judged that 
  • Discarding Factor VIII concentrates was too expensive (since hemophiliacs were all likely infected anyway)
  •  Surrogate tests, as implemented in USA for hepatitis C, were unscientific (We are so much smarter in Canada)
Bottom line: I give CBS credit for showing its dirty laundry (performance review) in public. In that sense, from a Canadian perspective, accountability exists. 
As always, comments are most welcome. 

Further Reading