Saturday, July 24, 2010

United we stand? (Musings on competition for blood donors)

This blog examines a recent news item on the effects of a poor economy and increased competition for donors among blood suppliers in the USA and muses on economic basics, as applied to blood suppliers. The blog ends with a silly skit suggesting what competition for donors might look like in Canada, where Héma-Québec reigns supreme in La Belle Province and CBS has a monopoly in the Rest of Canada. The title derives from an old hit song by the British pop group, Brotherhood of Man.

BLOG'S GENESIS
Unlike fractionated blood products, where commercial drug companies "duke it out" across the globe, competition in providing blood and blood components is something foreign to Canada and many other countries. Hence, this item from the USA recently caught my eye:


Apparently, in Pennsylvania competition for donors has become fierce: the Pittsburgh-based Central Blood Bank (a division of the Institute for Transfusion Medicine) has increased the number of blood drives in Erie County, although it doesn't supply blood to hospitals there.

"The turf battle came to a head July 1 when Community Blood Bank held an impromptu blood drive outside the Sheraton Erie Bayfront Hotel, while the Central Blood Bank was holding an indoor one. Employees from each blood bank exchanged heated words, but the two organizations haven't talked since then...."
A Community Blood Bank spokesperson is reported as saying,
  • "It's a shame. We used to work together on projects. Not anymore."
  • The Central Blood Bank declined to return the reporter's phone calls requesting comment.
So, competition for blood donors seems to have taken a nasty turn in the USA. The news item goes on to report that, with the current struggling US economy, the Community Blood Bank will lose money in 2009-10. It has not laid off employees but has increased its blood prices.
Pointedly, Community Blood Bank's website specifies that it "only draws from the areas in which it supplies."
Writing a blog on the blood system as a business in which blood suppliers compete was further promoted when the latest Journal of Blood Services Management issue came out, prefaced by a letter explaining that it cannot meet its planned quarterly schedule. In reviewing the types of articles wanted, competition was listed as a suitable topic. For more on JBSM, see last July's blog, "Transfusion lite" - Back in the USSR?

For interest, you can now read the first JBSM issue free online.
ECONOMICS PRIMER
What follows is a simplistic take on complex economic issues. I'm totally unqualified on the subject, being a mere, somewhat cynical observer of private sector machinations to generate profits. But, hey, why let ignorance stop one from voicing opinions.
Canadian Blood Services (CBS) and America's Blood Centers (Héma-Québec, but not CBS, belongs) are non-profit organizations (NPOs). By definition, NPOs use profits, if there are any, to pursue goals, rather than distributing them to owners or shareholders.
To survive, NPOs and other businesses must be profitable in most years or at least break even. That means that revenues must exceed expenses. Successful companies increase revenues or decrease expenses or do both.

DECREASE EXPENSES
Decreasing expenses involves strategies such as
1. Decreasing overall staff (a significant cost) via automation, centralization, regionalization, e.g., CBS's move to only 3 blood testing centres for all of Canada and one National Contact Centre for booking donor appointments

2. Decreasing staffing costs, achieved by hiring less qualified staff who can be paid less, e.g., CBS's move to use "donor care associates" in donor screening (as opposed to RNs)
3. Hiring more part-time and casual staff whose health care, pension, and other benefits do not need to be contributed to by the employer (statistics are hard to obtain and are not usually publicly accessible)
4. Forming consortia (or merging with others) to facilitate volume purchases by the group, e.g., Group Services for America's Blood Centers
INCREASE REVENUES
Companies can increase revenues via increased sales volume or increased prices. In Canada (and other countries with mainly government-funded national blood suppliers), increasing revenues is not an option except by negotiating with relevant governments and who knows what goes on in those dark and dirty meetings, certainly not I.
In general, strategies used by companies to increase revenues may include the following. Some of these may apply to US blood suppliers.
  • Create a demand for products, if none exists, or an increase demand (e.g., commercial umbilical cord blood banks such as Alpha Cord and Pacific Cord .The latter offers 'concierge service'!)

  • Get ahead of the curve by moving into emerging, 'latest/greatest' in-demand products, and charging more for them (so called value-based pricing) e.g.,human cells, tissues, and cellular- and tissue-based products
  • Produce a better product than competitors, preferably at a competitive price, or argue for your product's value-added benefits (e.g., leukoreduced red cells, double red cell collections, improved customer service)
  • Increase distribution area so that the number of potential clients increases (rapid, reliable long distance transportation)
  • Increase clients with loss leaders ("Like our cheap RBC? Now have we got a deal for you...."), and later promote products with high profit margins (e.g., inexpensive or free instrumentation with costly, ongoing reagents)
  • Entice more clients with a positive corporate image, e.g., promote impressions of quality products and services via public relations campaigns and community involvement
  • Develop an effective and easily recognizable brand identity for the organization, e.g., CBS's logo and tag line, It's in you to give
  • From the website: "Canadian Blood Services has updated all key brand positioning elements and personality traits. The result is a focus on positioning Canadian Blood Services as the trusted place where Canadians can share their health and vitality to help others regain theirs."

  • SILLY SUMMER SKIT
    Since it's summer, and the city where I reside had its "silly summer parade" on Canada Day (July1), here's a skit that I hope makes you laugh. It's totally tongue in cheek and written with affection for the characters involved. My apologies to all concerned for taking such liberties.
    Just as the Pittsburgh's Central Blood Bank made an apparent raid into the territory of the Community Blood Bank, I could not help but wonder, WHAT IF Héma-Québec made a similar raid from Hull, Quebec across the river into Ottawa, Ontario, the site of CBS's head office? (Rough translation follows the skit.)
    START OF SILLY SKIT
    • Graham (shocked): "Francine, quelle surprise! Mais, que fais-tu ici?
    • Francine (playful): "Bonjour, Graham. Ça Va?"
    • ===================================
    • Graham (puzzled but now more formal): "Mais, pourquoi, Francine? Vous êtes sur 'my turf'!"
    • Francine (smiling): "Oui, mais nous sommes toutes les canadiennes, n'est-ce pas?"
    • ===================================
    • Graham (ashen-faced): "Merde, Francine! J'accuse! N'avez vous aucune pitié?"
    • Francine (chuckling with a wicked gleam in her eyes): "Graham, c'est un signe des temps. Vive le Héma-Québec! ...(long pause...) Vive le Héma-Québec libre!"
    • ===================================
    • Graham (sweating profusely): Mindy, aidez-moi, s'il vous plait! Notre amie, elle est....'bonkers'! Il doit être son expérience avec ces Européens fou au ISBT!"
    • Mindy (ruefully shaking her head and with a mischievous glint in her eyes): "Désolé, mais vous êtes vous-même, mon ami! Voulez-vous le numéro de téléphone de Heather?"
    SILLY SKIT (ROUGH TRANSLATION)
    • Graham (shocked): "Francine, what a surprise! But what are you doing here?
    • Francine (playful): "Good day, Graham. How goes it?"
    • ===================================
    • Graham (puzzled): "But why, Francine? You are on my turf!"
    • Francine (smiling): "Yes, but we are all Canadians, no?"
    • ===================================
    • Graham (ashen-faced): "Sh_t, Francine! I accuse! Have you no pity?"
    • Francine (chuckling with a wicked gleam in her eyes): "Graham, it's a sign of the times. Long live Héma-Québec! ...(long pause...) Long live a free Héma-Québec!" (see historical relevance in Canada)
    • ===================================
    • Graham (sweating profusely): "Mindy, please help me! Our friend, she is....bonkers! It must be her experience with those crazy Europeans at ISBT!"
    • Mindy (casually shaking her head and with a mischievous glint in her eyes): "Sorry, but you are on your own, my friend. Do you want Heather's phone number?"
    .............END OF SILLY SKIT.........
    Doesn't a donor competition scenario, in Canada or anywhere, seem nuts? Everyone knows the maxim, united we stand, divided we fall, but is a Pennsylvania blood center ignoring it? Here's a sugar-sweet song version of the axiom:
    MORE FUN
    Another scenario comes to mind. WHAT IF the Brits made a raid across the Atlantic to poach American blood donors. As you ponder, consider lyrics for an updated version of this catchy Johnny Horton mega-hit, The Battle of New Orleans (funky version from Ed Sullivan show)
    For a serious glimpse into CBS's view of its business management strategies:

    1. The transformation of CBS. Strategy management to create results .....[Source: Sophie de Villers, Balanced Scorecard Forum in Dubai, UAE , March 2010]
    2. Embedding a results-based management culture / Moving modern management forward (Speaking notes) ....[Source: Ian Mumford, Performance and Planning Exchange Conference, May 2003]

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


    Sunday, June 20, 2010

    I will remember you (Musings on mentorship)

    In an article in the June 2010 issue Transfusion* Nancy Heddle wrote:
    "Appropriate training and mentorship will serve as the foundation for the next generations of clinical trial specialists."
    * Heddle NM. The randomized controlled trial: in celebration of Transfusion's 50th. Transfusion 2010 Jun;50(6):1173-8 (Published online Jan 15 2010)

    This got me thinking about mentorship in transfusion medicine (TM) and how well this tradition is continuing. The blog's title comes from a love song by Canada's Sarah McLachlan, a song that can be applied to diverse relationships.
    Mentorship can be defined many ways, but I mean it simply as many informal ways, large and small, that professionals guide less experienced colleagues to help them enhance their knowledge, skills, and careers, while simultaneously gaining much in return.

    ANECDOTES
    First, some personal anecdotes. Over the years I've been fortunate to have several mentors, most of whom probably do not realize that I consider them mentors. As you read, consider reflecting on those who have mentored you.

    One mentor was the lab manager at my first job working as a lab technologist. The manager encouraged me to read and eventually I devoured the three 'bibles' of the time, known simply as Race & Sanger, Issitt, and Mollison. The gems, both theory and practice, inside those textbooks gave me a solid foundation in TM, an advantage that helped my career progress.

    During these early years the odd misstep was also tolerated, as when I decided to change a method in the reference lab (there were no written SOPs at the time), an alteration that I thought was brilliant but, in my ignorance, did not realize could have adversely affected test results. I received a well deserved and controlled verbal 'spanking' along with rationales for why my innovation was bad, but was not fired or otherwise disciplined. Instead I continued as a valued employee who had the ear of the manager and input into lab policies and operations. Despite being pre-quality systems, a culture of blame did not exist, a lesson that has stayed with me to this day.

    A second mentor was a transfusion service physician with whom I worked closely for several years after becoming an educator and clinical instructor. Our relationship helped build confidence, especially being accepted as a colleague without any hint of a pecking order. Sharing many a laugh over student responses in oral exams (one example: anti-A1 lectin = Delicious biflorus) significantly contributed to a sense of collegiality.

    Working together on a research project and various interactions involving students enhanced my respect for the physician, who had incredible knowledge of immunohematology practices and the techie side of the lab. The confidence gained during this time to deal with physicians on a footing of mutual respect was essential to my career over the ensuing years.


    Other mentors included a technologist who encouraged me to get involved with my professional society, which opened up many networking doors and led to lifelong friendships; and a colleague who taught by example valuable teaching skills, particularly the critical importance of respect and empathy for one's students as individuals.

    MENTORSHIP in TM
    There are many mentorship papers in the literature.
    [Note that you can filter results to reviews and free full text - see right side of screen.]

    In preparing this blog, I also searched the Internet for mention of mentors in a TM setting. Some examples:

    1. ASH has a mentor award.
    General criteria to receive the award:

    "...awardees will have had a sustained career commitment to mentoring, a significant positive impact on their mentees' careers, and through their mentees have advanced research and patient care in the field of hematology."
    2. Several TM physicians discuss mentors and their influence. Random examples:



  • Ira Shulman's profile for BloodMed.Com
  • Paul Ness in an interview in HemOnc Today

    • The value of mentors in medical education is discussed by Natalie J. Belle (known as njbmd on the Student Doctor Network) in her blog entry on pathology (unfortunately, no longer online).

      Of interest: "My pathologist mentor for Transfusion Medicine had a profound influence on the manner in which I practice medicine today. He was an excellent professor with a wonderful staff who was quite willing to show an eager medical student all aspects of Transfusion Medicine."
      • "...willing staff and eager students..." Hmmm...
      WHAT MAKES A GOOD MENTOR / MENTEE?
      Two articles in particular caught my eye, one on each side of the mentorship relationship:

      1. Davis OC, Nakamura J. A proposed model for an optimal mentoring environment for medical residents: a literature review. Acad Med. 2010 Jun;85(6):1060-6.


      In brief, to develop a model of optimal mentoring for medical residents, the authors searched the literature. They found six attributes of a good mentor that were consistent across the 20 papers that met their inclusion criteria and that can serve as interactional foundations that underlie an optimal mentoring relationship:

      • emotional safety
      • support
      • protégé-centeredness
      • informality
      • responsiveness
      • respect
      Among other things, this study suggests that, when guiding students and new staff, by modeling appropriate behaviors, we should convey that

      • not knowing everything is normal and "okay";
      • their needs are more important than ours;
      • they are colleagues (not nuisances); and
      • we respect them by responding to challenges, even those that differ from current dogmas.
      2. On the other side, proteges also have responsibilities as explained in this paper:

      According to the author, who discusses formal mentorship in the USA military, but whose ideas apply more broadly, the 10 most important qualities of ideal proteges (mentees / learners) include
      1. Love of learning
      2. Self -starter
      3. Confidence
      4. Prudent risk taking
      5. Flexibility to rebound after mistakes
      6. Enthusiasm
      7. Open minded to advice and constructive criticism
      8. Commitment to relationship with mentor
      9. Loyalty (keeping confidences)
      10. Gratefulness, to include becoming a mentor to others
      As a former educator, I believe that these qualities constitute what could be considered the ideal student. The only thing I would add is a willingness to challenge established practices and policies rationally (asking why and requesting evidence), as opposed to accepting everything passively or offering knee-jerk opposition to authority (seen in some students, and a normal part of growing up).
      A teacher's reply may often be the equivalent of
      • historical precedence (no good reason - it's always been done this way)
      • practicality (e.g., allows for reduced staffing on weekends)
      • favorite 'hobby horse' of local pooh-bah (colleagues are afraid to challenge pooh-bah's beliefs, especially those of a grand pooh-bah)
      WITHER THE MENTORS?
      So, do TM professionals entering the field today, whether physician, medical technologist, scientist, or nurse, get the mentorship they need to develop as the 'next generation'? I'll speak to the technologist side of the question as this is what I know best.
      Mentorship in the clinical lab seems on the wane. With ongoing cutbacks and finding ways to do more with the same or less, technologists have little or no time to train new staff fully, let alone mentor them.
      Yes, training and competency assessment occur, as they must, but with few resources everything often devolves to the basic minimum. Is this situation specific to technologists or does it apply to other professionals on the TM team? Feedback is appreciated.
      As well, with fewer technologists as TM specialists, training may not include problem solving skills, since cross-trained staff are directed to pass problems to supervisors. The option to by-pass problem solving by on-the-bench technologists may accommodate current realities, but the question arises,
      • "What if there is eventually no one suitably trained to investigate anomalies and problems?"
      With the anticipated retirement of baby boomers, this issue becomes more relevant. 


      BOTTOM LINE
      New recruits to TM need mentors. Indeed, without mentors there soon may be no recruits. The challenge is how to foster mentorship with diminished resources.
      If potential recruits see TM as a fulfilling career (financially, intellectually, emotionally) AND if TM professionals view mentoring as an opportunity to make a real difference, mentoring will happen no matter what the challenges.
      I have always been surprised, delighted, and humbled when colleagues acknowledge me as a mentor. There is absolutely nothing - NOTHING - that compares to the satisfaction of knowing that you played a role, no matter how small, in students choosing TM as a career, or that respected colleagues consider you to be a mentor.
      Sarah McLachlan's I remember you offers a fitting sentiment for all mentors and mentees:

      I will remember you
      Will you remember me?
      Don’t let your life pass you by...
      JUST FOR FUN
      Enjoy Islands in the Stream, a delightful duet by Dolly Parton and Kenny Rogers. 

      Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice...and we have some (see below). Thanks to those who posted - great food for thought.

      Monday, May 24, 2010

      Smile on your brother: Musings on labour woes in the blood system

      The idea for this month's blog came from the latest labour relations difficulties facing North America's blood suppliers. The title derives from the lyrics of a 1960s song recorded by many, Get Together.

      USA - American Red Cross [ARC]

      Canada

      This blog uses the above labour conflicts to offer musings on the role of trust among TM health professionals. Because the underlying issue in any management / employee negotiation relates to trust, I will not discuss the specifics of the news reports. Besides, without in-depth knowledge of what is actually happening, analysis would be folly.
      Many good friends are either staunchly pro- or anti-union health professionals. I know from experience that discussing union issues, like religion and politics, is sure to lead to passionate disagreements fueled by anecdotes and emotion, not objective, evidence-based logic, and may result in hard feelings. I'm hoping not to wander into that morass as the blog's narrative unfolds.
      UNIONS
      As background, to my knowledge, Canada's blood system, both blood suppliers and hospital-based transfusion services, are mostly unionized. Unionized workers usually include laboratory technologists, lab assistants, and nurses, and a diverse group of other staff, e.g., clerical, IT, lab scientists, maintenance, etc.
      Some employees, e.g., TS laboratory managers and blood centre management positions, may be "out of scope" (not included in union contracts).
      Practical implications of being out-of-scope include the
      • ability to negotiate salaries and benefits directly with employers (and to keep them private from co-workers);
      • subtle promotion of a them-versus-us mentality;
      • ability of employers to fire you without the hassle of a union grievance.
      As well, for non-union health professionals at senior levels, including dismissal terms in personal contracts, and threats of legal action for wrongful dismissal, may result in generous, golden handshakes for staff such as TS and blood centre medical directors.
      Many of the news items referenced in this blog involve contract negotiations. From my experience observing Canada's blood system, frequently workers do not trust employers / management to do the right thing for employees, patients, and the public at large. The worker view is often that management has a hidden agenda, typically to save money, even at the expense of safety.
      Conversely, it's not that rare for employers / management to regard unions negatively, and by extension to view their members as overpaid and more or less lazy, with unions leading to unwarranted, costly job perks and promotion of the most senior rather than the most competent staff. Management seldom voices such opinions publicly and would deny them if asked, but these viewpoints exist nonetheless.
      Indeed, these perspectives reflect public opinion, with proponents on both side of the union issue.
      The unproductive, adversarial mentality in labour negotiations seems relatively common everywhere despite major progress in labour relations worldwide during the 20th C.
      The sad fact is, that with contract negotiations, a lack of mutual trust is common. When discussions reach an impasse, each side often sees the other as self-serving and sometimes in even more negative terms.
      Tidbit: In 2007, the percentage of employees that were members of a trade union (Source: OECD - Union density 1960 - 2007) included:
      • Australia: 10% (2006)
      • Canada: 29.4%
      • Norway: 53.7%
      • Sweden: 70.8%
      • UK: 28%
      • USA: 11.6%
      These statistics likely do not include the employees such as physicians and university professors who are not members of a union, per se, but do belong to professional associations that act as unions by negotiating contracts and benefits.
      A ROSE BY ANY OTHER NAME
      When is a union not a union? When it calls itself a professional association. When working at the University of Alberta I was in the Association of Academic Staff, which negotiated salaries and benefits for professors. The Association's activities approximate that of a trade union.
      In Canada, health care is a provincial jurisdiction and provincial medical associations negotiate physician fees that are binding for insured services.
      Despite their loftier broader goals and objectives, Canadian provincial medical associations perform some of the same functions as unions. Yet unions may be disdained by some professionals partly because of their origin as trade unions, with "trades" somehow being more lowly than professions.
      For interest, Norwegian and Swedish physicians have no problem in identifying their medical associations as unions. Many of their physicians are state employees, as are physicians in many other European countries.
      To my knowledge, Canada's transfusion medicine physicians (hematologists, hematopathologists, pathologists) who work for transfusion services and blood suppliers are usually salaried employees, although they often have multiple appointments that earn additional salary. In essence, they too belong to professional associations that function partly as trade unions.
      TRUST
      People who work as part of any health care team must trust each other's competence, trust that each will to do the best job possible, maintain a high level of quality care, and put the patient first. There are checks and balances in the TM system, e.g., audits of blood transfusion requests, error management programs, etc., but the system would not function without trust in a colleague's motivation and competence. The first instinct of health professionals is to trust each other to maintain high practice standards, unless shown otherwise. For example:
      • When talking to a nurse on the ward who reports a possible transfusion reaction or to a physician in the ER who requests unmatched RBC, do lab technologists routinely think, "That lazy bum is so self-serving"?
      • When discussing follow-up treatment of patients suffering from transfusion complications with nurses, or holding a staff meeting with laboratory staff to plan implementation of an new LIS, do TS medical directors routinely think, "These nurses / techs deserve less pay and fewer benefits"?
      • When management staff from national blood suppliers consult with blood centre medical directors across the country, does "head office" routinely think, "These MDs don't have patient safety at heart. Their attitude is deplorable."?
      Do management staff who are not members of a health profession (whether representing health regions, hospitals, blood suppliers, or governments) often think such thoughts about members of the TM team?
      I think not. The many technologists, nurses, and physicians that I have known over a lifetime in Canada's blood system are dedicated to patient safety and trust each other to provide the highest quality care possible.
      How is it that trust seems to evaporate with labour negotiations?
      CASE STUDY
      In the mid-90s in Alberta, health care restructuring caused major job losses in the laboratory sector. One result was the creation of Calgary Laboratory Services* (CLS), a private lab that assumed 100% of clinical lab services in Calgary, one of the province's two major cities.
      * CLS is now a wholly owned subsidiary of Alberta Health Services (organization responsible for providing publicly funded hospital and other health care in Alberta)
      The case study below describes how a union (HSAA) and private-sector lab (CLS) cooperated under extremely traumatic circumstances. It paints a rosy picture of what's possible. I have no idea how closely it conforms to reality but there may be some lessons here.
      All this lack of trust and conflict reminds me of a song from the 1960s:
      As the song's lyrics go,

      C'mon people now, Smile on your brother Ev'rybody get together, Try and love one another right now

      Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. Let me know if you think I'm off the mark.



      Sunday, April 18, 2010

      April, the cruelest month (Musings on transfusion costs)

      This month's blog is slightly different than most - a potpourri of loosely related tidbits on transfusion-related costs. It's April and money matters seem apt. The blog discusses 3 recent news items and ends with why April is the cruelest month. The blog's title comes from The Waste Land, a poem by T.S. Eliot.

      #1. Tidbits on Biotech Profits

      Immucor, a US-based company that sells instruments for testing donated blood and pretransfusion patients, recently released financial results for its fiscal 2010 third quarter.

      The buzz among laboratorians has always been that companies that sell instrumentation make their money on reagents, not instruments (which occasionally are supplied free of charge).

      Immucor's latest financial results are instructive:

      • Overall gross margin* = 69.2%
      • Traditional reagents: $510,000 revenue (gross margin* = 77.4%)
      • Capture** reagents: $18,080,000 revenue (gross margin = 80.2%)
      • Instruments*: $10,277,000 revenue (gross margin = 12.2%)
      * Gross margin is short for gross profit margin
      Gross Profit Margin Percentage = (Revenue - Cost of Sales)/Revenue
      ** The automated instruments use Capture solid phase technology


      Example: If a company sells a computer for $1000 (revenue) and the cost of sales (materials, labor, shipping costs, etc.) is $200, then the gross profit margin = 800/1000 = 80%. For more, see
      Immucor's margins are higher than many others in the biotech supply industry.
      Tidbit #1 musings

      Using Immucor's data (sample size=1), the long held lab buzz about where instrumentation companies make their profit appears correct. And a gross profit margin of ~80% is high compared to many companies in this general business sector. No doubt managers consider ways to leverage this tidbit to their advantage when negotiating instrumentation contracts.

      Should we care that a supplier's profit margin is high? How does it impact transfusion costs?

      #2. Tidbits on Cost of IVIG
      Canada has a high per capita rate of IVIG use, in 2008 more than twice as high as the UK, and marginally higher than even the USA.

      Other Canadian-related tidbits from this editorial include
      • CBS supplies IVIG to hospitals free of charge. In fiscal year April 2008 to March 2009, the total cost of IVIG use in Canada was $244.2 million.
      • This cost represented ~18.9% of CBS's entire budget (budget for all blood component and plasma protein products, human-derived and recombinant).
      • An IVIG dose of 1 g/kg for a 75-kg person costs ~$5000.
      • Without a formal system of accountability for IVIG use in most hospitals, mechanisms to ensure optimal and appropriate IVIG use are important to develop.
      And that's what CBS in collaboration with NAC has been doing since 2004:
      For interest, I looked up the gross profit margin of one of the major IVIG players in Canada, Talecris Biotherapeutics. For the 4 quarters ending Dec. 2009 Talecris's gross profit margin averaged ~41%. Of course, IVIG is but one of their major products.
      Tidbit #2 musings
      Because CBS is publicly funded, IVIG costs Canadian taxpayers $200 - $300 million/year. No matter where we live and regardless of who pays, both as citizens and as health professionals, we all have a vested interest in seeing that the cost of such products is warranted in terms of clinical outcomes.
      3. Tidbits on TM-related Economics Research
      An editorial* in the April Transfusion discusses a paper ** that investigates the cost of red cell transfusion in surgical patients in 4 hospitals (2 in the USA, 1 each in Austria and Switzerland).

      * Custer B. The cost of blood: did you pay too much or did you get a good deal? (editorial) Transfusion 2010 Apr; 50(4): 742-4.
      **
      Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusion in surgical patients at four hospitals. Transfusion 2010;50:753-65.
      The research was funded by SABM, made possible by grants from suppliers of various brands of synthetic erythropoietin. Weirdly, a company called Masimo, not listed as funding the study, put out a press release on its outcomes:
      In his Transfusion editorial Custer makes the following key points (summarized):
      • Although the basic purpose of health economic research is to link money spent to outcomes to help select expenditures that have the greatest benefit for individuals and/or society, there is no consensus on whether studies should try to answer questions that maximize benefit for individuals or society as a whole.
      • Patient outcomes are critical to whether blood safety and transfusion are worth the cost.
      • If outcomes for similar patients are better at hospitals that use more blood or have the highest transfusion costs, then the premise that transfusion costs are too high is invalid.
      This last one got me thinking. According to the author's logic (taken to its logical conclusion), if a transfusion alternative like erythropoietin or autologous red cell salvage costs more than transfusing donated human red cells, but has improved patient outcomes (shorter hospital stays,etc.), then a premise that its increased cost compared to allogeneic transfusion is too high is invalid. Unfortunately, health economics research is more complicated and difficult to evaluate, as the author goes to great lengths to explain.
      Regarding the study by Shandler and colleagues, Custer concludes:
      • "Does a cost between $500 and $1200 per RBC unit transfused represent a good use of resources? Once again there is no single answer."
      Tidbit #3 musings
      As noted in an earlier blog (Dr. Strangeblood or how I learned to start worrying and hate the numbers), which also involved a paper by Custer*:
      • One of the main challenges with [cost effective analyses) is, as the computer nerds say, GIGO, Garbage in, garbage out....
      * Custer B, Hoch JS. Cost-effectiveness analysis: what it really means for transfusion medicine decision making. Transfus Med Rev 2009 Jan;23(1):112.
      Which is not to say that cost-analysis researchers input garbage. It's just to realize that, depending on the study design and inputs, you can claim almost any outcome you want. Unfortunately, when critically analysed, study results may not mean much.
      Summary
      As shown, the potpourri of tidbits all deal with money, a relevant topic for April when income tax is due, at least in Canada and the USA:
      • Immucor's gross profit margin on instrument reagents is 80%. Should we care and how can we best use this factoid?
      • Canada has a high per capita rate of transfusing IVIG, a costly plasma derivative, motivating CBS and NAC to produced evidence-based guidelines for its use. This we should care about.
      • The cost of transfusion has been under-estimated but what does it really mean?
      As usual, I think we can all benefit by getting back to sufficient costing basics to allow us to assess these economic studies effectively.
      April - The cruellest month
      On 11 April 1969 the Beatles single "Get Back" was released, and an alternative version became the closing track of Let It Be (1970), released just after Paul McCartney announced he was leaving the band 40 years ago.
      As T.S. Eliot wrote in his poem The Waste Land:
      April is the cruellest month, breeding
      Lilacs out of the dead land, mixing
      Memory and desire, stirring
      Dull roots with spring rain.
      Addendum: I'm still curious why Masimo would pay for a press release for a study that it did not fund. If you know the connection, please write.

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

      Saturday, March 20, 2010

      You can't always get what you want (Musings on HIV's discovery & how ads become news)

      This blog is about what we think we're getting compared to what we're actually getting, hence the blog's title, taken from an old Rolling Stones classic:
      The blog
      1. Briefly reviews HIV's discovery and how the initial HIV screening test was developed and by who - a intriguing tale if there ever was one
      2. Discusses how development of the anti-HIV test may have become the top story in AABB Smartbrief, Mar. 3, 2010
      As background, I subscribe to several e-newsletters, including AABB Smartbrief. The top story from March 3, 2010 was "HIV blood testing revamped global health crisis for 25 years." The issue's subject line was, "March 3, 2010 - HIV blood test helped address health crisis."
      Note that the AABB Smartbrief item focuses on Abbott's test and reads almost as though Abbott played a heroic role:
      • Before Abbott, a global, broad-based health care company, developed a blood test that could be used to screen blood donors for antibodies to HIV, one in every 100 blood transfusions were infected with HIV in some U.S. cities. That first test took Abbott scientists nine months working around the clock to develop....
      Part 1: Trip down memory lane - DISCOVERY OF HIV AND ANTI-HIV TEST
      The discovery of what we now call HIV and development of the initial HIV screening test is fascinating - a saga that I once used to increase student interest in transfusion medicine and the related topics of
      • How research has transmogrified from a world of colleagues sharing knowledge for the benefit of all to one where secrecy and cutthroat intrigues reign, largely due to the commercialization of research and the potential for immense wealth;
      • How money can influence the ethics of those involved in research and providing health care
      The HIV saga centres on two researchers, Robert Gallo and Luc Montagnier, and the patenting of the HIV screening test by the Americans. I'll review the key elements and leave it to readers to flesh out the story by reading the linked resources.

      A biography of Robert Gallo and the controversy over who discovered the AIDS virus and its initial screening test is reported in brief here (American perspective):
      The complete saga of the HIV test and its associated patent dispute is documented in

      Institutional response to the HIV blood test patent dispute and related matters.Staff Report of the Subcommittee on Oversight and Investigations Committee on Energy and Commerce, United States House of Representatives
      The HIV test controversy is complex and messy, but the main elements (simplified) include:

      1. Gallo's lab (Laboratory for Tumor Cell Biology or LTCB), which was working on isolating what it called HTLV III, received a LAV sample (lymphadenopathy associated virus) from Luc Montagnier's lab at the Institut Pasteur (IP) in Paris in Sept. 1983.
      2. The following April, Gallo claimed to have discovered the AIDS virus, HTLV-III.

      It turned out that Gallo's AIDS virus was Montagnier's LAV. The French had discovered the virus first, shared it with the Americans for research purposes, and the Americans claimed the discovery. We do not know how this happened (Gallo' lab had several possible explanations), just that it did.

      3. In April 1984 the U.S. Department of Health and Human Services (HHS) filed a patent for the Gallo lab's anti-HTLV III antibody test. The French had developed a similar test (anti-LAV) and had filed for a patent in Sept. 1983.

      On April 23, 1984, HHS Secretary Margaret Heckler announced:
      • "... the probable cause of AIDS has been found -- a variant of a known human cancer virus [this turned out to be false, but Gallo had discovered leukemia-related HTLV-I and also HTLV-II], called HTLV-III ... a new process has been developed to mass produce this virus ... we now have a blood test for AIDS which we hope can be widely available within about six months. We have applied for the patent on this process today."
      4. Subsequently, Gallo's lab sold the HIV cell line to Abbott, which developed the American test.

      5. The Institut Pasteur eventually initiated legal action, arguing that Gallo's blood test was based upon a virus substantially identical to the LAV strain first isolated by Montagnier. After much obfuscation (particularly by American researchers about how HTLV-III and LAV came to be the same virus), the lawsuits were ultimately settled, as documented in
      When it was finalized in March 1987, the settlement included agreements for blood test patents, patent royalties, and scientific events. Montagnier and Gallo agreed to call themselves co-discoverers of the AIDS virus and co-authored "Chronology of AIDS Research" that supposedly reflected the most significant contributions of IP and LTCB scientists.
      HIV Blood Screening Tests
      The two sides agreed that both group's patents would remain in place with the names of each side's scientists added to the other side's patent, supposedly because an inadvertent error was made in listing the inventors when patent applications were filed.

      Both sides also agreed to donate most of the blood test royalties to a foundation established as part of the agreement. 25% of the combined donated royalties were committed for AIDS research; HHS and IP received the remaining 75% in equal shares.

      This arrangement was changed in 1994 to provide a larger royalties share to the Institut Pasteur, presumably because HHS belatedly realized that the IP had not received a fair share. Gallo's use of the IP virus for the LTCB blood test was barely mention by HHS.

      6. It's worth noting that in 1985 France delayed introduction of the American HIV screening test. According to critics, the delay was to buy time to commercialize the French test, as reported in Blood Money (one reporter's overview of the French 'tainted blood' scandal from Discover Magazine).
      Regardless, as could be anticipated with any new diagnostic test, Abbott's anti-HIV test initially had considerable problems with false positives and negatives. Tidbit - The American Red Cross task force initially chose the French test over the American, not politically correct for the times or later.

      The HIV discovery controversy and Abbott's anti-HIV test difficulties are documented in
      7. Naturally, following the lawsuit resolution, everyone played nicey-nice and developed a suitable cover story:
      8. In 2008, the awarding of the Nobel Prize in Medicine & Physiology to Montagnier and his colleague Barre-Sinoussi (omitting Gallo) re-opened the controversy.
      Predictably, many U.S. commentators cried foul, as exemplified in this commentary: A prize tarnished. Euro-bias robs Gallo of a Nobel Prize

      The author essentially concludes that if unfair Europeans won't give Americans like Gallo the Nobel Prize, the USA should set up its own prize, one to eclipse the Nobel.

      Tidbit: Americans have won many more Nobel Prizes than citizens of any other country.

      Part 2: APPEARANCE VS REALITY
      As mentioned, the AABB Smartbrief March 3 issue focuses on Abbott's role in developing the HIV blood test 25 years earlier. The AABB Smartbrief item points to this article:
      Nowhere does this news item indicate that it is a re-write of this Abbott's press release:
      Of course, it's standard practice for news media to use press releases almost verbatim as an easy way to get stories. Indeed this practice is one of the benefits of press releases. LIke many press releases, this one was picked up by numerous news organizations, most of which indicated the source.

      BUT DID YOU KNOW....?
      The Smartbrief linked news item, focusing on Abbott as it did, made me look further into AABB Smartbrief. Here's what I found. Did you know that companies can sponsor these news section items?
      • Top Story
      • Science & Health
      • Hot Topics
      • Emerging Trends
      • Industry News & Practice
      According to the AABB Smartbrief advertising media kit, for a fee, sponsors can
      • Integrate their message and brand into the day’s top news
      • Include their logo at the top of the news section and messaging below the stories
      As the brochure claims,

      AABB SmartBrief has quickly grown to become the most frequently read AABB news vehicle. Surpassing 17,000 subscribers in May 2009, the daily e-newsletter has more than 260,000 impressions during an average month. Of those readers, approximately 30 percent open AABB SmartBrief every day, and 8.5 percent click through on a story.

      Side bar on privacy
      For interest, the display of one ad to one viewer on one web page is called an impression (a unit of advertising on the Web). Each time an ad loads onto a user's screen, it can count as one impression.

      I was not surprised that AABB Smartbrief knows how many readers open the newsletter daily since I have occasionally been frustrated to notice an automatic reply sent from my computer without my permission to aabb@smartbrief.com, e.g.,
      • Here's your auto (was Re: July 16, 2007 - VA facilities to use automated disease surveillance system) I was so annoyed that I saved this one
      Also, opening e-mail messages can be tracked via graphics in formatted e-mail messages so that a record can be kept of which IP addresses have received and opened specific e-mails (a troubling invasion of privacy). Graphics used for tracking are sometimes called "Web bugs," especially if the tracker is not the same company as the message sender.

      I'm unaware whether AABB Smartbrief uses embedded graphics to obtain viewer statistics, but it does use autoresponders, and it does track the open-rates of e-mails and click behaviors from e-mails to help identify which newsletter parts are most popular with readers, as noted in its privacy policy.

      About information sharing, the Smartbrief policy states:
      • No personal information is ever shared with any other partner organizations, advertisers or other third parties without first obtaining the explicit consent of the subscriber.....
      • We also may collect or have a third-party collect on our behalf aggregated statistical information about our subscribers and the ways in which they use our products and services. This information does not identify you personally. We use this information for market research purposes and to improve the quality of the products and services we offer. We reserve the right to disclose aggregated, non-personally identifiable information collected from our users to third parties for any purpose.
      BOTTOM LINE
      Every AABB Smartbrief contains advertisements that are designated as such. But it turns out that top news stories and other apparent news items can be advertisements paid for by sponsors.

      AABB Smartbrief does not hide this policy. The info is there for anyone who scrolls to the bottom of any e-mailed AABB Smartbrief and clicks on "Download Media Kit."

      But the advertisement-becomes-news-story policy is not exactly transparent. Without accessing the innocuous advertising media kit, you would never know what you are getting.

      Did Abbott pay AABB Smartbrief to get its self-congratulatory press release integrated into the day's top news story via a proxy, Digital Journal, operating as a 'participatory' news outlet since 2006?

      We will likely never know. But it's certainly possible. As the song goes, you can't always get what you want, but you can keep on trying.

      It's a given that we cannot believe at face value what we see in newspapers, hear on television, and read on Internet blogs like this one. Not surprisingly, the newsletters we subscribe to via our professionals associations also need to be critically analysed, just as research papers do.

      I'll conclude by saying that I enjoy AABB Smartbrief immensely and always open it and scan for items of interest, allowing my acess and reading choices to be tracked.
      My new pastime is to assess if any given top story, emerging trend, etc., is a legitimate news item or a "integrated" paid advertisement. And isn't the HIV saga still intriguing after all these years?

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

      Monday, February 15, 2010

      We are the world - Musings on how we can lessen the global trade in body parts

      As Valentine's Day approached, I got to thinking about what it means to give of ourself to family, friends, and total strangers.

      A Canadian Blood Services press release about a new initiative, "Improving organ and tissue donation and transplantation (OTDT) in Canada," made me wonder what motivates some to give so generously, whether by donating blood or by donating tissues and organs.

      The blog's title comes from the Lionel Ritchie - Michael Jackson song of the same name. It's hard to realize that it was 25 years ago that 'United Support of Artists for Africa' (aka 'USA for Africa') recorded what has become the biggest selling single of all time:

      The song has been in the news again recently as it was re-recorded just this month to help the people of Haiti:
      Organ & Tissue Donation
      This blog concentrates on organ donation and tissue donation (rather than blood) and focuses on organ donation in Australia, Canada, UK, and USA. Some random statistics:

      Australia
      In 2008, 259 Australians donated organs benefiting 846 transplant recipients [NSW Factsheet]

      Around 1700 people are on Australian organ transplant waiting lists at any one time. In 2009, 247 organ donors gave 799 Australians a new chance in life. [AODAW]

      Canada

      In 2008 CBS was given a government mandate to develop a recommendation for a new national OTDT system in consultation with stakeholders, the public, and the medical community.

      "Canada is one of the only countries in the western world without a national, coordinated system for organ and tissue donation and transplantation. [OTDT, 2010]
      Statistics from Organ Donation & Transplant Association of Canada
      • 4330 people were on the waiting list for an organ transplant.
      • 215 people died while waiting for an organ transplant.
      • 303 people withdrew from the waiting list. (People are withdrawn from the waiting list when they become too sick to receive a transplant, opt out of the surgery, or their health improves.)
      • 2083 transplants took place.
      • 1541 of those transplants were made possible because of deceased donors.
      Also see Organ donation & transplantation in Canada (Govt. of Canada):The organ donor rate in Canada continues to be mediocre despite efforts in recent years to increase it....

      UK
      • Last year 3,237 organ transplants were carried out in the UK but the number needing a transplant is steadily increasing, with almost 8,000 people currently waiting for a transplant.
      • Around 1,000 die while waiting because of the shortage of donated organs. [NHSBT, 2008]
      USA
      From OrganDonor.Gov:
      • ~77 people receive organ transplants daily
      • 19 people die daily waiting for transplants (~7000/yr)
      International Donation Rates
      In 2007, the USA ranked 4th in organ donation, Canada 12th, and Australia 17th. (International Registry of Organ Donation & Transplantation, according to Transplant Australia)

      Transplant Australia also notes
      • Spain, Belgium, France, Norway, and Italy have “presumed consent” laws, where everyone is considered a donor unless they specify otherwise.
      • USA and Finland have an ‘opt in’ consent law where citizens provide express and informed agreement to donate organs in the event of their death.
      • Many factors beside legislation affect donor rates, including hospital processes, public awareness, religion and culture, road death toll rates and others.
      • Donation is still discussed with the family and the objections of next of kin are not overruled in Australia and all comparable countries, whether a presumed or informed consent model is in place.
      Related news items - Spain leads the way in organ donation

      WHY NOT DONATE?
      There are many reasons why more of us do not donate our organs and tissues:
      CONSEQUENCES OF ORGAN SHORTAGES
      Although not this simple, in most economies a shortage of organs will operate like shortages of other commodities and obey the laws of supply and demand, i,e, if demand increases while availability decreases or remains low, prices will rise.

      Invariably, shortages mean that the rich will be able to obtain expensive goods and services unavailable to the poor. Globally we see this with HIV/AIDS and hemophilia:
      Comparisons from World Federation of Hemophilia 2008 Global Survey on the use of FVIII concentrates (see p.27) show a striking trend:
      FVIII use per capita* (% recombinant) * total IUs used divided used by total population
      • Australia: 6.21 (87%)
      • Canada: 4.64 (100%)
      • USA: 5.21 (81%)
      • Georgia: 0.39 (0%)
      • India: 0.005 (0%)
      • Nigeria: 0.0003 (19%)
      To get a sense of life in the developing world, see the typical patient profiles in this paper:
      BODY ORGANS
      With body organs, we get the specter of the poor selling their body parts to rich 'medical tourists' of the industrialized West.
      BOTTOM LINE
      In effect, the low rate of organ donation by those of us in the privileged West has consequences.
      • Not only do our friends and loved ones die waiting for transplants.
      • We also unwittingly contribute to our fellow citizens prolonging their own lives by preying on the least fortunate on the planet, those so desperate that they will give up a kidney to feed their families.
      Valentine's Day has just passed and many of us showed our love of others by giving a card, a gift, etc. Can we each do more? As the song goes.... (listen along by right clicking and opening in a new tab or window)
      We are the world
      We are the children
      We are the ones who make a brighter day
      So let's start giving...
      How to Become an Organ Donor
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      Sunday, January 10, 2010

      Checklists - Simply the best? (Musings on mistake proofing)

      This blog muses on using checklists for preventing mistakes in transfusion medicine (TM). The title comes from the inimitable Tina Turner's 1989 mega-hit, Simply the best.

      The blog was motivated by an interview on Charlie Rose with Dr. Atul Gawande (see short promotional clip) about his new book:

      The book (hereafter called "The Checklist") is getting much play in the media and is being hailed as brilliant.

      What struck me was that the simple checklist and equivalent low tech mistake-proofing tools have been used in the TM laboratory for some time and more recently applied to physician blood ordering practices and nursing blood administration processes and procedures

      In a way SOPs can be considered a type of checklist. They involve procedural steps that must be completed before proceeding to the next one. For example, to check a patient history in the LIS prior to pretransfusion testing:
      1. Check for previous records using current patient name. (Check!)
      2. If record is found, compare the following information on the current request to the previous patient record… (Check!)
      3. Investigate and resolve any discrepancies (Check!) …. etc.
      SOPs gained widespread use in TM when government regulation came to blood centres and later hospital transfusion services (TS). As quality systems were adopted, the TS developed laboratory and nursing transfusion-specific SOPs.

      However, one problem with SOPs is their format, which does not correlate well with the way people learn. See Designing SOPs for Learners (Rohse & Cameron-Choi)

      As the authors note, when it comes to instructions, less is often more, which is one reason why job aids (problem solving flowcharts, visual aids, and checklists) have become important tools in the TS laboratory.

      On the wards, tools such as pocket guides were developed for various nursing functions, e.g., REACT and RESPONSE (Sunnybrook & Woman’s Hospital, Toronto).
      A related approach to making SOPs more effective was used by Berte in working with the BC PBCO to develop a provincial TMS manual, in which SOPs lack preambles and begin immediately with work instructions. (See Developmental Model)

      Although SOPS, simple checklists and other mistake-proofing mechanisms are extensively used by technologists and nurses, for various reasons these tools have been slow to reach physician training and practice in which the historical training model has been, "See one, do one, teach one":

      With this history, and even given recent advances in medical education, Gawande's case for physicians using brief checklists is compelling.

      A PubMed and web search identified a few physician-related “hits,” e.g.,

      One TS strategy targeted to physicians has been to build checklists into transfusion requisitions in the form of requiring doctors to check specified rationales for ordering particular blood components and products, as show on this order form.

      But overall, SOPs, checklists, et al., have not been widely adopted by TM physicians so far as I can determine and would welcome feedback on this issue.

      Musings

      Unfortunately, checklists, job aids, action-focused SOPs, and integrated picture / word instructions that I have seen are often too long and complex compared to the 2-minute ones discussed by Gawande. Considerable thought and expertise is required to develop concise yet inclusive checklists and their equivalents. Also, the checklist must be applied at the right spot in a process.

      Implementation problems may occur if checklists are seen as "make work" adding another layer of complexity to already stressed staff. Or they may be viewed as unneeded crutches denoting weakness, particularly by physicians as Gawande notes.

      A risk exists that checklists may lead to complacency, the same way double checking can. For example, if a nurse picking up blood from the TS lab has just seen a technologist confirm patient and donor identity against the requisition, he or she may not be as diligent in performing an independent check. The same may happen with two RNs checking donor blood unit and patient identity at the bedside prior to transfusion, which is why it's prudent to ensure that the first check picks up any discrepancies.

      So, as in the blog's title, is the simple checklist "simply the best” for preventing missed steps and increasing patient safety? As documented in The Checklist, concise checklists that include all critical steps can be lead to significant improvements.

      Of course, my question is false, since it's unnecessary to designate one mechanism as "the best" when multiple approaches have merit.

      For example, the 'cartoon' approach to SOPs with integrated text and diagrams can also help prevent errors, and seems particularly useful when equipment is involved. This is why so many "how to assemble" pamphlets use this approach, unfortunately often with too little or no text as in Ikea ("I'll keel ya!") assemblies.

      Given that multiple mistake-proofing tools are needed to accommodate different work environments with diverse procedures of varying complexity, and given that resources are finite, which tools should receive priority for development and evaluation?

      In transfusion medicine, much effort and expense has been devoted to developing technological solutions such as barcoding and radio frequency identification (RFID).
      Somehow we have come to rely, almost blindly, on technology as a cure-all for errors, most of it directed at eliminating errors associated with technologist and nursing procedures.

      Is the technology approach emphasized because we think that machines are foolproof and only humans make errors? This always amazes me because working with computers on the Internet all day, I routinely experience multiple errors made by computers, many seemingly inexplicable. Or do you believe that such errors are invariably operator error?

      Investigating simple mechanisms like checklists and SOPs for physicians who order blood occurs but has not received prominence. Perhaps The Checklist will result in some new research in this area.

      Bottom Line
      Regardless, all such mistake-proofing tools are meant to supplement, not replace, the practical training and professional development that health professionals receive as undergraduates and practitioners from their educators and mentors.

      For my money, the "simply the best, better than all the rest" influence on patient safety is the attitude of the individual health care professional. I’m biased. It’s not based on an RCT, just a lifetime of careful observation.

      Food for Thought


      Tell me, what is it you plan to do
      with your one wild and precious life?

      - from "The Summer Day" by Mary Oliver
      In an irreverent vein, to counter this lovely thought, remember this one?
      Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice.