Sunday, December 13, 2009

Stand by Me - Musings on conflict between TM professionals

Last updated: 30 Mar. 2014
This blog muses on conflict between health professionals in transfusion medicine (TM) and how to facilitate interdisciplinary teamwork. Given the holiday season, teamwork and ways to promote harmony seem fitting topics. For example, last year's December blog was titled "Let's get together and feel all right" after Bob Marley's classic, One Love.

This month's title comes from a coming-of-age movie with a great soundtrack and a song with the same name - Stand By Me.

Recent events in my home province of Alberta got me to thinking about interdisciplinary teamwork and communication in TM.

In brief, Alberta appears to be in the midst of another experiment in improving patient care or finding ways to save money, depending on your perspective. It's another because we went through something similar with "health care restructuring" in the 1990s.


This time the new 'powers that be' are promoting radical change' in who does what. Probably they want to allocate tasks to the lowest paid worker rather than rationalize who can best perform specific patient care tasks and create exemplary health care teams, but time will tell.

In Canada there is a current controversy surrounding physician assistants (added 22 Jan. 2010). Nurses oppose Ontario government's physician assistant role citing inadequate education, concerns over patient safety and unnecessary costs: 
In recent years, much ink and lip service has been devoted to promoting interdisciplinary teamwork but I wonder how much occurs overall, and in TM in particular, and how effective it is. Some of the issues are discussed in TraQ's Case O-6:
This paper cited in Case O-6 discusses physician / nurse tensions:
This resource from O-6 presents the case of an intern unable to accept advice from an experienced pharmacist:

  • Agency for Healthcare Research and Quality. One dose, 50 pills (Morbidity and Mortality Rounds on the Web)
As well, recently collegues and I have discussed INTD 410, an interdisciplinary course required of all health discipline students at the University of Alberta. As it happens, nursing students take the course later in their programs than medical students and inter-professional tensions occasionally arise, e.g., more experienced nursing students sometimes are tempted to 'gang up' on first year medical students, perhaps to retaliate for perceived or real slights on the wards or perhaps due to assimilating a culture of rivalry.

CLINICIANS vs TM LABORATORY
Over the years I have experienced, firsthand, both minor bickering and significant conflict between clinical staff (nurses and doctors) and technologists in the TM laboratory and continue to hear such anecdotes secondhand. For example, a common anecdote involves physicians (or nurses) being incredibly rude and dictatorial to lab staff who try to uphold safety standards related to patient specimen identity.

My take on this particular scenario is that the front line clinicians are likely under considerable stress treating a badly bleeding patient before their eyes and perceive the lab's "rules" as threatening the patient's life rather than being meant to save it. And it does not help if the laboratory technologist's communication of the issue appears to challenge the clinician's judgement since challenges to authority and competence are seldom viewed favorably by any health professional. Having the technologist be obsequious may be the response that the physician wants but it is not conducive to patient safety.
I briefly discussed tips for how to deal with conflict in this short article written for TraQ years ago:
Effective communication is fundamental to preventing professionals conflicts but a key cause of such conflict is the inability of each professional to appreciate the other's perspective and the realities of each work environment.

MUSINGS
The issues are complex, too complex to discuss fully in this blog. Nonetheless, below is food for thought on small ways to start to talk to each other, not at or past each other.


Educational initiatives such as the U of A's INTD 410 course and others can help. Obviously for health professionals to work as a team, they must train as a team.
Collaborative care means collaborative training

Education for interdisciplinary healthcare teams (from TraQ's Case O-6)
But what about those of us who never trained as part of a team and indeed grew up in a family where "we understood the professions as a conventional nuclear family, with doctor-father, nurse-mother, and patient-child"? (Savage & Smith)
As an aside, where do laboratory staff and other so-called "allied health professionals" fit in this cozy nuclear family of yore? Poor country cousins? Backward children kept in the basement and out-of-sight?  
Unseen servants who slave away but are seldom acknowledged even with eye contact, much as cleaning and kitchen staff are in today's hospitals or the homeless on our streets? I'll stop but you get the idea.
For those of us who trained and perhaps still work in such an anachronistic climate, and for educational programs without formal interdisciplinary courses, below are proffered suggestions for baby steps to help our sometimes dysfunctional family.

TECHNOLOGISTS / MEDICAL LABORATORY SCIENTISTS
For facilities with clinical internships, have students spend time shadowing knowledgeable and experienced nurses who administer transfusions. For example, this is done in the TM clinical rotation of MLS students, U of A where the transfusion safety officer happens to be a nurse who is also an MLS graduate.

For hospitals with or without interning technologists, have all lab staff do the same on a rotating basis. In this way, laboratory staff are exposed firsthand to the realities faced by nurses and staff get to know each other as individuals.

CLINICIANS
Medical students
As part of the often scant exposure to TM received by all medical students, transfusion service laboratories in teaching hospitals can facilitate exposure to the TM laboratory and its staff. This can be done in simple ways, e.g., at the U of A all first year medical and dental students participate in multiple, concurrent group seminars in which transfusion-related cases with TM laboratory data figure prominently.

To facilitate the many students involved, approximately two dozen volunteer facilitators are provided with notes and key learning points and supervise the cases. Besides hematopathologists and hematopathology residents, facilitators also include experienced medical laboratory technologists from the region's blood centre and hospital transfusion services.

Another positive baby step would be for TM-related cases at grand rounds to include components presented by medical laboratory technologists, nurses, and pharmacists, as appropriate.

It's in small ways such as this that interdisciplinary respect has the chance to develop.

Nurses
As for med students above, nursing students can benefit from clinically relevant lab-focused presentations involving laboratory staff as instructors and facilitators. As well, providing nurses with structured exposures* to the TS lab both during their training and afterwards could serve as the equivalent of technologists shadowing nurse transfusionists.

[* for example, experiences that stress patient and donor blood identity and the consequences of misidentification and how easily it can occur; importance of maintaining blood components in a temperature-controlled environment, etc.]
In Canada increased direct contact between nurses and technologists is facilitated via provincial blood coordinating offices and a network of regional transfusion safety officers, whose numbers include both nurses and technologists.

It's an encouraging sign of the times that the current President of the Canadian Society for Transfusion Medicine is a registered nurse.

BOTTOM LINE
Conflict is bound to occur in a work environment involving life and death. It is not a major issue in TM but nevertheless exists. Much remains to be done to break down the mental silos in which TM professionals often work and that sometimes contribute to conflict. Even small steps can help.


Like everything in life, it's hard to demonize someone you can put a face to, have learned something from, and have chatted with in a collegial atmosphere.

As the song from the movie of the same name goes,
Only then can we truly become the Champions of the Transfusion World. (grin)

As always, the views are mine alone. Comments are most welcome.

Sunday, November 15, 2009

We can work it out (Musings on public vs private health systems)

This blog muses on how transfusion medicine (TM) in the USA compares to the rest of the developed world, particulary Canada, in terms of overall cost, efficiencies, and clinical outcomes.

As a Canadian, monitoring the U.S. debate on health care is frustrating. Particularly annoying is hearing our system regularly trashed on U.S. cable shows, mostly be those who do not have a clue about Canadian health care, and occasionally by Canadian physicians heavily invested in private health care.

Of course, like any system Canada's is not perfect but it provides universal coverage (like the rest of the developed world) and we're trying to improve it.

Nonetheless, to me the lies and distortions south of the border are galling. The blog's title derives from an old Beatles tune that I hope comes true:



Don't worry - This blog is not going to delve deeply into the U.S. - Canada health care debate, where views tend to be as passionately held as religious convictions.

The idea for the blog came from this journal article & news item (featured in TraQ's November newsletter):

The journal paper made me wonder if anyone had similarly researched TM in the USA and Canada, or TM in the USA vs TM in other countries with universal health care and a national blood service in which users do not pay for blood and blood products, i.e., the public pays via taxes and the burden does not fall to those unfortunate enough to get sick and require transfusion.

There have been reports published comparing such aspects between countries as blood donor screening criteria and overall structure and organization. And Vox Sang has international forums (fora for purists), which survey the basics of blood systems around the globe and international practices on just about every type of practice, e.g.,

  • Autologous blood salvage
  • Clinical indications for various blood components
  • Hemovigilance
  • Massive transfusion protocols
  • Technical topics such as electronic crossmatching, routine Rh typing, hemolytic disease of the newborn serologic analysis
The types of studies I have in mind would compare TM-related costs, efficiencies, and clinical outcomes in various developed countries. Such costs are incredibly difficult to identify with validity. But in countries with national blood services, these figures should be determinable, albeit with many assumptions, provisos, limitations and perhaps even a glut of 'weasel words' as often appear in cost studies due to the many variables involved.
For example, Canadian Blood Services has only three testing facilities and 12 manufacturing facilities to serve all of Canada except Quebec. Canada is the 2nd largest country in the world, just behind Russia and just ahead of the USA in territorial size.
CBS's annual reports include an incredible amount of hard data:

Some tidbits from the report above:
  • Whole blood collections: 915,858
  • Staff costs constitute ~60% of total 'Transfusable Products' expenses
  • Cost per unit* for year ending 31 Mar. 2009: $377.11
  • *ratio of total expenses to shipments of all products
A few possible comparisons for international studies:

1. Relative cost of the overall blood system
We know that Canada's health system is less expensive than the U.S. system, because the administrative costs are less when there is a single payer. Indeed, The U.S. spends more per capita on health care than any comparable country. Does this apply to the blood system too?

2. Average cost per RBC transfused
In Canada, CBS and Hema Quebec collect and process all whole blood donations intended for allogeneic transfusion.What does a typical unit of RBC cost to produce in Canada and how does it compare with the same average cost in the USA, UK, Australia, etc.?

3. Utilization management of blood components and blood derivatives according to whatever clinical guidelines exist

For example, do countries with national blood services and government -supported provincial blood offices achieve equivalent or better clinical outcomes and financial savings compared to the USA? See



ADDITIONAL MUSINGS
In the mid-1990s in Alberta, the Canadian province where I reside, the government decreased financing of the laboratory system by ~40%. Among many results, students in the MLS program where I taught had difficulty finding jobs in Canada. However, because they wrote the ASCP MT exam at the end of their program, many obtained employment in the U.S., including in transfusion service labs.

Canadian grads were amazed at the U.S. system in which an incredible amount of their time was spent on what to bill for various lab tests, something that was not required in Canada. Yet this emphasis on fees and cost did not result in more evidence-based test rationales.

Grads often reported that the U.S. labs they worked in were still routinely performing tests that had been abandoned in Canada in the 70s and 80s, tests that contributed little, if anything, to treatment or clinical outcomes.

Granted, it's a small sample, perhaps the anecdotal reports of a few dozen graduates. But even so, publicly funded TM laboratories in Canada had managed to implement evidence-based test rationalization before many American counterparts.

And government programs such as the BC PBCO have made impressive improvements in utilization management of blood and blood components.

Can a public system of transfusion medicine, and universal health care in general, possibly be equivalent, or even superior to, a private one? We can no doubt work it out, eventually.

Additional Resources
For more on health care comparisons in general, see:

As always, 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. 

Saturday, October 10, 2009

Don't ask, don't tell... Time to fold 'em or bad moon rising?

It's not every day that a national blood supplier and blood donor are involved in a lawsuit involving blood, sex, duplicity, and a constitutional challenge. That's happening now in Ottawa and generating plenty of press coverage.

In brief, CBS sued a gay blood donor, Kyle Freeman, who lied repeatedly on his blood donor screening questionnaire, and the donor subsequently sued CBS and Health Canada. This blog examines the issues involved in the dueling lawsuits.

The blog offers musings on the MSM deferral policy for blood donors. Its title is a takeoff on


The Controversy
The key issue involves the MSM (men who have sex with men) deferral policy for blood donors. As described on the CBS website:

  • "...the policy excluding MSM is the subject of debate between the LGBTTQ (lesbian, gay, bisexual, transsexual, two-spirited, and queer) communities, who view it as a discriminatory policy and patient groups that depend on blood products, and who feel it is a critical safety measure."
In other words, is lifetime deferral for MSM scientifically justified to protect the blood supply because the incidence of HIV is much higher in men who have had sex with men than it is in individuals having exclusively heterosexual sex or is the policy discriminatory?
The controversy surrounding MSM policies has been widely reported, particularly protests on university campuses, which have tended to be full of passionate, hyperbolic political rhetoric, e.g.,
Note: The above SAQD pamphlet refers to the 2007 McLaughlin Report. Readers are well advised to read the original report below.
BACKGROUND
CBS, like many blood services worldwide, following the dictums of its government regulator Health Canada, bans donations from men who have sex with men, the so-called MSM policy. The CBS predonation screening question on the "Record of Donation" reads,
  • "Have you had sex with a man, even one time since 1977?"
Other Countries
MSM policies vary globally. From the CBS website:

  • Countries requiring indefinite deferrals: USA, UK, France, Germany, Switzerland, Holland, Norway, Denmark, Sweden, Finland, Iceland and Hong Kong
  • Countries with shorter deferral periods:
  • 1 year - Argentina, Australia, Japan, Hungary
  • 5 years - South Africa*
  • 10 years - New Zealand
  • Italy has a deferral based on specific activities

* According to the SA National Blood Service, the SA deferral was changed from 5 yrs to 6 mths in 2006.
The UK blood service also provides a Summary of International Policies relating to the Exclusion of Men who have Sex with Men from Blood Donation

In 2007 CBS reviewed its policy and decided to retain an indefinite deferral, effectively a permanent ban, as explained here
The UK has also recently issued a position statement on its policy:
THE COURT CASE
CBS's position on the lawsuit is provided on its website.
The main facts of the case as reported in the media:

  • CBS accused Kyle Freeman, a gay man, of 'negligent misrepresentation' for lying on the screening form.
  • Freeman then sued CBS and Health Canada for $250,000 claiming CBS violates his charter rights* and those of other gay men by asking male donors about having sex with a man.*Canada's Charter of Rights and Freedoms
  • Freeman donated blood 18 times between 1990 and June 2002 but the case focuses on the 4 times he donated following the creation of CBS in 1998, i.e., between June 1998 and June 2002. (Canada's blood supplier prior to 1998 was the Canadian Red Cross.)
  • In June 2002 Freeman sent CBS anonymous e-mails admitting he lied on the questionnaire.
  • CBS attempted to get his Internet service provider to reveal his identity.
  • Freeman's blood donor screening HIV tests were negative but he has had gonorrhea and late latent syphilis.
For more details, see TraQ's news reports.
Interested Parties
Two other organizations have weighed in on the case:
The Canadian Hemophilia Society has 'intervenor status' in the case. CHS supports the position of CBS and Health Canada in maintaining the current MSM donor deferral criteria. Individuals with hemophilia were devastated by the tainted blood scandal of the 1980s, as documented in the Krever Report and elsewhere.


The Canadian AIDS Society will appear as a 'Friend of the Court.' It contests the constitutionality of the lifetime deferral on
men who have sex with men and proposes an amendment.

THE DEBATE
Below are the arguments on both sides of the MSM policy.
USA

This document outlines the AABB, ABC and ARC position: They believe that the deferral period for MSM should be consistent with deferrals for those judged to be at risk of infection via heterosexual routes. i.e., 12 months.



CANADA
UK
Debate in the British Medical Journal:
BOTTOM LINE
If current blood donor screening tests for HIV and other agents leave no residual risk for transmitting infections then there would be no need for intrusive screening questions about high risk behaviors, i.e., a policy of Don't ask, don't tell.
Obviously there is some residual risk, albeit small, that make predonation questions essential.

The McLaughlin Report concludes this about MSM deferral periods:
  • Available evidence strongly suggests that a 1-yr deferral would "almost certainly give rise to an incremental risk of transfusion-transmitted infection"
  • Evidence is less clear for a 5- yr or 10-yr deferral partly because "current level of residual risk is so low that there are, inevitably, substantial ranges of uncertainties associated with the risk estimation."
  • "...there is no firm evidence that such a change in the deferral period ...would result in an incremental level of risk, although the possibility of a small increase in risk cannot be entirely ruled out."
  • "Under these circumstances, other social policy issues, relevant to the idea of changing the deferral period for MSM, become worthy of additional consideration."
This excerpt from the Report is instructive:
  • Therefore, would ...changing the MSM deferral period to 5 years pass the risk hurdle successfully? In the end, this is a matter of judgment, that is, a matter on which reasonable people may disagree.
  • What we can say with some assurance is that, at the very least, it may provisionally pass the risk hurdle. In other words, it is “within the ballpark” for discussion.
  • As a result, it is fair to ask if there may be other types of benefits that are likely to flow from making this policy change...
  • (1) ...possible impact on the size of the future donor pool, and
  • (2) ...potential social benefit attendant upon reducing the perceived stigma associated with homosexuality.
So....let's shorten the deferral for MSM to potentially get more blood donors and lessen a social stigma. And this based on a judgement on which reasonable people may disagree and is within the "ball park" of acceptable risks. Hmmmm......
The McLaughlin Report says that health risk data are equivocal and constitute very small risks so let's consider other worthwhile goals.

I'm always uneasy when someone suggests blood safety changes based on cost effectiveness or on politically expedient issues such as lessening social stigmas. Despite the clear desirability of such goals, patient safety should be the overarching, if not sole, determining factor.

The Gambler's wise advice is that you got to know when to fold 'em, know when to hold 'em.

Will the FDA, Health Canada and blood suppliers like CBS decide to fold 'em and change the lifetime MSM deferral policy to a shorter period?

Ladies and gentlemen, place your bets.

I see a Bad Moon Rising if changes to blood safety policies are based on pressure from activists as opposed to evidence of no incremental risk, accepting that zero risk is impossible.

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





Wednesday, September 09, 2009

Ghostwriters in the sky and kickbacks: Through a glass darkly?

This month's blog is a takeoff on a classic 1950's song, Riders in the Sky (aka Ghost Riders in the Sky), recorded by Vaughn Monroe and more than 50 others. (Note: I recommend that you right click on all links and choose Open in new tab.)
The blog is a protest of sorts. Do you ever feel like protesting? Or are we all so cynical in the 21st century that we accept shady practice as standard practice?
The focus will be on these items in TraQ's September newsletter:
  • Ghostwriting of scientific papers in industry-initiated papers
  • Pfizer, the world's largest drug company, fined for illegal marketing and kickbacks to physicians
GHOSTWRITING
In its simplest form, ghostwriting occurs when someone has significantly contributed to writing a paper but is not mentioned in the paper. In universities this is know as plagiarism and can result in serious consequences, including student expulsion. In the world of medical research it seems to be business as usual.
Examples
Earlier this year Merck was accused of ghostwriting and even producing its own "medical journal".
Apparently, it is not uncommon* for drug companies to have favorable papers about their products ghostwritten internally or contracted out, then published under the names of willing physicians who receive 'honoraria': (* not uncommon, an example of a litotes, a new word I learned this year, courtesy of my pal, RMC)
The Glaxo news article is instructive. The reporter writes:
  • An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.
  • Direct quote from the memo: “Physicians will be eager to participate ... regardless of their professional stature.’’

And as the TV infomercial hucksters shout, "Wait, there's more...."
ILLEGAL MARKETING AND KICKBACKS
In a nutshell, according to news reports, Pfizer
  • Pleaded guilty to promoting the painkiller Bextra (withdrawn in 2004) for uses that were not approved by regulators
  • Settled civil allegations regarding kickbacks to doctors who prescribed other drugs, although Pfizer denies these charges
News Items
  1. Pfizer receives biggest criminal fine in US history for mispromoting drugs & paying kickbacks
  • $2.3 billion is 4th fine of Pfizer or a subsidiary since 2002 over illegal marketing
  • Pfizer Fact Sheet (US govt)

  • Yes, they paid a $2.3 billion fine (that's a B for BILLION). Speculation is that the fine was so large because the practices had occurred over time with no change in behavior despite earlier fines.
    THROUGH A GLASS DARKLY?The unseen players in all of this are the physicians who lend their names to papers they never wrote and who accept kickbacks, as in this March 2009 report in the NY Times:


    All these stories made me speculate that we may be viewing our world 'through a glass darkly' (Bible, New Testament, 1 Corinthians 13:12). Are we looking into a dark mirror that poorly reflects the true situation?

    Us versus Them?
    I wonder if transfusion medicine professionals have ever tried their hand at ghostwriting for so-called 'honoria' or taken kickbacks for prescribing or promoting products such as IVIG and erythropoietin?
    If not blatant kickbacks, how about
    • sponsorship of research?
    • support for blood conservation programs?
    • a consulting position?
    • funds to travel to conferences, whether speaking favorably about the product or not?
    • or who knows what else?
    Of course, research sponsorship and other program funding are not in themselves wrong, indeed they are welcome. It's only if the support influences outcomes, which is why medical journals have moved to more transparent forms of disclosing conflicts of interest and competing interests. Readers are left to judge whether or not funding has influenced a study.
    The news items above describe clear cases of unethical physician behavior that could result in a doctor losing a license to practice. But ethical lines can become very fuzzy once we accept even simple perks that slowly lead to more and more entanglement with commercial interests, no matter how seemingly benevolent at first.
    Moreover, is it only 'them' or does it include 'us', members of the transfusion medicine community? Are we looking through a glass darkly?
    LIGHTEN UP TIME
    These current news items remind me of Sackett and Oxman's spoof on how doctors can grow rich pimping for drug companies:

    In that vein, here's a fun ditty and a feel-good song that expresses a wish for all of us:
    As always, the views expressed 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. 

    Addendum
    Please see the comment below. It's satisfying to get some feedback and I encourage others to comment too.

    Thursday, August 06, 2009

    Musings on Peter and Dilbert Principles: Thinking outside our little boxes

    Last month featured a tongue-in-cheek characterization, sight unseen, of a new journal, the Journal of Blood Services Management or JBSM. This blog is a follow-up on JBSM, now that I have read the journal's first issue.

    As someone who creates transfusion-related case studies, including those in soft sciences* such as management and education (e.g, Case A8: Severe hemolytic transfusion reaction involving a student), I was naturally drawn to the journal's case study.


    * disciplines based on qualitative (not quantitative) analysis of data or research that uses more subjective and difficult-to-control measures and designs and depends on conjecture
    Each issue JBSM will feature a fictional case based on real events with analysis by invited blood center managers and others. The purpose of the cases is to foster professional development for new and experienced managers.

    "The Case of the Overworked Technical Director"
    The first case—The Case of the Overworked Technical Director—illustrates the challenges that can occur when employees with technical backgrounds make the transition to management. Based on the discussion, the case could just as easily been called "The Case of the Incompetent Technical Director."

    I encourage readers to obtain a copy of JBSM to review the case in depth.

    In brief, CM, a lab technologist with 12 years experience at a blood center, has been in the job of Director of Technical Operations for 6 months with responsibility for four areas: testing, manufacturing, hospital services, and the reference lab. He is performing poorly. He is late with numerous managerial reports, budgets, performance evaluations, etc., and spends time on the bench after hours and on weekends helping out with three unfilled staff vacancies.

    The JBSM editor invited three people** to analyse the case by responding to these questions: What do you see as the problem in this case? What advice would you give CM's immediate supervisor, the blood center Chief Operating Officer (COO)?



    ** two presidents & CEOs of blood centres and a member of the US Army's Medical Service Corps taking a PhD
    The commentators have much to say, which can be distilled to
    • set clear performance expectations and provide timely feedback for failures
    • reinforce confidence in the person
    • provide training, coaching, and mentoring
    • reassign if performance does not improve
    Musings on the JBSM Case Study

    The case's commentators present the standard menu of how to improve staff performance. Moreover, they take it for granted that managers are expected to set priorities and meet deadlines regardless of events around them.
    • No one questioned whether the facility was understaffed and if there were casual or part-time staff whom CM could ask to cover vacancies until they were filled.
    • No one wondered whether the center's organizational chart had significant gaps at the supervisory level and whether there were supervisors between CM and the trench workers who could be asked to help prepare reports.
    • No one discussed whether the COO performed incompetently by not providing adequate expectations, feedback, and training and allowing this to continue for half a year. They said that the COO "should have" set expectations, etc., but that's as far as they go. Perhaps the COO needs training?
    • No one asked if the CEO knew that the COO had been ignoring a problem for 6 months.
    It's somewhat ironic because blood centers must have a quality system in place whose quality system essentials include personnel, their duties, training, and competency assessment. Top managerial staff such as COOs, it seems, escape the same scrutiny that middle managers and front-line technical workers experience.
    When things go wrong, those at the top often tend to focus on the failings of those at the middle and lower echelons without questioning the related performance of top managers, i.e., themselves. It's human nature but not productive. Dilbert's view:
    The commentators also tended to focus on the individual and his shortcomings rather than considering a root-cause-analysis approach to assess if there were systemic failings in the organization. In this case, it's likely that there are systemic problems.

    Musings On Incompetence in General - The Peter Principle (PP)
    This case models the PP developed by education professor Dr. Laurence Peter that "every employee tends to rise to his or her level of incompetence."

    Peter's Corollary: The PP has a corollary, roughly stated as,

    "In time, every position tends to be occupied by an employee who is incompetent to carry out duties and thus work is accomplished by those who have not yet reached their level of incompetence."

    In the TM lab world the PP is seen in two areas:
    1. As in this JBSM case study, technical staff who are promoted to management on the basis of longevity and a history of sound technical performance, regardless of leadership, managerial, communication, and people skills.
    2. Pathologists, sometimes anatomic pathologists with little or no clinical pathology training and experience, and PhD scientists who direct and manage clinical laboratories and blood centres, regardless of any aptitude for, or education in, management and leadership.
    If blood centers in the USA are a business, albeit non-profit ones, are those at the top knowledgeable about financial management, marketing of services, competing for investment capital, and other business basics as discussed at an NFB Leadership Forum in April (reported in the June 2009 issue of AABB News)?
    As for management and leadership skills, think of all the pathologists and PhD level doctoral scientists that you know who direct blood centres and clinical labs. They are usually very competent physicians and researchers. But what about management skills? For example:
    • Do they typically have strong interpersonal and people management skills?
    • Exemplary oral and written communication skills, which includes listening not just telling?
    • Are they good motivators of people?
    • Team players who value the experience and expertise of other health professionals?
    • Passionate about the vision they see for the organization, a vision that captures the imagination of employees?
    Upper level executives need both management and leadership skills, preferably both and especially the latter. My experience is that there are a few gems out there, superstars who have all of the above and more. But many pathologists and PhD scientists in leadership positions ... not so much.
    Just like technical staff, MDs and PhDs were not educated and trained in these skills and are unlikely to gain them by osmosis from merely being in the job.
    BOTTOM LINE
    Challenges can occur when employees with technical backgrounds make the transition to management AND also when employees with clinical and scientific backgrounds make the transition to management.
    • Incompetence is an equal-opportunity failing that knows no professional boundaries.
    • Our little boxes, whether technical, medical, or scientific should not constrain us from examing the big picture and critically analysing our role in contributing to any systemic management problems.
    Dilbert Principle (DP)
    When discussing the PP and incompetence, one cannot help but mention the DP, a satirical observation by Scott Adams that companies tend to promote least-competent employees to management to limit the damage they can do. In the Dilbert strip of February 5, 1995 Dogbert expresses the DP in its extreme:
    Just for Fun: A few of my favorite Dilbert strips
    Multitasking (Aug. 3, 2009)
    First human to fail the Turing Test (Mar. 30, 2008) [ Turing test ]

    Passwords for morons (Jan. 17, 2007)

    Joy of training (Dec. 26, 2006)

    Abuse of meetings (Aug. 16, 2004)

    Dealing with managers (Aug. 7, 2003)
    How to thwart useless meetings (Aug. 26, 2001)

    LITTLE BOXES
    Finally, here's an old ditty sung by Pete Seeger, an American folk music legend.
    As always, the views expressed 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. 

    Saturday, July 11, 2009

    "Transfusion lite" - Back in the USSR?

    This blog is a provacative sendup of a new journal affiliated with the AABB.

    In the July issue of Transfusion AABB announced a new journal, The Journal of Blood Services Management, in an editorial by Paul M. Ness and Philip D. Schiff: "The Journal of Blood Services Management, a new administrative focus for TRANSFUSION":

    The JBSM will include a broad spectrum of organization and management issues facing blood service managers. Topics will include financial management, supply chain management, LEAN/6 Sigma, regulatory matters, manufacturing management, donor recruitment, public relations and communications, information technology management, hospital and customer relations, governance matters, international issues, services within hospital-based blood services, tissue program management, risk management, competition, leadership, and general medical and technical service management.

    I have not read the first issue because it is not available on the web and I have not yet received my paper copy of Transfusion. It's always late for some reason, maybe due to residing in Canada?
    The new journal (JBSM - sorry, I could not resist the emphasis) is a collaboration between AABB and Group Services for America’s Blood Centers (GSABC).
    The GSABC mission statement:

    • "To create a stakeholder-driven group purchasing enterprise that more effectively serves the members of America's Blood Centers"
    From JBSM overview (on the GSABC website)
    • The Journal of Blood Services Management will be the premier journal for thoughtful leaders in blood center and transfusion service management.
    Articles will generally fall into two broad categories:
    1. Those grounded in theory and/or papers using scientific research methods....
    2. Those focusing on innovative blood service management approaches that are based on well reasoned-extensions of existing research, experiential knowledge, or exemplary cases (e.g., thought pieces, case studies, top executive interviews).
    The journal wants articles that are "engaging, lively, challenging, and stimulating." I particularly liked this tidbit:

    We recognize that many potential authors may be intimidated at the thought of writing for a peer reviewed Journal. We wish to reassure these authors that the editorial staff is willing to assist in any way possible to help you write a paper for submission. For those who have never written a paper for peer review, you may wish to think of it as nothing more than writing a “term paper”.

    "Nothing more than writing a term paper" is an interesting choice of words, given that the journal is targetted to "thoughtful leaders."
    I am confident that most AABB members, including me, will thoroughly enjoy JBSM:
    • I like thought pieces and approaches that use experiential knowledge, which are more or less the equivalent of blogs like this one. No need to use scientific research methods and worry about solid evidence.
    • Papers will be more practically oriented, hence more relevant to those who work in the TM trenches beyond the research milieu of academia. Many Transfusion papers remain unread for various reasons, including content that is perceived, rightly or wrongly, as irrelevant to practice and content that is beyond the reader's knowledge base.
    CONCERN
    Despite being keen about a new transfusion journal with promising content, I cannot help but wonder if the appearance of JBSM is yet another baby step on the long journey to making financial concerns and cost efficiencies paramount in transfusion medicine.
    Transfusion medicine as a business is also featured in the June 2009 issue of AABB News, which includes a report on an NFB Leadership Forum held in April in Florida:
    • NBF leadership forum focuses on innovating for the future

    According to the report, attendees at this private meeting discussed issues that would be at home on the programs and in the board rooms of any business or industry. Speakers included industry leaders from
    • Ortho-Clinical Diagnostics
    • GE Healthcare
    • Haemonetics
    • Fenwal
    • Bay City Capital (venture capitalists)
    • ITxM
    • Florida Blood Services
    • Puget Sound Blood Center
    • AABB
    • ARC
    Advice included recommendations to
    • Examine the potential for partnerships, mergers, and outsourcing
    • Implement lean strategies to decrease waste
    • Focus on productivity indicators
    • Diversify income
    • Centralize compatibility testing
    • Compete against other health sectors for investment capital
    • Develop technologies that reduce labor and reagent costs
    Recommendations more clearly TM-related with direct clinical implications were to develop blood utilization programs and transfusion guidelines.
    Oh, yes, "and we must remember the donors and patients because that is who we are trying to serve." (Jim AuBuchon, President and CEO of PSBC)
    As has been noted in earlier blogs, as the economy has worsened, papers that promote cost analysis as a primary driver of TM policies such as donor testing have become more common. Patient safety always enters such cost-focused papers and presentations but almost always as an after-thought or a robotic mantra unrelated to the actual take-home messages.
    QUARTERLY PRAVDA? (Pravda definition)
    JBSM's scope fits rather nicely with the ideas expressed at the NBF leadership forum. It could serve as a propaganda arm of the GSABC, AABB, and NFB. Thought pieces and interviews on financial management, LEAN, and competition could easily promote ideas currently favoured by 'captains of industry'.

    Ah, but what about peer review, you say. Well, peer review of traditional scientific papers has been criticized for years:


    Particulary troubling is the long trail of evidence that demonstrates that peer reviewers are often biased toward papers that affirm their own convictions.
    Where does this leave peer review of non-research based papers such as thought pieces and interviews of TM bigwigs?
    As a political analogy (try to jettison your own biases on this topic), think of former US VP Dick Cheney holding forth on his favorite theories and world view:
    • Who among George W. Bush's cabinet, aides and other 'true believers' is going to be the bearer of bad news that the VP's views do not stand the test of evidence?
    • There is Colin Powell, but we know what happened to him.
    SUMMARY
    JBSM promises to be an interesting addition to the transfusion literature. I could have joined the crowd and praised its appearance instead of giving it this tongue-in-cheek critique and calling it Transfusion lite and raising the possibilty of its use as a propaganda tool. But that would not have been thought-provoking or challenging, virtues praised in the new journal's overview.
    FOR FUN
    • Paul singing "Back in the USSR" (Red Square, 2003), only possible after the fall of the USSR
    • CD has wonderful scenes of joyous Russians reacting to the once fobidden music


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

    Addendum to last month's blog: "Plus ca change, plus c'est la meme chose (Where are the Hearts of Gold?)" (Musings on why publishers charge for celebrating the dead)

    Saturday, June 06, 2009

    Plus ca change, plus c'est la meme chose (Where are the Hearts of Gold?)

    This blog is about how journal publishers are so concerned with the bottom line that they cannot see the forest for the trees. It's another riff on the cost of obituaries in scientific journals, i.e., musings on why publishers charge for celebrating the dead.

    In Jan. 2006 I wrote a blog titled, The cost of an obituary in Transfusion.
    Transfusion medicine giant, JJ van Loghem of the Netherlands, died in 2005 and his obituary was featured in the Nov. 2005 Transfusion. I wanted to include van Loghem's obituary (giving full credit to Transfusion) on a website for transfusion professionals.

    The publisher at the time, Blackwell Scientific, had a link to "Order permissions", which brought up the Copyright Clearance Center from which you can choose to distribute an article in several ways and get a "quick price." The CCC charged $306 US to put the obit on a website, about $355 CDN then, and $31 US to send it in an e-mail to one person. The cost for the obituary was the same as for any scientific paper.

    Well, another TM giant has died, Charles Salmon of France and his obituary is in both the May 2009 issue of Vox Sanguinis (ISBT) and the June 2009 issue of Transfusion (AABB). Blackwell Scientific merged with Wiley in 2007 and Blackwell's journals are now available via Wiley Interscience.

    Being an AABB member I have online access to Transfusion but, curious about the current cost of viewing an obituary, I registered as a non-subscriber at Wiley and investigated 24-hr access to the obit.

    Bottom line - the cost to read the obit for personal use was ~$35 CDN. I cannot find any information on the cost of republishing it on a website.

    As mentioned in the earlier blog, the Nov. 2005 Transfusion had an editorial on the movement towards open (free) access to published scientific literature and the competing reality that publishing quality journals is costly. The editorial focused on the NIH policy requesting recipients of NIH funding to deposit on PubMed Central (free access to all) the author's version of an accepted manuscript produced with NIH support within 12 months of publication and what that meant for authors submitting papers to both Transfusion and PubMed Central.

    The authors ended by noting:


    AABB, Blackwell Publishing, and TRANSFUSION editors have been discussing open access, and the Journal may introduce options in the future to make authors' work available in an additional open archive. Although it is clearly attractive to gain wider exposure for articles via public access, we must carefully weigh the pros and cons of such exposure to ensure that any negative effects on the Journal are minimized. We urge TRANSFUSION authors and readers to remain awareof these evolving developments and to participate in the lively dialogue that is likely to continue in the coming years.

    To my knowledge, the new publisher Wiley Interscience does not make research papers from any of its journals available in an open archive. Not even celebratory obituaries.

    As the French say, Plus ca change, plus c'est la meme chose.


    As I wrote 3 years ago, it seems wrong to pay to provide a wider distribution to an obituary that pays tribute to a great TM pioneer. It's not as though reproducing the obituary would deprive the authors of their livelihood or impact the publisher's revenues.

    Here's a short excerpt from the Charles Salmon's Transfusion obituary by Jean-Pierre Cartron and Philippe Rouger (which I believe falls under US copyright "fair use"):



    At first austere, sometimes quite terrifying at some meetings, Charles Salmon was in fact a simple and very warm man. Charles Salmon has always been able to listen, advise, guide, and sometimes scold those who have had the chance to know him. We cannot name all his staff as they are numerous, but many have contributed significantly to the research he has initiated and all are deeply grateful for what he has given them and the time he spent with them. He was a demanding master, but also an example of scientific rigor.

    FUN DIVERSION
    A sometimes terrifying man, who was a warm man.... Reminds me once again of the cliche that you cannot judge a book by its cover.

    Just for fun, an instructive example of a book cover being misleading is this comparison:



    Which song rendition of this sultry, sexy blues song is better?

    BOTTOM LINE

    Back to Wiley Interscience being incapable of nuance, being unable to offer an obituary of a great TM pioneer for free. Such content, celebrating a life of contributions to the field, falls outside Transfusion's aims and scope as well as those of Vox Sang.


    Wouldn't it be great if young TM professionals, those unable to pay for society memberships or journal subscriptions, or not lucky enough to have free access to medical library holdings, could read about the life of such pioneers?

    If freely available, other websites could link to the obituaries and create an exponential readership. Yet the publisher makes no concessions.

    As Canadian Neil Young might say, it's an apparently endless search for A Heart of Gold.

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

    Saturday, May 09, 2009

    Sweet dreams are made of this...

    This blog muses on how to access reliable information needed for professional practice.

    As the old Annie Lennox song goes, Sweet Dreams are made of this .... everybody's looking for something.

    After reviewing some of the more reliable resources, the blog will identify and recommend one resource that is freely available to all and offers high quality advice on an endless variety of issues by a range of international experts - la crème de la crème for practical TM advice.

    Where can TM health professionals, including medical technologists, nurses, and physicians, access high quality information beyond their immediate circle of friends and colleagues, who frankly may not be the best sources? Obvious resources include

    1. Transfusion-related journals, requiring subscriptions except for those on PubMed Central, including:

    2. Published literature on PubMed, again requiring subscriptions or access via local medical libraries that offer access to health staff
    3. Cochrane Library, free in many countries
    4. Major TM association sites, "anchor websites" as I call them, but many resources are limited to members
    5. Government-associated websites, inc. national blood transfusion services (small selection - many more exist)
    AUSTRALIA

    CANADA

    UK WITHER ADVICE YOU CAN COUNT ON?
    But what about reliable advice related to specific issues that may not be covered in published papers or available on websites? Frankly, many if not most, of the practice-related questions that arise can only be answered by consulting colleagues with relevant experience and expertise.

    So, how to access the experts? Today it's especially important to tap the knowledge that is seldom found in textbooks or research papers, including tacit knowledge that professionals may not even realize they have.
    Many professional associations offer informal consultation, but only to members, via forums such as the
    Several mailing lists exist, such as two that I manage:
    • "transfusion" (moderated bilingual list of Canada's TSOs)
    • MEDLAB-L, the largest English language mailing list for lab professionals in all disciplines, which is semi-moderated and has many subscribers who specialize in transfusion medicine
    There are also independent start-ups such as Blood Bank Talk (unmoderated)
    Crème de la Crème
    In my view the best resource currently available for TM professionals to obtain high quality advice is the
    Editor and Moderator is Ira A. Shulman, MD, with help from Assistant Editor and Moderator W. Tait Stevens, MD.
    Anyone can subscribe to the e-Network Forum newsletter, which alerts subscribers to new discussion topics.
    So what makes the CBBS e-Network Forum such a valuable resource? In my view its key strengths include
    • Submissions are edited and moderated by TM experts, resulting in a high signal to noise ratio, which is critical to busy professionals

    • Moderator Ira Shulman, who was an early adopter of Internet technology as a tool for TM professional development and has a built-in heat seeking missile for "spotting a rat at 50 paces"

    • Range of worldwide experts who subscribe to the e-Network Forum and respond to question - Subscribers include Yanks, Canucks, Brits, Kiwis, Aussies, and more, including some of the "leading lights"

    • Participants may be identified or anonymous, but if the latter, enough information is divulged to specify location at a minimum, and often more such as profession and position

    • Easy to use interface, with an effective search utility



    As the Annie Lennox "Sweet Dreams" lyrics go,
    Sweet dreams are made of this.
    Who am I to disagree?
    I travel the world and the seven seas
    Everybody's looking for something.

    Some of them want to use you.
    Some of them want to get used by you.
    Some of them want to abuse you.
    Some of them want to be abused.
    If you subscribe to the CBBS e-Network Forum newsletter, you will not be used or abused. Without subscribing you can still access a fabulous resource for your every day transfusion practice dilemmas just by visiting the website..

    For interest, there is another "Sweet Dreams," this one by American country legend, Patsy Cline.

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

    Thursday, April 09, 2009

    "Boogie Woogie Bugle Boy Of Company B" - Back to the future!

    Transfusion medicine colleagues - get ready for a sea change:
    The tide has finally turned. All the griping heard over the years about ineffective and costly measures to protect the blood supply will soon bear fruition. Something will finally triumph over the impossible desire for zero risk and the associated measures that were implemented and fueled by the HIV and HCV tragedies of the 1980s and '90s.

    How do I know?

    The April issue of Transfusion has no less than 5 papers that discuss
    • tests that have outlived their usefulness
    • ineffective donor deferrals
    • proposed measures that are over-kill
    These papers continue the drum beat of two papers discussed in earlier blogs:
    (i) "The Rapa Nui caveat" in the Feb. 2009 issue of Transfusion, which argued for a more flexible approach to the precautionary principle, an approach that did not defer and turn off younger donors who could spread their discontent via social networking, and called for a national workshop to review donor restrictions.
    (ii) "Cost-effectiveness analysis: what it really means for transfusion medicine decision making" in the Jan. 2009 issue of Transfusion Medicine Reviews, which proposed using cost effectiveness as a key driver of decisions on donor safety measures.
    This blog will briefly and selectively review the growing drum beats for modified blood donor screening in the April Transfusion. I call it, "Boogie Woogie Bugle Boy Of Company B - Back to the future!" The blog presents musings on scrapping several blood donor screening tests and policies.
    Obtaining a complete understanding of each paper's nuanced content will require reading the originals, which are rich in details not presented here.
    Reader Challenge - Identify the Real 'Perp'
    As you read, determine what you believe is the 'something' that is primarily responsible for the current increasing calls for a major shift in donor screening, namely scrapping several existing tests and policies. Why is there a push on now? Potential answers are sprinkled throughout the papers, much like clues and red herrings in a mystery novel.
    THE PAPERS
    Paper #1 (Research paper)

    Goldman M, Xi G, Yi Q-L, Fan W, F. O'Brien SF. Reassessment of deferrals for tattooing and piercing. Transfusion 2009;49(4):648-54.
    Today, tattoos and piercing are increasingly frequent in donors. After Canada decreased its deferral period for tattoos from 12 to 6 months in 2005, Goldman, et al. conducted a study to determine the prevalence of tattoos and piercings in donors, the impact of the decreased deferral on viral marker rates, and changes in blood availability.
    They found the following donor rates (% performed in the past 6 mths):
    • Tattoos - 14% (0.4%)
    • Pierced ears - 54% (0.7%)
    • Piercings of other body parts - 10% (0.3%)
    Transmissible disease test results were unchanged (21.6 versus 19.2 per 100,000 before and after). The number of tattoo- and piercing-related deferrals declined by 21% and 32%, respectively.
    Their conclusions:
    • Data suggest that donor deferral for recent tattoo or piercing contributes little to blood safety in Canada, since decreasing the deferral period did not change the TD marker rate.
    • The value of other temporary deferrals should similarly be reassessed.
    Paper #2 (Research paper)
    The authors used the American Red Cross (ARC) database to demonstrate that a confirmed positive serologic test for syphilis (STS) would have detected zero new HBV, HCV, or HTLV infections among more than 3 million fully tested repeat donors during 2006 - 2007. They estimate that STS might identify approximately 0.1 HIV 'window-period' (w-p) donations every 2 years among ARC donors.
    Conclusion - the current surrogate value of the syphilis test appears to be negligible.
    Paper #3 (Editorial)
    • Katz LM. A test that won't die: the serologic test for syphilis. Transfusion 2009; 49(4): 617-9.
    This editorial reviews the long history of screening donors using an STS. Introduced in the 1950s, STS has survived as a surrogate test for other transfusion-transmitted diseases, despite the multitude of additional tests and policies that identify T. pallidum infection in donors.
    Katz reviews the many reasons why the continued use of STS as a surrogate test makes little sense. He also contends that surrogacy is no longer the driver for continued STS donor screening. Rather the test remains entrenched due the TM community's inability to prove a negative, namely that transfusion-transmitted syphilis will not occur if the test is removed.
    Moreover, although the direct cost of donor STS screening is trivial, the cost of the test's non-specificity is substantial, resulting in needless destruction of 1000s of blood components annually. Other approaches that he sees as similarly wasteful include
    • Deferral of tens of 1000s of US donors for tourist travel to Mexico for a tiny malaria risk
    • Year-round WNV testing
    • Opting for near universal testing for infection with T. cruzi
    Paper #4 (Review)
    The authors review human prion disorders, the etiology of vCJD, vCJD cases in transfusion recipients, the precautions taken to reduce that risk, potential future safety precautions such as filters and a test, and all the uncertainties therein.
    Some of their interesting assertions:
    • Study of transfusion-transmitted (TT) vCJD is difficult given that it requires transfusion traceability of 10-30 years, perhaps almost as long as the human life span.
    • Even if TT vCJD becomes a certainty, transfusion benefits greatly outweigh any risk.
    • Never before have so many measures been taken in transfusion medicine to counteract a risk that is numerically so low, some taken even before the first case of TT vCJD had been reported.
    • The precautionary principle has not just gone into the law: it has also penetrated the senses.
    Paper #5 (Editorial)
    • Menitove JE. Accepting donors with tattoos and other in-favor changes. Most of the change we think we see in life is due to truths being in and out of favour. (The Black Cottage—Robert Frost 1914). Transfusion 2009; 49(4):615-6.
    Menitove's editorial initially comments on Goldman's tattoo / piercing study but then discusses the broader issue of scientific truths being in and out of favour.
    Three arguments are particularly instructive:
    • Patient and donor safety remain priorities but since 2008 it is unquestionably "in favor" to use dollars wisely. The USA should adopt selective testing strategies. i.e., test donors only once for T. cruzi rather that test every donation, discontinue syphilis testing, and investigate selective testing for HTLV antibodies.
    • Tension between evidence-based decisions and those based on the precautionary principle, both are in vogue and seemingly diametrically opposed, confound the discussion. Perhaps the emerging change in [USA] national politics to pragmatism and empiricism will reengage efforts to resolve this disconnect and permit acceptance of some risk.
    • Patient and donor care are primary concerns, but indifference to economics will stifle growth and discourage investment. Dialogue with emerging suppliers must emphasize long-term opportunities in transfusion medicine and cellular therapies.
    Conclusion: Today's challenging climate presents an opportunity to bring about significant change and accept more risk. Sufficient future donors and dollars will not meet patient needs unless we reevaluate and revise truths longing to be in favor.

    MUSINGS

    A few random musings on these papers:
    #1. Today, tattoos and piercing are increasingly frequent in donors and constitute a significant cause of deferrals among young blood donors, who are desperately needed to keep the system sustainable. Goldman and colleagues provide evidence for safely decreasing the time deferral on tattoos and body piercings.
    Note that tattoo parlors still present a potential risk of transmitting infectious diseases:
    #2. Zou et al. provide evidence that syphilis testing, retained mainly as a surrogate for other infections, has little value as a surrogate for HBV, HCV, or HTLV infections, although in the USA it could perhaps detect 1 HIV w-p unit every 20 years.
    So many syphilis studies, so little action, and as Katz notes in his editorial:
    • It's impossible to prove a negative, i.e., no STS, no transfusion-transmitted syphilis, which perpetuates inefficient tests and policies.
    Lumping in other tests and policies such as malaria deferral for travel to Mexico, screening for WNV year-round, and near universal T. cruzi testing as similarly ineffective and costly seems almost anecdotal, given that the author did not provide much, if any, evidence to support these contentions.
    #3. Lefrère and Hewitt bemoan the example of safety precautions for TT vCJD, claiming that "never before have so many measures been taken in transfusion to counteract a risk that is numerically so low."
    I am reminded of Churchill's words about RAF fighter pilots during the Battle of Britain in WWII:
    • Never in the field of human conflict was so much owed by so many to so few.
    As applied to TT vCJD, this would perhaps become,
    • Never in the field of transfusion medicine was so much owed by so few to so many.
    Lefrère and Hewitt's point is that vCJD precautions are over-kill given the rarity of the condition.
    It's worth recalling that the once orthodox position of TM experts was that the human form of "mad cow disease" was not transmitted via transfusion, that is until the discovery of vCJD in 1996 and the first transfusion-associated case of vCJD reported in 2003.
    For a superb examination of the complex issues involved in implementing a test for vCJD, see:
    #4. Menitove's editorial initially comments on the tattoo / piercing study of Goldman, et al. but then discusses the broader issue of scientific truths being in and out of favour.
    In a way, Menitove is talking about the concept of scientific paradigm shifts as first postulated by Thomas Kuhn in The Structure of Scientific Revolutions, but on a much smaller, even minuscule, scale.Okay, it's a stretch, but I've been wanting to get the cliche paradigm shift into one of these blogs for a long time.
    The fact that today hepatitis C is no longer significantly associated with tattoos is not so much a truth that has fallen out of favour as a truth that is no longer valid. Truths change when enough evidence points to their fallacy. Truths being in and out of favour implies that they are still valid but no longer popular with the scientific community.
    The precautionary principle (PP), evidence-based medicine (EBM), and cost-effective analysis can be in and out of favour, but truth, not so much.
    PP vs EBM?
    Menitove also sees the PP and EBM as diametrically opposed competitors for making decisions. To me, the conflict is not as extreme.
    First, there is not much in transfusion medicine that is evidence-based. Many of our practices reflect historical precedent, physician beliefs and preferences based on their teachers, and happenstance.
    To protest strongly that a particular donor deferral policy or screening test is not evidence-based is disingenuous, given that hardly any transfusion practices are. And it's not as if needless transfusions do not cause significant harm and cost vast sums of money. That said, two wrongs do not make a right.
    Second, the PP does require some evidence, just not higher level evidence. The principle implies that there is a responsibility to protect the public from harm if research discovers a plausible risk, especially if it is a severe risk. But the proof of harm need not be certain, and cause and effect do not need to be fully established. Indeed, for serious threats, lack of scientific certainty should not be a reason to postpone preventative interventions.
    Many transfusion risks constitute plausible and serious risks worthy of applying the PP. Surely we are obligated ethically to apply interventions that help prevent transmission of serious diseases.
    Third, often unstated in the PP are the notions that interventions should be
    • effective
    • not make things worse, e.g., not dry up the supply of available donors to the point where patient lives are at risk
    • not cost so much time and money that other equally or more important safety measures are threatened
    As they say in the law, res ipsa loquitur - the thing speaks for itself.
    Unfortunately, the devil is always in the details.That's where EBM studies help. They do not so much compete with the PP for which test or policy should be implemented, but rather act to
    • Identify if a particular threat is indeed plausible and serious and thereby worthy of applying the PP AND then
    • Identify which intervention options are effective and do not cause harm
    EBM supports the validity of PP-motivated interventions. Treating EBM and PP as mutually exclusive opposites is easy to do (I have done it myself) but it only serves to undermine the basic goodness of the PP.
    I have not read anywhere that the PP is meant to implement ineffective, costly, harmful safety measures. But neither do PP-motivated measures need to be perfectly effective and cheap. That's a standard not applied to other interventions.
    Also, I noticed that Menitove used, "Patient and donor safety remain priorities / are primary concerns, but..." twice. This reminds me of Queen Gertrude in Hamlet saying, "The lady doth protest too much, methinks."
    Shovel-ready?
    Lastly, Menitove presented an argument that I have not seen used before, at least not directly - that indifference to economics will stifle growth and discourage investment.and that suppliers need to be told about long-term opportunities in TM. In other words, TM health professionals need to help grow the biotechnology sector, so that it will be there when needed for emerging threats.
    In particular, those involved on the blood centre side of the business need to nurture suppliers so that the commercial infrastructure is in place for 'shovel-ready' projects should they be urgently needed. Otherwise the industry may migrate to more profitable ventures in the transfusion service and other sectors.
    BOTTOM LINE
    The tide has turned and it's back to the future. Who knows what year we will be beamed back to. When syphilis testing is dropped, as it inevitably will be, it will be early days, indeed:
    The Real 'Perp'
    So, what do you believe is the 'something' that is primarily responsible for the current increasing calls for a major shift in donor screening policies - a shift that involves scrapping several existing policies and tests? Why have the drum beats increased now?
    What is the real 'perp' and what are the red herrings?
    • Dedication to patient safety?
    • Belief in evidence-based medicine?
    • Need to save money?
    Of course, the above choices may not include the most plausible explanation. It's possible that the real key driver is something else.
    FURTHER READING


    Tattooing & piercing in Canada (2004 backgrounder)

    Alter HJ. Pathogen reduction: a precautionary principle paradigm. Transfus Med Rev. 2008 Apr;22(2):97-102.

    And do not forget this paper - it spells out just how complex blood safety policy decisions are:
    Mapping out the consequences of screening blood donations for PrPSc (UK DOH)
    Earlier related blogs:
    Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice.