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 (People are withdrawn from the waiting list when they become too sick to receive a transplant, opt out of the surgery, or their health improves.)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?
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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.

Posted by Blut at 6:16 PM 2 comments
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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:
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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.

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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.
    Posted by Blut at 2:32 PM 1 comments

    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. 
    Posted by Blut at 8:50 PM 0 comments
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    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)
    Posted by Blut at 6:22 PM 0 comments
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    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. 
    Posted by Blut at 8:10 PM 6 comments
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