Everywhere you look these days, transfusion journals and newsletters are filled with discussions on cost-effective and how organizations need to find ways to reduce costs while maintaining or improving blood safety. The clichéd business jargon of the 1990s is pervasive in the TM literature, now used by physicians in suits (as opposed to lab coats) to whom it has come, albeit late.
I've long been an advocate of risk management as applied to test rationalization in the transfusion service and taught students about the health care piggy bank not being bottomless. Choices must be made and, when we fund some tests and procedures, it automatically means others cannot be funded.
But something about the current discussion on cost, benefit, and risk as applied to protecting the safety of the blood supply disturbs me.
1. AIDS AT 30
I've long been an advocate of risk management as applied to test rationalization in the transfusion service and taught students about the health care piggy bank not being bottomless. Choices must be made and, when we fund some tests and procedures, it automatically means others cannot be funded.
But something about the current discussion on cost, benefit, and risk as applied to protecting the safety of the blood supply disturbs me.
1. AIDS AT 30
June's issue of AABB News features '30 years of fighting AIDS' and focuses on major advances in blood safety resulting from nucleic acid amplification testing (NAT).
AABB president James Aubuchon is also quoted in 'AIDS at 30':
"We should congratulate ourselves on what we have accomplished...in our approach to infectious diseases and these accomplishments have allowed us to turn our attention to other problems such as bacteria in platelets and TRALI."Presumably "our approach to infectious diseases" includes applying the precautionary principle to blood safety.
2. RISK-BASED DECISION MAKING
A consensus conference on risk-based decision making for blood safety was held in Toronto in Oct. 2010 and will be discussed at the 2011 AABB meeting in San Diego. The proceedings were published in July.
- Leach Bennett J, Blajchman MA, Delage G, Fearon M, Devine D. Proceedings of a Consensus Conference: Risk-Based Decision Making for Blood Safety. Transfus Med Rev. 2011 Jul 13. [Epub ahead of print]
Also see
- Wilson K. A framework for applying the precautionary principle to transfusion safety. Transfus Med Rev. 2011 Jul;25(3):177-83.
- Is the extent of the exposure large?
- Is the consequence of the exposure serious?
- Is the consequence of the exposure irreversible?
- Is there minimal cost associated with the removal of the exposure?
- Is there a minimal negative health effect associated with removing the exposure?
The precautionary principle, while improving blood safety, has inevitably produced increased blood costs and led to 'push-back' in the form of questioning whether it has gone too far.
As noted in an earlier blog, "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."
To me, the report on the consensus conference (Risk-Based Decision Making for Blood Safety) indicates the direction of future decision making:
- Cost is becoming increasingly important and the precautionary principle as applied to transfusion medicine will be shaped to fit what is financially desirable.
Ongoing evidence exists that blood suppliers are in trouble and need to reduce costs.
- Three Florida blood banks to merge to provide the "the safest blood supply at the lowest possible cost"
- Florida blood banks fight a turf war over blood donors
- organizations that merge or form partnerships "can benefit from higher margins, greater expense control and economies of scale."
- 'A roundtable discussion: from thoughts on supply and demand to what keeps us up at night'
Each merger is unique, but in general, mergers are driven by a rationale to lower costs, grow geographically and access hospital markets that are crossing current blood center lines. Often it's about pricing strategies. (Stacy Sime, President and CEO, LifeServe Blood Center)4. HISTORICAL PERSPECTIVE
In this 1998 CMAJ article written on the eve of CBS taking over the blood system in English Canada ("Concerns mount as transfusion medicine loses its lustre"), Noel Buskard and other luminaries in Canada's TM firmament discussed not only the legal risks involved in transfusion medicine but also a trend toward
- "a 'pharmaceutical model' in which the physician is based in-house, reports to a CEO-style business manager and doesn't have a connection to patients or other institutions."
Today the guys who get air time at AABB and other conferences are those who promote strategies to achieve cost-effectiveness.
From Jeffrey McCullough's presentation (Consensus Conference on Risk-Based Decision Making):
- In response to a variety of developments over the past 25 years, the culture and structure of blood organizations have evolved. These organizations have moved from a medical model involving individualized decision making resembling patient care to a systems-based pharmaceutical manufacturing model, with new approaches to quality assurance. Organizational structures have been transformed; and new kinds of leadership are now valued, such as manufacturing and business expertise.
- Governed by the principle that “safety of the blood supply is paramount”, these organizations have achieved significant improvements in blood safety. However, that paradigm is evolving and potentially conflicts with other principles, such as the notion that “decisions…will be made within a health risk management framework, which places on an equal footing the 3 critical elements of cost, benefit, risk”. (Words in quotation marks are from referenced sources)
REMEMBERING
Noel Buskard was the medical director of Vancouver's Canadian Red Cross blood centre during the early years of the AIDS tragedy in which 1000s across Canada and around the globe were infected with HIV and hepatitis from blood transfusions. He quit the Red Cross in 1991 saying it had developed a "fortress mentality" when confronted with the AIDS tragedy.
For a fascinating trip down memory lane, see
- 1984: Noel Buskard saying there is no evidence of AIDS being transmitted by a blood product in Canada and discussing the cost-benefit ratio in giving hemophiliacs factor VIII. (CBC news video)
- An Annotated Chronology of the History of AIDS in Toronto: The First Five Years, 1981-1986 (based on Toronto newspaper reports of significant events that occurred in Toronto and elsewhere)
Lest we forget:
- 1994: The Tragedy of Factor VIII concentrate (CBC news video)
Reading the current papers on blood safety and talk of 'acceptable risk', and balancing risk and cost, I cannot help but remember this interview of the daughter of a Manitoba hemophiliac, Ed Kubin.
Many moons ago when I worked at the Winnipeg Red Cross, Ed and his brother Barry would regularly pick up their supplies of cryoprecipitate from the lab. (Yes, it was just pre-factor VIII concentrate)
Many moons ago when I worked at the Winnipeg Red Cross, Ed and his brother Barry would regularly pick up their supplies of cryoprecipitate from the lab. (Yes, it was just pre-factor VIII concentrate)
Writing this blog brings to mind this gem by Canada's Gordon Lightfoot
I'm pretty sure you can read my mind on where I stand on the issue of 'acceptable risk' and who pays the price.
BOTTOM LINE
So, what is it about the current discussion on risk management and the safety of the blood supply that disturbs me? It's that those doing the talking seem to be leaning towards cost being the main determining factor, despite the lip service paid to safety.
We know that credible evidence is needed to show that an intervention to prevent a given risk may add to blood safety, but evidence need not be overwhelming, according to the precautionary principle. Did the AIDS and HCV tragedies not teach us that? Unfortunately, emerging threats to the blood supply do not often come with good data on how large the true exposure is and evidence is often unclear in the early days.
If cost is given too much weight, as seems likely, we are doomed to commit the errors of the past. And it isn't the docs making the decisions who will pay the ultimate cost.
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BOTTOM LINE
So, what is it about the current discussion on risk management and the safety of the blood supply that disturbs me? It's that those doing the talking seem to be leaning towards cost being the main determining factor, despite the lip service paid to safety.
We know that credible evidence is needed to show that an intervention to prevent a given risk may add to blood safety, but evidence need not be overwhelming, according to the precautionary principle. Did the AIDS and HCV tragedies not teach us that? Unfortunately, emerging threats to the blood supply do not often come with good data on how large the true exposure is and evidence is often unclear in the early days.
If cost is given too much weight, as seems likely, we are doomed to commit the errors of the past. And it isn't the docs making the decisions who will pay the ultimate cost.
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As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. This blog was updated 7 Aug. 2011.
