Sunday, December 07, 2008

"Let's get together and feel all right"

This blog entry features two Canadian websites that offer a wealth of useful resources and tools, the BC Provincial Blood Coordinating website,, which has just been redesigned, and, a website for CBS transfusion medicine (TM) residents.


I'm a big supporter of sharing resources. As Bob Marley, the Jamaican reggae singer-song writer- musician said in his One Love mega-hit:
  • "Let's get together and feel all right."
Sharing helps transfer knowledge and expertise to the next generation of professionals, especially harder now that:
  • So many are about to retire
  • Financial constraints leave less money to spend on education and real-world training
  • Staff shortages result in less time for mentoring new staff
  • Restructuring has led to more generalists and fewer specialists
Today it's especially important to try to capture the type of knowledge that is seldom found in textbooks, including the type of tacit knowledge that we often do not even realize we have.

Sharing can be thought of in terms of physics and the Law of Conservation of Energy, i.e., the amount of energy in a closed system is constant, but as Bob Heterick, former president of EDUCOM said:

This blog's featured websites play a key role in keeping TM education within individual institutions and locales robust.


The BC PBCO was the first PBCO created in Canada and over the years has set a high standard for others to follow. The redesigned website offers many world class resources, e.g.,

Thanks to a friend and colleague, Shanta Rohse (who I consider a Renaissance woman in that she has broad intellectual interests in both the arts and sciences), I learned about (LT) aka "Blood Depot," a site for its TM residents that CBS has made available to the public.
LT has a wealth of resources and this blog entry is meant to feature a few of the many "goodies" on the site, managed by CBS resident coordinator, Dr. Ben Saxon.

For example, here you can find

  • Designing SOPS for learners and the related "Cognitive learning principles checklist" (**Please see Shanta's clarification in "Comments" below)

  • Topic teaching: many valuable presentations - a great way to get an overview of key TM topics

I encourage you to navigate the BC PBCO and Learn Transfusion sites to access all that they have so generously shared. Future blogs will feature other key TM websites around the globe that are leaders in developing and sharing TM resources, leading to improved transfusion practice and patient safety.

Disclosure: I am the webmaster for TraQ, a program of BC PBCO, but I alone am responsible for this blog and all its contents.
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

Tuesday, November 04, 2008

"I'm the decider" & the doctrine of preemptive strikes

A timely post for November 4, 2008, presidential election day in the USA...

Late night comedians have satirized George W. Bush for his "I'm the decider" statement, although what he said was true. And the U.S. President's most consequential decision appears to have been based on faulty information about weapons of mass destruction (WMD) in IraQ but it fits with his doctrine of preemptive strikes.

An informative and entertaining paper in the Oct. 1st issue of Blood, which features ASH 50th anniversary reviews, reminded me of issues surrounding being a decider and how the validity of decisions depend on the quality of information and how the precautionary principle can easily go awry.

Alter HJ, Harvey G. Klein HG. The hazards of blood transfusion in historical perspective. Blood 2008 Oct 1;112(7): 2617–26.

This paper by two giants in transfusion medicine reviews historical and current transfusion risks. From an historical perspective, as someone who worked in a blood centre when the Australian antigen (now HBsAg) was discovered and testing of blood donors was implemented, the authors' tale of its discovery revived old memories, as did their review of the entry of HIV into the blood supply.

However, this blog entry is NOT a trip down memory lane but a glimpse at what history tells us that today's transfusion recipients should expect when it comes to blood safety.

Two statements in the Blood review caught my eye because they remain topical and have ongoing relevance. The authors note that the blood bank community has been chastised for its perceived failure to act during the early days of the AIDS epidemic and outline the "real time" difficulties and pressures present during1982-84. They state:
  • "We write this not as apologists for early inaction, but to portray the immense, seemingly insurmountable dilemmas present at the time."
As an aside, I may be a bit cynical, but when someone says it's "not about the money," it almost always is, especially if they were not asked about money and bring it up out of the blue. In this case I'm sure the authors are sincere but the suspicion remains.

The second statement concerns the precautionary principle:
  • "One positive outcome of the AIDS tragedy was adoption of a new paradigm in blood transfusion, the precautionary principle, which states that 'for situations of scientific uncertainty, the possibility of risk should be taken into account in the absence of proof to the contrary' and that 'measures need to be taken to face potential serious risks.'" (definition comes from ref. 1)
What does this mean in practice? In essence, the precautionary principle is a preemptive strike.
It 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. Moreover, the proof of harm need not be certain and cause and effect do not need to be fully established.

In some ways the precautionary principle conflicts with an evidence-based medicine approach. To protect public safety, you do not need high-level evidence - safety is paramount and preemptive strikes are warranted. And it implies that financial considerations should not take precedence.

Put into the context of transfusion-associated HIV and hepatitis C in Canada, Justice Krever wrote (2):

  • "The slowness in taking appropriate measures to prevent the contamination of the blood supply was in large measure the result of the rejection, or at least the non-acceptance, of an important tenet in the philosophy of public health: action to reduce risk should not await scientific certainty.
  • When there was reasonable evidence that serious infectious diseases could be transmitted by blood, the principal actors in the blood supply system in Canada refrained from taking essential preventive measures until causation had been proved with scientific certainty.
  • The result was a national public health disaster."
In the aftermath of HIV and HCV, the precautionary principle has been applied to protecting the blood supply from vCJD and WNV ( 3,4). However, its application remains a challenge since it involves a volatile mix of
  • fear
  • risk
  • uncertainty
  • finite financial resources
See, for example:

Alter HJ. Pathogen reduction: a precautionary principle paradigm. Transfus Med Rev 2008 Apr;22(2):97-102. The abstract reads:
  • Although remarkable advances have been made in the prevention of the major transfusion-transmitted diseases, long intervals have transpired between the first recognition of transfusion risk and the implementation of a preventive strategy.
  • For hepatitis B virus, that interval was 30 years; for non-A, non-B/hepatitis C virus, 15 years; and for human immunodeficiency virus, West Nile virus, Trypanosoma cruzi, and bacteria, 3, 4, 5, and 18 years, respectively
  • In our existing reactive approach, there is a fundamental and inevitable delay before we can react; and thus, infections are destined to occur. The continued emergence or reemergence of transfusion-transmitted infections calls for a new paradigm of preemptive pathogen reduction (PR).
  • Two PR systems, psoralen/UV-A and riboflavin/UV-A, have shown efficacy and safety for platelets and plasma; and psoralen/UV-A technology has been successfully implemented for platelets in Europe. Pathogen reduction can eliminate or reduce the risk for any nucleic acid containing agent, including bacteria, and thus will be effective for all but prion diseases. It is possible to introduce PR for platelets and plasma now and to concentrate resources on developing PR for red cells.
  • This will require an intellectual and financial commitment from the National Institutes of Health, the Food and Drug Administration, industry, and the blood bank establishment, just as occurred for nucleic acid testing (NAT) technology. This can be done if there is sufficient will to do it.
It is inevitable that money continues to exert a strong influence on public policy decisions. But should it be the key deciding factor? It appears to have been a key concern regarding Canada's decision not to implement surrogate tests for non-A, non-B hepatitis (
  • These estimated costs of surrogate testing did not take into account the medical, economic, or societal costs that would be saved by a reduced incidence of post-transfusion non-A, non- B hepatitis if surrogate testing were implemented. Cost, without recognition of the benefits of testing, continued to dominate the discussions during the next three years about whether to implement surrogate testing in Canada....
  • The effect of the failure to implement surrogate testing in Canada is illustrated by the Blajchman–Feinman study itself, which confirmed that surrogate testing would have significantly reduced the incidence of post-transfusion hepatitis. The results of the study, published in The Lancet in 1995, support the conclusion that the implementation of both surrogate tests would have reduced the incidence of post-transfusion hepatitis by 75 per cent, and the incidence of post-transfusion hepatitis C by 85 per cent, in the period before the introduction of HCV-antibody testing in Canada.
  • The decision of the Red Cross not to implement anti-HBc and ALT testing of blood donations in Canada as surrogates for non-A, non-B hepatitis was not an acceptable one.
A related positive outcome of the AIDS tragedy not mentioned by Alter and Klein is implementation of an informed consent process specifically for transfusions.

nformed consent in general has evolved with the entire movement away from the earlier paternalism of the doctor-patient relationship in which the typically male doctor was seen as the loving father-who-knew-best who protected the child-patient. But the AIDS and hepatitis C debacle gave informed consent for transfusion a huge kick start.

Today the health care paradigm is ideally one of a team involving doctors, nurses, and other health professionals. And responsibility for medical treatment is shared, with the physician as interpreter and reliable guide, but with the patient as the ultimate decision-maker. See, for example

informed consent model was absent during the AIDS crisis of the early 1980s:
  • "From early 1983, it was clear that AHF concentrate was a risky product. The failure to tell hemophilia recipients of Factor VIII concentrate about the risks of this treatment and about alternative treatments seems especially serious in the light of present-day emphasis on the autonomy of patients in decisions involving their health." (5)
The odds are that one day we or our friends and loved ones will require a blood transfusion. As potential recipients of blood, what should we expect? We should expect
  • physicians to have used evidence-based medicine methods to select treatment options;
  • risks and benefits of transfusion to have been objectively assessed;
  • alternatives to transfusion to have been considered;
  • blood suppliers to have supplied blood components and products that are as safe as possible, including using the precautionary principle to protect the blood supply;
  • to be asked to give our consent to transfusion and that it be informed consent.

#1. If I need a blood transfusion, just like 'Dubya,' I expect to be the decider. And I expect to receive reliable unbiased information from my doctors.

But are there risks involved in too much patient "decider" autonomy? How do we achieve an effective balance?
These are topics beyond the scope of this blog entry.

#2. It's possible to interpret President Bush's decision about WMD as the precautionary principle gone awry - too much emphasis on fear and over-estimating the risk and too little on evidence-based assessments - a classic case of "err on the side of safety" with a preemptive strike gone incredibly wrong.

In contrast, in the 1980s the precautionary principle was all but ignored by blood systems around the globe with tragic results. Today the balance has shifted, but not totally.

How do we achieve the right balance of caution yet prevent paranoia, recognizing that zero risk does not exist? How do we balance fear, risk, uncertainty, and finite financial resources?
These are difficult challenges.

In the end government plays a major role, because it funds research on adverse transfusion events and hemovigilance systems, regulates the blood system, develops public health policies that affect the blood supply, and in many countries almost totally funds the blood system.

So on this U.S. election day, and on any election day anywhere, the electors are also the deciders. They get to decide who
  • best represents their concerns and philosophies on public safety issues that require balancing fear, risk, uncertainty, and resources;
  • they most trust to apply the precautionary principle and launch a judicious preemptive strike against an imminent, emerging transfusion danger.
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 


1. Stoto MA. The precautionary principle and emerging biologic risks: lessons from human immunodeficiency virus in blood products. Semin Hematol. 2006 Apr;43(2 Suppl 3):S10-2.
2. Krever H. The blood supply system in Canada: systemic problems in the 1980s. Commission of Inquiry on the Blood System in Canada. Final report. Ottawa: Canadian Government Publishing; 1997;989.

3. Vamvakas EC, Kleinman S, Hume H, Sher GD. The development of West Nile virus safety policies by Canadian blood services: guiding principles and a comparison between Canada and the United States. Transfus Med Rev 2006 Apr;20(2):97-109.

4. Wilson K. The Krever Commission — 10 years later. CMAJ 2007 Nov 20; 177(11).

5. Leveton LB, Sox HC, Jr., Stoto MA, eds. HIV and the Blood Supply: An Analysis of Crisis Decision Making. Committee to Study HIV Transmission Through Blood and Blood Products, Institute of Medicine 1995.

Sunday, October 12, 2008

Responsibility - what's that?

The October issue of Transfusion has many interesting papers.

Two items caught my eye and got me to thinking how we view responsibility when colleagues fail to provide optimal care. We seldom get upset. Is it because we value calm, reasoned reactions over emotional responses? Because a quality system promotes a blame-free approach and focuses on systemic problems? Because we believe, "Let he who is without sin cast the first stone"?

This blog is about how we as a profession responsible for the safety of the blood system deal with physicians who order inappropriate transfusions and how that process compares with how we deal with other health professionals who do not follow established best practices. Besides the Transfusion papers, an Australian report featured the same problem:
The two Transfusion papers that caught my eye were
The first paper was a magnet - who can resist the notion of an immaculate transfusion? The authors describe the immaculate transfusion as issuing blood for transfusion when no order to transfuse exists.

After their transfusion service began to require a photocopy of a physician's order to transfuse blood before issuing products for transfusion (except when the need for rapid issue was more important than full compatibility testing), they audited blood requests for compliance to having a written physician order. As would be expected, they found various inappropriate blood requests, including some immaculate transfusions.

My guess is that they mean a virginal transfusion, since immaculate conception is a doctrine that believes that Mary, biblical mother of Jesus, was born without original sin. But
immaculate transfusion has a nice ring to it.

The second paper initially jumped out because of its Canadian authors, two of whom I know. But more significantly, I have always been interested in cryo, a wonderful discovery by Judith Pool in 1965 that gave new life to people with hemophilia. See this reminiscence by Dr. Martin Inwood:

Cryo's downfall?
Cryo became associated with the tainted blood scandal of the1980s and its legitimate uses became fewer with the development of safer alternatives (e.g., recombinant Factor VIII and desmopressin, aka DDAVP). Over time, it seemed that cryoprecipitate and its association with the AIDS tragedy
had become an outcast, a black sheep of the blood component family, admittedly nothing like the association of FVIII concentrate prepared from huge plasma pools of tens of 1000s of potentially infected donors.

Somewhat surprisingly, cryo continues to be used extensively, and inappropriately in many cases, as has been documented in this large Canadian study.
To keep with a biblical analogy, (I know it's a stretch), it is almost as if cryo was a prodigal son , a product that behaved badly yet was somehow rehabilitated.
  • If you like music, listen for the prodigal son reference as the Dubliner's sing Wild Irish Rover.
The study in the October 2008 issue of Transfusion involved a 2 month audit of cryoprecipitate use in 25 major Canadian hospitals. Cryoprecipitate transfusions were designated
  • appropriate if a fibrinogen level (taken 6 hr before/after transfusion) was not more than 1.0 g/ L
  • inappropriate if the pretransfusion fibrinogen level was more than 1.0 g/L and posttransfusion fibrinogen level was more than 1.0 g/L or not performed
4370 units of cryoprecipitate were transfused in 603 events to 453 patients representing 62% of cryoprecipitate issued to Canadian hospitals during the study.

Allowing that current recommendations for appropriate cryo transfusion are based on the opinion of TM experts, since no randomized controlled clinical trials have been done, the authors use the criterion of bleeding and significant hypofibrinogenemia (fibrinogen 0.8-1.0 g/L), which is generally considered appropriate.

Results. Using a fibrinogen level of at or below 1.0 g/L as "appropriate," (and ignoring whether patients were bleeding):
  • 24% of cryoprecipitate transfusions were considered appropriate
  • 34% were inappropriate
  • 42% - appropriateness could not be determined
The authors conclude that "A 2-month audit of cryoprecipitate use in Canada revealed that most cryoprecipitate use in Canada is not in accordance with published guidelines." They note that, "During the period of our audit, up to 72 percent of patient exposures likely only carried risk, with no perceivable benefit."

What are inappropriate transfusions?
These papers discuss unauthorized transfusions and inappropriate transfusions. If unauthorized transfusions are immaculate conceptions, what analogies apply to inappropriate transfusions? Inappropriate transfusions include
  • transfusing the wrong blood component (e.g., transfusing plasma as a blood volume expander instead of non-blood products such as saline, pentastarch, et al., which also need to be transfused appropriately but carry no infectious risks)
  • infusing the wrong dose (e.g., transfusing 4 RBC when 2 would achieve the desired clinical effect)
  • transfusing a blood component or product when transfusion is not clinically indicated
Why should we care?
Why should we care about transfusions that result in no immediate adverse event or in adverse events that are hard to document? Inappropriate transfusion implies that the treatment may
  • not do what it is supposed to do, namely improve the patient's condition or prevent further deterioration
  • potentially harm patients by exposing them to infectious disease risks and other adverse events
  • needlessly increase the cost of health care by wasting scarce blood products
According to this BMJ paper, reasons to reduce blood exposure include
  • Immunological complications
  • Red cell alloantibodies: haemolytic transfusion reaction
  • HLA antibodies: refractoriness
  • Transfusion related acute lung injury, post-transfusion purpura, transfusion associated graft versus host disease, etc.
  • Errors and "wrong blood" episodes
  • Infections (bacterial, viral, and possibly prion)
  • Immunomodulation (risk of infection or malignancy)
  • Litigation
  • Limited resource
At their worst, inappropriate transfusions constitute an unneeded treatment that is forced upon an unsuspecting victim who may or may not be harmed. At their best, who knows? Even if all they do is waste money, that is money that could be spent more effectively elsewhere.

Frankly, if I were to be transfused inappropriately with any blood product and contacted a transmissible disease (admittedly a low risk, but not zero) or suffer any adverse event, I would not think kindly on the physician who prescribed the transfusion. Even without any harm being done, I would resent the needless exposure to potential risks. Is this reasonable accountability? I would also wonder about how the inappropriate order got through the transfusion system, which presumably has processes to monitor and prevent inappropriate transfusions (more on this later).

Is this playing a non-productive blame game? Should I just say, "What the heck. My doctors were doing what they thought best, even though they were ignorant of good transfusion practice." Is ignorance a valid excuse?

How to detect, identify, and prevent inappropriate transfusion
The first step in prevention is to detect problems and classify them. With transfusion-associated adverse events, this is accomplished by hemovigilance systems.
With inappropriate transfusions, identification is harder. Such transfusions may not result in immediate harm or may result in adverse events that are difficult to link directly to transfusion as a significant cause. As well, the harm may be impossible to identify except by large studies, which, even then, cannot prove causation definitively.

With inappropriate transfusions, the identification process is usually done by developing standards against which ordering behavior is measured, then auditing performance for compliance with defined best practices and standards.

All of this takes resources and expertise, both of which are increasingly scarce.

We are in the infancy stage but have developed several tools.

Clinical indications
One tool is to include clinical indications on the transfusion request form, along with relevant hematogic and related criteria. Some examples:

  • RBC: Hb less than 70g/L or Hct. less than 21%
  • Platelets: less than 20 x 109/L
  • Cryoprecipitate: Bleeding and fibrinogen less than 1.0 g/L
Presumably, the inclusion of such guidelines on the form gives clinicians the clue that these are accepted indications for transfusion of a particular product and that they should carefully consider transfusion if their patient's situation falls outside the guidelines, realizing that a patient's overall clinical condition is paramount in decisions to transfuse.

Another blood utilization tool is the maximum surgical blood order schedule (MSBOS), which has been around for more than 30 years. See this example.

Transfusion service as gatekeeper
Transfusion service clinical laboratory scientists/technologists are expected to act as gatekeepers when clinical indications and data are not completed on forms or seem inappropriate, or when orders exceed the MSBOS. This puts them in an awkward position, for physicians generally do not like their decisions questioned by anyone, especially by non-physicians. TM labs generally contact the medical director or designate and have them deal with clinicians on a peer-to-peer basis.

However, sometimes circumstances dictate direct contact with clinicians. Ask any experienced technologist or nurse who has ever questioned a physician's order, usually indirectly, in the most respectful, even subservient manner, what the experience is like. In many cases, the experience is not pleasant, and sometimes down-right abusive.

From my experience surveying technologists across Canada who work in transfusion service laboratories about what happens when clinicians order questionable or clearly inappropriate transfusions, there are several possibilities:

  • Nothing at all happens. The inappropriateness may go unnoticed, may be ignored because staff are too busy, or may be ignored because a culture of questioning a doctor's orders is not encouraged.
  • If the blood order is drastically inappropriate and would clearly cause immediate harm, the TS medical director is contacted, intervenes, and manages to protect patient safety.
  • If the blood order does not correspond to current best practices and is inappropriate according to the TS's criteria for clinical use of a particular product, the TS medical director may or may not intervene.
The bottom line is that, if the clinician persists, the technologist is often told,
  • "Just give the blood."
Presumably, this happens because ultimate responsibility for patient treatment, including transfusion, rests with the attending physician AND, as would be expected, TS staff do not like having a policing role.

Other tools
Many other strategies and tools exist to promote safe and effective blood utilization but are beyond the scope of this blog. They include hospital transfusion committees, targeted education by Transfusion Safety Officers, hospital grand rounds, educational conferences, wallet cards with reminders of transfusion guidelines, websites with transfusion guidelines, etc.

Clinician education on appropriate blood use remains a significant challenge. An earlier blog a year ago focused on this topic:

The blog discusses a paper (Dzik S. Use of a computer-assisted system for blood utilization review. Transfusion 2007;47(s2): 142S) dealing with computerized physician order entry and computer-assisted blood utilization review and feedback.

In brief, the educational intervention in the paper is as follows:

  • A TM physician reviews daily reports of transfusion orders and clinicians who made questionable decisions to transfuse are targeted for education.
  • A non-judgmental e-mail is sent to the clinician within 24 hours of the decision to transfuse.The e-mail displays the pre- and post-transfusion lab data; provides the criteria for the review process; and links to an in-house educational site.
  • On the website, for each blood component the physiology of blood use is summarized and articles on the clinical use of blood are listed. Each article is linked to a summary of the paper's findings and to the published paper.
  • The e-mail invites the physician to reply if there are questions or concerns.
The author's innovative strategy uses a non-judgmental approach to educating physicians, which fits with the quality systems approach of being non-punitive and staying away from the blame game.

Other studies have shown varying degrees of effectiveness of educational interventions:

What is the responsibility of the TS medical director in preventing inappropriate and potentially harmful transfusions? What is the responsibility of ordering physicians? What is the responsibility of lab technologists and nurses who may notice that a doctor's transfusion order seems questionable?

The fact is that we all have varying degrees of responsibility.

My experience is that transfusion services have dedicated professionals who fight the good fight and achieve steady nano-progress with educating clinicians who order transfusions. Most clinicians have little transfusion education in their undergraduate programs - sometimes it amounts to only a few hours. This leaves a huge gap for transfusion services AND the physician to bridge.

What happens to physicians personally when they order inappropriate transfusions? In the absence of immediate patient harm, apparently, not much. The current approach is to improve a clinician's transfusion practice through gentle face-saving educational interventions designed to motivate voluntary changes in behavior. Maybe this is all that can be expected.

But how much responsibility do clinicians share for being knowledgeable about a treatment they provide? Decisions about transfusing patients are difficult and often made under stressful conditions. That said, a hallmark of educated professionals is to know what they do not know, to actively pursue continuing education, and to seek help when needed.

If technologists and nurses were to consistently break accepted best practices, and such behavior put patients at risk, what would happen? Would they receive nothing but educational interventions? Perhaps. For how long would repeated deviations be tolerated? In some regards,
technologists and nurses are in a different position, because best practices and guidelines are often documented in written SOPs used in the training of new staff and these SOPs must be followed.

blood safety standards specify that blood transfusion training is mandatory for all staff involved in transfusion practice. But apparently such training is not mandatory for physicians who prescribe blood transfusion.

Are physicians treated differently because of their status in the health care system or are they treated the same as other professions? Other than offering multiple voluntary educational opportunities and providing gentle education after the fact for those who order inappropriate transfusions, what strategies and tactics can improve physician transfusion practices? These are questions to ponder.

Is the current situation - ongoing inappropriate transfusions for multiple blood components and products - the natural result of what happens when there are no consequences for inappropriate behavior? Transfusions have the ability to do much good and to save lives but carry risks.


Today, blood utilization tends to focus on cost control of expensive plasma protein products such as albumin and IVIG. For example, in Canada for the year ending Mar. 31, 2008, IVIG was the largest single expense at $137.4 million, almost 16% of the total budget that neared $900 million.

See utilization management for some of the projects that have been done in this area.

Cost control is essential to sustain the entire blood system, but how can the focus on the most expensive products be better balanced with an overall utilization strategy? One idea is to use a variation of the original Pareto Principle (80-20 rule that 80% of the wealth was owned by 20% of the population) - namely, that 80% of consequences stem from 20% of the causes.

Should we try to prioritize? To identify the 10, 15, or 20% of the physicians or medical services that cause most (60, 70, or 80%?) of the inappropriate transfusions, regardless of cost, and target education at them?

We also need to balance the need for blame-free interventions with processes that better motivate clinicians to assume responsibility for becoming knowledgeable about transfusion practice. Assigning blame causes resentment and anger; it tends to drive people underground and undermine error prevention strategies.

However, should not blaming people equate with having no consequences, especially where patient safety is involved? This issue has been examined in

The author writes:
  • In my experience as both a regulator and safety exponent, systems issues usually accompany breaches of professional responsibility (weak regulations, reporting requirements, or inadequate training). It depends how you look and where.
  • A root cause analysis would nearly always identify systems problems and rarely individuals. Systems failures may also mitigate the level of responsibility for the individuals.
  • Where and how professional responsibility fits into the ‘‘no blame’’ culture is unclear. How can we make it clearer?
Whether immaculate, virginal, or something more "sinful," inappropriate transfusions remain an ongoing challenge around the globe.

One of the key issues is responsibility.

Take a peek at this rendition of Responsibility by the punk band MxPx. All docs ordering transfusions - Tx Rx?
- should take note of their behavior, as in the MxPx lyrics:
  • Responsibility? What's that?
  • Responsibility? Not quite yet.
  • Responsibility? What's that?
  • I don't want to think about it; we'd be better off without it...
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. .

Monday, August 18, 2008

I can't get no satisfaction

The Rolling Stone's biggest hit from 1965 was "I can't get no satisfaction".

Over 40 years later the song comes to mind when reading about pathology errors in Canada that have eroded public confidence. Although about Canada, the events and resulting news coverage should resonate in many countries.

Chorneyko K, Butany J. Canada's pathology. (editorial) CMAJ 2008 Jun 3;178 1523

The authors, one of whom is the president of the Canadian Association of Pathologists (Butany), acknowledge that "Canadian laboratories are not unique in facing workload and human-resource issues or problems pertaining to medical error and patient safety" and then note that Canada lacks a national quality assurance (QA) program such as the College of American Pathologists in the USA and similar organizations in the UK and Australia.

Unfortunately, they mention only Ontario and BC as having laboratory accreditation and proficiency testing programs, when other provincial programs exist, including what is arguably the longest functioning and very effective QA / proficiency testing program of the College of Physicians and Surgeons of Alberta,
including an excellent program for transfusion medicine.

Related news items that subsequently appeared include

This article begins, A horrendous series of blunders at a Newfoundland medical laboratory has raised a frightening thought: What if similar problems exist at other facilities across the country?
Several stories in national papers have erroneously reported that only Ontario and British Columbia have regulatory bodies with authority over medical laboratories, e,g.,
The National Post reports that the Canadian Association of Pathologists has called for a national diagnostic checklist to include test validation, staff training, competency assessment, standardization of operating procedures and equipment maintenance. These measures have been standard practice in transfusion and other clinical laboratories for years.

The news coverage creates the impression that Canadian labs put the public at grave risk.

To date some pathologists and laboratorians have commented:

Swaine, et al. point out that in Alberta laboratory accreditation and proficiency testing programs have existed since the 1960s and are administered by the College of Physicians and Surgeons of Alberta.

These authors focus on clinical pathology and the need to fund and resource laboratories adequately.


Laboratory technologists / clinical laboratory scientists / biomedical scientists constitute the 3rd largest group of health care workers, yet lab medicine as a career has long suffered from

  • low salaries (typically much less than nurses, which have a higher visibility)
  • limited upward mobility
  • poor understanding of the profession by the public and other health professionals
For example, most patient exposure to the lab is via blood collection. Few know that lab workers are well educated and skilled professionals who operate sophisticated equipment, problem solve, and work with physicians to help to diagnose illness. See

I have heard pathologists say that they too are often under-recognized and near the bottom of the respect ladder in medicine making recruitment difficult. For example, see

BOTTOM LINESerious pathology-related errors occurred, indicating a problem. The concept of a national body developing laboratory quality standards has merit, so long as any new program integrates with existing provincial programs and does not create another layer of bureaucratic regulation. All provinces need to develop functioning accreditation programs and existing provincial systems can be improved - hence the concept of continuous quality improvement.

However, the overall notion that Canada's clinical laboratories are uncontrolled back-waters of laboratory medicine that generate test results of poor quality is wrong. Additionally, headlines implying incompetence do not help desperately needed recruitment and undermine the professional pride and status of pathologists and laboratorians.

"I can't get no satisfaction" from the pathology lab errors in Newfoundland and Labrador, which likely led to incorrect treatments for almost 400 breast cancer patients.

"I can't get no satisfaction" that laboratory medicine has poor public visibility and is only marginally understood.

"I can't get no satisfaction" that laboratory professionals suffer from a lack of status among other health professionals.

"I can't get no satisfaction" from a possible public misconception of widespread clinical laboratory incompetence, especially as a blood banker. In Canada and in most countries transfusion medicine has led the way in implementing quality systems in clinical laboratories.

Of course, satisfaction should be internally generated and lab professionals are indeed dedicated to patient safety and intrinsically proud of their role on the health care team.

Keith and Mick got it wrong when they wrote:

I can't get no satisfaction
I can't get no satisfaction
'cause I try and I try and I try and I try.....

It's better to view satisfaction the way Mohandas K. Ghandi did:

  • Satisfaction lies in the effort, not in the attainment, full effort is full victory.
I'll go with the Mathatma for now....

Related resources

Sunday, July 06, 2008

Mourning becomes Electra

Updated: 28 Jan. 2017 (Fixed broken links)
This blog's title is taken from the play by Eugene O'Neill of the same name, which is an adaptation of the Greek trilogy “Oresteia” by Aeschylus.

The blog was motivated by a device
that automates blood component preparation just licensed by the FDA in the USA. The device's press release is one of the Industry News items in this month's TraQ newsletter. It caught my eye because of the name of the device, the Atreus.

After briefly discussing the names that manufacturers give their products, the blog will examine the pitches used to market automation, the related concept of lean manufacturing, and whether they constitute progress.

First, the product names. Atreus rang a bell because during my youth my Dad used to share his love of Greek mythology with me. Atreus was, to put it mildly, a pretty repellent dude even in a curse-stricken family where each generation gruesomely and tragically murdered family members and others out of some combination of pride, ambition, lust, and revenge.

One version of the Atreus myth (there are several) has Atreus and his brother murdering their father's illegitimate son (their half-brother) to please their mother. Then, after his brother seduces Atreus's wife, Atreus kills his brother's two sons and invites him to a banquet to feed him the flesh of his sons, whom Atreus had boiled. Atreus also saves the children's hands and feet to show to his brother. His brother later rapes his own daughter, who despite being Atreus's niece, becomes Atreus's wife. Atreus raises the child fathered by his brother as his own. Eventually Atreus's wife commits suicide and the child, in loyalty to his uncle (who he realizes is his real father), kills Atreus. Charming family.

Now why would Gambro / CaridianBCT want to name its new device after such a repugnant figure as Atreus? Other products have been named after characters in Greek mythology, for example, Immucor's Echo. In Greek mythology, the beautiful nymph Echo would distract Zeus's wife Hera with stories while Zeus ravished other mountain nymphs. When Hera discovered this, she punished Echo by taking away her voice, except in repetition of another's words. Later Echo fell in love with Narcissus but was rejected. The once talkative nymph eventually changed into rock leaving nothing but her voice to reply to those who shouted out.

It's likely Echo is meant to be a cute takeoff on its role as the little brother (little sister?) of Immucor's Galileo. Galileo contended that the earth rotated around the sun, thus contradicting the orthodoxy of the time (early 17th century) that the earth was the centre of the universe. For this crime he was convicted of heresy and spent his later years under house arrest. Naming products after pioneering scientific figures like Galileo makes sense, but Atreus and Echo....not so much.


Back to the Atreus® and other automated devices and instruments....

Is the Atreus® meant to eliminate "x" FTE staff who currently prepare blood components or just make their work easier and more satisfying?

Manufacturer's typically market automation with claims such as:The instrument/device will
  • do the boring "slug work," freeing staff for more interesting tasks that require more skill
  • prevent repetitive stress injuries
  • increase patient safety by decreasing errors since there are fewer steps for staff to perform
  • increase efficiency by saving time (better TAT with throughputs of "x" tests/hr)
  • increase test reliability by eliminating subjective reading of tests by staff
  • increase test sensitivity and specificity (hmm...can you really do both?)
  • improve process control
  • interface with existing LIS to decrease transcription errors (Oh, oh! Best to take LIS interface claims with a block of salt)
  • ensure positive identification and tracing via improved 2-dimensional bar codes
Notice how some of the standard pitches above emphasize putting staff first - more satisfying work, fewer injuries, easier work (instruments and computers do the "slug work" for you).

To lab managers and directors, marketing pitches include the motherhood issues above but tend to focus more on the bottom line, e.g., The instrument/device will/can

  • save money by eliminating "x" FTE
  • give a return on investment after "x" years
  • be maintained by a rhesus monkey available from our offshore supplier at a discounted price if ordered in volume (Just kidding on this one)
Effects of automation in lab areas such as clinical chemistry have been well documented:
This article in CAP Today sums up the transfusion medicine situation in 2002, as well as the motivations and perspectives of those in charge of the labs:
Naturally, automation fits well with the latest buzzword of the quality movement, "lean," as in "lean manufacturing." Lean is based on the principle that non-value-added activity constitutes waste and should be eliminated.

Like its cousins quality systems and six sigma, there is an entire industry built around lean. It helps to develop a business around a concept if you can give insiders the jargon that makes them "in the know" and keeps the non-enlightened out.
And lean is now huge in health care. Here's a lean hospital in the UK - for patients arriving in the emergency department, no more seeing doctors - docs do not add value to the process:
Hospitals, laboratories, and blood centres send staff to lean conferences to learn the principles and jargon of lean (muda, kaizan blitz, kanban, JIT, poka-yoke, etc.). Seems that everyone is making a buck from lean.
Try googling lean AND health care - on 6 July 2008 the search gave >7 million hits. Most seemed to be websites for consultants selling lean advice.
So is automation progress? Is lean progress? Progress can be defined many ways but it generally means improvement or growth, whether for individuals, organizations, societies, or humanity.

Are highly automated or lean labs progress for

  • staff who no longer have lab jobs? Have they gone on to bigger and more rewarding careers and lives?
  • remaining staff who load the instruments and press the buttons, letting the equipment do the analyses. Is their job satisfaction improved?
  • senior staff who do less but more interesting hands-on lab work and have more time to read computer printouts, attend meetings, and program spreadsheets with error management data and the like.
  • lab managers and directors who can more easily meet their goals with fewer resources now that costs are down?
  • patients, who constitute the true bottom line? Is their health care improved and safer?
Many would say, of course, automation and lean constitute progress - it's the current conventional thinking (orthodoxy). Even questioning automation and lean is heresy. However, if questioning of automation and lean principles bugs you, you may be experiencing cognitive dissonance.

On the other hand, if you are certain that automation and lean are progress for mankind, read on because shangri-la approaches:

Add robotics to lean hospitals and soon we'll have gotten rid of all the non-value-added waste in the health system, as well as most of the health professionals.

I wonder if there is a way to automate administering transfusions as this seems to be a area where deadly errors continue to occur? FromTraQ's July newsletter - International news: UK and USA:

Transfusion nurses could have improved and more satisfying work by investigating only unusual events that actually require their skill set. (I write with tongue firmly planted in cheek.)

I would call the automated transfusion device Electra after Atreus's granddaughter, who wanted her brother to avenge the death of their father by killing their mother, leading to the concept of the Electra complex.

I'm not altogether sure whether automation constitutes progress from a big picture perspective (benefits humankind), but it's irrelevant. Automation is here to stay and will only get more and more pervasive in health care.

Take that, Atreus! The curse goes on....
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

 Addition (3 Sept.2008)
Thanks to those who have commented.

In these blogs I'm really just asking questions, not providing definitive answers. Readers should decide for themselves based on their experience and reading the literature. Responses may vary widely depending what automation has meant for individuals personally.

Few of us have extensively studied the issue of automation over time. And what studies have been done get their results based on the questions asked, using measurable outcomes like reduced number of FTE staff, money saved according to defined algorithms and assumptions, and self-reporting by remaining staff about job satisfaction, etc. The internal validity of some of these studies is open to question and their generalizabilty is not universal.

As noted, "Many would say, of course, automation and lean constitute progress - it's the current conventional thinking (orthodoxy). Even questioning automation and lean is heresy."

My view is not so certain:
"I'm not altogether sure whether automation constitutes progress from a big picture perspective (benefits humankind)." It may or it may not.

Taken to its logical conclusion, and using a reductio ad adsurdum argument, if automation constitutes progress (a better life) for humans, then we should automate everything, leaving a few of us to do the routine work (load instruments, push buttons, etc.), while the rest of us sit around and problem solve until there are no problems left to solve because the automation has been perfected. Now, what to so with all this leisure time? Create a new Renaissance? Die of boredom?

I've reduced the proposition to an absurd conclusion, which could be a fallacious argument, just to show where my abstract and theoretical thinking about automation leads.

About inadequate staffing causing errors, I'm not sure that's been proven in the cases cited by the authors of "Canada's pathology" in CMAJ. Although it's logical that being overworked could be a contributing factor in causing errors, it would be risky to assume that it's a significant cause in individual cases without evidence. Many of the pathology errors were caused by the repetitive actions of a single pathologist such as Dr. Charles Smith, whose autopsy decisions were not always based on the evidence.

Lab systems are supposed to be designed to prevent and detect and correct any errors. Clearly the overall system failed in the case of the serious pathology lab errors that occurred.

Sunday, June 08, 2008

What's it all about, Alfie?

This month's blog is about how we spend our time in the context of transfusion medicine research. The title comes from the song What’s it all about Alfie? and the movie of the same name starring Michael Caine (and a later version with Jude Law). Perhaps you have pondered the meaning of this oldie-goldie from the 60s?

It's a cliche to say that to get the right answers you must ask the right questions, which is the researcher's equivalent of the techno-geek's GIGO.

But even more important is to know what questions of all the questions that could be asked are worthwhile spending time trying to answer. I would not call myself a researcher, although I have done applied research, but will not let that stop me from commenting or spouting off.

Two articles caught my attention in recent issues of Transfusion and Vox Sanguinis, both out of personal historical interest.

The first paper by a College of American Pathologists committee concerns blood bank serology, something at risk of becoming obsolete but nonetheless dear to my heart.

1. AuBuchon JP, de Wildt-Eggen J, Dumont LJ for the Biomedical Excellence for Safer Transfusion Collaborative and the Transfusion Medicine Resource Committee of the College of American Pathologists. Reducing the variation in performance of antibody titrations. Vox Sang 2008 Jul;95 (1):57–65.

Summary: Because antibody titration is difficult to standardize, the CAP proficiency testing program decided to investigate whether a detailed, uniform titration procedure would reduce variation in both tube-based and gel card titres (see abstract for details). Based on results from 35 laboratories, the U.S. authors concluded that a uniform method for antibody titration at 37°C and read at the antiglobulin phase in a tube-based method with a w+ end-point (compared to a 1+ end-point) reduced inter-laboratory variability.

Related reading:
Titrations - a blast from the past! Long ago I performed many a titration while working in Winnipeg with Dr. John Bowman - titrations on the plasma of women with anti-D who were candidates for intrauterine transfusion and on the plasma of women whose potent anti-D was used to manufacture Rh immune globulin.

One thing I know from working in a lab that used titrations as an adjunct to assess hemolytic disease of the newborn due to anti-D is that titre is an unreliable indicator of disease severity. Historically, it was used as a poor tool to assess whether invasive procedures such as amniocentesis and later PUBS were warranted.

Depending on the method, the red cell phenotype used, and operator technique, titres can vary significantly. Technically that's a 2-tube difference (or more) in a titration that uses a doubling dilution, e.g., titres of 4 and 8 are not considered significant but those of 4 and 16 would be.

While an anti-D (or anti-K) with a high titre (however that is defined) can alert us to the need to monitor current and future pregnancies, can getting more consistent inter-laboratory endpoints significantly influence clinical management?

Obtaining more reliable titres among labs is a good thing, but how important is it practically and clinically?

A second paper that makes the point:

2. Seltsam A, Agaylan A, Grueger D, Meyer O, Blasczyk R, Salama A. Rapid detection of JMH antibodies with recombinant Sema7A (CD108) protein and the particle gel immunoassay. Transfusion 2008 Jun;48(6):1151–5.

Summary: The German authors describe a method to detect anti-JMH with particles coated with recombinant semaphorin 7A, the protein that carries the JMH blood group antigens, presumably thus making identification of anti-JMH possible without having rare JMH-negative red cells.

Another blast from the past - John Milton Hagen. Was there a patient by this name like Mrs. Kellacher whose ani-K led to the discovery of the antiglobulin test by Coombs? I've forgotten.

Anti-JMH was once considered a high-titer, low-avidity (HTLA) antibody, now an outdated term. The phenomenon is caused by the low number of antigen sites on red cells, not by antibody avidity, and not all antibodies classified as HTLA have a high titre.

JMH antibodies are usually harmless, although they can cause serologists problems by hiding clinically significant antibodies, since they react with most red cells. Rare cases of people with a variant JMH phenotype producing a clinically significant alloantibody have been reported.

While it would be useful to be able to identify anti-JMH without having rare JMH-negative red cells, how important is it practically and clinically?

Related reading

Granted that these articles are cherry picked to serve a point, they do illustrate that sometimes research, even applied research, may have questionable technical or clinical relevance.
By happenstance, the June issue of Transfusion features the status of transfusion medicine in developing countries. Particularly noteworthy is this review paper:
The paper's conclusion begins by noting, Blood safety remains an issue of concern in Africa and especially in countries of Sub-Saharan Africa where the key factor to most transfusion-related problems is the lack of financial resources.
It ends with these words: .... this is one of the unfortunate paradoxes of the history of humanity: it is those regions most in need of the means to fight prevalent diseases that have least access to them.

Yet we in developed counties continue to spend resources on ways to improve titration reliability and identification of antibodies such as anti-JMH. Those who do such investigations are respected researchers who have devoted their professional lives to improving transfusion medicine. But how important are some of these initiatives in the grand scheme of things?

An earlier blog discussed this issue of the discrepancy between them and us:
The next time you read an article in a scientific journal - or if you are a researcher who is contemplating spending your valuable time and finite resources on investigating a problem, and you can choose from issues A, B, or C - I encourage you to ask, What's it all about Alfie?
The opening lyrics:
What's it all about, Alfie?
Is it just for the moment we live?
What's it all about when you sort it out, Alfie?
Are we meant to take more than we give.....
ADDENDUM- The nature of research

Unfortunately, research is often many tedious rounds of slogging it out with nothing working - until it does - should that happen. It may not. You cannot predict the result.

We can also differentiate between basic ("pure") research and applied research.

Pure research
, as historically done at universities, is typically driven by the curiosity of the researcher with no practical application in mind. The reason is to create new knowledge by following the researcher's interests and passions. Although sometimes denigrated as a waste of time and money by anti-intellectuals, basic research has often resulted in incredible, if unforeseen, benefits to mankind. For a fun peek into the lives of researchers see

Applied research, becoming predominant at universities (which some would argue is unfortunate) is more focused on solving particular problems. For example, medical research is typically applied research and compares various treatments or drugs to investigate which gives better patient outcomes. In a prospective experimental study, the researcher creates a null hypothesis (treatment A and treatment B are the same and will result in similar patient outcomes) and tests it by conducting experiments.

Often, research, regardless of its original purpose, results in unexpected, happy outcomes. For example, in the 1960s Baruch Blumberg was a geneticist (not a virologist) who was studying the genetic variation of proteins in blood. He and his colleagues decided to test the hypothesis that patients who received many transfusions might develop antibodies against polymorphic serum proteins which they had not inherited, but which the blood donors had.

Using double diffusion in agar gel they did find sera in multi-transfused patients that contained precipitating antibodies and in 1963 unexpectedly hit magic. When testing the sera of American hemophilia patients against that of an Australian aborigine, they found a precipitin band unlike any others and called it the Australia antigen.

Eventually, the Australia antigen was shown to be the HBsAg. In the process, one of Blumberg's technologist contacted hepatitis B. From this serendipitous discovery came tests for HBV infection and a vaccine. For the entire fascinating story, see

Unfortunately, HBV infection remains one of mankind's major diseases and killers.

Summary: Blumberg did not know if he would find antibodies in transfused patients stimulated by serum proteins in donor blood. Most particularly, he did not know that one of those proteins would be the hepatitis B surface antigen. And when he found it, no one knew what it was. My favorite quote about research is by Carl Sagan:
  • Somewhere, something incredible is waiting to be known.