As I got into it, I realized that something was amiss. Such reports simply do not exist in my own country (Canada) nor the USA, with which we share the longest border in the world between any two countries.
The blog's title comes from an old, iconic Red Rose tea commercial in Canada. Only in the UK and Down Under refers to the English-speaking world.
As most transfusion professionals know, SHOT, established in 1996, is the mother of all hemovigilance schemes and an exemplary example of transparency for blood transfusion systems worldwide.
It's also worth noting that blood transfusion in the developed world is safer than ever. When you examine hemovigilance reports you realize that Pogo was right. We have met the enemy and he is us.
Despite improved screening to prevent transfusion-transmitted diseases and the tainted blood tragedies of the 80s and 90s, and despite the massive effort to implement quality systems, we humans remain the challenge. The education and training of all health personnel is the single most crucial QSE.
SHOT 2010
Like all hemovigilance schemes, SHOT IS voluntary and gathers and investigates reports of adverse events, near misses and physiological reactions that may be linked to transfusion. Investigation of reported cases generally concludes, based on available evidence and its quality, that the adverse event (interpretations are mine)
- Had little if anything to do with transfusion (no evidence)
- Possibly resulted from transfusion (low-level evidence)
- Likely resulted from transfusion (good evidence but inconclusive)
- Definitely resulted from transfusion (strong evidence)
DEATHS
The worst first. SHOT 2010 includes 13 transfusion-related deaths, 3 in which transfusion directly and solely ('definitely') contributed. The putative contributory causes include:
- TACO: 6 (1 definitely, 3 likely, 2 possibly)
- ATR (acute transfusion reaction)*: 3 (1 definitely, 2 possibly)
- HTR (hemolytic transfusion reaction): 1 (definitely)
- Under-transfusion: 1 (possibly)
- Delayed transfusion: 1 (possibly)
- TRALI: 1 (possibly)
* ATR: Acute reactions occurring up to 24 hrs post-transfusion, excluding cases due to IBCT (incorrect blood component transfused), HTR, TRALI, TACO, TAD (transfusion-associated dyspnea) and bacterial contamination.MAJOR MORBIDITY
As well there were 101 cases involving major morbidity, 57 of which were classified as acute transfusion reactions.
CLASSIFICATION
Classifying cases is complex since adverse events and errors can be classified along multiple lines. Overall, of the 1464 cases in SHOT 2010, most (88.8%) fell into these categories:
- Acute transfusion reaction: 510 (34.8%)
- Involving anti-D immune globulin (RhIg): 241 (16.5%)
- Handling and storage errors: 239 (16.3%)
- Incorrect blood component transfused: 200 (13.7%)
- Inappropriate, unnecessary, under or delayed transfusion: 110 (7.5%)
Clinical: Lack of correct final identity check leads to an HTR (p. 21)
A patient with a haematemesis was in need of an urgent blood transfusion. The patient’s wristband was contaminated with blood and could not be read, and as a consequence the electronic bedside checking system was not used. The compatibility form filed in the patient’s notes, which belonged to another patient, was used to provide the identifiers for collecting the blood. The patient, who was group O RhD positive, was transfused with >50 mL of A RhD positive red cells prior to the error being recognised. The patient was admitted to ITU with intravascular haemolysis and renal impairment.Laboratory: Cord blood group allocated to wrong computer record, resulting in delay in administration (p. 65)
A cord blood group was correctly tested as RhD positive, but the result was erroneously uploaded to the maternal record on the laboratory computer system by a shift BMS [lab technologist] who did not normally work in transfusion. The error was only spotted when the clinical area enquired as to why there was no cord group available and why the maternal group was now showing as RhD positive.For fun: Related to incorrect blood components transfused, guess which area (clinical or laboratory) decreased its errors most compared to 2009. (Answer on p. 1 of the report)
DOWN UNDER
Both Australia and New Zealand have active hemovigilance systems that publish detailed public reports.
Australia
Australia produced its first report in 2008. The 2010 report deals with transfusion errors and adverse events that occurred July 2008–June 2009. The Oz hemovigilance system is not as mature as the UK system (no system is, at least in the English-speaking world) but the clear reporting and detailed case studies make for fascinating reading.
- 2010 National Haemovigilance Report (National Blood Authority)
The Kiwis produced their first report in 2005 and have a more advanced system than Australia's. For example, the NZ 2009 report includes antibodies involved in delayed hemolytic / serologic reactions and also donor adverse events.
For fun: Guess which two antibodies lead the delayed transfusion reaction list? (Answer on p. 24 of the report)
USA
The USA's Biovigilance Network was initiated only in 2006 and, so far as I know, has yet to publish public reports similar to SHOT, although data for individual diseases such as Chagas are available to AABB members.
- US Biovigilance website (part of AABB's site)
CANADA
What about my own country? On paper we seem to have a national hemovigilance system called TTISS but upon closer examination TTISS appears to be smoke and mirrors.
For example, the last published TTISS report available on the PHAC website is the
- 2004-5 TTISS report (and then only published in 2008)
Did the federal government decrease PHAC money at some point, so that it could not implement original plans for the hemovigilance system? Did PHAC decide hemovigilance was low priority compared to other public health issues?
Who knows? It's never discussed. Everyone just pretends.
Whatever the reason, Canada's blood system leaders may pretend that the emperor has new clothes, but it seems that TTISS has no clothes, much like Hans Christian Andersen's emperor.
Provincial government blood coordinating offices have TTISS programs and routinely state on their websites
- Data are disseminated regularly to stakeholders through TTISS Program Reports.
BOTTOM LINE
Kudos to the UK, Australia, and NZ governments and their respective blood systems for stepping up to the plate with hemovigilance.
But why do Canada and the USA lag behind when it comes to hemovigilance?
You can somewhat understand the USA situation. Unlike most countries in the developed world, it has a competitive, fragmented blood system involving multiple players.
As well, hemovigilance systems elsewhere are largely funded by governments, something some Americans on the right (or maybe even most Americans) equate with "socialized medicine" or worse, i.e., supported by delusionary 'commie pinkos' (big grin)
Still, the USA has a well developed blood system and it remains the richest country on earth. That its hemovigilance system is barely off the ground in 2011 is worrisome, if not to say pathetic.
But Canada's TTISS is inexplicable. Frankly, I'm embarrassed that we pretend to have a national hemovigilance system when we don't.
Maybe it's not that surprising. When it comes to hospital-based transfusion services, the feds have always employed smoke and mirrors.
In the early 2000s there was a big kerfuffle about government regulation of the blood system extending beyond blood suppliers to transfusion services. I even wrote about it:
- 2004 Letendre P. CSA Standards Z902-04:implications and issues. Blood Matters 2004 Jul;6(3):1–4.
We do not know why, but I suspect it's the government wanting to save money combined with a belief that transfusion service regulation is low priority, given that transfusion services must comply with standards to be accredited by provincial colleges of physicians and surgeons. This viewpoint may or may not be a valid argument.
But why the smoke and mirror pretence about hemovigilance? It's cheating. Makes me wonder what other deceptions our blood system leaders are conning us with.
JUST FOR FUN
Some golden oldies that seem to fit the federal government's modus operandi:
- Your cheating heart (Patsy Cline)
- The great pretender (The Platters)
- Who's sorry now (Connie Francis)
15 Nov. 2011: Just read an editorial in the Dec. issue of the BBTS journal, Transfusion Medicine:
- Roberts DJ. Public policy, blood safety and haemovigilance. Trans Med 2011; 21(6):357-8. Pub. online 14 Nov. 2011.
- accepting male blood donors who have had sex with men;
- desirability and practicalities of obtaining formal consent for blood transfusion.
"Both these recent decisions and the means to implement them depend directly or indirectly on a good quantitative analysis of the risk of blood transfusion. There could be no better illustration of the practical importance of reliable and comprehensive haemovigilance schemes. Establishing and maintaining such systems must be a priority for the development of safe and effective transfusion and transplantation services globally."As usual, the opinions are mine alone. Comments are most welcome.
Further Reading
UK
SHOT 2010 Educational Symposium (14 Oct. 2011):
"Transfusion - Are we over-reacting?" (Alison Watt, SHOT Operations Manager)
Stainsby D, et al. Serious hazards of transfusion: a decade of hemovigilance in the UK. Transfus Med Rev. 2006 Oct;20(4):273-82.Canada
Global shift towards increased biovigilance surveillance system. (CMAJ 2010. DOI:10.1503/cmaj.109-3195).
Pilot projects lay foundation for national tissue surveillance and traceability systemGLOBAL
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