Updated 1 Nov. 2012
This month's blog is about how much of the TM information we consume is meant to inform, how much is crafted to persuade, and how much info purveyors assume we’re owned by them, i.e., their poodles. The title is from a 1964 Lesley Gore song.
The blog was stimulated by 3 items:
1. Supposed news from new-medical.net in its 'Insights from industry' section:
- Blood banks: an interview with Celia Tombalakian, Worldwide Group Director, Immunohematology at Johnson & Johnson's Ortho-Clinical Diagnostics, Inc. (OCD)
3. Then I was reminded of a recent research paper by OCD staff published in AABB's Transfusion:
- South SF, Casina TS, Li L. Exponential error reduction in pretransfusion testing with automation. Transfusion. 2012 Aug;52(8):81S-87S.
Increasingly, I suspect that industry owns the transfusion medicine community. In a way, it's natural given that TM was healthcare but now is business and has been for awhile. Businesses depend on each other to survive. You scratch my back and I’ll scratch yours.
Today's AABB is more and more cosy with commercial interests, which is also natural given the reliance of the former on the latter for advertising revenues and conference support. Plus, as noted in earlier blogs, some AABB luminaries have close ties with industry. It's one big happy family.
The blog’s components - industry promoting automation via 3 mechanisms - are akin to a full court press in basketball in which industry pressures TM staff from every angle to buy into their false assertions about automation.
The blog's theme is how much industry thinks it owns us and attempts to baffle our brains with BS.
A common thread in industry’s automation initiative is to create false arguments. For example, manual methods have more processes than automation (true), therefore automated instruments have fewer chances for human errors to occur (true).
BUT… here’s the logical fallacy (the BS, if you will): Where do most serious TM errors occur? Are they related to manual testing?
Read and assess for yourself.
1. INTERVIEW
First note where this interview was published: news-medical.net
As with many so-called health sites, news-medical's business model is not immediately apparent without reading the fine print. And let's face it, that's the first thing we do when visiting a website, right?
Part of the 3239 word, 27 point,Terms and Conditions:
News-Medical hereby discloses that a commission or listing fee may be payable by Experts to News-Medical for any fees received by them as a result of an introduction of a client through the Website.Unsurprisingly, the site's underlying purpose is to sell stuff.
Besides industry news, news-medical, based in Australia, cheaply repackages health information from several sources, including a heavy reliance on Wikipedia under the Creative Commons Attribution-ShareAlike License.
Below is my summary of a few highlights of OCD’s Celia Tombalakian's interview with news-medical.net in question and answer format, with my comments, aka musings, in italics. Readers are directed to the full interview for exactly what she said.
The report is selective and my approach is facetious in places. But is it off the mark? You be the judge.
QUESTION: How is the blood banking industry currently being transformed?
CT's ANSWER
CT: Current focus is to improve transfusion safety and efficiency through technology solutions.
Ah, safety and efficiency, with safety mentioned first. Who can argue?
CT: Over past 20 yrs, the number of highly skilled technologists and scientists entering the global TM workforce has shrunk.
CT: Therefore, automation is becoming a standard part of blood bank laboratories because it eliminates many of the labor-intensive, time-consuming manual testing that requires specialized skills and significant experience to master.
Really? Her response implies that automation arose because of staff shortages, which misleads in a chicken and egg sort of way.
Why has the highly skilled technical and scientific TM workforce shrunk? Many reasons around the globe, inc. poor compensation for education involved (mainly USA), decreased health care funding, leading to regionalization and centralized testing, all facilitated by automation. Automated instruments continue to be marketed on their ability to decrease absolute numbers of highly skilled staff.
CT: Ultimately, automation can increase a lab’s capacity and help it operate more efficiently, even with a smaller staff.
A case can be made for how instruments are more reliable than humans, at least for some things. But notice there's no more mention of safety, only efficiency.QUESTION. Tell us about the new Bloodbanker App and its benefits over traditional blood banking tools.
CT's ANSWER
CT: ORTHO's Pocket Blood Banker app is an educational reference tool that combines genotyping and antibody indexing. Users can quickly determine genotypes based on results with Rh antisera via the Genotype Calculator and learn more about antibodies with the Antibody Index.
CT: Prior to the app, blood bankers used reference tools such as cardboard slide rules.
You gotta be kidding. Cardboard slide rules? Maybe that's what Ortho supplied customers back in the Jurassic age, but for decades I and many others taught MLS students how to determine Rh genotypes using their ... wait for it ... inbuilt computers, aka brains.
Reminds me of this exquisite Danish humour on computers: Medieval helpdesk
CT: Drawing from a deep understanding of the importance of and need for innovation in blood banking, OCD identified the need for more advanced tools and developed this new technology. The app reinforces our commitment to providing innovative solutions to our customers.
OMG, classic marketing and branding. We're wise, we're innovative, we're dedicated to helping clients. Please bring us cute babies to kiss.QUESTION: Could you introduce Ortho ON DEMAND and how it fits with OCDs overall focus?
CT's ANSWER
CT: ON DEMAND is an innovative virtual engagement platform that enables blood bankers to learn from and connect with experts on topics central to achieving science-driven safety and efficiency in the blood bank.
Attempt to reinforce Ortho's brand as innovative, Also love 'virtual engagement platform' and 'science driven.' Buzzwords convey modernity and objectivity, respectively. And note re-introduction of the safety and efficiency double whammy.
CT: With OCD’s strong TM history, we understand the importance of supporting industry through education and awareness.
We're the pros, we understand. Trust us.
CT: Because many of today’s blood bankers work longer hours with fewer financial resources, many laboratories have had to cut costs that previously supported career growth opportunities. Through our new platforms, we hope to help prepare blood bankers to address growing demands for TM expertise.
Excuse me? Labs have had to cut CE and CPD funding because staff work longer hours with less money? Does not compute. Pure bafflegab.
As for helping a growing demand for expertise, is there a growing demand for expertise? If so, it's to address what automation created in the first place, namely a diminished demand for technical and scientific expertise with fewer positions for TM specialists.
Frankly, automation and apps both contribute to and help alleviate a 'dumbing down' of the profession. I acknowledge that 'dumbing down' is a harsh catch phrase for staffing with less qualified personnel, not that such staff are dumb. I use the term to emphasize that apps do not contribute to developing expertise, but rather exist to alleviate lack of it.QUESTION. What impact do you think these initiatives will have on blood bankers?
CT's ANSWER
CT: Many of today’s blood bankers struggle to do more with less, working longer hours with fewer financial resources. Concurrently, instrumentation is more complex and the number of transfusions is increasing globally.
Meaningless bafflegab. Yes, cost constraints force blood bankers to do more with less.
But instrumentation is more complex? More complex than what? Earlier instruments? Manual testing? Do sales reps' spiels include these words? "Hey, our instrumentation is more complex. You need better trained dudes to operate it."
Also, in an age of blood conservation and a kazillion studies on real and unproven potential transfusion dangers, what evidence exists that transfusion numbers have increased? Does not compute.
CT: With reduced resources, many labs cut travel costs to learning events that could better prepare staff to address growing demands for TM expertise. Ortho ON DEMAND addresses this challenge by offering TM professionals free access to education according to their own schedules.
Offering free online education has merit. But it's not exactly true that today's over-worked TM professionals are clamouring to access education on their own schedules. Employers allot no time during work hours. Staff who are under-paid and feel under-appreciated are increasingly less motivated to take time away from families to further their careers.QUESTION: How do you think the future of blood banks will develop?
CT's ANSWER
CT: While technology has made many routine BB tasks faster and easier, the demand for blood continues to rise and the pace of processing blood continues to accelerate.
Demand for RBC transfusions (type that automated instruments process in transfusion service labs) is increasing? Where's the evidence? Surely all the efforts on blood management, blood conservation, and improved utilization are having an impact on RBC usage.
Pace of processing blood continues to accelerate? What does this mean? I could speculate but she doesn't explain.
CT: Hemovigilance and ensuring efficiency is of utmost importance to blood banks in maintaining a safe and accessible blood supply while keeping pace with accelerating demand for blood processing.
Sounds good but what has hemovigilance to do with OCD's automation and apps? And again the unexplained 'accelerated demand for blood processing.'
CT: The future of blood banks lies in technological solutions that will allow blood bankers to increase safety and efficiency in order to provide the best possible outcomes for patients.
Motherhood statement. But where is the evidence that automated ABO and Rh group testing and automated antibody screening have improved outcomes for transfused patients? Or that apps that generate Rh genotypes and describe antibodies have made a difference?
Surely, getting patient identification correct when drawing blood samples and correlating patient identity to crossmatched donor blood when administering blood remain THE hallmarks of safe transfusion practice, the 'right patient, right blood product, at right time' mantra.QUESTION: What are OCDs plans for the future? Would you like to comment further?
CT's ANSWER
OCD is the global leader in Transfusion Medicine, stemming from a 70-year history of protecting the safety of the worlds blood supply. We intend to continue our leadership of the market into the future, both with our products and through our service and support of the blood banking community.
Forgive me, but I'm jaundiced. Although I've known, liked, and respected many Ortho reps, having just read Blood Medicine (aka Blood Feud) about Ortho Biotech and Amgen's marketing of EPO products, protecting patient safety as applied to J & J or any Big Pharma company rings hollow.2. WEBSITE
Author Q & A
Simply put, Ortho ON DEMAND offers varied worthwhile educational talks by respected TM professionals, but promotes automation. To illustrate, the first 4 talks in its Presentation section are about automation.
I'm reminded that Ortho and its competitors such as Immucor operate on a razor-blade business model: cheap razors (instruments), with the real money made on expensive blades (reagents).
3. RESEARCH PAPER
This paper by OCD employees further shows how industry treats TM professionals like poodles, hoping to baffle brains with BS.
- South SF, Casina TS, Li L. Exponential error reduction in pretransfusion testing with automation. Transfusion. 2012 Aug;52(8):81S-87S.
Casina TS. Technologies to improve the future of blood banking. Med Lab Obs 2011 Oct;43(10):32. Excerpt:
- 'As the labor force shrinks, the rapidly evolving field of laboratory medicine is struggling to keep pace with the growing demand for blood and its components. Automation is becoming a standard part of blood bank laboratories because it can help eliminate the labor-intensive, time-consuming manual testing processes that require specialized skills and significant experience to master.'
Casina TS. What's new in transfusion services. Advance for Med Lab Professionals. Posted online 19 Sept. 2012. Excerpt:
- Transfusion of incompatible blood has the greatest potential for severe adverse events and health complications, including death. Fortunately, due to advances in transfusion medicine (TM) practices -improved blood testing, donor screening and the advent of automated systems - the blood transfused to patients is safer today than it's ever been.
- A study conducted by Ortho Clinical Diagnostics provides quantitative evidence of how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thereby improve the safety of blood transfusion. Evaluating the common testing methods above and leveraging failure modes and effects analysis (FMEA) to compare error potentials, the group concluded that automation significantly reduces defect opportunities in pretransfusion testing and could dramatically improve blood transfusion safety.
BACKGROUND: Human error associated with manual pretransfusion testing is a cause of transfusion-related mortality and morbidity and most human errors can be eliminated by automated systems.
STUDY DESIGN AND METHODS: Study’s goal was to compare error potentials of commonly used manual (e.g., tiles and tubes) vs automated (e.g., ID-GelStation and AutoVue Innova) group and screen (G and S) methods. G and S processes in 7 TS labs (4 with manual and 3 with automated methods) were analyzed to evaluate error potentials of each method.
Tiles? Really? Well, they could be large welled plates. But who uses these in routine manual pretransfusion testing?
RESULTS: Manual methods contained more process steps ranging from 22 to 39; automated methods contained 6 to 8 steps.
Roughly 4-5 times more steps for manual methods. Authors then use ‘risk priority numbers’ (RPN) - trust me, you don’t want to go there - to show manual method RPNs ranged from 5304 to 10,976 vs 129 and 436 for automated methods, conveniently making manual tests away more than 4-5 times as risky as automation.
What the hey! Let's go there. A team (needed to reduce subjectivity) of OCD researchers and staff at 7 TS labs determined how many defects were likely at each process step (defect opportunities) and decided where failures could occur, the likelihood that the failure would be identified, how frequently the failures might occur, and what the effects of those failures (severity) were. The result was a 10 point scale. An example:
Process Step 16 (tile or plate required tapping and rocking before reading reactions) had 18 defect opportunities. 18 represents 6 wells in the tile or plate in which it was possible to undertap reactants (6 defect opps), forget to tap the plate (6 defect opps), or overtap and splash reactants among wells (6 defect opps) for a total defect opportunity of 18 at that step (6 + 6 + 6 + = 18). The severity was rated 7 out of 10.
Wow! Talk about creative number crunching to get the results you want. The mind boggles....
CONCLUSION: This study provided quantitative evidence on how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thus would improve the safety of blood transfusion.
Oh sure. Is I or is I not your poodle?MORE MUSINGS
This study’s logical fallacy posits (love that word!) that most, or even many, serious transfusion errors result from manual testing of ABO and Rh groups and manual antibody screening. It's true that manual testing has potential to create more errors than automated testing.
The best evidence of where TM errors occur comes from the UK’s annual SHOT Reports. For example, consider
I’ll not bore you with too many specifics - you can read for yourself - but believe me, it’s NOT all about lab staff making technical errors when manually testing.
'Adverse reactions caused by errors' lists these causes of cumulative cases reviewed 1996-2011 (n=9925):
- Anti-D errors
- Inappropriate & unnecessary
- Handling & storage errors
- Incorrect blood component transfused (n>3000)
- Taking the blood sample from the correct patient
- Correct laboratory procedures
- Issuing of the correct component
- Identification of the right patient at the bedside at the time of transfusion
- It is clear from the SHOT 2011 data that identification of the correct patient remains a key issue and that this must become a core clinical skill.
So, what's it all about? Yes, automation can increase efficiency and increase safety by reducing human error. But is automation the TM saviour that industry reps and some TM professionals make it out to be?
When you examine the arguments of proponents, such as OCD's Celia Tombalakian or the research of OCD employees, their arguments do not stand up to scrutiny. They continually overstate how automated testing can improve safety and propose it as magic it is not.
Companies have a vested interest in promoting automated testing since the business model of cheap razor (instrument) and expensive blades (reagents) is what makes their industry viable.
Their multi-media advertisements are relentlessly promoted to TM professionals using flawed arguments that show they think they own us and we are their poodles.
FOR FUN
Industry's seeming hold on so many TM professionals brings to mind:
- You Don't Own Me (1964 ditty by Lesley Gore; this version in Australia, 1989)
- You Don't Own Me (Same song re-worked for 2012 USA election - thoroughly partisan. ALERT: Depending on your politics, you may be offended.)
- You Don't Own Me (Diane Keaton, Bette Midler, Goldie Hawn in 1996 movie The First Wives Club)
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