Showing posts with label SHOT. Show all posts
Showing posts with label SHOT. Show all posts

Monday, October 13, 2014

Bridge over troubled water (Musings on what to be thankful for as TM professionals)

Updated: 4 Jan. 2020 (Updated song's link)

Apparently being thankful can improve your life. A professor of psychology at the University of California says so. It must be true (she wrote with tongue in cheek). Actually (and I hate writing or saying 'actually' after hearing a news reporter begin every sentence with it), I suspect it's true in most circumstances. Not necessarily when linked to being obsequious, though.

I had earlier written another blog for October on a topic I often blog about (two guesses - see below) but rethought it, especially since it's Canada's Thanksgiving today. Accordingly, this month's blog is about three things I feel thankful about it in the world of transfusion medicine and two that I don't.

Despite the Canadian references, transfusion professionals worldwide should be able to relate. As you read, I encourage you to think about your career and assess if any of my musings agree with yours.  Please feel free to comment.

The blog's title derives from 1970 Simon and Garfunkel classic, one of my favorites.

TOP THREE 'THANKFULS'

#1. Career in Transfusion Medicine
My life in TM began by accident and I never should have been hired. I was a high school teacher who wanted to work in Winnipeg but jobs were hard to come by for a 21 year old with a year's experience teaching in a rural Manitoba 4-room high school.

Lo and behold - a friend said, 'Pat, Canadian Red Cross Blood Transfusion Service hires BSc grads because most med lab tech grads from Red River Community College are scared to work there.' Say, what? I later learned the fear was largely because the clinical rotation was pathetic. Students spending most time labelling tubes and similar scut work in between being told by technologists to get the ABO group right or they could kill a patient. Did I mention the clinical rotation was only 2 weeks then?

Soon I started work in a large combined blood centre and transfusion lab, the latter doing compatibility testing for all city hospitals and beyond, plus prenatal testing for northwestern Ontario. At first, I did not even know what the yellow stuff was when the red cells settled. True story. Could never happen today, a good thing.

I'm so thankful for the mentoring of generous colleagues. And for wanting and needing to read the 'bibles' of TM from front to back (every word). The books were penned by such icons as Issitt and Mollison, and included the AABB Technical Manual and a 'little red book' written for Red Cross staff by Dr. B.P.L. (Paddy) Moore (and others), National Director of the Red Cross Blood Group Reference Laboratory, who died in 2011. I wrote about Dr. Moore in a 2007 blog, 'My life as a blood eater.'

I worked in Winnipeg for 13 years, got Subject certification in Transfusion Science (no longer offered) from what is now CSMLS. My last 3 years were as the clinical instructor for new laboratory staff, RRCC students, and medical residents doing a transfusion medicine rotation in the only show in town. How crazy is that?


Looking back, I'm thankful that I worked in a busy laboratory where you never knew what to expect. Besides the routine of pretransfusion testing for scheduled surgery and anemic patients, at any time 24/7 patients might need massive amounts of blood in a hurry from a ruptured aneurysm to a GI bleed to a placenta previa during delivery. Often the lab was chaotic but it was organized chaos, even if that's an oxymoron.

Moreover, I'm thankful that in those days work was mostly hands-on and issues arose daily that required problem solving. For example, I worked with Dr. John Bowman when he did the first trials of antenatal Rh immune globulin and was involved in the work that led to this paper (I'm the Pat mentioned in the paper):
Eventually the blood donor side of the laboratory got an autoanalyzer, the Technicon BG-15. We called it 'Big George' and two staff (probably closet chemistry technologists at heart) opted to become 'specialists in automation'. Can you see the irony?
For an absolute hoot, when you have some time for 'mindfulness' reading, see these articles from 45 years ago by Canadian Red Cross staff, including Dr. B.P.L. Moore. The second includes, 'The possible future role of automated tests on blood donations is briefly discussed.' (Emphasis is mine.)
As to my career, the rest is history.... I'm thankful that I lucked out getting a teaching job in Medical Laboratory Science, University of Alberta, where I had the privilege of again working with generous, talented colleagues and teaching 100s of bright, inquisitive students, who kept me on my toes and forced me to keep learning. To be honest, at MLS I believe I had the best job teaching blood bank in the entire world.

Thinking about a career, particularly in later years, makes you realize how lucky you have been. I'm thankful to have worked in the trenches of blood banking doing work that made a difference and then to have gotten a job where that knowledge and skill could be passed to others. I hope that's true for you too.

As an aside, I'm thankful that I learned how to create web sites before it was easy (and you needed to know html code), which has stood me in good stead over the years, especially after I left real work. 

#2. Living in Canada

The good points of living in Canada are obvious, but that's not where I want to go. I imagine residents of many countries feel privileged for various reasons.

Instead, in keeping with the transfusion theme, I'm thankful that today Canadians are free to criticize CBS and our blood system leaders. Goodness knows, I do plenty of that and live to write another day.

October's TraQ newsletter has examples of criticism and responses to it:
In olden days, medicine was so paternalistic that physicians had god complexes. Some still do but times have changed, not just among health professionals but between doctors and patients, as in this 2011 Maureen Dowd column in the NY Times:
In many countries criticism of perceived authority is not allowed. And in some democracies health care workplaces exist where questioning prevailing orthodoxy, especially by those lower in the pecking order, is discouraged, even risky, career-wise. I'm grateful that's not true in Canada's transfusion medicine community, at least not the one I've been fortunate to work in.
#3. UK's SHOT
The UK's haemovigilance scheme (why is everything in UK TM a 'scheme'?), known universally as SHOT (Serious Hazards of Transfusion), is a world leader in hemovigilance.
Note, I've dropped the 'ae' diphthong, which still rears its ugly head in Canada, a carryover from transplanted Brits running our blood system. (big grin).
I'm thankful for SHOT, a godsend to TM professionals globally and one of the best tools for education and quality improvement ever. As an educator, I use it repeatedly to make instruction real to students and professionals alike.

The prior blog discussed an example from the 2013 SHOT report on how errors occur and touted it as a great CE resource. 
  • Stand by me (Musings on effects of errors on transfusion professionals)
I've mentioned SHOT again in order to emphasize one of the 'Bottom Two' issues below that I'm NOT thankful for.

One of the best parts of SHOT's reports are its case studies, which detail exactly what went wrong and provide learning points. As but one example from SHOT 2013:

  • Case 3: ABO incompatible transfusion despite a robust system of warning alerts on the laboratory information management system (LIMS)
  • Search for 'Case 3' (without the quotation marks)
Excerpt:
" An ABO incompatible red cell unit was transfused resulting in a haemolytic transfusion reaction. The blood was issued using an emergency protocol on the LIMS, which was not appropriate for the non-urgent clinical situation, and the computer warning flag stating that the units were incompatible was overridden several times by the biomedical scientist (BMS).

This incompatibility was not noted at the bedside and when the patient reacted to the transfusion, the doctor who was consulted advised that the transfusion should continue without reviewing the patient. The patient developed acute and delayed haemolysis, but no long-term sequelae."
Good stuff, no?

TWO NOT-THANKFULS
To give the blog a dash of hard cold reality and move from 'Kumbaya' territory, two TM realities I'm not grateful for:

NOT Thankful For #1
Canada's lack of a hemovigilance reporting similar to SHOT, where TM practitioners and educators alike, can see how our TM system is doing. Oh wait! Instead of the usual archived SILENCE, all of a sudden, TTISS is online with  - wait for it - summary tables:
Okay, I guess we should be thankful for small mercies. We're keeping statistics, so will be able to measure improvement. And finally a public report on all the data that's been collected, even though no news media have picked it up, hence no citizens will even know. Plus, no real details, no analysis. Baby steps...

For interest, I blogged about Canada's lack of hemovigilance reporting in 2011:
NOT Thankful For #2
Health Canada's stonewalling on Ontario's paid plasma clinics. I've blogged about this many times. HC's public consultation from April 2013 has transmogrified into SILENCE as 2015 approaches. Hmmm...

The one thing perhaps to be grateful for is the hope that 'no news is good news.' Not holding my breath.

LEARNING POINTS
1. I hope all readers can say they love their careers as I love mine. In some ways the 20th C was a golden age, especially for those of us who love immunohematology.

Work is something we do, first to provide essentials like shelter and food, second to be able to appreciate the good things in life that aren't free, and third, to make a difference in the world - to make life better for each other.

TM professionals are truly fortunate to love going to work each day and to be able to question authority. For so many on the planet that's not true. Best of all is knowing we make a difference, each in our small way. It's captured by Mary Oliver in her poem, The Summer Day:
'Tell me, what is it you plan to do
with your one wild and precious life?'
2. Where we live is an accident of birth. We in the industrialized west are so fortunate. Search Google's images for 'children garbage dumps' for  1000s of examples. Or people who say homosexuality should be accepted or places where female genital mutilation commonly occurs.

3. Some national blood systems spend time, energy, and money on improving transfusion practice and generously share it with the rest of us. The best example is SHOT, funded by the UK Blood Services. Kudos to NHSBT. Wish Canada and the USA would do more of the same. Hope springs eternal...

FOR FUN
What was my original Oct. blog's topic? Two guesses (my favorite 'hobby horses'):
A. Paid plasma clinics
B. HIV/AIDS
For  clue, look at TraQ's Oct. newsletter.
Now, on to the fun music selections. On the two TM issues I'm NOT grateful for, the song that comes to mind is Simon and Garfunkel's 1964 classic, 'The Sound of Silence,' #156 on Rolling Stone's list of the 500 Greatest Songs of All Time and one of the most covered songs of the 20th C.
On the three TM realities I am grateful for, the chosen song is another Simon and Garfunkel classic, 'Bridge Over Troubled Water' released in 1970, ranked #48 on Rolling Stone's list of the 500 Greatest Songs of All Time.

Why? Mainly because I'm grateful for this song and appreciate its lyrics.
Also, because one of the best things in life is to be grateful for our friends.
When you're weary, feeling small,
When tears are in your eyes, I will dry them all.
I'm on your side. When times get rough
And friends just can't be found,
Like a bridge over troubled water
I will lay me down.
As always the views are mine alone and comments are most welcome. Does any of this ring true? What are you grateful for these days?

Added 25 Nov. 2014

In reply to Anonymous, who notes Globe and Mail article:
Another article from Toronto Star on the news:
Seems CPR will try to open paid plasma collection centres in western Canada, likely BC or Alberta [vs Saskatchewan or Manitoba, where a paid plasma clinic exists in Winnipeg, but for plasma containing special antibodies, e.g., anti-D to produce Rh immune globulin)] because of their larger populations and openness to private medical facilities.

About CPR collecting plasma for research purposes in Ontario, I agree it would be interesting to see the protocol and informed consent for such a proposal. Thanks for the comments.

Added 3 Nov. 2014


In reply to Anonymous, who writes about introducing paid plasma clinics in Ontario:
  • "Policy decisions of this nature should not be made without hearing from those who are affected the most by the legislation: that is, the recipients of plasma-derived medicinal products represented by their associations”:
For reference, PPTA is Plasma Protein Therapeutics Association. PPTA represents the private sector, collectively known as plasma protein therapies and the collectors of source plasma used for fractionation. In other words, PPTA represents a part of Big Pharma whose business involves collecting, manufacturing, and selling blood-derived plasma products.

The link provided by Anonymous is to a paper in the Fall 2014 issue of The Source, a PPTA publication:
Page's article is PRO PAID PLASMA (my interpretation): Today's products derived from paid plasma  are safe and all user groups want paid plasma because they buy the premise that, without it, their lives are at risk.

Interesting that PPTA's Fall 2014 issue of The Source includes David Page's article, as well as an article by CBS CEO Graham Sher:
Dr Sher's take home message is the same as he's espoused in Canada;
  • [Paid plasma] is an issue of public policy, not product or patient safety.
  • Pharmaceuticals made with plasma from paid donors are safe, lifesaving products for patients in Canada and around the world.
  • Canadian Blood Services remains committed to voluntary donation for its donors.
Sher's article is PRO PAID PLASMA (my interpretation): Because paid plasma is safe, to use it or not depends on government policy.Without paid plasma, people would die. But, hey, CBS is committed to a voluntary blood system. 

The PPTA would not publish articles that were anything but PRO PAID PLASMA. 

Further Reading


Sunday, September 07, 2014

Stand by me (Musings on effects of errors on transfusion professionals)

Updated: 9 Sept. 2014
Recently, I browsed the Speaker abstracts and Poster abstracts for the BBTS annual conference to be held 24-26 Sept. in Harrogate, UK. The abstracts were published online 26 August 2014 as free full text. At the same time, I happened to be reading the UK's 2013 SHOT Report published in July. One abstract and a section of the 2013 SHOT coalesced to form the idea for this blog.

September's theme relates to all transfusion professionals, whether lab technologist/scientist, nurse, or physician. The blog’s title derives from a 1961 song by Ben E. King, covered more than 400 times and featured in a 1986 movie of the same name.

Of all the fascinating BBTS abstracts, the one chosen to build a blog around is under 'Clinical Audit/Service Improvement Short Paper Orals':
  • SI27. An exploratory research study into the effects of staff feelings and perceptions following a transfusion incident investigation. Transfus Med 2014;24 (Suppl. 2):19. 
    • By D. Creighton (SNBTS Edinburgh) and M. Wright (Glasgow Caledonian University, Glasgow)
The reason this abstract resonates is that in a long career as a lab technologist, supervisor, and educator I've been involved with and privy to many serious transfusion errors and their effects on the professionals involved.

What follows are my musings on the BBTS abstract and related personal memories, as well as what the 2013 SHOT Report says about causes of human error. The focus is on the effects that errors have on those who make them, realizing that it is patients who suffer irrevocable, sometimes fatal, consequences.

As an aside, with a background as a medical laboratory technologist (biomedical scientist) and transfusion science educator, what I like about the 2014 BBTS meeting is how many talks and posters directly relate to transfusion professionals who work in the laboratory.

2014 BBTS MEETING ABSTRACT
As noted, the abstract that stimulated the blog is by D. Creighton and M. Wright of the SNBTS Edinburgh, and Glasgow Caledonian University, Glasgow, respectively. Please read the complete abstract (Further Reading). My précis of it is as follows:
  • Most research on transfusion errors focusses on procedural errors, not human factors or staff emotions. This research examined the emotional impact of errors and contributing factors.
  • Researchers recruited and interviewed staff involved in a transfusion error and analysed results.
  • Of 12 staff, five agreed. The main human factors acknowledged by four participants were distraction and a busy work environment when the error occurred. 
  • All five expressed disbelief they had been involved.
  • Four were affected emotionally, experiencing insomnia and decreased confidence. 
  • Most worried about confidentiality and other staff knowing they’d made an error. 
  • Support was mainly positive but two participants experienced negative reactions from colleagues. 
  • All learned lessons which they would carry forward and share with colleagues. 
  • Participants’ reactions directly correlated to error severity and potential patient outcome.
The authors conclude that human factors need to be included in training packages. Reactions and feelings of staff involved in errors can be overwhelming and support is crucial.

MUSINGS
With the advent of quality systems and hemovigilance, transfusion medicine has long had a no-blame culture (at least in theory), as have health care systems in general. For example,
A no-blame culture is critical for patient safety. Health professionals must feel comfortable with reporting errors, including their own, so that hemovigilance and quality improvement programs can detect, analyse, and help prevent them in future. In an effort to encourage error reporting, we use blame-free terms such as events, incidents, and occurrences. Despite the talk, 'walking the talk' of no-blame attached to individuals who make errors is a tough slog.

PERSONAL MEMORIES
Below are two memories of transfusion-related errors I was involved in with serious consequences.

Memory #1 
Years ago when working in a combined centralized transfusion service/blood centre, one weekend when on shift by myself, I crossmatched a group AB patient for several RBC. The following Monday I was also working when the call for more blood came through. We had to order a new specimen as there was no more patient serum. (Yes, in olden days we routinely used clotted blood samples for pretransfusion tests and even patients without clinically significant antibodies were crossmatched by indirect antiglobulin test and more.)

Much to my horror the patient now typed as group O. I’m sure my entire insides shook as a colleague redid the patient’s ABO on the earlier sample. Absolute personal relief when it typed as group AB.

The transfusion service did the usual follow-ups. Called to stop any transfusions, asked how many RBC had been transfused and if patient was experiencing any signs and symptoms of a hemolytic transfusion reaction, requested new blood specimens, etc.

The patient experienced a severe hemolytic transfusion reaction but survived.  It’s amazing how resilient the human body is, even for those ill enough to be transfused:
We later learned that a hospital nurse had drawn the blood specimen from the wrong patient. Both the group AB and O samples came from patients in the same hospital room. And the RN in question was the highly respected liaison we dealt with at that hospital, the one who drew many of the blood samples and maintained the onsite ‘blood bank’ (refrigerator and associated request forms and records).

The effect on the implicated RN is unknown. Was the patient's family told what had happened? I doubt it. The effect on me - I’ll never forget it. 

If I had mistyped the first specimen, would I have been fired, even though it was the first ‘critical incident’ (or any error) I’d been involved in? Perhaps. That was a long time ago, pre-quality systems, when the concept of ‘system error’ was unheard of in health care. We were not unionized and worked long (indeed outrageous) hours without time off.

But before being fired, I suspect that I’d have resigned from the guilt and shame of having made the biggest error a lab technologist can make, mistyping a patient’s ABO group and putting a patient's life at risk. Because ABO errors can cause death, they require 100% accuracy, no room for error. Could counselling have helped? Maybe. Even more important would be the support, understanding, and ongoing respect of colleagues.

Of interest, the 2013 Annual SHOT Report reports 9 ABO incompatible red cell transfusions in 2013 and one patient death with the incompatible transfusion as a contributory factor.

Memory #2 
Much later, while employed as a university professor and clinical instructor for the transfusion service at a tertiary care hospital, one of my students made an error that caused a patient’s premature death. The error per se did not cause death but hastened it.

What was the error? Something so simple. Something that can happen if concentration wanders, or strategies are not in place to prevent them, or practitioners don’t follow procedures.

While performing antibody screens, the student mis-pipetted one patient’s serum into another patient’s tests. As a result the patient was transfused with incompatible red cells and subsequently died. I documented the error as a TraQ case study for the BC Provincial Blood Coordinating Office.

Although not directly involved with the error (the student was supervised by an experienced, exemplary technologist), I observed the aftermath first hand. The main effect was that the experienced, supervising technologist, one of the best, with great potential, soon left the lab for a career outside health care. Could this have been prevented? With proper support, I believe so.
  • TraQ's Case A8: Severe Hemolytic Transfusion Reaction Involving a Student (see Further Reading)
MAKING MISTAKES
When we make mistakes, our first reaction is to deny them. For example, as an instructor I noticed that students who made pipetting and other mistakes would invariably claim something like, “I KNOW I added the right things’, where ‘things’ could be patient serum, reagent red cells, etc. My response was always,
  • ‘Of course, you thought you were adding the right things to the tests. If you knew you were adding the wrong things, you’d stop and would not add them.’ 
Fortunately, because such errors are often easy to demonstrate, students could accept their errors, learn from them, and move on.

Sometimes, especially as students, we progress to blaming circumstances for our errors. And sometimes circumstances do play a role as when staff are overworked, morale is poor, and training and competency assessment are inadequate. These are the so-called system errors where the system is faulty and affects all involved.

2013 SHOT REPORT
A fascinating feature in the 2013 Report is the inclusion of the MHRA hemovigilance team's analysis of serious adverse events (SAEs) reported to Serious Adverse Blood Reactions & Events (SABRE).
  • Medicines and Healthcare products Regulatory Agency (MHRA) Report on Blood Safety and Quality Regulation in 2013 (See pp. 27-41)
In 2013, 2.9 million blood components were issued in the UK with only 705 SAE reports submitted. Human error accounted for 689 (97.8%) of the SAEs, where an SAEs is defined as
‘Any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.’
In brief, reports to SABRE showed that those making errors were aware of their local SOPs, which were complete and current. Individuals were either busy with urgent work when the error occurred (especially during out of hours shifts), or were otherwise distracted. In either case the result was an error due to a lapse in concentration.

Of all reported human errors, a lapse in concentration was the largest single cause, accounting for 35.6% (245/689) of errors. The next largest category related to omitting procedural steps or not following the correct procedure. About two thirds of all SAEs could have been prevented had correct procedures been followed.

The advice that especially caught my attention in the MHRA report:
  • Formal re-training is often proposed as a corrective measure but is usually only appropriate if the individual did not understand their initial training. If a trained, competent member of staff makes an error, the root cause will seldom, if ever, be addressed by re-training. 
  • Look for other reasons for the error, e.g., for an error due to loss of concentration when rushing, investigate why the staff member was rushing. Possible causes include a busy workload due to an emergency, poor planning, staff shortages due to lack of resources, or poor staff management
Being rushed is a reality for health professionals, now more so than ever. A major complicating factor has long been staff shortages and under-staffing caused by repeated health care restructuring, ongoing cutbacks to postsecondary education and health care, and more.

LEARNING POINTS
When errors happen, we in the TM community espouse a ‘no blame culture’. Sometimes it’s real, sometimes it’s pretence, in that, despite the nice words, staff are blamed and stigmatized.

But as the BBTS meeting abstract shows, we typically don’t consider the emotional effects of making errors on those involved. It’s all cool root cause analysis, perhaps targeting ‘system error’ as the culprit, but more often resulting in ‘training issue’ as the catchall for whatever goes wrong.

How the staff involved feel is seldom considered and, besides re-training, their emotional well being is largely ignored. At most a caring colleague might ask, 'Are you okay?' with the individual involved seldom replying honestly.

No-blame culture aside, making errors devastates health professionals and undermines confidence.  In some ways, that’s preferable to brushing off errors with, ‘Oh well, sh*t happens’. But without support, a serious error can have long-lasting negative effects on individuals and co-workers alike. Even well meaning colleagues may be critical, never overtly express it to those involved, thinking it could never happen to them, or secretly thinking, ‘Thank gawd that wasn't me!’

A critical issue is that we acknowledged making errors as human. If we haven’t made one yet in the lab or on the wards, we likely haven’t worked long enough. Or is it that we are perfect? Hmmm…. Tempted to say, ‘Let he who is without sin [error], cast the first stone.'

In that vein, I love this BMJ piece:
As an instructor I tried to model these words to show students it’s okay not to know. Who can know everything with today’s rate of knowledge turnover and technological advances? Don't know? Let’s find out.

Maybe we should add, ‘I made a mistake’ as three words we acknowledge but don’t let define or destroy us.

FOR FUN
We’re all in this world together and must support each other, especially when the going gets tough. As health professionals, any one of us is capable of making a devastating error. Support and compassion are not only kind but validate our humanity.

Think of this song the next time a colleague screws up. Could be you, yes it could.
I'll end by asking you to find 19 minutes to watch Dr. Brian Goldman's TED talk on physician error. That may seem a lot of time in our busy lives but think of all the time we waste on the Internet and television each day. You won't be disappointed with Goldman's talk. His message applies to all of us. Perhaps you can listen to it on your next walk or jog or over lunch?
As always the views are mine alone and comments are most welcome.
FURTHER READING
Meeting abstracts and resources like SHOT reports and TraQ's case studies are free continuing education and a great way to keep abreast of new developments and what’s trending. They make great bathroom (toilet/loo) reading to while the time away so that life’s baser functions serve a higher purpose.

Why not skim them online and then print content of most interest for later reading? Or print for discussing at staff meeting or journal clubs. Do journal clubs even exist any  more?

Wednesday, October 31, 2012

You don't own me (Musings on TM professionals as industry's poodles)

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:
2. The article motivated me to visit OCD's 'On Demand' website and register to see its offerings. 

3. Then I was reminded of a recent research paper by OCD staff published in AABB's Transfusion:
BACKGROUND
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.
Author Q & A
2. WEBSITE

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. 
Interestingly, one of the authors, TS Casina, an OCD marketing manager, also penned these 3 articles:

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.
Casina TS. References for "transfusion medicine reactions. Advance for Administrators of the Laboratory 2012 Oct;21(10):20. This paper is a reworked version of the one above. Excerpt: 
  • 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.
Can you see how marketing managers use a full court press and recycled material (with the help of willing publishers desperate for articles) to get their message out to industry's poodles, namely us?
Abstract Highlights (Transfusion paper)
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)
To quote SHOT: Key lesson from 2011 is an emphasis again on the importance of the essential steps of the transfusion process:
  • 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.
BOTTOM LINE
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 (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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Wednesday, November 09, 2011

Only in the UK & Down Under? Pity! (Musings on hemovigilance)

The UK's Serious Hazards of Transfusion (SHOT) report for 2010 became available in the summer, and I thought a blog on its key findings was in order before 2011 ends.

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)
So, what are the highlights of SHOT's 2010 report?

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%)
Another way to look at incidents and cases is to assess if they originated in clinical areas or transfusion service laboratories. I encourage you to read these sections of the report, which contain many valuable tidbits, or 'learning points' as the report calls them. Two examples:

 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.

New Zealand

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.
Of note, before 2006 the USA was one of the only developed countries in the world without a national hemovigilance program, just as it's one of the few without universal health care.

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
What gives? Either we have a national hemovigilance system or we don't. Is it another case of phantom transfusion committees that meet now and then to document they exist but never really do anything of substance?

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.
Really? The links go to the PHAC site with the most recent report the one for 2004-5. To call them 'reports' is farcical as they consist of an introduction and table of contents. Who is kidding who?

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:
At the time the TM community believed that CSA Standards applicable to transfusion services would become government regulations within approximately 2 years. That did not happen and has not happened yet, 7 years later.

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:
Will those responsible ever say "I'm sorry"? I doubt it.
ADDENDUM

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.
The editorial discusses the focus of the Dec. issue, i.e., SaBTO's recommendations on
  • accepting male blood donors who have had sex with men;
  • desirability and practicalities of obtaining formal consent for blood transfusion.
The author concludes:
"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 system
GLOBAL

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