Thursday, November 24, 2016

Don't stop (Musings on government regulation as a TM disruptive force)

Updated: 25 Nov. 2016
November's blog was stimulated by a Dark Report about an Australian conference on medical laboratory professionals exploring disruptive forces in healthcare (Further Reading). 

This will be the first in a series exploring disruptive forces that have and still affect, or will affect, the practice of transfusion medicine (TM) and its diverse practitioners. Each blog will deal with one disruptive force and its related aftermaths.

What is this blog about and why might you want to read it? It requires more than the cursory scan you no doubt give most of the info overload you receive daily. But if you want to understand, truly 'dig' current transfusion realities, please consider giving it a read.

Executive version (over the long haul of all the blogs in the series):
  • At heart, the blogs are designed to combat 'BS baffles brains';
  • Because disruption affects all transfusion professionals, I hope you see its relevance to your practice;
  • Sub-aims include being able to 
    • Differentiate disruptive forces from normal progress;
    • Identify beneficial forces from those worth resisting;
    • Make the most of positive disruptive forces to improve patient care and safety.
In the 'management speak' ubiquitous in blood supplier annual reports, the last aim would be to leverage disruption and create a centre that drives not just leading or bleeding edge innovation but innovation that leads to transformative change.  

The blog's title derives from a 1977 ditty by the Brit-US rock band, Fleetwood Mac.

INTRODUCTION
Disruption has been in the news a lot lately given the unexpected UK Brexit vote and Donald Trump's election as US President. A recent search of Google news stories for ''disruptive forces'' yielded 8,830 hits.

For decades now we've seen disruption in many aspects of our daily lives. A few examples, and I bet you can name even more:
  • Personal computers disrupt mainframes;
  • Apple's Macintosh WYSIWYG OS disrupts command-driven MS DOS; 
  • Internet disrupts everything;
  • Cable TV disrupts the networks;
  • Google disrupts libraries and the publishing industry;
  • Streaming services like Netflix disrupt DVD rental stores;
  • Apple's iPod disrupts music industry;
  • Uber disrupts taxis;
  • Airbnb disrupts hotels.
The list is endless. Disruption is big in the business world too, witness a new McKinsey Global Institute (management consulting firm) report, Ordinary Disruption: The Four Forces Breaking All the Trends: (Further Reading).

No doubt disruption is now established as the next big thing. But it's not new. Disruptive forces have affected clinical laboratories for decades. 

DISRUPTIVE FORCES
So what the heck are disruptive forces? The OED defines disruptive as 'innovative or ground-breaking'.

According to the UK consulting firm, Tomorrow Today Global:
A disruptive forces is not a force that results in incremental changes, improving products or services one step at a time. Rather disruptive forces result in a breakthrough or a step change that transforms society forever. Sometimes the disruption is complete and swift. 
The key here is a true disruptive force does not affect change in baby-steps but rather consists of a big step (innovation) that changes things forever. 

DISRUPTIVE FORCE #1: Tainted Blood Massive Screw-up
Being a medical laboratory technologist who became a transfusion science educator, I found it so tempting to begin with - you guessed it -  either laboratory automation or its latest iteration, molecular typing of red cell antigens and its kissin' cousin, personalized medicine. But I've resisted. 

The first blog will discuss the worldwide 'tainted blood' tragedy of the 1980s and '90s, which resulted in the related disruptive forces of 
  • Krever Inquiry (Royal Commission of Inquiry on the Blood System in Canada);
  • Vein-to-vein responsibility for blood transfusion;
  • Government regulation migrating from blood supplier to hospital transfusion services.
The focus will be on Canada because that's what I know best. But I suspect the transmogrification of blood suppliers and hospital transfusion services was similar in other countries, albeit some progressing faster, some slower than Canada. 

Note that I am an oldster (see 'Life as a blood eater' in Further Reading) and my recall is not perfect. If I inadvertently omit significant events or get things wrong, please comment below or e-mail me. My personal take on the highlights of these disruptive forces follows.

BLOOD SUPPLIERS
In Canada, the Krever Inquiry - 1993-1997 (Further Reading) -  resulting from the HIV and HCV 'tainted blood' scandals, had a huge impact on the blood supplier, the Canadian Red Cross Blood Transfusion Service (CRC-BTS). Krever was an earth-shaking disruptive force that eventually resulted in Canada creating two new blood suppliers in 1998

Goodbye CRC-BTS, hello CBS and H-Q!
THE FALL GUY
Think about it. The blood supplier that had managed Canada's blood system from the get-go in the 1940s was to disappear under a cloud of suspicion. 

In exchange for not bringing the case of Canada's tainted blood scandal to trial, the Red Cross pleaded guilty to violating the Food and Drug Regulation Act by distributing a contaminated, drug (Factor VIII concentrate). The $5,000 fine was the maximum penalty for that charge under the Act. 

Other court cases proceeded against individuals but with no convictions:
In effect,the CRC-BTS was the fall guy (not its complicit government paymasters) for the entire tragedy. Two factors at work were the typical physician sin of paternalism and government secrecy. The panacea was to create new organizations at arms-length from government that would be more transparent. 

Only something NEW could restore the faith of Canadians in the blood system. 

The reality was that the new blood suppliers had many of the same transfusion professionals serving as leaders (medical directors), and the trench workers were the same, mainly medical lab technologists performing blood donor testing.  It's not like experienced, skilled personnel were hanging around like low-lying fruit waiting to be picked.

Regulatory Compliance Project
Meanwhile, in the mid-1990s the Canadian Red Cross initiated a Regulatory Compliance Project whereby standard operating procedures (SOPs) to encompass all operations were to be written and used in all CRC-BTS centres. To implement the SOPs and to maintain the system, a training component was included. SOPs were to comply with current Good Manufacturing Practices (cGMP). 

During this time I taught at University of Alberta, but after hours participated as an external consultant in developing training materials. 

It's worth noting that the transition to SOPs and training - a huge undertaking - happened on the 'disgraced' soon-to-disappear Canadian Red Cross's watch.  

HOSPITAL TRANSFUSION SERVICES
Despite the long history of Quality Systemsthe first I became acutely aware of QSE (Further Reading) and their implications for hospital transfusion laboratories was at the CSTM 2000 annual conference in Quebec City. 

The Canadian province of Quebec had created transfusion safety officers (TSO), initially with both a medical technologist and nurse for 20 designated centres.  [Right click and select 'Translate to English']:
In 1999, following the report of the Krever Commission, a complete reorganization in transfusion medicine was initiated in the province of Quebec. To improve transfusion practice, roles and responsibilities were established for the professionals involved in the management of blood products from blood donor to recipient
Ontario, particularly at the McMaster University Medical Centre in Hamilton, had a few TSOs (CSTM blog - Gagliardi: Further Reading) who had become specialists in QSEs and writing standard operating procedures (SOP). 
And it was at this CSTM meeting I learned of the existence of the BC Provincial Blood Coordinating Office (PBCO), Canada's first PBCO, which had been created ~1998. 

A friend (CSTM blog - Chambers: Further Reading) introduced me to its then medical director as a 'geek' who could potentially manage and coordinate resources for its TraQ program (one of the luckiest days of my life).  

Soon I became aware of the extensive help the PBCO gave to transfusion services throughout BC to help with writing SOPs and training materials. The BC PBCO was ahead of the curve - way ahead of the curve. 
It's fair to say that these BC manuals served as templates for transfusion service SOPS written across Canada and perhaps beyond, particularly in developing nations since they were generously shared online.

Then in 2004 - a huge disruption - The Canadian Standards Association (CSA) published its Standards for “Blood and blood components” (also known as Z902-04). I wrote about it for the BC PBCO's Blood Matters newsletter:
INTERNATIONAL ASPECTS
It's worth noting that the UK's blood system, while not having a Krever-style commission until much later, was quite active and early in producing guidelines for transfusion services via the Red Book.

And the UK and Australia were leaders in creating transfusion safety officers: 
In the USA the AABB had its excellent Technical Standards but being AABB accredited was voluntary. Nonetheless, the AABB Standards served as best practice.

As in Canada, the government (FDA) regulated blood suppliers. I'm unaware about the U.S. situation, but in Canada, until the Krever Inquiry report on the tainted blood tragedy, inspections, if they occurred, lacked rigour. That's the politically correct way of saying government oversight of the blood supplier was a joke. For example, in my 13 years at CRC-BTS in Winnipeg, I cannot recall one inspection having happened. Maybe they did but I doubt it. These days, every staff member in a blood centre is ultra-aware when inspections and audits are to occur.

U.S. regulation and accreditation of blood transfusion labs is a quagmire of multiple bodies, e.g., AABB, FDA, CAP, CLIA, The Joint Commission, ISO 15189, COLA, and many others. Perhaps unfair but my best guess of the on-the-ground situation in U.S. hospital labs in the 20th C comes from graduates of the University of Alberta Med Lab Sci program, when so many went to work in the USA in the 1990s due to no jobs in Canada. 

First, U.S. employers loved them, probably because of their solid experience rotating in clinical labs, generally significantly more time than U.S. grads received. Second, I'll never forget their often humorous transfusion anecdotes. One example: 
  • 'My gawd, Pat they don't even label the test tubes for pretransfusion testing.' 
No doubt the situation is much improved today. Also worth noting is that the USA never had an inquiry into tainted blood scandals similar to Krever. And the U.S. was also late to adopt TSOs and hemovigilance.

SO WHAT DISRUPTION OCCURRED?
First, be aware that before Krever even blood suppliers in Canada did not have SOPS or follow cGMPs. I worked for the CRC-BTS for 13 years as a bench technologist, supervisor, and clinical instructor and the methods used to test donated blood were unwritten. Methods used to crossmatch blood for patient transfusion were also unwritten. New staff learned as surgeons traditionally did: 
  • See one, do one, teach one (Further Reading)
  • Sidebar: After 6 months in Jamaica more or less goofing off, and longing for cooler climes, I wanted to return to CRC-Winnipeg but had to first substitute for a vacationing staff member in CRC-Calgary returning to her family in South America for an extended vacation. 
  • Spent one day watching a technologist perform pretransfusion testing (method was quite different than Winnipeg's) and was asked to do one. Afterwards the lab manager asked my supervisor if I could do the job and her reply was, 
    • 'She's good to go.' That was it. I was now the sole night technologist for CRC-Calgary.
The Winnipeg CRC-BTS also performed pretransfusion testing for all city hospitals (unique in Canada) and many rural ones in Manitoba and NW Ontario. 

Re-SOPs, once I became a clinical instructor for Winnipeg CRC-BTS I spent an entire summer holiday writing SOPs for the transfusion lab. None existed and it seemed a good thing to do, not only for staff but also for students during their clinical rotation in the one transfusion service lab in town. 

What follows focuses on the disruptive impact to hospital transfusion services due to vein-to-vein responsibility for transfusion safety.

SOPs and Competency Training - Med Lab Technologists
As noted post-Krever Canada's blood supplier underwent a tremendous disruptive transformation to cGMPs and training. To those who worked pre-Krever, post-Krever was a different universe. 

The disruptive requirement in transfusion services to have written SOPS and related competency training at first, at least in Canada, applied mainly to medical laboratory technologists. This spawned an entire industry, first via government-funded PBCOs and their equivalents and soon by the need for hospitals or health regions to hire TSOs to educate and train the 'trench workers', whether technologists or the nurses who administered blood transfusions.   

The cost to the public purse was huge (new PBCOs and TSOs), as was the disruption to the daily lives of affected professionals. But having SOPs and training was wonderful because 
  1. They standardized lab methods - learning no longer depended on who taught you.
  2. Your competency - knowledge and practical skills - were documented;
  3. The system became much safer.
Some, like the USA's talented Lucie Berte capitalized and built a successful career around QSEs and SOP development with diverse global clients.

SOPs and Competency Training - Nurses
Soon nurses - those who administer blood transfusion - were affected by the disruption of regulatory requirements. Indeed, hemovigilance programs (also a disruptive force) such as the UK's SHOT show that many errors continue to be clinically related due to human error failing to ensure 'right blood to right patient' at the bedside. 

Checklists and clinical audits of administering blood transfusions are now the norm in many locales. But SOPs and checklists only work if humans follow them.

SOPs and Competency Training - Physicians
The one profession seemingly least affected by the disruption of regulatory requirements are the clinicians (physicians) who prescribe blood transfusion. Blood supplier medical directors, and especially transfusion service medical directors, are affected because they are ultimately responsible for ensuring patient safety. 

Physicians continue to receive minimal education in transfusion medicine (typically a few hours as medical students). Ordering practices may be somewhat controlled and monitored by computerized test-order-entry systems requiring laboratory data to justify ordering blood products and hospital transfusion committees. But do physicians actually do this or do they often leave an order for ward staff to perform? 

In some jurisdictions, more rigorous monitoring of expensive blood products such as IVIg exists. 

But from all I know, despite such monitoring, if physicians want a blood product, they usually get it despite poor clinical indications, especially if they are 'grand poo-bahs' in their hospital. 

That said, blood education is ongoing and jurisdictions such as the NHSBT's Patient Blood Management program report good progress.

SAY WHAT?
I've heard from colleagues that transfusion-related SOPS may have run amok in some locations. Specifically, they now include so many steps and documentation requirements that medical laboratory technologists can get lost in the trees and lose sight of the forest. It's complicated by centralized laboratories in which even staff in the main lab automatically default to asking the transfusion specialist to handle any problem, large or small. But that's a topic for another blog. 

Main point is that too much of a good thing can quickly go wrong.

SUMMARY
In Canada the tainted blood scandal was a disruptive force that led to the Krever Inquiry and the creation of two new blood suppliers as well as the related disruptive force of government regulation, resulting in vein-to-vein monitoring of the entire blood system and the creation of SOPs and competency training for most involved in blood transfusion. 

I say for most because the one profession that's been least affected are the physicians who order blood components and products. They've been affected, more or less so, depending on their locale, but 'least' is the operative word. Correct me if I'm wrong. Why do physicians largely merit a get-out-of-jail-free pass on blood transfusion? 

Medical laboratory technologists and nurses receive SOP training and must show competency before they can perform tasks independently. Every aspect of their technical and clinical job performance is regularly audited. Physicians not so much...

Canadian Blood Services has a great resource, its Clinical Guide to Transfusion. The first chapter explains everyone's responsibilities:
The ordering clinician's first duty is 'To carefully assessing the clinical need for each order'. How effectively is this monitored, I wonder? 

Because of a tragedy that killed 1000s, life as transfusion professionals changed forever in the 1990s. In Canada, the Krever Inquiry led to government regulation requiring SOPs and competency training, which eventually extended to vein-to-vein monitoring of the blood system.

These disruptions were good for all concerned and promoted patient safety, because that's what it's ultimately all about. 

As always, comments are most welcome.

FOR FUN
Couldn't resist this 1977 song by Fleetwood Mac, written by Christine McVie, which became the campaign song of Bill Clinton in the1992 US Presidential election. 
Don't stop, thinking about tomorrow,
Don't stop, it'll soon be here,
It'll be, better than before,
Yesterday's gone, yesterday's gone.
Don't you look back.

FURTHER READING

Dark Daily: In Sydney, Australia, Medical Laboratory Professionals Gather to Explore Disruptive Forces in Healthcare and How Labs Are Using Innovation and New Leadership Approaches to Successfully Transition to Value-Based Care

CSTM blogs - I will remember you:
Canada's Krever Inquiry

Life as a blood eater

Quality System Essentials (in brief)

Kotsis SV, Chung KC. Application of the "see one, do one, teach one" concept in surgical training. Plast Reconstr Surg. 2013 May;131(5):1194-201. 

Saturday, October 22, 2016

The Boxer (Musings on lies & jests in the blood industry)

Updated: 23 Oct. 2016

This blog, takes its theme from items in October's 'New on TraQ' and posts on my @transfusionnews Twitter account.

The title is from a 1969 ditty by Simon and Garfunkel.

For readers who choose not to read the full blog and to peak your curiosity, here is the executive version. The blog focuses on blood donor plasma, but not in the usual way I've blogged about plasma in the past. October's blog aims to

  • Showcase hypocrisy in the USA's not-for-profit blood industry, specifically the approach of community blood centers to blood donation;
  • Stimulate you to think about how your country's blood donor system operates and why national differences exist;
  • Interest you in reading at least the 'juicier tidbits' in Canadian Blood Services' 2015-16 Annual Report.
PLASMA DONATION in USA
In the USA you can donate plasma twice a week. The FDA allows 2 donations within a 7-day period, with at least 2 days between donations.

The main ways to donate plasma include

  • Commercial paid-plasma centers like  Biotest, CSL, Grifols (Canadian Blood Services plasma protein products supplier), OctaPharma, and more. 
    • They tell donors they are saving lives as opposed to admitting, 'We're exploiting you poor folks who need extra cash so we can make mega-bucks'.
  • 600 America's Blood Centers (ABC), who collect nearly 50% of the blood supply, of which the sole non-US member is Canada's Héma-Québec (where paying for plasma is illegal);
  • American Red Cross (ARC), which collects and processes about 40% of the USA's blood supply.
So far as I can tell (please correct me if I'm wrong), plasma collection in the USA is roughly as follows:

1. Paid-plasma centers offer donors varying amounts of money, but not directly (no direct cash payments, which might make it seem like 'filthy lucre' for selling a body tissue). 

Payment is via a card similar to a debit card. And some have cutesy loyalty programs. Examples:
2. ABC non-profit community blood centers like Blood Centers of the Pacific stress that volunteer blood donors provide a safer blood supply. 

Unsaid is that volunteers are safer than paid donors only for blood components such as red cells, platelets, and plasma (not plasma protein products, which, besides donor screening and testing, undergo many steps to make them safer, e.g., plasma quarantine, technology to inactivate viruses, and purification steps).  At least that's the theory based on evidence to date.

But all such centers offer an incredible amount of what they call 'swag' (products given away free, typically for promotional purposes). For example, Blood Centers of the Pacific's 'swag' for donating plasma. 


So what can Hero Reward Points get you? Quite a bit (and they apply to all donation types, not just plasma).

  • For example 1,600 Points for your first plasma donation earns a $25 Shopping eGift Card. 
  • Each successive donation earns 600 points. At two/week potential earnings can amount to 4800 pts/month or three $25 eGift cards. 
Admittedly $75/mth doesn't compare to the money donors could earn at paid-plasma centers. But donating is not exactly unpaid as it is in many countries.

3. American Red Cross offers a true voluntary blood donor system. No money or similar for donating red cells, plasma, platelets, whatever.

PLASMA DONATION in CANADA

When you donate plasma in Canada at CBS or H-Q  you get what all voluntary blood donors get. 


In Edmonton, that's 'Cookies by George' and maybe some juice. And I mean to munch away on, post-donation, and on-site.

CBS's 2015-16 ANNUAL REPORT
So how does CBS's Annual Report (begin on p. 39) fit with this blog's theme of donating plasma for payment (no matter how defined) vs donating voluntarily?

First, consider that the plasma protein product market, including intravenous immune globulin (IVIG), stood at US$18.5b in 2015 and will continue to grow.

CBS reports that from 2013-14 to 2015-16 Plasma Protein Products (PPP)  (bought in $US) increased from $459,120,000 (45% of total costs) to $623,198,000 (53% of total costs), an increase of 36%. 




Besides IVIG utilization, the exchange rate affected CBS's PPP costs, because the CDN$ decreased 29% v $US during this time. In Jan 2013 Canada's dollar vs USA dollar was $1.01 vs 0.72 cents in Jan. 2016.

For 2016-17 CBS is trying to mitigate being captive to the exchange rate with the US$ by using a forward currency contract with its PPP supplier, Grifols.

LEARNING POINTS
1. Are USA's non-profit centers hypocritical in saying they offer a voluntary blood donor system? As a Canadian, I find the USA's debit card and cutesy loyalty programs cringeworthy. You decide.

2. By relying on the USA's paid plasma system for most of its plasma protein products like IVIG, CBS is captive to the exchange rate with the US dollar. Why doesn't CBS challenge Canadians to donate more plasma?

CBS makes decisions assuming outsourcing is always cheaper. And it often is in the short-term. But in the long-term, who knows? Plus, relying so heavily on poorer Americans who donate a body tissue (plasma) for money is not admirable, especially when you give up on promoting voluntary plasma donation to Canadians because it costs more. See

CBS leaders have decided that Canadians cannot donate anywhere near enough plasma without even trying to challenge us.

3. CBS: How about challenging Canadians to donate plasma by being transparent (something you tout post-Krever) about the grim facts of what relying on USA's paid plasma costs tax payers?
Give young Canadian donors, those in community colleges, technical institutes universities, the chance to be voluntary plasma-donating heroes. Give long-standing oldster donors a chance to shine.
Don't cave and assume sufficient plasma donation in Canada is an impossible task, without even trying. Give our youngsters and oldsters a chance to prove you wrong. Or at least to increase plasma donation significantly. If a donate-plasma campaign falls short, so be it.

You haven't even tried, CBS. Despite all your 'leading edge' innovation rhetoric, you lack a vision for Canadian blood donors being special.

FOR FUN

To me Simon and Garfunkel's 'The Boxer' lyrics resonate with this blog.

  • The Boxer (Simon and Garfunkel, Live in NYC Central Park, 1981)
Such are promises
All lies and jest
Still, a man hears what he wants to hear
And disregards the rest.


As always, comments are most welcome.

FURTHER READING

The twisted business of donating plasma (28 May 2014)

All about blood banks.  A multibillion-dollar business in a nonprofit world (1991)


Saturday, September 24, 2016

The Sound of silence (Musings on transfusion professionals use of Twitter)

Updated: 25 Sept. 2016 
September's blog takes its theme from Twitter activity on my @transfusionnews Twitter account. The blog is shorter than usual (a good thing), but something I feel passionate about. 

The title is from a 1964 classic by Simon and Garfunkel.

For readers who choose not to read the full blog, here's the executive version. The blog's aims are to
  • Showcase prolific transfusion-focused tweeps from the English-speaking world - those who clearly believe in the power of social media like Twitter to engage and educate about transfusion.
  • Interest you in joining Twitter (even as a 'lurker' who reads but never posts, as so many were and are on mailing lists) or, if that's a bridge too far, at least bookmark one of the Twitter accounts (maybe mine?), and periodically read the latest. You can do so without being on Twitter. 
Bottom line: Being a transfusion professional is a career not a 9-5 job. Learning what's happening around the globe enriches and broadens our experience. And we can use Twitter tidbits to interest our students and inform our practice. That's a good thing. Note that I resisted saying we could leverage Twitter. 

Recently, while helping a friend with a project she did for the BC PBCO, international colleagues I met only on Twitter took time from their incredibly busy schedules to go away 'above and beyond' to assist. Being on Twitter is like having an amazingly diverse family whose members generously share knowledge and expertise.

TRANSFUSION TWEEPS OF NOTE
From my experience, here are the transfusion professionals, individuals who regularly distribute transfusion news via Twitter. I've not included blood suppliers like Canadian Blood Services (@itsinyoutogiveor professional associations like @aabb, @BritishBloodTS, and  @CanSocTransMed.

To my knowledge, these are transfusion medicine's prolific tweeps (number of tweets in brackets). The list is not all inclusive. I follow many valuable transfusion tweeps with fewer tweets and others with 1000s of posts but many unrelated to transfusion. 

AUSTRALIA (2)
Haemovigilance Guy @Haemovigilante (1300+) 
Dr Sandy Minck @DrSandyMinck (1,000+)
IRELAND (1)
Gerard Crotty @gmcrotty (18,000+)

GREAT BRITAIN  (8)
Sylvia Benjamin @Gogmum (6,500+) 
Tony Davies @Dobbysdad (1,800+) 
HarveysGang @Laird_Admiral (6,000+) 
Dr. Suzy Morton: @TransfusionWM (1,900+)
Kate Pendry @KatePendry  (4,000+)
TeamHaem @TeamHaem (6500+) 
Dan Smith @Dan1763 (3,900+)
CANADA (4)
Jenny Ryan @JRyanCS (5,300+) 
Elianna Saidenberg @ESaidenberg (2,600+) 
Cyber Bloodbanker @transfusion news (2,000+) - Me 
Ron Vezina @Vez_says (1300+)
SUMMARY
Did you notice that the Brits are the transfusion rock stars on Twitter? Why is that, I wonder? If I've missed any 'tweetaholics', please let me know. 

To discover who to follow on Twitter, use hashtags such as 
The last may produce unexpected results.
And when you find someone you like, see who they follow and who follows them.

FOR FUN
The blog's theme reminded me of a 1964 ditty by Simon and Garfunkel. Seems the transfusion twittersphere sadly suffers from the Sound of Silence, especially in Canada and the USA. Let's be disruptive and break the silence more, folks.
As always, comments are most welcome.

Tuesday, August 23, 2016

Who'll stop the rain (Musings on SHOT 2015's use of narrative fallacy)

Updated: 24 Aug. 2016 (tweaks +added video clip)
As last year, the August 2016 blog is stimulated by the UK's Annual SHOT Report, often featured in past blogs. SHOT has long been the best hemovigilance program anywhere and is a treasure trove of educational goodies.

This year's blog is not going to focus on the key results and recommendations of the SHOT 2015 Report but instead give a selective overview. Readers are directed to the Report for all its informative details (Further Reading). Instead the blog will feature only two pages of the 190 pp. report concerning a concept that fascinates me. The case discussed is techie-oriented but the broader lessons apply to all transfusion professionals.

EXECUTIVE SUMMARY: For eager readers who want to know the bottom line before reading further: The blog examines a thesis in the 2015 SHOT report that the narratives we construct after-the-fact to explain why events happen are often wrong and, moreover, prevent us from learning from our errors. Let's face it. SHOT's annual reports document the same and similar human errors year after year. My musings attempt to explain further some of the reasons we create narrative fallacies.

The blog's title derives from a 1970 song by John Fogerty of Creedence Clearwater Revival, rated #188 on Rolling Stone's '500 Greatest Songs of All time.'

2015 SHOT - SELECTED HIGHLIGHTS
Tidbits related to metrics:
First, for perspective, in 2014 there were 2,663,488 blood components issued in the UK (74% RBC). SHOT received reports of 3668 cases or 13.8 reports per 10,000 blood components.

By comparison, in 2015, the number of blood components issued in the UK decreased by 3.2% to 2,577,276 (73.5% RBC). SHOT received reports of 3965 cases or 15.4 reports per 10,000 blood components, an 11.6% increase. Of course, besides more events occurring, the increase could also be due to more complete reporting.

The total number of reports analysed and included in SHOT's 2015 Report is 3288 compared to 3017 reports in the 2014 SHOT Report (9% increase). 

Risk of potentially infected donation entering the blood supply (2012-14)
Hepatitis B 1 in 1.6 million
Hepatitis C 1 in 26 million
Human immunodeficiency virus  1 in 6 million

Risk of death or serious harm from transfusion per components issued (imputability 1-3*) 2015
Death 1 in 100,000
Death from error  1 in 320,000
Major morbidity  1 in 15,500

* Imputability: 1=Definitely related;2=Probably related;3=Possibly related

ERRORS (2015) 
Similar to 2014, ~78% of 3288 analysed cases were caused by error.
Human error accounted for 96.7% of serious adverse events reported to the MHPRA.

Most SHOT reports involve often multiple mistakes related to human factorsThe number of adverse reactions and events related to poor communication and poor clinical decisions are a concern.

Laboratory errors have increased and many laboratories are under pressure with vacancies (some longstanding) and increased workloads.

More than a third of NHS staff reported work-related stress in the 2015 staff survey. Emergency departments struggle: 2 in 5 new consultant physician posts were not filled. Overall funding is tight. 

DEATHS
Patient transfusion-related death is the worst adverse event. In 2015 there were 2 deaths definitely related to transfusion, 9 probably related, and 15 possibly related.

A good figure to show deaths (n=26) correlated to type of serious adverse event is Figure 3.2 on p. 10 of the SHOT Report:

Transfusion-related deaths reported in 2015 by imputability (Copyright SHOT) [Click to enlarge]


NARRATIVE FALLACY - BACKGROUND
As noted, this blog focuses on but two pages of SHOT 2015 because they interest, indeed fascinate, me. The pages appear under 'Error Reports: Human factors' (pp. 24-5) and discuss the role of narrative fallacy in explaining why people do not learn from mistakes. In particular SHOT provides a case (Case 6) that outlines how 3 narrative fallacies occurred involving only one patient's case.

Honestly, who else but the British would discuss a psychological phenomenon like narrative fallacy in a major transfusion medicine report on hemovigilance? With narrative fallacy we concoct erroneous stories to explain facts that we encounter. 

I'm pretty sure in Canada, if we had a hemovigilance system that published its finding for the public, including the transfusion community (we don't), it would deal with numbers almost exclusively, and, beyond that, propose how transfusion professionals could leverage errors into improved transfusion safety and innovate to span the translational continuum from vein-to-vein.

Narrative fallacy can be discussed on many levels (Further Reading). Political examples:

UK: Some Labour Party MPs on the losing 'remain' side in the 2016 brexit vote appear to have rationalized the 'leave' result as significantly due to the lukewarm support and effort of their leader, Jeremy Corbyn. Labour passed a no-confidence vote triggering an upcoming leadership election. It's a narrative fallacy that gives a scapegoat, always satisfying as it stops the need for more in-depth analysis and perhaps unpleasant revelations about Labour Party MPs and officials misjudging the mood of its base.

USA: Some foreign watchers of the 2016 Presidential election patronizingly see Trump supporters as mainly poorly educated bigots, a narrative fallacy that has the advantage of fitting into existing misconceptions some have about the USA. Which isn't to say that some supporters are bigots and that Trump seems happy to feed their needs. 

But Trump supporters, like all Americans, are much more diverse than that, as shown by this Pew Research Center graphic (July7, 2016):
7-7-2016 2-30-10 PM
People are not going to unravel Trump's success without fully examining the spectrum of why people vote for him. Settling on a simple narrative (fallacy) won't do it.

The same applies to the 'whys' of anything people perceive as an 'adverse event'. We need to understand before we can learn from mistakes made and identify contributing factors. Of course, in the political examples above, some may see the events as good, not bad. 

In contrast, the transfusion medicine examples from SHOT 2015 below are clearly adverse events. But I hope you will see that the narrative fallacies are analogous in that the stories used to explain them stop further investigation and work against learning from errors made.

NARRATIVE FALLACY - SHOT 2015
SHOT 2015 introduces its use of narrative fallacy as follows:
'Humans have a tendency to construct stories around facts, which serves a purpose in making sense of the world that might otherwise be seen as too complicated. The natural instinct is to make patterns in order that the world is seen as a simple place, so a narrative is often constructed to explain the facts. Humans are hard-wired to try and turn chaos into order, so they can feel in control of their world. However, this can be termed ‘narrative fallacy’ (Taleb, 2007) because these rationalisations come after the effect and are not based on empirical data. 
...Narrative fallacy means that against all logic, individuals often do not learn from adverse events. Instead of seeing the error as a learning opportunity, the event is rationalised in a more comforting way....'
'Error Reports: Human factors' (pp. 24-5) 
Case 6: Three narrative fallacies add to confusion when grouping a patient after an allogeneic haemopoietic stem cell transplant (HSCT). 

CASE SUMMARY: In brief, the patient was a known group O and, unknown to the laboratory, had received a group A HSCT. A series of ABO grouping anomalies were incorrectly explained by 3 separate narrative fallacies outlined below. 

Besides the role of narrative fallacy, the case serves to stress the importance of communication between institutions, and also between colleagues, patients, manufacturers, everyone on the health care team. I love this clip from Cool Hand Luke:
 

Non-laboratorians may also glean how complex pretransfusion testing can be and the need for well educated, experienced medical laboratory technologists/biomedical scientists. 

Readers not well versed in the technical details of blood grouping or protocols for transfusing patients with HSCT may wish to scan the nitty-gritty of fallacies and focus on [my musings in brackets] after each fallacy. 

It's not the technical details that are key, it's the way our minds work, the stories we tell ourselves, and how often we misinterpret the evidence, typically in ways that are convenient to our needs.

Narrative fallacy 1
A known group O patient's pretransfusion blood sample gave mixed field (MF) with anti-A several times on an analyser suggesting the presence of transfused group A donor rbc. 

A second analyser gave the same MF result. Because fibrin was noticed on the top of the reaction well, fibrin was removed from the sample and it was re-centrifuged, leading to a negative result with anti-A. 

Staff concluded (narrative fallacy 1) that fibrin was responsible for the initial MF because the new result now agreed with the patient’s historical group.

The patient was correctly transfused group O rbc but also group O platelets, incorrect for a group O patient receiving a group A HSCT, which the lab staff were unaware of. 

[Because fibrin is a cause of blood testing anomalies in laboratory tests, the second result which agreed with the patient's historical blood group, seemed logical. Perhaps as importantly, lab workers always prefer inconvenient, unexpected test results to disappear as it makes our life simpler. This trait surely applies to MDs and RNs too.]

Narrative fallacy 2
When it was later known that the patient was post-transplant, the analyser manufacturer was asked to explain the discrepancy of a MF group A in instrument 1, but an eventual 'normal' group O using instrument 2.

The manufacturer wrongly proposed that repeat centrifugation of the sample might have concentrated donor rbc lower in the tube, seemingly logical, because transfused rbc would usually be older and heavier than patient rbcs and be at the bottom of blood samples. 

That could cause the O grouping result if instrument 2's sampling tip was testing rbc lower in the patient's blood sample than instrument 1's, a common explanation for missing post-transfusion MF groups on analysers.

But the manufacturer's narrative does not fit the facts in any way. When disparate grouping results occurred the ‘donor’ rbc would have been from the engrafting group A HSCT and not transfused group O donor rbc, because the group O cells were the patient’s.

[My guess, a guess shaped by biases, is that manufacturers often get asked about their instruments missing MF in blood grouping tests. In this case the manufacturer may have been on auto-pilot because they gave a standard answer even knowing the patient had a stem cell transplant. 

In a way it reminds me of how physicians (indeed all health professionals) often decide and diagnose based on intuition and pattern recognition ('I've seen this before'), not on all the presenting evidence and possibilities before them, certainly not on analysis of recent research. Narrative fallacies save time for busy practitioners but occasionally may have tragic results for patients.]

Narrative fallacy 3
Three days after the first blood groupings a fresh sample was received, but laboratory staff were still unaware of the patient’s HSCT. MF again occurred with anti-A, but this time the person doing the grouping explained (narrative fallacy) that the MF result was due to group O donor rbc transfused over the weekend. 

The test result was modified to a 3+ positive, giving a group A result. However, authorisation failed, because the patient was historically group O.

A repeat sample also grouped as A with MF. Lab staff eventually discovered that the patient had received an ABO-incompatible HSCT at another Trust, which had not been communicated to them. The transplant was reason for the MF: as the transplant engrafted, transplanted donor-origin group A rbc were present along with the patient’s own group O rbc. 

This narrative fallacy could have led to the patient being mis-grouped as an A patient who was transfused with O donor rbc, instead of being a post-transplant group O patient in the process of becoming group A.

[To me, in the absence of more case details, the lab technologist concluding the patient was group A, 'modifying' (falsifying?) a blood group test result to fit the narrative that transfused group O cells caused the MF, is mind boggling. I suspect that significant contradicting evidence would need to be ignored to create this narrative fallacy. More information is needed. If you are a UK TM colleague and know more details, I'd love to hear them. 

Again, a guess about how this narrative fallacy could happen relates to something else that SHOT 2015 discusses: Laboratory errors have increased and many laboratories are under pressure with vacancies and increased workloads.]


Techie stuff - if you are so inclined: 
Unusual that a MF test result would be 'modified' to 3+ positive, as MF is nothing like a strong 3+. Wonder what 'modified' means because it suggests something totally unacceptable - recording a false result to fit a preferred narrative. Just guessing but was that because the lab's SOPs or information system (LIS) require anything less than a 3+ result in a blood group test to be investigated further? 
Regardless, in this case, the historical record (probably in the LIS) produced a failed authorisation. In general, mistyping a patient's ABO blood group, especially a group O patient, can have catastrophic consequences if they are then transfused after an electronic (non-serological) crossmatch with ABO-incompatible rbc. Of course, an ABO discrepancy, including MF in a patient's ABO group, would prevent use of the electronic crossmatch.  
Not mentioned in the SHOT report is how the patient's reverse group tested. Group O recipients would have anti-A in their serum/plasma for months, making concluding the patient is group A difficult. The patient's anti-A would be continually 'mopped up' by adsorbing to donor-produced A antigen-bearing cells, possibly creating delayed hemolysis. But immediately post-transplant the anti-A should be relatively strong, precluding transfusion with group A rbc until engraftment occurs and a serological crossmatch is compatible. 
FURTHER MUSINGS
Think back for a moment to the HIV/AIDS 'tainted blood' scandal of the 1980s and 1990s and the narrative fallacies it spawned.
At first the narrative fallacy was the disease was gay-related immune deficiency (or GRID), comforting to those who were not gay because, 'Hey, it can't affect us.' 
After it was reported in hemophiliacs and Haitians, a narrative fallacy proposed that the disease originated in Haiti. 
The Canadian Red Cross BTS and its medical experts believed that probably all hemophiliacs were already infected by FVIII concentrates made from tens of 1000s of blood donors and conveniently opted to use up its large stockpile of untreated (unsafe) FVIII concentrates.  
With these and other narrative fallacies, the transfusion medicine community took an exceedingly long time to accept the disease could be transmitted via blood transfusion.
I encourage you to think about the comforting and convenient stories we in the TM community tell ourselves, whether in the lab, on the wards, in blood donor clinics and clinician's offices, and wonder if our stories could be narrative fallacies.

Remember that grappling with complex information and mysteries strains our brains and brains like to save energy. Stories allow us to process and retain information more easily by showing a pattern that solves a mystery. Often our stories comfort us by confirming pre-existing beliefs or just making life simpler.
For techies who've stuck with the blog to the end, an inside joke: Think of all the trouble we go to in the lab to get rid of troublesome (unexplained) test results in antibody screens or antibody identification panels that don't show a pattern. The go-to narrative fallacy is ? Clinically insignificant cold agglutinins, of course. 
FOR FUN
The blog's theme reminded me of a CCR 1970 ditty, sometimes associated with opposition to the Vietnam War. SHOT 2015 discusses narrative fallacies - stories we tell ourselves - in the context of phenomena that prevent us from learning from our mistakes. 
Long as I remember the rain been comin' down.  
Clouds of mystery pourin' confusion on the ground.  
Good men through the ages tryin' to find the sun. 
And I wonder, still I wonder, who'll stop the rain

As always, comments are most welcome. 

FURTHER READING
UK SHOT website 
SHOT: 2015 Annual Report 
Miller S. Myth based medicine. Br J Gen Pract. 2015 Jun; 65(635): 313. E-pub 2015 May 26.  
Taleb NN. The Black Swan (2007) 
Related TM blog (Aug. 2015): The early days (Musings on educating young TM professionals)