Thursday, December 29, 2016

Don't worry, be happy (Musings on decreased government funding as a TM disruptive force)

Updated: 2 Jan. 2017 

Last December I got a bit mushy and wrote
  • Islands in the Stream (Musings on how love of transfusion medicine unites us) [Further Reading]
This year I'm not as sentimental and am okay with being a grinch who stole Christmas. Besides Dr. Seuss's tale has a happy ending. Not saying it applies to this blog, though it may. You decide.

Continuing the series on disruptive forces that affect, or will affect, the practice of transfusion medicine (TM) is hard. Why? Mainly because of all TM health professionals, to date the ones who have been most affected by disruptive forces are medical laboratory technologists / biomedical scientists (whatever they're called in your country). I suspect that an in-depth discussion of laboratory realities would cause many nursing and physician eyes to glaze over.

Including the three main TM professionals is part of the challenge of writing TM blogs. For the most part I try to write about big picture 'poop' that affects all so lab techs, nurses, docs can relate.

So what is December's blog about? It's about the disruptive force of DECREASED GOVERNMENT FUNDING of health care in those nations where universal health care exists, and to a lesser extent in the USA.

USA readers may think the blog is not as relevant because you don't have government-funded universal health care like the rest of the developed world (Further Reading). But from what I've read on medical laboratory and clinical laboratory educator lists, similar things happen in the US, perhaps for different reasons. For example, consolidation is rampant in the blood industry. (Further Reading)

The blog was stimulated by a seemingly odd source:

  • How physicians can keep up with the knowledge explosion in medicine (Further Reading) 
One suggested solution was to create the equivalent of 'paralegals' for medicine. Yes, my mind works in strange ways. More later.

The blog title derives from an 1988 ditty, 
which I've used before, by 10-time Grammy award winner, Bobby McFerrin . 

In an effort to keep the blog short and sweet, well at least shorter, I'll muse on Canada and leave it to you to judge if similar events apply to your country. References for many of the points will not be provided because they are available by doing simple Google searches. For example, in writing a literature review, you do not need to reference facts taken as a given and available in many resources, e.g., Donald Trump will become the 45th US President.

December's blog was also partly motivated by the economy currently tanking in my Canadian province of Alberta because prior governments made us depend on the price of oil to provide government services, including health care. Unfortunately, our economy regularly tanks. Suffering from boom and bust cycles is normal if you depend on others for prosperity, others like Saudi Arabia and the nations that make up OPEC (Further Reading).

The blog reflects on the disruptive force and effects of governments deciding to save money on the backs of health care professionals and the health system, including patients. First I outline the immediate effects in general of decreased funding, then present long term consequences for transfusion medicine.


Decreased health care funding began in a big way in Canada in the 1990s. Driven by right wing ideology, provincial governments (responsible for health care in Canada under our constitution) decided to save money in many ways, including by cutting funding to health care, particularly clinical laboratories. 

The result was a concurrent move to regionalize and centralize laboratory testing because it facilitated saving money by eliminating laboratory administrative staff and 'trench workers' alike (See Dianne Powell, Further Reading).

Management gurus tapped into the big government money available to consultants by propounding
 catch-phrases such as 'right sizing' and 'working smarter, not harder'. All in the belief that 'BS baffles brains', which it apparently does when it comes to governments to whom bafflegab is second nature.

'Working smarter, not harder' particularly rankles because it led to managers of transfusion labs trying to do more with less  - in effect, being guinea pigs to government experiments - and considered failures if they couldn't.

For example, if five labs became one lab, the first to be axed could be four lab supervisors, now that only one was needed. Similarly, the five trench workers who covered the midnight shift as the sole technologist on duty could become one worker. You get the idea. What happened in Canada due to this disruptive force was many lab technologists, mainly middle managers and trench workers, lost their jobs.

Education programs
Concurrently, med lab technology/science programs closed across Canada, since far fewer graduates were needed. 

In Canada in the 1990s only two programs survived in the 4 western provinces (constituting ~31% of Canada's population) and both were in Edmonton, Alberta, perhaps due to the programs' strength, since Alberta was the province hurt worst by funding cutbacks. I taught in one (MLS, University of Alberta) and was a clinical instructor for the other (NAIT).

Medical lab technologists/clinical lab scientists
Under NAFTA, those with university degrees were lucky to get clinical laboratory jobs in the USA, where shortages had become extreme. Others had to give up the career they loved and had worked at for up to decades when laboratory jobs disappeared.

Clinical placements
Another factor was that government cutbacks resulted in clinical labs becoming under-staffed. Staff could barely keep up with doing core work (patient testing), let alone train students. As a result no one wanted to, or even could, train students, even though it was in their best in interest for succession planning.

Semi-automated and fully automated lab instruments found great favour and prospered in the era of decreased government funding of clinical laboratories. Instrument manufacturers promised their impressive looking instruments would decrease staff numbers, a tempting advantage since staff had costly benefits such as supplementary health insurance and pensions.

Companies also tried to take the edge off axing technologists by claiming now they could concentrate on more interesting skills and let the instrument do the 'grunt work' (my phrase). Cue a kumbaya moment. Except those without a job wouldn't be singing.

But, oh how pathologists' eyes would light up at the thought of becoming less of a cost centre in the hospital hierarchy. Of course, the more bells and whistles the gizmos had, the bigger the eyes.

No one seemed to care that

  • Government money was sucked outside Canada to multinational for-profits, rather than to staff who worked in Canadian communities, paid taxes and raised their families here. 
  • Lab automation operates on a razor-blade business model
  • Despite promises of smooth integration with lab information systems, automated instruments often had a hidden cost - the need to buy middleware so they could 'talk' to the LIS. And then the fun begins.
Perhaps nurses can add to this discussion, at least I hope so. In Canada, decreased government funding of health care led to unemployed graduate nurses being recruited to the USA, Australia, NZ, pretty much everywhere outside Canada. More than 20 years later, Canadian hospitals still suffer because there are not enough nurses to staff operating rooms, emergency departments, etc.

Indeed, the nursing shortage is growing because of an aging workforce (Further Reading). Impending baby-boomer retirement affects all health professions.

In Canada, decreased government funding did not affect physicians as much as med lab techs and nurses, mainly because physician numbers are much lower. However, in Alberta in the 1990s lab physicians lost jobs and, as might be expected, were compensated much more than other health professionals.  See 'History of 1990s Laboratory Restructuring in Alberta':

In a way the long-term consequences of decreased government funding are the same for lab technologists, nurses, and physicians. Here I'll focus on transfusion medicine tidbits.

How have TM labs coped (saved money), and with what effect on medical laboratory technologists/scientists, post-government funding cuts?

Regionalization and centralized testing laboratories and increased automation all led to decreased staffing needs. But more than that, automated instruments led to a decreased need for well trained transfusion specialists.

Less educated and specialized staff
Hospital transfusion service labs are more than happy to decrease costs by hiring lab assistants (some with formal educational qualifications but also those trained on the job). Generalist technologists who work in other labs such as chemistry and hematology also play a key role, especially in labs beyond the centralized transfusion service lab and in rural areas.

The result has been fewer and fewer transfusion specialists with more and more staff relying on the few specialists to problem solve and keep transfusion service laboratories functioning safely. When TM specialists retire, who can fill their key role?

For decades, some TM educators have referred to hiring less well educated staff as the 'dumbing down' of the profession. That sounds harsh but does not mean that lab assistants or generalists are dumb because they clearly are not and deserve respect. Rather it means that with the advent of automation and 'mistake-proofing' tools, many staff no longer need to be as educated and trained as before. For example:

Mistake-proofing is designing processes and devices to help prevent errors and make them obvious at a glance. Synonyms include error-proofing, fail-safing, and the politically incorrect idiot-proofing. Mistake-proof devices are common in daily life. Ex:

  • Beeping alerts when keys are left in cars or headlights are left on
  • Computer dialogue box that asks, "Do you want to save the changes you made...."
Mistake-proofing tools are also commonly used in transfusion processes and include:
  • Checklists for specific processes;
    • Inspection checklists for receiving blood into inventory;
    • Pretransfusion nursing checklists;
  • Colour-coding of ABO antisera;
  • Cross-checking work done by others;
  • Barcodes on donor bag labels;
  • RFID for release of transfusion units from refrigerators and more (Further Reading)
Bottom line - Labs: To make a transfusion lab run safely, some staff  must be well educated transfusion specialists.  How many depends on the locale, test volume, patient mix, etc. My experience is there are too few specialists and they're aging, about to retire in large numbers.

How have hospitals and blood suppliers coped (saved money), and with what effect on nurses, post-government funding cuts?

In hospital wards across Canada there are fewer and fewer RNs, also fewer LPNs. Instead we have a new category of health worker, called by various names, including heath care aides and nursing attendants.

In Canadian hospitals, such workers usually have formal qualifications taking about a year to complete, including an internship. They often are the main care givers, especially to the elderly in long-term care.

Besides being short-staffed, the big nursing change within hospitals, discussed in the first 'disruptive force' blog, is the advent of transfusion nurse specialists/safety officers and blood conservation nurses. But they arose from the tainted blood tragedy and government regulation, not government cost-saving measures.

Blood suppliers
In Canada, as a cost saving measure, CBS decided to axe the number of expensive nurses it employs by hiring cheaper on-the-job trained 'donor care associates'.

* Health Canada approves new blood donor screening model (10 Feb. 2013)

This correlates to how USA blood donor centers operate, where  phlebotomists are trained on-the-job to draw donor blood and perform other functions. Having a Certificate of Phlebotomy helps since employers would rather get trained staff to decrease their costs.

Once I joked that CBS may do the same with its transport staff.

Bottom line - Nursing: I've no idea how well 'donor care associates' work at CBS and what effect, if any, their employment has had on nurses, other than fewer jobs available. On hospital wards, nurses suffer from short-staffing and a different mix of staffing, which is stressful.

How have TM labs 
coped (saved money), and with what effect on medical staff, post-government funding cuts? With regionalization and centralized testing labs, fewer transfusion service medical directors exist because one physician fulfills the role for an entire health region. 

And, although all staff have responsibility, transfusion service medical directors are ultimately responsible for keeping patients safe, which becomes more challenging with staff shortages and a different mix of staff.  

In the health care system in general, several strategies have been floated to decrease physician costs, and some have been tried. 

For example, in Alberta a system of primary care networks exists (Further Reading). They work well (I've accessed one myself) and consist of physicians and other health professions, including nurse practitioners, dietitians, respiratory therapists, exercise specialists, etc.

The cost saving derives from the benefits of preventative medicine and using less expensive health professionals as appropriate. Now that Canada has assisted dying legislation, the Alberta government expanded the list of medical professionals authorized to assist patients with their deaths to include nurse practitioners. (Further Reading) 

The news item that caught my eye dealing with physicians:

  • How physicians can keep up with the knowledge explosion in medicine (Further Reading)
The article proposed interesting solutions:
  • Create 'paralegals' for medicine (para-medicals)
    • Meaning let nurses and junior doctors do more
  • Build a learning medical information ecosystem
  • Wow, what a bafflegab mouthful! At first it seemed to mean teamwork between health professionals (always a great idea), but then the authors pivoted to information technology. 
Always the technological solution, eh? Makes me laugh because I know physicians who have difficulty using their office computer system to renew a prescription easily. And some of these docs are not that old.
  • Mutter, mutter...Why won't it let me select renew? Aaargh! (Then writes it in pen on the computer print-out)
And how many physicians resist Twitter as a huge waste of time and don't see it as a valuable tool? Yet they attend medical rounds for the sandwiches (and to be seen) and chitchat or snooze or check e-mails throughout? Or perhaps, just to show how clever they are, ask the presenter an obscure question?  Perhaps I'm being too cynical but that's how it seems sometimes.

Bottom line - Physicians: On a personal level, transfusion physicians have been more successful than lab technologists and nurses in fighting job loss caused by government cutbacks. Or maybe it just seems that way because their numbers are fewer. Of course, medical directors of transfusion service labs feel the full staffing effects of having fewer specialist lab technologists/scientists.

I cannot but smile imagining physicians being told they must concede a significant percentage of what they always considered their health care role to others. But don't worry about it, docs, it's to your advantage. Others will now do the boring 'grunt work'. And you'll be able to concentrate on the interesting, complex stuff you were educated for. Don't worry, be happy.


With cost cutbacks, low morale affects all health professions to varying degrees. My experience is morale falls mainly due to uncertainty, lack of control, and feeling devalued

When government cutbacks occur, health systems are stressed to the max and are forced to change. You might think of it as tough love. The change includes finding innovative ways to keep functioning safely. What often results is a series of experiments, experiments in which both staff and patients are the guinea pigs. 

Often outside consultants are brought in to push and implement what is often the hobbyhorse that's become their cash cow. Sorry, couldn't resist the mixed metaphor. They implemented 'the solution' elsewhere and now they're the experts, commanding big money. It's led to the joke
  • 'We're consultants and we're here to help you.' [Sure you are.]
➽In this system-wide experimental laboratory where cost saving rules, the biggest impact on staff is uncertainty and loss of morale. Change is always hard but even 'keeners' can soon become unhappy when they learn that they have no control over events, including job loss. Competent, skilled staff are let go because their positions are eliminated. In a unionized environment sometimes the 'best and brightest' lose jobs due to lack of seniority.

Moreover, staff who survive the cuts often feel guilty. The 'Why me, not them' syndrome. Suddenly folks you've worked with for years are gone, perhaps needing to change careers they love, and you're left for no apparent good reason. Some may even need a job to care for their families away more than you do but....

In such an environment staff invariably begin to feel devalued. Unfortunately, this is one of the most long-lasting invidious effects of cost restraint in which it matters not how capable someone is, how dedicated or how loyal. Staff begin to feel like checkers being moved around a board, where any checker will do. 

Effects such as low morale take a long time and much effort to reverse. It seems that some feelings are branded into people's souls, and not in a good way. 

The other long-lasting invidious effects are mistrust and cynicism about the intentions of governments, that with a limited money pot, make choices that cripple a health system and leave it with a lasting hangover. This happened in Alberta, Canada in the 1990s.

Similarly, where massive funding cutbacks lead to significant job loss, internal disruption and re-organization, distrust and cynicism invariably extend to the administrators who lead the health system, whether those at hospitals or the blood supplier. 

The health care system becomes similar to a dysfunctional family with some of its characteristics
'One or both parents exert a strong authoritarian control over the children. Often these families rigidly adhere to a particular belief (religious, political, financial, personal). Compliance with role expectations and with rules is expected without any flexibility.'
In the case of health care, the de rigueur belief system includes cliches such as 'do more with less', 'work smarter, not harder', the lean business model and its many variants rule. Oh, and by the way, no dissent allowed

One final tidbit: The long-term effect of decreased government funding leading to less educated and trained staff is disconcerting because 
  • A little knowledge is a dangerous thing. 
The most dangerous folks in any profession are those who do not know what they don't know. And that plays out daily on hospital wards and in transfusion services labs, where we can only hope there are enough well educated specialists to catch errors leading to patient harm. 

In this blog I muse about the short- and long-term effects of the disruptive force of decreased government funding for health care and transfusion medicine in particular.It's happening everywhere.Will governments have a

It's doubtful. Today governments still do not consult frontline workers enough, or at all, about coming cutbacks and give them an opportunity to participate fully in a transparent change process.

Changing government policy is difficult and analogous to Newton's First Law of Motion:
A body at rest will remain at rest unless an outside force acts on it, and a body in motion at a constant velocity will remain in motion in a straight line unless acted upon by an outside force.
A sufficient outside force hasn't acted because professionals in the health system tend to accept whatever poop falls on their heads and do everything to make it work. Don't rock the boat, yes, this worries us, but let's wait and see. Somehow we'll muddle through, even if it creates much stress to us.

That's the thing. Physicians, nurses, lab technologists/scientists in transfusion service labs make the system work, regardless of the personal cost to their health and well being. And those in charge, physician-administrators
 (see below), bureaucrats, politicians alike, seem happy to let them. 

This song has been used before because it fits some of the blogs and, face it, I obviously like it.

For interest, in 1988 McFerrin's song was used by 'Bush 41'  - a one term President - as his official campaign song without McFerrin's permission. McFerrin protested, stated he'd vote against GHW Bush, and dropped the song from his performances. Ouch!

Anyway, given recent political events in the USA, you can likely guess my take on Donald Trump. Similarly for the long-term effects of government cutbacks, I could slit my throat (figure of speech) or sing this song and I choose the latter.

Here's a little song I wrote
You might want to sing it note-for-note
Don't worry, be happy
In every life we have some trouble
But when you worry, you make it double
Don't worry, be happy Don't worry, be happy now

As always comments are most welcome.


CSTM blog: I will remember you: Dianne Powell on lab restructuring

Dec. 2015 blog: Islands in the Stream (Musings on how love of transfusion medicine unites us)

How physicians can keep up with the knowledge explosion in medicine (19 Dec. 2016)

The rise of the hospital administrator [Reality is that hospital administrators railed at in the article are often physicians who've become 'suits'.]

Alberta's Primary Care Networks | Edmonton Southside PCN

Alberta government expands medical professionals authorized to assist patients with their deaths, by including nurse practitioners (12 Dec. 2016)

Truth about the nursing job market

USA blood industry consolidation

Blood industry shrinks as transfusions decline (2014)
Blood centers should position themselves to be agents (not victims) of change (2014)

U.S. health care from a global perspective

U.S. spends more on health care than other high-income nations but has lower life expectancy, worse health
Middleware revolution bridging automation gaps

UK health agency plans RFID trial to staunch transfusion errors (2006)

The case for RFID in blood banking (USA perspective, 2016)

Saudi's destructive oil freeze (March 2016)

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.

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. 

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.

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!
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.  

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:
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.

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.

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.

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.

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.


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.
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.


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.

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.

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.


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.


The twisted business of donating plasma (28 May 2014)

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