Saturday, June 13, 2015

I heard it though the grapevine (Musings on AABB promoting academia-industry partnerships)

Updated: 15 June 2015

June's blog is stimulated by May's issue of 'AABB News' featuring 'Advancing Cellular Therapies Together'. 

The blog's title derives from a Marvin Gaye classic covered by Creedence Clearwater Rival in 1970.

Frankly, the rah-rah! uncritical tone of the AABB articles surprised me. They mentioned logistical challenges to academia - industry partnerships but not one, repeat, NOT ONE, of the well known pitfalls when industry funds medical research. Didn't even allude to such problems existing.

Why no mention of pitfalls? Is it because of AABB's self-interest in promoting a business line?

In her editorial, 'Advocating for Cellular Therapies', AABB president Lynne Uhl writes:
'AABB will continue to advocate for clear regulatory pathways that avoid overly burdensome requirements for existing cellular products and promote rapid translation of novel findings from CT and regenerative medicine research to treatments for diseases.'
Sounds logical that AABB would advocate for easier access of medical discoveries to the marketplace where they can help patients. But the stance aligns with industry's usual complaint that governments set up needless roadblocks and should just get out of the way because industry will ensure patient safety. Really? LOL!

Let's take a brief closer look at AABB News' cellular therapy features.

AABB NEWS ARTICLES
A few selected highlights from 3 articles:
1. Evolving partnerships between academia and industry (p.4)

'As state and federal government funding...has declined... industry support has allowed many academics to continue their research, and academic institutions ... justify such collaboration as a pathway for the commercialization of important discoveries for the common good.'
2. Academia and industry collaborate in cellular therapy partnerships (pp. 8-10)
This article is an interview with Yongping Wang, MD, PhD, scientific director of the stem cell laboratory at the Children's Hospital of Philadelphia (CHOP) and Deborah Sesok-Pizzini, MD, MBA, chief of the blood bank and transfusion medicine division at the CHOP.

'The partnership gives both parties a new outlook on their work. It also brings together the different strengths of the two enterprises, which hopefully results in synergy.'
'The ultimate goal of these partnerships is to develop a mutually beneficial relationship that will result in scientific advancements.'
3. Advancing cellular therapies through partnerships (pp. 12-17)
'Many institutions and companies form partnerships drawing on each other's strengths to ease and speed the journey to market.' 
California Institute for Regenerative Medicine (CIRM): 'We are working to remove the barriers that slow research, without compromising safety.'
WHY RESEARCHERS AND UNIVERSITIES LOVE INDUSTRY FUNDING
  1. Government research grants are getting harder to obtain.
  2. Researchers may lose positions without outside research money because public universities increasingly suffer from decreased government funding and expect staff to be self-funded, especially in medical faculties.
  3. Industry funding combats the long-standing bias that universities are 'ivory towers' divorced from the real world.
WHY BIG PHARMA LOVES UNIVERSITY COLLABORATION
  1. Outsourcing cheaper, as those in blood industry know
  2. Adds credibility, especially if researchers are seen as 'thought leaders' 
  3. Access to research facilities cheaper than building them
  4. Well educated staff who work for free, inc. PhD students
  5. Way to recruit scientists and see future staff in action
  6. Form of advertisement, if researchers are in same field 
  7. Free advertising as universities tout industry partnerships to combat 'ivory tower' stereotype
WHAT COULD GO WRONG?
The short answer is just about everything. Of course, just because Big Pharma funds a study does not invalidate it. Most studies with commercial applications are funded by industry. But the scientific community needs to assess every aspect of such studies carefully using the hallmarks of critical analysis of scientific literature.

I'll highlight two threats that industry funding poses to medical research:

1. Easier Research
Industry tends to fund technology- and drug-based research because they are its business lines and such research happens to be easier. Big Pharma and the biotechnology industry doesn't fund difficult qualitative research on soft skills such as communicating, conflict management, human relations, negotiating, team building
, etc.  Why would it? 

Yet soft skills deficiencies account for serious errors in patient care. For example:

Communication
Communication deficiencies are common causes of adverse transfusion events. Patients with special transfusion needs such as those requiring irradiated or CMV-negative blood components are particularly at risk when communication fails.The spectrum of communication deficiencies includes the following failures:

  • Physicians not communicating with nurses, technologists, pharmacists, etc., and vice versa
  • Attending physicians not communicating with residents and interns
  • Staff from one unit not communicating with another unit
  • Staff on one shift not communicating with the next shift
  • Documentation not accompanying patients from facility to facility
Which research would industry be more likely to fund?
  • Educational research to improve health professional communication
  • Technology-based mistake-proofing tools like Blood Loc, a combination-lock-secured disposable bag that ensures positive identification occurs before blood can be unlocked and transfused
No brainer, right? Funding techno-solutions involves easier research. No messy human traits to deal with. 

Research priorities
Of course, to make the point, I've given an apples-and-oranges example of competing research needs. But make no mistake, within transfusion medicine many pressing research needs compete for limited funds


For example, on 25-26 March 2015, the U.S. National Heart, Lung, and Blood Institute (NHLBI) hosted a conference on 'State of the Science in Transfusion Medicine', for which AABB provided highlights. Priorities identified included
  • Need to integrate basic science within clinical trials design
  • Research to determine how to make better products, whether synthetic, bioengineered or 'pharmed' 
  • Several other themes: 
    • Hemostasis
    • Donor health and safety
    • Transfusion requirements of different patient populations, particularly pediatric and neonatal patients
I cannot help but wonder where all the research on molecular blood typing fits in the priorities identified at the NIH conference. Immucor and others claim it will 'revolutionize blood bank operations' and they work hard to make that goal a reality. But is it the best use of scarce research funding? See my take:
Having industry control which research 
gets done is not good.

2. Funding Effect
Financial interests can influence research outcomes in many undesirable ways. (See Resnick below) Besides outright fraud, well intentioned researchers may produce biased results unconsciously. 


For example, suppose I'm a university researcher who's increased my prestige and job stability because I've obtained a $1 million contract from Big Pharma to collaborate on investigating a new cellular therapy in what industry calls the 'niche area of oncology'. (Who knew cancer was a niche business line?)

A negative research result or one that shows only a marginal benefit will not further my career. But I'm ethical and have no intention of deliberately skewing results. Resnick below explains the nitty-gritty of what can go wrong from start to finish:

  • Problem selection 
  • Research design 
  • Data collection 
  • Data analysis 
  • Data interpretation 
  • Publication and data sharing 
A funding effect on medical research is real. I repeat, funding does not negate research, but we need to be aware of its insidious influence.

BOTTOM LINE
Collaboration and partnerships between academia and Big Pharma (and other health-related industries) are facts of life. Such collaboration has many benefits and many pitfalls.

Can the transfusion medicine community, particularly NA leading organizations such as AABB, please take its self-interest blinkers off and give members some credit for having a brain?

Vacuous, Rah! Rah! articles undermine AABB's credibility. I expect better from an organization I've respected and been a member of for 40 years.

Sidebar: Does 40 year membership mean I'm eligible for 'emeritus / life membership' in AABB?
AABB proposed bylaw change:
"Emeritus Membership to be renamed Life Membership with the eligibility requirement to be changed from 10 consecutive years of Individual Membership in AABB to 30 consecutive years."
As always, comments are most welcome.

FOR FUN
The version of the blog's title song that I I prefer is CCR's.

Don't you know I heard it through the grapevine
Not much longer would you be mine
I heard it through the grapevine
I'm just about to love my mind

What did I hear via the grapevine of AABB News? That respected organizations like AABB now mindlessly promote academia-industry collaboration as if it was the greatest invention since sliced bread. And not a whisper, not a hint of the real possibility of down-sides. Clearly they're industry's poodles.

FURTHER READING

Monday, May 18, 2015

Heart of Gold (Musings on sucking $ from body tissues)

Updated: 27 May 2015
May's blog was motivated by three items in TraQ's May newsletterUse of 'liquid gold' in two news items and an EU-funded report that showed 'a clear tension between the plasma derivative (PD) and the blood/blood components sectors'. Links to articles are provided below:
  • Unregulated USA stem cell industry is 'wild west', in which liposuction fat was described as 'liquid gold' because patients pay big bucks for fat-based stem cells
  • Canberra Red Cross calling on donors to consider donating 'liquid gold' plasma
  • EU-funded report calls for changes to plasma regulation
The blog's title derives from a 1972 ditty by Canadian Neil Young.

1. USA'S QUACK FAT-BASED STEM CELL INDUSTRY

A brief excerpt (revised for brevity and clarity): 
The liquid is a dark red 'soup', a mixture of fat and blood, that is pumped out of the patient's backside (fat ass?), treated with a chemical, run through a processor, and injected into knees, elbows, faces, penises, you name it. 
The 'soup'  is rich in stem cells, magic bullets that, according to some doctors, can be used to treat just about anything from anti-aging to face-lifts to multiple sclerosis to ALS.
It's quackery, critics say. But it's a mushrooming business,almost wholly unregulated. 
Those profiting call it "patient-funded research". Others say charging patients to participate in medical research is  unethical, unauthorized, for-profit human experimentation. 
The number of stem-cell clinics across the U.S. has surged from a few in 2010 to more than 170 today. Many clinics are linked to large, for-profit chains such as Cell Surgical Network.
Of course, it's quackery. Another example of medical professionals with vested interests promoting unproven treatments for gain.

2. AUSTRALIAN RED CROSS'S 'LIQUID GOLD'

The Australian Red Cross Blood Service (ARCBS) in Canberra promotes plasma donation via plasmapheresis because of a growing need.

A spokesperson said that plasma is used for 18 different treatments including burns victims, trauma patients and cancer patients, plus being used successfully as an immunity booster.

"We call it liquid gold because it can save so many lives."

Hard to decipher this news item. The spokesperson is likely referring to blood components (e.g., fresh frozen plasma, cryoprecipitate, etc.) and plasma derivatives. Most donated plasma in Australia is processed by the plasma fractionator, CSL Behring, to make many products that ARCBS buys back, I assume, and distributes to hospitals. If incorrect, please let me know.

And Australian donors are not paid, in the same way that Canadian plasmaphereis donors are not paid for plasma, although I assume some is sent for processing to manufacturers and sold back to CBS. From CBS's 2013-14 Annual Report (p. 40):

'Given that self-sufficiency is not operationally or economically feasible in a volunteer, unpaid model, Canadian, Blood Services strives to maintain a sufficiency of 30 per cent for immunoglobulin (Ig). 
The demand for Ig, continues to rise in Canada and internationally, and, to meet our needs, Canadian Blood Services purchases, surplus recovered plasma (from voluntary donations) from the United States for fractionation.' 
Seems that Canada supplies 30% of its own plasma for immunoglobulins, a plasma derivative / plasma protein product. But buys the rest --'recovered plasma' donated by unpaid, volunteer American blood donors  --  from non-profit US blood organizations. Really?

The worldwide PD market was estimated at $11.8b USD in 2009. Plasma truly is liquid gold, especially for manufacturing companies like Grifols with a global market share of about 20%. In 2013 Grifols net profit rose by a whopping 34.6% to 345.6 million.

3. EU REPORT CALLS FOR CHANGES TO PLASMA REGULATION

An EU-funded report looked at the plasma industry and produced several recommendations based on what industry wanted.

Some of the highlights:
  • The International Plasma Fractionation Association railed against the trend for ever-larger clinical trials for new or modified plasma products, most pronounced for coagulation factor products, making it harder and more expensive to run clinical trials.
  • Call for harmonization of regulations covering the selection of donors and plasma in the USA and Europe because, for example, mutual recognition of inspection reports could cut costs.
  • IPFA expressed concerns and suggestions related to regulations on donation, e.g., legal status of eligibility criteria, mandatory presence of medical staff, recall/exclusion for (v)CJD. 
    • For example, they said a permanent presence of a physician in a plasmaphaeresis centre adds significant costs without adding any substantial benefit. Qualified health professionals (nurses or who knows who) can do the job. 
  • The Report also notes a clear tension between private, for-profit companies supplying plasma derivatives to a steadily growing market, including unproven clinical uses, and the public sector, supplying a relatively stable demand for blood and blood components.
In other words, for-profit plasma manufacturers want to minimize costs in any way to maximize already fabulous profits for their shareholders.

BOTTOM LINE
Stem cells, plasma, and even molecular blood typing as in April's blog, While my guitar gently weeps -- It's all about the money, folks. 


Are the quack fat-derived stem cell entrepreneurs all that different from the paid plasma industry shilling IVIg as the latest and greatest for who knows what? 

Or that different from molecular genotyping companies and their advisory TM experts implying that any blood transfusion without genetically matched donors is 'bad blood' or not 'best practice' or so 20thC? 

Those trying to influence decision makers are powerful lobbyists with vested interests in the $ billions. 

And sometimes with support and collusion from transfusion medicine's 'thought leaders'.

FOR FUN
Rather than promote body tissues as 'liquid gold' I'd rather promote a 'heart of gold'. Silly me? A losing battle but one worth fighting.

As always comments are most welcome. 

FURTHER READING

Sunday, April 12, 2015

While my guitar gently weeps (Musings on the seduction of technology)

Updated: 13 April 2015
April's blog focuses on news items from TraQ's latest newsletter that have a commonality. 
  • The main item deals with a molecular assay to identify 35 red cell antigens from 11 blood groups. 
  • The other, included to illustrate the blog's theme but mainly here for fun, focuses on the clinical uses of platelet-rich plasma (PRP). 
I'll leave it to readers to ascertain what the stories have in common. The blog's title derives from a 1968 George Harrison ditty in the Beatles 'White Album'. 

 NEWS ITEMS
MUSINGS on MOLECULAR BLOOD TYPING 
Typing of blood group antigens at the molecular level has been in the works for years. Now it's moving beyond its original special uses because of technological advances, decreasing costs, and lobbying by vested interests. 

However, its cost-effectiveness is still unproven. Immucor's PreciseTypeTM HEA test costs ~$350 USD but that likely varies significantly depending on individual contracts. And any cost study I've read in journals like AABB's Transfusion is so dependent on assumptions as to be almost meaningless and needs to be read carefully and critically.

Also, molecular blood typing is not the be-all, end-all for the 100s of blood group antigens that exist, since not all are DNA-defined. But the list of antigens covered is impressive and includes nearly all clinically important blood group systems (see Further Reading). 

Of course, other companies besides Immucor compete in the molecular blood typing business, including BloodChip® by Progenika Biopharma.(Source: Greg Denomme's paper in Further Reading)

Regardless, molecular blood typing has no end of proponents, mild and strong. For example:
I wrote a blog on this topic years ago: 
  • Snip, snip the party's over (Dec. 2010) 
    • Suggest you read it later, if the mood strikes. My predictions have come true but they were no-brainers. 
Me Medicine
Now molecular blood typing is being marketed as personalised medicine, ie., the tailoring of medical treatment to individual characteristics of each patient. The idea derives from the 13-year, $3 billion Human Genome Project. For example, Immucor advertises PreciseType this way:
Makes it seem that anything less is substandard. Get with the program, health care providers, because it's all about me.

But many experts like Donna Dickenson, emeritus professor of medical ethics and humanities at the University of London and research associate at the HeLEX Centre, University of Oxford caution that
MUSINGS: PLATELET-RICH PLASMA (PRP) 
I'd read several news items over the years about PRP's use in orthopedics, particularly for athletes:
And recently the owner of a local restaurant I frequent mentioned that she had her own plasma injected into her knee but had to pay for it as it wasn't covered by Canada's universal health care system, at least for her. She said her knee caused a lot of pain (she's a 50-something server in the restaurant) but apparently it wasn't bad enough to be operated on yet. 

With that as background, recent news items on PRP's expanding clinical uses caught my attention. Medical tourism grows daily, at least for the rich. Seems Dubai now has more plastic surgeons per capita than any other city in the world and hopes to attract half a million medical tourists by 2020. 

The penis and vagina PRP nonsense was included just for fun. But really, Academy Award nominees got a coupon for a Priapus Shot? You cannot make this stuff up. 

BOTTOM LINE 
Okay, I lied because I'm sure you've gotten the blog's theme by now:
  • Where there's a buck to be made or an agenda to be advanced, clinical uses of diagnostic tests and products will inevitably expand well beyond what's evidence-based. 
TM poster-child for phenomenon? Intravenous immunoglobulin (IVIg). 

But what's surprising, at least to me, is how few voices, especially in the TM community, question the *expanded use* of innovations like molecular typing of red blood cell antigens under the guise of me-medicine. Particularly since our so-called 'thought leaders' are so into evidence-based these days. 

I understand why advances that help solve real TM problems are celebrated. But why the uncritical approach? Is it because blood typing at the molecular level is 
  • A marvelous innovation and all want to be seen as 'with-it' hipsters on DNA's bandwagon? Versus being old-fogeys who resist change? 
  • Way to develop a business line and maximize earnings in a shrinking field like TM in age of 'blood conservation '├╝ber alles', e.g., AABB? 
  • Outright self-interest for those who specialized in molecular technology and need to maximize their career's life-span?  
  • Seen as eliminating humans from the equation, such as interpreting serological test results, thus must be good? 
  • High-throughput automated innovation, another way to decrease costs by eliminating those pesky creatures, aka staff, with their costly salaries, benefits, and pensions? 
    • Better to give money to international companies than keep staff, aka tax payers and community builders, employed at home?
    • Plus many staff are probably contemplating retirement anyway and eliminating their jobs will help make that decision easier? 
  • Viewed as best thing since sliced bread, not just a significant innovation with specific uses, motivating proponents to abandon whatever critical thinking skills they ever had?  
BOTTOM LINE 
Personally, I wholeheartedly agree that molecular blood typing is a useful, indeed marvelous, advancement that will make blood transfusion safer for many. Celebrate its potential but please don't promote it beyond clear clinical uses so that anything else seems sub-standard, as in this over-the-top headline: 
  • 'Boston Children’s Hospital ends BAD BLOOD between donors, patients' (Emphasis is mine)
FOR FUN 
'While My Guitar Gently Weeps':
  • #136 on Rolling Stone's "The 500 Greatest Songs of All Time"
  • #7 on its list of 100 Greatest Guitar Songs of All Time
  • #10 on its list of The Beatles 100 Greatest Songs. 
While my guitar gently weeps (Paul McCartney and Eric Clampton tribute to George Harrison, Queen's Golden Jubilee, London 2002) 
I don't know why nobody told you 
How to unfold your love 
I don't know how someone controlled you 
They bought and sold you. 

I look at the world and I notice it's turning 
While my guitar gently weeps 
With every mistake we must surely be learning 
Still my guitar gently weeps 

As always the views are mine alone and comment are most welcome.

FURTHER READING 
References for those who want to delve further into the blog's topics. 
Molecular blood typing
Nice overview: Denomme GA. Prospects for the provision of genotyped blood for transfusion. Brit J Haem 2013 Oct;163(1):3-9.

For molecular blood typing in detail, see these papers from 2009. Info overload but fascinating insight into predicting the future (All papers free full text): 

Molecular blood group diagnostics.Transfus Med Hemother. 2009 Jun; 36(3): 154–155.(editorial) 

Five expert opinions on the question ‘Will genotyping replace serology routine blood grouping in the future?’ 
Interpretations are mine. (Author origins refer to where they worked then, not necessarily nationality.) 
  • Opinion 1: Only partly. Unlikely unless... (Germany) 
  • Opinion 2: Probably (Switzerland) 
  • Opinion 3: For some applications (Austria) 
  • Opinion 4: Personalized versus Universal Blood Transfusions – Combining the Efforts: Probably but in combination with enzymatic conversion (ECO) to remove A and B antigens (Sweden) 
  • Opinion 5: Yes (Netherlands) 
Platelet-rich Plasma 

Monday, March 16, 2015

I will remember you (Musing on retiring TM professionals & their patients)

As always, stay tuned for revisions 
This month's blog was triggered by ongoing retirements of longtime colleagues, medical laboratory technologists (clinical lab scientists) who work in transfusion services, blood centres, and Canada's provincial blood coordinating offices. The retirements come to my attention because I manage a mailing list ('transfusion'), whose subscribers are mainly Canadian and include laboratorians and nurses.

Because I've blogged about similar themes before, I decided to keep it short and add a few related news items from TraQ.

The blog's title derives from a memorable song by Canadian Sarah McLachlan, one that I've used before and love.

RETIREMENTS
We have known for ages that all health professions have an ageing workforce and that many would retire shortly, presumably leading to significant staff shortages.

Another long-standing concern is an impending brain drain. The loss would be especially acute in the laboratory 
due to automation, regionalization, and centralization, once the few remaining transfusion specialists retire with insufficient knowledge transfer to the next generation. Succession planning has not been a priority in health systems where staff barely have enough time to perform routine tasks needed for safe patient care.

As noted, over the past couple of years, many transfusion colleagues whom I've known for decades have retired, or are about to. They worked from coast to coast to coast in Canada and made incredible contributions to our transfusion medicine system. They seldom, if ever, get the national credit they deserve upon retiring.

Just a thought. Perhaps the CSTM would consider celebrating some of these wonderful transfusion professionals on its website as an ongoing feature?

NEWS ITEMS
1. Israel: Health system faces severe shortage of medical laboratory workers . Key points:
  • Close to half of Israel's lab workers are 55 or older
  • Lab worker with a doctorate and eight years' seniority gets 34 shekels ($8.80) an hour, similar to a hospital orderly
  • As expected, graduates prefer to work in other sectors
That low wage is pretty incredible.

2. Canada: CBS Regina component production lab to close in 4-5 years, as production moves to Calgary 


CBS's long-term plan is to regionalize blood component production to a few centres the way it regionalized blood donor testing earlier. Employees who find themselves without a job transfer to other positions (if available), move to other locations (impossible for many), or leave the organization.

The strategy is to innovate, mobilize knowledge, be on the leading edge of best practice, rightsize, leverage business lines, and be a leaner organization. 
Translation: Put safety first in all communications because it makes us look good but get rid of as many staff as possible, hire cheaper ones, save money. 

3. Scotland: Infected with hepatitis C via transfusion, woman charts her journey back to life

Interesting report of a Scottish woman who contacted transfusion-associated HCV ~27 years ago when she gave birth to a child and received 4 blood transfusions.

The UK experience with compensating people infected with HCV via transfusion is messy.

We need patients to remind us that, when the blood system gets it wrong, as it so tragically did with HIV/AIDS and HCV, people may die. And if they survive, they suffer for a long time and in many ways.

MUSINGS

  • Let's not forget our retired transfusion colleagues who dedicated their careers to helping others. We owe them a lot, not the least of which is friendship, mentoring, support, and many a shared laugh at meetings. For a chuckle see this conference cartoon via @academicssay on Twitter
  • To refresh the profession, we need to pay people a competitive salary, i.e., competitive to what health professionals with similar education and training earn. 
  • Leveraging and other management jargon, ubiquitous in our transfusion leaders' communication these days, fools no one. It's about the cost savings, stupid. 
  • Our transfusion 'thought leaders' (how's that for jargon?) continue to brag that the system is the safest it's ever been. And it is. That cocksure confidence was what led to the HIV/HCV tragedies. I'd prefer a little less braggadocio, a little more humbleness.
  • Let's never forget the patients in our care whose lives were harmed because our transfusion medicine leaders - caring and dedicated and extremely bright - nonetheless screwed up.
FOR FUN
Only one song fits this blog's theme:

And I will remember you
Will you remember me?
Don't let your life pass you by
Weep not for the memories. 

As always comments are most welcome.

Saturday, February 07, 2015

Islands in the stream (Fun musings on TM's crusade to cut costs - there's an app for that!)

Updated: 14 Feb. 2015

This blog derives from an article in the Jan. 3, 2015 issue of The Economist:
The blog is a follow-up, a sidebar in newspaper parlance, to a blog I wrote for TraQ's January newsletter:
The earlier blog discusses the rancor and over-the-top claims that can occur during contract negotiations, especially when employers such as national blood suppliers consistently opt to cut costs by hiring cheaper, less educated staff.

The current blog muses on HR 'what ifs' related to saving money by using outsiders and training remaining staff 'on the cheap' using apps. The tone is irreverent, the content tongue-in-cheek. If you're offended, don't be.

The blog's title derives from a 1983 Bee Gees song. The Bee Gees were the brothers Gibb, born on Isle of Man, who sold more than 220 million records worldwide.

#1. What if...
CBS, Canada's national blood supplier, expanded its Donor Care Associate initiative ('multi-skilled clinic employees' perform all clinic functions, from venipuncture to donor screening, tasks previously done by RNs) beyond nursing to transportation?

In northern climates I envisage 'Transport Care Associates' working for blood suppliers such as BFDC ('Blood Fluids Dot Ca').

In tropical climates, perhaps turtles, slow but steady and reliable?

#2. What if...
An equivalent to Amazon's 'Mechanical Turk' existed for transfusion services?  Why not a global blood bank work force where transfusion medicine specialists 

  • Work from home
  • Choose own work hours
  • And no one needs to pay for their benefits except them
  • National blood suppliers would crow to government paymasters, 'Look how we've decreased costs.'
  • Not mentioning on whose backs savings were realized and probably increasing the CEO's salary for his great work
Let's call it 'BB-a-Go-Go' with these business lines:
  • BBaGG-IH: Want expert help with an unexpected crossmatch incompatibility, complex antibody identification, blood grouping conundrum, any immunohematology challenge? 
    • Get these IH folks fast as they're a dying breed.
  • BBaGG-Scribe: Need experienced SOP writers or help creating a blood contingency plan to deal with severe blood shortages from pandemics and other disasters? 
    • They'll create e-text files. Bonus: Older Scribe staff will produce notes in readable cursive writing in the margins of existing documents. Yes, really!
  • BBaGG-Consultants: Looking for 'suits' to down-size the organization or decimate it by out-sourcing tasks to for-profit firms, then flee the ugly aftermath? 
    • Our 'suits' don't clean up the detritus of the 'past civilization' but we can supply grief counsellors for a fee.
  • BBaGG-RN: Seeking advice for how to tame and educate pit-bull nurses refusing to re-draw mislabelled specimens? Typically, the RN's dialogue proceeds as follows:  
    • 'I know I took blood from the right patient.'
    • 'Don't you know you're risking the patient's life with your stupid lab rules?'
    • 'The poor patient has been "stuck" 4 times today already!'
For an extra fee, we offer the online RN-tailored course, 'Quality Control, what's it all about, Alfie?'
  • BBaGG-Dominatrix: Desperate to neuter abusive docs who insist on blood now, who don't care about your 'bloody positive antibody screen nonsense', just want group O RBC NOW, because they were told in med school group O was the universal donor, safe for all?
    • With Dominatrix Plus, the physician gets a safe word or phrase to indicate they cannot take it any more. We suggest 'Lab uber alles' or 'I'm lab's poodle'.
Other 'BB-a-Go-Go' business lines are possible. Feel free to suggest some in Comments.

#3. What if
A smartwatch app existed that included all the pre-administration checks that a nurse must do before administering a transfusion? Let's call it 'Last Chance':

  • The watch has a camera that monitors the checks, and beeps if one were missed, identifying the missed detail. 
  • A nursing manager  - for fun, the spitting image of Nurse Jackie - pops up on the watch's screen and gives a video message about what to do next and why you better do it NOW. 
  • The bedside nurse can reply and ask questions with a video message in return. 
The app could also include built-in alerts to check the patient during and after the transfusion.

With bulk purchases, buyers get the add-on, 'Doomsday Clock', which shows how close to midnight it is, indicating how close the nurse came to an OMG! patient disaster.

#4. What-if
An app existed that allowed instant access to transfusion medicine experts, 24-7? 


Say you're a hematopathology/hematology resident on-call and the biomedical scientist / lab technologist calls with an issue you've never heard of. Chances are she or he knows more than you but you can never admit it.

You could call the transfusion service medical director, yet again, further digging your own grave, or you could use this 'killer app',  PMA ('Protect My Ass') for medical residents. Currently, versions exist only for Blackberry and iOS phones, plus iOS tablets.

Wait, there's more! PMA includes a simulation of how residents can learn to be obsequious to RNs on the wards, bowing to their superior knowledge and experience, and learning from it.
SUMMARY
The Economist's piece expertly analyses the pros and cons and obstacles to the ongoing trend of on-demand freelancers who work without job security, without benefits, without pensions.

That's where national blood suppliers like Canadian Blood Services are heading. It's a trend everywhere.

My view is the trend is inevitable but not progress, not admirable. And, as The Economist points out, a freelance work force doesn't contribute to happy staff who consistently give their all for employers they love and respect, and whose success is tied to theirs.

BUT the trend exists because .... [you fill in the blank] 


Wish List: I'd like to see an app that translates management's weasel words into what they're really saying. One example: 
  • 'We're pleased to report a "cost saving" of ...' probably means,
    • We've eliminated expert frontline staff;
    • Replaced them with less educated, cheaper staff; 
    • Perhaps replaced them with automated equipment, likely sending money to a foreign international company rather than hiring local staff and keeping wages in the community;
    • And given execs a bonus and pay raise for their brilliance in decreasing costs.
FOR FUN
This duet of the Bee Gees song is perhaps the best country duet of all time. One of my favorites, the song fits what I see the transfusion medicine community should be but isn't. The lyrics also suit upcoming Valentine's Day.

Islands in the stream
That is what we are
No one in between
How can we be wrong
Sail away with me
To another world
And we rely on each other....

Not a disco fan but this Bee Gee ditty from 'Saturday Night Fever' with John Travolta is irresistible. Also relates to TM workers in era of cost restraints:
As always the views are mine alone and comments are most welcome.

Friday, January 09, 2015

All you need is love (Musings on national blood supplier HR woes)

Updated: 11 Jan. 2015

January's blog derives from news about unionized employees of Canadian Blood Services in Ontario considering strike action and the public rancor that occurred between employer and employees. The strike is apparently off, as is often the case, but what happened bears comment.

Suspect no matter where you live, what your transfusion health profession, staffing issues in blog are relevant. Do you think your employer focuses on decreasing costs? Saves money by hiring less well educated and trained staff? Cares more about the bottom line than staff welfare? But spouts rhetoric to the contrary? Then this blog's for you.

The blog's title derives from a 1967 Beatles ditty, All you need is love

Disclosure: I worked for ~13 years as a medical technologist, supervisor, and clinical instructor for CBS's predecessor, Canadian Red Cross, before becoming an instructor in MLS, University of Alberta and since then have been hired by CBS as a consultant on many projects.
BACKGROUND
1. Ontario's CBS employees, belonging to the Ontario Public Service Employees Union (OPSEU), claimed the CBS management wanted to lay off skilled health-care professionals and replace them with lower-paid workers:

2. The union wrote a letter to CBS staff about CBS's intention:
3. OPSEU published ads in 14 newspapers across Ontario and made videos that claimed that CBS's HR policies threatened the safety of Canada's blood system, as in the earlier AIDS/HCV tragedy:
4. CBS strikes back in the form of Ian Mumford, CBS's chief supply chain officer's e-mailed statement:
MUSINGS
Be aware that I am a staunch union supporter, despite their shortcomings. Love Pete Seeger and all he stood for.


Was in a union as a tenured professor at University of Alberta. Yes, it was the Association of Academic Staff, but a union all the same. 

When I worked for Canadian Red Cross's Blood Transfusion Service (BTS) in Winnipeg, we worked ridiculous hours at low pay. When I mentioned staff couldn't continue to work long weekend shifts (~24 hrs) and whatever it took to process huge blood donor clinics, the medical director, a man I respected until then, kindly said the equivalent of, 'You can always quit. I'll be glad to supply a reference.'

Also, I believe that CBS has a policy to hire the cheapest possible staff, to train them for specific jobs, and claim they're 'safe' with documented competency assessment.

This is exemplified by CBS's 'donor care associates' program, approved by Health Canada:

Of course, CBS's 'cheapest staff' policy was vetted by Health Canada.  Why the cheapest possible? Because the federal government and its regulatory agency, HC, as well as the provincial governments responsible for Canada's healthcare system, are invested in reducing costs. I've blogged about this often.

And I well understand, but strongly disagree with, how public health and government employers under cost constraints prefer to hire casual and part-time staff. I lived it in the 1990s when the Alberta government cut ~40% from the laboratory medicine budget.

The result was massive lab technologist job losses, followed by years of casual and part-time employment, all so employers did not need to provide various staff benefits. Despicable. Also, many transfusion medicine experts lost jobs as transfusion services hired 'generalist' technologists who were supervised by fewer and fewer transfusion specialists.

Many transfusion medicine laboratories face succession planning issues as older transfusion specialists retire. The crunch may occur in 10-15 years when more and more specialists retire.

BUT....
To me the OPSEU ads are over-the-top and do the cause more harm than good. CBS's hiring practices are NOT admirable. Hiring less well educated staff and training them on-the-job puts more of a burden on busy, well educated and trained staff. Hiring practices that lead to long-time staff being without benefits are despicable.

Indeed, current CBS HR policies create real potential safety issues, to say nothing of staff discontent and workplace resentment. I suspect nobs like CEO Graham Sher and chief supply chain officer Ian Mumford do not have a clue about how staff in the trenches feel. And maybe those earning mega-bucks don't even care. 

But to imply CBS hiring policies threaten the safety of the blood supply, like the HIV/AIDS and HCV tragedies of the 1980s and 1990s did, is nonsense. Such claims make it easy for CBS to dismiss real concerns about their business plans that put cost above all else.

And yes, Canada's blood system has morphed into a business, not healthcare. None more so than Canadian Blood Services. CBS is not patient-centred, it's cost-centred. And staff is one of its biggest cost-centres. CBS gets rid of staff without a thought. Indeed, CBS congratulates itself for how much it cuts costs on the backs of staff.

But, please, those concerned should analyse each CBS policy rationally. Its policies may be sh*t on many levels, but they're NOT equivalent to the 1980s AIDs tragedy. 
False arguments that make it easy for CBS to dismiss legitimate concerns don't help.

My career path with two major employers (blood supplier, university med lab science program) seems antiquated. [I don't count consulting because it's a hodgepodge of 'jobettes'.] In contrast, today's workers can expect many employers with little job security.  

But despite conflicts, I considered both employers my family. I loved the organizations and believed we were on the same side, wanting to help and serve others. Canadian Red Cross BTS is where I grew up, literally. Teaching transfusion science in MLS at the University of Alberta was the best transfusion-related teaching job in the world. Hands down!

Reading the CBS-OPSEU rancor, makes me glad I'm a dinosaur of sorts. Are such HR issues between national blood suppliers and staff relevant elsewhere around the globe? You tell me.

FOR FUN
Always sorry to see animosity between union and employer (CBS) but I understand why. Yet to me, life is too short to be opponents. Surely, cooperating and understanding are better. My experience puts me on the union's side, despite its faults and hyperbole on blood safety. But I prefer cogent arguments to over-the-top claims, easily dismissed. 


Perhaps kumbaya, but I love this Beatles song:

  • All you need is love (Paul McCartney, Stewart, Joe Cocker [now deceased], and many rock n' roll legends, Party at the Palace, 2002)
My edits to Lennon-McCartney lyrics:
There's nothing you can do that can't be UNdone
Nothing you can sing that can't be UNsung
Nothing you can say that can't be UNsaid
But you can learn how to play the game
It's easy... Love is all you need. 
As always, comments are most welcome.

Wednesday, December 10, 2014

Angel (Musings on communication errors in TM)

Updated: 13 Dec. 2014

This month's blog derives from news items appearing in TraQ's monthly newsletter involving Jehovah's Witnesses in NZ and the UK, and the availability of online legal summaries.

In particular, the blog features a case from NZ in which communication failures led to a woman's death. Her death likely could have been prevented if the surgeon had known that she was a Jehovah's Witness and had refused to be treated with blood and blood products.

The case is all the more tragic because her surgery was routine, elective laparoscopic cholecystectomy. Even with 'open surgery,' transfusion may be required but seldom is. For many years, transfusion services have done only a type and screen, just in case blood is needed.

So, although involving a Jehovah's Witness, the blog is about communication and how critical it is to patient safety.

The title derives from a 1997 much-covered song by Canada's Sarah McLachlan.

BACKGROUND
UK SHOT Reports always feature cases that emphasize the importance of communication to transfusion safety. Musings on communication failures and examples from SHOT follow the NZ report.

NZ CASE
Below is my edited version of key case details as described in the report. I've kept the NZ spelling (with the diphthong 'ae' used in many former British colonies,though not so much in Canada with our proximity to the USA).

1. Ms A was seen by a surgeon at an outpatient clinic (Hospital 1). A surgeon confirmed gallstones and she was put on a waiting list for an elective laparoscopic cholecystectomy.

2. Later Ms A attended a nurse-led pre-admission clinic, where she confirmed that she did not consent to the use of blood and blood products.

3. Ms A was admitted for surgery. Surgeon Dr C and anaesthetist Dr D met with her to discuss the operation and to complete the process of obtaining informed consent.

4. When the surgery began Dr C was unaware of the patient's views on blood transfusion. The matter was not raised during the surgical 'Time Out', when any issues of concern are brought to the attention of the OR team. (See below for info on surgical 'timeouts'.)

5. Surgery began at 9 am. Because of difficulties, at 9.50 am, the laparoscopy was converted to open surgery. Ms A's gallbladder was removed and the operation ended at 11.15 am.

6. Bleeding occurred during surgery, but not enough to cause concern. Ms A was transferred to the Recovery Unit at 11.25 am.

7. There were concerns about Ms A's condition from about noon. Initial measures were unsuccessful and it was thought that she was probably bleeding internally.

8. Dr C instructed that Ms A was to be transfused, at which point he was advised of her blood product refusal.

9. Dr C determined that further surgery was needed to identify and address the cause of the bleeding. Ms A, still partially sedated, confirmed that she would not accept blood.

10. Permission was sought from Ms A's mother to override Ms A's directive but she said she could not do this.

11. Ms A was returned to the OR and surgery began at 2.55pm. Because no obvious bleeding point was identified, Dr C determined that the best course of action was to pack the liver bed and close the abdomen, so that Ms A could be transferred to a facility better able to manage her condition.

12. Arrangements were made to transfer Ms A by helicopter to Hospital 2. When the helicopter crew arrived, it was decided that transfer was inappropriate due to likely hypoxic brain injury. Ms A was confirmed dead at 6.59 pm.

SUMMARY
For more information, and key findings, I encourage you to read the full report below. 62 pages is a lot but many are appendices, plus it's fascinating. Documented tidbits include
  • At 2.29 pm, prior to the second surgery, Ms A's Hb was 45 g/L
  • At 3.26 pm, post second surgery, Ms A's Hb was 11 g/L 
A physician at Hospital 2, where she was to be transferred, said about the second surgery:
"Pre-operatively her haemoglobin level was 45, which in a Jehovah's Witness who refused blood product transfusion I felt was life threatening. Post-operatively her haemoglobin was 11 which is almost incompatible with survival.

At some stage I suggested using concentrated factor VII, which if used early enough before severe dilutional anaemia has occurred might control the bleeding. I thought [Ms A] was almost certainly going to die..."
Recommendations and Follow-up actions are on pp 42-3 of the Report and include mandating that 
  • Those involved review their practices and apologise to Ms A's family in writing.
  • Appropriate medical colleges be sent a copy of the report, and advised of the names of Drs C and D.
MUSINGS
The communication failures in the NZ case highlight a long standing issue in transfusion medicine. Communication errors are common causes of adverse events.

Patients with special transfusion needs such as those requiring irradiated or CMV-negative blood components are particularly at risk when communication fails.The spectrum of communication deficiencies includes:
  • Physicians failing to communicate with nurses, technologists, pharmacists, and other health professionals and vice versa
  • Attending physicians failing to communicate with residents and interns
  • Staff from one unit failing to communicate with those from others
  • Staff on one shift failing to communicate with those on the next shift
  • Documentation failing to accompany patients from facility to facility
  • Health personnel failing to listen carefully to patients
Common tools to prevent communication errors include mistake-proofingaka as the politically incorrect 'idiot-proofing'.

Error proofing is  ubiquitous in society, e.g., beeping alerts when keys are left in cars or headlights are left on. Non-communication transfusion-related examples include
  • Colour-coded ABO typing sera, 
  • Pretransfusion nursing checklists 
  • Cross-checking work done by others
  • Eliminating identification errors via technology, e.g., barcodes, RFID
Preventing communication errors between TM professionals is more onerous because it involves complex, long term strategies such as
  • Developing standard operating procedures and tools (forms, letters, patient cards) to facilitate intradepartmental, interdepartmental, and inter-facility communication
  • Implementing methods to train and retrain health professionals to value effective communication and teamwork
  • Fostering a culture that eliminates communication barriers such as hierarchies within and between professions, and boundaries between departments
  • Developing information management systems to facilitate information transfer
SHOT REPORTS
Below is a small selection of communication issues documented by SHOT over the past decade (most recent first). (I've sometimes edited the original text.)

1. SHOT 2012 has 50 'hits' for 'communication'
One example (p.16, under 'Human factors in hospital practice'):
  • The errors described in this SHOT report consistently demonstrate failures in communication and handover that lead to adverse incidents, some life-threatening, in transfusion practice.
  • Failures of 'handover' (communication errors) may occur as the patient travels between wards and departments within a hospital, between clinicians in different hospitals, and between hospitals and community settings. 
  • Why? Often it's because of the human tendency to assume that someone else is responsible
2. SHOT 2013 has 48 'hits' for 'communication'
One example (p. 42 under 'ABO incompatible transfusions n=12'):
  • This shows the importance of communication between clinicians and laboratory staff in an emergency. There was no historical record available for the patient and laboratory staff issued FFP based on the misleading grouping result.
3. SHOT 2003 has 21 'hits' for 'communication'

Fewer 'hits' mean nil because the report includes 107 cases in which patients with special needs were transfused with the wrong blood. Of these, 81 involved patients at risk of GVHD for whom there was a failure to provide irradiated components.

The following three examples from SHOT 2003 (p. 23) illustrate the issues (italics not in original):
Case 10. Lack of awareness of guidelines puts patient at risk. A 66 year old male patient received fludarabine for chronic lymphatic leukaemia. The ward staff were unaware of the indication for irradiated blood components and so the laboratory was not informed.

Over a 5 month period the patient received 13 units of unirradiated red cells. 
Case 11. Failure of communication in shared care. A 14 year old male was admitted for an open lung biopsy following which he bled and required transfusion. He had previously received a stem cell transplant in another hospital in the same Trust, but there was no facility to link the two transfusion laboratory computer systems and the requester was not aware of the previous history.

Non-irradiated red cells were given. 
Case 12. No notice taken of an informed patient. An elderly male patient was admitted to hospital A with an ischaemic foot. He informed the ward staff that he required regular transfusion with 'special blood' at hospital B.

The ward confirmed with the transfusion laboratory at hospital B that he had an anti-ANWJ but this information was not passed on to the laboratory at hospital A who were undertaking pretransfusion testing.

The antibody screen was negative and 3 units of red cells were issued electronically and transfused. The patient had a rise in temperature and a raised bilirubin, and died 8 days later from bronchopneumonia.
As documented by SHOT, communication failures continue to happen because they involve humans, and 'to err is human'.

BLOG's TITLE SONG
Sarah McLachlan's 'Angel' (often mistitled 'In the arms of an angel') has been used so often as a song of comfort that it's almost become a cliche. To me it fits a blog that describes a series of communication failures that resulted in a tragedy that need not have happened.This performance with iconic guitarist Santana is a 'oner'.
  •  Angel (by Sarah McLachlan with Carlos Santana)
In the arms of the angel fly away from here
from this dark cold hotel room and the endlessness that you fear.
You are pulled from the wreckage of your silent reverie.
You're in the arms of the angel, may you find some comfort here.
You're in the arms of the angel, may you find some comfort here.
The song's origin is not at all what it's come to symbolize: Sarah says it was inspired by articles about musicians turning to heroin to cope with the pressures of the music industry and subsequently overdosing.

FURTHER READING
1. 'Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery', including
1. A pre-procedure verification process
2. Surgical site marking
3. Surgical "time out" immediately prior to starting the procedure
2. A Report by NZ's Health and Disability Commissioner (30 June 2014)
Nelson Marlborough District Health Board
General Surgeon, Dr C
Anaesthetist, Dr D 
3. News item: Jehovah's Witness dies after refusing blood transfusion (20 Oct. 2014)