Wednesday, January 20, 2016

Simply the best (Musings on paid plasma & TM colleagues I've know)

Updated: 23 Jan. 2016
January's blog is a two-fer, derived from a news item in TraQ's monthly newsletter and a blog series written for the Canadian Society for Transfusion Medicine (CSTM).

The title derives from a 1989 Tina Turner classic. And it relates to the CSTM blogs, not paid plasma. But I suspect you could figure that out. Paid plasma and its Canadian players are the antithesis of the best.

Although this blog and the CSTM blogs are from a Canadian perspective, I'm confident you will see how the content and issues relate to you, no matter where you practice.

For links to news items and resources, see Further Reading at the blog's end.


#1. MUSINGS - HONORING COLLEAGUES / RECORDING HISTORY
I encourage readers to read this new series of blogs on the Canadian Society for Transfusion Medicine site. To date there are two blogs, with many more to come.  As I wrote to introduce the first blog:

Each blog begins with my musings on the individual, followed by a brief background on the person's career, sometimes with my comments throughout. 
If you're looking for a rah-rah, rosy view of Canada's transfusion medicine field, this ain't it. Why? Although all participants enjoyed their careers and love the transfusion profession, they also speak honestly about both the ups and downs. Perhaps their reflections will resonate with your experiences.
Take a peek. Blogs present real experience with honest opinions that challenge the 'powers that be'. I encourage you to comment on the CSTM website and give your experiences, whether similar or different.

Now for the NOT BEST. 

#2. MUSINGS - PAID PLASMA REDUX

Oh, no, I can hear you scream. Not paid plasma in Canada again! Yep, because it's in the news again. To me, it's like whack-a-mole or the gift that keeps on giving, blog-wise. So much to learn from this Canadian saga, and most of it BAD.

Don Davies, a federal MP with a centre-left Canadian political party (NDP) has called on paid plasma clinics to be banned. Already not allowed in 2 provinces (Ontario and Quebec), a company, Canadian Plasma Resources, now has plans to set up in the Canadian province of Saskatchewan and has the approval of its right-of-centre government.

Party characterizations are mine. Feel free to disagree. Note that in Canada's political system, jurisdiction over health care belongs to the provinces.
Bottom line, and one reason why I think writing about this again is useful:
  • MP Davies bases objections on safety. Since Canada has one of the safest blood systems in the world, this is a hard sell. More credible arguments against paid plasma are nuanced.
Safety
In a nutshell, the safety risks of paid plasma are exceedingly small but not zero. Any remaining risks are rare and relate to the 

  • Poor and needy potentially lying on blood donor screening questionnaires to get the money, combined with 
  • Reality of window periods of negativity (even short ones), such that screening tests may not detect early infection.
Another risk factor is that of unknown new and emerging infections that may be transfusion-transmissible. You can bet they exist, just as death and taxes are sure things.

In both cases, the infections would need to escape existing donor screening questions and tests, as well as current processes in the manufacture of plasma derivatives (e.g., albumin and immune globulins such as IVIg and Rh immune globulin), including

  • Plasma quarantine
  • Technology to inactivates viruses
  • Purification steps
Can transfusion-associated risks happen with plasma derivatives? Yes. Likelihood? Extremely low. One unknown is the human factor. Humans make mistakes, otherwise known as 'shit happens'.  

But, similar to winning the USA's Power Ball $1.6b lottery (odds are ~1 in 292 million), eventually someone will do it. If you're the unlucky patient  who gets a transfusion-transmissible disease, no matter how unlikely, it matters not.

Moral/philosophical
Canada, like many nations, adopted an altruistic view of blood donation, meaning paid plasma donation is an anathema.

But paid plasma donation has existed since the 1960s in Canada, something paid plasma advocates love to point out:


As far back as the 1960s, the Rh Institute in Winnipeg paid Rh negative women with potent anti-D causing severe HDN and fetal death a small honorarium for their time in donating plasma by plasmapheresis. 
Side-Bar: Never mentioned in the literature - something that fell under the radar: In the 1960s Canadian Red Cross Blood Transfusion Service (CRC-BTS) bled employees for blood typing antisera and paid us. How much? A whopping $5/donation.
As a group A CRC-BTS medical lab technologist employee, I donated plasma for anti-B antisera and was injected with soluble B antigen to increase my anti-B titre. My group B co-worker had her anti-A similarly boosted and plasmapheresed for anti-A. 
Such donations ceased when my co-worker's first child had severe ABO-HDN. Physician in charge realized it was not a good idea to boost the strength of ABO antibodies in young women of childbearing age. Doh!
Back to anti-D: Donation initially occurred at CRC-BTS (now CBS). As someone involved I can testify that the 'Rh ladies', many of whom had fetuses stillborn due to severe hemolytic disease of the fetus and newborn (HDN or HDFN) did not donate for the small honorarium. 
Rather it was to help other woman not have to suffer their pain and in gratitude to Dr. John Bowman, who donated his own group O Rh-negative blood for exchange transfusions, pioneered inter-uterine transfusions (IUTs), which gave them living children, as well as pioneering antenatal Rh Immune globulin manufactured from their plasma, which prevented HDFN in others.
  • So, please, don't buy the guff that today's poor who donate for money are in any way similar to these women donating anti-D in Winnipeg. 
Since then a commercial company (Cangene, now defunct and part of Emergent Biosolutions) expanded to paying not only the 'Rh ladies' with potent anti-D, but others with special antibodies to manufacture plasma derivatives such as hepatitis B immune globulin (HBIG). 

Canada's approach to commercialized, private medicine
To some extent Canadians have looked our collective noses down on the commercialization of blood donation (and health care in general) in our U.S. neighbour.
Ignoring the ethics of paying the poor for plasma and charging those unfortunate enough to be sick for health care, many Canadian medical lab technologists/scientists who work in the USA are astounded at the bureaucratic nightmare associated with hospital transfusion services charging patients for each and every pretransfusion test.
  • Need a type and screen? Ka-ching!
  • Have an antibody to identify? Ka-ching! 
  • Need antigen-negative red cells? Ka-ching! 
  • Need multiple red cell, plasma, and platelet transfusions? Ka-ching! 
  • Require special blood products like irradiated red cells? Ka-ching!
Patients can be billed $1000s of dollars. Many don't have private insurance associated with employment or are not poor enough to get Medicaid or are elderly (Medicare).

For more on USA's system of paid blood donation and private healthcare, see Further Reading (Domen and AABB and Deciphering USA's Health Insurance System (an information page I created with significant help from a MEDLAB-L subscriber).


What does 'paying' donors mean?
Today USA's so-called 'non-profit' blood banks do not directly pay whole blood and plasma donors money. It's done via various incentives. 


Sample 'non-profit' blood bank incentives (via Oklahoma Blood Institute):

Paid plasma collection centers, some operated from abroad, e.g., Australia's CSL, are different. They prey on the poor and make a lot of money doing so. Even they now have sense enough to shy away from the filthy lucre ($$$) and do not pay donors directly. It's usually done by prepaid debit cards, as explained here:
BOTTOM LINE: Many Canadians think this is the way to go. I do not.Those promoting paid plasma lay on the fear and guilt: people will die without a sufficient supply of plasma derivatives. Then they play the hypocrisy card, noting that CBS buys products made from paid plasma donors. 

What they don't say is 'Let's build the plasma collection centres next to homeless shelters so we can get our supply 'on the cheap'. Renting or buying a facility will also cost less. Value-added! Let's leverage the location to improve our bottom line and pay higher dividends to our investors.' Because it's all about the money, stupid!

For interest, someone sent this as a comment to an earlier blog and it's never been more relevant:

"Regarding Paid Plasma and the potential go ahead in Saskatchewan (SK):

We have had no public consultation in SK. and we are still don’t know what happened to the results from the Health Canada Public Consultation on the Safety of Paid Plasma Donations.
The CBS doesn’t collect as much as they could because of cost not donor availability but this reality gets stood on its head to appear that there are not enough donors and we actually need this. 
CHS and CBS support the deal adding credibility not to a Baxter or Octapharma but instead to a bunch of guys that really do not appear to be very credible. 
It's all incredibly interesting. Can't help but wonder who will be handling the testing of samples for CPR?"
MY TAKE. Health Canada and CBS both come across as a joke in this sorry saga:
Can HC make a decision that doesn't ebb and flow in the wind depending on how key stakeholders lean? And if profit-motivated Canadian Plasma Resources opens for business in SK, who will do the transmissible disease testing?

Can CBS please stop with the weasel words that they support voluntary blood donation but, hey, paid plasma is safe and, by the way, we REALLY need it?


FOR FUN

When I write about my colleagues, I always think of Tina's song:
As always, the views expressed are mine alone. 

Comments are most welcome (you can do so anonymously). See below. 
FURTHER READING
My 5 prior bogs on paid plasma (Some internal links to news items may not work but you'll get the idea)
Paid plasma clinics must be banned: NDP (15 Jan. 2016)

AABB: Billing for Blood and Transfusion Services: Frequently Asked Questions and Answers

Deciphering USA's Health Insurance System  (Generous help with links supplied by James Pusavat, a MEDLAB-L subscriber from the USA)


Domen RE. Paid-versus-volunteer blood donation in the United States: a historical review. Transfus Med Rev. 1995 Jan;9(1):53-9.

What is USA's Medicare vs Medicaid? / Also see 
Investopedia

This next paper is a beauty. Gives all you need to know about paid plasma in Canada, and its advocates:

Saturday, December 19, 2015

Islands in the Stream (Musings on how love of transfusion medicine unites us)

Updated: 20 Dec. 2015
December's blog is based on a request from CSTM to 'put my money where my mouth is' and follow up on a statement from a March 2015 blog:
'Just a thought. Perhaps the CSTM would consider celebrating some of these wonderful transfusion professionals on its website as an ongoing feature?'
As a longtime CSTM member and active blogger, guess it was natural to ask me and I was happy to oblige. Of course, blogs on individual careers cannot be written without the help of their subjects. So I asked, and they've kindly complied with only a little arm twisting.

As a value added benefit, blogs about lifelong transfusion medicine professionals document not only their contributions but also their experiences. Having remembrances in writing creates a historical record. And the only way to document this type of history is by asking questions of those who lived it.

This blog consists of 'teasers' about blog subjects to be featured on the CSTM website. 

They're all Canadians and mainly medical laboratory technologists / scientists. I encourage TM workers around the globe, whether med lab technologists, nurses, or physicians, to see themselves and their careers in these portraits and snippets of what transfusion medicine was like in the 20th C.

In some ways the blogs document the 'best of times and worst of times' to use one of the most famous opening lines ever in a novel, Dickens' opener to 'A Tale of Two Cities':
'It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope ... in short, the period was so far like the present period....'
The blog's title derives from a Bee Gees ditty whose title was taken from a Hemingway novel. Sung by Rogers and Parton, it became one of the best country duets of all time. 

CSTM BLOG SUBJECTS

In no particular order, a small sampling of blogs to come. This med lab professional...

1. Began his career in the UK where he met R.R. Coombs of Cambridge University, emigrated to Canada to work in Winnipeg's Rh Institute with the likes of Dr. John Bowman and Marion Lewis (awarded AABB's most prestigious Karl Landsteiner Award in 2001 and 1971, respectively) and ended his distinguished career in southern Alberta. 

2. Worked for Canada's blood suppliers (Red Cross/CBS) in multiple roles and several hospitals where in the 1990s she experienced the Alberta government's deep cuts to laboratory medicine funding, resulting in lab restructuring in which up to 40% of med lab techs in Edmonton lost their jobs and were faced with a career change.

3. Began her career as a PhD immunologist with research and academic experience in clinical microbiology, cancer research and immunology in several countries and later earned a masters in Health Admin. In 1994 she began working for Justice Krever on the Commission of Inquiry on the Blood System in Canada, eventually becoming executive coordinator and scientific advisor. Since then she has worked around the globe for the WHO on many blood-related projects in Third World countries.

4. Born in Hong Kong, began his career with BS in Med Tech from the University of Hawaii. Obtained ART certification (CSLT/CSMLS ) in Immunohematology, worked for Canada's blood supplier and several hospital transfusion services. Later he became business manager / technical education specialist for a diagnostic company, providing many educational workshops at TM conferences and beyond.

Many more transfusion professionals have agreed to be featured in CSTM blogs. If you want to suggest candidates, please do. 

Musings on History
I'll end with a few quotations on history. Perhaps the most famous is attributed to Santayana:
  • 'Those who do not remember the past are condemned to repeat it.'
Churchill's is also a beauty:
  • 'History will be kind to me for I intend to write it.' 
Who could omit this true witticism by George Bernard Shaw?
  • 'We learn from history that we learn nothing from history.'
On a more serious note, one I particularly like by M. Scott Peck:
  • 'The whole course of human history may depend on a change of heart in one solitary and even humble individual - for it is in the solitary mind and soul of the individual that the battle between good and evil is waged and ultimately won or lost.'
Then there's this:

When the blogs become available on CSTM's site, they will be referenced in TraQ's monthly newsletter. I'm hoping they will both inform and entertain, snippets of transfusion medicine history as experienced by those who lived it.

As always, comments are most welcome. 

FOR FUN
To me 'Islands in the Stream' means that, although as transfusion professionals we have separate careers that are different (like islands in the stream), our love for transfusion medicine unites us. Enjoy this 'tour de force' duet:
As always, comments are most welcome.

Sunday, November 15, 2015

Look what they've done to my song, Ma (Musings on misuse of Twitter)

Updated: 16 Nov. 2015
November's blog was motivated by monitoring the AABB's twitter account during and after the 2015 Annual Meeting in October. 

The blog's title derives from a 1970 ditty by Melanie Safka, known professionally as Melanie. 

As an AABB member since 1975 (40 years), and being an early adopter of social media (mailing lists as of 1994 and Twitter since 2011), I'm naturally interested in how professional associations use social media. [FYI: Tried Facebook and hated it.] 

Be aware that you can follow Twitter accounts without being on Twitter. It's a good way to keep current on the latest transfusion news. Just bookmark (favorite) an account and visit daily, weekly, whatever suits your needs.

Why read the blog? Maybe to see what Twitter's all about? Or  how you as an individual or member of a transfusion-related professional association may want to use it to benefit the profession? To read the blog takes 5-10 minutes out of a 1440 minute 24 hours (maximum of ~0.7%).

AABB BACKGROUND
For interest, the AABB is one of the largest transfusion medicine related professional associations in the world, if not the largest, at least in the West. A few statistics from AABB's 2014 Annual Report:

AABB has more than 5000 members:
  • 5,420 Health Care Professionals
  • 1,294 Physicians
  • 149 Residents
  • 29 e-Members
  • 298 Emeritus Members
I'd guess non-physician AABB individual members are mostly medical laboratory technologists/scientists.

AABB's Transfusion had almost 500,000 articles downloaded. That's impressive and I'm curious who's doing all the downloads.

AABB revenue ($US) from 
  • Dues: $3,084,744
  • Annual meeting: $3,956,264
  • Print sales: $2,577,601
  • Education: $5,065,813
Let's agree that AABB is a huge professional association. If you read the annual report, you will see that expenses are also large.

AABB MEETING/POST-MEETING TWEETS
With that as background, let's examine recent @AABB activity. Tweets during the annual meeting, Oct. 24-27, 2015, are summarized as follows. Non -substantive tweets are those that are 'me too' or thanks.

Day (Date): Number of tweets (n,% non-substantive)
Day 1 (Oct. 24): 47 (7, 15%)
Day 2 (Oct. 25): 48 (9, 19%)
Day 3 (Oct. 26): 29 (3, 10%)
Day 4 (Oct. 27): 30 (7, 23%)
Total = 154
Average tweets each day = 38.5. Non-substantive tweets over 4 days: ~17%
Post-meeting (28 Oct. - 14 Nov)
17 days of tweets: 32 tweets with 11 thanks 
Average tweets each day = 1.8. Non-substantive tweets over 17 days: ~34% 
See @AABB 2015 Annual Meeting tweets  (Non-substantive tweets in pale green)

NOTE: You can access tweets that include https:// as follows:
  • Highlight the URL, e.g., https://t.co/WAox1aGgm8 in the first tweet 
  • Don't include the "
  • Right click highlighted text
  • Select 'Go to https://t.co/WAox1aGgm8'
So what do AABB's tweets reveal about how health-related professional associations use Twitter?

MUSINGS
Twitter's Background
First, be aware that Twitter  - founded in 2006 - is a relative Johnny-come-lately to social media. Twitter didn't take off until years later and Twitter's 500 million users pale compared to Facebook's claimed 1 billion+ users. 

Twitter is popular, even indispensable in crises, because you discover what's happening before it's on live news channels. Indeed, news media now identify what's happening via Twitter. During the latest Paris terrorist attacks, I saw breaking news on Twitter before it appeared on CBC, BBC, CNN. 

Yet, many health professionals do not use Twitter at all. They learned Facebook and are unwilling to endure Twitter's learning curve. Plus many see Twitter's 140 character limit as meaning it's mickey mouse, only about tweeting what you had for breakfast, as if anyone cares.

Indeed, many professional associations do not know how to use Twitter to maximum advantage, likely because they see it of minimal value, albeit something they need to do if they want to be considered 'with it'. 

AABB vs Other Associations
As a large organization, AABB has a relatively active Twitter account compared to much smaller transfusion medicine associations, those with fewer resources, such as BBTS  and CSTM, both of which tend to post more substantive tweets. To my knowledge, ANZSBT isn't on Twitter.

Designated Person Tweeting
I know from one of my Twitter accounts, @transfusionnewsthat tweeting substantive news to interest others requires time, effort, and discernment. It definitely helps to have the time and motivation to share significant 'goodies' but especially to have a transfusion background.

Would love to know who tweets for AABB. A paid staff member? Transfusion background required? What guidelines, if any, are provided regarding suitable content and frequency?

Bottom Lines
AABB is to be commended for maintaining an active Twitter account. That many tweets thank folks is also commendable and creates goodwill. 

But...and there's always a 'but' in my blogs...If I were tweeting for AABB, I'd include many more substantive tweets. Many of the @AABB tweets that I did not categorize as 'me too' and 'thanks' were not particularly substantive. 

What do I mean by 'substantive'? Tweets that are significant and meaningful to users and useful in their professional lives. Information and resources they didn't otherwise know about and are grateful for.

Because that's the beauty of Twitter. Despite it's 140 character limit, it's a wonderful medium for disseminating useful information quickly to many users. Yes, it should be fun and foster goodwill but mostly distribute information to those interested. That's one of Twitter's key strengths. 

Another is Twitter's ability to provide feedback and opinions. Yet few professional organizations use it for that. For example, I've never seen a professional organization use a poll or ask followers important questions. 

Yes, AABB's tweets during its annual meeting and thereafter were touch-feely but disappointed. From a huge organization I expect more. 

As Napolean said, 'If you're going to take Vienna, take Vienna'. Similarly, if you're on twitter, use it wisely to good advantage.

FOR FUN
This song written and recorded by Melanie Safka for her 1970 'Candles in the Rain' album fits the blog because it expresses how I feel about professional associations that misuse Twitter. 

Not abuse, just misuse. The blog is meant to be food for thought for how we can all improve our tweets so that busy professionals find them more useful.

Need I mention that I love this song for its clever lyrics?
Or try this fun duet: 
Look what they done to my song, ma.
Look what they done to my song.
Well it's the only thing
That I could do half right
And it's turning out all wrong, ma.
Look what they done to my song.

As always, comments are most welcome.

SUGGESTED READING

Sunday, October 18, 2015

Little boxes (Musings on when established clinical labs become passé)

Updated: 3 Nov. 2015
October's blog focuses on three news items from The Dark Daily/Dark Report about clinical laboratories in the USA and Canada.
If you're not lab or not in North America, the blog has tidbits about health care fraud that could be coming to a lab near you, and demographic trends that affect your health profession and country. My musings will expand the scope slightly to include the role of innovation in upsetting existing apple carts.

The blog's title derives from an anti-establishment ditty written by Malvina Reynolds that became a hit for her pal Pete Seeger in 1963. Be forewarned - you either love it or hate it. It was written about USA in the 1950s when most readers were not yet born.
For links to news items below, please see Further Reading.
NEWS ITEMS
1. USA: Biggest case of Medicare fraud and abuse in history of clinical laboratory business.

Apparently clinical lab companies and their executives were paid $500 million in 2010-14 from lab test claims submitted to the USA's Medicare (health insurance for Americans aged 65 and older who have worked and paid into the system and for younger people with disabilities) and Tricare (health benefits for military personnel, retirees, and their families), perhaps $1.2 billion if amount taken from private insurers is added.
US federal attorneys allege the fraud involved: 

  • Payments to physicians for shipping and handling lab specimens;
  • False processing fees;
  • Kickbacks to physicians;
  • Illegal sales agreement in which sales staff were paid a monthly fee plus 19.8% of lab revenue;
  • Payments to induce doctors to order large multi-assay panels, including many medically unnecessary lab tests.
At its core, it seems that several private clinical labs and their executives fleeced the U.S. government for more than $1 billion.

2. Canada
  • Medical laboratories face squeeze from retiring labor force, and more.
  • Canada's innovative medical and pathology laboratories share their successes at Toronto Executive Edge Conference. 
In Canada, as elsewhere, a major challenge is how to deal with an ever increasing number of lab specimens when governments continue to decrease lab funding. Labs are asked to do more with less, an old story dating to at least the 1990s in my bailiwick, Alberta, Canada.
According to reports on the Executive Edge Conference in Toronto:

  • Labs will need to cut costs without compromising quality, thereby creating a demand for lab professionals skilled in Lean, Six Sigma, and process improvement (Further Reading: 'Can health care learn from assembly lines?')
  • To support the growing demand for personalized medicine, labs must upgrade their information technology systems (See earlier blog for my take on personalized medicine)
  • Training programs for med lab technologists/scientists struggle to find labs willing to provide practical clinical training required for students to be certified (Old story. Cost constraints in health care have a huge negative impact on educating health professionals)
  • The number of trained healthcare professionals is fewer than needed (True for nurses and physicians and long true for med lab scientists/technologists but unsure it holds true today for Canadian lab technologists) 
  • No mass retirement by baby boomers, at least not yet (Tsunami of golden oldies retiring hasn't happened yet)
3. Smartphone 'Dongle'achieves capabilities of big clinical laboratory analyzers: Diagnoses three diseases at once from single drop of blood.
The innovative smartphone device  - mobile and inexpensive, making it ideal for use in developing nations - diagnoses HIV and syphilis with a finger prick of blood and displays results on a smartphone screen within 15 minutes.

The device performs an enzyme-linked immunosorbent assay (ELISA) without requiring stored energy because power is drawn from the smartphone. Plus it performs a triplexed immunoassay not currently available in a single test format: HIV antibody, treponemal-specific antibody for syphilis, and non-treponemal antibody for active syphilis infection.

The question is, Could such technology eventually find a place in medical laboratories in developed nations? And how would established labs push back? As with POCT, by citing the legitimate safety needs for quality control and lab oversight or ?

MUSINGS
So there you have it. 

  • Private clinical labs in USA bribe physicians to order unnecessary lab tests and promote other unethical practices. 
  • Clinical labs in Canada and elsewhere struggle with under-funding and are told to adopt Japanese assembly line solutions to save themselves, i.e., to cut costs without sacrificing quality.
  • In Canada private clinical labs exist in parallel with public labs and are paid by provincial governments. No case of fraud has ever been raised against private Canadian labs that I'm aware of. Could it happen in future? Who knows. 
  • Innovative start-ups threaten established clinical labs who push back, big-time, sometimes with valid concerns, sometimes without. As an example 
Personally, on the private vs public lab issue, I'm glad that Alberta cancelled the RFP on a $3-billion contract under the previous government to Sonic Healthcare of Australia. Rightly or wrongly, I have more confidence in private labs with a history in Alberta. And even more confidence in Alberta's publicly owned and operated laboratories.
Regardless, US experience with private labs defrauding government is disturbing. Like Big Pharma's many lapses, does the profit motive trump ethics?


As to the Executive Edge Conference in Toronto, I've focused on issues that interest me. Lean and Six Sigma are trends that mostly give consultants mega-bucks and naturally claim big benefits to justify the fees. On staffing shortages, unsurprisingly, the tsunami of retirements hasn't yet occurred for 'boomer' health professionals. Suspect it'll occur in the next five years.  

 
The smart phone dongle is one of many innovations yet to be validated and will no doubt be challenged as has Theranos's technology, which uses a few drops of blood via a finger-prick rather than the usual tube of blood via venipuncture (Further Reading).


Such innovations, similar to point-of-care testing (POCT),are often administered by nurses. For patient safety, lab professionals have the expertise to see what can go wrong and know that nurses may not, especially when it comes to a sound understanding of quality control of lab instruments.

POCT is now standard practice in most health facilities in the developed world, and often overseen by the clinical laboratory. (Nice guidance from UK's IBMS on the role of the laboratory in POCT)

Ultimately, innovative lab devices may make any debate on public vs private laboratories passé. They may increase the likelihood of fraud by private labs as they struggle for relevance. Because if innovative miniature lab devices succeed, we won't need the ticky-tacky big box labs we grew up with and know as clinical laboratories. 

FOR FUN
'Little boxes' is an anti-establishment song from more than 50 years ago that challenged the conformity of 1950s America. Somehow I suspect it still resonates today because all around I see transfusion folks who pretty much agree with the orthodoxy of the day and question nil. For example:

  • Personalized, precision medicine is the best thing since sliced bread. If you're not red cell genotyped to match with blood donors, you're second class, dude.
  • Lean and Six Sigma is where it's at. Let's get rid of all the waste. Yes, Lean has done 'good things' but it's curious that waste seldom happens at management/executive levels (see Further Reading)
As noted earlier, you'll either hate Little Boxes or love it.
As always, comments are most welcome.
FURTHER READING
USA: Biggest case of Medicare fraud and abuse in history of clinical laboratory business 

Canada: Medical laboratories face squeeze from retiring labor force, and more (Dark Daily, 25 Aug. 2015)
Canada's innovative medical and pathology laboratories shared successes at Toronto conference (Dark Daily, 14 Oct. 2015)

Smartphone 'Dongle' achieves capabilities of big clinical laboratory analyzers: Diagnoses three diseases at once from single drop of blood
Smartphone, finger prick, 15 Minutes, diagnosis done!

LEAN

Wednesday, September 16, 2015

Sweet dreams are made of this (Musings on personalized medicine)

Please stay tuned - revisions are sure to come
September's blog derives from increased marketing of medical treatments and clinical laboratory tests as personalized medicine tailored to the individual characteristics and needs of each patient. Seems like a great idea, right?  

After all, in the age of 'selfies' it's all about me. 

The title is from a 1983 ditty by the British duo, the Eurythmics (Annie Lennox and David Stewart). 

PERSONALIZED MEDICINE
'Personalized medicine' is a term that drives me nuts.  This April I blogged about molecular blood typing being marketed as personalized medicine:
  • While my guitar gently weeps (Musings on the seduction of technology) [Further Reading]
Five years ago I had sniffed its perfumed allure with the blog
  • Snip, snip the party's over (Musings on the seductive rise of DNA typing of blood groups) [Further Reading]
WAIT, THERE'S MORE
Now a new variation has arisen, the latest and greatest 'term du jour' ('term d'année?') is Precision Medicine:
  • Red blood cell transfusion. Precision vs imprecision medicine  [Further Reading]
One sentence in the article stood out as a red flag:
'Although currently not practical, providing extended antigen matching by molecular techniques to all patients should improve typing accuracy and reduce alloimmunization.'
If past is prologue, even if impractical and relatively expensive, eventually molecular genotyping will be done for all transfusion recipients. After all, who can resist the sales pitch of personalized and precision medicine?

BANDWAGON
Certainly the United States, with its private health care system, cannot resist and has jumped on the bandwagon. Similarly, so has Canada, UK and other industrialized nations. 

As to the developing world, well they're stuck making do with 20thC medicine, un-personalized and un-precision.

Of course, a genuine case can be made to tailor tests and treatments to individuals, especially those with special needs such as blood group genotyping for sickle cell and thalassemia patients. 

But why the rush to personalized / precision medicine as embodied by molecular blood genotyping? It's likely because of the reasons cited in 'While my guitar gently weeps':
  • To be seen as 'with-it' hipsters on DNA's bandwagon vs being old-fogeys who resist change; 
  • Way for TM organizations to develop business lines and increase earnings in age of blood conservation; 
  • Self-interest for those who specialized in molecular technology; 
  • No humans interpreting serologic test results must be safer; 
  • High-throughput automation decreases costs by eliminating staff, with their salaries, benefits, and pensions.
Plus it's good for private enterprises that develop and market test systems and health profession leaders who want to be seen as in the real world of business efficiency. 

ANATOMY OF A SALES PITCH 
Today, many businesses promote and sell stuff that we do not  need. The aim is to trick us into thinking we need the latest and greatest. 

Consider Apple's iPhone. The premise is that potential buyers don't even know what they want until Apple tells them. They don't really need to market it because all geeks know they must have one to be part of the in-crowd. 
  • It's the same reason why all TM docs know their facilities must do molecular typing.
Apple builds beautiful products and justifies price with features and benefits no one else can match. Whether you need the features is another matter. But once you've seen them, Apple will make you think you do. 
  • Similarly, serologic blood typing cannot match molecular typing. Whether you need the benefits of molecular typing is a moot point.
Apple built one of the most hardcore fan bases of any product, called Apple fanboys/fangirls and, before the iPod/iPad/iPhone revolution, macophiles. I was one and would show disdain for Windows every chance I got. 
  • Today, molecular red cell genotyping fans abound and can barely suppress a sneer when mentioning serology and immunohematology. The fan base of influential TM leaders is hard to combat and develops a momentum all its own.
It's worth recalling that whether selling an iphone, tablet, used car or botox, a good sales rep will FOCUS ON

1. BENEFITS and VALUE, NOT PRICE
Some examples [My comments]: 

Before molecular genotyping transfusion service labs had to use inefficient, labor-intensive serologic assays. 2
[PL: Red cell serology is passé, based on inefficient testing that costs more because of paying laboratory technologists for their time.]
Now in the 21st century and with the emergence of precision medicine, inexpensive molecular typing paired with powerful bioinformatics has enabled mass-scale red blood cell genotyping. 2
[PL: Get with the 21stC. Molecular typing is cheap (really?) and it's twinned with bioinformatics. Bioinformatics sounds pretty darn impressive. We've got datasets coming out the wazoo.]
Web-based data storage and analytics are revolutionizing the provision of antigen-negative blood with an efficiency scarcely conceived of just a decade ago. 2
[PL: You'll be on the bleeding edge and very, very efficient. Plus it's analytics, for gawd sake. And 'analytics leverage data in a particular functional process (or application) to enable context-specific insight that is actionable'.  
Wowsa! Leverage,data, process, context-specific, and actionable in the same sentence. I'm in jargon heaven. Gotta love analytics.]
2. EMOTIONS, NOT REASON
Blood incompatibility remains a significant problem with lifelong consequences that adds to the burden of healthcare delivery and may result in life-threatening delays in care.3

If an antigen-negative patient receives blood from an antigen-positive donor, it could trigger an immune reaction, where the blood recipient’s immune system develops antibodies that can attack and reject the donor RBCs.3
[PL: If you buy our product you will prevent the dreaded immune response and save patient lives. You don't wanna kill folks, do you buddy?]
With today’s dual focus on improving health outcomes and lowering healthcare costs, preventing alloimmunization is the ultimate goal in transfusion medicine. Accordingly, a best practice for the hospital or transfusion center is to create a patient phenotype profile with the PreciseType test before a patient receives his or her first-ever transfusion.3
[PL: Do you dig what TM's ultimate goal is? It's about preventing alloimmunization. (Who knew!) Are you into best practices, a thought leader? Because if you are, you better buy our kit right now, before some patient gets immunized!]
NAYSAYERS
There are those who question the orthodoxy of personalized / precision  medicine and caution against potential pitfalls.  Two examples that examine personalized medicine from a broad perspective:

1) 'Why you shouldn't know too much about your own genes.' [Further Reading] Sample quote: 
  • Here is the under-appreciated corollary to the new age of personalized medicine: just because you can do a genetic test, doesn't mean you should.
2) Juengst ET, Flatt MA, Settersten RA, Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent Rep. 2012 Sep-Oct; 42(5): 34­40. [Further Reading1Sample quote: 
  • 70 million Baby Boomers, now or soon-to-be over age 60, seek to live not just longer, but healthier and more productive lives. 
  • When they fully understand and embrace personalized medicine, it will create an unprecedented level of consumer demand. 
  • When physicians feel they may incur liability for not offering a test that provides information on optimal care, the impetus toward adoption will be even greater.
LEARNING POINTS
Eventually, everywhere in the developed world, red cell matching of patient and donors will routinely be done by molecular blood typing. It will be precision medicine, personalized medicine done using kits supplied by foreign companies and performed by minimally trained, inexpensive local staff supervised by a well educated lab professional.

If employers plan wisely, staff can be hired part-time or casual so they won't need to worry about benefits and pensions. 

In Canada government health care money will flow abroad, giving sustenance to anonymous investors of Immucor, et al. They'll leverage our health care dollars where they WON'T do the most good for our communities, all in the name of efficiency and safety.

POSTSCRIPT
Am I similar to 19thC Luddites, protesting against new labour-economizing technologies? Maybe, though I'm not against technology per se and have embraced computers and the Internet from the get-go.

But, hot damn! I'm gonna get my genome profile done because it's all about me. And I can get it done for $199 CDN by 23andme...not that I really want to know.

And if I ever need a blood transfusion, I'm not into being second class and will demand complete molecular antigen typing with donor blood. Not that I'll get it now but definitely one day. None of that passé serology for me!

FOR FUN
A great song, one of my favorites, that highlights the allure of molecular blood typing and personalized / precision medicine. 
  • Sweet Dreams [are made of this] (Annie Lennox, Live 8, Hyde Park, London, 2005)
'Sweet dreams are made of this
Who am I to disagree?'
As always, comments are most welcome.

FURTHER READING

1. Juengst ET, Flatt MA, Settersten RA, Jr. Personalized genomic medicine and the rhetoric of empowerment. Hastings Cent Rep. 2012 Sep-Oct; 42(5): 34­40. (Free full text)
2. Klein HG, Flegel WA, Natanson C. Red blood cell transfusion. Precision vs imprecision medicine. JAMA. Pub online 10 Sept. 2015. (Free full text)
3. Immucor: PreciseType™ HEA Test 

Other
Carolyn Johnston. Why you shouldn't know too much about your own genes. (Washington Post, 11 Sept. 2015)

USA FDA: Paving the way for personalized medicine. FDA’s role in a new era of medical product development  

US News & World Report. Personalized medicine

USA White House. Next steps in developing the precision medicine initiative

Prior Related Blogs
While my guitar gently weeps (Musings on the seduction of technology) |  April 2015

Snip, snip the party's over (Musings on the seductive rise of DNA typing of blood groups) | Dec. 2010

Saturday, August 15, 2015

The early days (Musings on educating young TM professionals)

Upfated: 18 Aug. 2015
August's blog was stimulated by the UK's Annual SHOT Report, which  has featured in past blogs many times. SHOT has long been the best hemovigilance program anywhere and is a treasure trove of educational goodies we can all learn from.

Since it's summer in the northern hemisphere, when many transfusion professionals will be enjoying the outdoors of our all too short summers (at least in Canada) the blog will consist of selected mini-musings on 2014 SHOT.

The blog's title derives from a song by Canadian folk singer/song writer, Chris Luedecke, known professionally as 'Old man Luedecke".

2014 SHOT - SELECTED HIGHLIGHTS
For perspective, in 2014 there were 2,663,488 blood components issued in the UK (74% RBC). SHOT received reports of 3668 cases or 13.8 reports per 10,000 blood components.
The following are but a few of my personal highlights. See Further Reading for the full SHOT Report.

Overview (What causes adverse events?)
In 2013, 77.6% of all incidents reported to SHOT were caused by errors & it's similar in 2014.
There is increasing concern about the impact of reductions in numbers and seniority of staff in the NHS.

SHOT 2013 reported that many, often multiple, errors are made during the transfusion process and data from 2014 were analysed similarly. As well, adverse events are grouped into 3 main categories. Failures relate to
  • Patient identification 
  • Communication 
  • Documentation 
Deaths (Worst transfusion-associated adverse event)
In 2014, there were 2 deaths definitely attributed to transfusion, 1 hemolytic transfusion reaction and 1 transfusion-associated circulatory overload (TACO). Delayed transfusion contributed to 3 deaths.

ABO-incompatible RBC transfused (Key because ABO mismatches can lead to patient death, major morbidity)
N=10 (0 deaths, 1 major morbidity). This compares to 9 in 2013 and 12 in 2012. All were due to clinical (not laboratory) error.

Near misses (Avoiding major patient consequences often due to luck)
Wrong blood in tube accounted for 686/1167 (58.8%) of all near misses, where a near miss is defined as,

"Any error, which if undetected, could result in the determination of a wrong blood group or transfusion of an incorrect component, but was recognized before the transfusion took place."
MUSINGS
Below are musings on a few highlights in SHOT 2014 (edited for brevity). Some caught my imagination because they were odd, and some involved serious adverse events.

#1. False Identity
(p. 45) describes several cases where the 'patient' is responsible for giving false identity. For example:
Case 2: Staff member involved in deliberate identity fraud
A blood group did not match the patient's historical record. Concurrent Haematology and chemistry samples were rejected and repeats of all samples requested.
Investigation revealed that test requests were initiated by a staff member. Samples were from a family member but labelled with the staff member's own details. The staff member returned to work after suspension and re-training.

Musings: A similar case occurred years ago at UAH in Edmonton, where a medical resident labelled his own blood sample as that of a patient in order to discover a particular lab result. To my knowledge he was given a bollocking and educated on why this was NOT a good idea.
Case 3: Pregnant woman conceals her identity
  •  A 24 year old woman had an ultrasound scan at a hospital where she was advised to terminate a pregnancy. 
  • The patient attended another hospital giving a friend's name for identity but her own father as next of kin. 
  • She had a surgical termination which was complicated by 
    • Massive haemorrhage requiring transfusion with RBC, FFP, and cryoprecipitate; 
    • Emergency intervention and uterine artery embolisation; 
    • Followed by admission to the intensive therapy unit , all at the first hospital. 
  • When her father was called in he confirmed she was his daughter but that the name on her wristband was not hers.
Musings: Years ago, when I worked in Winnipeg for the then Red Cross centralized transfusion service/blood centre, a similar case occurred. I crossmatched blood for a young woman having a therapeutic abortion. She had assumed the identity of her friend, who just happened to have a blood group on record.

Interesting that patients providing false identity still exists. It likely occurs much more often than we know because we only catch the ones where the 'false patient' has a prior blood group record or the real patient requires blood in the future. 
I also wonder about false identity in the USA where universal health insurance doesn't really exist yet. Do people who lack insurance for a needed procedure use a friend's identity?

In Canada it's now standard practice for physician offices to require photo ID, not just a provincial health care card. 
#2. ABO-incompatible red cell transfusions (pp.23,44)
As noted earlier, of 10 ABO-incompatible red cell transfusions, all were caused by clinical (not laboratory) errors.

  • In 7/10 cases there was a failure in correct patient identification, with no bedside checks performed. 
  • Actions taken varied but in one case 2 nurses were dismissed, in others staff were supported, retrained and their environment modified. 
SHOT gathered evidence that staff do not follow protocols and procedures and needs to investigate why.
  • In 7/10 clinical errors, group A RBC were transfused to group O patients
  • 2 were transfused in emergencies, 3 others were 'urgent'
  • One event occurred in a young woman during a liver transplant. The group O patient was bleeding and a new anaesthetist, who was an observer, 'helped' by taking the unit of blood from the refrigerator and transfused it. It was group A blood. 
  • The OR practitioner noticed the error when less than 50mL had been transfused. 
  • The patient died from complications following respiratory arrest. 
  • Root cause analysis resulted in several changes to surgical procedures.
Musings: It's amazing that 7/10 wrong ABO transfusions involved failed patient identification, with no bedside checks performed by clinical staff (presumably mainly RNs but including Drs, as in the case of the anesthetist described above). Unsurprisingly, most (5/7) occurred with urgent transfusions.

In the one case where 2 nurses were dismissed, I wonder if their errors were the final straw in a list of major errors. Because firing staff does not fit with today's no-blame culture of support and retraining, as occurred in other cases.
As SHOT notes, when health professionals do not follow established procedures and protocols, we need to identify why to prevent future occurrences.
#3. Most adverse events caused by error
SHOT documents that in 2013 and 2014 more than 75% of all incidents were caused by errors and expresses increasing concern about the impact of reductions in numbers and seniority of NHS staff.
Musings: Cutbacks and increasing numbers of senior staff retiring are concerns worldwide. Remaining staff are overworked and often lack needed experience and expertise. 
Unfortunately, few senior staff exist to mentor them and share the practical knowledge and skills absent in journals and textbooks. That's if remaining staff even have time to read and consult them.
FOR FUN
Although Canadian Chris Luedecke's touching song 'The Early Years' is about his children and family life, it resonates with me from a professional perspective. Listen to the lyrics. They're delightful.

In today's health care environment, despite many obstacles, educators must lead by example and take time to educate and train young transfusion professionals to instill values that ensure the next generation puts patient safety above all else. Knowledge and skills, of course, plus clear rationales for all those pesky 'rules' are key.

But ultimately it's DNA-ingrained ethics that protects patients so that even overworked, busy health professionals meticulously follow established SOPS such as routinely and always checking patient identity. 

Fact is, those early days when we train the next generation, they don't last. We must get 'em while the gettin' is good.

You got to hold on,
It goes so fast
These early days, well,
They don't last.
You got to enjoy [train] them.
They go so fast.
The baby days, well, they don't last.
FURTHER READING
As always, comments are most welcome.