Monday, August 18, 2008

I can't get no satisfaction

The Rolling Stone's biggest hit from 1965 was "I can't get no satisfaction".

Over 40 years later the song comes to mind when reading about pathology errors in Canada that have eroded public confidence. Although about Canada, the events and resulting news coverage should resonate in many countries.

Chorneyko K, Butany J. Canada's pathology. (editorial) CMAJ 2008 Jun 3;178 1523

The authors, one of whom is the president of the Canadian Association of Pathologists (Butany), acknowledge that "Canadian laboratories are not unique in facing workload and human-resource issues or problems pertaining to medical error and patient safety" and then note that Canada lacks a national quality assurance (QA) program such as the College of American Pathologists in the USA and similar organizations in the UK and Australia.

Unfortunately, they mention only Ontario and BC as having laboratory accreditation and proficiency testing programs, when other provincial programs exist, including what is arguably the longest functioning and very effective QA / proficiency testing program of the College of Physicians and Surgeons of Alberta,
including an excellent program for transfusion medicine.

Related news items that subsequently appeared include

This article begins, A horrendous series of blunders at a Newfoundland medical laboratory has raised a frightening thought: What if similar problems exist at other facilities across the country?
Several stories in national papers have erroneously reported that only Ontario and British Columbia have regulatory bodies with authority over medical laboratories, e,g.,
The National Post reports that the Canadian Association of Pathologists has called for a national diagnostic checklist to include test validation, staff training, competency assessment, standardization of operating procedures and equipment maintenance. These measures have been standard practice in transfusion and other clinical laboratories for years.

The news coverage creates the impression that Canadian labs put the public at grave risk.

To date some pathologists and laboratorians have commented:

Swaine, et al. point out that in Alberta laboratory accreditation and proficiency testing programs have existed since the 1960s and are administered by the College of Physicians and Surgeons of Alberta.

These authors focus on clinical pathology and the need to fund and resource laboratories adequately.

VISIBILITY AND STATUS OF PATHOLOGY and LABORATORY MEDICINE

Laboratory technologists / clinical laboratory scientists / biomedical scientists constitute the 3rd largest group of health care workers, yet lab medicine as a career has long suffered from

  • low salaries (typically much less than nurses, which have a higher visibility)
  • limited upward mobility
  • poor understanding of the profession by the public and other health professionals
For example, most patient exposure to the lab is via blood collection. Few know that lab workers are well educated and skilled professionals who operate sophisticated equipment, problem solve, and work with physicians to help to diagnose illness. See

I have heard pathologists say that they too are often under-recognized and near the bottom of the respect ladder in medicine making recruitment difficult. For example, see


BOTTOM LINESerious pathology-related errors occurred, indicating a problem. The concept of a national body developing laboratory quality standards has merit, so long as any new program integrates with existing provincial programs and does not create another layer of bureaucratic regulation. All provinces need to develop functioning accreditation programs and existing provincial systems can be improved - hence the concept of continuous quality improvement.

However, the overall notion that Canada's clinical laboratories are uncontrolled back-waters of laboratory medicine that generate test results of poor quality is wrong. Additionally, headlines implying incompetence do not help desperately needed recruitment and undermine the professional pride and status of pathologists and laboratorians.

"I can't get no satisfaction" from the pathology lab errors in Newfoundland and Labrador, which likely led to incorrect treatments for almost 400 breast cancer patients.

"I can't get no satisfaction" that laboratory medicine has poor public visibility and is only marginally understood.

"I can't get no satisfaction" that laboratory professionals suffer from a lack of status among other health professionals.

"I can't get no satisfaction" from a possible public misconception of widespread clinical laboratory incompetence, especially as a blood banker. In Canada and in most countries transfusion medicine has led the way in implementing quality systems in clinical laboratories.

Of course, satisfaction should be internally generated and lab professionals are indeed dedicated to patient safety and intrinsically proud of their role on the health care team.

Keith and Mick got it wrong when they wrote:

I can't get no satisfaction
I can't get no satisfaction
'cause I try and I try and I try and I try.....

It's better to view satisfaction the way Mohandas K. Ghandi did:

  • Satisfaction lies in the effort, not in the attainment, full effort is full victory.
I'll go with the Mathatma for now....

Related resources


Sunday, July 06, 2008

Mourning becomes Electra

Updated: 28 Jan. 2017 (Fixed broken links)
INTRODUCTION
This blog's title is taken from the play by Eugene O'Neill of the same name, which is an adaptation of the Greek trilogy “Oresteia” by Aeschylus.

The blog was motivated by a device
that automates blood component preparation just licensed by the FDA in the USA. The device's press release is one of the Industry News items in this month's TraQ newsletter. It caught my eye because of the name of the device, the Atreus.

After briefly discussing the names that manufacturers give their products, the blog will examine the pitches used to market automation, the related concept of lean manufacturing, and whether they constitute progress.


PRODUCT NAMES
First, the product names. Atreus rang a bell because during my youth my Dad used to share his love of Greek mythology with me. Atreus was, to put it mildly, a pretty repellent dude even in a curse-stricken family where each generation gruesomely and tragically murdered family members and others out of some combination of pride, ambition, lust, and revenge.


One version of the Atreus myth (there are several) has Atreus and his brother murdering their father's illegitimate son (their half-brother) to please their mother. Then, after his brother seduces Atreus's wife, Atreus kills his brother's two sons and invites him to a banquet to feed him the flesh of his sons, whom Atreus had boiled. Atreus also saves the children's hands and feet to show to his brother. His brother later rapes his own daughter, who despite being Atreus's niece, becomes Atreus's wife. Atreus raises the child fathered by his brother as his own. Eventually Atreus's wife commits suicide and the child, in loyalty to his uncle (who he realizes is his real father), kills Atreus. Charming family.


Now why would Gambro / CaridianBCT want to name its new device after such a repugnant figure as Atreus? Other products have been named after characters in Greek mythology, for example, Immucor's Echo. In Greek mythology, the beautiful nymph Echo would distract Zeus's wife Hera with stories while Zeus ravished other mountain nymphs. When Hera discovered this, she punished Echo by taking away her voice, except in repetition of another's words. Later Echo fell in love with Narcissus but was rejected. The once talkative nymph eventually changed into rock leaving nothing but her voice to reply to those who shouted out.


It's likely Echo is meant to be a cute takeoff on its role as the little brother (little sister?) of Immucor's Galileo. Galileo contended that the earth rotated around the sun, thus contradicting the orthodoxy of the time (early 17th century) that the earth was the centre of the universe. For this crime he was convicted of heresy and spent his later years under house arrest. Naming products after pioneering scientific figures like Galileo makes sense, but Atreus and Echo....not so much.

MARKETING PITCHES

Back to the Atreus® and other automated devices and instruments....

Is the Atreus® meant to eliminate "x" FTE staff who currently prepare blood components or just make their work easier and more satisfying?

Manufacturer's typically market automation with claims such as:The instrument/device will
  • do the boring "slug work," freeing staff for more interesting tasks that require more skill
  • prevent repetitive stress injuries
  • increase patient safety by decreasing errors since there are fewer steps for staff to perform
  • increase efficiency by saving time (better TAT with throughputs of "x" tests/hr)
  • increase test reliability by eliminating subjective reading of tests by staff
  • increase test sensitivity and specificity (hmm...can you really do both?)
  • improve process control
  • interface with existing LIS to decrease transcription errors (Oh, oh! Best to take LIS interface claims with a block of salt)
  • ensure positive identification and tracing via improved 2-dimensional bar codes
Notice how some of the standard pitches above emphasize putting staff first - more satisfying work, fewer injuries, easier work (instruments and computers do the "slug work" for you).

To lab managers and directors, marketing pitches include the motherhood issues above but tend to focus more on the bottom line, e.g., The instrument/device will/can

  • save money by eliminating "x" FTE
  • give a return on investment after "x" years
  • be maintained by a rhesus monkey available from our offshore supplier at a discounted price if ordered in volume (Just kidding on this one)
Effects of automation in lab areas such as clinical chemistry have been well documented:
This article in CAP Today sums up the transfusion medicine situation in 2002, as well as the motivations and perspectives of those in charge of the labs:
LEAN
Naturally, automation fits well with the latest buzzword of the quality movement, "lean," as in "lean manufacturing." Lean is based on the principle that non-value-added activity constitutes waste and should be eliminated.

Like its cousins quality systems and six sigma, there is an entire industry built around lean. It helps to develop a business around a concept if you can give insiders the jargon that makes them "in the know" and keeps the non-enlightened out.
And lean is now huge in health care. Here's a lean hospital in the UK - for patients arriving in the emergency department, no more seeing doctors - docs do not add value to the process:
Hospitals, laboratories, and blood centres send staff to lean conferences to learn the principles and jargon of lean (muda, kaizan blitz, kanban, JIT, poka-yoke, etc.). Seems that everyone is making a buck from lean.
Try googling lean AND health care - on 6 July 2008 the search gave >7 million hits. Most seemed to be websites for consultants selling lean advice.
PROGRESS?
So is automation progress? Is lean progress? Progress can be defined many ways but it generally means improvement or growth, whether for individuals, organizations, societies, or humanity.

Are highly automated or lean labs progress for

  • staff who no longer have lab jobs? Have they gone on to bigger and more rewarding careers and lives?
  • remaining staff who load the instruments and press the buttons, letting the equipment do the analyses. Is their job satisfaction improved?
  • senior staff who do less but more interesting hands-on lab work and have more time to read computer printouts, attend meetings, and program spreadsheets with error management data and the like.
  • lab managers and directors who can more easily meet their goals with fewer resources now that costs are down?
  • patients, who constitute the true bottom line? Is their health care improved and safer?
Many would say, of course, automation and lean constitute progress - it's the current conventional thinking (orthodoxy). Even questioning automation and lean is heresy. However, if questioning of automation and lean principles bugs you, you may be experiencing cognitive dissonance.

On the other hand, if you are certain that automation and lean are progress for mankind, read on because shangri-la approaches:

Add robotics to lean hospitals and soon we'll have gotten rid of all the non-value-added waste in the health system, as well as most of the health professionals.

AUTOMATION FOR NURSES?
I wonder if there is a way to automate administering transfusions as this seems to be a area where deadly errors continue to occur? FromTraQ's July newsletter - International news: UK and USA:

Transfusion nurses could have improved and more satisfying work by investigating only unusual events that actually require their skill set. (I write with tongue firmly planted in cheek.)

I would call the automated transfusion device Electra after Atreus's granddaughter, who wanted her brother to avenge the death of their father by killing their mother, leading to the concept of the Electra complex.

BOTTOM LINE
I'm not altogether sure whether automation constitutes progress from a big picture perspective (benefits humankind), but it's irrelevant. Automation is here to stay and will only get more and more pervasive in health care.

Take that, Atreus! The curse goes on....
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

 Addition (3 Sept.2008)
Thanks to those who have commented.

In these blogs I'm really just asking questions, not providing definitive answers. Readers should decide for themselves based on their experience and reading the literature. Responses may vary widely depending what automation has meant for individuals personally.

Few of us have extensively studied the issue of automation over time. And what studies have been done get their results based on the questions asked, using measurable outcomes like reduced number of FTE staff, money saved according to defined algorithms and assumptions, and self-reporting by remaining staff about job satisfaction, etc. The internal validity of some of these studies is open to question and their generalizabilty is not universal.


As noted, "Many would say, of course, automation and lean constitute progress - it's the current conventional thinking (orthodoxy). Even questioning automation and lean is heresy."

My view is not so certain:
"I'm not altogether sure whether automation constitutes progress from a big picture perspective (benefits humankind)." It may or it may not.

Taken to its logical conclusion, and using a reductio ad adsurdum argument, if automation constitutes progress (a better life) for humans, then we should automate everything, leaving a few of us to do the routine work (load instruments, push buttons, etc.), while the rest of us sit around and problem solve until there are no problems left to solve because the automation has been perfected. Now, what to so with all this leisure time? Create a new Renaissance? Die of boredom?

I've reduced the proposition to an absurd conclusion, which could be a fallacious argument, just to show where my abstract and theoretical thinking about automation leads.


About inadequate staffing causing errors, I'm not sure that's been proven in the cases cited by the authors of "Canada's pathology" in CMAJ. Although it's logical that being overworked could be a contributing factor in causing errors, it would be risky to assume that it's a significant cause in individual cases without evidence. Many of the pathology errors were caused by the repetitive actions of a single pathologist such as Dr. Charles Smith, whose autopsy decisions were not always based on the evidence.

Lab systems are supposed to be designed to prevent and detect and correct any errors. Clearly the overall system failed in the case of the serious pathology lab errors that occurred.

Sunday, June 08, 2008

What's it all about, Alfie?

This month's blog is about how we spend our time in the context of transfusion medicine research. The title comes from the song What’s it all about Alfie? and the movie of the same name starring Michael Caine (and a later version with Jude Law). Perhaps you have pondered the meaning of this oldie-goldie from the 60s?

It's a cliche to say that to get the right answers you must ask the right questions, which is the researcher's equivalent of the techno-geek's GIGO.

But even more important is to know what questions of all the questions that could be asked are worthwhile spending time trying to answer. I would not call myself a researcher, although I have done applied research, but will not let that stop me from commenting or spouting off.

Two articles caught my attention in recent issues of Transfusion and Vox Sanguinis, both out of personal historical interest.

The first paper by a College of American Pathologists committee concerns blood bank serology, something at risk of becoming obsolete but nonetheless dear to my heart.

1. AuBuchon JP, de Wildt-Eggen J, Dumont LJ for the Biomedical Excellence for Safer Transfusion Collaborative and the Transfusion Medicine Resource Committee of the College of American Pathologists. Reducing the variation in performance of antibody titrations. Vox Sang 2008 Jul;95 (1):57–65.

Summary: Because antibody titration is difficult to standardize, the CAP proficiency testing program decided to investigate whether a detailed, uniform titration procedure would reduce variation in both tube-based and gel card titres (see abstract for details). Based on results from 35 laboratories, the U.S. authors concluded that a uniform method for antibody titration at 37°C and read at the antiglobulin phase in a tube-based method with a w+ end-point (compared to a 1+ end-point) reduced inter-laboratory variability.

Related reading:
MUSINGS
Titrations - a blast from the past! Long ago I performed many a titration while working in Winnipeg with Dr. John Bowman - titrations on the plasma of women with anti-D who were candidates for intrauterine transfusion and on the plasma of women whose potent anti-D was used to manufacture Rh immune globulin.

One thing I know from working in a lab that used titrations as an adjunct to assess hemolytic disease of the newborn due to anti-D is that titre is an unreliable indicator of disease severity. Historically, it was used as a poor tool to assess whether invasive procedures such as amniocentesis and later PUBS were warranted.

Depending on the method, the red cell phenotype used, and operator technique, titres can vary significantly. Technically that's a 2-tube difference (or more) in a titration that uses a doubling dilution, e.g., titres of 4 and 8 are not considered significant but those of 4 and 16 would be.

While an anti-D (or anti-K) with a high titre (however that is defined) can alert us to the need to monitor current and future pregnancies, can getting more consistent inter-laboratory endpoints significantly influence clinical management?

Obtaining more reliable titres among labs is a good thing, but how important is it practically and clinically?

A second paper that makes the point:

2. Seltsam A, Agaylan A, Grueger D, Meyer O, Blasczyk R, Salama A. Rapid detection of JMH antibodies with recombinant Sema7A (CD108) protein and the particle gel immunoassay. Transfusion 2008 Jun;48(6):1151–5.

Summary: The German authors describe a method to detect anti-JMH with particles coated with recombinant semaphorin 7A, the protein that carries the JMH blood group antigens, presumably thus making identification of anti-JMH possible without having rare JMH-negative red cells.

MUSINGS
Another blast from the past - John Milton Hagen. Was there a patient by this name like Mrs. Kellacher whose ani-K led to the discovery of the antiglobulin test by Coombs? I've forgotten.

Anti-JMH was once considered a high-titer, low-avidity (HTLA) antibody, now an outdated term. The phenomenon is caused by the low number of antigen sites on red cells, not by antibody avidity, and not all antibodies classified as HTLA have a high titre.

JMH antibodies are usually harmless, although they can cause serologists problems by hiding clinically significant antibodies, since they react with most red cells. Rare cases of people with a variant JMH phenotype producing a clinically significant alloantibody have been reported.

While it would be useful to be able to identify anti-JMH without having rare JMH-negative red cells, how important is it practically and clinically?

Related reading

BOTTOM LINE
Granted that these articles are cherry picked to serve a point, they do illustrate that sometimes research, even applied research, may have questionable technical or clinical relevance.
By happenstance, the June issue of Transfusion features the status of transfusion medicine in developing countries. Particularly noteworthy is this review paper:
The paper's conclusion begins by noting, Blood safety remains an issue of concern in Africa and especially in countries of Sub-Saharan Africa where the key factor to most transfusion-related problems is the lack of financial resources.
It ends with these words: .... this is one of the unfortunate paradoxes of the history of humanity: it is those regions most in need of the means to fight prevalent diseases that have least access to them.


Yet we in developed counties continue to spend resources on ways to improve titration reliability and identification of antibodies such as anti-JMH. Those who do such investigations are respected researchers who have devoted their professional lives to improving transfusion medicine. But how important are some of these initiatives in the grand scheme of things?

An earlier blog discussed this issue of the discrepancy between them and us:
The next time you read an article in a scientific journal - or if you are a researcher who is contemplating spending your valuable time and finite resources on investigating a problem, and you can choose from issues A, B, or C - I encourage you to ask, What's it all about Alfie?
The opening lyrics:
What's it all about, Alfie?
Is it just for the moment we live?
What's it all about when you sort it out, Alfie?
Are we meant to take more than we give.....
ADDENDUM- The nature of research

Unfortunately, research is often many tedious rounds of slogging it out with nothing working - until it does - should that happen. It may not. You cannot predict the result.

We can also differentiate between basic ("pure") research and applied research.

Pure research
, as historically done at universities, is typically driven by the curiosity of the researcher with no practical application in mind. The reason is to create new knowledge by following the researcher's interests and passions. Although sometimes denigrated as a waste of time and money by anti-intellectuals, basic research has often resulted in incredible, if unforeseen, benefits to mankind. For a fun peek into the lives of researchers see

Applied research, becoming predominant at universities (which some would argue is unfortunate) is more focused on solving particular problems. For example, medical research is typically applied research and compares various treatments or drugs to investigate which gives better patient outcomes. In a prospective experimental study, the researcher creates a null hypothesis (treatment A and treatment B are the same and will result in similar patient outcomes) and tests it by conducting experiments.

SERENDIPITY
Often, research, regardless of its original purpose, results in unexpected, happy outcomes. For example, in the 1960s Baruch Blumberg was a geneticist (not a virologist) who was studying the genetic variation of proteins in blood. He and his colleagues decided to test the hypothesis that patients who received many transfusions might develop antibodies against polymorphic serum proteins which they had not inherited, but which the blood donors had.

Using double diffusion in agar gel they did find sera in multi-transfused patients that contained precipitating antibodies and in 1963 unexpectedly hit magic. When testing the sera of American hemophilia patients against that of an Australian aborigine, they found a precipitin band unlike any others and called it the Australia antigen.

Eventually, the Australia antigen was shown to be the HBsAg. In the process, one of Blumberg's technologist contacted hepatitis B. From this serendipitous discovery came tests for HBV infection and a vaccine. For the entire fascinating story, see

Unfortunately, HBV infection remains one of mankind's major diseases and killers.

Summary: Blumberg did not know if he would find antibodies in transfused patients stimulated by serum proteins in donor blood. Most particularly, he did not know that one of those proteins would be the hepatitis B surface antigen. And when he found it, no one knew what it was. My favorite quote about research is by Carl Sagan:
  • Somewhere, something incredible is waiting to be known.

Friday, May 16, 2008

Those were the days, my friends

Updated: 28 July 2020 (Fixed song's link)

Something a bit lighter this month to celebrate springtime and fall, depending on your hemisphere....

This feature in the May issue of Transfusion caught my eye:

  • Transfusion Medicine History Illustrated, Ruth Sanger, a rare early photograph
The photo shows Ruth Sanger (1918 - 2001), a giant of the transfusion medicine field, performing blood typing tests in the lab, circa 1946.

The photo and accompanying synopsis of her life's work brought to mind a book that I had read and enjoyed many years ago:

  • Blood Groups in Man by Race, R. R. and Sanger, R.
First published in 1950, the 6th and final edition of BGIM came out in1975. The textbook was easy to read and humourous in spots as the authors clearly had a great sense of humour. The blood group findings were totally based on manual agglutination techniques, which as with many good things became outdated because of technological advancement, in this case when molecular genetics techniques appeared in 1980s.

Co-authored by Rob Race, the man she was to marry in 1956, BGIM was an extension of Sanger's PhD thesis on
“The Multiplicity of Blood Group Systems.”

See a review of the 2nd edition by WM Mollison: J Clin Pathol 1954 Nov; 7(4): 357.

BGIM was one of several bibles that I decided to read cover-to-cover (just for fun on my own time) when I began my blood bank career:

  • Blood Transfusion in Clinical Transfusion by P.L. (Patrick) Mollison
  • Applied Blood Group Serology by Peter Issitt
With these books out of print and of historical interest, I wonder how many of today's blood bankers would recognize the names of pioneers like Ruth Sanger, Rob Race and Patrick Mollison? Moreover, how many people even read today's blood bank textbooks just for fun, or at all?

If reading is a lost art, the history of our field will grow ever dimmer, which is unfortunate. See,
for example:

How Coombs conceptualized the antiglobulin test while riding on a wartime train in England:

How the Fisher-Race theory of Rh inheritance came about by Race discussing the problem of Rh inheritance with the mathematician R.A. Fisher in a Cambridge pub over pints of beer:
On a personal level, two of my earlier blogs about life in the old days seem apt:
And for a real blast from the past
  • Schmidt PJ, Greenwalt TJ. Hints to blood groupers, 1950. Transfusion 2006; 46(3): 448-53.
Abstract:

Sixty years ago, the premier blood grouping laboratory was that of Robert Race in London. Agglutination tests and blood grouping had provided breakthroughs in immunology, genetics, and the solution of clinical problems. The significance of immunohematology was recognized by the clinical hematology community as a potent force in the expanding field of disorders of the
blood and blood-forming organs.
The instructions by Race to his London workers entitled Hints to Blood Groupers provide a picture of the immunohematology laboratory even before automation and differed slightly from the American techniques that derived from Landsteiner. Before agglutination is replaced in the near future by the emergence of molecular methods, the detailed method of a superb laboratory is recorded.

If you can access the full text of Hints to Blood Groupers, it's worthwhile. Two tidbits (from 60 years ago!) that foreshadow the documentation requirements of a quality system:

  • Always control every serum. If say one of the controls is, unavoidably, elderly, note this down (subsequent inspectors of your protocols should know this).
  • Look carefully at your results and repeat any dubious ones, as soon as possible. Repeat again if necessary and make new protocols for the repeats. It is no good saying you have repeated it and get the same results. That would soon be forgotten if not written down.
Or how about, If you want to speak to a person working, try to see when it will cause least disturbance....

Priceless!


As an aside, I love molecular diagnostics. How methods such as PCR work (scroll & click on arrow to start animation) are fascinating and the benefits to science and society are indisputable, including the ability to close the "window of negativity" for HIV, HCV, and other infections in blood donors.

The history of the discovery of the polymerase chain reaction makes interesting reading. See, for example, Kary Mullis's acceptance speech when awarded the 1993 Nobel Prize in Chemistry for his discovery of PCR

This story, disputed by others, was also told earlier by the controversial Mullis in Scientific American:

  • Mullis, K. The unusual origin of the polymerase chain reaction." Sci Am 1990; 262: 56.
Regardless of loving biotechnology, I think that dudes like Willy Flegel and Greg Denomme are going a Taq, err...tad too far when they try to relegate routine serological methods in the transfusion service lab to the trash bin of technological history. 
Cheers, Pat (aka Terminus Taquaticus)

Wednesday, April 02, 2008

Educating Rita: How we exclude qualified workers

INTRODUCTION
This blog entry begins by juxtaposing a global blood supply with a global work force for purposes of comparison. It then focuses on my view of how roadblocks keep even the most qualified medical laboratory technologists out of Canada. Perhaps this situation exists in your country too?

Canada actively recruits physicians, nurses, pharmacists and other health professionals. See

Recently, there has been a flurry of news about ISBT128 due to AABB requiring ISBT 128 implementation by May 1, 2008, an event that has been more than 10 years on the planning.

There are many benefits to ISBT128 labels and globalization of the blood supply is one:
  • Blood suppliers routinely sell products in the global market;
  • During disasters, blood products may be shared around the world.
The globalization angle caught my eye because I have long been involved in helping medical laboratory technologists and their equivalents (biomedical scientists, medical laboratory scientists, etc.) find work internationally. North America currently has a shortage of laboratory technologists and other health care workers that is projected to worsen due to an aging work force.

ROADBLOCKS
In Canada we need foreign professionals to alleviate staff shortages, at least temporarily, while we educate and train sufficient numbers of home-grown workers. But under the umbrella of protecting public safety we make it difficult for foreign-trained, well qualified medical laboratory technologists to work in Canada.

1. General Certification
The main made-in-Canada roadblock is lack of subject certification in transfusion science and other disciplines. Canada requires general certification provided by the CSMLS, which ceased offering subject certification (except for cytogenetics and clinical genetics) years ago because of cost.

For an example of a program of study, see MLS courses at the University of Alberta. (MLS also has a pre-professional year - MLS website) Note:
In Canada MLS at UA is the only integrated MLS program leading to both CSMLS certification and a BSc degree. It has courses such as research projects and molecular genetics that are not included in other Canadian generalist programs.

Other Canadian programs are 2 or 3 years and lead to certification. Although not required, today many students who enter such programs already have university degrees. A few years ago there was a movement to get the integrated BSc as the entry level qualification to the profession, but it failed due to lack of support from government and employers.

The reason this is noteworthy is that lab technologists
from the UK and Down Under, aka biomedical scientists, have qualifications that in many respects are more than what is required in Canada yet face significant roadblocks to being able to work here.

Use it or lose it
The effect of general certification is that experienced technologists who have worked in transfusion medicine labs for years, even if eligible to write CSMLS exams, will find it difficult to write an exam that includes questions involving clinical chemistry, microbiology, hematology, and histotechnology. After 5, 10, or 15 years of working in a transfusion service, no one can recall the nitty gritty of other disciplines. Even if they could, the knowledge turnover would make most of their prior learning obsolete.

Practical implication: Experienced blood bankers from countries such as England, Scotland, the USA, Australia and NZ must get upgrading in other lab disciplines in order to have a hope of passing the certification exam. Upgrading may involve taking a series of refresher courses (many of which do not include the exam competencies) or an entire training program of 2-3 years

Note: The CSMLS general certification exam is based on a competency profile that focuses on outcomes, not content. The competencies do not mention the traditional laboratory disciplines and are not organized around them. However, the exam questions do require knowledge, skills, and judgement in specific content areas.

2. Educational Diversity
A second roadblock is that education and training of medical laboratory technologists varies greatly around the globe. A few examples:

(i) Despite its emphasis on non-discipline specific competencies, Canadian training currently involves clinical rotations in 5 areas: clinical chemistry, hematology, histotechnology, microbiology, and transfusion science. American generalist education does not include histotechnology.


Practical implication:
Americans with generalist certification cannot challenge the Canadian certification exam without taking a course in histotechnology theory and practice.

(ii) While Canadian education and training is generalist, other countries focus on specialization. For example, UK certification has multiple routes but often involves specialization right from the start of clinical training. Graduates with an honours degree in biomedical science from a UK educational institution accredited by the IBMS cover multiple disciplines but then get employed by the NHS as a trainee biomedical scientist for 2 years, during which they are required to complete a portfolio that shows their competencies. This training could be all in a transfusion service.

Similarly, NZ and Australian programs also allow candidates to specialize during their clinical training, usually in 2 disciplines.

Practical implication: UK, Australian and NZ trained biomedical scientists cannot obtain Canadian certification without obtaining practical experience in labs outside the ones that they chose to specialize in. Clinical laboratories are already struggling to train Canadian students.

(iii) The USA allows subject specialization.

Practical implication: Experienced blood bankers with ASCP or NCA subject certification cannot work in Canada because of the lack of subject certification in Canada.

CASE STUDY - EDUCATING RITA
This is the case of a real person (Rita) whose name and specific details have been changed.

Rita is a UK-trained biomedical scientist who has worked as a biomedical scientist in a transfusion service in England for ~14 years, the last few as a transfusion safety officer (TSO). She has a BSc honours degree in Physiology and Microbiology and worked at the NHS as a trainee biomedical scientist in hematology and blood bank. She now wants to come to Canada with her family and find work in a Canadian transfusion service.

Rita's experience as a TSO is excellent. She has worked with nurses and physicians in an educative role, developed policies and SOPs, conducted audits of transfusion practice, helped implement Better Blood Transfusion, participated in SHOT, developed e-learning packages, presented reports to hospital administration, liaised with regional colleagues, spoken at conferences, and managed projects such as implementation of blood salvage devices and blood tracing software.

There is no doubt that Rita is well qualified to work in a Canadian transfusion service as a TSO, where she would bring a wealth of experience and a refreshing broader perspective. However, Rita is not eligible to write the Canadian general certification exam. She has no practical internship in histology, clinical chemistry, and clinical microbiology. Even if she had practical experience in all required areas, Rita's education and training occurred more than 10 years ago. Recall is difficult and practices have changed.

Bottom line - Rita could contribute much to a Canadian transfusion service but she may not get the chance. One option, assuming her family could afford and support it, is to go back to school for 2-4 years and take a Canadian med lab tech program. Does this sound likely? Is it reasonable? Is it an efficient use of education resources?

What is the wrong with this picture? Why cannot a country that needs qualified transfusion workers put processes in place that are not one-size-fits-all solutions that exclude many of the most qualified candidates and contribute marginally or not at all to patient safety?

With ISBT 128 we have facilitated a global blood supply. Let's figure out how to get a global work force.

More Information
Comments are most welcome.

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Wednesday, February 27, 2008

Signs you live in the 21st century

As usual, I alone am responsible for the ideas in this blog.

Have you seen these lists about life in the 21st century? They usually begin with jokes such as, "You just tried to enter your password in the microwave. "

This blog is not just about "Automating the transfusion service in the 21st century." It is also about "us and them."

The triggering antecedent for the blog was a television program I watched last year (Canada's Next Great Prime Minister) in which college and university students competed to earn a $50,000 educational scholarship and a 6-mth internship with the contest's sponsor.

One of the questions was, "What do you think will be the overwhelming challenge of the 21st century?" As I recall, the replies included stopping global warming and combating terrorism. But none touched upon what I thought would be one of the most challenging problems that we face.

That problem resurfaced when I read the editorial by Suzanne Butch in the March 2008 issue of Transfusion:
  • Butch S. Automating the transfusion service in the 21st century. Transfusion 2008; 48 (3):406-7.
The editorial supplemented a paper describing work in the UK to develop and test a system for total electronic control of the blood transfusion process:
The UK study evaluated remote blood issue combined with an electronically controlled transfusion process and found that it reduced the time to make blood available for surgical patients and improved transfusion efficiency.

Briefly, the electronic process is as follows:
1. Before transfusing blood, staff use a hand-held computer to make multiple scans prompted by the device:
  • Staff's user identification bar code
  • Identification bar code on patient's wristband
  • Blood unit compatibility label, unit number, and product code
2. The hand-held computer
  • Confirms if the bag is correct for the patient; if not, indicates "Do Not Transfuse" and sounds an alert
  • Prompts users to
  • -->Orally clarify patient's identification (first name, surname, and date of birth) and to check all details displayed on the computer screen
  • -->Perform other essential pretransfusion checks, including unit expiry date
  • -->Enter pretransfusion patient observations into computer
  • Once these checks are completed, prompts users that it is safe to begin the transfusion.
3. A final transfusion report, including observations done during and after transfusion, is printed and kept in the patient's medical records.

4. Information from the hand-held computer is downloaded to a blood bank computer by docking into a computer or by a wireless connection to the hospital network.

[For more on bar codes and RFID, see TraQ's Technology clearinghouse.]

In her editorial Butch notes that technology to improve transfusion safety and documentation has been available since the 1990s but few facilities have implemented total electronic patient identification from specimen collection to testing and transfusion.

She says that now is the time to ask software vendors and instrument manufacturers to develop such systems, whether using bar codes, RFID, or other technologies, in order to provide safer and more efficient use of blood components and human resources. She notes that, although it will be costly, in the USA forces such as the Joint Commission and CAP now advocate better patient identification systems.

Which brings me to the underlying theme of this blog: us and them

We in the West are spending or are preparing to spend a large amount of money to approach total positive identification and reduce transfusion errors caused by misidentification to zero or near zero. Although such errors are rare, we naturally strive to make them even rarer. And we already spend vast sums to prevent transfusion transmitted diseases, some of which are themselves very rare in our societies.

All of which is wonderful - wonderful for us.

But what about blood transfusion in developing countries? A few newspaper items are instructive:

Vietnam: Many in poverty earn a living selling their blood (Feb. 2008)

China: Deadly blood trade (Nov. 2007)

India: Professional blood donors may soon be jailed (Nov. 2007)

India: Most blood banks are not equipped to carry out even mandatory tests for diseases like AIDS, hepatitis B and C (May 2007)

Peru:Families of children infected with HIV via transfusion demand compensation (Sept. 2007)

Trinidad & Tobago: Desperate patients are charged 100s of dollars for a pint of blood (Dec. 2007)

US AND THEM
The contrast is clear. We operate Mercedes Benz blood transfusion systems whereas they run horse and buggy operations, if that. We use expensive technology to make transfusion not only safer but more efficient. We have the luxury of striving to be more efficient in a world where transfusion, indeed life, is unsafe for so many.

So what, you say? That's just the way it is in the world and it's not specific to transfusion. In everything, we are haves and they are have-nots. All correct.

Just think that every year there are 500 million - 1/2 billion - new cases of malaria in the world and that every 30 seconds a child dies of malaria (see WHO - Malaria). The numbers for those dying of diarrhea and other preventable conditions are equally staggering. These overpowering problems leave transfusion medicine barely on the health care map in developing countries.

In contrast, we in the West spend millions on food and medical care for our pets, eat ourselves into obesity, complain that we can never remember our passwords because we have too many, and diligently strive to make blood transfusion zero-risk.

And that's a problem - a BIG problem, if not THE problem of the 21st century. With modern communication systems reaching every part of the globe, how long can such inequities continue? How long before the have-nots do something about it? And how can we in good conscience just stand idly by and continue to accept our good fate?

Perhaps the Transfusion papers made me think about global disparities because I have friends working in blood transfusion in Vietnam and Cambodia. They work for a pittance - it is more like volunteering. Their informal reports on the reality is more than you could imagine. Think the worst, then multiply it a 1000 fold.

What can and should be done about these disparities? What can we do as individuals? Some possibilities:
Just some food for thought as we go back to fretting about all the things we fret about in our daily professional lives....

Signs you live in the 21st century really depend on where you were born and live.

If you know of more organizations where individuals can help or would like to give feedback, please click on the comments link below. There are already 2 thoughtful commentaries - many thanks to the contributors.

NOTE:
For those of you who read the blog below (To consolidate or not to consolidate? Who shall inherit the wind?),
there have been several comments added.

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Saturday, January 19, 2008

To consolidate or not to consolidate? Who shall inherit the wind?

This blog entry's title is a take-off on He that troubles his own house shall inherit the wind...(Proverbs 11:29), i.e., if you create problems for your own community, even if inadvertently, it will come back to you in some way. The play Inherit the Wind, whose title comes from the biblical proverb, is about limiting an individual’s freedom to think. These themes run throughout this blog.

By serendipity I came across the blog, Save our Blood Service, subtitled "Don't mess with the NBS". The blog's purpose appears to be to try to prevent centralization of the UK National Blood Service and to inform workers about related events.

NOTE: The discussion that follows represents my personal views alone.

The UK plan to go from 14 centers to only 3 centres is currently being reviewed (possibly due to widespread opposition by staff?) with a decision expected shortly. From what I can tell, the planned reorganization has been in the works since at least the Fall of 2006.
There are no doubt multiple rationales for the plan, but a major one must be saving money. And since staff accounts for a major percentage of costs, presumably staff layoffs will occur. Accordingly, there have been protests over blood centre cuts.
Canada experienced a similar process in which CBS consolidated to 3 testing centres for the entire country (except for Quebec, where Héma-Québec is the blood supplier), as well as other reorganizations such as using one consolidated call centre.

From my perspective, despite efforts by CBS, the Canadian initiative was preceded by years of uncertainty in which staff first wondered if their centre would be one of the lucky ones to remain as a test site, followed by more anxiety about what would happen to them once they knew for certain that their centre was toast, test-wise. Telling staff that they were being kept apprised of decisions, providing communication mechanisms to alleviate concerns, and promises of support to help staff obtain new employment did not appear to lessen the angst significantly.


Over the years, it has seemed to me that when restructuring occurs that threatens significant layoffs - such as the massive changes that happened in Alberta in the early to mid-1990s -
some management decisions have been temporarily held back from front line staff ostensibly to facilitate their ability to focus more positively on the work at hand. Of course, it is a policy never admitted to publicly.

The powers-that-be may act paternalistically and appear to believe that staff cannot handle bad news that threatens their livelihood. Moreover, a relatively common scenario, particularly for letting middle management and more senior staff go (valued, long-term employees), involves telling them at the very end of a business day that their services are no longer needed, simultaneously removing their computer access, and escorting them to the door. These practices do not engender loyalty in staff who remain.

As to CBS restructuring and what it accomplished, in March 2002 CBS had 4756 staff employed mainly in 14 regional centres. In 2001/02, blood operations expenditures were $351 million, a 14.7% increase over the previous year.Combined administration/overhead for the national level and regional centres was $85.4 million, representing 24% of blood operations expenditures.
  • Source: Performance Review of Canadian Blood Services. Final Report (Oct. 15, 2002)
I do not know how many staff are now in blood operations and realize that new initiatives may have increased staffing in some areas. But presumably there are valid comparisons that can be linked to consolidated testing and restructuring.

So.....DID CBS RESTRUCTURING SAVE MONEY - HOW MUCH?


One of the goals of creating CBS in 1998 after the so-called tainted blood tragedy documented by the Krever Report was to achieve transparency. To my knowledge, although CBS annual reports have outlined in general terms some of the efficiencies and benefits resulting from restructuring and consolidated testing, CBS has never published a comprehensive report documenting what was achieved financially as savings to tax payers who fund the service, and documenting benefits to hospital clients (transfusion services) and improved patient safety. If such a report exists, I'm sure my esteemed colleagues and friends in CBS will show me the light. (big grin)

If the UK NBS plan goes ahead, staff would find it useful to know ahead of time what the proposed advantages are, not just in terms of motherhood claims (it will save money; it will result in improved services to hospitals, etc.) but in terms of financial savings and other hard criteria against which success can eventually be measured. My experience has been that staff appreciate being told the straight goods. As well, should layoffs result, treating staff respectfully as valued employees, and as adults who deserve to know the reality in order to plan their futures, should be a given, indeed, a priority.


Personally, I will find it fascinating to see if the UK plan goes ahead and, if yes, in what form. If a country the size of Canada, the 2nd largest in the world, can have but 3 test centres for English Canada, it would seem that the UK can. Some of the key questions are
  • What are the savings and how will they be realized? (staff, equipment, overhead, etc.)
  • How many staff will be laid off or otherwise dealt with?
  • Are there significant benefits besides saving money?
Equally fascinating will be examining why the plan did not go ahead, if it does not. Protests did not stop the massive restructuring and downsizing that happened in Alberta in the '90s. But it's reassuring to see people try to influence the decision makers and inform colleagues, such as whoever created Save our Blood Service has done.

The blog's title is somewhat ironic because people who argue for restructuring typically cite change as being necessary for survival and see change as the way to save the system. The question is, what kind of change and does it really achieve its stated goals. If you do not get it right, you generate continuous cycles of centralization and decentralization that are satirized in A surrealistic mega-analysis of redisorganization theories.


Regardless, blogs have a bottom-up approach, a form of people power that I admit to liking. Kudos to the person behind
Save our Blood Service!

Feedback is welcome - please just click on Comments below.

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NOTE:The following feedback was provided by Ian Mumford, Chief Operating Officer, Canadian Blood Services, who gave permission to post it.

Pat-- Your blog was recently brought to my attention. Although you offer opinions on a wide range of issues I want to specifically respond to your January 19, 2008 comments regarding the consolidation of donor testing within Canadian Blood Services.

It appears you are uncertain as to the reasons for the consolidation. The objectives were very clear, right from the beginning. The primary objective was to increase the safety of the blood supply. This objective was the overriding factor for all decisions.
Improving safety was done by:
  • Introducing new technology with improved sensitivity, specificity and reproducibility
  • Creating an environment that expedites the assessment of new tests, methodologies and instruments
  • Decreasing the amount of time required to implement new tests that address emerging threats
  • Standardizing processes across CBS
  • Enhancing process control through automation
  • Moving to an integrated, fully GMP compliant, quality-driven system
The secondary objective was to increase the cost effectiveness of testing.
Improving cost effectiveness was done by:
  • Streamlining and improving the processes in place
  • Maximizing the testing throughput for expensive, highly automated testing equipment
  • Increasing cost management by standardizing consumables and supplies and leveraging a national procurement process
As you note a number of staff were impacted. A comprehensive Career Bridging program was developed for those staff. The program included educational and relocation allowances in addition to severance packages (as provided for in collective agreements). Staff members impacted by the consolidation of testing were given priority for available positions if they wished to relocate to a future consolidated testing site. A number of staff took this opportunity and many have had careers with progressive responsibility as a result. In addition, some staff members at a future consolidated testing site who were impacted by the MAK Progesa implementation were able to be reassigned to testing and other staff members found other job opportunities within CBS.

So what has happened?

The primary objective for increased safety of the blood supply has been met. The three Donor Testing laboratories are now highly automated with testing platforms that are the state-of the art for donor screening, e.g. the Abbott PRISM for serological transmissible disease testing and the Roche s201 system for West Nile Virus testing and Galileo for antibody screening. Most processes have been standardized with clear points of process control, many of which are automated. Standardization of processes has permitted staff transfer to an alternate site for short periods to manage implementation of major projects. A laboratory information system (LIS) has been implemented to increase process control for the automated transfer of test results from test equipment to LIS and after appropriate review, the upload of these results to MAK Progesa for the appropriate management of donors and blood components. There has been a decrease in testing critical non-conformances. We have had increased agility to introduce new tests such as West Nile Virus in response to an emerging threat. WNV was implemented in less than six months, an achievement that could not have been contemplated before consolidation. We now have the ability to manage single unit WNV testing during the infectious season on a real time basis.

The secondary objective for increased cost effectiveness in donor testing has also been met. The project expected to decrease the cost of baseline testing by 6% in the first year. This objective was exceeded by 100%, the first year on going costs were reduced by 12%. There has been continuous improvement in cost management year over year through efficiencies in utilization of assay kits and reagents and standardization of consumables and supplies.

Over the last decade, donor testing has continually increased in complexity and the level of technology available. These changes, which have improved the safety of donor testing, have made the concept of multiple, small laboratories unsustainable practically and economically.

Change is always challenging, especially for those directly involved and I can appreciate that all of the communications and support we provide may not lessen the angst. It's interesting that although some staff want to know about even the possibility of change months and months in advance, others tell me they only want to be informed when final decisions are made and a way forward is set.

Overall the consolidation of donor testing was successful and impacted staff were treated with the upmost of respect.

Ian Mumford
Chief Operating Officer
Canadian Blood Services


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