Monday, September 05, 2011

With love from me to you - Blood buddies (Musings on staff shortages & succession planning in transfusion medicine)

This blog was stimulated by the August 2011 issue of AABB News, which explores laboratory workforce shortages soon to be exacerbated as baby boomers* retire in large numbers. (*Boomers are generally anyone born between 1946 and 1965, meaning they will reach 65 between 2011 and 2030 and 60 between 2006 and 2025). I particularly enjoyed "Where have all the blood bankers gone?", the focus of this blog.

The title derives from an early Beatles song that illustrates the blog’s ‘big idea’.

Although the blog deals with medical laboratory shortages, I encourage physicians and nurses to read on and assess how the discussion applies to them since pathologist and nursing shortages are well documented. Recent Canadian examples:
Saskatchewan regulation breach linked to pathologist shortage (CMAJ, 9 Aug. 2011)s
LABORATORY WORKFORCE SHORTAGES

In my area of the world, and perhaps in yours, we've struggled with a lab work force shortage for close to 20 years. See an old record I wrote about events in Alberta as they happened:

ABBB News covers many of the salient issues related to lab staffing shortages but the proffered solutions seem like treading water to me. Perhaps I'm skeptical but, as the French say, plus ça change, plus c'est la même chose.

In particular, I wish the AABB article had mentioned one of the most pertinent consequences of staff shortages and the impending exodus of the boomers: loss of expertise, especially the 'tacit knowledge' missing from text books or journals.

If tacit knowledge can be transferred, it is likely transferred by ongoing close interaction between experts with tacit knowledge and those who lack it. More on this later.

To my mind, what's needed is a big idea to supplement the series of bandaid solutions currently on offer. First, let's examine some aspects of the AABB News article, "Where have all the blood bankers gone?"

STAFF RETENTION
On the issue of staff shortages related to technologists leaving the profession, "Where have all the blood bankers gone?" reports that poor salary is acknowledged as the main reason people leave and offers these additional factors:

1. Stress
2. Scheduling
3. Limited potential to advance
4. Increased workload as staff numbers decrease
5. Lack of recognition as a profession

To combat these ‘drivers’, several strategies are proposed:

1. Evaluate wages & benefits

Musings
In an age where mergers are increasingly common to save entire organizations such as blood centers, are the wages of medical technologists likely to be high on management's agenda?

As noted in the round table discussion in the July 2011 issue of Journal of Blood Services Management, the CEOs who arrange the mergers seem able to keep their positions, perhaps renamed but at similar salaries (in the $300,000 to $500,000 range judging by those publicly available).

Fact is, one executive salary could likely pay for 5-10 additional technologists, thereby reducing stress and workload and helping to retain staff. Or one CEO salary could increase the annual salaries of 5 senior technologists by perhaps $50,000 each (or 10 technologists by $25,000/yr), thereby motivating them and those who succeed them to stay on the job. Similarly, one executive salary could fully pay for 60 or more staff to attend annual conferences (or 5/yr for 12 yrs). Or subsidize 50% of the cost for at least 5 people to attend for 24 yrs.
But that ain't what's happening or likely to happen, is it?
2. Engage & empower staff with learning opportunities

Musings
Good strategy, but hard to institute given today’s cost constraints.
When staff struggle with inadequate time to do the actual work, setting aside time during the work day for good stuff like journal clubs becomes increasingly difficult. Also, when staff feel devalued, motivation to learn outside of work time wanes significantly. Doesn't make it right, and is short-sighted, career-wise, (we are all responsible for our own learning), but there it is.
As well, in the current climate funding for attending conferences has dried up for all but the most senior staff. Some enlightened organizations partially fund congress attendance for one of more junior staff but this is fairly rare today.
3.. Develop career ladders for professional growth and advancement

Musings
Using USA terminology, creating special programs for MLTs/CLTs who want to move to the "scientist" level is a good idea, but how many universities are currently interested in creating NEW programs with limited enrollment? How many MLTs/CLTs can fund additional education? How many can leave work and family, even for short hands-on sessions to supplement distance education study? Some can but many cannot.
4. Create efficient work flow processes

Musings

'Lean' is supposedly not about reducing staff but about reducing waste and the need for skilled staff to do rote or manual tests so they are free to perform more skilled, interesting tasks.
Rote is one thing, but as someone who started in the profession when most blood bank testing was manual, that was one of the benefits of working in blood bank, as opposed to clinical chemistry where instruments have ruled for decades.

If Six Sigma & other lean management programs reduce waste and free up worker time, in the article’s context, lean can help reduce stress and workload and therefore act to retain staff.

But it's all pretty theoretical. Lean can assist many desirable outcomes, but has anyone seen a paper whereby, post-lean, laboratory staff retention rates are shown to improve significantly?

Who knows - maybe lean is like IVIg, the cure-all for every disorder known to humankind.....
5. Integrate automated solutions

Musings
Of course, automation has now infiltrated even the manual bastion of the transfusion service.
Like lean, blood bank instrument manufacturers promote automation as a way to free staff from routine work so they can do more interesting things. However, at the same time automation is promoted as a way to lessen the need for knowledgeable staff so that cross-trained techs, who are not transfusion specialists, can do the work. As well, manufacturers always note the number of staff that can be eliminated by their marvelous machines often named after characters in Greek mythology.
So which is it?
  • Automation enhances staff retention by freeing them from boring manual tasks and letting them do interesting things? Any studies on this?
  • Or automation helps eliminate the need for knowledgeable, specialized staff?
  • Or both? That is, automation has the potential to be totally liberating, liberating staff from boredom and ultimately from their jobs, all the while making clinical laboratories lean, efficient and error free.
TRAINING PROGRAMS

The AABB article also discusses the decline in medical laboratory science training programs. From my experience in Canada, here's what happened:

  1. Governments withdrew funding from health care and laboratories in particular. See 'History of 1990s Laboratory Restructuring in Alberta'
  2. Faced with decreased funding, health care organizations instituted lab restructuring, regionalization, and automation, which led to a dramatic decrease in the need for medical laboratory technologists (and pathologists).
  3. The same trends made it increasingly difficult for laboratories to find the staff and time to train student technologists.
  4. The drop in demand, along with decreased funding for educational institutions and the inability to find adequate internship placements, led to schools closing.
  5. Move forward several years and severe shortages appear, exacerbated by the lack of training programs and non-existent internship spots, as well as the reality that skilled health professionals take years to educate and train.
Now we're in catch-up mode, as described in the AABB News article. Proposed educational strategies include career ladders (discussed above) and online education to obtain sustainable numbers with decreased cost.

Unfortunately, new or expanded programs are a hard sell in most locales, especially with the rise of automation, regionalization, and centralized testing, all designed to require fewer highly skilled staff.

Increased awareness of the profession is also discussed in the AABB piece. Although worthwhile, improved recognition for medical laboratory science as a career is such a long goal I will not discuss it here. Medical laboratory science professional associations and education programs devote much time an effort to this elusive goal.

BIG IDEA?

So, while we stumble along with bandaids, the hemorrhage of knowledgeable lab staff continues and with them the tacit knowledge that cannot be found in print.

If the number of training programs and clinical placements magically increase, will there be any specialized transfusion experts left to pass on knowledge missing from textbooks and journals to the next generation? I doubt it. Not without adding a big idea to the bandaid mix.

So what's mine? I suggest an old idea that has never been fully adopted by the transfusion medicine community - a succession plan for transfusion professionals as a whole based on mentorship.

Granted, mentoring still happens informally to varying degrees some of the time but mentoring has decreased in recent years.

Mentoring is not a solution to staff shortages per se but rather an adjunct to help with succession planning for the profession as a whole.

And just because it's a big idea doesn't mean it cannot be implemented in baby steps by far-sighted leaders.

BLOOD BUDDIES

Call the mentoring program something catchy, a name that reinforces that's it's fun and unpretentious, e.g., Blood Buddies.

Funding
Employers, governments, professional associations, manufacturers. Time they 'walked the talk', don't you think?

How?
  • Get by-in from local power brokers
  • Recruit newly close-to-retiring and retired experts willing to act as mentors*
  • Identify workplaces willing to test the concept
  • Generate topics where tacit knowledge is the norm
  • Assess mentee needs with their full participation
  • Develop prototypes and pilot projects to test the idea ("proof of concept")
  • Draft ways to evaluate pilot projects, including measuring outcomes
* Why older workers? Because they know what the current generation does not know that’s important to know. Because many are motivated to transfer knowledge as a parting gift ‘with love from me to you’. Oldie goldies have a wealth of experience to share.

Once mentoring program details are fleshed out, ask newly retired professionals (nurses, medical technologists, physicians), those with the respect of colleagues, to contribute one day a month, or whatever works for them, to pass on to the next generation what they see as the most important lessons from their careers, to include scientific, clinical, managerial, educational, and political aspects.

Solicit not just the 'big names' that speak year after year at conventions but respected professionals who have toiled out of the spotlight, the unsung heroes, as it were.

Think Global

Facilitate communication between retired transfusion professionals across the globe to discuss mentoring ideas and international mentoring sessions using the Internet.

Why not? The technology is there for free face-to-face sessions between individual and small groups.

Based on my experience, there are many experts that, depending on your country, you may not have heard of.  I know from MEDLAB-L that we can all learn from each other, regardless of profession and country.

SCENARIOS

So, what could 'Blood Buddies' look like?
  • Medical technologist, nurses, and physicians participating in interdisciplinary mentorship programs
  • Local, regional, national, and international programs
  • F2F: Series of informal, interactive workshops at local blood centers and hospitals, focused on practical aspects of key lessons learned over a lifetime. Notice I did not say presentations and topics would be co-generated by mentors and mentees.
  • Online: Individual and small group learning facilitated by Skype and similar free tools.
  • Integral components would be case studies to illustrate tacit knowledge.
BOTTOM LINE

Staff shortages of transfusion professionals will worsen in the coming decades. We can continue to apply the same bandaids, even though many do not appear to be working well. Best to evaluate their effectiveness to assess which ones have made a difference.

Will transfusion leaders - the powerful physician-CEOs and medical directors who run TM - do what it takes to improve staff shortages and the loss of tacit knowledge? I doubt it. Most of the talk in professional newsletters like AABB News about staff shortages is so much smoke and mirrors.

I'll know everyone is serious when

1. Post-merger, some extraneous blood center CEOs are let go and a proportion of their salaries is applied to wage raises for medical technologists or new hires or CE funding.

2. CEOs, VPs, and assorted medical directors at the top of the food chain voluntarily forego some of their salaries to make those of medical technologists more competitive (Okay, stop laughing....But as CEOs earn 5-10 times as much, or more, as technologist, why not, especially if they are serious about solving shortages.)

3. Employers, especially the pathologists who run transfusion laboratory services, actively and forcefully lobby governments to strengthen existing medical laboratory science programs

4. More medical directors donate some of their CE funding to allow technologists to attend conventions.

5. Employers designate more funds for educational initiatives for medical technologists.

6. More medical technologists volunteer to participate in CE programs on their own time.

7. Governments fund more MLS educational programs and provide funding for more clinical training placements.

Unfortunately, the 'movers and shakers' have NOT taken serious action yet and likely never will.

Call me an idealist but these are the things that concern me when reading the fuzzy thinking and hypocrisy that passes for expert opinion about staffing shortages in AABB publications. This sounds harsh, and it is. But if I wrote only nice things, readers would soon be comatose. Just like a 'goody-two-shoes' police inspector in a mystery, 'nice' has no legs.

Mentoring by near and recent retirees is a suggestion to supplement current bandaids. Mentoring addresses a real knowledge loss, one that is happening now and will continue to worsen as more people retire.

Maybe it doesn't matter that tacit knowledge is lost. We probably won't know until it's too late.

In the meantime, enjoy

Two ‘beauties’ from my 2010 post on mentoring:

As always, the ideas are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice.  - see several  Comments below.

Further Reading on mentoring

  1. Saskatchewan nurses
  2. CLMA
  3. Women in leadership
  4. Beck SJ, Laudicina RJ. Passing the torch: Mentoring the next generation of laboratory professionals. Clin Lab Sci. Winter 2001.
  5. Beck, SJ, Laudicina, RJ. Mentoring tomorrow's leaders in education. Clin Lab Sci Winter 2001.
  6. Kapanka ARH. Journey to the millennium: mentoring in the clinical laboratory. Med Lab Observer, May 1998.
  7. Laudicina RJ. Mentoring for retention and advancement in the multigenerational clinical laboratory. Clin Lab Sci. 2001 Winter;14(1):48-52.

Wednesday, August 03, 2011

If you could read my mind (Musings on 'acceptable risk' & who pays the price)

This month, seeing as it's the 'dog days of summer', I'll muse on multiple related items about transfusion risks and economics that made me ponder days gone by. The blog's title comes from an old Gordon Lightfoot song.


Everywhere you look these days, transfusion journals and newsletters are filled with discussions on cost-effective and how organizations need to find ways to reduce costs while maintaining or improving blood safety. The clichéd business jargon of the 1990s is pervasive in the TM literature, now used by physicians in suits (as opposed to lab coats) to whom it has come, albeit late.

I've long been an advocate of risk management as applied to test rationalization in the transfusion service and taught students about the health care piggy bank not being bottomless. Choices must be made and, when we fund some tests and procedures, it automatically means others cannot be funded.

But something about the current discussion on cost, benefit, and risk as applied to protecting the safety of the blood supply disturbs me.

1. AIDS AT 30

June's issue of AABB News features '30 years of fighting AIDS' and focuses on major advances in blood safety resulting from nucleic acid amplification testing (NAT).


Michael Busch notes that 99.999% of HIV cases are being detected and "The risk curve is approaching zero, but it's never going to be zero exactly."

AABB president James Aubuchon  is also quoted in 'AIDS at 30':
"We should congratulate ourselves on what we have accomplished...in our approach to infectious diseases and these accomplishments have allowed us to turn our attention to other problems such as bacteria in platelets and TRALI."
Presumably "our approach to infectious diseases" includes applying the precautionary principle to blood safety.

2. RISK-BASED DECISION MAKING


A consensus conference on risk-based decision making for blood safety was held in Toronto in Oct. 2010 and will be discussed at the 2011 AABB meeting in San Diego. The proceedings were published in July.
Also see
In this paper, Wilson, who also participated in the consensus conference on risk-based decision making, offers the following factors as a standardized way to decide which type of precaution, if any, to implement for a given transfusion risk:
  1. Is the extent of the exposure large?
  2. Is the consequence of the exposure serious?
  3. Is the consequence of the exposure irreversible?
  4. Is there minimal cost associated with the removal of the exposure?
  5. Is there a minimal negative health effect associated with removing the exposure?
Assuming that definitive data are available (not always possible), using these guidelines presumably means do something if a big exposure, serious and irreversible consequences exist (e.g., HIV infection). How cost and negative effects on the donor supply influence decisions and interact with the other factors is less clear.


The precautionary principle, while improving blood safety, has inevitably produced increased blood costs and led to 'push-back' in the form of questioning whether it has gone too far.


As noted in an earlier blog, "The principle implies that there is a responsibility to protect the public from harm if research discovers a plausible risk, especially if it is a severe risk. But the proof of harm need not be certain, and cause and effect do not need to be fully established."


To me, the report on the consensus conference (Risk-Based Decision Making for Blood Safety) indicates the direction of future decision making:
  • Cost is becoming increasingly important and the precautionary principle as applied to transfusion medicine will be shaped to fit what is financially desirable.
3. COST REDUCTION
Ongoing evidence exists that blood suppliers are in trouble and need to reduce costs.
June's AABB News also features a report on the 9th Annual National Blood Foundation Leadership Forum held in April 2011 in Miami. Richard Gundling, VP of Healthcare Financial Management Association, is quoted as saying that
  • organizations that merge or form partnerships "can benefit from higher margins, greater expense control and economies of scale."  
The July issue of Journal of Blood Services Management (published with Transfusion) includes this article:
  • 'A roundtable discussion: from thoughts on supply and demand to what keeps us up at night' 
A sample comment:


Each merger is unique, but in general, mergers are driven by a rationale to lower costs, grow geographically and access hospital markets that are crossing current blood center lines. Often it's about pricing strategies. (Stacy Sime, President and CEO, LifeServe Blood Center)
4. HISTORICAL PERSPECTIVE


In this 1998 CMAJ article written on the eve of CBS taking over the blood system in English Canada ("Concerns mount as transfusion medicine loses its lustre"), Noel Buskard and other luminaries in Canada's TM firmament discussed not only the legal risks involved in transfusion medicine but also a trend toward
  • "a 'pharmaceutical model' in which the physician is based in-house, reports to a CEO-style business manager and doesn't have a connection to patients or other institutions."
What would the physicians quoted in this 1998 article think of the current emphasis (ascendancy?) of the economics of transfusion medicine, especially when juxtaposed with managing risk? If they want to thrive in the current system, I imagine they would keep pretty quiet.


Today the guys who get air time at AABB and other conferences are those who promote strategies to achieve cost-effectiveness.


From Jeffrey McCullough's presentation (Consensus Conference on Risk-Based Decision Making):
  • In response to a variety of developments over the past 25 years, the culture and structure of blood organizations have evolved. These organizations have moved from a medical model involving individualized decision making resembling patient care to a systems-based pharmaceutical manufacturing model, with new approaches to quality assurance. Organizational structures have been transformed; and new kinds of leadership are now valued, such as manufacturing and business expertise.
  • Governed by the principle that “safety of the blood supply is paramount”, these organizations have achieved significant improvements in blood safety. However, that paradigm is evolving and potentially conflicts with other principles, such as the notion that “decisions…will be made within a health risk management framework, which places on an equal footing the 3 critical elements of cost, benefit, risk”. (Words in quotation marks are from referenced sources)
REMEMBERING
Noel Buskard was the medical director of Vancouver's Canadian Red Cross blood centre during the early years of the AIDS tragedy in which 1000s across Canada and around the globe were infected with HIV and hepatitis from blood transfusions. He quit the Red Cross in 1991 saying it had developed a "fortress mentality" when confronted with the AIDS tragedy.
Noel was the President of the CSTM (1998-2000). For speaking publicly about safety issues throughout his career, he was awarded the 2001 Whistleblower Award from the B.C. Freedom of Information and Privacy Association.

For a fascinating trip down memory lane, see
5. PATIENTS - RISK BEARERS WHO PAY THE PRICE
Lest we forget:


Reading the current papers on blood safety and talk of 'acceptable risk', and balancing risk and cost, I cannot help but remember this interview of the daughter of a Manitoba hemophiliac, Ed Kubin.

Many moons ago when I worked at the Winnipeg Red Cross, Ed and his brother Barry would regularly pick up their supplies of cryoprecipitate from the lab. (Yes, it was just pre-factor VIII concentrate)


Writing this blog brings to mind this gem by Canada's Gordon Lightfoot
I'm pretty sure you can read my mind on where I stand on the issue of 'acceptable risk' and who pays the price.

BOTTOM LINE
So, what is it about the current discussion on risk management and the safety of the blood supply that disturbs me? It's that those doing the talking seem to be leaning towards cost being the main determining factor, despite the lip service paid to safety.

We know that credible evidence is needed to show that an intervention to prevent a given risk may add to blood safety, but evidence need not be overwhelming, according to the precautionary principle. Did the AIDS and HCV tragedies not teach us that? Unfortunately, emerging threats to the blood supply do not often come with good data on how large the true exposure is and evidence is often unclear in the early days.

If cost is given too much weight, as seems likely, we are doomed to commit the errors of the past. And it isn't the docs making the decisions who will pay the ultimate cost.
---------------------------------
As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice.  This blog was updated 7 Aug. 2011.

Sunday, June 26, 2011

"Shine a light" (Musings on what we take for granted & shouldn't)

This month's blog is a 'twofer.' Both parts arose from reading the May issues of AABB's Transfusion and AABB News. The blog's title derives from a Rolling Stones ditty of the same name.

MUSING #1 - On detecting mom's antibodies in babes

The first musing was stimulated by
The paper shows something true about many, if not most, transfusion medicine policies, namely that they are not evidence-based.

During a long teaching career, I'd often discuss with medical laboratory science students that what we do is based on many things, but seldom evidence. Shaikh and Sloan's paper illustrates the point perfectly.

Students are routinely told that newborns do not produce detectable ABO antibodies until about four months of age and, if ABO antibodies (isohemagglutinins) are detected, they are of maternal origin. The corollary is that maternal ABO antibodies can be detected in newborns up to 4 months of age, with implications for transfusion compatibility.

For example, AABB Standards specify that neonates up to 4 months who are not group O require testing for maternal anti-A / anti-B in order to receive ABO-specific RBCs. Instead of testing, most transfusion services simply issue group O RBCs to infants up to 4 months of age.

Shaikh and Sloan's study of ~1309 infants showed that 6.4% of infants up to 1 month of age had detectable maternal isohemagglutinins, while no infants 2-4 months of age had them. The practical implication is that infants who are at least 2 months old can safely receive ABO-specific RBCs without testing for maternal anti-A or anti-B, thus freeing technologist time and increasing the supply of group O RBC.

How refreshing to see some of our long-held assumptions tested and revised based on evidence....

Rh immune globulin (RhIg)
Many other TM policies lack appropriate evidence. One of the classics is the guideline to inject RhIg into Rh negative females within 72 hours of delivering an Rh positive (or weak D positive) newborn.  Like many transfusion-related policies, administering RhIg within 72 hours of delivery arose by happenstance and was not based on evidence:

In the USA initial experiments with Rhig involved ‘volunteers’ from Sing Sing prison. ('volunteers' is used loosely since it is debatable that anyone in prison is truly a volunteer.) Male prisoners were injected with various volumes of D+ red cells and later given different doses of RhIg to see what prevented them from making anti-D. Because researchers were allowed in the prison only from Monday to Friday, there was a subgroup that got a red cell injection on Friday but only received RhIg on Monday. It was from this group that the 72 hour recommendation arose.
Fortunately, the 72 hour guideline for RhIg seems to work. Would 96 hrs. or another number of hrs. work just as well? We do not know.

OTHER GUIDELINES

Similar well established guidelines with minimal evidence include to

(i) Begin transfusion within 30 minutes of removing RBCs from a temperature-controlled environment (4oC refrigerator)

(ii) Complete transfusion of RBC within 4 hours of removing them from a temperature-controlled environment
.... and many similar guidelines.

My sense is that, if providing a specific number enhances patient safety and helps transfusion professionals rather than handcuffs them with impractical requirements, and, if historical guidelines seem to work, sticking with them makes sense.

Policies that offer simple specifics are especially prudent for staff who may lack the in-depth knowledge and experience often needed to assess individual cases. With increased hiring of casual and part-time staff (nursing and laboratory), increased use of generalist technologists rather than transfusion specialists, and physicians with little transfusion medicine education in charge of rural laboratories (and those ordering blood anywhere), simplified policies are needed and appropriate.

MUSING #2 - On spinning and valentines

Two items caught my eye in the May issue of AABB News:

(1) The Pall advertisement on p. 15 (Take a greener approach to whole blood processing) promotes its transfer bag for cryo pooling. The ad has a lovely photo of lily pads and a frog against a green backdrop but it struck me as spinning the meaning of green almost to what's known as greenwashing.

As elusive as greening is to define, it's generally considered to include a constellation of these practices:

  • Reduce consumption, especially reduce use of resources like water and fossil fuels
  • Transition to renewable energy sources
  • Reduce waste, particularly waste that's not biodegradable, eg., plastic bags
  • Minimize pollution
At its essence green means being friendly to the environment and protecting the pale blue dot for future generations.

More efficient use of a product like a plastic transfer bag (even allowing that Pall's transfer bag increases efficiency) doesn't necessarily equate with being green, except in the broadest sense, so as to make the term almost meaningless. The problem with misleading advertising, even when claims are inflated relatively benignly, is that such spinning undermines  customer confidence that the company is transparent in other areas.

(2) The second item was "Mergers and acquisitions on the manufacturing side," a priceless valentine to the manufacturers interviewed for the article (Haemonetics, CaridianBCT, Novartis Diagnostics). The industry reps who were interviewed (top brass like CEOs and VPs) were allowed to spin their mergers without comment and in the process smoothly managed to insert the benefits of their services and products.

According to the piece, in all cases it seems that mergers are good: (my comments in brackets)

  • Good for the companies (for their bottom lines due to goodies like economies of scale and bulk purchasing but always kumbaya-ville for the two corporate cultures - I doubt it)
  • Good for their employees (at least before staff are let go or vacant positions due to retirement,etc., are not filled forcing remaining staff to do more, often with less)
  • Good for customers (until less competition and more oligopolies influence pricing in favour of manufacturers. As an example, has the oligopoly of Immucor and Ortho Clinical Diagnostics, with their razor-blade business models, led to lower reagent prices? )
Mergers create oligopolies. Many outcomes are possible but one is that oligopolies drive prices up. Increased competition is supposed to be advantageous to consumers since it drives prices down and is a major rationale for the benefits of free enterprise. Less competition, by extension, is bad, especially for customers.

The AABB, by allowing industry's rosy win-win claims to go unchallenged and by publishing self-promoting descriptions of products, gave the companies thousands of dollars of free advertising. The organization depends on its industry advertisers, but that's quite the valentine, nonetheless.

The musical ending to this blog and the source of its title is the Rolling Stones' rock-gospel song:
It's worth noting that Shine a light was originally titled Get a line and was about the worsening drug addiction of then band member Brian Jones.

As to Shaikh and Sloan's research on how long mom's antibodies are detectable in babes, how about this Beatles classic?
And just for fun, to give the moon its due, one of my favorite songs:
As always, the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 

Wednesday, March 16, 2011

Cultivate, convert, and cloak 'em - Sweet dreams? (Musings on chasing the 'holy grails' of blood transfusion)

Recent research papers posted to TraQ stimulated this blog. It's a 'quick and dirty' look at current research into how to make blood, and by extension blood transfusion, safer. The title derives from the research processes involved and a favorite song of mine co-written by Annie Lennox and originally released by the Eurythmics in 1983.

For years researchers have tried to find the 'holy grail' of blood transfusion in the form of the ideal oxygen-carrying red cell substitute, a search that has eluded them to date.
Although blood substitute research continues, currently many other research pathways are being explored.

Not included in this blog is an early research pathway - chop 'em - whereby enzymes chop off A and B antigens and convert all red cells to group O cells. So far research has not led to practical use. Also see this paper from 21 years ago:

CULTIVATE 'EM
Scientists in many countries are working on developing synthetic blood from embryonic stem cells but Scotland has embarked on a project to produce blood on an industrial scale.

In 2009 the Scottish National Blood Transfusion Service in collaboration with several universities began a trial to provide an unlimited supply of group O Rh negative red cells for emergency transfusions. The project has just received a further injection of funds.

Research will require cross-disciplinary teams involving medicine, bioprocess technology, and engineering.
CONVERT 'EM

Researchers in Hamilton, Ontario, Canada demonstrated the ability to generate hematopoietic progenitor and mature blood cells directly from human skin fibroblasts. News reports:
Research paper:

Converted skin cells were able to produce red cells, white cells, and platelets.

The McMaster team will also investigate converting excess, unwanted fat cells into blood using the same method. Can't you just see it?

CLOAK 'EM
Researchers in Montreal, Quebec, Canada investigated a novel way to develop a 'universal' red blood cell that involves encasing individual red blood cells within a shell formed from a biocompatible polymer. News items:
Research paper:

The polymer hides A, B, and D antigens from their respective antibodies and acts as a chemical cloaking device by masking rbc surface antigens that would otherwise trigger an immune response. The red cells still function because oxygen can penetrate the shell, allowing the rbc to supply oxygen to body tissues and organs. Patients with encapsulated rbc would eventually produce their own red cells to replace camouflaged cells, which would ultimately be broken down and excreted.

The immunocamouflage' mimics a 'find me if you can' scenario seen many times in nature.

SUMMARY

A common thread of these research initiatives is the need for interdisciplinary teams, yet another reason to break down the silos that professionals live in.

All projects are in the early stages, at least 5-10 years from being implemented in the real world. Only time will tell if they go the way of the elusive blood substitute or come to fruition and make transfusion safer.
Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 

Sunday, January 23, 2011

'Tough Titty' and other iPad apps (Musing on 'revolutionary' apps for TM)

This month's blog discusses how the over-hyped iPad and similar tablets could be used to improve TM practices. The title includes a reference to the 1968 Beatles classic
Two items motivated this blog

1. Clinical chemistry blog (Aargh! - the dreaded discipline with all the automated instruments) Recently, I came across this blog from the AACC:
and wondered how ideas for curbing the cost of expensive molecular testing outsourced to reference labs could be applied to transfusion medicine. It interested me as a follow-up to last month's blog:
One strategy that amused was a scheme for pop-up prices to appear when a clinician was making an electronic test order. The pop-up could contain product or test utilization information and one to four dollar signs ($ - $$$$), as is common for hotel and restaurant listings.

The blog outlines several approaches to minimizing the cost of send-out tests and is worth reading, as is this related resource:
2. Slew of news items on the iPad frenzy extending to medical schools, as exemplified by
Seems there are many medical apps being developed (See Further Reading below) and I wondered how future iPad applications could be used in transfusion medicine. One potential use that came to mind was IVIG utilization.

The IVIG Challenge
In Canada (and elsewhere) an enormous amount of time, expense, and expertise has been applied to IVIG utilization. Canada's per capita use of IVIG grew by ~115% between 1998 and 2006, making Canada one of the world's highest per capita users, with most growth attributed to off-label use.

In 2008 Canada's use was still more than twice as high as the UK, and marginally higher than even the USA. Source:
  • Nahirniak S, Hume H A. Guidelines for the use of IVIG for primary immune deficiency and solid organ transplantation. (editorial) Transfus Med Rev: 2010 Jan; 24(1, Suppl1): S1-S6.
As would be expected, IVIG utilization is a major focus of Canada's NAC and utilization management programs are operated by various provincial blood coordinating offices such as that of the BC PBCO.

Often utilization schemes involve personal gate keeping by physicians who are TM specialists, all of whose decisions must be standardized, an effective but high maintenance solution.

As well, strategies that involve education and training of clinicians is a hard slog, as discussed by Dzik:
  • Dzik S. Use of a computer-assisted system for blood utilization review. Transfusion 2007;47(s2): 142S.
In brief, the author's hospital used multiple blood utilization strategies, including a computer-assisted system with
  • Computerized physician order entry
  • Computer-assisted blood utilization review and feedback
Dzik acknowledged that the computer program was rudimentary and needed to improvements. For more details, see this Sept. 2007 blog:
Iggy, the IVIG app

In the future, perhaps we will have Iggy, an IVIG app available to clinicians on their iPads, iPhones, etc., which may even be networked to the hospital or regional health IS. When a doc orders IVIG via an electronic order system, the Iggy app would kick in. Can't you just see it?
Hey, dude, that's $10,000 and that's just for starters! Are you really, really sure the patient will benefit? What's the evidence? Read all about it here. Oh, and dude, you are the only one to order this product for this condition in this health region in the past year. In case you were wondering, this distinction is not good. Text or Skype and we can discuss.
Other useful apps

How about these as potential TM apps?

1. Abacus - The RhIg app for those who are mathematically challenged and cannot calculate the correct number of RhIg vials to inject.
2. Frappuccino - The 'FP doesn't cut it' app for all those docs who use frozen plasma inappropriately.
3. Prefried - The app envisioned by John Judd, who cautions that prewarm technique was never meant to be used to determine the clinical significance of antibodies and can prewarm away clinically significant antibodies.
4. Tough titty - The 'You don't need a titration' app for docs who request an anti-D titre in pregnant women who received RhIg at 28 weeks and show a 1+ anti-D at delivery.
Bottom line

So.... How about TM professionals getting together with geeky app developers to create medical applications for iPads and other tablets that can improve transfusion medicine practice? To use a cliche, for once let's get ahead of the curve. The iPad is over-hyped but the potential is there.

I would love to hear your ideas for transfusion-related iPad apps, off the wall and funny or serious. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 

Further Reading

Mostly news about the iPad and its application in medical schools

Added Feb.1, 2011: Clinical pathology laboratories should prepare for the iPad era (Dark Daily, 24 Jan. 2011)

Stanford School of Medicine to give iPad to all incoming medical students

Is the iPad helping to modernize medicine?

Will iPad transform med school?

Associated Press looks at iPad use at Stanford's medical school (click on video)

Age of e-medicine

UCI also receive iPads

iAnnotate PDF – First iPad app required by Stanford School of Medicine

Top 5 medical apps for the iPad

25 iPad apps for health care

Medical applications

See how easy it is - tutorials

Please check the comments - good stuff! Thanks to those who contributed.

Monday, December 20, 2010

Snip, snip, the party's over? (Musings on the seductive rise of DNA typing of blood groups)

Updated: 28 Jan. 2017 (Fixed broken links)
December's blog's title comes from
  • A song by Willie Nelson: The party's over
  • Single-nucleotide polymorphism or SNP (pronounced snip), the basis of most blood group DNA typing. Simply put, a SNP is a DNA sequence variation that occurs when a single nucleotide in the genome differs between members of a species or paired chromosomes in an individual.
The use of seductive is tongue in cheek. Not sure if I mean 'harmful but enticing'. Perhaps insidious would be apter, i.e., 'developing so gradually as to be well established before becoming apparent'?

The blog discusses
  • Increasingly cozy relationship between TM professionals and the biotechnology industry;
  • Molecular typing of blood groups and its uses;
  • What DNA typing potentially means for the TM laboratory's work force;
  • A futuristic farce on where all this might lead.
BLOG'S ORIGIN

The idea for this blog came from these sources:
  1. Announcement in the AABB Weekly Report (17 Dec. 2010) of a new section in Transfusion devoted to blood group genomics with Connie Westhoff, currently director of genomics and immunohematology at the New York Blood Center, as the section's associate editor.
  2. DNA typing resonated because a recent blog (Aug. 2010) discussed Immucor' s investment in DNA typing, specifically its purchase of Bioarray Solutions in Aug. 2008: Goldfinger's filings, a customer's toolkit (Musings on business intelligence) and Immucor's belief that "molecular immunohematology will revolutionize blood bank operations."
  3. By chance, in researching a case study, I had just read two articles on molecular typing, one co-authored by Westhoff:
Westhoff CM, Sloan SR. Molecular genotyping in transfusion medicine. Clin Chem 2008;54(12): 1948-50.
Reid ME. Transfusion in the age of molecular diagnostics. Hematology 2009.

FYI: Marion Reid, a legend at the New York Blood Center and recipient of the 2006 International Woman in Transfusion Award.
COZY ARRANGEMENTS?
Interestingly, the Westhoff and Reid papers above list author involvement with Bioarray Solutions (and its earlier name, Bioarray), a company whose products DNA type red cell and HLA antigens.
Westhoff and Sloan paper's disclosure of potential conflicts of interests:Consultant or Advisory Role: C.M. Westhoff, BioArray, Ltd. and Immucor Inc. S.R. Sloan, Bioarray Solutions.

Reid paper's conflict-of-interest disclosure: The author receives research funding and royalties from patents from BioArray Solutions.
As evidenced by these examples, world class TM professionals often advise biotechnology companies and Bioarray Solutions has its share of respected advisors. Besides the three already mentioned, I came across others. It's accepted that industry needs input from professionals and the practice is common.

Of note, industry financing involving direct and indirect payment (consulting, food, travel, product samples, you name it) is estimated as high as $29 billion/year.

SO WHAT?
Questions to ponder:
  • Could consulting for a biotech firm, presumably for a fee, influence a person's perspective towards the technology in general?
  • How about earning royalties for a patent used by the company?
  • Could association with a company, current or past, influence a person in a role as editor of a journal section specifically dealing with research and developments in the company's field?
What happens when respected, leading experts, individuals who are the targetted clients of a particulate technology, also advise the companies as consultants and later serve as gate keepers of peer review for what is often company-sponsored research?

My gut tells me that something could happen, despite the obvious integrity of those involved. Arrangements, many of which are not transparent, seem too cosy to generate confidence in the system.

Can anything be done? Perhaps not. 

DNA TYPING - TM USES
To quote from Immucor's 2010 SEC Form 10-K report in discussing Bioarray Solution's DNA technology:
"In many countries, blood pre-transfusion testing is limited to the prevention of transfusion reactions and not for the prevention of alloimmunization, which occurs when antigens foreign to the patient are inadvertently introduced into the patient’s blood system through transfusions. If alloimmunization occurs, the patient develops new antibodies in response to the foreign antigens, thereby complicating future transfusions.
By using multiplex, cost-effective molecular testing, our molecular technology allows testing to prevent alloimmunization for better patient care."
Not unsurprisingly Immucor focuses on preventing alloimmunization, as this use would considerably expand profits. As I noted in the earlier blog: "In a consumer society, if a real need does not exist, companies try to create one."

So what are the legitimate uses of molecular typing to determine blood groups?

Scenarios where DNA typing could prove useful include these scenarios (see Further Reading for more details of each scenario):

1. Recently transfused patients with unexpected antibodies who have two red cell populations.

2. Patients with a positive direct antiglobulin test where available typing antisera reacts only by the indirect antiglobulin test.

3. Fathers of infants carried by Rh negative woman with anti-D where the father is Rh positive.
DNA typing the father for the RhD gene can determine homo- or heterozygosity for D and indicate if the fetus is definitely D+ and should be monitored.
If being D-negative is possible, the fetus should be Rh typed using fetal DNA from cells obtained by amniocentesis or by testing cell-free, fetal-derived DNA in maternal plasma.

If the fetus is Rh negative, mother and fetus do not need to be monitored.
4. Pregnant women who appear to be weak D, in order to differentiate between weak D and partial D, since usually only the latter can make anti-D. Potentially, Rh immune globulin could be given only to females with a D variant who are partial D.

5. Extended phenotype matching of donor blood for patients with sickle cell disease.

The above scenarios are not exactly pressing. Many situations have work-arounds or present limited safety risks to patients. Granted they offer useful adjuncts to serologic testing.

As to the nuts and bolts of pretransfusion compatibility testing, routine ABO and Rh typing do not warrant molecular methods, nor does preventing alloimmunization in general as Immucor would have its investors believe.

WORK FORCE IMPLICATIONS
Although molecular methods for typing red cell antigens are available in some locations, today the technology is mainly used by reference laboratories to supplement traditional serologic typing methods done 'in the trenches'.

Despite good progress, significant practical and scientific limitations remain and the issues are complex, as discussed in the papers in Further Reading. Seltsama and Doescher cover the scientific issues extensively. The 'high-throughput platforms' mentioned by adherents are not quite ready for prime time live in your neighbourhood blood centre and transfusion service.

Thus, work force effects will not be snip-snip, where SNIP is defined as
  • To cut, clip, or separate with short, quick strokes
Rather the SNP cut will be long and slow before staff hemorrhaging begins. But begin it will.

All TM laboratory professionals know that serology is in its last gasps. This is shown by the paucity of immunohematology papers in journals such as Transfusion. For example, December's issue has two and neither deals with red cells.

Rest assured that once 'high-throughput platforms' become widely available for molecular typing, regardless of whether sound scientific rationales exist, antigen phenotyping of all kinds will be taken over by molecular methods. It's simply too seductive, especially with so many TM leaders on side with the program.

As with automation, vendors will justify initial costs or high ongoing maintenance and supply charges (if a 'razor and blade' business model is chosen) with the promise of "reduced headcounts"  -  eliminating jobs for people in the community in favour of sending money to commercial enterprises elsewhere, where corporate profits are the main concern.

'SUGAR PLUM FAIRYLAND'
Seeing as it's the festive season, let's peek into a futuristic world populated by sugar plum fairies. I've mined some stereotypes (hope they bring a chuckle) and all is written with warm goodwill.

Here's the premise. What if companies pushing automation, other high throughput instruments, and information systems to support them have their way and almost every transfusion service laboratory job is eliminated?

In such a fairyland:

DNA typing platforms will match patients with donors for all major blood group antigens and pretransfusion serologic tests will become redundant.

Labs will be staffed by inexpensive 'multi-skilled workers' with no formal qualifications, all supervised by technical specialists (perhaps one per shift) now in a 'leadership role better aligned with their skills'.

Lab technologists / scientists will be free to take a buyout, a generous offer of $100 per year worked. They will, however, be forced to hawk their collection of syringes and tourniquets on street corners to finance a nursing education, which they can now consider since nurses no longer have much patient contact.

Since gowns became de rigeur for personal protection in the lab, they will sport white lab coats and happily be mistaken for physicians who have long claimed the lab coat as their uniform of record despite most never having set foot in a lab (too dark and dingy down in those basements). 

On the clinical side, other technology (bar code scanners, RFID, and the like) will ensure positive patient and donor unit identification. Smiling robots will administer blood transfusions, leaving nurses free to rant about newbie residents and those nitpicking idiots in the lab, have wild sex in the closets, and fantasize about Nurse Jackie one day killing Dr. House.

Yet more technology in the form of biosensors implanted in patients will decide when blood transfusion is warranted using programmed best practice guidelines, determine which components are needed, measure their effectiveness post-transfusion, and communicate all via wifi to a central information system nicknamed Big Bro (BB for short).

TS medical directors will sit in their offices playing on iPads with100s of fun apps all tailored to what Gregory House would be like as a hematologist versus a hematopathologist.
  • On breaks, the wunderkind millennials will tweet each other about how to pay off student loans before retiring.
  • About-to-retire boomers will obsess about stock portfolios.
  • Late Generation Xers will text about how, if they hear once more how great the Beatles and 1960s were, they will throttle their parents.
SMALL MERCIES
In the absence of sugar plum fairies, when reduced serologic antigen phenotyping eventually occurs, the serologic mainstays will remain as they are now, antibody detection and identification. Thank goodness for the immune response. The party's not quite over...."These are still the days, my friends".
Have a well deserved, fun-filled and relaxing holiday season with friends and family. And may the farce be with you....

FURTHER READING

Reid ME. The Rh antigen D: a review for clinicians. Blood Bulletin 2008 Apr; 10(1).

Reid ME. Transfusion in the age of molecular diagnostics. Hematology 2009.

Seltsama A, Doescherb A. Sequence-based typing of human blood groups. Transfus Med Hemother. 2009; 36(3): 204–212. Published online 2009 May 14.

Westhoff CM, Sloan SR. Molecular genotyping in transfusion medicine. Clin Chem 2008;54(12): 1948.

As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 

Tuesday, November 23, 2010

OneMatch, one love - Do you believe in love? (Musings on stem cell & organ donation)

This blog is about the fast approaching so-called 'season of giving' and what we do give vs could give. The title comes from a mix of CBS's OneMatch program and songs by Bob Marley & Cher.

The blog has multiple origins (resources featured in TraQ's monthly newsletter):

Naturally, you're probably thinking, "Oh no, this is going to be a kumbaya feel-good and terminally boring blog. Believe it or not, at a national TM conference in Vancouver a few years ago, after giving a talk on the benefits of sharing TM resources, I invited colleagues on stage to sing this 60s song to the amusement of attendees, not necessarily the buddies I coerced on stage.

Well, if you are thinking the blog is feel-good pap, you are wrong. The blog is not going to stretch the envelope by alluding to the salaries of TM executives and risk alienating colleagues, but it is going to be relatively short and not particularly sweet.

Show me the money
Let's begin with how much money you are going to spend for the coming holidays:

  • Does your workplace have a gift exchange where you buy each other inexpensive 'giftoids' (maximum $10 or $20) that you struggle to make as untacky as possible?
  • Will you travel to ski on slopes covered with powder snow or to lie in the sun on white sand beside a blue-green ocean?
  • Will your friends and relatives get gifts they can live without?
  • Some or all of the above?
Here's an alternative. This holiday season, why not resolve to give someone a gift that they cannot live without? More specifically:
  • Your organs when you die - and most of us never know when
  • An organ, or part of one you can spare, while alive
  • The easiest gift of all, your stem cells
As a fall back, you can always donate blood. That's good, but you can do so much more.
IDEAS

  1. Instead of a gift exchange at work, hold a blood drive challenge or stem cell sign-up and see who donates or registers more ('oldies' vs under 45s; XYs vs XXs; etc.)
  2. Take the plunge and sign up to be a stem cell donor. In Canada, register at OneMatch; in the UK, British Bone Marrow Registry; in Australia, ABMDR; in New Zealand, NZBMDR; in USA, NMDP.
  3. No matter where you live, watch this CBS video with your family, friends, or co-workers. Hear Shamir and OneMatch staff explain it all (~9 mins well spent - you probably spend more time on a toilet break)
Think you know it all? Just how knowledgeable are you?

BOTTOM LINES

No matter where you live, you can:
  • Specify organ donations in your will;
  • Discuss the donating issues and your wishes with your family so they don't cop out when the time comes and they are grieving;
  • Become a stem cell donor while alive and an organ donor when you die.
Let's face it. If you are a TM health professional, you and your family likely have a lot and you may have heard of this biblical verse (paraphrased):
  • To whom much is given, much shall be required. -- Luke 12:48
By joining a stem cell registry, you could be THE ONE - a donor who saves the life of a fellow human being anywhere in the world. Most registries are networked.

If you are too old or have health issues that disqualify you, why not talk to your children and grandkids about becoming stem cell and organ donors?

Of course, you could do nothing and celebrate the holidays as usual.

But why not show those you care about - and yourself - who you really are? Cut the rationalization crap and JUST DO IT!

Now for the songs in the blog's title....

  • One love (wonderful video of Bob Marley's classic)
  • Believe (Cher in 1998 at age 52 - one of the best selling singles of all time - Get your dancing shoes on!)
And if you think the blog was too sweet after all, see
  • Kumbaya (What many consider a cliche, sung by Joan Baez, one of my heroes from the 60s, and a fabulous voice even if you lean towards the bubba and redneck end of the political spectrum)
Resources
As always the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 

Saturday, October 23, 2010

'Get back' Jo Jo (Musings on cognitive dissonance)

This blog is about competing blood safety standards and a current conflict that caused me to muse on cognitive dissonance. The title comes from a catchy 1969 Beatles song with silly lyrics.

Cognitive dissonance (CD) is a fascinating thing. I've experienced it several times over the years, ie., the uncomfortable mental conflict that arises when holding incongruous beliefs simultaneously. An example is the conflict that many nicotine addicts feel knowing that smoking is bad for them, yet at the same time managing to convince themselves that it is not that bad, even believing it is "good" for them in some ways (e.g., helps to cope with stress, fit in with peers, etc.)

Currently I'm experiencing CD that started with the
The letter requests a meeting to discuss AABB's concern about TJC's creation of a separate set of blood standards for hospitals. Excerpts:

"AABB was both surprised and dismayed to see that The Joint Commission has determined not to incorporate AABB standards into its most recent proposed standards, but rather to draft a separate set of blood standards applicable to hospitals accredited under The Joint Commission's laboratory accreditation program."

"We do strongly believe that the proliferation of overlapping, but potentially divergent, standards for transfusion services and blood banks is a disservice to hospitals and will actually decrease patient safety as hospitals work to adhere to two separate sets of standards. Further, the time and resources that will be required to ensure that the proposed standards do accurately reflect AABB standards, now, and in the future, are significant."
As mentioned in the letter, AABB standards have existed since 1958 and are widely adopted within the USA and worldwide. I do not know why TJC decided to set up another set of blood standards that do not incorporate AABB standards. The US blood bank community already has an array of compulsory government regulators and voluntary accrediting bodies, including FDA / CBER, AABB, CAP, FACT, and TJC.

That said, regarding the new TJC regulations and their impact on hospital laboratories, AABB-accredited or not, I have no idea about the range of opinions that may exist within the USA. Nor will I wade into the morass of competing blood standards and regulations in the US.

COGNITIVE DISSONANCE
Instead, this blog muses on the cognitive dissonance that unexpectedly occurred after reading the AABB's TJC letter.
For those who do not know, TJC operates accreditation programs for a fee to subscriber hospitals and other health care organizations (> 17,000). Most state governments recognize TJC accreditation as a condition of licensure and Medicaid (health program for low income individuals / families) reimbursement. Like all voluntary accrediting organizations, AABB also charges users for its inspection and accreditation services.
The two competing thoughts:

  • Thought "A": AABB standards are exemplary and, of course, AABB is right in saying, "What the hey! Slow down and reconsider these new TJC standards. This is nuts and could harm patients!" They said it more respectfully, of course, but that's the core message.
  • Thought "B": Yes, all that's true, but AABB has a big investment in its standards and a vested interest in preventing anything that threatens to undermine their primacy. Many of its activities revolve around standards, especially the standards and associated accreditation activities, as well as AABB Consulting
Indeed, standards are arguably the AABB's prime line of business, more important than its role as a professional association. The AABB standards are its main brand. Think of AABB and what do you think of? Standards. If American, think of blood safety standards and what comes to mind? The AABB. Even its mission statement incorporates the term standards:
  • AABB advances the practice and standards of transfusion medicine and cellular therapies to optimize patient and donor care and safety.
In a nutshell:

  • Thought A: AABB is clearly right and has the moral high ground because it's fighting for patient safety.
  • Thought B: AABB is motivated by self-interest and fighting for survival of its main business line.
What to do with the cognitive dissonance that arises? CD theory proposes many ways to reduce CD. Dilbert has several CD-related beauties:
The coping mechanisms in the Dilbert cartoons are discussed in

So, let's see. I could reduce dissonance by thinking as follows (a few examples, some tongue in cheek):
  • "AABB may be motivated by self interest, but it does such good work, I don't care."
  • "TJC is out of line, dead wrong." (I don't know TJC's rationales and would like to hear its viewpoint first.)
  • "AABB does good work. But what it proposes is in its self interest and has to be taken with a huge grain of salt."
  • "TJC is a good organization. It must know what it's doing. I just don't know what the justification is yet."
  • "AABB has jumped at the chance to accredit everything going. It wants to dominate the TM standards world, evidenced by removal of 'American' and 'blood banks' from the name. They are power hungry and will fight to the last standard standing."
For now, the questions remain. Which position is closest to the truth? Who cares? Should we all care?

CANADA

Interestingly, for years the Canadian Society for Transfusion Medicine has produced
In 2004 the Canadian Standards Association came out with a new set of blood standards, revised in 2010:
This resulted in the need for CSTM to revise its standards to incorporate CSA standards. So with TJC and AABB, some aspects seems like deja vu all over again (to quote Yogi Berra).

At the time I wrote about the impact on hospital transfusion services:

Excerpts:

  • "While regulations and standards share many similarities, they differ in one fundamental respect: regulations apply standards through the force of law and provide penalties for noncompliance. Standards, in and of themselves, are never legislative tools. To have the force of law, standards must be incorporated into the regulations.
  • Health Canada is currently developing new regulations specific to blood and blood components intended for transfusion under the Food and Drugs Act. Health Canada will use CSA Standards as one of several tools employed to develop new federal regulations for blood and blood components. Based on the Standards, a goal of the proposed regulations is to outline clear and intelligible requirements, allowing for timely updating as new technologies / products / issues emerge, and achieving greater harmonization in Canada related to blood collection, handling and post-market surveillance.
  • A review of Z902-04 is currently underway [ by Health Canada] to determine which parts can be referenced in the new regulations. Some sections of the standards fall outside of Health Canada’s jurisdiction and will not be referenced in the new regulations."
Tidbits:
  • Since the 2004 article was written, CSA Z902-04 has come and gone, replaced by CSA Z902-10, and still no regulations for hospital transfusion services have materialized from Health Canada.
  • CSTM is a relatively small organization yet has had to invest much time and energy to revise CSTM Standards for Hospital Transfusion Services to comply with CSA Z902-10.
Where does all this leave organizations that had been using CSTM Standards? Where does it leave the CSTM Standards?

BOTTOM LINE

In the USA, AABB is 'dismayed' that TJC chose not to incorporate AABB standards into its most recent proposed standards and strongly believes that proliferation of overlapping, potentially divergent, blood standards is a disservice to hospitals and will decrease patient safety.
  • Is AABB clearly right? Does it have the moral high ground because it's fighting for patient safety?
  • Or is AABB motivated by self-interest and fighting for survival of its main business line?
  • Are both statements true?
  • Does any of this matter?
Readers can decide for themselves. Perhaps the issues will become clearer as events unfold.

But it's obvious that anyone with AABB accreditation (nearly 2000 institutions, the vast majority in the USA, and no doubt including all of the large transfusion service laboratories) - and any institution thinking of becoming accredited - would be unhappy to say the least. If unchanged, TJC's action will cost AABB-accredited institutions time and energy that could be better spent elsewhere.

In the meantime, the song that comes to mind is this irreverent Beatle ditty, sung here by Paul McCartney in live performance:
Maybe The Joint Commission ('Jo Jo') should get back to where it once belonged?

And for a fun change of pace, since summer has come to an end, at least in my corner of the globe, from André Rieu's 2004 concert in Cortona, Tuscany, a lovely version of

  • The Rose (Carmen Monarca, Carla Malfioletti, and Suzan Erens)
As always, the views are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice.