If you could read my mind (Musings on hard-to-believe TM news)

Updated: 7 July 2014

June's blog is another take-off on cartoonist Gary Clement's weekly feature, 'Week in Review' in Canada's National Post, e.g., Week of May 18-24, 2014. They capture the week's news with a smile.

The blog's title derives from an old Gordon Lightfoot song that has been covered by many artists.

Topics include an eclectic selection of recent news items in TraQ's newsletter. All four have a whiff of unbelievability. Since some aspects seem unbelievable, my treatment of the stories is irreverent.

Also see my latest BBTS blog:

• Do you believe? (Musings on cloud-based software services by a transfusion medicine techno heretic)

1. This is kinda gross (and does it work?)

• India: Goat blood enema used to help treat thalassemia patients (8 June 2014) 

The principal investigator said the enemas ensure hemoglobin levels do not go down drastically and research has proved it. Cases existed in which patient blood transfusion needs were reduced to half or even less.

I couldn't find the research in PubMed, but, if you can, let me know. Patient blood management is the flavour of the year as evidenced by the number of papers in TM journals and May's issue of AABB News:

• 'Patient blood management hits prime time' (Content under 'Departments' in left menu is free)

According to the CEO message, AABB recently published Standards for a Patient Blood Management Program plus launched a new PBM consulting program. Indeed, no doubt smelling the ka-ching potential, AABB created a new PBM section on its website.

Perhaps all the blood management consultants aiming to make big bucks should wake up and smell the sheep dung?

2. This is turning a blind eye (or protecting one's butt?)

• Australia: NBA downplays Jehovah's Witness not declaring potential conflicts of interest to sit on transfusion guidelines panel (2 June 2014)

Australia's National Blood Authority (NBA), a well respected government organization that does much valuable work, appointed Shannon Farmer, a Jehovah's Witness, as the key consumer representative on a government panel developing new transfusion guidelines for Australia's hospitals. Nil inappropriate about that except Mr. Farmer didn't declare

• Formally, or otherwise it seems, that he was a Jehovah's Witness. 

• His consultancy work since 2007 to an Austrian business involved in commercial tendering for patient blood management projects around the world.

• Receiving fees for consulting and lecturing from multinational pharmaceutical companies,e.g., J and J.

When informed, the NBA said it would review the details. Whether or not possible conflicting interests are of "sufficient conflict" is a moot point. 

Fact is they were not declared and at the time of his appointment Farmer was described as "consumer" and "independent consumer advocate". An NBA spokesperson is quoted as saying, "The NBA believes any potential conflict of interest, real or perceived, should be declared."

So far as I can tell Shannon Farmer is not a physician nor a PhD researcher, yet:

• He's an Adjunct Research Fellow, School of Surgery, at the University of Western Australia, where he's listed as an author on multi-authored papers about blood. 
• LinkedIn shows he's an Adjunct Senior Research Fellow Centre for Population Health Research, Curtin University.
• He's lectured extensively on bloodless surgery and blood conservation.  
• He's apparently an expert on transfusion medicine.

Yet it's hard to discover which degrees he has, where he went to school, or any of the normal qualifications of someone who's an author, lecturer, and expert on TM, with university appointments.

And none of the above profiles even hint that he's consulted for years to Austria's 'Medicine and Economics' business involved in commercial patient blood management projects globally.

How can you not know that someone you appoint to panels developing national blood transfusion guidelines is a member of a religion that forbids transfusion and earns big bucks implementing blood management programs internationally? How can you say, when information comes to light, 'These aren't sufficient conflicts'?

Isn't this equivalent to someone being appointed to a government panel on the future of private laboratories in Alberta (Canada, UK, you name it)

• Who is a member of a political party whose policies are pro-private medicine (pro-private everything)?
• Who consults for (perhaps partially owns) a private laboratory consortium bidding for government contracts?

Sorry, the non-physician Jehovah's Witness as TM expert and global blood management consultant who advises on transfusion guidelines, didn't declare potential conflicts, makes millions off blood management, and was initially listed as a consumer and consumer advocate doesn't meet the sniff test. 

Or...he's a fine fellow, does good work, and the NBA thinks it's okay that he didn't declare potential conflicts, despite their policies, because the conflicts are not serious ones?

3. This is glimpse into murky reality of paid plasma (and is it real?)

• USA: Twisted business of donating plasma for money (28 May 2014)

You know from past blogs that I'm against paid plasma clinics in Canada. But this account of paid plasma centers in the United States seems unbelievable. Examples (paraphrased):

Albuquerque's Yale Plasma, on a strip where panhandlers convene, resembles a pawn shop. 

CSL Plasma has no chairs. Donors crouch on the floor or stand in long lines until they plass. Asking a young man if he minded squatting, I’m told CSL removed the complementary seating to “keep the bums out of here.”

[Yale Plasma is part of DCI Biologicals. The center (pic via Google) is close to both a university and community college. Note 'Earn Big Cash' in window.]

Ron, an unemployed schoolteacher began regularly plassing 6 years ago to make ends meet for his new son. He was disqualified at a local center because he had many visible tattoos but accepted at another “that was less picky.”

At a CSL center “Bubba” said he was homeless and an alcoholic and had been plassing for nearly 15 years with no ill effects other than "sometimes my arm hurts really bad." He says he was unhappy when he drank too much to pass the protein level test, but claimed he later discovered, “If I swallow ketchup before going in I can pass any test they throw at me.”

For interest CSL is Australia’s chosen national plasma fractionator and under contract to Australia’s NBA.

This report of paid plasma centers seems unbelievable. Tattoos, donors crouching on floors, 'Bubbas' swallowing ketchup and thinking it tricks tests to measure plasma protein levels? On the other hand, You can't make this stuff up. Real life trumps fiction?

4. This is how to discourage feedback (mimics Health Canada on how to get feedback on paid plasma?)

The Canadian Standards Association (CSA) recently sent a notice via the CSTM that it seeks feedback on

•  Blood and Blood Components, Draft 3rd ed. (Public review to 25 July, 2014)

I assume that when health or government organizations want feedback on things like transfusion guidelines, they make it easy for users since professionals are busy people. Whenever giving feedback is more difficult that it need be, several possibilities exist:

1. Feedback isn't really wanted. 
2. Feedback is wanted but the organization's convenience is placed above that of the users from whom feedback is asked.
3. Those responsible for obtaining feedback for the organization are incompetent.

How does the way the CSA asked for feedback on Blood and Blood Components, Draft 3rd ed. strike you? Here's what I experienced:

First, the CSA notice of the third draft (dated 15 May 2014) and how to access it, was sent to CSTM members on 28 May 2014. How the 2-week delay occurred is unknown (but not critical).

Second, to access the draft, you must register (provide a valid e-mail address and password).

Third, you must confirm your e-mail address. This allows you to access and print your comments and to resume commenting later.

Fourth, presumably your identity can be tracked. If curious, CSA has a Privacy policy but it requires work to find:

• Find and then click on Terms of Use, which is at the bottom of the page, then scroll all the way to the bottom of the next page to the last paragraph and click on Privacy:
• With respect to the collection, use and disclosure of personally identifiable information, please see Privacy.  By using the Site, you consent to having CSA Group contact you in connection with additional draft standards that may be available at the Site. If you do not wish to be contacted, you may opt out by sending an email publicreview2@csa.ca. If you choose to opt out, you may lose some of benefits of which are associated with use of the Site.

Then on the NEXT (now 3rd page), you get to CSA Group Web Site Privacy Statement.

Fifth, there is no way to download the entire document. Instead you must access each section of the document on the website and submit comments separately for each of 23 sections, plus 5 tables and 2 annexes. And each section has multiple parts and sub-parts. 

As an example, section 4 alone (General) has spots for ~90 Comments, each of which must be clicked on to submit comments. Hmmm.... 

• Alert: Expect digit finger to suffer from repetitive stress injury. Feel free to bill CSA for any lost productivity or needed splints? 

Sixth, apparently 60 days is the time used by CSA for obtaining feedback. But having the 60 days occur in June and July when many Canadians are on vacation seems perverse. 

Do you believe CSA truly wants maximum input from users into its blood standards? If yes, then possibility 2 or 3 above must be in play, ie., either it's all about them (not you) or they're incompetent.

Perhaps Health Canada is the role model for CSA? We know how HC tried its best to get feedback from Canadians on paid plasma clinics: 

• Day tripper (Musings on HC's instructions to the jury on paid plasma)

Added 7 July 2014
Anonymous (see below) added an update to Canada's paid plasma saga:

• Re-elected Ontario govt plans to ban paid plasma clinics

It's a battle of the pro-business federal Conservatives with Canadian Blood Services and Health Canada as their surrogate poodles.

I'm aware of the case for paid plasma but it's wrong for Canada. If paid plasma is good, why not paid red cells, stem cells, and organs like kidneys, etc.

And don't bring up the Cangene case in Winnipeg where paid plasma has long existed. I was there (Canadian Red Cross) at the beginning. Paying women for their plasma containing potent anti-D, who had fetuses die of Rh hemolytic disease of the fetus and newborn, is so NOT like paid plasma clinics in the USA and what Canadian clones propose by setting up shop next to homeless shelters.

FOR FUN
Some aspects of each item seem unbelievable:

• Goat blood enemas are effective in preventing anemia in thalassemia patients?
• Australia's NBA didn't know about potential conflicts of a key consumer rep on a government panel developing transfusion guidelines and then didn't care?
• Paid plasma clinics in the USA, one of which (CSL Behring) is a major supplier to Australia's NBA, 'plasses' homeless alcoholics and offers no chairs for donors waiting to be bled?
• Canada's CSA wants input so much it opts for feedback on the 3rd ed. of Blood and Blood Components that requires users to give feedback over June and July and enter data into 100s and 100s of web-based forms? 

What do you think about all this? For me, a song by Canada's Gordon Lightfoot comes to mind:

• If you could read my mind 

If you could read my mind, love
What a tale my thoughts could tell....

As usual, comments are most welcome.

'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

• AABB Letter to The Joint Commission Regarding Proposed Blood Transfusion Service and Donor Center Standards

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:

• CD cartoons
• My favorite

The coping mechanisms in the Dilbert cartoons are discussed in

• Fighting cognitive dissonance & the lies we tell ourselves

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

• CSTM blood safety standards

In 2004 the Canadian Standards Association came out with a new set of blood standards, revised in 2010:

• CSA Standards for Blood and Blood Components Z902-10

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:

• CSA Standards Z902-04: implications and issues

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:

• Get back

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.