The long and winding road (Musings on 30 years of transfusion-associated AIDS)

Updated: 13 Dec. 2013

AABB's Transfusion for October 2013 is a themed issue.

• Thirty years of progress since recognition of transfusion-associated AIDS

Since few transfusion professional will probably read, let alone scan, all 238 pages, this blog will review the two items (among several gems) that I found most interesting, a commentary and a letter to the editor from authors in Brazil.    

• Dubin C, Francis D. Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic. Transfusion 2013 Oct;53(10 Pt 2):2359-64. (Commentary)   
• Salles NA, Levi JE, Barreto CC, Sampaio LP, Romano CM, Sabino EC, Júnior AM. Human immunodeficiency virus transfusion transmission despite nucleic acid testing. Transfusion 2013 Oct;53(10 Pt 2):2593-5. (Letter)  

The blog's title derives from a 1970 Beatles tune. But why blog about an old transfusion issue like HIV/AIDS? I can see some of you yawning. After all, our blood supply in developed nations is the safest it's ever been.

We in the transfusion medicine community can congratulate ourselves on how safe we have made blood from viruses like HIV, HBV, HCV, and WNV. Fact is, we often do. 

Now the main threats for fortunate us exist elsewhere. As but two examples, transfusing an incorrect blood group (due to patient misidentification) and transfusing the wrong blood product (perhaps due to clinician lack of knowledge or communication errors between hospital departments).

Why blog on HIV/AIDS?

1. Because AIDS was in the news 30 years ago, it follows that health professionals age 45 or younger were children at the time and unlikely to be aware of HIV and AIDS.

2. We're told by transfusion experts that the era of transfusion transmitted infections is all but over due to these reasons:

• Better pre-donation screening
• Almost foolproof donor testing for infectious diseases
• Manufacturing processes such as viral inactivation and filtration

But it's not. Besides the situation in the 'third world' in which governments cannot afford expensive tests and do not have the infrastructure to support them, human and systemic errors happen, infectious disease tests are not 100% sensitive, and donors may lie about risky behavior on predonation screening questions.

3. Significant historical events should be acknowledged as a sign of respect.

4. George Santayana got it right: Those who cannot remember the past are condemned to repeat it.

DISCLOSURE: Be aware, what follows is not always politically correct. I mean no disrespect but will call 'em as I see 'em (or recall 'em). Also, the content is highly selective based on my biases. Lastly, there's more than a few 'tacky' aspects to the so-called tainted blood tragedy. Have barf bags handy.

For interest, the Transfusion special issue features 6 papers on HIV (from China, Hong Kong, Germany, South Africa, Zimbabwe, and the International NAT study Group). Also included are 7 papers on hepatitis, 4 on NAT, and 4 on other viruses.

BACKGROUND
A brief trip down memory lane... My early days at Canadian Red Cross were pre-AIDS. Then we screened blood donors only for syphilis and later the hepatitis B surface antigen (HBsAg). The 'good old days' of farcical government regulation, no SOPs. Training was sort of like the long-standing medical school model:

•  See one, Do one, Teach one.

Early infectious disease tests were far from perfect. For example, I have fond memories (nightmares at the time) of trying to visualize the white precipitin lines of positive HBsAg reactions between donor serum and anti-HBs wells after counterimmunoelectropheresis (CIEP). CIEP was a  'second generation' test that was the first test used to mass screen blood donors for hepatitis. To say such tests were subjective is an understatement.

HIV / AIDS ERA
A few historical highlights / lowlights:

1981: Then came AIDS, first reported as 'gay-related immune deficiency' (GRID) in 1981, and soon identified in sex workers, Haitians in the USA, and IV drug users. Cause unknown.

1982: The term AIDS first appeared when it was used by the CDC to describe a disease affecting the immune system. Cause unknown.

1982: Evidence for a blood-borne pathogen transmitted by transfusion emerged when reports of AIDS were reported in 3 hemophilia A patients who were heterosexual, had no other known risk factors, and were frequently transfused with Factor VIII concentrate. Cause unknown.

1984: The US government held a press conference to announce that Robert Gallo, a National Cancer Institute scientist, had discovered the cause of AIDS, which he named HTLV-III, and had invented a screening test worth mega-bucks.

1983: In truth the French research team of Luc Montagnier (who later delved into quackery) discovered HIV a year earlier and had sent Gallo a sample to investigate. They called it lymphadenopathy-associated virus (LAV). 

1984: Gaëtan Dugas dies. He was a French Canadian flight attendant linked by CDC to 40 of the first 248 reported cases of AIDS in USA, purported to be 'patient zero', a claim later disputed.

• The Appalling Saga of Patient Zero (Time Magazine, June 24, 2001)
• AIDS - The truth about 'patient zero' (Toronto Star, May 6, 2013)

1985: Once it became known that Ryan White, a hemophiliac, had contracted AIDS from a blood transfusion, school officials banned him from classes. Ryan died of AIDS at age 18 in 1990.

1985: US President Reagan, he of 'win one for the Gipper' fame, first used the word AIDS, expressing skepticism in allowing children with AIDS to continue in school although he supported their right to do so.

1985: Blood donor tests for HIV began in USA, Canada and elsewhere.

1985: The Pasteur Institute filed a lawsuit against the National Cancer Institute to claim a share of the royalties from the NCI's patented AIDS test.

1986: HIV is adopted as name of the virus that causes AIDS.

1994: The battle for patent rights to the HIV test lasted for more than a decade and ultimately favored the French claim, although all decided to play nicey-nicey in the end.

2008: Montagnier and Françoise Barré-Sinoussi shared the 2008 Nobel Prize in Medicine and Physiology for the discovery of HIV (along with  Harald zur Hausen, who discovered that human papilloma viruses can cause cervical cancer). Gallo was frozen out.

• Was Robert Gallo robbed of the Nobel Prize?

See amfAR for an interesting review of AIDS, 1981-2011.

TRANSFUSION'S SPECIAL ISSUE

My take on this commentary, written from a USA perspective, but applicable everywhere:

Dubin C, Francis D. Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic. Transfusion 2013 Oct;53(10 Pt 2):2359-64.  (Commentary) 

I love that AABB included a commentary by Cory Dubin and Dr. Donald Francis. Kudos!

• Corey Dubin is President of the Committee of Ten Thousand and also serves on the FDA's BPAC. Also see this 1996 interview: Blood, money and AIDS: Hemophiliacs are split. Liability cases bogged down in disputes
• Dr. Don Francis now sits on the Board of Global Solutions for Infectious Diseases. His work while at CDC on HIV/AIDS was chronicled in Randy Shilts' book, And the Band Played On. (You can rent the film. Well worth it.)

A few selected excerpts from Closing the circle: a thirty-year retrospective on the AIDS/blood epidemic (which I've condensed):

AIDS devastated 4 generations of families with hemophilia. But the real story predates HIV/AIDS. Pharmaceutical firms are required to manufacture safe biologics, yet the blood community remained indifferent to the presence of hepatitis in the blood supply for decades.

That indifference set the stage for the HIV/AIDS catastrophe. It was as if a 'collective denial' spread through the blood community. Despite warning signals, the system allowed dangerous practices such as collecting plasma from prisoners and importing plasma from undeveloped countries. Plasma collection in prisons did not end until 1993. 

In hemophilia, factor concentrates were the 'Golden Goose' that revolutionized treatment. Concentrates brought independence from hospitals and convenient treatment. 

Widespread denial blinded the entire blood system. The CDC warned the blood community, but inertia prevailed. What followed was one of the worst medical disasters in history.

Authors' take home message
In 2013, 30 years after transfusion-associated HIV/AIDS was confirmed, we must not become complacent due to improved regulations and scientific gains. We must resist the influence of conflict of interest while rejecting the scientific and medical arrogance that contributed to the AIDS/blood epidemic. We must never forget the human cost. We must prepare for the unexpected and unforeseen.

MUSINGS

* Because Factor VIII concentrates were a god-send to patients with hemophilia, physicians kept transfusing the product, even realizing the danger, because they

(1) Thought most hemophiliacs were already infected (2) Believed the alternative was patients potentially bleeding to death

* Physicians were in denial about HIV / AIDS in the blood system, illustrated in this interview with Dr. Noel Buskard of Canadian Red Cross (Sorry about the short ads). Quote: Physicians and hemophiliacs must weight the cost benefit ratio in every therapy - If I give you an aspirin there is a risk...

* Canada's Krever Report makes it clear that transfusion experts, however well motivated, screwed up, big time.

The slowness in taking appropriate measures to prevent the contamination of the blood supply was largely due to experts rejecting, or at least not accepting, an important tenet of the precautionary principle.
When there was reasonable evidence that serious infectious diseases could be transmitted by blood, the principal actors in the blood supply system in Canada refrained from taking essential preventive measures until causation had been proved with scientific certainty. The result was a national public health disaster.

Best line from the Dubin and Francis commentary:
We must resist the influence of conflict of interest while rejecting the scientific and medical arrogance that contributed to the AIDS/blood epidemic.

Now to the themed issue's letter to the editor in Transfusion:

* Salles NA, Levi JE, Barreto CC, Sampaio LP, Romano CM, Sabino EC, Júnior AM. Human immunodeficiency virus transfusion transmission despite nucleic acid testing. Transfusion 2013 Oct;53(10 Pt 2):2593-5.     

Key facts: * The risk of HIV transmission by blood transfusion in a blood center in São Paulo, Brazil was estimated to be 0.68 per 100,000 donations [6.8/million] using nucleic acid testing (NAT) on minipools of six donations. 

[For reference, in Canada the residual risk of HIV is 1 per 8 million donations, where residual risk is estimated as the incidence multiplied by the window period.]

* In November 2012, a leukemia patient became HIV-positive after 47 transfusions of RBCs and platelets. Upon follow-up, one donor was found to be HIV positive, with a pattern that suggested he likely donated a few days after becoming infected.

* The donor had denied all risk factors in the interview when donating and continued to deny high-risk behavior in 3 subsequent visits to the blood bank, even after his HIV status was disclosed to him. He also did not self-defer by confidential unit exclusion before the implicated donation.

* The literature has several reports of transfusion-transmitted HIV in the NAT-negative window period, although this case may have the lowest documented viral load.

* This case shows that even individual NAT (not pools of 6 donors) by the most sensitive methods available might not detect HIV. Thus, we must to continue to understand motivations for blood donation and publicize the risk of donating shortly after risky behaviors.

MUSINGS
Blood donors lie and infectious disease screening test are not perfect. HIV windows of negativity still exist no matter how short. Transfusion-associated HIV is extremely rare. But if it's you or a loved one who becomes infected, you don't care how rare it is.

Transfusion professionals must resist becoming blasé about how protected the blood supply in developed countries is from HIV and other infectious agents. Unfortunately, many are blasé.

For example, in Canada we have Health Canada and the CEO of CBS saying that paid plasma donation is no big deal because infectious disease screening tests and manufacturing processes used to produce plasma derivatives like IVIg are foolproof.

As an aside, on a related issue in 2013 Health Canada decided to allow men to donate blood if they haven't had sex with a man in the last five years. 

For years the gay community has campaigned to drop the permanent ban on blood donation for MSM donors on the grounds the ban is unscientific and discriminates. 

CBS's Public Affairs put out an interview with Dr. Dana Devine, Vice President, Medical, Scientific & Research Affairs on the changed MSM policy.  She noted that it will take years to gather valid data set to evaluate impact of changed policy on blood safety as incidence of HIV+ donors is extremely low. 

The geek in me wants to suggest it's a matter of statistical power: The ability of a study to detect a real difference, if one exists. Power is affected by how big the difference is and sample size. If a difference is big, it's easier to detect. And large sample sizes make a real difference easier to detect .

I'll end on a personal note with a newspaper article that appeared in the Toronto Star, Feb. 18, 2006 but is no longer online. I hope the Star doesn't mind that I've reproduced it. 

• ©Toronto Star: `It's a fear that plays on all of us' 

When I worked at Canadian Red Cross in Winnipeg, Barry and Ed Kubin would drop by periodically to pick up cryoprecipitate and, later, Factor VIII concentrate.

FOR FUN
Admittedly, it's hard to say 'for fun' on an issue that has devastated so many. But please enjoy this 1970 ditty by The Beatles, the last one released shortly after they broke up and while all 4 were alive. 

* The Long and winding road (Paul McCartney and The Beatles)

As always, comments are welcome.

Lest we forget (Musings on accountability of national blood suppliers)

Updated 12 Nov. 2013

This month's blog was completed on November 11, 2013, known as Remembrance Day in Commonwealth countries and commemorated on this day because the Great War ended in 1918 at the '11th hour of the 11th day of the 11th month'. Hence its title, Lest we forget. 

I started a draft of the blog after reading CBS's 2013 Report to Canadians (published 4 Oct.). Like issues of AABB's Transfusion, it became bathroom reading.  Initially the blog was going to be a few miscellaneous musings and questions on tidbits that struck me. As usual, I hoped a theme would magically emerge by publication date. 

Then on Oct. 28, 2013 independent performance review of CBS by Ernst & Young was released, which answered some questions. CBS also posted a management response to the performance review.

That's when the blog's focus became clear. The annual report and performance review were about accountability, something we should never forget.  It's self-evident that organizations and health professionals on the public payroll need to be accountable. To whom and for what is the stuff of cliches and open to discussion, if not debate.

So.....If you're 'into' transfusion medicine and blood banking, these reports are loaded with goodies worth reading. 

Even if 'you're not just that into blood suppliers,' the CBS report and performance review provide a banquet of food for thought.

I hope it relates no matter where you live. For comparison to other nations with publicly funded blood suppliers, see

• Australian Red Cross Blood Service Report, 2011-12
• NHS Blood and Transplant Report, 2012/13

What follows are my musings on a few selected aspects of the CBS report and performance review, the 'goodies' I find most fascinating or amusing (she said with an evil grin). Read on if you too are curious about 

• How it's efficiencies über alles when it comes to reducing staff costs by consolidating testing and production, outsourcing, decreasing staff and hiring less qualified ones
• Not so much emphasis on efficiency when it comes to executive compensation
• How much it costs to produce transfusable products 
• Cost and trends for plasma-derived products such as immunoglobulins

Before beginning, as the review notes, kudos to CBS, which has successfully:

• Regained public and stakeholder trust in the blood supply 
• Implemented safety procedures and tests resulting in a blood system where safety aligns with international leading practices 
• Increased stakeholder engagement and transparency through open Board meetings, national and regional liaison committees

Transparency remains an issue but, compared to others, CBS bares its inner goings-on admirably. We are the champions...

SMALL POTATOES NIT-PICKING
First, as a webmaster I can't help but notice that when you go to the CBS website, it takes 4 clicks to get to the Report's entry page. And, unless you notice the menu at the top, it's a whopping 15 more 'Next' clicks to get to the Financial Report entry page, where you can select several versions of the 'nitty-gritty' such as

• Management analysis (pp. 24-63)

Wow, that was hard work! Didn't see the menu the first go-round. 

CBS BACKGROUND FACTS
Canada is the world's second largest country by land mass with a population of ~ 35 million, mostly concentrated near the USA border.

To serve this population and geographical area (excluding Quebec), CBS currently has (graphic, p.30 of annual report)

• 42 permanent collection sites
• 2 blood testing facilities 
• 10 manufacturing facilities (4 were axed - 'consolidated' - in 2012-13 with more scheduled to close in the future)

CBS

• Operates with ~4,700 staff and 17,000 volunteers
• Collects ~ 1 million units of whole blood and apheresis donations annually
• Has a budget of ~$1 billion paid for by Canadian tax payers

BUSINESS LINES
CBS has these business lines:

• Transfusable Products (RBC, platelets, plasma)
• Plasma Protein Products (also transfusable, but what the hey)
• Diagnostic Services
• Stem Cells
• Organs and Tissues

Only the first three will be mentioned in the blog. 

Now the good stuff, an 'executive version' through the filter of my biases.

1. STAFFING, EFFICIENCIES, COSTS, PRODUCTIVITY

Staff

Full-time equivalent positions (FTEs) decreased by ~124 FTEs, within the Transfusable Products program, which contributed to $22 million of efficiencies. 

CBS reports staff costs as $276,824,000 or ~58% of total costs.
Presumably this does not include executive compensation. 

Staff costs are often cited as higher than 58% but it's hard to compare workplaces. Regardless, staffing usually constitutes the highest cost, so employers continue to eliminate well educated staff and look for cheaper, invariably less well trained, workers. 

Efficiencies

Under the umbrella of efficiencies, every year CBS decreases the number of staff, hires less trained, cheaper staff, and considers outsourcing. It's a big deal. For example, the CBS performance review mentioned 

• Efficiency 93x, efficiencies 25x, efficient 8x. Total=126

In its response to the performance review, CBS mentioned 

• Efficiency 50x, efficiencies 43x, efficient 5x. Total=98

In fairness, the review mentioned the motherhood issue of safety 226 times. 

Cost

Of course, cost is closely related to efficiency. The performance review mentioned it 747 times. Which more or less reveals the performance review's priority, decreasing government costs. Judging by mentions ('hits' in search term parlance), cost is more than 3 times as important as safety.

The review's Recommendation #23: 

'CBS should continue to explore opportunities to optimize staff mix by implementing the use of donor care associates.'

The CBS response

CSB acknowledges that the largest cost driver in the collections function is staff costs.....CBS will continue to review its staff mix and optimize where viable. 

The Donor Care Associates role has been piloted ....and Health Canada approved this role in April 2013. The organization is planning to further implement the Donor Care Associates role over the coming fiscal years.

The CBS website explains the purpose of hiring 'donor care associates' and training them: The strategy is to better align skills and knowledge of staff to the requirements of the clinic functions. 

Oh yah. Aligning staff skills and knowledge to functions is what it's all about, meaning hiring cheaper staff, similar to right sizing, biz jargon for layoffs, firings, or, less toxic, not filling vacant positions when staff leave or retire. But not less toxic to remaining staff who must do more with less and suffer burnout as a result.

Productivity

The review claims that, while CBS has improved its productivity, measured by labour hours per unit, by 5% since 2008-09:

CBS remains less productive than comparable blood services organizations in donor recruitment and production and distribution processes. 

Higher staff costs account for most of the difference in whole blood clinic costs compared to 2 of the 3 other blood service organizations reviewed. 

Approximately 75% of CBS employees are unionized.

The 3 comparable blood organizations reviewed remain a mystery, but surely one is Canada's Héma-Québec, perhaps the one with equally 'high staff costs.' 

My read is that Ernst & Young are suggesting CBS should increase productivity by paying staff less. Hard to do in unionized setting unless you replace well paid staff by less educated ones. For example:

• 6 staff work 3 hours to produce outcome. If average wage is $20/hr cost is $360 (6x3x20) 
• If staff paid $10/hr, cost is only $180. 

Hey, immediately we're 100% more productive. Viva CBS! We are the champions...

2. DIAGNOSTIC SERVICES 

Besides aligning skills to function, apparently CBS can also decrease costs by divesting some or all of its Diagnostic Services business line. 

For interest, CBS's Diagnostic Services includes many things but mostly it's the patient side of CBS: prenatal testing, pretransfusion testing, and antibody investigations (patients and donors). In other words, Diagnostic Services is largely staffed by medical technologists who love red cell serology. 

My ears perked because for a short time in 1999-2000 I was 'assman' in the diagnostic services lab at the CBS Edmonton Centre. (assman, how the Quality Dept. addressed mail to the assistant lab manager). 

Diagnostic Services is an ongoing interest, having worked in one in Winnipeg for 13 years at the Canadian Red Cross Blood Transfusion Service - a large combined blood centre and regional crossmatch and prenatal testing facility  - that morphed into CBS, post-Krever Commission. 

And the lab in Edmonton is currently managed by a graduate of the first Med Lab Science class I taught from start to finish at the University of Alberta, one of my original 'kids'.

With that history, any mention of divesting Diagnostic Services gets immediate attention. The review's Recommendation #32: 

The provincial and territorial governments should work with CBS to investigate opportunities to decrease costs.  

Decreasing costs may be achieved through centralization of testing or divesting testing services performed by CBS to local hospitals. 

Transferring prenatal and pretransfusion testing from CBS to local hospitals has long been discussed in Canada's transfusion community. 

The irony is that CBS's pretransfusion testing lab in Winnipeg is already a cost-effective, centralized testing service. Same with prenatal testing in Alberta. So transferring these functions to local hospitals would mean significant increased cost to health regions. 

Since the money all comes from the same pot (the provinces and territories), it may actually cost more to transfer testing to hospitals, to say nothing of the changes they would need to make and adapt to. 

Or perhaps CBS will have a go at further centralizing diagnostic services as they have donor testing and component production. 

Before entering the morass of  executive compensation at CBS, two items that should be 'ho hum'...

3. COST PER UNIT
CPU is the ratio of total expenses to shipments of all products. According to the CBS annual report

• Cost per unit for 2012-13 was $386

Although cost comparisons are impossible, given differences in how they are calculated, in bathroom reading I noticed that the UK NHSBT reports the costs of a unit of RBC  in 2012-13 as £123/unit ($204 CDN).

So raw data show the UK blood supplier as ~50% more efficient than Canada. An unfair comparison since CBS data include all products, not just RBC, and we're a huge country compared to them. Still interesting....

4. PLASMA DERIVED PRODUCTS
As a percentage share of total expenses, CBS reports transfusable products and plasma-derived ones as almost equal. 

• 47.2% Transfusable Products
• 46.3% Plasma Protein Products* 

* Plasma protein products include plasma-derived and recombinant therapeutic products, e.g., immunoglobulin (Ig), albumin, hyperimmunes, and clotting factors (factor IX, factor VIII, factor VIIa).

Plasma protein products such as Ig continue to be those with high continued growth.

CBS reports that, since self-sufficiency for plasma protein products  is not operationally or economically feasible in a volunteer, non-remunerated model, they try to maintain a sufficiency of 30% for Ig. 

To meet demand for Ig, CBS buys surplus recovered plasma from voluntary donations from the USA for fractionation.

It's debatable that CBS has ever seriously tried to get more plasma from volunteers. In March 2013 it closed a plasma collection centre in Thunder Bay, effectively exporting jobs to the USA.

My take on the plasma collection closure:

• While my guitar gently weeps (Musings on CBS's ongoing behavior)

Seems that CBS buying plasma from USA to produce Canada's plasma protein products is cheaper than collecting plasma ourselves. Fair enough, but why not be transparent? 

Which is why I'm skeptical of CBS's statement in the 2013 report:

• Self-sufficiency for plasma protein products  is not operationally or economically feasible in a volunteer, non-remunerated model.

Have they ever seriously tried? If paid plasma donors are heroes, wouldn't volunteers be even more heroic?

• CSL recognizes plasma donors for lifesaving contributions to treating rare diseases 
• Behring celebrate contributions of DONOR-HEROES during International Plasma Awareness Week

Then there's the matter of paid plasma collection sites coming to Canada, seemingly supported by Health Canada and CBS CEO Sher.

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

5. EXECUTIVE COMPENSATION
CBS executive compensation (pp. 62-3 of annual report) includes several elements:

• Base salary
• Annual pay-at-risk, long-term incentives
• Pension, benefits and perquisites

In 2012-13 CBS executives earned $283,000 to $342,000, with the CEO Graham Sher earning $560,000. 'Compensation at risk' as a percentage of base pay was 25% for the CEO and 20% for most executives.

'Compensation at risk' is tied to performance measures and means the percentage of base salary that executives could lose if they don't achieve defined performance measures. Using the figures above, it means the CEO could earn between $420K and $560K depending on performance.

It's not public knowledge but I wonder if the CBS CEO, or any executives, have ever lost any 'compensation at risk.' It would also be more transparent if specific performance measure criteria were public, given that Canadian tax payers foot the bill.

If not, 'compensation at risk' sounds good but may be a bit of a scam, which is why the performance review on executive compensation is informative. The review notes that 

• Compensation of CBS leadership team is positioned at the high end or exceeds the range against other comparable national publicly funded organizations.
• The analysis found that the low end of CBS executive compensation is positioned slightly higher than the average for comparators, while its high end is 20% to 30% higher than comparators.

Also, the review assesses that, while CBS has a formal process in place, as well as processes to support their continuous professional development,

• The review of the process found that there is a lack of clarity in how and which performance indicators and outcomes are linked to executive management compensation.

So like much of what CBS spouts, it sounds good, but is not transparent and may be total bafflegab. Or not. We don't know, which is the problem.

Speaking of bafflegab, or annoying, pompous jargon that consultants dream up, the CBS management response to the performance review has 10 'hits' for best practice, 16 for leverage, and 47 for strategic. 

At least they weren't thinking outside the box or proposing a paradigm shift.   

SUMMARY
Lest we forget, all players in publicly funded health care need to be accountable, including governments, health institutions, service providers, clients, health professionals, and patients. 

To whom is CBS MAINLY accountable? 

To governments (provincial and federal) on whose dime it operates and to whom cost is king? To its customers, hospital transfusion services and their clients (patients) to whom safety is paramount? 

My take: The priority of governments today is cost-efficiency. Yes, lip service to safety but the CBS performance review referenced safety 226 times versus cost 747 times and efficiency (meaning cost efficiency) 126 times.

And accountable for what?

For improving and maintaining blood safety? For saving tax payers money? My take: Both with cost the priority. 

Nothing has changed from the '80s and '90s when Canada's blood experts judged that 

• Discarding Factor VIII concentrates was too expensive (since hemophiliacs were all likely infected anyway)
•  Surrogate tests, as implemented in USA for hepatitis C, were unscientific (We are so much smarter in Canada)

Bottom line: I give CBS credit for showing its dirty laundry (performance review) in public. In that sense, from a Canadian perspective, accountability exists. 

• We are the champions (Queen, Freddy Mercury)

As always, comments are most welcome. 

Further Reading

• Canada's blood supply 10 years after Krever
• CBS 2013 Report to Canadians
• Independent performance review of CBS  
• Management response to performance review

Both sides now (Musings on transfusion medicine illusions)

Updated: 17 Nov. 2013

This month I couldn't resist a blog on abstracts from the 2013 AABB Annual Meeting in Denver, Oct. 12-15, published in Transfusion, Vol. 53, No. 2S, September 2013 Supplement.

Some people use People as bathroom reading. For ~38 years (since becoming an AABB member in 1975), mine has been Transfusion, with the meeting abstract issue offering many enjoyable hours 'on the throne'. Ok, cue the chorus of, 'Get a life!' 

What follows are random observations, covering a few of the many goodies that struck me in this year's abstract supplement. 

Because the AABB meeting is on when this blog is published, I realize that few North Americans will read it. Maybe after they return home and equilibrate? 

The blog's title derives from an iconic song by Canada's Joni Mitchell.

TRANSFUSION PROFESSIONALS
First, using electronic access to Transfusion as an AABB member, the following data was complied.

In the Administrative and Scientific sections, searches for references to health professionals yielded the following results, i.e., number of search 'hits':

Administrative (Scientific)

• Physician: 60 (54)
• Nurse: 37 (11)
• Technologist: 28 (8)
• Clinician: 8 (15)
• Medical director: 6 (2)
• Pharmacist 1 (0)
• Perfusionist: 2 (0)

Using the scientific section, the top four would be
* physician-clinician-nurse-technologist

What stands out is how physicians dominate both abstract sections. 

SO WHAT?
It follows that physicians dominate AABB meeting abstracts. They dominate AABB's Board of Directors and certainly dominate the ability to do research. 

AABB's 2012-13 Elected Board (n=19):

• 13 MDs (68%)
• 4 Medical technologists (21%)
• 2 PhDs (11%)

Is it an illusion that nurses and medical technologists are equal to physicians in the TM stratosphere or do they continue to be historical underlings?

AUTHOR COUNTRIES
Founded in 1947, in 2005 AABB changed its name from American Association of Blood Banks to AABB. The change reflected that AABB has members in many countries and includes all of transfusion medicine plus cellular therapies.

In the Administrative and Scientific sections, searches for references to author countries showed that the USA dominates abstract presentations at annual meetings. The AABB website gives this breakdown of meeting abstracts: 

2013 Abstracts	No. accepted	Acceptance rate
Domestic	445	90%
International	215	83%

These numbers make the meeting look very international and do not fit what a quick scan showed.

Administrative section: Most non-USA authors are Canadians with 6 abstracts. Other countries such as Italy have 2 abstracts.

Scientific section: Outside of American authors, Canadians have the most abstracts (sorry, no exact count but based on a quick review Canada is number two). This reflects that it's cheaper for Canadians to attend meetings in the USA than transfusion professionals in Europe, Asia, Africa, and Down Under. It would be interesting to know how many of the 'international' abstracts were from Canadians.

Another major factor influencing AABB attendance is that transfusion professionals from Australia, NZ, and European countries have major conferences of their own to attend:

• HSANZ, ANZSBT and ASTH Annual Scientific Meeting
• BBTS conference
• ISBT congresses in Europe and Asia

SO WHAT?
AABB is not as international as it likes to portray itself. Despite boasting of membership from ~80 nations, outside of Americans, Canadians predominate. Its 19-member Board has only three non-Americans: Canadians Graham Sher of CBS and Jeannie Callum of Sunnybrook HSC in Toronto, and Mike Murphy of the UK's NBSBT and Radcliffe Oxford University Hospital.

Annual meeting attendees are mostly Americans, followed by Canadians.

Is it an illusion that AABB is an international organization? Or is it really a NA organization dominated by Yanks, with a few token Canucks? 

AABB ABSTRACTS
Now to the three abstracts selected for this blog. 

1. AP123 Transfusion Audits: Looking Beyond the Obvious

Authors: R M Bhavnagri, S M Armstrong, K Sanford. Transfusion Medicine, Virginia Commonwealth University Medical Center, Richmond, VA, USA.

The authors noted that transfusion audits are required by regulatory bodies to assess nursing protocols. They decided to use audits to build better relationships between nursing and blood bank staff. 

They rotated audits among every technologist in the transfusion service. This allowed staff to form relationships with nursing staff on each shift. The result was that relationships between nursing and blood bank staff improved.  

Comment: I really liked this abstract because anything that fosters blood bank and nursing understanding is good.
Is this an illusion? Will nurses and laboratory technologists ever be blood brothers and sisters? Evidence grows that this is so, especially in countries where medical laboratory technologists form a significant portion of transfusion safety officers. [See abstract 3 below.]

2. AP76 Bridging the Gap: The Success of Daily Transfusion Medicine Meetings

Authors: A L Sutton, N K Case, K Sanford.Transfusion Medicine, Virginia Commonwealth University Medical Center, Richmond, VA, United States 

Pathology residents continually rotate through the TM laboratory and it's the responsibility of pathology physicians and medical lab scientists to guide residents through their rotations. A new director noted a communication gap between the lab, residents, and director and implemented daily meetings.

The 20-30 minute meetings are held in the director's office and attendance is mandatory for TM residents, the charge medical technologist, and TM supervisors. 
Meetings have a consistent agenda and include blood product inventories, antibody workups, and much more. They're also an opportunity for residents to ask questions. 

Comment: Daily meetings are a great opportunity to exchange information and keep everyone apprised of current TM activities and issues.  Daily meetings that include the medical director, pathology residents, and medical technologists help bridge communication gaps.  

Equally important, they can lessen status gaps in the health profession pecking order. Disrespecting colleagues is harder when you've spent time with them close-up and know them as people.
Is this an illusion? Do medical directors have the time, let alone the will, to spend 30 minutes in daily meetings with residents and lab staff? Only if they see it as time well spent. One of the value-added benefits would be that it promotes medical technologists becoming an integral part of the health care team. 

3. P11 2012 Transfusion Safety and Patient Blood Management Survey

Authors: C Slapak, K Gagliardi. Community Blood Center/Community Tissue Services, Dayton, OH, United States; Southwestern Ontario Regional Blood Coordinating Network, McMaster University, Hamilton, ON, Canada. 

In 2012~ 40 programs based on an informal network of transfusion safety and patient blood management professionals existed in the USA.  

An online survey was circulated to transfusion safety officers, blood management coordinators, or similar in the USA and Canada  using informal US networks and the Canadian 'Transfusion' mailing list.  

108 professionals replied: 62% from Canada, 32% from US, and 6% from other countries. Almost all Canadian programs have existed for over 5 years (95%) compared to just over half of US programs (54%). 

Professional backgrounds:  

• nursing (24% Canada, 77% US) 

• laboratory (72% Canada, 9% US) 

• 6% physicians or others

The most common words in the position titles were Transfusion Safety (50%).

Training is mainly via professional experience, networking, and attending meetings. Only 8% use a formal TSO training program. 

Comment: Canada has more experience with transfusion safety officers than the USA.The UK and Australia also have more experience than the US. Although the evidence is mostly anecdotal, as in the USA, nursing has no monopoly but tends to dominate TSO positions in the UK, Australia, and NZ. [If this is not so, I'd love to hear from colleagues there.]  For example, from 'Towards Better, Safer Blood Transfusion'. A Report For The Australian Council For Safety And Quality In Health Care (Feb. 2005):

These key individuals have various titles (Transfusion Nurse, Transfusion Nurse Specialist or Consultant, Transfusion Safety Officer, Haemovigilance Officer, Specialist Practitioner of Transfusion). They are usually recruited from nursing backgrounds. They act a vital 'bridge' between the different provider groups engaged in the transfusion 'safety chain', in particular those beyond the hospital laboratory.

In contrast, in Canada medical laboratory technologists outnumber nurses 3 to 1 as transfusion safety officers or equivalent.

Is Canada's experience an illusion? It seems not, but why the preponderance of 'transfusion safety' nurses outside Canada whereas medical technologists here hold their own? An added benefit of a good mix of nurses and technologists is that understanding the daily work realities of each profession grows, and with it, increased respect. 

FOR FUN
Lately, I've listened to many songs written by Canada's Joni Mitchell. The blog's title was selected to reflect the 'we-they' schism between nurses and transfusion service technologists, including the nursing - technologist TSO dichotomy in the rest of the world compared to Canada. 

But other potential illusions include:

• Are nurses and technologists 'equal' to physicians on the health care team? (where equal means valued and respected equally for their expertise)
• Is AABB a true international organization? Or more a NA group with delusions of grandeur and global aspirations to promote its standards and associated business line, AABB Consulting Services?
• Can nurses and technologists one day be blood brothers and sisters, treating each other with respect, even awe, for their respective skills?  
• Will medical technologists ever become an integral part of the health care team, as respected as professionals with direct patient contact?

Joni Mitchell songs:

• Both sides now (~600 'cover' versions by other artists and counting)

I've looked at life from both sides now 
From up and down and still somehow 
It's life's illusions I recall 
I really don't know life at all. 

Two other fabulous songs that Joni wrote:

• Big yellow taxi
• Woodstock

As always, comments are most welcome. And we have some...

Reply #1: Re-Dr. Gwen Clarke's comment below:

Appreciate the feedback. Nice touch to include weekly telecons for colleagues in Edmonton-area hospitals. Like you say, daily meetings help promote communication, a team approach, and opportunities to learn and teach.

I've always been struck at how communication failures play a role in so many adverse events in the UK's SHOT reports. For example (from p. 6 of the 2012 SHOT Report):  

The headlines from 2012 reporting are a continued high rate of error related to omission of essential procedural steps and communication failures. 

Suspect that communication improves outside meetings too as it's easier to phone someone you see every day and works both ways for physicians and lab technologists to consult each other more.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Reply #2: Re-Kate Gagliardi's comment below:

First, about including your abstract (#3 above: Transfusion Safety and Patient Blood Management Survey), my apologies. It's been on my to-do list to write and tell you it was in October's blog, but....

Believe it (or not) it would have happened today. <;-)

Suspect Canada's situation, where many who are not formal 'transfusion safety officers' share bits and pieces of the role, apply universally. 

Appreciate your frank comments on UK's SHOT ('gold standard') vs Canadian and American hemovigilance programs. Reminds me of a 2011 blog:

• Only in the UK & Down Under? Pity! (Musings on hemovigilance)

Sad that it's still relevant 2 years later. I keep looking for published, current data from Canada and USA. Doesn't happen.

About AABB holding meetings on Canadian Thanksgiving, that breaks me up. Case of, "If it didn't happen in USA, it didn't happen"? Unfair to American colleagues but AABB should take note, if only to maximize meeting profits.

As to TSO 'RN vs Medical Technologist' issue, I'd love to hear your views. In the meantime, I'll pursue it on other media such as Canada's TSO "transfusion" mailing list and report back here. 

Thanks again. Your input is much appreciated.  
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

I will remember you (Musings on realities for nurses and residents)

Updated: 13 Oct. 2013

September's blog was stimulated by recent personal experiences in a local inner city hospital with ~700 beds, treating ~ 450,000 patients/year. I spent much time in the hospital over 5 days and came away impressed with frontline health care staff. 

In contrast, I happened upon a news item about a lawsuit that did not impress: 

• SmithKline Beecham vs Abbott Laboratories: Abbott removes juror because he's gay in suit over hiking HIV drug price

The blog's title derives from an iconic song by Canada's Sarah McLachlin.

First the good news. Being naturally curious and a people observer, during the recent encounter with our health system, I learned many tidbits about work realities for Drs (surgeons and residents), RNs, LPNs, pharmacists, occupational therapists, respiratory technologists, nursing aides, cleaners, and more.

In brief, I have an enhanced appreciation of colleagues in the front lines of the interdisciplinary health care team. They work under incredible pressure, yet those I observed invariably put the patient first and were caring professionals. 

As background, as a medical laboratory technologist who worked in a transfusion service lab for many years, I've encountered many nurses, those I call 'pitbulls', because they aggressively challenge 'rules' the blood bank has related to identity that are designed to ensure patient safety. That makes my new found appreciation all the more sweet.

Thank you surgeons, residents, RNs, and all staff at Royal Alexandra Hospital (Nursing Station 31), Edmonton, Alberta, Canada.

Some things I observed:

• RAH entrance: 2 security officers holding what could be a homeless man with a beaten face, him screaming, 'I f*ckin' did nothing, you bastards.'

• Signs say 'No smoking on RAH property' but 'patio' outside main entrance always full of patients smoking. Not similar at University Hospital. Perhaps a losing battle in inner city?

• Most memorable image of RAH: Emaciated male exits nursing station 31 with fag in mouth, going for a smoke.  Frankly, despite being one of those ex-smokers who is now fanatically anti-smoking, I don't begrudge him his smoke. 

• Exiting RAH elevator on 3rd floor: Mother angrily screams at ~12 yr old girl that she needs to say something when asked a question. Mom walks towards the ward area and screams, 'Where the f*ck are we?' Then mutters, 'Wrong floor', and stomps away leaving child to follow. My heart ached for child. Mother obviously stressed but no excuse to abuse child. Miracle if kid survives a mom like that. 

• Respiratory technologist attaches a BiPap to patient in respiratory distress in ward's special 'observation room' (2 RNs for 4 post-op patients), all the while training a student. As a longtime blood bank clinical instructor, I was impressed by his expertise and patience. Later one of the RNs asked the respiratory tech if respiratory could give an in-service on use of the BiPap. Good stuff. 

• Patient in observation ward for those who need observing carefully post-surgery, and who are attached to many monitoring instruments (and where every few minutes machines beep loudly  - sleep is impossible in the  hubbub of activity) screams, 'Shut up! I'm trying to sleep.' Another patient comments, 'Stuff him in the closet' and he replies, 'Yes, please.'

• Elderly gent on observation ward, post-surgery, keeps screaming, 'Let me outta here. They've kidnapped me. I've got to go home' and tries to rip off his monitoring equipment. His elderly wife patiently says, 'No dear. You've got to stay.' 

• Several times a day a patient leaves the observation room for a regular hospital room and a new patient comes in. This is when two staff members enter and strip the bed, then wipe down (disinfect) every part of the bed, tables, and any surface the patient may have touched. It's a frenzy of cleaning, hard grunge work, but it's got to be done and quickly, to prepare for the new patient. 

You get the idea. Every day is total chaos but residents, nurses and all staff maintain their cool and keep caring for all their patients no matter how difficult they and the environment may be.

INDUSTRY
Now the bad news. Watching nurses and docs perform under trying situations makes me all the more disturbed to see how industry colleagues continue to put their interests ahead of patients and seemingly use every tactic to maximize profits and win lawsuits.

Indeed, I could recite many cases that definitively show that Big Pharma routinely behaves badly but I'll limit it to a current case.

Smithkline Beecham (SKB) v. Abbott Laboratories (USA)

SKB v Abbott is about whether it is permissible for a lawyer to 'strike' (remove) would-be jurors from a case because of sexual orientation.  In this antitrust lawsuit involving HIV medications, an attorney for one of the companies exercised a so-called peremptory strike, effectively removing a possible juror because he was or appears to be, could be, homosexual.

The case involves Abbott challenging the only known gay juror during voir dire for a trial in which SKB challenged Abbott's controversial 400% price increase for an HIV medication.

In other words, Abbott wanted to get rid of a gay juror presumably because it believed he would be biased against them for their exorbitant price for HIV meds.

How did Abbott know he was gay?
When the judge asked how they knew he was gay, Abbott pointed to his mannerisms, his residence in West Hollywood and his previous work as a freelance screenwriter.

What to say? Jesus wept? Oh, give me an effing break? Geez, if you're 'straight' what cases does that preclude you from?

Be aware that SKB is no better than Abbott. Name any Big Pharma company and it's easy to discover how they routinely behave badly. For example,

• SKB overcharged AIDS Healthcare Foundation $2.2 million for drugs, the nonprofit claims in court

BOTTOM LINE
Frontline health professionals work under incredibly stressful conditions and yet put patients first and remain cheerful and helpful. 

As someone who has worked in a transfusion laboratory and taught all my working life, I have new respect for the nurses. They carry the burden of dealing with patients who often are close to impossible to handle and may go into a life-threatening crisis at any time. To say nothing of the many bodily fluids they have to clean up with a smile and kind word.

As to Big Pharma, it seems the bottom line is all that matters. Frankly, drug and diagnostic reps are often fine colleagues. But they're at the mercy of their employers. 

For Fun
To all the nurses, residents, and other health professionals at RAH, Nursing Stn 31, in Edmonton, rest assured,

• I will remember you

Further Reading

• Norvir Price Increase -- Boycott Abbott
• Court to Decide if Lawyers Can Block Gays From Juries
• SmithKline Beecham v. Abbott Labs: Should Batson apply to gay jurors?
• WSJ Uncovers Abbott's Norvir-Busting Marketing Strategies
• Smithkline Beecham Plaintiff - Appellee/Cross-Appellant v. Abbott Laboratories Defendant-Appellant/
• Smithkline Beecham Corporation v. Abbott Laboratories ("Sexual Orientation of Jurors")

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