Don't worry, be happy (Musings on the safety of our blood supply)

Updated: 1 Aug. 2014 (If you've visited before, refresh your browser)

Below is a copy of a Comment made to the earlier bog, Turn,Turn, Turn. and my reply to it. I decided to write a separate blog because Turn was getting too long and the Comment stimulated other aspects of the paid plasma issue, most noteworthy, safety.

The safety aspects I'll touch upon include 

• Foolproofing. Our blood experts assume blood safety is now foolproofed (no longer susceptible to human incompetence, error, or misuse) because the blood tragedies of the 80s and 90s are of historical interest only. 
• Put another way, many blood experts (thought leaders) developed an arrogance that exudes, 'We're so much smarter now.' 
• They base it on implementing quality systems, improved blood screening tests, and more stringent government regulation. 
• Cost constraints, mainly affecting the nature and number of staff.
• Despite the best foolproofing tools (see Further Reading below), not all facilities can afford them.
• And humans working short-staffed and under pressure, and those with less formal education, are more prone to human error, especially if the system itself is flawed due to cost constraints. 

The blog's title derives from a Bobby McFerrin ditty from 1988.

First, Anonymous's comment from the Turn blog:

Anonymous wrote: Two quotes from G. Sher that appear 4 days apart in the media. PLEASE include this in a future blog!

“Canadian Blood Services has successfully managed the blood and blood products supply for Ontarians for more than 15 years. We are confident in the safety and sustainability of the current blood and blood products system in Canada, and we recognize Ontario’s role in preserving voluntary blood and plasma donation in this province.”

Dr. Graham Sher
CEO, Canadian Blood Services
Ontario official press release July 22, 2014

Anonymous: A quote from Friday just four days prior:

Dr. Graham Sher, CEO of Canadian Blood Services, is concerned about “the mischaracterization of this as a safety issue, as opposed to a public policy issue.” 

“People are caught in a paradigm from 30 years ago and are saying that paid plasma donors are unsafe and therefore we shouldn’t be allowing a paid facility in Canada because it’s an unsafe thing to do and people are going to die as a result. That, to me, is fear-mongering and it’s inaccurate.” 

Equating paid donors with an unsafe product would mean 80 per cent of the plasma drugs in Canada aren’t safe. And that’s simply not true, says Sher, calling them “extraordinarily safe.” 

“We may have moral objections and philosophical objections to paying,” he says. “But let’s not make it an issue about safety when it’s not about safety.”Sher says that as long as Canadian Plasma Resources operates safely and doesn’t impact the voluntary donor base, it would have “no objection to existing side by side with this company.” 

Toronto Star, Isabel Teotonio

Anonymous: To say that transfusion medicine with [is] totally safe is to believe in a perfect product. That is arrogant and dangerous. I want CBS to understand the ever present risk and be vigilant and consistently working to minimize this risk. To do less will lead down the dark road of the Red Cross and unknown catastrophes.

My response to Anonymous

To be fair, CBS CEO Sher called plasma derivatives 'extraordinarily safe' but I agree the impression he creates is that they are 'totally safe'.

And I suspect that his carefully crafted public comments inadvertently create mixed messages. Dr. Sher likely thinks he's been perfectly clear:

• CBS supports a voluntary blood donor system.
• CBS supports Ontario's right to protect a voluntary donor system.
• Paid plasma is safe (as safe as voluntary donor plasma).
• Object to it on moral and philosophical grounds, but not safety.
• If a paid plasma company operates safely and doesn't adversely affect voluntary donation, CBS would not object to existing side by side with it.

That last bit is a tad weaselly. We may not know if paid plasma centres or manufacturers of plasma derivatives or non-profit blood suppliers like CBS operate safely until an inspection or 'tainted blood' disaster shows they didn't. Sure, they all must meet stringent government regulations and be periodically audited, but errors happen all the time. And not just historically.

Mistakes (systematic and individual) regularly occur today. For example:

#1. In 2012 the USA's FDA fined the American Red Cross $9.59 million for violating blood safety rules. Note this is 2012, not 1982 or 1992.

Sometimes audit findings seem trivial, i.e, nitpicking that's unlikely to translate to patient harm. But ARC violations were serious, not trivial. All of the violations merit discussing but I'll choose just one, one that health professionals, indeed everyone, can relate to:

• Most of the regional operating centres of the Red Cross were seriously understaffed.

Understaffing has long been a reality in health care. Why? Cost constraints and cutbacks. The powers that be usually opt to cut staff or substitute more highly educated, and therefore more expensive, staff with less educated, cheaper staff that are trained on the job and supervised by fewer well educated, expensive staff.

A classic example is CBS's 'donor care associates' mentioned in my blog of Nov. 2013:

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

The blog dealt with CBS's 2013 Report to Canadians, which mentioned cost a whopping 747 times.  

Cost savings apparently applies to worker bees, not top CBS executives. In 2012-13 CBS executives earned $283,000 to $342,000, with the CEO Sher earning $560,000. No doubt all well earned. To get top talent, you must pay top dollar. Just odd how cost savings seldom translate to executives.

As a joke I created a cartoon about possible other CBS 'care associates'

Understaffing played a role in ARC's blood safety violations. Staffing levels invariably adversely affect blood safety. We often get away with it, until we don't.

#2. Another example of systematic and individual staffing issues and ineffective government regulation  is shown by this news item:

• Group O patient dies of hemolytic transfusion reaction after receiving group B RBC (24 July 2014)

Note this happened in 2014 in Hazelton, PA, USA, not a third world nation. Besides inadequate staffing, among many findings the state Department of Health concluded:

•  The governing body was ineffective in carrying out their responsibilities to approve, implement and enforce standards of quality management and improvement for the hospital by failing to ensure the chief executive officer provided a safe setting for patients receiving blood.

In Canada, our current government's commitment to science versus saving money (in the run-up to a 2015 election) is suspect. Not wanting to become too political, but our government has cancelled Statistics Canada's long-form census and been accused of muzzling scientists, even to the point of investigation by Canada's Information Commissioner. 

I wonder if Health Canada, the government body charged with regulating and protecting our blood supply, has been adversely effected by staff cuts due to the government's desire to balance the budget prior to an election. 

They've taken a long time to rule on Canada's paid plasma collection centres, having first held a round table (closed to the public) in April, 2013. In July 2013 I wrote a blog about it:

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

Still no answer a year later. Why?

#3.  A key part of expert certainty of the safety of our blood supply is all the pre-donation screening questions, post-donation tests and manufacturing processes used, especially for plasma derivatives like IVIg. The blood supply in developed countries is safe today, much safer than in the past. 

But the blood supply not totally safe. Many things can go wrong:

• Predonation screening questions only are effective if donors answer honestly. See CBS's Record of Donation. 
• Current tests only work for known infectious disease risks such as HIV and have a small window of negativity. For example, CBS says the window (time between infection and detection by current tests) of HIV is ~ 16 days. 
• HIV on the rise among gay and bisexual men (Yet there's much political pressure to change Canada's MSM policy.) 
• Many manufacturing processes help keep plasma derivatives safe, inc
• Donor screening and testing
• Plasma quarantine
• Technology that inactivates viruses
• Purification steps

Seems foolproof, no? Except it isn't. The system only works for transfusion-transmitted infections we know about.

For example, in 1994 it was discovered that the plasma derivative Rh immune globulin in Ireland had been contaminated with HCV in 1977-78 from a singe donor. Plasma derivatives are made from 1000s of donors and it only takes one to escape detection.

• HCV wasn't discovered until the late 1980s. 
• At least 390 Irish women were shown to be infected with HCV-RNA. 
• By 1998, €206 million (~$300 million CDN in today's money) was paid to these women and others infected with HCV via transfusion.

In Canada, at least 30,000 Canadians were infected with HCV between 1986 and 1990. And all because  Canada's experts failed to use surrogate tests for non-A, non-B hepatitis (as was done in the USA) because they judged the tests to be unscientific. Compensation to Canadians infected with HCV during this time totaled over $1 billion.

BOTTOM LINE
I dig that the blood supply in developed nations like Canada is exceedingly safe compared to 20-30 years ago. But I prefer to be skeptical vs championing, 'Don't worry, be happy,' as CBS CEO Graham Sher does.

ADDED 31 JULY (amended 1 Aug. 2014)
In reply to the Comment below from Anonymous (Curtis), whose main points were:

1. Anonymous: You state that he [Dr. Sher] inadvertently sends mixed messages. I contend that he rides the fence on purpose. I have it from reliable sources that CBS wants of offload the cost of collecting plasma. They are just not efficient at it and look to the US model as a way to achieve this. 

My reply: You're likely right that CBS CEO Sher tries to have it both ways, given how CBS closed Thunder Bay's plasma collection facility in 2012. I blogged about it, noting that CBS obfuscated its real reason for closing the centre: Operating a Canadian plasma centre is more expensive than buying surplus plasma from the USA.

• While my guitar gently weeps (April 8, 2012)

2. Anonymous: This is why Ian Mumford of CBS was part of the Dublin Consensus Statement that everyone points to as a paper that outlines the successful co-existence of the private sector and the public sector in the plasma industry. 

My reply: The Dublin consensus is like politics in which we all agree on motherhood and apple pie:

• Dublin Consensus Statement on vital issues relating to the collection of blood and plasma and the manufacture of plasma products

Reality is often different:

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

For interest, according to LinkedIn, Mumford is responsible for ensuring CBS consistently provides high quality transfusable, plasma protein and stem cell products to customers at the right time, at the right place, and at the right cost. Likely the last is most important, given CBS's focus on cutting costs to satisfy provincial pay masters. 

3. Anonymous: I contend that Dr Sher when asked by his employer... the government of Ontario he does what a loyal employee does and that is make them look good. 

My reply: CBS is funded by all Canada's provinces and territories except Quebec (which operates Héma-Québec), not just Ontario. According to CBS's website, Canada's Health Ministers are responsible for the overall expenditure of public funds but do not have the power to direct operational decisions of the Board of Directors or Canadian Blood Services staff.

But your point has merit. Sher's pronouncement on the Ontario government's proposed legislation to ban paid plasma was to be expected, in that there was no way he could be political and publicly contradict a provincial government's policies. 

4. Anonymous: However, I also know that he has been privately petitioning for the Ont Govt to let CPR open.

My reply: Assume you have it on good sources, but I can't give such an accusation credence without confirmation. All  can say is, if true, it would not surprise me. It fits with Sher's public statements:

• Purchased plasma safe, essential (8 May 2014)

FOR FUN
Love this song with the reggae beat I learned in Jamaica, circa 1969.

• Don't worry, be happy (Bobby McFerrin)

As always, the opinions are mine alone and feedback is most welcome.

FURTHER READING
These resources are for those who want to explore some of the issues affecting blood safety in-depth.

Plasma derivative safety

• Pathogen Safety (Plasma Protein Therapeutics Association)
• Hepatitis C virus infection from contaminated anti-D immune globulin in Ireland. Eurosurveillance 1999 Apr 29;3(18).  
• Kenny-Walsh E for the Irish Hepatology Research Group. Clinical outcomes after hepatitis C infection from contaminated anti-D immune globulin. N Engl J Med 1999; 340:1228-33.

Foolproofing (Applies mainly to hospital based transfusion where computers are seen as answer to human error.)

• Challenge and change in blood bank systems marketplace (CAP Today, 9/13:16)
• Guidelines for the use of RFID technology in transfusion medicine. Vox Sang 2010 Apr; 98(2).
• UK SHOT: Lessons for transfusion laboratory staff (2010)

Staffing
It's hard to find reports on inadequate staffing, mainly because overworked professionals, especially those in the laboratory, fear that, by speaking out, they'll suffer repercussions, not just to their current job but in their careers.

• Alberta nurses reach tentative deal with Alberta Health Services (8 July 2014)
• Workload was not addressed: “It means there is a lot of work ahead for us in terms of the issues around workload, and short staffing and overcapacity and all those things that create situations where patient safety is compromised.”
• Guidance on safe nurse staffing levels in the UK (Royal College of Nursing, 2010)
• 1990s laboratory restructuring in Alberta, Canada

The sound of silence (Musings on blood safety regulations)

This month's blog is a short snapper. I've meant to try this for awhile, since some say that blogs should be relatively short, i.e., 250-500 words. Mine are typically much longer and it no doubt takes dedicated readers to read them. 


The blog's title derives from an old Simon and Garfunkel classic.


The blog is a personal synopsis (with musings) of this paper, available as free fulltext from the Jan. issue of Transfusion:

• Lee SC, Shaz B, Arena R, Sloan S, Fung M, Ramsey G. Red blood cell products: consideration of the discrepant temperature ranges permitted for storage versus transport. Transfusion. 2012 Jan;52(1):195-200.

RATIONALE
Why the paper appealed: 


1. It gets at the craziness that characterizes so many of the 'rules' governing transfusion medicine;


2. Away back when, circa 1974, having just been promoted to clinical instructor at the Winnipeg Red Cross Blood Transfusion Service* (now CBS), I went to a multi-day workshop sponsored by Ortho in Don Mills, Ontario, just outside Toronto. 

*Winnipeg BTS was a combined transfusion service (serving all of Winnipeg and environs, stretching into NW Ontario) and blood centre, still the only one in Canada.

One of the required workshop tasks was for each attendee to research a topic and present it to the group. The topic I chose was the 'storage lesion.' 


Pretty sexy, eh? I knew nothing about it, so thought may as well learn something. Who'd have 'thunk' ATP and 2,3 DPG would still be current 35+ years later?


NITTY GRITTY
As background, AABB and the U.S. FDA require RBCs to be stored between 1 and 6°C for up to 35 or 42 days depending on the anticoagulant-preservative solution. However, RBCs can be transported in containers that keep the temperature between 1 and 10°C. 


The U.S. FDA recently clarified storage vs transport: RBCs issued in coolers to an OR are in storage and not transport, hence must be kept at 1 and 6°C.


Other countries have similar distinctions for storage vs transport. The origin of the different temperatures ranges for RBC storage and transport is unknown.


Imagine this scenario:


1. Unused RBC units are returned from the OR to the transfusion service at 8°C and are discarded since they exceed the 1 to 6°C storage range.


2. RBC units from the blood supplier arrive at the transfusion service at 8°C and are placed into inventory since they adhere to the 1 to 10°C for transport.


Say what? Difference makes little sense. As the authors write [paraphrased]:

(1) Differing temperature ranges likely do not increase patient safety and should be reconsidered, since improved utilization and cost control of all hospital services is essential. Increased wastage of an already scarce resource can lead to low blood inventories, putting patients at risk.

(2) The change from OR fridges to coolers was to reduce incompatible blood transfusions associated with using shared refrigerators for several ORs where blood for patients of different ABO groups were stored. But the cost of improved safety has been increased blood wastage to comply with temperature regulations that lack scientific verification.

CONCLUSION
The authors' conclusion (paraphrased):

Data show there may be no detriment to increasing the storage temperature range to 1 to 10°C for a few hours, such as while RBCs are in a cooler in the OR. But data are incomplete and may not apply to storage with current materials. Research on differences in metabolite formation, biochemical changes, and microbial growth between RBCs stored at 1 to 6°C and 1 to 10°C would help demonstrate the most appropriate storage temperature range. 

MUSINGS
Kudos to the authors for tackling this issue. In a way it's sad that the authors use cost constraint as a major motivator for re-thinking the regulations. No doubt money 'makes the world go around.' But why weren't such rules challenged a long time ago on science alone?


Wouldn't it be great if more iffy, nutball regulations (those lacking scientific evidence) were challenged?


Perhaps the 'powers that be' could develop a mechanism for trench workers in various countries to suggest which regulations may not be warranted? Then research could be done that clarifies the issue.


Suitable challenges would involve regulations that 

• Seem arbitrary (unrelated to safety) 
• Are inconsistent with other regulations
• Cause increased work / money without apparent justification

FOR FUN

• Money makes the world go around (from Cabaret) All too true and paramount in today's blood system.

• Sound of silence (Simon & Garfunkel) The song title fits behavior in the TM community about iffy rules and regulations. But mainly it's included because I love the tune, lyrics and artists.

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.