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.
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.
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.
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:
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)
#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
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.
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.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.
- While my guitar gently weeps (April 8, 2012)
My reply: The Dublin consensus is like politics in which we all agree on motherhood and apple pie:
Reality is often different:
- Dublin Consensus Statement on vital issues relating to the collection of blood and plasma and the manufacture of plasma products
- 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:FOR FUN
- Purchased plasma safe, essential (8 May 2014)
Love this song with the reggae beat I learned in Jamaica, circa 1969.
- Don't worry, be happy (Bobby McFerrin)
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.
- 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)
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