Wednesday, December 10, 2014

Angel (Musings on communication errors in TM)

Updated: 13 Dec. 2014

This month's blog derives from news items appearing in TraQ's monthly newsletter involving Jehovah's Witnesses in NZ and the UK, and the availability of online legal summaries.

In particular, the blog features a case from NZ in which communication failures led to a woman's death. Her death likely could have been prevented if the surgeon had known that she was a Jehovah's Witness and had refused to be treated with blood and blood products.

The case is all the more tragic because her surgery was routine, elective laparoscopic cholecystectomy. Even with 'open surgery,' transfusion may be required but seldom is. For many years, transfusion services have done only a type and screen, just in case blood is needed.

So, although involving a Jehovah's Witness, the blog is about communication and how critical it is to patient safety.

The title derives from a 1997 much-covered song by Canada's Sarah McLachlan.

BACKGROUND
UK SHOT Reports always feature cases that emphasize the importance of communication to transfusion safety. Musings on communication failures and examples from SHOT follow the NZ report.

NZ CASE
Below is my edited version of key case details as described in the report. I've kept the NZ spelling (with the diphthong 'ae' used in many former British colonies,though not so much in Canada with our proximity to the USA).

1. Ms A was seen by a surgeon at an outpatient clinic (Hospital 1). A surgeon confirmed gallstones and she was put on a waiting list for an elective laparoscopic cholecystectomy.

2. Later Ms A attended a nurse-led pre-admission clinic, where she confirmed that she did not consent to the use of blood and blood products.

3. Ms A was admitted for surgery. Surgeon Dr C and anaesthetist Dr D met with her to discuss the operation and to complete the process of obtaining informed consent.

4. When the surgery began Dr C was unaware of the patient's views on blood transfusion. The matter was not raised during the surgical 'Time Out', when any issues of concern are brought to the attention of the OR team. (See below for info on surgical 'timeouts'.)

5. Surgery began at 9 am. Because of difficulties, at 9.50 am, the laparoscopy was converted to open surgery. Ms A's gallbladder was removed and the operation ended at 11.15 am.

6. Bleeding occurred during surgery, but not enough to cause concern. Ms A was transferred to the Recovery Unit at 11.25 am.

7. There were concerns about Ms A's condition from about noon. Initial measures were unsuccessful and it was thought that she was probably bleeding internally.

8. Dr C instructed that Ms A was to be transfused, at which point he was advised of her blood product refusal.

9. Dr C determined that further surgery was needed to identify and address the cause of the bleeding. Ms A, still partially sedated, confirmed that she would not accept blood.

10. Permission was sought from Ms A's mother to override Ms A's directive but she said she could not do this.

11. Ms A was returned to the OR and surgery began at 2.55pm. Because no obvious bleeding point was identified, Dr C determined that the best course of action was to pack the liver bed and close the abdomen, so that Ms A could be transferred to a facility better able to manage her condition.

12. Arrangements were made to transfer Ms A by helicopter to Hospital 2. When the helicopter crew arrived, it was decided that transfer was inappropriate due to likely hypoxic brain injury. Ms A was confirmed dead at 6.59 pm.

SUMMARY
For more information, and key findings, I encourage you to read the full report below. 62 pages is a lot but many are appendices, plus it's fascinating. Documented tidbits include
  • At 2.29 pm, prior to the second surgery, Ms A's Hb was 45 g/L
  • At 3.26 pm, post second surgery, Ms A's Hb was 11 g/L 
A physician at Hospital 2, where she was to be transferred, said about the second surgery:
"Pre-operatively her haemoglobin level was 45, which in a Jehovah's Witness who refused blood product transfusion I felt was life threatening. Post-operatively her haemoglobin was 11 which is almost incompatible with survival.

At some stage I suggested using concentrated factor VII, which if used early enough before severe dilutional anaemia has occurred might control the bleeding. I thought [Ms A] was almost certainly going to die..."
Recommendations and Follow-up actions are on pp 42-3 of the Report and include mandating that 
  • Those involved review their practices and apologise to Ms A's family in writing.
  • Appropriate medical colleges be sent a copy of the report, and advised of the names of Drs C and D.
MUSINGS
The communication failures in the NZ case highlight a long standing issue in transfusion medicine. Communication errors are common causes of adverse events.

Patients with special transfusion needs such as those requiring irradiated or CMV-negative blood components are particularly at risk when communication fails.The spectrum of communication deficiencies includes:
  • Physicians failing to communicate with nurses, technologists, pharmacists, and other health professionals and vice versa
  • Attending physicians failing to communicate with residents and interns
  • Staff from one unit failing to communicate with those from others
  • Staff on one shift failing to communicate with those on the next shift
  • Documentation failing to accompany patients from facility to facility
  • Health personnel failing to listen carefully to patients
Common tools to prevent communication errors include mistake-proofingaka as the politically incorrect 'idiot-proofing'.

Error proofing is  ubiquitous in society, e.g., beeping alerts when keys are left in cars or headlights are left on. Non-communication transfusion-related examples include
  • Colour-coded ABO typing sera, 
  • Pretransfusion nursing checklists 
  • Cross-checking work done by others
  • Eliminating identification errors via technology, e.g., barcodes, RFID
Preventing communication errors between TM professionals is more onerous because it involves complex, long term strategies such as
  • Developing standard operating procedures and tools (forms, letters, patient cards) to facilitate intradepartmental, interdepartmental, and inter-facility communication
  • Implementing methods to train and retrain health professionals to value effective communication and teamwork
  • Fostering a culture that eliminates communication barriers such as hierarchies within and between professions, and boundaries between departments
  • Developing information management systems to facilitate information transfer
SHOT REPORTS
Below is a small selection of communication issues documented by SHOT over the past decade (most recent first). (I've sometimes edited the original text.)

1. SHOT 2012 has 50 'hits' for 'communication'
One example (p.16, under 'Human factors in hospital practice'):
  • The errors described in this SHOT report consistently demonstrate failures in communication and handover that lead to adverse incidents, some life-threatening, in transfusion practice.
  • Failures of 'handover' (communication errors) may occur as the patient travels between wards and departments within a hospital, between clinicians in different hospitals, and between hospitals and community settings. 
  • Why? Often it's because of the human tendency to assume that someone else is responsible
2. SHOT 2013 has 48 'hits' for 'communication'
One example (p. 42 under 'ABO incompatible transfusions n=12'):
  • This shows the importance of communication between clinicians and laboratory staff in an emergency. There was no historical record available for the patient and laboratory staff issued FFP based on the misleading grouping result.
3. SHOT 2003 has 21 'hits' for 'communication'

Fewer 'hits' mean nil because the report includes 107 cases in which patients with special needs were transfused with the wrong blood. Of these, 81 involved patients at risk of GVHD for whom there was a failure to provide irradiated components.

The following three examples from SHOT 2003 (p. 23) illustrate the issues (italics not in original):
Case 10. Lack of awareness of guidelines puts patient at risk. A 66 year old male patient received fludarabine for chronic lymphatic leukaemia. The ward staff were unaware of the indication for irradiated blood components and so the laboratory was not informed.

Over a 5 month period the patient received 13 units of unirradiated red cells. 
Case 11. Failure of communication in shared care. A 14 year old male was admitted for an open lung biopsy following which he bled and required transfusion. He had previously received a stem cell transplant in another hospital in the same Trust, but there was no facility to link the two transfusion laboratory computer systems and the requester was not aware of the previous history.

Non-irradiated red cells were given. 
Case 12. No notice taken of an informed patient. An elderly male patient was admitted to hospital A with an ischaemic foot. He informed the ward staff that he required regular transfusion with 'special blood' at hospital B.

The ward confirmed with the transfusion laboratory at hospital B that he had an anti-ANWJ but this information was not passed on to the laboratory at hospital A who were undertaking pretransfusion testing.

The antibody screen was negative and 3 units of red cells were issued electronically and transfused. The patient had a rise in temperature and a raised bilirubin, and died 8 days later from bronchopneumonia.
As documented by SHOT, communication failures continue to happen because they involve humans, and 'to err is human'.

BLOG's TITLE SONG
Sarah McLachlan's 'Angel' (often mistitled 'In the arms of an angel') has been used so often as a song of comfort that it's almost become a cliche. To me it fits a blog that describes a series of communication failures that resulted in a tragedy that need not have happened.This performance with iconic guitarist Santana is a 'oner'.
  •  Angel (by Sarah McLachlan with Carlos Santana)
In the arms of the angel fly away from here
from this dark cold hotel room and the endlessness that you fear.
You are pulled from the wreckage of your silent reverie.
You're in the arms of the angel, may you find some comfort here.
You're in the arms of the angel, may you find some comfort here.
The song's origin is not at all what it's come to symbolize: Sarah says it was inspired by articles about musicians turning to heroin to cope with the pressures of the music industry and subsequently overdosing.

FURTHER READING
1. 'Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery', including
1. A pre-procedure verification process
2. Surgical site marking
3. Surgical "time out" immediately prior to starting the procedure
2. A Report by NZ's Health and Disability Commissioner (30 June 2014)
Nelson Marlborough District Health Board
General Surgeon, Dr C
Anaesthetist, Dr D 
3. News item: Jehovah's Witness dies after refusing blood transfusion (20 Oct. 2014)

Monday, November 10, 2014

To dream the impossible dream (Musings on TM research)

As always, stay tuned for updates

November's blog is based on an abstract from AABB's 2014 meeting in Transfusion. I always read 'Education and Training' abstracts (one of the smaller sections - go figure!), and this one caught my eye:
  • A14-030D: Chargé SB, Walsh GM. Bridging the gap: knowledge mobilization and transfusion medicine research. Transfusion 2014 Sept;54(2S):231A. 
The authors are from CBS's Centre for Innovation. 'Leading edge' on the Centre's website grates but at least it isn't 'bleeding edge.' As soon as I read 'knowledge mobilization' in the abstract I thought, 
  • 'OMG, not more management bafflegab by Canada's national blood supplier!' 
  • If there's a new buzzword out there like knowledge mobilization, you can bet CBS management will jump on it. 
That said, reading the abstract, I lost my skepticism, well at least some of it. The project to educate front-line CBS staff about the organization's research initiatives and research team is admirable.

The blog's title derives from the principal song of the musical 'Man of la Mancha' based on Cervantes' 17th C classic, Don Quixote. I hope that transfusion professionals the world over can relate to the blog's musings on the nature of research.
ABSTRACT 
Here's my version of the CBS research initiative. (Read full abstract for more details) 

Title: Bridging the gap: knowledge mobilization and transfusion medicine research
Why do it?  To transfer knowledge generated by basic and clinical research to those whose work it may affect. Unfortunately, journal publications and conference presentations have limited access.
What did they do? CBC developed these tools:
  • Summaries in plain language of notable publications were published online monthly and aimed at all stakeholders, including donors.
  • Knowledge to Munch OnInternal follow-up to major conferences, inc. 
    • Displays of conference posters
    • Distributing an electronic conference report
    • Lunch and Learn national webinars highlighting conference presentations. 
What did they find? Summaries in plain language: Between March 2013 and March 2014, 10 Research Units were online and downloaded >1100 times.

Knowledge to Munch On:
  • 66 conference presentations were available to staff who couldn't attend conferences
  • 3 electronic conference reports were downloaded 747 times in the 3 months after publication
  • Lunch and Learn: 8 presentations were attended by 263 staff.
    •  96% agreed with, 'This event enhanced my knowledge.' 
    •  76%felt that the knowledge was applicable to their practice.
What did they conclude? The programs' impacts are measurable and need more developing and monitoring to achieve a greater impact.

My take on the CBS research project
  1. Demographics: Who viewed the posters, downloaded the summaries and reports, attended and participated (geographical locale and health profession)?
  2. When were various components of the program available and accessed? During the work day vs lunch hours, coffee breaks, and after hours at home?
  3. Plain language summaries of 10 research units downloaded a total of  >1100 times over a year is NOT very much. 
  4. Was a Likert 5-point scale used to assess participant feedback? e.g., 96% agreed with, 'This event enhanced my knowledge' and '76% felt that the knowledge was applicable to their practice.'
Seems like a good start. Wonder how much time, effort, funds were spent and how committed CBS is to maintain the project, given the organization's overpowering emphasis on cost cutbacks, even related to its core business lines.

MUSINGS on RESEARCH
1. Research means being incurably curious about the world. Researchers, especially those involved in basic research, conduct many experiments year after year with failure after failure and little hope of success, until it happens, if it does. 

2. How many researcher dudes have you even heard of (and they are mainly dudes)? You may recognize the names of the luminaries who publish in leading journals and present often at conferences. 

But if you are a front-line transfusion professional, whether lab technologist /biomedical scientist, nurse or physician, you likely do not read papers or attend sessions on basic research, whose titles are often indecipherable. Even applied research gets little readership unless it directly affects us.

3. Many types of research existSee this primer on medical researchOn a simplistic level
  • Basic research is wondering if inherited traits might make different groups of people more or less susceptible to the same disease.
  • Applied research is trying to develop a screening test for HIV once we know it causes AIDS, and possibly making mega-bucks in the process.
4. It's easy for people to slag researchers as egg heads divorced from reality. These guys and gals get to attend conferences and seemingly live a charmed, stress-free life compared to those in the trenches. 

Indeed, I live in a university city where some politicians have long dissed academics as not living in the 'real world'. Anti-intellectualism is popular among populist politicians and a sure vote winner with some.

5. What the public does not see is the stress of researchers: 
  • Proving their worth annually by winning scarce research funds
  • Keeping spirits up in the face of experiments extending for years 
  • Defending criticism from peers when they publish findings
  • Facing condescension by some who perceive them as pampered 'ivory tower' dwellers.
6. Basic research, often derided, has a record of producing major scientific findings. One example:
Hepatitis BApplied research is all the rage among politicians these days, but basic research rivals it via serendipity. 
Hepatitis B kills more than 700,000 people annually. Prevalence is highest in sub-Saharan Africa and East Asia, where most people become infected during childhood and 5-10% of adults are chronically infected. Vertical transmission from mother to child is common. About half of all cases of hepatocellular carcinoma are attributed to chronic HBV infection.  
Today all blood donations are screened for HBV thanks to its discovery by Dr. Baruch S. Blumberg 
In 1976, Dr. Blumberg won the Nobel Prize for Physiology and Medicine for his discovery of the hepatitis B virus. He and his colleagues discovered the virus in 1967. 
But Blumberg began as a medical anthropologist interested in the genetics of disease susceptibility. He wondered if inherited traits might make different groups of people more or less susceptible to the same disease. The research had nil to do with hepatitis.
His research involved using antibodies from multi-transfused hemophiliac patients to test blood samples collected around the world. When an antibody from a New York hemophiliac reacted with an antigen in the blood of an Australian aborigine, they called it the 'Australia antigen', and the serendipitous path to a life-saving discovery was made. 
The Au antigen was subsequently found in the serum of many multi-transfused leukemia patients. Was it related to causing leukemia? Then Blumberg's laboratory technologist developed hepatitis B. And ultimately it became clear that the Australian antigen was the hepatitis B surface antigen
Soon a lab test was developed to screen blood donors and a vaccine was developed.
BOTTOM LINES
  • Basic research, with unknown outcomes, often trumps applied research, despite applied research being the flavour of the decade. 
  • A researcher's life is not all roses. Far from it. 
  • All health professions should get to know each other better, including the researchers who work behind the scenes and whose work can affect us all.
FOR FUN
The blog's title derives from the musical, Man of La Mancha, based on Cervantes' Don Quixote, and its song, 'To dream the impossible dream'

Like Don Quixote, researchers are sometimes seen as impractical, naive, idealist dreamers. Researchers dream the dream daily. It keeps them going. They never know when something momentous will be discovered, something to improve the lives of people, like Blumberg's Australian antigen did.
As always, comments are most welcome.
FURTHER READING
  • Baruch S. Blumberg

Monday, October 13, 2014

Bridge over troubled water (Musings on what to be thankful for as TM professionals)

Updated: 25 Nov. 2014

Apparently being thankful can improve your life. A professor of psychology at the University of California says so. It must be true (she wrote with tongue in cheek). Actually (and I hate writing or saying 'actually' after hearing a news reporter begin every sentence with it), I suspect it's true in most circumstances. Not necessarily when linked to being obsequious, though.

I had earlier written another blog for October on a topic I often blog about (two guesses - see below) but rethought it, especially since it's Canada's Thanksgiving today. Accordingly, this month's blog is about three things I feel thankful about it in the world of transfusion medicine and two that I don't.

Despite the Canadian references, transfusion professionals worldwide should be able to relate. As you read, I encourage you to think about your career and assess if any of my musings agree with yours.  Please feel free to comment.

The blog's title derives from 1970 Simon and Garfunkel classic, one of my favorites.

TOP THREE 'THANKFULS'

#1. Career in Transfusion Medicine
My life in TM began by accident and I never should have been hired. I was a high school teacher who wanted to work in Winnipeg but jobs were hard to come by for a 21 year old with a year's experience teaching in a rural Manitoba 4-room high school.

Lo and behold - a friend said, 'Pat, Canadian Red Cross Blood Transfusion Service hires BSc grads because most med lab tech grads from Red River Community College are scared to work there.' Say, what? I later learned the fear was largely because the clinical rotation was pathetic. Students spending most time labelling tubes and similar scut work in between being told by technologists to get the ABO group right or they could kill a patient. Did I mention the clinical rotation was only 2 weeks then?

Soon I started work in a large combined blood centre and transfusion lab, the latter doing compatibility testing for all city hospitals and beyond, plus prenatal testing for northwestern Ontario. At first, I did not even know what the yellow stuff was when the red cells settled. True story. Could never happen today, a good thing.

I'm so thankful for the mentoring of generous colleagues. And for wanting and needing to read the 'bibles' of TM from front to back (every word). The books were penned by such icons as Issitt and Mollison, and included the AABB Technical Manual and a 'little red book' written for Red Cross staff by Dr. B.P.L. (Paddy) Moore (and others), National Director of the Red Cross Blood Group Reference Laboratory, who died in 2011. I wrote about Dr. Moore in a 2007 blog, 'My life as a blood eater.'

I worked in Winnipeg for 13 years, got Subject certification in Transfusion Science (no longer offered) from what is now CSMLS. My last 3 years were as the clinical instructor for new laboratory staff, RRCC students, and medical residents doing a transfusion medicine rotation in the only show in town. How crazy is that?

Looking back, I'm thankful that I worked in a busy laboratory where you never knew what to expect. Besides the routine of pretransfusion testing for scheduled surgery and anemic patients, at any time 24/7 patients might need massive amounts of blood in a hurry from a ruptured aneurysm to a GI bleed to a placenta previa during delivery. Often the lab was chaotic but it was organized chaos, even if that's an oxymoron.

Moreover, I'm thankful that in those days work was mostly hands-on and issues arose daily that required problem solving. For example, I worked with Dr. John Bowman when he did the first trials of antenatal Rh immune globulin and was involved in the work that led to this paper (I'm the Pat):
Eventually the blood donor side of the laboratory got an autoanalyzer, the Technicon BG-15. We called it 'Big George' and two staff (probably closet chemistry technologists at heart) opted to become 'specialists in automation'. Can you see the irony?
For an absolute hoot, when you have some time for 'mindfulness' reading, see these articles from 45 years ago by Canadian Red Cross staff, including Dr. B.P.L. Moore. The second includes, 'The possible future role of automated tests on blood donations is briefly discussed.' (Emphasis is mine.)
As to my career, the rest is history.... I'm thankful that I lucked out getting a teaching job in Medical Laboratory Science, University of Alberta, where I had the privilege of again working with generous, talented colleagues and teaching 100s of bright, inquisitive students, who kept me on my toes and forced me to keep learning. To be honest, at MLS I believe I had the best job teaching blood bank in the entire world.

Thinking about a career, particularly in later years, makes you realize how lucky you have been. I'm thankful to have worked in the trenches of blood banking doing work that made a difference and then to have gotten a job where that knowledge and skill could be passed to others. I hope that's true for you too.

As an aside, I'm thankful that I learned how to create web sites before it was easy (and you needed to know html code), which has stood me in good stead over the years, especially after I left real work. 

#2. Living in Canada
The good points of living in Canada are obvious, but that's not where I want to go. I imagine residents of many countries feel privileged for various reasons.

Instead, in keeping with the transfusion theme, I'm thankful that today Canadians are free to criticize CBS and our blood system leaders. Goodness knows, I do plenty of that and live to write another day.

October's TraQ newsletter has examples of criticism and responses to it:
In olden days, medicine was so paternalistic that physicians had god complexes. Some still do but times have changed, not just among health professionals but between doctors and patients, as in this 2011 Maureen Dowd column in the NY Times:
In many countries criticism of perceived authority is not allowed. And in some democracies health care workplaces exist where questioning prevailing orthodoxy, especially by those lower in the pecking order, is discouraged, even risky, career-wise. I'm grateful that's not true in Canada's transfusion medicine community, at least not the one I've been fortunate to work in.
#3. UK's SHOT
The UK's haemovigilance scheme (why is everything in UK TM a 'scheme'?), known universally as SHOT (Serious Hazards of Transfusion), is a world leader in hemovigilance.
Note, I've dropped the 'ae' diphthong, which still rears its ugly head in Canada, a carryover from transplanted Brits running our blood system. (big grin).
I'm thankful for SHOT, a godsend to TM professionals globally and one of the best tools for education and quality improvement ever. As an educator, I use it repeatedly to make instruction real to students and professionals alike.

The prior blog discussed an example from the 2013 SHOT report on how errors occur and touted it as a great CE resource. 
  • Stand by me (Musings on effects of errors on transfusion professionals)
I've mentioned SHOT again in order to emphasize one of the 'Bottom Two' issues below that I'm NOT thankful for.

One of the best parts of SHOT's reports are its case studies, which detail exactly what went wrong and provide learning points. As but one example from SHOT 2013:
  • Case 3: ABO incompatible transfusion despite a robust system of warning alerts on the laboratory information management system (LIMS)
  • Search for 'Case 3' (without the quotation marks)
Excerpt:
" An ABO incompatible red cell unit was transfused resulting in a haemolytic transfusion reaction. The blood was issued using an emergency protocol on the LIMS, which was not appropriate for the non-urgent clinical situation, and the computer warning flag stating that the units were incompatible was overridden several times by the biomedical scientist (BMS).

This incompatibility was not noted at the bedside and when the patient reacted to the transfusion, the doctor who was consulted advised that the transfusion should continue without reviewing the patient. The patient developed acute and delayed haemolysis, but no long-term sequelae."
Good stuff, no?

TWO NOT-THANKFULS
To give the blog a dash of hard cold reality and move from 'Kumbaya' territory, two TM realities I'm not grateful for:

NOT Thankful For #1
Canada's lack of a hemovigilance reporting similar to SHOT, where TM practitioners and educators alike, can see how our TM system is doing. Oh wait! Instead of the usual archived SILENCE, all of a sudden, TTISS is online with  - wait for it - summary tables:
Okay, I guess we should be thankful for small mercies. We're keeping statistics, so will be able to measure improvement. And finally a public report on all the data that's been collected, even though no news media have picked it up, hence no citizens will even know. Plus, no real details, no analysis. Baby steps...

For interest, I blogged about Canada's lack of hemovigilance reporting in 2011:
NOT Thankful For #2
Health Canada's stonewalling on Ontario's paid plasma clinics. I've blogged about this many times. HC's public consultation from April 2013 has transmogrified into SILENCE as 2015 approaches. Hmmm...

The one thing perhaps to be grateful for is the hope that 'no news is good news.' Not holding my breath.

LEARNING POINTS
1. I hope all readers can say they love their careers as I love mine. In some ways the 20th C was a golden age, especially for those of us who love immunohematology.

Work is something we do, first to provide essentials like shelter and food, second to be able to appreciate the good things in life that aren't free, and third, to make a difference in the world - to make life better for each other.

TM professionals are truly fortunate to love going to work each day and to be able to question authority. For so many on the planet that's not true. Best of all is knowing we make a difference, each in our small way. It's captured by Mary Oliver in her poem, The Summer Day:
'Tell me, what is it you plan to do
with your one wild and precious life?'
2. Where we live is an accident of birth. We in the industrialized west are so fortunate. Search Google's images for 'children garbage dumps' for  1000s of examples. Or people who say homosexuality should be accepted or places where female genital mutilation commonly occurs.

3. Some national blood systems spend time, energy, and money on improving transfusion practice and generously share it with the rest of us. The best example is SHOT, funded by the UK Blood Services. Kudos to NHSBT. Wish Canada and the USA would do more of the same. Hope springs eternal...

FOR FUN
What was my original Oct. blog's topic? Two guesses (my favorite 'hobby horses'):
A. Paid plasma clinics
B. HIV/AIDS
For  clue, look at TraQ's Oct. newsletter.
Now, on to the fun music selections. On the two TM issues I'm NOT grateful for, the song that comes to mind is Simon and Garfunkel's 1964 classic, 'The Sound of Silence,' #156 on Rolling Stone's list of the 500 Greatest Songs of All Time and one of the most covered songs of the 20th C.
On the three TM realities I am grateful for, the chosen song is another Simon and Garfunkel classic, 'Bridge Over Troubled Water' released in 1970, ranked #48 on Rolling Stone's list of the 500 Greatest Songs of All Time.

Why? Mainly because I'm grateful for this song and appreciate its lyrics.
Also, because one of the best things in life is to be grateful for our friends.
When you're weary, feeling small,
When tears are in your eyes, I will dry them all.
I'm on your side. When times get rough
And friends just can't be found,
Like a bridge over troubled water
I will lay me down.
As always the views are mine alone and comments are most welcome. Does any of this ring true? What are you grateful for these days?

Added 25 Nov. 2014

In reply to Anonymous, who notes Globe and Mail article:
Another article from Toronto Star on the news:
Seems CPR will try to open paid plasma collection centres in western Canada, likely BC or Alberta [vs Saskatchewan or Manitoba, where a paid plasma clinic exists in Winnipeg, but for plasma containing special antibodies, e.g., anti-D to produce Rh immune globulin)] because of their larger populations and openness to private medical facilities.

About CPR collecting plasma for research purposes in Ontario, I agree it would be interesting to see the protocol and informed consent for such a proposal. Thanks for the comments.

Added 3 Nov. 2014

In reply to Anonymous, who writes about introducing paid plasma clinics in Ontario:
  • "Policy decisions of this nature should not be made without hearing from those who are affected the most by the legislation: that is, the recipients of plasma-derived medicinal products represented by their associations”:
For reference, PPTA is Plasma Protein Therapeutics Association. PPTA represents the private sector, collectively known as plasma protein therapies and the collectors of source plasma used for fractionation. In other words, PPTA represents a part of Big Pharma whose business involves collecting, manufacturing, and selling blood-derived plasma products.

The link provided by Anonymous is to a paper in the Fall 2014 issue of The Source, a PPTA publication:
Page's article is PRO PAID PLASMA (my interpretation): Today's products derived from paid plasma  are safe and all user groups want paid plasma because they buy the premise that, without it, their lives are at risk.

Interesting that PPTA's Fall 2014 issue of The Source includes David Page's article, as well as an article by CBS CEO Graham Sher:
Dr Sher's take home message is the same as he's espoused in Canada;
  • [Paid plasma] is an issue of public policy, not product or patient safety.
  • Pharmaceuticals made with plasma from paid donors are safe, lifesaving products for patients in Canada and around the world.
  • Canadian Blood Services remains committed to voluntary donation for its donors.
Sher's article is PRO PAID PLASMA (my interpretation): Because paid plasma is safe, to use it or not depends on government policy.Without paid plasma, people would die. But, hey, CBS is committed to a voluntary blood system. 

The PPTA would not publish articles that were anything but PRO PAID PLASMA. 

Further Reading


Sunday, September 07, 2014

Stand by me (Musings on effects of errors on transfusion professionals)

Updated: 9 Sept. 2014
Recently, I browsed the Speaker abstracts and Poster abstracts for the BBTS annual conference to be held 24-26 Sept. in Harrogate, UK. The abstracts were published online 26 August 2014 as free full text. At the same time, I happened to be reading the UK's 2013 SHOT Report published in July. One abstract and a section of the 2013 SHOT coalesced to form the idea for this blog.

September's theme relates to all transfusion professionals, whether lab technologist/scientist, nurse, or physician. The blog’s title derives from a 1961 song by Ben E. King, covered more than 400 times and featured in a 1986 movie of the same name.

Of all the fascinating BBTS abstracts, the one chosen to build a blog around is under 'Clinical Audit/Service Improvement Short Paper Orals':
  • SI27. An exploratory research study into the effects of staff feelings and perceptions following a transfusion incident investigation. Transfus Med 2014;24 (Suppl. 2):19. 
    • By D. Creighton (SNBTS Edinburgh) and M. Wright (Glasgow Caledonian University, Glasgow)
The reason this abstract resonates is that in a long career as a lab technologist, supervisor, and educator I've been involved with and privy to many serious transfusion errors and their effects on the professionals involved.

What follows are my musings on the BBTS abstract and related personal memories, as well as what the 2013 SHOT Report says about causes of human error. The focus is on the effects that errors have on those who make them, realizing that it is patients who suffer irrevocable, sometimes fatal, consequences.

As an aside, with a background as a medical laboratory technologist (biomedical scientist) and transfusion science educator, what I like about the 2014 BBTS meeting is how many talks and posters directly relate to transfusion professionals who work in the laboratory.

2014 BBTS MEETING ABSTRACT
As noted, the abstract that stimulated the blog is by D. Creighton and M. Wright of the SNBTS Edinburgh, and Glasgow Caledonian University, Glasgow, respectively. Please read the complete abstract (Further Reading). My précis of it is as follows:
  • Most research on transfusion errors focusses on procedural errors, not human factors or staff emotions. This research examined the emotional impact of errors and contributing factors.
  • Researchers recruited and interviewed staff involved in a transfusion error and analysed results.
  • Of 12 staff, five agreed. The main human factors acknowledged by four participants were distraction and a busy work environment when the error occurred. 
  • All five expressed disbelief they had been involved.
  • Four were affected emotionally, experiencing insomnia and decreased confidence. 
  • Most worried about confidentiality and other staff knowing they’d made an error. 
  • Support was mainly positive but two participants experienced negative reactions from colleagues. 
  • All learned lessons which they would carry forward and share with colleagues. 
  • Participants’ reactions directly correlated to error severity and potential patient outcome.
The authors conclude that human factors need to be included in training packages. Reactions and feelings of staff involved in errors can be overwhelming and support is crucial.

MUSINGS
With the advent of quality systems and hemovigilance, transfusion medicine has long had a no-blame culture (at least in theory), as have health care systems in general. For example,
A no-blame culture is critical for patient safety. Health professionals must feel comfortable with reporting errors, including their own, so that hemovigilance and quality improvement programs can detect, analyse, and help prevent them in future. In an effort to encourage error reporting, we use blame-free terms such as events, incidents, and occurrences. Despite the talk, 'walking the talk' of no-blame attached to individuals who make errors is a tough slog.

PERSONAL MEMORIES
Below are two memories of transfusion-related errors I was involved in with serious consequences.

Memory #1 
Years ago when working in a combined centralized transfusion service/blood centre, one weekend when on shift by myself, I crossmatched a group AB patient for several RBC. The following Monday I was also working when the call for more blood came through. We had to order a new specimen as there was no more patient serum. (Yes, in olden days we routinely used clotted blood samples for pretransfusion tests and even patients without clinically significant antibodies were crossmatched by indirect antiglobulin test and more.)

Much to my horror the patient now typed as group O. I’m sure my entire insides shook as a colleague redid the patient’s ABO on the earlier sample. Absolute personal relief when it typed as group AB.

The transfusion service did the usual follow-ups. Called to stop any transfusions, asked how many RBC had been transfused and if patient was experiencing any signs and symptoms of a hemolytic transfusion reaction, requested new blood specimens, etc.

The patient experienced a severe hemolytic transfusion reaction but survived.  It’s amazing how resilient the human body is, even for those ill enough to be transfused:
We later learned that a hospital nurse had drawn the blood specimen from the wrong patient. Both the group AB and O samples came from patients in the same hospital room. And the RN in question was the highly respected liaison we dealt with at that hospital, the one who drew many of the blood samples and maintained the onsite ‘blood bank’ (refrigerator and associated request forms and records).

The effect on the implicated RN is unknown. Was the patient's family told what had happened? I doubt it. The effect on me - I’ll never forget it. 

If I had mistyped the first specimen, would I have been fired, even though it was the first ‘critical incident’ (or any error) I’d been involved in? Perhaps. That was a long time ago, pre-quality systems, when the concept of ‘system error’ was unheard of in health care. We were not unionized and worked long (indeed outrageous) hours without time off.

But before being fired, I suspect that I’d have resigned from the guilt and shame of having made the biggest error a lab technologist can make, mistyping a patient’s ABO group and putting a patient's life at risk. Because ABO errors can cause death, they require 100% accuracy, no room for error. Could counselling have helped? Maybe. Even more important would be the support, understanding, and ongoing respect of colleagues.

Of interest, the 2013 Annual SHOT Report reports 9 ABO incompatible red cell transfusions in 2013 and one patient death with the incompatible transfusion as a contributory factor.

Memory #2 
Much later, while employed as a university professor and clinical instructor for the transfusion service at a tertiary care hospital, one of my students made an error that caused a patient’s premature death. The error per se did not cause death but hastened it.

What was the error? Something so simple. Something that can happen if concentration wanders, or strategies are not in place to prevent them, or practitioners don’t follow procedures.

While performing antibody screens, the student mis-pipetted one patient’s serum into another patient’s tests. As a result the patient was transfused with incompatible red cells and subsequently died. I documented the error as a TraQ case study for the BC Provincial Blood Coordinating Office.

Although not directly involved with the error (the student was supervised by an experienced, exemplary technologist), I observed the aftermath first hand. The main effect was that the experienced, supervising technologist, one of the best, with great potential, soon left the lab for a career outside health care. Could this have been prevented? With proper support, I believe so.
  • TraQ's Case A8: Severe Hemolytic Transfusion Reaction Involving a Student (see Further Reading)
MAKING MISTAKES
When we make mistakes, our first reaction is to deny them. For example, as an instructor I noticed that students who made pipetting and other mistakes would invariably claim something like, “I KNOW I added the right things’, where ‘things’ could be patient serum, reagent red cells, etc. My response was always,
  • ‘Of course, you thought you were adding the right things to the tests. If you knew you were adding the wrong things, you’d stop and would not add them.’ 
Fortunately, because such errors are often easy to demonstrate, students could accept their errors, learn from them, and move on.

Sometimes, especially as students, we progress to blaming circumstances for our errors. And sometimes circumstances do play a role as when staff are overworked, morale is poor, and training and competency assessment are inadequate. These are the so-called system errors where the system is faulty and affects all involved.

2013 SHOT REPORT
A fascinating feature in the 2013 Report is the inclusion of the MHRA hemovigilance team's analysis of serious adverse events (SAEs) reported to Serious Adverse Blood Reactions & Events (SABRE).
  • Medicines and Healthcare products Regulatory Agency (MHRA) Report on Blood Safety and Quality Regulation in 2013 (See pp. 27-41)
In 2013, 2.9 million blood components were issued in the UK with only 705 SAE reports submitted. Human error accounted for 689 (97.8%) of the SAEs, where an SAEs is defined as
‘Any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood or blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.’
In brief, reports to SABRE showed that those making errors were aware of their local SOPs, which were complete and current. Individuals were either busy with urgent work when the error occurred (especially during out of hours shifts), or were otherwise distracted. In either case the result was an error due to a lapse in concentration.

Of all reported human errors, a lapse in concentration was the largest single cause, accounting for 35.6% (245/689) of errors. The next largest category related to omitting procedural steps or not following the correct procedure. About two thirds of all SAEs could have been prevented had correct procedures been followed.

The advice that especially caught my attention in the MHRA report:
  • Formal re-training is often proposed as a corrective measure but is usually only appropriate if the individual did not understand their initial training. If a trained, competent member of staff makes an error, the root cause will seldom, if ever, be addressed by re-training. 
  • Look for other reasons for the error, e.g., for an error due to loss of concentration when rushing, investigate why the staff member was rushing. Possible causes include a busy workload due to an emergency, poor planning, staff shortages due to lack of resources, or poor staff management
Being rushed is a reality for health professionals, now more so than ever. A major complicating factor has long been staff shortages and under-staffing caused by repeated health care restructuring, ongoing cutbacks to postsecondary education and health care, and more.

LEARNING POINTS
When errors happen, we in the TM community espouse a ‘no blame culture’. Sometimes it’s real, sometimes it’s pretence, in that, despite the nice words, staff are blamed and stigmatized.

But as the BBTS meeting abstract shows, we typically don’t consider the emotional effects of making errors on those involved. It’s all cool root cause analysis, perhaps targeting ‘system error’ as the culprit, but more often resulting in ‘training issue’ as the catchall for whatever goes wrong.

How the staff involved feel is seldom considered and, besides re-training, their emotional well being is largely ignored. At most a caring colleague might ask, 'Are you okay?' with the individual involved seldom replying honestly.

No-blame culture aside, making errors devastates health professionals and undermines confidence.  In some ways, that’s preferable to brushing off errors with, ‘Oh well, sh*t happens’. But without support, a serious error can have long-lasting negative effects on individuals and co-workers alike. Even well meaning colleagues may be critical, never overtly express it to those involved, thinking it could never happen to them, or secretly thinking, ‘Thank gawd that wasn't me!’

A critical issue is that we acknowledged making errors as human. If we haven’t made one yet in the lab or on the wards, we likely haven’t worked long enough. Or is it that we are perfect? Hmmm…. Tempted to say, ‘Let he who is without sin [error], cast the first stone.'

In that vein, I love this BMJ piece:
As an instructor I tried to model these words to show students it’s okay not to know. Who can know everything with today’s rate of knowledge turnover and technological advances? Don't know? Let’s find out.

Maybe we should add, ‘I made a mistake’ as three words we acknowledge but don’t let define or destroy us.

FOR FUN
We’re all in this world together and must support each other, especially when the going gets tough. As health professionals, any one of us is capable of making a devastating error. Support and compassion are not only kind but validate our humanity.

Think of this song the next time a colleague screws up. Could be you, yes it could.
I'll end by asking you to find 19 minutes to watch Dr. Brian Goldman's TED talk on physician error. That may seem a lot of time in our busy lives but think of all the time we waste on the Internet and television each day. You won't be disappointed with Goldman's talk. His message applies to all of us. Perhaps you can listen to it on your next walk or jog or over lunch?
As always the views are mine alone and comments are most welcome.
FURTHER READING
Meeting abstracts and resources like SHOT reports and TraQ's case studies are free continuing education and a great way to keep abreast of new developments and what’s trending. They make great bathroom (toilet/loo) reading to while the time away so that life’s baser functions serve a higher purpose.

Why not skim them online and then print content of most interest for later reading? Or print for discussing at staff meeting or journal clubs. Do journal clubs even exist any  more?

Saturday, August 09, 2014

The way we were (Musings on TM history and its lessons for today)

Updated: 11 Aug. 2014
This month's blog discusses 3 recent news items (and associated scientific papers) related to men who have sex with men (MSM), HIV risks, and blood donation, plus a paper written by Canadian transfusion medicine experts on Canada's perspective on donor criteria for MSM.

The blog's title is from a 1975 Barbra Streisand classic (one of my favorites) and theme from an eponymous movie starring her and Robert Redford.

Please read the news items and papers as they provide fascinating, useful details beyond the brief reports presented in the blog. Although the specifics involve North America, the content and learning points apply everywhere.

1. USA: HIV positive man arrested and charged after donating plasma for $30
A man admitted to police that he donated plasma at BioLife in Elkhart, Indiana even though he knew he was HIV positive. He'd lost his job and needed money. 
Biolife pays $30 for plasma via a debit card and is a division of Baxter Healthcare
The plasma donor was charged with three counts of attempting to transfer contaminated body fluids and one count of transferring contaminated body fluids.
2. USA: Activists fight MSM policy (lifetime deferral if even once since 1977) with National Gay Blood Drive on 11 July, 2014.
The blood drive involves gay and bisexual men who want to donate bringing proxy donors who are eligible to donate and publicizes what activists believe is an outdated discriminatory and unscientific policy. 
The news item outlines the key issues on both sides of the argument with quotes from Paul Strengers, medical director at the Dutch Sanquin Blood Supply Foundation (anti-changing the policy) and the American Medical Association (pro-change). 
Related: AABB, ABC, ARC Joint statement on National Gay Blood Drive
Among other things, the US organizations were concerned that the event might disrupt blood center operations but support "rational, scientifically based deferral periods that are applied fairly and consistently among blood donors who engage in similar risk activities."
3. USA: 5 reasons HIV is on the rise among young gay and bisexual men
In brief, according to HIV researchers at CDC, the reasons include young gay and bisexual men's partners are more likely to
  • Have and transmit HIV
  • Engage in risky sexual practices
  • Use drugs
  • HIV's stigma could make people less likely to get tested
  • Younger men weren't around for worst of the HIV/AIDS epidemic and are less likely to know the dangers
Related: Johnson AS, Hall HI, Hu X, Lansky A, Holtgrave DR, Mermin J. Trends in diagnoses of HIV infection in the United States, 2002-2011. JAMA 2014;312(4):432-4.

4. Goldman M, Lapierre D, Lemay L, Devine D, Sher G. Donor criteria for men who have sex with men: a Canadian perspective. (Commentary) Transfusion 2014 Jul;54(7):1887-92.
With other jurisdictions considering a change in MSM policies, this paper was written by Canadian blood experts who thought it might be of value to share Canada's experience. It outlines CBS and Héma-Québec's extensive processes to consult interest groups / stake holders to achieve a consensus to support Canada changing its long-standing permanent deferral for MSM to a 5-year deferral from last MSM contact
The 'Commentary' begins by outlining the history of the HIV/AIDS/HCV 'tainted blood' disaster in Canada, which led to the Krever Royal Commission of Inquiry into Canada's blood system and its 'damning' (my word) 1997 report.  
As a result, in 1998 CBS and Héma-Québec were created; blood was regulated as a drug with blood centres considered biologics manufacturers, with more stringent regulatory oversight by Health Canada. 
I'll present only a few key highlights of the paper, those selected through my biased eyes. Also note [my Comments].
HISTORY: [One of the most explicit mea culpas I've seen from Canadian TM experts]:
* There was a lag between implementing measures to reduce transmission of AIDS/HIV in Canada compared to the US and others, including donor deferral criteria, HIV antibody testing, and sole use of adequately virus-inactivated factor concentrates.

* Delays contributed to infection of many transfused patients, with the hemophilia population particularly devastated by HIV. Delays also occurred in adopting measures to reduce HCV transmission. 
* Anger and bitterness over the (mis)management of HIV and HCV risk by the blood system cast a long shadow over the new organizations, CBS and H-Q. 
[Why did the delays occur? What's the root cause? A focus on cost over safety? A belief in evidence-based science that failed to consider what experts did NOT know? Or?]
STATISTICS: As of 2011 PHAC reports there were ~71,000 prevalent and 2250-4100 annual incident cases of HIV in Canada. MSM risk was high for prevalent and incident infections, accounting for about half of new infections.
* Large MSM studies demonstrate seroprevalence rates from 10% to 20% but generally recruit participants in gay venues and focus on currently sexually active MSM, often with frequent partner change (not those in longstanding monogamous relationships or those sexually inactive for a long time).

[Incidence of HIV seroprevalence in gays in long monogamous relationships is unknown.]

* With sensitive antibody detection assays and minipool nucleic acid testing (NAT), the window period for HIV is estimated at 9 to 11 days
* Residual risk for HIV is estimated at less than 1 in 8 million units at CBS and in the USA is 1 in 1.5 million units, due to higher rates of HIV+ donors. 
[FYI, residual risk is the risk of an infectious donation being present in the blood supply after all donor and donation screening activities occur and unsuitable donations are removed and discarded.  See Current information on the infectious risks of allogeneic blood transfusion - Residual risk. Put another way, it's the OOPS! factor.]
RISKS
* Risk modeling in Canada found the incremental risk of a 5-year deferral for MSM was less than 1 infected HIV unit entering the blood supply in 1000 years. 
* A 5-year deferral for MSM would not substantially increase transfusion-associated HIV in Canada. Similar modeling studies were done in France, UK, and USA. 
[Sounds great, eh? Almost as if we can crow, 'Don't worry, be happy'. But the fly in the ointment...] 
* 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where data are often sparse. Additionally, they do not provide information on novel or emerging threats.' 
[Modeling involves many assumptions based on minimal data – so much for evidence-based. Plus, obviously new and emerging threats (unknown) are absent from modeling studies.]
MUSINGS
I'm not going to report the guts of the Canadian paper, which outlines the processes used in Canada in 2001, 2006, 2008, 2009, 2011, and 2012 except to mention the Kyle Freeman court case.

But please read the paper if you have access because it explains the science and politics of MSM and blood donation as few resources have and the emotions and tension that marked the debate historically and still do.

In brief, the Freeman case involved a gay man who informed CBS via an anonymous e-mail that he donated and lied about his MSM status. To trace the anonymous e-mail and apply the appropriate deferral code, CBS sued for negligent misrepresentation as a way to obtain his identity from his e-mail service provider. He counter-sued, claiming CBS violated his rights under the Canadian Charter of Rights and Freedoms.

Freeman lost. Key elements of the judgment in favor of CBS were that blood donation is a gift and not a right and that MSM policy is not discriminatory based on sexual orientation.
Relevant reading:
LEARNING POINTS
MSM, HIV, and blood donation continue to be controversial and political. To me, key points from the Transfusion paper and related news items include 

#1. Goldman paper: 'Although modeling studies are useful to estimate small risk increments, they involve assumptions about many variables, where evidence is lacking. As well, they do not provide information on new or emerging threats.

In other words, models of HIV and other infectious disease risks to the blood supply are based on assumptions backed up with more or less zero data and do NOT consider new threats. So much for evidence-based decisions touted by TM experts.

#2. The role that student and gay rights activists play in changing blood safety policy is pure politics.

They claim discrimination (and a case can be made based on MSM vs engaging in risky behaviors regardless of gender) but ignore that HIV-prevalence of MSM presents a real risk to the blood supply. Moreover, HIV is on the rise among young gay and bisexual men, current HIV tests have a window period of 9 to 11 days, and donors may lie on blood donor screening questionnaires.

#3. Goldman paper: 'For patient groups, many of whom are chronic users of the blood supply, the change meant putting aside their fears of the past, assessing the available scientific information, and trusting in the system.'

To me, this is 'Don't worry, be happy' time (see earlier blog). Trust us. We've got your back covered based on science. Oh yah!

#4. All this aside, blood suppliers worldwide will cave to the political pressure of activist interest groups, claim it's evidence-based, and it won't affect blood safety until it does.

UK PERSPECTIVE
For interest, the UK's NHSBT donor policy on MSM:
The change means that only men who have had anal or oral sex with another man in the past 12 months, with or without a condom, are asked not to donate blood. 
Men whose last sexual contact with another man was more than 12 months ago are eligible to donate, subject to meeting the other donor selection criteria.
Other nations have permanent (indefinite) deferral or a 5 year deferral.              
FOR FUN
The blog's topic is not funny. The 'for fun' bit is just for enjoying the song. Looking back on the HIV tragedy and its impact on blood transfusion, I'm reminded of the innocent way we were before HIV appeared.
Mem'ries,
Light the corners of my mind
Misty water-colored memories
Of the way we were. 
Scattered pictures,
Of the smiles we left behind
Smiles we gave to one another
For the way we were.
Can it be that it was all so simple then?
Or has time re-written every line?
If we had the chance to do it all again
Tell me, would we? Could we? 
Mem'ries, may be beautiful and yet
What's too painful to remember
We simply choose to forget.
So it's the laughter
We will remember
Whenever we remember...
The way we were...
As always the views are mine and mine alone and feedback is most welcome.