Showing posts with label NHSBT. Show all posts
Showing posts with label NHSBT. Show all posts

Saturday, January 28, 2017

Four strong winds (Musings on trends identified by Malcolm Needs' 3rd CSTM blog)

Updated: 29 Jan. 2017
This month I'm going to feed off CSTM blogs on the career of the recently retired UK's Malcolm Needs (Further Reading). 

Typically, in the CSTM 'I will remember you' series of blogs, I offer my musings on what the featured author writes. But for January I've developed comments originally written for Malcolm's third CSTM blog (not yet published) into a stand-alone TM blog. So in a way this blog will foreshadow Malcolm's upcoming blog on regrets, concerns, and challenges, and serve as an advertising 'teaser' for it.

The blog's title comes from a 1963 song by the iconic Canadian duo, Ian and Sylvia. The blog is organized as a take-off on the song's title.

Strong Wind #1: AUTOMATION 
In his upcoming third blog, Malcolm mentions automation in the context of how it has changed the skill mix of staff employed in transfusion hospital laboratories. I've written about automation often including in 2010:
  • Goldfinger's filings, a customer's toolkit: Musings on business intelligence (Further Reading)
In the July 23, 2010 filing of its FORM 10-K Immucor (Form 10-K reports, which public companies file with the U.S. Securities and Exchange Commission, offer comprehensive business overviews of a registrant's business, such as history, competitors, risk factors, legal proceedings.) , one maker of blood bank automation (Immucor) writes:
'Our long-term growth drivers revolve around our automation strategy. We believe innovative instrumentation is the key to improving blood bank operations and patient safety, as well as increasing our market share around the world.'[Note they put improvements and patient safety up front, but increasing market share is their prime concern.]
'We believe our customers...benefit from automation. Automation can allow customers to reduce headcount as well as overtime in the blood bank, which can be a benefit given the current shortage of qualified blood bank technologists.' [Reduce headcount is a nice euphemism for get rid of staff and their costly benefits. Diagnostic companies also tout automation as freeing lab technologists/biomedical scientists to do more interesting tasks. And of course, if you can remove the human, you remove most of the error, or so it is said.]
  • 'We believe that instrument placements are the most effective way to gain market share ... Because our business operates on a “razor/razorblade” model....' [A razor/ blade model means give them the instruments relatively cheaply, because we can soak them with reagents costs, which continue forever.]
'In the new field of molecular immunohematology, we are currently developing the next generation automated instrument for the DNA typing of blood for the purpose of transfusion, which we believe will be the future of blood bank operations.' [And, by gawd, if a demand doesn't exist, we'll create one. See Strong Wind #4 below
Aside on automation: As a long-time transfusion science instructor (1974-99), graduates often told me they chose to work in hospital transfusion service labs because of the hands-on testing, correlating test results with patient diagnosis and history, and problem solving. They didn't choose clinical chemistry, in particular, because that clinical lab was heavily automated. Loading patient specimens on instruments and relying on software to flag abnormal results struck them as not nearly as engaging as transfusion science, or clinical microbiology, for that matter. 

Other grads obviously loved the highly automated clinical labs, and not just because job opportunities were more abundant. Of course, those who went to work for the blood supplier - on the 'dark side' as I affectionately call donor testing, where I enjoyed working in prehistoric days - inadvertently were sucked into the world of automated, mass testing of donor samples. 

Indeed, transfusion service labs whose test volumes warrant it, have moved into automated testing big time, as shown in the 'Goldfinger's filings' blog.

Strong Wind #2: LEAN
In his third blog, Malcolm also mentions LEAN. LEAN is a biggie in NA too, touted as an industry 'saviour', developed in Japan by the American Deming. LEAN expanded into health care ages ago. LEAN is promoted as allowing clinical laboratories and component production facilities to do more with less. 

For example, Canadian Blood Services (CSB) cooperates with Toyota and makes videos about  it. CBS higher level staff sport Master Black Belts in Lean Six Sigma. Jargon (~bafflegab) abounds as LEAN, Kaizen, and Six Sigma run together in a blur. 

Moreover, LEAN consultants make a great living by marketing it to health providers and training staff in-house. 

In 2008 I wrote a blog on automation and LEAN: 'Morning becomes Electra' (Further Reading). Refer to my views on whether automation and LEAN are progress, given that progress generally means improvement or growth, whether for individuals, organizations, societies, or humanity. 

Bottom line: Add automation and robotics to LEAN hospitals and soon we'll have gotten rid of all the non-value-added waste in the health system, as well as most of the health professionals. But is it progress?

Strong Wind #3: STANDARDIZATION
In his upcoming blog 3 Malcolm mentions that, in an effort to streamline how laboratories work, and to standardise (Brit spelling - grin) the work, a 'one size fits all' campaign was instituted in all NHSBT reference laboratories. 

From talking to colleagues in the field, I sense that standardized operating procedures (SOPS) are now 'SOPs on steroids'. Some hospital transfusion service lab SOPs are now so complicated that even long-time transfusion specialists must consult them often as they perform routine procedures they've done 100s of times. Do 'busy' SOPs increase patient safety? To me it's likely staff lose focus on patients due to the extreme emphasis on paperwork. 

Whenever a national blood supplier in any country tries to standardize work across laboratories or regions, my initial reaction is Beware! In his blog Malcolm explains the ways in which standardization doesn't always fit. My guess is that frontline staff aren't consulted enough initially and the head office folks writing the SOPs don't have the experience to realize it's a no-go from the get-go. 

Later the organization may ask for feedback on the SOPs that have been rolled out but seldom acts on it. Staff may even stop offering feedback because they've learned it's useless. 

I saw staff giving up firsthand in my brief stint as 'assman' at CBS (1999/2000). Staff tolerated nonsensical inaction from head office, because their feedback was met with a brick wall of silence and un-returned e-mails. Perhaps more senior people on-site knew little, too, because they were never told. Frankly, I shook my head in bewilderment at how dedicated, talented staff had come to accept the unacceptable. But, being naive, I went up the chain at head office until I found someone with real authority, who, when told what was occurring, fixed it immediately. 

About nation-wide SOPs:
  • Sometimes it seems as if they've been written by folks who have never performed the procedure, at least not currently;
  • Or maybe the writers know one lab's methods and don't understand that it won't fit others, a version of the cliché, 'a little knowledge is a dangerous thing';
  • Or perhaps standardization is a significant someone's current hobby horse;
  • Or, and here's the crux of the matter, standardization will save money in writing and revising. Never mind that they won't work operationally for every laboratory.
What's going on with SOPs in hospital transfusion service labs is a mystery. But I suspect it relates to government regulation and inspections by Health Canada (HC). 

HC regulators presumably gather input from all the stakeholders before new standards / regulations are instituted. But how much medical lab technologists / scientists play a role is debatable. 

My sense is that HC inspectors of transfusion labs have little, if any, first-hand knowledge of working transfusion medicine. Their concern focuses on documentation that processes have been validated and paperwork exists, regardless if it adds to patient safety, or even if they don't truly understand what it means. 

Strong Wind #4: MOLECULAR RBC GENOTYPING
Also in his third blog, Malcolm welcomes blood group genotyping as long overdue in immunohematology labs. 

As with any new technology, many constraints to widespread adoption exist, including staff expertise and cost. In the USA an added roadblock has been convincing government to pay for special DNA blood grouping when some of it is hard to justify with evidence. Naturally, patients with the money can get it. 

Again, see my 2010 blog, 'Snip, snip, the party's over?' for an overview of the issues (Further Reading). I see genotyping as a great innovation, but decry the increasing move to expand its uses beyond what can be justified clinically as a return on investment (ROI) in the technology. 

Moreover, I understand why, given that some folks have built their careers on it, and also dig the seductive lure of 'personalized medicine' (typical, over-the-top Rah!Rah! snake oil).  

For interest, see the UK's 'Red Book' (incredible resource) on 'Clinical applications of blood group molecular typing'.

LEARNING POINTS
In his upcoming third blog, Malcolm identifies concerns and challenges and shows hope for the future of TM labs. The issues he identifies are significant forces. Automation, LEAN, standardization, and molecular blood grouping are 'four strong winds' currently shaping transfusion medicine laboratories worldwide. At their heart, I see these 'winds' as deriving from 
  • Vested commercial interests;
  • Cost constraints and the need to do more with less;
  • Government regulation gone amok.
FOR FUN
Given Malcolm's four topics, I decided the 1963 song by Canadian icons Ian and Sylvia was too good to resist. Of interest, in 2005 this song was voted the top Canadian song of all time, quite an honour given that Canadians have written many great songs. 

The song is a reflection on a failed romance, but the phrase, 'if the good times are all gone' resonates with me. Of course, even the earth's seas and mountains change over time, nothing is forever. Also, as an Alberta resident for ~40 years, I can attest there is plenty to do here all year round. 

Not sure, however, just who all these TM changes/trends benefit. As always, I hope the blog is 'food for thought' for readers. Watch for Malcolm's multiple blogs at CSTM. His second will be published this weekend (Jan. 28-29) and third in Feb. 2017.
  • Four strong winds (Ian and Sylvia 1986 reunion concert)
    • At end see Murray McLauchlan, Judy Collins, Gordon Lightfoot, Emmylou Harris (left to right) join them on stage.
Four strong winds that blow lonely, seven seas that run high,
All those things that don't change, come what may.
If the good times are all gone, and I'm bound for moving on,
I'll look for you if I'm ever back this way.

Comments are most welcome.
FURTHER READING

Friday, February 19, 2016

Sweet Dreams (Musings on a recent transfusion-related nightmare)

Updated: 28 Feb. 2015 (see CBS's Dr. Sher audio clip at end)
February's blog derives from news items in TraQ's monthly newsletter that resulted in my dreaming from a 'what if' perspective.

The title derives from a Eurythmics ditty that I've used several times before. Was reminded of it again from this Twitter post from 
@SantaCruzbio:



For links to news items and resources, see Further Reading at the blog's end.


I HAD A DREAM 
Dreamt I was a Canadian who had a blood transfusion in 2018 and contacted a debilitating, deadly disease. Turns out 1000s of folks around the globe got the same transfusion-associated disease and many died within a few years before they discovered a treatment that works for many, but not all, and not forever. 

THE DISEASE
The disease I contacted was named 
  • Arrogant Scientific Syndrome by Highly Analytical Tossers after those who allowed it to happen (ASSHAT for short)
At first ASSHAT appeared in homosexual and bisexual males, so was deemed sexually transmitted and soon it showed up in IV drug abusers, presumably via contaminated needles. 

Hence, the perspective developed that it was the victim's fault - THEM - and wouldn't affect WE- those of us outside those groups. In other words, the typical WE-THEY bigotry. 

I DREAMT THE NEWS TODAY, OH BOY...
In my dream, here are but 6 things that happened in Canada, and no doubt occurred elsewhere, given that government bureaucrats, medical administrators, and physicians (sometimes the same individuals wearing different hats) are similar the world over.

1. The transfusion medicine community naturally denied ASSHAT was transfusion-transmitted until the evidence was overwhelming. They knew the blood supply was safe, so much safer than before. After all, the new transmissible disease test for hepatitis B had been implemented ~10 years ago. We felt safe.

2. At first the blood supplier chose not to screen out high-risk donors for fear of blood shortages, aided by interest group lobbying.

3. The blood supplier and its government funders were so concerned about saving money that they cut corners, in secret, of course. Specifically, they chose
  • Not to purchase a safer blood product for hemophiliacs in order to use up contaminated inventory, apparently thinking they were likely already infected, so what the hey! Or perhaps they thought better to give contaminated products than none at all, given the dangers of severe bleeding? Maybe they thought they were leveraging existing inventory to save money. Who knows?
  • To delay implementing a test for ASSHAT because money was tight.
4. Someone, who knows who or how, destroyed key documents, minutes of meetings) of the Canadian Blood Committee. This group influenced, if not outright decided, most of the above decisions.

5. At an individual level, a paternalistic physician chose not to tell an older man's wife that her husband was ASSHAT-positive because the physician was sure they were not having sex. No doubt he thought he was being kind. Wrong! The wife came down with ASSHAT and sued the physician, which is how we found out about it.

6. Ultimately, police laid 32 criminal charges against senior scientists at Health Canada, the Canadian Red Cross Society and Armour Pharmaceutical Co. Guess how many were convicted?

OUTCOME
In Canada a commission of inquiry was set up ~12 years later in 2030 and completed its report in 2034. That was 16 years after I contacted ASSHAT. 

But I was one of the 'lucky ones' who was still alive. And I benefited because the federal government  offered $120K in 'humanitarian assistance' in exchange for a promise we would not sue. The provinces later offered $30K/year for life. 

Those who got variant ASSHAT, resulting from the blood supplier failing to use surrogate tests used in the USA, threatened to sue for equal treatment and the government paid out millions of dollars. 

Many of those affected by both diseases died before compensation was available. Sometimes I suspect maybe that was the idea.

Then I dreamt that I was British and had a worse nightmare. The inquiry into ASSHAT offered only one wimpy recommendation after 6 years of inquiry, held more than 25 years after the ASSHAT tragedy. I had died by then.

LEARNING POINTS
Think what happened in my horrific dream couldn't happen, that it's just too far out, too sci-fi? Think again. It already has. Think it couldn't happen again? Why? The physicians and blood administrators who made the decisions decades ago were smart, caring people. But not infallible when confronted with financial constraints, interest group lobbying, and political pressure.

Canada was one of the few, maybe only, countries that held an extensive legitimate inquiry into what is typically called in the media, the tainted blood scandal

Canada's Krever Commission had 50 recommendations. The first was to compensate victims. Recommendation 2:
    • Blood is a public resource.
    • Donors should not be paid.
    • Sufficient blood should be collected so that importation from other countries is unnecessary.
    • Access to blood and blood products should be free and universal.
    • Safety of the blood supply system is paramount.
But apparently paying blood donors is now okay, at least for plasma, because we are so much smarter today and our technology is so much better. Sure it is. 

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

FOR FUN
I chose Sweet Dreams as the music for the blog because it's ironic. My dream was not a Sweet Dream but rather a nightmare. Nonetheless, I love this ditty:
  • Sweet Dreams [are made of this] (Annie Lennox, Live 8, Hyde Park, London, 2005)
Sweet dreams are made of this.
Who am I to disagree?
I travel the world and the seven seas
Everybody's looking for something.

Some of them want to use you.
Some of them want to get used by you.
Some of them want to abuse you.
Some of them want to be abused.


Thanks to Anonymous (see Comments below) for link to this video by CBS CEO Dr. Graham Sher:





Also thanks to Anonymous for 

  • Audio clip (~10 mins): CBS CEO Graham Sher's interview (CBC, The Current, 25 Feb. 2016) 
    • Transcript of interview
    • Apparently, the manufacturing process for plasma derivatives kills anything and everything. Why even test plasma collected for fractionated products? Maybe the price of IVIg would come down?
FURTHER READING
Canada
UK

Saturday, August 15, 2015

The early days (Musings on educating young TM professionals)

Updated: 18 Aug. 2015
August's blog was stimulated by the UK's Annual SHOT Report, which  has featured in past blogs many times. SHOT has long been the best hemovigilance program anywhere and is a treasure trove of educational goodies we can all learn from.

Since it's summer in the northern hemisphere, when many transfusion professionals will be enjoying the outdoors of our all too short summers (at least in Canada) the blog will consist of selected mini-musings on 2014 SHOT.

The blog's title derives from a song by Canadian folk singer/song writer, Chris Luedecke, known professionally as 'Old man Luedecke".

2014 SHOT - SELECTED HIGHLIGHTS
For perspective, in 2014 there were 2,663,488 blood components issued in the UK (74% RBC). SHOT received reports of 3668 cases or 13.8 reports per 10,000 blood components.
The following are but a few of my personal highlights. See Further Reading for the full SHOT Report.

Overview (What causes adverse events?)
In 2013, 77.6% of all incidents reported to SHOT were caused by errors & it's similar in 2014.
There is increasing concern about the impact of reductions in numbers and seniority of staff in the NHS.

SHOT 2013 reported that many, often multiple, errors are made during the transfusion process and data from 2014 were analysed similarly. As well, adverse events are grouped into 3 main categories. Failures relate to
  • Patient identification 
  • Communication 
  • Documentation 
Deaths (Worst transfusion-associated adverse event)
In 2014, there were 2 deaths definitely attributed to transfusion, 1 hemolytic transfusion reaction and 1 transfusion-associated circulatory overload (TACO). Delayed transfusion contributed to 3 deaths.

ABO-incompatible RBC transfused (Key because ABO mismatches can lead to patient death, major morbidity)
N=10 (0 deaths, 1 major morbidity). This compares to 9 in 2013 and 12 in 2012. All were due to clinical (not laboratory) error.

Near misses (Avoiding major patient consequences often due to luck)
Wrong blood in tube accounted for 686/1167 (58.8%) of all near misses, where a near miss is defined as,

"Any error, which if undetected, could result in the determination of a wrong blood group or transfusion of an incorrect component, but was recognized before the transfusion took place."
MUSINGS
Below are musings on a few highlights in SHOT 2014 (edited for brevity). Some caught my imagination because they were odd, and some involved serious adverse events.

#1. False Identity
(p. 45) describes several cases where the 'patient' is responsible for giving false identity. For example:
Case 2: Staff member involved in deliberate identity fraud
A blood group did not match the patient's historical record. Concurrent Haematology and chemistry samples were rejected and repeats of all samples requested.
Investigation revealed that test requests were initiated by a staff member. Samples were from a family member but labelled with the staff member's own details. The staff member returned to work after suspension and re-training.

Musings: A similar case occurred years ago at UAH in Edmonton, where a medical resident labelled his own blood sample as that of a patient in order to discover a particular lab result. To my knowledge he was given a bollocking and educated on why this was NOT a good idea.
Case 3: Pregnant woman conceals her identity
  •  A 24 year old woman had an ultrasound scan at a hospital where she was advised to terminate a pregnancy. 
  • The patient attended another hospital giving a friend's name for identity but her own father as next of kin. 
  • She had a surgical termination which was complicated by 
    • Massive haemorrhage requiring transfusion with RBC, FFP, and cryoprecipitate; 
    • Emergency intervention and uterine artery embolisation; 
    • Followed by admission to the intensive therapy unit , all at the first hospital. 
  • When her father was called in he confirmed she was his daughter but that the name on her wristband was not hers.
Musings: Years ago, when I worked in Winnipeg for the then Red Cross centralized transfusion service/blood centre, a similar case occurred. I crossmatched blood for a young woman having a therapeutic abortion. She had assumed the identity of her friend, who just happened to have a blood group on record.

Interesting that patients providing false identity still exists. It likely occurs much more often than we know because we only catch the ones where the 'false patient' has a prior blood group record or the real patient requires blood in the future. 
I also wonder about false identity in the USA where universal health insurance doesn't really exist yet. Do people who lack insurance for a needed procedure use a friend's identity?

In Canada it's now standard practice for physician offices to require photo ID, not just a provincial health care card. 
#2. ABO-incompatible red cell transfusions (pp.23,44)
As noted earlier, of 10 ABO-incompatible red cell transfusions, all were caused by clinical (not laboratory) errors.

  • In 7/10 cases there was a failure in correct patient identification, with no bedside checks performed. 
  • Actions taken varied but in one case 2 nurses were dismissed, in others staff were supported, retrained and their environment modified. 
SHOT gathered evidence that staff do not follow protocols and procedures and needs to investigate why.
  • In 7/10 clinical errors, group A RBC were transfused to group O patients
  • 2 were transfused in emergencies, 3 others were 'urgent'
  • One event occurred in a young woman during a liver transplant. The group O patient was bleeding and a new anaesthetist, who was an observer, 'helped' by taking the unit of blood from the refrigerator and transfused it. It was group A blood. 
  • The OR practitioner noticed the error when less than 50mL had been transfused. 
  • The patient died from complications following respiratory arrest. 
  • Root cause analysis resulted in several changes to surgical procedures.
Musings: It's amazing that 7/10 wrong ABO transfusions involved failed patient identification, with no bedside checks performed by clinical staff (presumably mainly RNs but including Drs, as in the case of the anesthetist described above). Unsurprisingly, most (5/7) occurred with urgent transfusions.

In the one case where 2 nurses were dismissed, I wonder if their errors were the final straw in a list of major errors. Because firing staff does not fit with today's no-blame culture of support and retraining, as occurred in other cases.
As SHOT notes, when health professionals do not follow established procedures and protocols, we need to identify why to prevent future occurrences.
#3. Most adverse events caused by error
SHOT documents that in 2013 and 2014 more than 75% of all incidents were caused by errors and expresses increasing concern about the impact of reductions in numbers and seniority of NHS staff.
Musings: Cutbacks and increasing numbers of senior staff retiring are concerns worldwide. Remaining staff are overworked and often lack needed experience and expertise. 
Unfortunately, few senior staff exist to mentor them and share the practical knowledge and skills absent in journals and textbooks. That's if remaining staff even have time to read and consult them.
FOR FUN
Although Canadian Chris Luedecke's touching song 'The Early Years' is about his children and family life, it resonates with me from a professional perspective. Listen to the lyrics. They're delightful.

In today's health care environment, despite many obstacles, educators must lead by example and take time to educate and train young transfusion professionals to instill values that ensure the next generation puts patient safety above all else. Knowledge and skills, of course, plus clear rationales for all those pesky 'rules' are key.

But ultimately it's DNA-ingrained ethics that protects patients so that even overworked, busy health professionals meticulously follow established SOPS such as routinely and always checking patient identity. 

Fact is, those early days when we train the next generation, they don't last. We must get 'em while the gettin' is good.

You got to hold on,
It goes so fast
These early days, well,
They don't last.
You got to enjoy [train] them.
They go so fast.
The baby days, well, they don't last.
FURTHER READING
As always, comments are most welcome.