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?

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. 

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'.

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.
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.