Showing posts with label automation. Show all posts
Showing posts with label automation. 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

Wednesday, October 31, 2012

You don't own me (Musings on TM professionals as industry's poodles)

Updated 1 Nov. 2012

This month's blog is about how much of the TM information we consume is meant to inform, how much is crafted to persuade, and how much info purveyors assume we’re owned by them, i.e., their poodles. The title is from a 1964 Lesley Gore song. 

The blog was stimulated by 3 items:
1. Supposed news from new-medical.net in its 'Insights from industry' section:
2. The article motivated me to visit OCD's 'On Demand' website and register to see its offerings. 

3. Then I was reminded of a recent research paper by OCD staff published in AABB's Transfusion:
BACKGROUND
Increasingly, I suspect that industry owns the transfusion medicine community. In a way, it's natural given that TM was healthcare but now is business and has been for awhile. Businesses depend on each other to survive. You scratch my back and I’ll scratch yours.

Today's AABB is more and more cosy with commercial interests, which is also natural given the reliance of the former on the latter for advertising revenues and conference support. Plus, as noted in earlier blogs, some AABB luminaries have close ties with industry. It's one big happy family.

The blog’s components  - industry promoting automation via 3 mechanisms - are akin to a full court press in basketball in which industry pressures TM staff from every angle to buy into their false assertions about automation.

The blog's theme is how much industry thinks it owns us and attempts to baffle our brains with BS. 

A common thread in industry’s automation initiative is to create false arguments. For example, manual methods have more processes than automation (true), therefore automated instruments have fewer chances for human errors to occur (true). 

BUT… here’s the logical fallacy (the BS, if you will): Where do most serious TM errors occur? Are they related to manual testing? 

Read and assess for yourself.

1. INTERVIEW
First note where this interview was published: news-medical.net

As with many so-called health sites, news-medical's business model is not immediately apparent without reading the fine print. And let's face it, that's the first thing we do when visiting a website, right?

Part of the 3239 word, 27 point,Terms and Conditions:
News-Medical hereby discloses that a commission or listing fee may be payable by Experts to News-Medical for any fees received by them as a result of an introduction of a client through the Website.  
Unsurprisingly, the site's underlying purpose is to sell stuff.

Besides industry news, news-medical, based in Australia, cheaply repackages health information from several sources, including a heavy reliance on Wikipedia under the Creative Commons Attribution-ShareAlike License.

Below is my summary of a few highlights of OCD’s Celia Tombalakian's interview with news-medical.net in question and answer format, with my comments, aka musings, in italics. Readers are directed to the full interview for exactly what she said. 

The report is selective and my approach is facetious in places. But is it off the mark? You be the judge.

QUESTION: How is the blood banking industry currently being transformed?

CT's ANSWER
CT: Current focus is to improve transfusion safety and efficiency through technology solutions.  
Ah, safety and efficiency, with safety mentioned first. Who can argue?
CT: Over past 20 yrs, the number of highly skilled technologists and scientists entering the global TM workforce has shrunk. 
CT: Therefore, automation is becoming a standard part of blood bank laboratories because it eliminates many of the labor-intensive, time-consuming manual testing that requires specialized skills and significant experience to master.  
Really? Her response implies that automation arose because of staff shortages, which misleads in a chicken and egg sort of way.  
Why has the highly skilled technical and scientific TM workforce shrunk? Many reasons around the globe, inc. poor compensation for education involved (mainly USA), decreased health care funding, leading to regionalization and centralized testing, all facilitated by automation.  Automated instruments continue to be marketed on their ability to decrease absolute numbers of highly skilled staff.
CT: Ultimately, automation can increase a lab’s capacity and help it operate more efficiently, even with a smaller staff. 
A case can be made for how instruments are more reliable than humans, at least for some things. But notice there's no more mention of safety, only efficiency.
QUESTION. Tell us about the new Bloodbanker App and its benefits over traditional blood banking tools.

CT's ANSWER
CT: ORTHO's Pocket Blood Banker app is an educational reference tool that combines genotyping and antibody indexing. Users can quickly determine genotypes based on results with Rh antisera via the Genotype Calculator and learn more about antibodies with the Antibody Index.
CT: Prior to the app, blood bankers used reference tools such as cardboard slide rules. 
You gotta be kidding. Cardboard slide rules? Maybe that's what Ortho supplied customers back in the Jurassic age, but for decades I and many others taught MLS students how to determine Rh genotypes using their ... wait for it ... inbuilt computers, aka brains.

Reminds me of this exquisite Danish humour on computers: Medieval helpdesk
CT: Drawing from a deep understanding of the importance of and need for innovation in blood banking, OCD identified the need for more advanced tools and developed this new technology. The app reinforces our commitment to providing innovative solutions to our customers. 
OMG, classic marketing and branding. We're wise, we're innovative, we're dedicated to helping clients. Please bring us cute babies to kiss. 
QUESTION: Could you introduce Ortho ON DEMAND and how it fits with OCDs overall focus?

CT's ANSWER
CT: ON DEMAND is an innovative virtual engagement platform that enables blood bankers to learn from and connect with experts on topics central to achieving science-driven safety and efficiency in the blood bank. 
Attempt to reinforce Ortho's brand as innovative, Also love 'virtual engagement platform' and 'science driven.' Buzzwords convey modernity and objectivity, respectively. And note re-introduction of the safety and efficiency double whammy.
CT: With OCD’s strong TM history, we understand the importance of supporting industry through education and awareness. 
We're the pros, we understand. Trust us.
CT: Because many of today’s blood bankers work longer hours with fewer financial resources, many laboratories have had to cut costs that previously supported career growth opportunities. Through our new platforms, we hope to help prepare blood bankers to address growing demands for TM expertise. 
Excuse me? Labs have had to cut CE and CPD funding because staff work longer hours with less money? Does not compute. Pure bafflegab.
As for helping a growing demand for expertise, is there a growing demand for expertise? If so, it's to address what automation created in the first place, namely a diminished demand for technical and scientific expertise with fewer positions for TM specialists.
Frankly, automation and apps both contribute to and help alleviate a 'dumbing down' of the profession. I acknowledge that 'dumbing down' is a harsh catch phrase for staffing with less qualified personnel, not that such staff are dumb. I use the term to emphasize that apps do not contribute to developing expertise, but rather exist to alleviate lack of it.
QUESTION. What impact do you think these initiatives will have on blood bankers?

CT's ANSWER
CT: Many of today’s blood bankers struggle to do more with less, working longer hours with fewer financial resources. Concurrently, instrumentation is more complex and the number of transfusions is increasing globally. 
Meaningless bafflegab. Yes, cost constraints force blood bankers to do more with less.  
But instrumentation is more complex? More complex than what? Earlier instruments? Manual testing? Do sales reps' spiels include these words?  "Hey, our instrumentation is more complex. You need better trained dudes to operate it."   
Also, in an age of blood conservation and a kazillion studies on real and unproven potential transfusion dangers, what evidence exists that transfusion numbers have increased? Does not compute.
CT: With reduced resources, many labs cut travel costs to learning events that could better prepare staff to address growing demands for TM expertise. Ortho ON DEMAND addresses this challenge by offering TM professionals free access to education according to their own schedules.
Offering free online education has merit. But it's not exactly true that today's over-worked TM professionals are clamouring to access education on their own schedules. Employers allot no time during work hours. Staff who are under-paid and feel under-appreciated are increasingly less motivated to take time away from families to further their careers.
QUESTION: How do you think the future of blood banks will develop?

CT's ANSWER
CT: While technology has made many routine BB tasks faster and easier, the demand for blood continues to rise and the pace of processing blood continues to accelerate.  
Demand for RBC transfusions (type that automated instruments process in transfusion service labs) is increasing? Where's the evidence? Surely all the efforts on blood management, blood conservation, and improved utilization are having an impact on RBC usage.
Pace of processing blood continues to accelerate? What does this mean? I could speculate but she doesn't explain.  
CT: Hemovigilance and ensuring efficiency is of utmost importance to blood banks in maintaining a safe and accessible blood supply while keeping pace with accelerating demand for blood processing. 
Sounds good but what has hemovigilance to do with OCD's automation and apps? And again the unexplained 'accelerated demand for blood processing.'
CT: The future of blood banks lies in technological solutions that will allow blood bankers to increase safety and efficiency in order to provide the best possible outcomes for patients. 
Motherhood statement. But where is the evidence that automated ABO and Rh group testing and automated antibody screening have improved outcomes for transfused patients? Or that apps that generate Rh genotypes and describe antibodies have made a difference? 
Surely, getting patient identification correct when drawing blood samples and correlating patient identity to crossmatched donor blood when administering blood remain THE hallmarks of safe transfusion practice, the 'right patient, right blood product, at right time' mantra. 
QUESTION: What are OCDs plans for the future? Would you like to comment further?

CT's ANSWER
OCD is the global leader in Transfusion Medicine, stemming from a 70-year history of protecting the safety of the worlds blood supply. We intend to continue our leadership of the market into the future, both with our products and through our service and support of the blood banking community. 
Forgive me, but I'm jaundiced. Although I've known, liked, and respected many Ortho reps, having just read Blood Medicine (aka Blood Feud) about Ortho Biotech and Amgen's marketing of EPO products, protecting patient safety as applied to J & J or any Big Pharma company rings hollow.
Author Q & A
2. WEBSITE

Simply put, Ortho ON DEMAND offers varied worthwhile educational talks by respected TM professionals, but promotes automation. To illustrate, the first 4 talks in its Presentation section are about automation. 

I'm reminded that Ortho and its competitors such as Immucor operate on a razor-blade business model: cheap razors (instruments), with the real money made on expensive blades (reagents).

3. RESEARCH PAPER
This paper by OCD employees further shows how industry treats TM professionals like poodles, hoping to baffle brains with BS. 
Interestingly, one of the authors, TS Casina, an OCD marketing manager, also penned these 3 articles:

Casina TS. Technologies to improve the future of blood banking. Med Lab Obs 2011 Oct;43(10):32. Excerpt:
  • 'As the labor force shrinks, the rapidly evolving field of laboratory medicine is struggling to keep pace with the growing demand for blood and its components. Automation is becoming a standard part of blood bank laboratories because it can help eliminate the labor-intensive, time-consuming manual testing processes that require specialized skills and significant experience to master.'
Casina TS. What's new in transfusion services. Advance for Med Lab Professionals. Posted online 19 Sept. 2012. Excerpt:
  • Transfusion of incompatible blood has the greatest potential for severe adverse events and health complications, including death. Fortunately, due to advances in transfusion medicine (TM) practices -improved blood testing, donor screening and the advent of automated systems - the blood transfused to patients is safer today than it's ever been.
Casina TS. References for "transfusion medicine reactions. Advance for Administrators of the Laboratory 2012 Oct;21(10):20. This paper is a reworked version of the one above. Excerpt: 
  • A study conducted by Ortho Clinical Diagnostics provides quantitative evidence of how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thereby improve the safety of blood transfusion.  Evaluating the common testing methods above and leveraging failure modes and effects analysis (FMEA) to compare error potentials, the group concluded that automation significantly reduces defect opportunities in pretransfusion testing and could dramatically improve blood transfusion safety.
Can you see how marketing managers use a full court press and recycled material (with the help of willing publishers desperate for articles) to get their message out to industry's poodles, namely us?
Abstract Highlights (Transfusion paper)
BACKGROUND: Human error associated with manual pretransfusion testing is a cause of transfusion-related mortality and morbidity and most human errors can be eliminated by automated systems. 
STUDY DESIGN AND METHODS: Study’s goal was to compare error potentials of commonly used manual (e.g., tiles and tubes) vs automated (e.g., ID-GelStation and AutoVue Innova) group and screen (G and S) methods. G and S processes in 7 TS labs (4 with manual and 3 with automated methods) were analyzed to evaluate error potentials of each method.
Tiles?  Really? Well, they could be large welled plates. But who uses these in routine manual pretransfusion testing?  
RESULTS: Manual methods contained more process steps ranging from 22 to 39; automated methods contained 6 to 8 steps.  
Roughly 4-5 times more steps for manual methods. Authors then use ‘risk priority numbers (RPN)  - trust me, you don’t want to go there -  to show manual method RPNs ranged from 5304 to 10,976 vs 129 and 436 for automated methods, conveniently making manual tests away more than 4-5 times as risky as automation.
What the hey! Let's go there. A team (needed to reduce subjectivity) of OCD researchers and staff at 7 TS labs determined how many defects were likely at each process step (defect opportunities) and decided where failures could occur, the likelihood that the failure would be identified, how frequently the failures might occur, and what the effects of those failures (severity) were. The result was a 10 point scale. An example: 
Process Step 16 (tile or plate required tapping and rocking before reading reactions) had 18 defect opportunities. 18 represents 6 wells in the tile or plate in which it was possible to undertap reactants (6 defect opps), forget to tap the plate (6 defect opps), or overtap and splash reactants among wells (6 defect opps) for a total defect opportunity of 18 at that step (6 + 6 + 6 + = 18). The severity was rated 7 out of 10.
Wow! Talk about creative number crunching to get the results you want. The mind boggles....
CONCLUSION: This study provided quantitative evidence on how automation could transform pretransfusion testing processes by dramatically reducing error potentials and thus would improve the safety of blood transfusion.
Oh sure. Is I or is I not your poodle?
MORE MUSINGS
This study’s logical fallacy posits (love that word!) that most, or even many, serious transfusion errors result from manual testing of ABO and Rh groups and manual antibody screening. It's true that manual testing has potential to create more errors than automated testing.

The best evidence of where TM errors occur comes from the UK’s annual SHOT Reports. For example, consider 
I’ll not bore you with too many specifics  - you can read for yourself - but believe me, it’s NOT all about lab staff making technical errors when manually testing. 

'Adverse reactions caused by errors' lists these causes of cumulative cases reviewed 1996-2011 (n=9925):
  • Anti-D errors 
  • Inappropriate & unnecessary
  • Handling & storage errors
  • Incorrect blood component transfused (n>3000)
To quote SHOT: Key lesson from 2011 is an emphasis again on the importance of the essential steps of the transfusion process:
  • Taking the blood sample from the correct patient 
  • Correct laboratory procedures
  • Issuing of the correct component
  • Identification of the right patient at the bedside at the time of transfusion
  • It is clear from the SHOT 2011 data that identification of the correct patient remains a key issue and that this must become a core clinical skill.
BOTTOM LINE
So, what's it all about? Yes, automation can increase efficiency and increase safety by reducing human error. But is automation the TM saviour that industry reps and some TM professionals make it out to be? 

When you examine the arguments of proponents, such as OCD's Celia Tombalakian or the research of OCD employees, their arguments do not stand up to scrutiny. They continually overstate how automated testing can improve safety and propose it as magic it is not. 

Companies have a vested interest in promoting automated testing since the business model of cheap razor (instrument) and expensive blades (reagents) is what makes their industry viable. 

Their multi-media advertisements are relentlessly promoted to TM professionals using flawed arguments that show they think they own us and we are their poodles. 

FOR FUN

Industry's seeming hold on so many TM professionals brings to mind:
  • You Don't Own Me (Same song re-worked for 2012 USA election - thoroughly partisan. ALERT: Depending on your politics, you may be offended.)
  • You Don't Own Me (Diane Keaton, Bette Midler, Goldie Hawn in 1996 movie The First Wives Club)
Comments are welcome but due to excess spam this section is removed. Please send comments to me personally.



Thursday, August 26, 2010

Goldfinger's filings, a customer's toolkit (Musings on business intelligence)

Updated: 28 Jan. 2017 (Fixed broken links)
This blog's thesis is only slightly tongue in cheek but its title definitively is. The title derives from the ubiquitous toolkits currently found everywhere in transfusion practice, and the 1964 James Bond movie, Goldfinger in which the eponymous character is obsessed with gold, much like private companies are focussed on profits, albeit not usually with the same gleeful fervour as a sinister villain.

As an aside, Goldfinger has special memories for me because I saw the film in Tel Aviv, Israel in 1965. We had to buy tickets ahead of time (none sold at the door) and catch much of the dialogue by reading the French sub-titles (goodness knows why) due to the uproarious cheering of the audience at every Sean Connery feat. We were told that television was only on for a few hours each day and movies were incredibly popular.
By happenstance I came across the SEC Form 10-K Annual report for Immucor, a blood industry supplier of automated instruments and reagents. The 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.

Now before your eyes glaze over, if you work in the blood system in any capacity, I highly recommend that you take a peek at these fascinating reports. In a way, it's akin to industrial espionage, i.e., gaining access to information about a company’s plans, products, clients, and trade secrets in order to gain insights and predict their actions, including marketing strategies and sales pitches.

Normally it's competitors who engage in industrial espionage, but if you buy a company's products and services, you can potentially use the information to your advantage. Spying is illegal if the information is private but, since the SEC records are public, it's all above board and fair game.

Donning our sleuth caps, let's examine just a few aspects of the business intelligence that's publicly available in Immucor's July 2010 SEC filing and how it can be used to advantage by potential clients.

The specific information is most relevant to those in the lab but the lessons can be applied to dealing with any sales representative and related marketing, advertising, and selling strategies targetted to your profession.

Immucor's SEC 10-K report merely serves as an example. To all my sales rep friends and colleagues, as they say in the Godfather films, "It's not personal. It's strictly business."

Reality is that companies spend considerable time and effort getting to know potential customers and understand their likes, dislikes, wants and needs. Think of those free wine and cheese parties, dinners, and tour-the-bay cruises you've attended at conferences. They weren't just to create goodwill. Similarly, customers can benefit from knowing how companies think and what tools they will probably use to get you to buy.

Here's a mini-toolkit to get you started. Quoted text is from Immucor's SEC Form 10-K report (23 July 2010).

1. AUTOMATION

"Our strategy is to drive automation in the blood bank."

MUSINGS

Obviously, automation must be strongly promoted, since it is in Immucor's interest to sell its instruments and automated ("capture") reagents. As mentioned in an earlier blog, the latter have one of the highest gross profit margins in the industry, 80.2% in Immucor's 3rd quarter for 2010.

From a client's perspective, profits in the range of 80% may seem excessive. But profits are the primary purpose of private enterprises. From the company's perspective, the higher the profit the more they will be able to
  • pay shareholders
  • raise additional financing
  • survive in hard times
  • invest in R&D that can develop new products and lead to continued or increased profits.
However, to drive automation and increase profit, automation must be seen not as a way to increase profits, but as a way for clients to save money while improving safety.

Hence the comapany's sales pitch:

"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.

We also believe that automation can improve patient safety, can increase operational efficiency and, for customers such as integrated delivery networks with multiple blood banks, can permit the standardization of best practices.

For Immucor, automation allows us to gain market share and secure a long-term, contractual relationship with our customers."

MUSINGS

On the safety issue, while it may be true (or not), is there published evidence to support a decrease in life-threatening errors and resultant increase in patient safety after Immucor's automated instruments have been introduced in the transfusion service?

Don't ya' love "reduce headcount," an euphemism for eliminate staff, and interesting that it merits first place ahead of "improve patient safety."

About the "current shortage of qualified blood bank technologists", this largely happened because restructuring and regionalization with associated automation led to fewer jobs, which in turn led to closures of medical technology schools. Concurrently, at least in Canada, nurse and physician education programs were also decimated.

In Canada, in response to increased demand, more technologists (nurses and doctors) are now being trained, but a significant number of jobs for technology graduates continue to be part-time.

In a way, automation contributed to a shortage of "qualified blood bank technologists" and now automation is being promoted as a solution to the shortage. Say what?

Fact is that automation allows for less trained staff to perform routine work in the transfusion service and leads to fewer blood bank specialists. Isn't it having it both ways to say that automation now solves the problem that it intrinsically helped create?

In the past, I recall that Immucor promoted its automated instruments to transfusion services as a way to save ~1.5 staff members and to allow remaining staff to concentrate on more 'important stuff' for thinking technologists (i.e., humans) such as identifying antibodies.

In today's economic climate, I imagine that cost saving is still the main mantra of the sales reps, with patient safety tossed in as a 'feel good' justification for eliminating jobs.

With automation, it's worth considering what is actually happening, i.e, a transfer of money from people (staff) residing in a community (people who pay taxes, buy houses, shop and support local businesses, and contribute to community life) to generating profits for a large corporation situated elsewhere. Does this benefit society in the long run? Complicated question but I sometimes wonder.

Obviously those considering automation need to extensively analyse multiple factors between competitors such as
  • initial capital costs
  • ongoing maintenance and reagent costs
  • sensitivity and specificity (as applicable)
  • ease of use
  • ease of transition and implementation (impact on other processes & procedures)
  • redesign of physical layout, etc.
  • training requirements, and more
Potential clients should also consider Immucor's huge gross profit margins when negotiating reagent contracts. And it's worth remembering that those long-term contracts for reagents are where the money is. From the NEC submission:

"As of May 31, 2010, we had an instrument backlog of approximately 179 Echos and 43 Galileo/NEOs. This backlog represents instrument orders that have been received but the instruments have either not been installed or the customer validation process has not been completed.

As such, the instruments are not generating recurring reagent revenue at their expected annualized run rates. ....we had not recognized approximately $16.7 million in deferred revenue from instrument sales contracts that had reagent price protection and from extended warranty sales."

Note that Immucor considers extended sales contracts to have built-in reagent price protection. Did they mean protection for themselves or clients or both?.

#2. NEW PRODUCTS

Successful companies must continually innovate to create new products and generate new profits.

" For the fiscal years ended May 31, 2010...we spent approximately $15.4 million...for research and development. Research and development expenses have increased over the past three years due to the acquisition of BioArray...and the subsequent development work on our molecular immunohematology offering."

"In August 2008, we invested in what we believe will be the future of the blood bankmolecular immunohematology....With the goal of improving transfusion medicine, we believe that molecular immunohematology will revolutionize blood bank operations.

In many countries, blood pre-transfusion testing is limited to the prevention of transfusion reactions and not for the prevention of alloimmunization, which occurs when antigens foreign to the patient are inadvertently introduced into the patient’s blood system through transfusions. If alloimmunization occurs, the patient develops new antibodies in response to the foreign antigens, thereby complicating future transfusions.

By using multiplex, cost-effective molecular testing, our molecular technology allows testing to prevent alloimmunization for better patient care."

MUSINGS

In a consumer society, if a real need does not exist, companies try to create one.

So, can we now expect an onslaught of propaganda and industry-funded research to convince us that preventing alloimmunization is where it's at and what we should strive for?

My gut reaction is fuggedaboutit! But the writing is already on the wall:
#3. RISKS

Under "Risks", Immucor lists FDA "administrative action", governmental investigations and litigation, fluctuations in foreign currency, and more. Three that stood out:

(i) "A catastrophic event at our Norcross, Georgia facility would prevent us from producing many of our reagent products.

Substantially all our reagent products are produced in our Norcross facility.... and we currently have no plans to develop a third-party reagent manufacturing capability.

Therefore, if a catastrophic event occurred at the Norcross facility, such as a fire or tornado, many of those products could not be produced until the manufacturing portion of the facility was restored and cleared by the FDA.

We maintain a disaster plan to minimize the effects of such a catastrophe, and we have obtained insurance to protect against certain business interruption losses.

However, there can be no assurance that such coverage will be adequate or that such coverage will continue to remain available on acceptable terms, if at all."

MUSINGS: Despite a disaster plan to minimize effects (on clients and the bottom line?) the company's main worry seems to be that its insurance may not cover its losses.

Clients need to include a scenario with a possibly very long delay in obtaining reagents in their disaster plans. Think not only of time to restore production but also time to obtain FDA clearance on a restored facility.

(ii) "Gross margin volatility may negatively impact our profitability."

"Our gross margin may be volatile from period to period due to various factors, including instrument sales, reagent product mix and manufacturing costs....

The higher margins on the Capture reagents used on our instruments may not be enough to offset the lower margins on the instruments themselves...."

MUSINGS: Once again, the importance of Capture reagents to profits is emphasized. Immucor's gross profit margins for these reagents are among the highest in the business. When faced with, "Have I got a deal for you", best to think twice.

(iii) "If customers delay integrating our instruments into their operations, the growth of our business could be negatively impacted."

From time to time in the past, some of our customers have experienced significant delays between the purchase of an instrument and the time at which it has been successfully integrated into the customer’s existing operations and is generating reagent revenue at its expected annualized run rate. 
 

These delays may be due to a number of factors, including staffing and training issues and difficulties interfacing our instruments with the customer’s computer systems.

Because our business operates on a “razor/razorblade” model, such integration delays result in delayed purchases of the reagents used with the instrument.

A number of steps have mitigated these integration delays: improved performance of our field service staff, better instrument instructions, increased use of internet-based remote diagnostic tools, and more efficient scheduling of instrument installations....."

MUSINGS

Potential clients should note the reasons for delayed implementation and acknowledgement of the “razor/razorblade” business model.

A razor/razorblade model is the well established business tactic of selling dependent goods for different prices. The one-time product is sold at a discount, while the second dependent one for which repeated purchases are required, is sold at a considerably higher relative price. Think of the practically free razor but expensive replacement razor blades or the low priced video game console and its dependent high priced games.

4. COMPETITORS

"In the U.S. and Canada, Ortho-Clinical Diagnostics (“Ortho”), a Johnson & Johnson company, is our main competitor. In Western Europe, our principal competitors are Bio-Rad Laboratories, Inc. (“Bio-Rad”) and Ortho. Both Ortho and Bio-Rad sell instrumentation as well as reagents. Our principal competitor in Japan is Ortho."

MUSINGS

There is not much competition in transfusion service / immunohematolgy automation, nor for reagents for non-automated testing. Immucor, along with its main US competitor, Ortho-Clinical Diagnostics, is being investigated by the US Department of Justice concerning possible criminal violations of the antitrust laws.

Perhaps not unsurprisingly, both are the subjects of several private civil suits by customers (hospitals) seeking class certification and alleging price fixing.

Anytime you have a market oligopoly, a virtual duopoly, allegations of collusion and price fixing are bound to occur, but they are almost impossible to prove. 

FURTHER BUSINESS INTELLIGENCE
For interest, a few more blood industry companies with SEC Form 10-K reports:
  • Johnson & Johnson (1 Mar. 2010) (parent company of Ortho-Clinical Diagnostics)
  • Tidbit in report (OCD has many more products besides reagents and automated instruments for pretransfusion blood testing)
  • "The Ortho-Clinical Diagnostics franchise achieved sales of $2.0 billion in 2009, a 6.6% increase over the prior year primarily attributable to the recent launch of the VITROS 3600 and 5600 analyzers."
  • Bio-Rad Laboratories (26 Feb. 2010)
  • Beckman Coulter (22 Feb. 2010)
  • Haemonetics (1 June 2010) - One tidbit (and are we surprised?):
  • "Our devices use single-use, proprietary consumables, and these consumable sales represent 87% of our total revenues."
BOTTOM LINE
You can discover many useful tidbits in SEC Form 10-K filings. These tidbits can be used to help customers decide on suppliers and to leverage information when negotiating contracts. I hope that this Goldfinger toolkit has given a few ideas.

For fun, here's the theme song from the Bond movie of the same name:
As always, the ideas are mine alone. Comments are most welcome BUT, due to excessive spam, please e-mail me personally or use the address in the newsletter notice. 

Sunday, July 06, 2008

Mourning becomes Electra

Updated: 28 Jan. 2017 (Fixed broken links)
INTRODUCTION
This blog's title is taken from the play by Eugene O'Neill of the same name, which is an adaptation of the Greek trilogy “Oresteia” by Aeschylus.

The blog was motivated by a device
that automates blood component preparation just licensed by the FDA in the USA. The device's press release is one of the Industry News items in this month's TraQ newsletter. It caught my eye because of the name of the device, the Atreus.

After briefly discussing the names that manufacturers give their products, the blog will examine the pitches used to market automation, the related concept of lean manufacturing, and whether they constitute progress.


PRODUCT NAMES
First, the product names. Atreus rang a bell because during my youth my Dad used to share his love of Greek mythology with me. Atreus was, to put it mildly, a pretty repellent dude even in a curse-stricken family where each generation gruesomely and tragically murdered family members and others out of some combination of pride, ambition, lust, and revenge.


One version of the Atreus myth (there are several) has Atreus and his brother murdering their father's illegitimate son (their half-brother) to please their mother. Then, after his brother seduces Atreus's wife, Atreus kills his brother's two sons and invites him to a banquet to feed him the flesh of his sons, whom Atreus had boiled. Atreus also saves the children's hands and feet to show to his brother. His brother later rapes his own daughter, who despite being Atreus's niece, becomes Atreus's wife. Atreus raises the child fathered by his brother as his own. Eventually Atreus's wife commits suicide and the child, in loyalty to his uncle (who he realizes is his real father), kills Atreus. Charming family.


Now why would Gambro / CaridianBCT want to name its new device after such a repugnant figure as Atreus? Other products have been named after characters in Greek mythology, for example, Immucor's Echo. In Greek mythology, the beautiful nymph Echo would distract Zeus's wife Hera with stories while Zeus ravished other mountain nymphs. When Hera discovered this, she punished Echo by taking away her voice, except in repetition of another's words. Later Echo fell in love with Narcissus but was rejected. The once talkative nymph eventually changed into rock leaving nothing but her voice to reply to those who shouted out.


It's likely Echo is meant to be a cute takeoff on its role as the little brother (little sister?) of Immucor's Galileo. Galileo contended that the earth rotated around the sun, thus contradicting the orthodoxy of the time (early 17th century) that the earth was the centre of the universe. For this crime he was convicted of heresy and spent his later years under house arrest. Naming products after pioneering scientific figures like Galileo makes sense, but Atreus and Echo....not so much.

MARKETING PITCHES

Back to the Atreus® and other automated devices and instruments....

Is the Atreus® meant to eliminate "x" FTE staff who currently prepare blood components or just make their work easier and more satisfying?

Manufacturer's typically market automation with claims such as:The instrument/device will
  • do the boring "slug work," freeing staff for more interesting tasks that require more skill
  • prevent repetitive stress injuries
  • increase patient safety by decreasing errors since there are fewer steps for staff to perform
  • increase efficiency by saving time (better TAT with throughputs of "x" tests/hr)
  • increase test reliability by eliminating subjective reading of tests by staff
  • increase test sensitivity and specificity (hmm...can you really do both?)
  • improve process control
  • interface with existing LIS to decrease transcription errors (Oh, oh! Best to take LIS interface claims with a block of salt)
  • ensure positive identification and tracing via improved 2-dimensional bar codes
Notice how some of the standard pitches above emphasize putting staff first - more satisfying work, fewer injuries, easier work (instruments and computers do the "slug work" for you).

To lab managers and directors, marketing pitches include the motherhood issues above but tend to focus more on the bottom line, e.g., The instrument/device will/can

  • save money by eliminating "x" FTE
  • give a return on investment after "x" years
  • be maintained by a rhesus monkey available from our offshore supplier at a discounted price if ordered in volume (Just kidding on this one)
Effects of automation in lab areas such as clinical chemistry have been well documented:
This article in CAP Today sums up the transfusion medicine situation in 2002, as well as the motivations and perspectives of those in charge of the labs:
LEAN
Naturally, automation fits well with the latest buzzword of the quality movement, "lean," as in "lean manufacturing." Lean is based on the principle that non-value-added activity constitutes waste and should be eliminated.

Like its cousins quality systems and six sigma, there is an entire industry built around lean. It helps to develop a business around a concept if you can give insiders the jargon that makes them "in the know" and keeps the non-enlightened out.
And lean is now huge in health care. Here's a lean hospital in the UK - for patients arriving in the emergency department, no more seeing doctors - docs do not add value to the process:
Hospitals, laboratories, and blood centres send staff to lean conferences to learn the principles and jargon of lean (muda, kaizan blitz, kanban, JIT, poka-yoke, etc.). Seems that everyone is making a buck from lean.
Try googling lean AND health care - on 6 July 2008 the search gave >7 million hits. Most seemed to be websites for consultants selling lean advice.
PROGRESS?
So is automation progress? Is lean progress? Progress can be defined many ways but it generally means improvement or growth, whether for individuals, organizations, societies, or humanity.

Are highly automated or lean labs progress for

  • staff who no longer have lab jobs? Have they gone on to bigger and more rewarding careers and lives?
  • remaining staff who load the instruments and press the buttons, letting the equipment do the analyses. Is their job satisfaction improved?
  • senior staff who do less but more interesting hands-on lab work and have more time to read computer printouts, attend meetings, and program spreadsheets with error management data and the like.
  • lab managers and directors who can more easily meet their goals with fewer resources now that costs are down?
  • patients, who constitute the true bottom line? Is their health care improved and safer?
Many would say, of course, automation and lean constitute progress - it's the current conventional thinking (orthodoxy). Even questioning automation and lean is heresy. However, if questioning of automation and lean principles bugs you, you may be experiencing cognitive dissonance.

On the other hand, if you are certain that automation and lean are progress for mankind, read on because shangri-la approaches:

Add 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.

AUTOMATION FOR NURSES?
I wonder if there is a way to automate administering transfusions as this seems to be a area where deadly errors continue to occur? FromTraQ's July newsletter - International news: UK and USA:

Transfusion nurses could have improved and more satisfying work by investigating only unusual events that actually require their skill set. (I write with tongue firmly planted in cheek.)

I would call the automated transfusion device Electra after Atreus's granddaughter, who wanted her brother to avenge the death of their father by killing their mother, leading to the concept of the Electra complex.

BOTTOM LINE
I'm not altogether sure whether automation constitutes progress from a big picture perspective (benefits humankind), but it's irrelevant. Automation is here to stay and will only get more and more pervasive in health care.

Take that, Atreus! The curse goes on....
Comments are most welcome BUT, due to excessive spam,  please e-mail me personally or use the address in the newsletter notice. 

 Addition (3 Sept.2008)
Thanks to those who have commented.

In these blogs I'm really just asking questions, not providing definitive answers. Readers should decide for themselves based on their experience and reading the literature. Responses may vary widely depending what automation has meant for individuals personally.

Few of us have extensively studied the issue of automation over time. And what studies have been done get their results based on the questions asked, using measurable outcomes like reduced number of FTE staff, money saved according to defined algorithms and assumptions, and self-reporting by remaining staff about job satisfaction, etc. The internal validity of some of these studies is open to question and their generalizabilty is not universal.


As noted, "Many would say, of course, automation and lean constitute progress - it's the current conventional thinking (orthodoxy). Even questioning automation and lean is heresy."

My view is not so certain:
"I'm not altogether sure whether automation constitutes progress from a big picture perspective (benefits humankind)." It may or it may not.

Taken to its logical conclusion, and using a reductio ad adsurdum argument, if automation constitutes progress (a better life) for humans, then we should automate everything, leaving a few of us to do the routine work (load instruments, push buttons, etc.), while the rest of us sit around and problem solve until there are no problems left to solve because the automation has been perfected. Now, what to so with all this leisure time? Create a new Renaissance? Die of boredom?

I've reduced the proposition to an absurd conclusion, which could be a fallacious argument, just to show where my abstract and theoretical thinking about automation leads.


About inadequate staffing causing errors, I'm not sure that's been proven in the cases cited by the authors of "Canada's pathology" in CMAJ. Although it's logical that being overworked could be a contributing factor in causing errors, it would be risky to assume that it's a significant cause in individual cases without evidence. Many of the pathology errors were caused by the repetitive actions of a single pathologist such as Dr. Charles Smith, whose autopsy decisions were not always based on the evidence.

Lab systems are supposed to be designed to prevent and detect and correct any errors. Clearly the overall system failed in the case of the serious pathology lab errors that occurred.