Sunday, October 18, 2015

Little boxes (Musings on when established clinical labs become passé)

Updated: 3 Nov. 2015
October's blog focuses on three news items from The Dark Daily/Dark Report about clinical laboratories in the USA and Canada.
If you're not lab or not in North America, the blog has tidbits about health care fraud that could be coming to a lab near you, and demographic trends that affect your health profession and country. My musings will expand the scope slightly to include the role of innovation in upsetting existing apple carts.

The blog's title derives from an anti-establishment ditty written by Malvina Reynolds that became a hit for her pal Pete Seeger in 1963. Be forewarned - you either love it or hate it. It was written about USA in the 1950s when most readers were not yet born.
For links to news items below, please see Further Reading.
1. USA: Biggest case of Medicare fraud and abuse in history of clinical laboratory business.

Apparently clinical lab companies and their executives were paid $500 million in 2010-14 from lab test claims submitted to the USA's Medicare (health insurance for Americans aged 65 and older who have worked and paid into the system and for younger people with disabilities) and Tricare (health benefits for military personnel, retirees, and their families), perhaps $1.2 billion if amount taken from private insurers is added.
US federal attorneys allege the fraud involved: 

  • Payments to physicians for shipping and handling lab specimens;
  • False processing fees;
  • Kickbacks to physicians;
  • Illegal sales agreement in which sales staff were paid a monthly fee plus 19.8% of lab revenue;
  • Payments to induce doctors to order large multi-assay panels, including many medically unnecessary lab tests.
At its core, it seems that several private clinical labs and their executives fleeced the U.S. government for more than $1 billion.

2. Canada
  • Medical laboratories face squeeze from retiring labor force, and more.
  • Canada's innovative medical and pathology laboratories share their successes at Toronto Executive Edge Conference. 
In Canada, as elsewhere, a major challenge is how to deal with an ever increasing number of lab specimens when governments continue to decrease lab funding. Labs are asked to do more with less, an old story dating to at least the 1990s in my bailiwick, Alberta, Canada.
According to reports on the Executive Edge Conference in Toronto:

  • Labs will need to cut costs without compromising quality, thereby creating a demand for lab professionals skilled in Lean, Six Sigma, and process improvement (Further Reading: 'Can health care learn from assembly lines?')
  • To support the growing demand for personalized medicine, labs must upgrade their information technology systems (See earlier blog for my take on personalized medicine)
  • Training programs for med lab technologists/scientists struggle to find labs willing to provide practical clinical training required for students to be certified (Old story. Cost constraints in health care have a huge negative impact on educating health professionals)
  • The number of trained healthcare professionals is fewer than needed (True for nurses and physicians and long true for med lab scientists/technologists but unsure it holds true today for Canadian lab technologists) 
  • No mass retirement by baby boomers, at least not yet (Tsunami of golden oldies retiring hasn't happened yet)
3. Smartphone 'Dongle'achieves capabilities of big clinical laboratory analyzers: Diagnoses three diseases at once from single drop of blood.
The innovative smartphone device  - mobile and inexpensive, making it ideal for use in developing nations - diagnoses HIV and syphilis with a finger prick of blood and displays results on a smartphone screen within 15 minutes.

The device performs an enzyme-linked immunosorbent assay (ELISA) without requiring stored energy because power is drawn from the smartphone. Plus it performs a triplexed immunoassay not currently available in a single test format: HIV antibody, treponemal-specific antibody for syphilis, and non-treponemal antibody for active syphilis infection.

The question is, Could such technology eventually find a place in medical laboratories in developed nations? And how would established labs push back? As with POCT, by citing the legitimate safety needs for quality control and lab oversight or ?

So there you have it. 

  • Private clinical labs in USA bribe physicians to order unnecessary lab tests and promote other unethical practices. 
  • Clinical labs in Canada and elsewhere struggle with under-funding and are told to adopt Japanese assembly line solutions to save themselves, i.e., to cut costs without sacrificing quality.
  • In Canada private clinical labs exist in parallel with public labs and are paid by provincial governments. No case of fraud has ever been raised against private Canadian labs that I'm aware of. Could it happen in future? Who knows. 
  • Innovative start-ups threaten established clinical labs who push back, big-time, sometimes with valid concerns, sometimes without. As an example 
Personally, on the private vs public lab issue, I'm glad that Alberta cancelled the RFP on a $3-billion contract under the previous government to Sonic Healthcare of Australia. Rightly or wrongly, I have more confidence in private labs with a history in Alberta. And even more confidence in Alberta's publicly owned and operated laboratories.
Regardless, US experience with private labs defrauding government is disturbing. Like Big Pharma's many lapses, does the profit motive trump ethics?

As to the Executive Edge Conference in Toronto, I've focused on issues that interest me. Lean and Six Sigma are trends that mostly give consultants mega-bucks and naturally claim big benefits to justify the fees. On staffing shortages, unsurprisingly, the tsunami of retirements hasn't yet occurred for 'boomer' health professionals. Suspect it'll occur in the next five years.  

The smart phone dongle is one of many innovations yet to be validated and will no doubt be challenged as has Theranos's technology, which uses a few drops of blood via a finger-prick rather than the usual tube of blood via venipuncture (Further Reading).

Such innovations, similar to point-of-care testing (POCT),are often administered by nurses. For patient safety, lab professionals have the expertise to see what can go wrong and know that nurses may not, especially when it comes to a sound understanding of quality control of lab instruments.

POCT is now standard practice in most health facilities in the developed world, and often overseen by the clinical laboratory. (Nice guidance from UK's IBMS on the role of the laboratory in POCT)

Ultimately, innovative lab devices may make any debate on public vs private laboratories passé. They may increase the likelihood of fraud by private labs as they struggle for relevance. Because if innovative miniature lab devices succeed, we won't need the ticky-tacky big box labs we grew up with and know as clinical laboratories. 

'Little boxes' is an anti-establishment song from more than 50 years ago that challenged the conformity of 1950s America. Somehow I suspect it still resonates today because all around I see transfusion folks who pretty much agree with the orthodoxy of the day and question nil. For example:

  • Personalized, precision medicine is the best thing since sliced bread. If you're not red cell genotyped to match with blood donors, you're second class, dude.
  • Lean and Six Sigma is where it's at. Let's get rid of all the waste. Yes, Lean has done 'good things' but it's curious that waste seldom happens at management/executive levels (see Further Reading)
As noted earlier, you'll either hate Little Boxes or love it.
As always, comments are most welcome.
USA: Biggest case of Medicare fraud and abuse in history of clinical laboratory business 

Canada: Medical laboratories face squeeze from retiring labor force, and more (Dark Daily, 25 Aug. 2015)
Canada's innovative medical and pathology laboratories shared successes at Toronto conference (Dark Daily, 14 Oct. 2015)

Smartphone 'Dongle' achieves capabilities of big clinical laboratory analyzers: Diagnoses three diseases at once from single drop of blood
Smartphone, finger prick, 15 Minutes, diagnosis done!