2009 a Pivotal Year in Healthcare IT

2009 is proving to be a pivotal year in healthcare IT. Recent authoritative articles and reports on health IT problems largely validate the issues presented at this blog and others focusing on health IT issues, and at my academic website on HIT difficulties started over a decade ago, in 1998, freely available to the industry.

These articles and reports have ultimately led to a U.S. Senate investigation of the healthcare IT industry initiated in Oct. 2009 (link below).

2009 may be the year that healthcare IT vendors will finally begin to understand that not lending credence to decades of teachings from Medical Informatics professionals on healthcare IT design, implementation, lifecycle support, involvement of end users, and sales and marketing has been harmful to their businesses and to their investors. Instead, the commercial health IT companies took a simplistic management information systems-based approach to building medical devices in an incomparably complex environment they did not -- or did not care to – understand.

These devices are, in fact, virtual medical devices that happen to reside on a computer, not business computing systems that happen to be used by clinicians. These medical devices are soon to undergo regulation as such in the EU (pdf report from the Swedish Medical Products Agency here), Canada, the U.S. and other countries as well.

The teachings of Medical Informatics about such devices have been documented in the extensive literature of Medical Informatics. For example, the book “A History of Medical Informatics in the United States, 1950 to 1990” by informatics pioneer Morris F. Collen (published in 1995) explicitly demonstrates the progression of the field and the wisdom of the pioneers dating back to the 1950’s, as in the bons mots here.

The 2009 articles and reports below demonstrate numerous undesirable outcomes of the management information systems approach to development and implementation of virtual clinical devices:

• The Joint Commission’s “Sentinel Event Alert on Healthcare IT” is here.

• The U.S. National Research Council’s "Current Approaches to U.S. Health Care Information Technology are Insufficient" and link to a full report on an investigation of healthcare IT lack of progress is here.

• The UK Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

• The Washington Post’s article on the influential HIT vendor lobby “The Machinery Behind Healthcare Reform” is here.

• Hoffman and Podgurski’s paper from Case Western entitled “e-Health Hazards: Provider Liability and Electronic Health Record Systems” on EHR medical and legal risks is here.

• My commentary on the May 2009 AMIA workshop report on healthcare IT failure with free PDF is available here.

• My commentary on a sentinel Mar. 2009 JAMA article by University of Pennsylvania researchers Ross Koppel and David Kreda “Health Care Information Technology Vendors' Hold Harmless Clause: Implications for Patients and Clinicians” on unsafe contract terms demanded by healthcare IT, and the violations of Joint Commission safety standards and fiduciary responsibilities committed by hospital governance personnel who agree to such terms, is here.

• A link to the Oct. 25, 2009 Washington Post article “Electronic medical records not seen as a cure-all” and my commentary are here.

Finally, and perhaps most importantly, the Oct. 16, 2009 letter to major healthcare IT vendors from Senator Charles E. Grassley (ranking member of the United States Senate Committee on Finance) initiating a Senate investigation of corporate practices is here (PDF).

I have used this medieval illustration in a prior post on these pages, but sadly in this case it is probably even more highly appropriate:

"Margaritas ante Porcos" - click to enlarge

Not to be gratuitously impolite, but hard truths are often an unpleasant medicine, especially when ignoring those truths results in adverse consequences to patients and their caregivers.

-- SS

Impressions of Hawai'i

I recently went to Hawai'i for the American Society of Human Genetics meeting in Waikiki, followed by a one-week vacation on Kaua'i with friends. It was my first time in Hawai'i and I really enjoyed it. The Hawai'ians I encountered were kind and generous people.

Early European explorers remarked on the beauty, strength, good nature and exellent physical development of the native Hawai'ians. The traditional Hawai'ian diet consisted mostly of taro root, sweet potatoes, yams, breadfruit, coconut, fish, occasional pork, fowl including chicken, taro leaves, seaweed and a few sweet fruits. It would have been very low (but adequate) in omega-6, because there simply isn't much of it available in this environment. Root crops and most fruit are virtually devoid of fat; seafood and coconut contain very little omega-6; and even the pork and chicken would have been low in omega-6 due to their diets. Omega-3 would have been plentiful from marine foods, and saturated fats would have come from coconut. All foods were fresh and unrefined. Abundant exercise and sunlight would have completed their salubrious lifestyle.

The traditional Hawai'ian diet was rich in easily digested starch, mainly in the form of poi, which is fermented mashed taro. I ate poi a number of times while I was on Kaua'i, and really liked it. It's mild, similar to mashed potatoes, but with a slightly sticky consistency and a purple color (due to the particular variety of taro that's traditionally used to make it).

I had the opportunity to try a number of traditional Polynesian foods while I was on Kaua'i. One plant that particularly impressed me is breadfruit. It's a big tree that makes cantaloupe-sized starchy green fruit. Breadfruit is incredibly versatile, because it can be used at different stages of ripeness for different purposes. Very young, it's like a vegetable, at full size, it's a bland starch, and fully ripe it's starchy and sweet like a sweet potato. It can be baked, boiled, fried and even dried for later use. It has a mild flavor and a texture similar to soft white bread. It's satisfying and fairly rich in micronutrients. On the right are breadfruit, coconut and sugarcane, three traditional Hawai'ian foods.

I find perennial staple crops such as breadfruit very interesting, because they're much less destructive to soil quality than annual crops, and they're a breeze to maintain. I could walk into the backyard of the apartment I was renting and pick a breadfruit, soak it, throw it in the oven and I had something nutritious to eat in just over an hour. It's like picking a bag of potatoes right off a tree. Insects and birds didn't seem to like it at all, possibly because the raw fruit exudes a bitter, rubbery sap when damaged. Unfortunatley, breadfruit is a tropical plant. Temperate starchy staples that were exploited by native North Americans include the majestic American chestnut in the Appalachians, and acorns in the West. These are both more work than breadfruit to prepare, particularly acorns which must be extensively soaked to remove bitter tannins.

One of the foods Polynesian settlers brought to Hawai'i was sugar cane. I had the opportunity to try fresh sugar cane for the first time while I was on Kaua'i. You cut off the outer skin, then cut it into strips and chew to get the sweet juice. It was mild but tasty. I don't know if it was a coincidence or not, but I ended up feeling unwell after eating several pieces. It may simply have been too much sugar for me.

Modern Hawai'i is a hunter-gatherer's dream. There are fruit trees everywhere, including papayas, wild and cultivated guavas, mangoes, avocados, passion fruit, breadfruit, bananas, citrus fruits and many others. Many of those fruits did not predate European contact however. Even pineapples were introduced to Hawai'i after European contact. Coconuts are everywhere, and we could pick one up for a drink and snack on almost any beach. The forests are full of wild chickens (such as the one at left) and pigs, both having resulted from the escape and subsequent mixing of Polynesian and European breeds. Kaua'ians frequently hunt the pigs, which are environmentally damaging due to their habit of rooting through topsoil for food. Large areas of forest on Kaua'i look like they've been ploughed due to the pigs' rooting. Humans are their only predators and their food is abundant.

While I was on Kaua'i, I ate mostly seafood (including delicious raw tuna poke), poi, breadfruit, coconut and sweet fruits-- a real Polynesian style hunter-gatherer diet! I swam every day, hiked in the lovely interior, and kayaked. It was a great trip, and I hope to return someday.

.

Impressions of Hawai'i

I recently went to Hawai'i for the American Society of Human Genetics meeting in Waikiki, followed by a one-week vacation on Kaua'i with friends. It was my first time in Hawai'i and I really enjoyed it. The Hawai'ians I encountered were kind and generous people.

Early European explorers remarked on the beauty, strength, good nature and exellent physical development of the native Hawai'ians. The traditional Hawai'ian diet consisted mostly of taro root, sweet potatoes, yams, breadfruit, coconut, fish, occasional pork, fowl including chicken, taro leaves, seaweed and a few sweet fruits. It would have been very low (but adequate) in omega-6, because there simply isn't much of it available in this environment. Root crops and most fruit are virtually devoid of fat; seafood and coconut contain very little omega-6; and even the pork and chicken would have been low in omega-6 due to their diets. Omega-3 would have been plentiful from marine foods, and saturated fats would have come from coconut. All foods were fresh and unrefined. Abundant exercise and sunlight would have completed their salubrious lifestyle.

The traditional Hawai'ian diet was rich in easily digested starch, mainly in the form of poi, which is fermented mashed taro. I ate poi a number of times while I was on Kaua'i, and really liked it. It's mild, similar to mashed potatoes, but with a slightly sticky consistency and a purple color (due to the particular variety of taro that's traditionally used to make it).

I had the opportunity to try a number of traditional Polynesian foods while I was on Kaua'i. One plant that particularly impressed me is breadfruit. It's a big tree that makes cantaloupe-sized starchy green fruit. Breadfruit is incredibly versatile, because it can be used at different stages of ripeness for different purposes. Very young, it's like a vegetable, at full size, it's a bland starch, and fully ripe it's starchy and sweet like a sweet potato. It can be baked, boiled, fried and even dried for later use. It has a mild flavor and a texture similar to soft white bread. It's satisfying and fairly rich in micronutrients. On the right are breadfruit, coconut and sugarcane, three traditional Hawai'ian foods.

I find perennial staple crops such as breadfruit very interesting, because they're much less destructive to soil quality than annual crops, and they're a breeze to maintain. I could walk into the backyard of the apartment I was renting and pick a breadfruit, soak it, throw it in the oven and I had something nutritious to eat in just over an hour. It's like picking a bag of potatoes right off a tree. Insects and birds didn't seem to like it at all, possibly because the raw fruit exudes a bitter, rubbery sap when damaged. Unfortunatley, breadfruit is a tropical plant. Temperate starchy staples that were exploited by native North Americans include the majestic American chestnut in the Appalachians, and acorns in the West. These are both more work than breadfruit to prepare, particularly acorns which must be extensively soaked to remove bitter tannins.

One of the foods Polynesian settlers brought to Hawai'i was sugar cane. I had the opportunity to try fresh sugar cane for the first time while I was on Kaua'i. You cut off the outer skin, then cut it into strips and chew to get the sweet juice. It was mild but tasty. I don't know if it was a coincidence or not, but I ended up feeling unwell after eating several pieces. It may simply have been too much sugar for me.

Modern Hawai'i is a hunter-gatherer's dream. There are fruit trees everywhere, including papayas, wild and cultivated guavas, mangoes, avocados, passion fruit, breadfruit, bananas, citrus fruits and many others. Many of those fruits did not predate European contact however. Even pineapples were introduced to Hawai'i after European contact. Coconuts are everywhere, and we could pick one up for a drink and snack on almost any beach. The forests are full of wild chickens (such as the one at left) and pigs, both having resulted from the escape and subsequent mixing of Polynesian and European breeds. Kaua'ians frequently hunt the pigs, which are environmentally damaging due to their habit of rooting through topsoil for food. Large areas of forest on Kaua'i look like they've been ploughed due to the pigs' rooting. Humans are their only predators and their food is abundant.

While I was on Kaua'i, I ate mostly seafood (including delicious raw tuna poke), poi, breadfruit, coconut and sweet fruits-- a real Polynesian style hunter-gatherer diet! I swam every day, hiked in the lovely interior, and kayaked. It was a great trip, and I hope to return someday.

.

Did a Yakuza Boss Pay "A Million Dollars for One Liver?"

One of the more bizarre stories to appear on Health Care Renewal just resurfaced.  To summarize, in June, 2008, we posted about the strange case of four Japanese men, allegedly affiliated with Yakuza criminal organizations, who received liver transplants from the UCLA Medical Center, apparently with some alacrity. All likely paid full list prices for their procedures, and two later donated $100,000 each to the medical center. The case raised concerns by several notables (including Senator Charles Grassley, and Professor Arthur Caplan) about the integrity of the transplant system. Presumably these concerns were based on suspicions that the four may have received a higher priority than others on the list. More concerns should have been raised after it was revealed that shadowy characters threatened a reporter who started to investigate the case in Japan, and the reporter's family (see post here).  Later, the Chancellor for Medical Sciences and Dean of the David Geffen School of Medicine's public response to the case side-stepped all the important concerns while deploying a series of logical fallacies (see post here).

Then, despite all the colorful details and ethical concerns presented by this story, it faded from view for a year and a half. 

Last night, the US investigative reporting television show "60 Minutes" aired a follow-up on the Yakuza transplants, following closely on the publication of a book, Tokyo Vice, by Jake Adelstein, the reporter who first broke the story.

The web-based version of the 60 Minutes story reprised the main points, but added emphasis to a few of interest to Health Care Renewal. 

First, the 60 Minutes piece raised suspicions that the Yakuza members paid a premium to jump the UCLA liver transplant priority list:

Getting into the U.S. was one thing, but getting a liver transplant at a leading American medical center like UCLA was something else altogether.

'What's the average waiting time for someone in California waiting for a liver transplant?' [CBS correspondent Lara] Logan asked California attorney Larry Eisenberg.

'It's probably realistically three years. And it could be much longer,' he replied.

Not for Tadamasa Goto, who got a liver in just six weeks. Eisenberg finds that surprising, especially since Goto was number 80 on the waiting list.

'It should not be possible that an unsavory character from out of the country, with ties to organized crime, comes into the United States and gets a priority and obtains a transplant,' Eisenberg said.

Two families, Eisenberg's clients, both lost loved ones waiting for livers at another transplant center in the same area: Salvador Ceja was number two on the waiting list; John Rader was number five.

'Do you think, for one second, that this was legitimate? That they stood in line and waited just like your husband did?' Logan asked Rader's widow Cheryl.

'Absolutely not,' she replied. 'No. Because nobody gets a liver that quickly.'

'I think they were playing God,' Yolanda Carballo, Ceja's stepdaughter, added. 'Now, I think they were picking and choosing who they wanted to give a liver to.'

'So, in your minds, what was this about?' Logan asked.

'Money,' Rader said. 'Spoke loud and clear. And they listened.'

'That's what it was all about. Money,' Carballo agreed.

Three of Goto's Yakuza cronies also got liver transplants at UCLA. For them, money was no object. UCLA says each of their transplants cost about $400,000 dollars; the Yakuza all paid cash.


The hospital also acknowledged Goto and another Yakuza each made $100,000 donations to the transplant center.


Adelstein says Goto paid even more. 'According to police documents and sources, a million dollars for Goto. A million dollars,' he told Logan.

'A million dollars for one liver?' she asked.

'A million dollars for one liver,' Adelstein said.

Second, 60 Minutes emphasized the risk Mr Adelstein faced after he drew attention to the story of the Yakuza liver transplants at UCLA:

Tadamasa Goto returned to his life of crime as a Yakuza godfather and it all stayed hidden until Adelstein was tipped off. It took him years to piece together the details for a newspaper story. Then, when word got out that Adelstein knew, the Yakuza tried to buy his silence, offering him half a million dollars.

Asked if he was tempted by the cash offer, Adelstein said, 'Of course I'm tempted. You know? When someone offers you half a million dollars not to write something, but then again, you know I don't want to be owned by organized crime the rest of my life.'

Adelstein wrote the story for 'The Washington Post' and it eventually made its way back to Japan. The news infuriated the Yakuza bosses. For Goto, it was a humiliating blow from which he would never recover.

'I heard from someone very close to him that as he was leaving and getting in his car he said, 'That goddamn American Jew reporter, I wanna kill him,'' Adelstein said.

Japanese and U.S. law enforcement agents took Goto's threat seriously.

Adelstein now lives alone, under Tokyo police protection; his wife and children are in hiding.

'Are you concerned that there is an American citizen here whose life is at risk?' Logan asked the U.S. Embassy's Mike Cox.

'Very much so. I mean, we think the Japanese police are doing what they can to make sure that no harm comes to Mr. Adelstein. I mean, we certainly don't want to see anything happen to him,' Cox said.

'What do you have to do in your daily life to stay alive?' Logan asked Adelstein.

'You have to keep your rooms shuttered, because you don't want a sniper to pick you off across from somebody’s house,' he said.

Asked if he lives in darkness, Adelstein said, 'When I'm up in my room typing, yes. All the rooms are shuttered. You gotta be very careful on rainy days. Because when Yakuza take people out, they like to do it on rainy days, because fewer people are on the streets and the rain washes away trace evidence.'

Even in disgrace, Tadamasa Goto still has a small army of loyal soldiers and a hit out on Jake Adelstein. The Yakuza say he will never be safe.

'When someone does something that causes them (Yakuza) to lose face, they will use any means possible, legal or illegal, to crush the person who has gotten in their way, who has humiliated them,' the disguised Yakuza boss told Logan.

Finally, 60 Minutes found that the UCLA Medical Center continued to be uncooperative, cloaking its refusal to categorically refute allegations that it sold a liver for a million dollars in concerns with patient confidentiality:

Asked if UCLA knew who these people were, Adelstein said, 'When you see guys with lots of tattoos, missing fingers, wouldn't it occur to you, like, 'Oh, this guy is a gangster.' I can't believe they didn't know.'

Attorney Eisenberg says transplant rules require extensive background checks on every patient. Yet, UCLA insisted to federal investigators they had 'no knowledge' that Goto or his cronies had ties to Japanese organized crime.

UCLA declined all of 60 Minutes' requests for interviews. The only thing the medical center will say on the record is that their program has been reviewed and found to be in 'total compliance' with liver transplant rules.

The hospital told us, 'state and federal patient confidentiality laws prohibit UCLA from responding to the…issues raised by 60 Minutes.'

'In my opinion, the medical center has a moral and ethical obligation to determine the source of those funds,' Eisenberg said.

'A moral and ethical obligation, but apparently no legal obligation?' Logan asked.

'Well, it's not addressed in the rules specifically,' Eisenberg said

As I wrote in my first post on this case, you just can't make this stuff up...

However, the colorfulness of the case should not distract from its very serious implications.  We have written a lot in this blog about the anechoic effect, how cases with important implications about ethics, governance and leadership in health care often fail to attract the attention they deserve.  We have opined that academics and professionals have realized that it is simply "not done" to discuss cases which might offend the powerful leaders of health care organizations.  We have written about whistle-blowers who have lost jobs or been theatened with lawsuits.  But in this case, the journalist who wrote about the case allegedly has received death threats and lives in hiding under police protection.  This may be the most serious case of the anechoic effect known.

Furthermore, we have written a lot in this blog about how leaders of health care organizations ought to uphold their organizations' mission and the core values to which physicians and other health care professionals have sworn devotion.  The continued disinclination of UCLA leadership to respond to charges that its medical center accepted $1 million to put Japanese gangsters at the head of the liver transplant list may reflect fear of gangsters who also allegedly threatened the life of the journalist who reported the case.  But by failing to rebut such charges, the leadership leaves the impression that they cannot claim to be better than the moral equivalents of gangsters.  Institutions that aspire to join "the ranks of the nations [sic] elite medical schools" ought also to aspire to have leaders that have better ethics than Yakuza bosses.  

Transparency International has suggested that health care corruption is a global scourge that costs lives.  Serious health care reform cannot ignore health care corruption as a cause of excess costs, denied access, and poor quality.  Health care organizations ought to be held to a higher standard of ethics, and be less prone to corruption than, for example, garbage hauling firms.  Health care organizations ought to subscribe to rigorous codes of ethics, impartially enforced, which apply to all within the organizations, including top leaders.  While the accused need to be afforded due process, whistle-blowers must also be protected.  In my humble opinion, true health care reform requires so confronting health care corruption.  Maybe the leadership of the Gefen School of Medicine might want to consider setting an example in this regard. 

Note: Jake Adelstein's book is available here, and it was reviewed by Reuters here and by the AP (via the Canadian Press) here.

A Bridge in Brooklyn and an Electronic Medical Records Bargain: Only One Hundred Nineteen Million Dollars Per User - Tolls Included

One of the favorite debates people involved in IT seem to like to have is over the meaning of "failure" of IT projects.

Merriam-Webster dictionary:

Main Entry: fail·ure
Pronunciation: \ˈfāl-yər\

Function: noun

Etymology: alteration of earlier failer, from Anglo-French, from Old French faillir to fail

Date: 1643

1 a : omission of occurrence or performance; specifically : a failing to perform a duty or expected action b (1) : a state of inability to perform a normal function <kidney failure> — compare heart failure (2) : an abrupt cessation of normal functioning c : a fracturing or giving way under stress
2 a : lack of success b : a failing in business : bankruptcy
3 a : a falling short : deficiency b : deterioration, decay
4 : one that has failed

The UK House of Commons Public Accounts Committee report on disastrous problems in their £12.7 billion national EMR program is here.

Only the most stubborn would argue that this case and the latest data is not representative of a "failure" in the truest sense of that word:

Only 175 people using flagship NHS software, says minister

Lorenzo care records system is likely to be costing taxpayer hundreds of thousands of pounds per user per year

Written by Tom Young

Computing.co.uk, 30 Oct 2009

There are only 174 clinicians using Lorenzo patient software across the five early adopter trusts, according to Mike O'Brien, minister for the National Programme for IT (NPfIT).

Five Boroughs Partnership, Bradford Teaching Hospitals NHS Foundation Trust, University Hospitals of Morecambe Bay, Hereford Hospitals and South Birmingham have only ever had 19 clinicians using the systems at the same time.

Lorenzo is one of two software packages being used to set up centralised electronic health records as part of the £12.7bn National Programme for IT. This part of the programme is already running four years late.

Lorenzo is being supplied by services company CSC to trusts in the north of England and by its developer iSoft directly to trusts in the south after Fujitsu was fired from the programme.

The other patient software package is Cerner Millennium, being supplied by BT in London and a handful of trusts in the south.

By Google:

£12,700,000,000 = USD $20,770,850,000

By my calculations, that works out to:

£72,571,429 or USD $118,690,571 per user of this software.

While a somewhat satirical and sardonic calculation, that's about 73 million pounds or 119 million dollars per user, after almost a decade of work.

What more can be said than "stunning?"

The information came from a parliamentary question tabled by Richard Bacon MP.

Last week in the Commons he said:

"I tabled a question yesterday about the number of hospital trusts where Lorenzo has been partially deployed, asking how many users — how many concurrent users — of Lorenzo there are.

"It is literally just a handful, which means that the cost per user is not what one would expect… the cost is going to be many hundreds of thousands — possibly even more than a million — pounds per user per year."

Bacon said there has not been a single deployment of Lorenzo in 2009 because these early adopter trusts were having such problems.

"The reason is that the handful of deployments attempted have been an absolute mess, causing chaos in the hospitals where they were tried," he said.

Operations of entire hospitals were disrupted by software. This represents unconsented IT experiments on human subjects gone massively awry. Whether the "chaos" caused anyone harm seems never to be stated.

Deployments of Cerner Millennium have also caused problems, with St Barts in London now facing fines of £400,000 a month for missing patient care targets as a result of problems with the system.

Bacon also points out that the recently signed contracts with BT to deploy Cerner Millennium at hospitals in the south require BT to be paid even if the hospitals refuse the systems – a possibility if they think they will not work.

I would suggest someone in the UK provide screen shots and/or a YouTube video of these systems in operation so others can understand how such results can occur. (Oh, wait: the vendor contracts probably prohibit that, the hospital executives having signed such contracts also having signed away their fiduciary responsibilities to patients and clinicians.)

... Junior Treasury minister Sarah McCarthy-Fry defended The NPfIT in the debate.

She said: "We all acknowledge that the NHS IT project is hugely ambitious [profoundly overambitious would perhaps be more accurate - ed.] and that it is essential that we get it right. [The Minister appears to be a master of the obvious - ed.] It is obvious to everybody that many challenges remain.

"We still believe that Cerner Millennium and Lorenzo will be able to support the NHS in the long term."

Right.

I have a bridge in Brooklyn, NY for sale. Perhaps the UK teams responsible for this debacle would be interested. After all, the cost per user of the bridge would be remarkably low, far less than USD $118 million - and the users could even be made to pay a toll for each use:

For sale: a bridge in Brooklyn.

Perhaps in our own U.S. national health IT initiative, we'll come in at a lower cost per user than $118,690,571 - perhaps about $118,690,570.99 ?

After all, those Medical Informatics specialists act like know-it-alls about healthcare IT, and since domain-specific education and expertise are irrelevant in healthcare management, why should anyone listen to them?

-- SS