"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this letter in today’s WSJ that I think says it all about complex technological projects, including (perhaps especially) healthcare IT.

Emphases mine:

Wall St. Journal
Letter to the Editor
Dec. 16, 2010

Manhattan Spirit for Cyber Defense

In “How to Fight and Win the Cyberwar” (op-ed, Dec. 6), Mortimer Zuckerman uses the analogy of the Manhattan Project to build the atomic bomb in World War II and suggests forming a “Cyber Defense Administration” (CDA).

We need to keep in mind how the Manhattan Project managed to succeed in achieving its objectives. The direction and top management of the project was by scientists like Robert Oppenheimer, who understood the scientific details of the project, and project director Gen. Leslie Groves, who made sure the scientists got what they wanted. This is not like any bureaucracy in the U.S. government today.

I would visualize a CDA more as a TSA- or EPA-type bureaucracy with a politically sensitive lawyer or bureaucrat at the top, and having to go down two or more administrative levels before you find the first Ph.D.-level computer scientists with a history of serious research and publications in computer/network security. The head of the CDA would probably be clueless about the computer science details and would have no basis for making rational decisions. This is a field where the devil is in the details, and to truly understand those details requires much more than bureaucratic and political skills.

Whoever created the Stuxnet worm that attacked Iran’s nuclear program’s computers probably was not managed by a bureaucrat, but by a team of very high-level scientists who clearly understood the details. Countries like China often have real experts running their organizations, not just politically smooth bureaucrats who go from job to job with a false theory that a “good manager can manage anything.”

In reality, especially in a field like cyber security, a good manager can only manage what he understands. Our bureaucrats will lose the cyberwar against scientists who understand the details.

Dallas Weaver

Huntington Beach, Calif.

It is a bureaucratic conceit to think that a "good manager" can manage major healthcare IT projects - or pharmaceutical companies - or anything else outside their core competencies.

This holds true even assuming, at best, that one of their "core competencies" is competency itself (warning: PDF).

-- SS

"Good Managers" And Complex Technological Projects - Recipe for Poor Results?

Once more on the topic of CIO’s and other health IT leaders lacking in solid healthcare informatics and clinical credentials, there’s this letter in today’s WSJ that I think says it all about complex technological projects, including (perhaps especially) healthcare IT.

Emphases mine:

Wall St. Journal
Letter to the Editor
Dec. 16, 2010

Manhattan Spirit for Cyber Defense

In “How to Fight and Win the Cyberwar” (op-ed, Dec. 6), Mortimer Zuckerman uses the analogy of the Manhattan Project to build the atomic bomb in World War II and suggests forming a “Cyber Defense Administration” (CDA).

We need to keep in mind how the Manhattan Project managed to succeed in achieving its objectives. The direction and top management of the project was by scientists like Robert Oppenheimer, who understood the scientific details of the project, and project director Gen. Leslie Groves, who made sure the scientists got what they wanted. This is not like any bureaucracy in the U.S. government today.

I would visualize a CDA more as a TSA- or EPA-type bureaucracy with a politically sensitive lawyer or bureaucrat at the top, and having to go down two or more administrative levels before you find the first Ph.D.-level computer scientists with a history of serious research and publications in computer/network security. The head of the CDA would probably be clueless about the computer science details and would have no basis for making rational decisions. This is a field where the devil is in the details, and to truly understand those details requires much more than bureaucratic and political skills.

Whoever created the Stuxnet worm that attacked Iran’s nuclear program’s computers probably was not managed by a bureaucrat, but by a team of very high-level scientists who clearly understood the details. Countries like China often have real experts running their organizations, not just politically smooth bureaucrats who go from job to job with a false theory that a “good manager can manage anything.”

In reality, especially in a field like cyber security, a good manager can only manage what he understands. Our bureaucrats will lose the cyberwar against scientists who understand the details.

Dallas Weaver

Huntington Beach, Calif.

It is a bureaucratic conceit to think that a "good manager" can manage major healthcare IT projects - or pharmaceutical companies - or anything else outside their core competencies.

This holds true even assuming, at best, that one of their "core competencies" is competency itself (warning: PDF).

-- SS

BLOGSCAN - FDA don't need no smart old people 'round

We have posted numerous times about the requirement for seasoned expertise (the kind that only comes with age) in healthcare leadership.

FDA, CDC and other HHS agencies may have different ideas:

http://gooznews.com/?p=2194

Age Purge in FDA Press Office?
December 5, 2010
By GoozNews

FDA Webview (subscription required) reports that the new FDA associate commissioner for external affairs, Beth Martino, 31, a former Kansas aide to HHS secretary Kathleen Sebelius, has conducted a purge of senior specialists, all aged over 50, in her office and in the press office. The abrupt removals were made to make room for younger people closer to Martino’s own age, the trade journal reports. “She’s uncomfortable with people who know more than she does,” a source told FDA Webview.

Three of the displaced staffers, public affairs officers Elaine Gansz Bobo, 52, Dick Thompson, 65, a former Time magazine science editor, and Ira Allen, 62, a seasoned health care journalist, were offered the choice of being terminated as probationary hires for fabricated “incompetence” or resigning. Similar purges are reportedly occurring at other HHS agencies, including Centers for Disease Control.

Neither Martino nor FDA senior deputy commissioner Joshua Sharfstein, whose duties include chairing the FDA’s transparency initiative, responded to FDAWebview’s request for comment.

If this story is true, it is not only illegal age discrimination under the Age Discrimination in Employment Act of 1967 (ADEA), it is deleterious to the appropriate functioning of federal agencies charged with safeguarding public health - via talent mismanagement.

-- SS

BLOGSCAN - FDA don't need no smart old people 'round

We have posted numerous times about the requirement for seasoned expertise (the kind that only comes with age) in healthcare leadership.

FDA, CDC and other HHS agencies may have different ideas:

http://gooznews.com/?p=2194

Age Purge in FDA Press Office?
December 5, 2010
By GoozNews

FDA Webview (subscription required) reports that the new FDA associate commissioner for external affairs, Beth Martino, 31, a former Kansas aide to HHS secretary Kathleen Sebelius, has conducted a purge of senior specialists, all aged over 50, in her office and in the press office. The abrupt removals were made to make room for younger people closer to Martino’s own age, the trade journal reports. “She’s uncomfortable with people who know more than she does,” a source told FDA Webview.

Three of the displaced staffers, public affairs officers Elaine Gansz Bobo, 52, Dick Thompson, 65, a former Time magazine science editor, and Ira Allen, 62, a seasoned health care journalist, were offered the choice of being terminated as probationary hires for fabricated “incompetence” or resigning. Similar purges are reportedly occurring at other HHS agencies, including Centers for Disease Control.

Neither Martino nor FDA senior deputy commissioner Joshua Sharfstein, whose duties include chairing the FDA’s transparency initiative, responded to FDAWebview’s request for comment.

If this story is true, it is not only illegal age discrimination under the Age Discrimination in Employment Act of 1967 (ADEA), it is deleterious to the appropriate functioning of federal agencies charged with safeguarding public health - via talent mismanagement.

-- SS

Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corporate CEOs who pretend to be health care experts.  Of course this all really is not so funny, because the bogus expertise appears not in MAD Magazine, but in the most respected media outlets with the most influence over health care policy.

 This week's example comes from the Wall Street Journal's vaunted CEO Council.  A summary of its health care panel appeared early this week in that newspaper.

The panel included Angela Braly President and CEO, Wellpoint Inc., William A. Hawkins Chairman and CEO, Medtronic Inc., and Klaus Kleinfeld Chairman and CEO, Alcoa.  Angela Braly, a lawyer with no obvious record of direct experience in health care or related fields (see her bio here), received total compensation from WellPoint of more than $13 million in 2009, while presiding over various snafus and ethical missteps (most recently here, and with a further catalog here.)   William Hawkins, who has an undergraduate degree in engineering, and an MBA, received total compensation from Medtronic of over $9 million in fiscal 2010.  His direct involvement in health care or related fields apparently ended after his undergraduate years, when he was said to have done research in pathology (see his bio here).   He presided over Medtronic's settlement of thousands of patients' lawsuits that alleged injuries due to a faulty lead on one model of a Medtronic implantable cardiac defibrillator for over $200 million.  The company's other recent questionable activities may be found here.  Dr Kleinfeld's doctorate is in strategic management, but he has no obvious health care background (see his bio here.)   (The panel apparently had a "subject expert," Dr Risa Lavizzo-Mourey, a physician who is now CEO of the Robert Wood Johnson Foundation, but she was not quoted directly in the WSJ edited transcript.)

So what could we expect from a panel on health care that included no one with direct experience or expertise in health care, but two CEOs who managed to become extremely wealthy courtesy their employment by health care companies? 

Here is Ms Braly on changing incentives:

This really gets to the fact that right now we have a fee-for-service payment system, so we pay for quantity rather than quality. And very importantly, we think we need to redesign the way in which we reimburse for health care.

So,

Reimbursement could come in the form of accountable care organizations or patient-centered medical homes or pay-for-performance or risk sharing. There are a number of ways—and we didn't want to be completely prescriptive in terms of what that reimbursement formula would be.

The issue is not quantity versus quality, but cognitive, including primary care vs procedures. Ms Braly completely ignores how the government takes only the advice of the RUC to set physician payments, and how her company just apes that example (see posts here). Ms Braly also completely ignored how her company could actually try to change reimbursement on its own. There is no law that says it must follow the example set by Medicare.

So what she said about changing "delivery incentives" is just nonsense, to use a polite term.

Then we have Dr Kleinfeld ostensibly on transparency, but really on thinking about health care as if it were done on a production line:

Let me first talk about the transparency aspect. It was very informative to hear from those that are in the industry how big a variation you have in practices across the board.

If I were to look at a set of factories that make the same thing, and one does it in five days and the other one in 10 days, and the one that does it in five days is cheaper than the one that does it in 10 days, why would I not bring everybody down to the five days?

So the question is, what hinders the health-care industry from applying the same mechanics? There was agreement that today for every important disease category there are also quality indicators that are accepted that you could use to see what is the quality delivered.

Once you control the process, once you bring the quality up, the costs go down.

Dr Kleinfeld does not seem to realize that health care involves taking care of unique patients. Even when patients have common problems, they have unique mixtures of other medical problems and personal characteristics. The physician's most basic pledge is to do what is best for each individual patient. Treating them as if they were identical widgets on a production line makes absolutely no sense.  One cannot apply the "same mechanics" that apply on a production line, because actually taking care of patients is not done, and does not at all resemble what happens on a production line. It goes without saying that Dr Kleinfeld seems to have no idea how complex and fraught with error the process of measuring quality in health care actually is.

His remarks again, to put it politely, were nonsense.

Finally, there was Mr Hawkins in a similar vein:

Contrary to popular belief, we actually have very good medical care in this country, and with the proliferation of evidence-based medicine, we have determined that there are best practices for how we can treat hypertension or some of the neurodegenerative diseases or diabetes. And the reality is, as you look across different systems, there's a lot of variability in what people are doing.

We talked about the importance of publishing or being very clear about what are the best practices for dealing with hypertension, and then making sure that we have the means by which people will be held accountable moving forward in that area.

Maybe we should acknowledge that at least Mr Hawkins tried to concentrate on hypertension, which may have a slightly more secure evidence base than some other conditions. But the implication still is that there are "best practices" when the complexity of real patients in a real health care context makes figuring out what really is best for individual patients very challenging. Maybe that is why we used to try to leave such decisions up to doctors, other health professionals, and their patients.

However, it seems that the CEOs of big health care corporations seem to feel the need to justify their ridiculous total compensation by opining on health care topics that are completely beyond their experience, training, and expertise. The real problem is that probably because of the assumption that those huge salaries must correlate with huge expertise and intelligence, their opinions are taken seriously. The quotes above did not come from MAD Magazine. They came from a highly respected and prestigious conference sponsored by and whose results were published by the Wall Street Journal.

To truly reform health care, we need to stop pretending that general business or law training makes someone a health care expert, and that being paid a lot of money by a health care corporation makes one a bigger health care expert.   We need to go back to developing health care policy with the help of people who actually know something about health care, and who are not paid by particular health care corporation to support their vested interests. 

Prominent Health Care Policy Advice from People Sans Health Care Expertise

It is two days after the US Thanksgiving holiday, and one thing I am thankful for is the continued hilarity generated by health care corporate CEOs who pretend to be health care experts.  Of course this all really is not so funny, because the bogus expertise appears not in MAD Magazine, but in the most respected media outlets with the most influence over health care policy.

 This week's example comes from the Wall Street Journal's vaunted CEO Council.  A summary of its health care panel appeared early this week in that newspaper.

The panel included Angela Braly President and CEO, Wellpoint Inc., William A. Hawkins Chairman and CEO, Medtronic Inc., and Klaus Kleinfeld Chairman and CEO, Alcoa.  Angela Braly, a lawyer with no obvious record of direct experience in health care or related fields (see her bio here), received total compensation from WellPoint of more than $13 million in 2009, while presiding over various snafus and ethical missteps (most recently here, and with a further catalog here.)   William Hawkins, who has an undergraduate degree in engineering, and an MBA, received total compensation from Medtronic of over $9 million in fiscal 2010.  His direct involvement in health care or related fields apparently ended after his undergraduate years, when he was said to have done research in pathology (see his bio here).   He presided over Medtronic's settlement of thousands of patients' lawsuits that alleged injuries due to a faulty lead on one model of a Medtronic implantable cardiac defibrillator for over $200 million.  The company's other recent questionable activities may be found here.  Dr Kleinfeld's doctorate is in strategic management, but he has no obvious health care background (see his bio here.)   (The panel apparently had a "subject expert," Dr Risa Lavizzo-Mourey, a physician who is now CEO of the Robert Wood Johnson Foundation, but she was not quoted directly in the WSJ edited transcript.)

So what could we expect from a panel on health care that included no one with direct experience or expertise in health care, but two CEOs who managed to become extremely wealthy courtesy their employment by health care companies? 

Here is Ms Braly on changing incentives:

This really gets to the fact that right now we have a fee-for-service payment system, so we pay for quantity rather than quality. And very importantly, we think we need to redesign the way in which we reimburse for health care.

So,

Reimbursement could come in the form of accountable care organizations or patient-centered medical homes or pay-for-performance or risk sharing. There are a number of ways—and we didn't want to be completely prescriptive in terms of what that reimbursement formula would be.

The issue is not quantity versus quality, but cognitive, including primary care vs procedures. Ms Braly completely ignores how the government takes only the advice of the RUC to set physician payments, and how her company just apes that example (see posts here). Ms Braly also completely ignored how her company could actually try to change reimbursement on its own. There is no law that says it must follow the example set by Medicare.

So what she said about changing "delivery incentives" is just nonsense, to use a polite term.

Then we have Dr Kleinfeld ostensibly on transparency, but really on thinking about health care as if it were done on a production line:

Let me first talk about the transparency aspect. It was very informative to hear from those that are in the industry how big a variation you have in practices across the board.

If I were to look at a set of factories that make the same thing, and one does it in five days and the other one in 10 days, and the one that does it in five days is cheaper than the one that does it in 10 days, why would I not bring everybody down to the five days?

So the question is, what hinders the health-care industry from applying the same mechanics? There was agreement that today for every important disease category there are also quality indicators that are accepted that you could use to see what is the quality delivered.

Once you control the process, once you bring the quality up, the costs go down.

Dr Kleinfeld does not seem to realize that health care involves taking care of unique patients. Even when patients have common problems, they have unique mixtures of other medical problems and personal characteristics. The physician's most basic pledge is to do what is best for each individual patient. Treating them as if they were identical widgets on a production line makes absolutely no sense.  One cannot apply the "same mechanics" that apply on a production line, because actually taking care of patients is not done, and does not at all resemble what happens on a production line. It goes without saying that Dr Kleinfeld seems to have no idea how complex and fraught with error the process of measuring quality in health care actually is.

His remarks again, to put it politely, were nonsense.

Finally, there was Mr Hawkins in a similar vein:

Contrary to popular belief, we actually have very good medical care in this country, and with the proliferation of evidence-based medicine, we have determined that there are best practices for how we can treat hypertension or some of the neurodegenerative diseases or diabetes. And the reality is, as you look across different systems, there's a lot of variability in what people are doing.

We talked about the importance of publishing or being very clear about what are the best practices for dealing with hypertension, and then making sure that we have the means by which people will be held accountable moving forward in that area.

Maybe we should acknowledge that at least Mr Hawkins tried to concentrate on hypertension, which may have a slightly more secure evidence base than some other conditions. But the implication still is that there are "best practices" when the complexity of real patients in a real health care context makes figuring out what really is best for individual patients very challenging. Maybe that is why we used to try to leave such decisions up to doctors, other health professionals, and their patients.

However, it seems that the CEOs of big health care corporations seem to feel the need to justify their ridiculous total compensation by opining on health care topics that are completely beyond their experience, training, and expertise. The real problem is that probably because of the assumption that those huge salaries must correlate with huge expertise and intelligence, their opinions are taken seriously. The quotes above did not come from MAD Magazine. They came from a highly respected and prestigious conference sponsored by and whose results were published by the Wall Street Journal.

To truly reform health care, we need to stop pretending that general business or law training makes someone a health care expert, and that being paid a lot of money by a health care corporation makes one a bigger health care expert.   We need to go back to developing health care policy with the help of people who actually know something about health care, and who are not paid by particular health care corporation to support their vested interests. 

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" at this link.

It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.

It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.

Here's an explanation by Dr. Fotsch:

... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.

In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.

[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.]

They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns.

[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]

Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play.

Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.

While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:

Fotsch:

… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error.

[What about contributory or causative designer error? – ed.]

“I didn’t know it would do that"

[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]

... or “I didn’t know that it pre-populated that"

[Why did it pre-populate? Was that inappropriate for the clinical context, such as in this example?]

... or “I didn’t know I shouldn’t cut and paste"

[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]

... or “I wasn’t paying attention to this"

[Perhaps due to distractions from mission hostile user interfaces? -ed]

... or maybe the user interface was a little confusing

[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]

Actual software errors appear to be the exception rather than the rule as it relates to EHR events.

["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]

That’s at least as I understand it.

[Understand it from whom? Hopefully not from me or my extensive website on the issues, the site whose header sadly now appears as below - ed.]

A new, unfortunate header for my website on health IT failures. Click to enlarge the shaded area, or click here to go to the site.

In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.

These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked eight part series on mission hostile health IT:

From "GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE"
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.

... SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.

For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.

I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.

-- SS

Addendum 11/28/10:

This passage ends the main essay at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" and is quite relevant here:

... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), http://www.bmj.com/cgi/content/full/320/7237/768:

Summary points:

• Two approaches to the problem of human fallibility exist: the person and the system approaches
  

• The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness

• The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

• High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.

-- SS

EHRevent.org CEO Edward Fotsch MD: The Real Challenge with EHRs is -- User Error?

Additional detailed answers to the questions I raised here and here about a new site EHRevent.org, for reporting of healthcare IT-related medical errors, can now be found at a HIStalk interview entitled "HIStalk Interviews Edward Fotsch MD, CEO, PDR Network (EHR Event)" at this link.

It is an interesting interview. I certainly find the recognition of need for an EHR/clinical IT problems reporting service a major cultural advancement in healthcare.

It's still unclear to me how -- and why -- this organization originated with little to no public knowledge and involvement, especially considering the organization types mentioned below that participated, and how it will function in interactions with myriad healthcare IT stakeholders.

Here's an explanation by Dr. Fotsch:

... We work with a not-for-profit board called the iHealth Alliance. They Alliance is made up of medical society executives, professional liability carriers, and liaison representatives from the FDA. They govern some of the networks that we run, and in exchange for that, help us recruit physicians. Professional liability carriers, for example, promote our services that send drug alerts to doctors because that’s good and protective from a liability standpoint.

In the course of our conversations with them roughly a year ago, when we were talking about adding some drug safety information into electronic health records, we came across the fact that there were concerns from the liability carriers that there was no central place for reporting adverse EHR events or near misses or potential problems or issues with electronic health records.

[Translation: the carriers saw their losses potentially increasing as a result of litigation arising from EHR-related lawsuits, and decided to do something proactive- ed.]

They were interested in creating a single place where they could promote to their insured physicians that they could report adverse EHR events. Then it turned out that medical societies had similar concerns.

[That must have been one of the best-kept secrets on Earth considering the promotion EHR's have received as a miracle-working technology, and the lack of expression of concerns from those societies - ed.]

Rather than have each of them create a system, the Alliance took on a role of orchestrating all of the interests, including some interest from the FDA and ONC in creating an electronic health record problem reporting system. That’s how it came into play.

Our role in it, in addition to having a seat on the iHealth Alliance board, was really in network operations — in running the servers, if you will, which didn’t seem like a very complicated task. Since business partners we rely on for our core business were interested in it, it was easy to say yes. It frankly turned out to be somewhat more complicated than we originally thought [I predict they haven't seen anything yet; wait until they get knee deep into real world EHR issues - ed.], but now it’s up and available.

While I find the recognition of need for an EHR/clinical IT reporting service a major advancement, I am nonetheless troubled by certain statements made by Dr. Fotsch. They seem at odds with the theoretic and empirical findings of medical informatics, social informatics, human-computer interaction and other fields relevant for health IT evaluation, and/or seem to demonstrate biases about HIT. My comments are in red italics:

Fotsch:

… Probably what we’re seeing more often than not, the real challenge with EHRs like any technology, turns out to be some form of user error.

[What about contributory or causative designer error? – ed.]

“I didn’t know it would do that"

[Why did the user not know? Lack of training, poor manuals, or overly complex information systems lacking informative messages and consistency of control-action relationships, as an example? -ed]

... or “I didn’t know that it pre-populated that"

[Why did it pre-populate? Was that inappropriate for the clinical context, such as in this example?]

... or “I didn’t know I shouldn’t cut and paste"

[Then why did the software designers enable cut and paste, without some informative message on overuse, such as length of text cut and pasted?– ed.]

... or “I wasn’t paying attention to this"

[Perhaps due to distractions from mission hostile user interfaces? -ed]

... or maybe the user interface was a little confusing

[What is "a little confusing?" (Is that like "A little pregnant?) And why was it confusing? User intellectual inadequacy, or software design issues leading to cognitive overload? - ed.]

Actual software errors appear to be the exception rather than the rule as it relates to EHR events.

["Actual software errors" are defined as, what, exactly--? Loss of database relational integrity as a result of a programming error, as apparently recently happened at Trinity Health, a large Catholic hospital chain as reported in HIStalk? Memory leaks from poor code? Buffer overflows? What?]

That’s at least as I understand it.

[Understand it from whom? Hopefully not from me or my extensive website on the issues, the site whose header sadly now appears as below - ed.]

A new, unfortunate header for my website on health IT failures. Click to enlarge the shaded area, or click here to go to the site.

In summary, a "blame the user" attitude seems apparent. There appears to be little acknowledgment of the concept of IT "errorgenicity" - the capacity of a badly designed or poorly implemented information system to facilitate error, and of the systemic nature of errors in complex organizations to which ill-done IT can contribute.

These are concepts understood long ago in mission critical settings, as in this mid 1980's piece from the Air Force cited in my previously-linked eight part series on mission hostile health IT:

From "GUIDELINES FOR DESIGNING USER INTERFACE SOFTWARE"
ESD-TR-86-278
August 1986
Sidney L. Smith and Jane N. Mosier
The MITRE Corporation
Prepared for Deputy Commander for Development Plans and Support Systems, Electronic Systems Division, AFSC, United States Air Force, Hanscom Air Force Base, Massachusetts.

... SIGNIFICANCE OF THE USER INTERFACE

The design of user interface software is not only expensive and time-consuming, but it is also critical for effective system performance. To be sure, users can sometimes compensate for poor design with extra effort. Probably no single user interface design flaw, in itself, will cause system failure. But there is a limit to how well users can adapt to a poorly designed interface. As one deficiency is added to another, the cumulative negative effects may eventually result in system failure, poor performance, and/or user complaints.

Outright system failure can be seen in systems that are underused, where use is optional, or are abandoned entirely. There may be retention of (or reversion to) manual data handling procedures, with little use of automated capabilities. When a system fails in this way, the result is disrupted operation, wasted time, effort and money, and failure to achieve the potential benefits of automated information handling.

In a constrained environment, such as that of many military and commercial information systems, users may have little choice but to make do with whatever interface design is provided. There the symptoms of poor user interface design may appear in degraded performance. Frequent and/or serious errors in data handling may result from confusing user interface design [in medicine, this often translates to reduced safety and reduced care quality - ed.] Tedious user procedures may slow data processing, resulting in longer queues at the checkout counter, the teller's window, the visa office, the truck dock, [the hospital floor or doctor's office - ed.] or any other workplace where the potential benefits of computer support are outweighed by an unintended increase in human effort.

In situations where degradation in system performance is not so easily measured, symptoms of poor user interface design may appear as user complaints. The system may be described as hard to learn, or clumsy, tiring and slow to use [often heard in medicine, but too often blamed on "physician resistance" - ed.] The users' view of a system is conditioned chiefly by experience with its interface. If the user interface is unsatisfactory, the users' view of the system will be negative regardless of any niceties of internal computer processing.

I am not entirely happy when the CEO of an organization taking on the responsibility of being a central focus for EHR error reporting makes statements that are consistent with unfamiliarity with important HIT-relevant domains, as well as a possible pro-IT, anti-user biases.

For that reason as well as the other questions raised at my prior posts (such as the onerous legal contract and apparent lack of ability of the public to easily view the actual report texts themselves), I cannot recommend use of their site for EHR problems reporting.

I recommend the continued use of the FDA facilities until such time as a compelling argument exists to do otherwise.

-- SS

Addendum 11/28/10:

This passage ends the main essay at my site "Contemporary Issues in Medical Informatics: Common Examples of Healthcare Information Technology Difficulties" and is quite relevant here:

... An article worth reviewing is "Human error: models and management", James Reason (a fitting name!), BMJ 2000;320:768-770 (18 March), http://www.bmj.com/cgi/content/full/320/7237/768:

Summary points:

• Two approaches to the problem of human fallibility exist: the person and the system approaches
  

• The person approach focuses on the errors of individuals, blaming them for forgetfulness, inattention, or moral weakness

• The system approach concentrates on the conditions under which individuals work and tries to build defenses to avert errors or mitigate their effects

• High reliability organizations---which have less than their fair share of accidents---recognize that human variability is a force to harness in averting errors, but they work hard to focus that variability and are constantly preoccupied with the possibility of failure.

-- SS

21st century EMR experiments: messing around with people's lives in a broke city, while not having a clue what you're doing

I was astounded to read the following passage in an interview of the current chief medical information officer at Detroit Medical Center ("DMC") Detroit, MI:

DMC tried CPOE in 2003 and said it would regroup and try it again. What lessons were learned from that first attempt?

In 2003 we did try at one hospital — a more community-based hospital — on two units. We did it on our rehab unit, the psych unit. I think the first lesson we learned there was that it was really just designed as, or worked out as, an IT project. I mean, it was really IT-led and there wasn’t clinical involvement from the get-go.

There wasn’t really a leadership pattern that had physician and nursing components to it. There wasn’t a design phase that included a lot of clinicians. There wasn’t leadership buy-in from the hospital. We took the product from the vendor and implemented what they gave us. It was really doomed to fail from the start. [Doomed, that is, due to inexcusable health IT illiteracy for the year 2003 - ed.]

This is striking for a number of reasons, least of which is the tone in which the failure is presented, a tone that suggests this failure and its "lessons" were banal in character and something that "just happens." It's as if by 2003 there was no other way to have done due diligence and learned these lessons, other than by actual experimentation on hospital floors with live patients and busy clinicians.

If this story had appeared about a health IT project in, say, 1983 or 1993, it would have been less remarkable. By 2003, however, the literature on how do do health IT "right" (and on how not to do it, including all the faults mentioned about DMC's efforts), was quite voluminous.

The medical informatics literature from AMIA and IMIA, textbooks such as Lorenzi and Riley's "Organizational Aspects of Health Informatics: Managing Technological Change" (ed. 1 - 1995), sites such as my own on HIT failures (freely available and one of the first hits one received via google on searches on "Healthcare IT failure" and similar concepts even then), and other resources could have prevented the CPOE failure - if someone at DMC or their consultants had had the meta-knowledge to know of their existence or the managerial savvy to ask, and the initiative to actually read the materials and heed the advice of experts.

Instead, this sounds like a classic example of hospital mismanagement, via not knowing what you don't know, and not caring.

What is described is a failure due to HIT naivete and managerial dyscompetence (or incompetence) around technology management that should not have existed in hospitals in an American city in 2003. One should wonder what other mishaps occured in other domains of medical technology under this type of "leadership."

Clinical personnel and patients are the potential victims - not laboratory rats. The story is certainly remarkable in terms of risk presented by this experiment on live patients, and again for its banal tone regarding that crucial issue. It is well known that poorly done CPOE is associated with medication errors, not a happy event on a psychiatry unit or PM&R/rehab unit (where elderly frail patients often abound).

The story is also remarkable due to the waste of money it represents in a city not exactly rolling in money, looking somewhat like Dresden after the WW2 firebombing and with wide sections of former residential land designated for demolition and "return to nature."

Instead of spending money on "let's try to figure out CPOE today, all by ourselves!" health IT experiments, perhaps the money could have been used for better care of Detroit's poor.

The "lessons learned" in 2003 could and should have been learned for free and without risk to patients - in a public library.

I ask:

• Did patients get injured in this debacle? If they did, are the records sealed? We may never know.

• Has DMC truly learned the lessons of 2003 fully, or do similar problems continue?

• Were the executives responsible for this failure held accountable in any meaningful fashion?
  

Finally - and this is my major point - how many organizations in 2010 and beyond are similarly stuck in the stone age regarding how to "do health IT well"?

I believe the answer is "far too many."

-- SS

21st century EMR experiments: messing around with people's lives in a broke city, while not having a clue what you're doing

I was astounded to read the following passage in an interview of the current chief medical information officer at Detroit Medical Center ("DMC") Detroit, MI:

DMC tried CPOE in 2003 and said it would regroup and try it again. What lessons were learned from that first attempt?

In 2003 we did try at one hospital — a more community-based hospital — on two units. We did it on our rehab unit, the psych unit. I think the first lesson we learned there was that it was really just designed as, or worked out as, an IT project. I mean, it was really IT-led and there wasn’t clinical involvement from the get-go.

There wasn’t really a leadership pattern that had physician and nursing components to it. There wasn’t a design phase that included a lot of clinicians. There wasn’t leadership buy-in from the hospital. We took the product from the vendor and implemented what they gave us. It was really doomed to fail from the start. [Doomed, that is, due to inexcusable health IT illiteracy for the year 2003 - ed.]

This is striking for a number of reasons, least of which is the tone in which the failure is presented, a tone that suggests this failure and its "lessons" were banal in character and something that "just happens." It's as if by 2003 there was no other way to have done due diligence and learned these lessons, other than by actual experimentation on hospital floors with live patients and busy clinicians.

If this story had appeared about a health IT project in, say, 1983 or 1993, it would have been less remarkable. By 2003, however, the literature on how do do health IT "right" (and on how not to do it, including all the faults mentioned about DMC's efforts), was quite voluminous.

The medical informatics literature from AMIA and IMIA, textbooks such as Lorenzi and Riley's "Organizational Aspects of Health Informatics: Managing Technological Change" (ed. 1 - 1995), sites such as my own on HIT failures (freely available and one of the first hits one received via google on searches on "Healthcare IT failure" and similar concepts even then), and other resources could have prevented the CPOE failure - if someone at DMC or their consultants had had the meta-knowledge to know of their existence or the managerial savvy to ask, and the initiative to actually read the materials and heed the advice of experts.

Instead, this sounds like a classic example of hospital mismanagement, via not knowing what you don't know, and not caring.

What is described is a failure due to HIT naivete and managerial dyscompetence (or incompetence) around technology management that should not have existed in hospitals in an American city in 2003. One should wonder what other mishaps occured in other domains of medical technology under this type of "leadership."

Clinical personnel and patients are the potential victims - not laboratory rats. The story is certainly remarkable in terms of risk presented by this experiment on live patients, and again for its banal tone regarding that crucial issue. It is well known that poorly done CPOE is associated with medication errors, not a happy event on a psychiatry unit or PM&R/rehab unit (where elderly frail patients often abound).

The story is also remarkable due to the waste of money it represents in a city not exactly rolling in money, looking somewhat like Dresden after the WW2 firebombing and with wide sections of former residential land designated for demolition and "return to nature."

Instead of spending money on "let's try to figure out CPOE today, all by ourselves!" health IT experiments, perhaps the money could have been used for better care of Detroit's poor.

The "lessons learned" in 2003 could and should have been learned for free and without risk to patients - in a public library.

I ask:

• Did patients get injured in this debacle? If they did, are the records sealed? We may never know.

• Has DMC truly learned the lessons of 2003 fully, or do similar problems continue?

• Were the executives responsible for this failure held accountable in any meaningful fashion?
  

Finally - and this is my major point - how many organizations in 2010 and beyond are similarly stuck in the stone age regarding how to "do health IT well"?

I believe the answer is "far too many."

-- SS

More Contaminated Heparin, But Who Leads the Company Who Supplied It?

We have posted multiple times over the last two years about the deadly contaminated heparin from China. (See the case summary and link at the end of this post.)

One of the key players in this case was a company called Scientific Protein Laboratories (SPL). The company that sold the heparin in the US under its logo, Baxter International, had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from Scientific Protein Laboratories, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

Even More Contaminated Heparin?

Now it looks like SPL may have sold contaminated heparin elsewhere, after the above story of the contaminated heparin sold by Baxter became public, as reported by Alicia Mundy in the Wall Street Journal:

A major U.S. heparin wholesaler received a complaint from a corporate customer about a contaminated batch of blood thinner in October 2008, but didn't investigate for almost a year, according to a recent Food and Drug Administration notice to the company.

Scientific Protein Laboratories LLC got the customer complaint months after the FDA announced nationwide recalls of many heparin products.

In more detail,

In a report last month, reviewed by The Wall Street Journal, the FDA told SPL that it 'did not adequately investigate a complaint that affected product quality.' The report said SPL didn't begin a probe of the contamination complaint until September 2009, and failed to investigate 'other lots of heparin that may have been associated with the complaint.'

The FDA said Wednesday it cited SPL for 'violations of current good manufacturing practice' and is still investigating. 'FDA believes the issue does not present a significant public-health risk,' it said. An FDA spokeswoman said the batch in question never reached patients.

After SPL looked into the October 2008 complaint, it found that the contaminated raw material was used in two processed batches of heparin , the FDA report said. SPL ended its review of one batch in June 2010. It didn't investigate the second, the FDA said.

It looked like this instance of contaminated heparin did not pose a public health hazard because the company to whom it was shipped, possibly alerted by the case above, tested and rejected the SPL heparin

SPL said Wednesday the heparin lots in question 'passed all the then-required, state-of-the-art testing' to detect contamination, however trace amounts of contaminant, oversulfated chrondroitin sulfate, were found by a customer using their own specialized testing. The company also said no adverse events were reported involving the batch in question. [Ed - apparently because the buyer realized the problem and never used the batch in its products that were provided to the public.]

So even after the whole problem of oversulfated chrondroitin sulfate contaminated heparin had become a public scandal, the company that passed along the heparin that became subject of that scandal had "state-of-the-art testing" that could not adequately detect that specific contaminant, although the company to whom it sold the heparin apparently was able to test for it.

Providing pure, unadulterated products is the most elementary responsibility of drug companies. The US Food and Drug Administration was set up mainly to ensure the purity of drugs (and only later, to ensure their effectiveness and then safety). Yet some US companies have proven unable to assure the purity of their products. (For another prominent case, go here.)  Now we have an instance in which a company still seemed unable to check their products for impurities even after they knew dangerous impurities could be present and had been present in other batches of the products they sold, and even after other companies had figured out how to perform such checks.

As we have said before, seemingly infinitum, if we want a health care system that provides good quality, affordable, accessible care, we need health care leaders who put the wellbeing of patients ahead of their own pocketbooks, and to hold them accountable for doing so.

Holding Leaders Accountable, If Only One Could Find Them

By the way, this case further illustrates how far from that ideal we are, because it is not even obvious who the leaders of SPL who ought to be held so accountable actually are.  The SPL web-site says nothing about corporate governance or leadership. 

After some Google searching, it turns out that the reason for this is that SPL was bought out by private equity firm American Capital Strategies Ltd in 2006, two years before the contaminated heparin scandal became manifest.  Although American Capital Strategies Ltd is publicly traded, its 2010 proxy statement and most recent publicly available annual report (of 2008) say almost nothing about SPL.  Private equity firms are known for acquiring troubled companies and trying to turn quick profits from them, often from stringent cost-cutting and selling off assets.  They are not particularly known for their devotion to better patient care.  None of the top executives and directors of American Capital Strategies Ltd seem to have health care backgrounds or experience or any other reason to sympathize with the core values of health care professionals.

Further Google searching did suggest that the CEO of SPL is one David G Strunce, but revealed little biographical information about him.  How he and other executives of that company might better be held accountable is not obvious.

So what will it take to get the leaders of pharmaceutical companies to take their responsibility to provide pure, unadulterated drugs more seriously? How will society be able to better hold those leaders accountable?  How can we get leaders of health care to put the health of the people ahead of their own financial returns? 

The case of the adulterated heparin suggests these questions will not be easily answered.

Case Summary

In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.



(For a more detailed summary of the case, look here.)

More Contaminated Heparin, But Who Leads the Company Who Supplied It?

We have posted multiple times over the last two years about the deadly contaminated heparin from China. (See the case summary and link at the end of this post.)

One of the key players in this case was a company called Scientific Protein Laboratories (SPL). The company that sold the heparin in the US under its logo, Baxter International, had outsourced production of the active ingredient to a long, and ultimately mysterious supply chain. Baxter got the active ingredient from Scientific Protein Laboratories, which in turn obtained it from a factory in China operated by Changzhou SPL, which in turn was owned by Scientific Protein Laboratories and by Changzhou Techpool Pharmaceutical Co. Changzhou SPL, in turn, got it from several consolidators or wholesalers, who in turn got it from numerous small, unidentified "workshops," which seemed to produce the product in often primitive and unsanitary conditions. None of the stops in the Chinese supply chain had apparently been inspected by the US Food and Drug Administration nor its Chinese counterpart.

Even More Contaminated Heparin?

Now it looks like SPL may have sold contaminated heparin elsewhere, after the above story of the contaminated heparin sold by Baxter became public, as reported by Alicia Mundy in the Wall Street Journal:

A major U.S. heparin wholesaler received a complaint from a corporate customer about a contaminated batch of blood thinner in October 2008, but didn't investigate for almost a year, according to a recent Food and Drug Administration notice to the company.

Scientific Protein Laboratories LLC got the customer complaint months after the FDA announced nationwide recalls of many heparin products.

In more detail,

In a report last month, reviewed by The Wall Street Journal, the FDA told SPL that it 'did not adequately investigate a complaint that affected product quality.' The report said SPL didn't begin a probe of the contamination complaint until September 2009, and failed to investigate 'other lots of heparin that may have been associated with the complaint.'

The FDA said Wednesday it cited SPL for 'violations of current good manufacturing practice' and is still investigating. 'FDA believes the issue does not present a significant public-health risk,' it said. An FDA spokeswoman said the batch in question never reached patients.

After SPL looked into the October 2008 complaint, it found that the contaminated raw material was used in two processed batches of heparin , the FDA report said. SPL ended its review of one batch in June 2010. It didn't investigate the second, the FDA said.

It looked like this instance of contaminated heparin did not pose a public health hazard because the company to whom it was shipped, possibly alerted by the case above, tested and rejected the SPL heparin

SPL said Wednesday the heparin lots in question 'passed all the then-required, state-of-the-art testing' to detect contamination, however trace amounts of contaminant, oversulfated chrondroitin sulfate, were found by a customer using their own specialized testing. The company also said no adverse events were reported involving the batch in question. [Ed - apparently because the buyer realized the problem and never used the batch in its products that were provided to the public.]

So even after the whole problem of oversulfated chrondroitin sulfate contaminated heparin had become a public scandal, the company that passed along the heparin that became subject of that scandal had "state-of-the-art testing" that could not adequately detect that specific contaminant, although the company to whom it sold the heparin apparently was able to test for it.

Providing pure, unadulterated products is the most elementary responsibility of drug companies. The US Food and Drug Administration was set up mainly to ensure the purity of drugs (and only later, to ensure their effectiveness and then safety). Yet some US companies have proven unable to assure the purity of their products. (For another prominent case, go here.)  Now we have an instance in which a company still seemed unable to check their products for impurities even after they knew dangerous impurities could be present and had been present in other batches of the products they sold, and even after other companies had figured out how to perform such checks.

As we have said before, seemingly infinitum, if we want a health care system that provides good quality, affordable, accessible care, we need health care leaders who put the wellbeing of patients ahead of their own pocketbooks, and to hold them accountable for doing so.

Holding Leaders Accountable, If Only One Could Find Them

By the way, this case further illustrates how far from that ideal we are, because it is not even obvious who the leaders of SPL who ought to be held so accountable actually are.  The SPL web-site says nothing about corporate governance or leadership. 

After some Google searching, it turns out that the reason for this is that SPL was bought out by private equity firm American Capital Strategies Ltd in 2006, two years before the contaminated heparin scandal became manifest.  Although American Capital Strategies Ltd is publicly traded, its 2010 proxy statement and most recent publicly available annual report (of 2008) say almost nothing about SPL.  Private equity firms are known for acquiring troubled companies and trying to turn quick profits from them, often from stringent cost-cutting and selling off assets.  They are not particularly known for their devotion to better patient care.  None of the top executives and directors of American Capital Strategies Ltd seem to have health care backgrounds or experience or any other reason to sympathize with the core values of health care professionals.

Further Google searching did suggest that the CEO of SPL is one David G Strunce, but revealed little biographical information about him.  How he and other executives of that company might better be held accountable is not obvious.

So what will it take to get the leaders of pharmaceutical companies to take their responsibility to provide pure, unadulterated drugs more seriously? How will society be able to better hold those leaders accountable?  How can we get leaders of health care to put the health of the people ahead of their own financial returns? 

The case of the adulterated heparin suggests these questions will not be easily answered.

Case Summary

In summary, Baxter International imported the "active pharmaceutical ingredient" (API) of heparin, that is, in plainer language, the drug itself, from China. That API was then sold, with some minor processing, as a Baxter International product with a Baxter International label. The drug came from a sketchy supply chain that Baxter did not directly supervise, apparently originating in small "workshops" operating under primitive and unsanitary conditions without any meaningful inspection or supervision by the company, the Chinese government, or the FDA. The heparin proved to have been adulterated with over-sulfated chondroitin sulfate (OSCS), and many patients who received got seriously ill or died. While there have been investigations of how the adulteration adversely affected patients, to date, there have been no publicly reported investigations of how the OSCS got into the heparin, and who should have been responsible for overseeing the purity and safety of the product. Despite the facts that clearly patients died from receiving this adulterated drug, no individual has yet suffered any negative consequence for what amounted to poisoning of patients with a brand-name but adulterated pharmaceutical product.



(For a more detailed summary of the case, look here.)

Interface Problems, Ill-Informed Leadership, Suppression of Whistle Blowing: A New Look at a Historic Case

Three issues that come up frequently on Health Care Renewal are problems with man-machine interfaces in health care information technology (IT), as in this post by Dr Scot Silverstein; ill-informed and mission-ignorant or hostile leaders, sometimes in a position to overrule health care professionals, as in this post; and whistle-blowers, and their silencing.

A truly amazing story just surfaced that deals with all these issues, albeit not in health care.  If it is true, and if it had been revealed earlier, maybe society would have become more concerned earlier with these issues, and maybe they would have not ended up plaguing health care so.

Let me first just go through the basic structure of the story to underline the parallels with health care issues.  Then I will quote the specifics.

(If you do not instantly recognize the story, I suggest going through this post sequentially, not jumping to the end, to make its impact more clear.)

The Structure of the Story

Introduction
A large corporation had just put on-line, with much publicity, a high-technology system that was advertised as bigger, faster, better than the competition. 

Confusing Interface and Terminology, Wrong Control Input 

A few days after becoming operational, those in charge suddenly noticed a looming and severe problem.  A technician was ordered to make an extreme control input to avoid the problem.  However, there was confusion about the terminology of the input.  While the system he was controlling was new, and had a new interface, it was operating in an area in which the old terminology, from a time in which the interface for the particular control worked in the opposite direction, was still in use.  So his extreme input was in exactly the wrong direction.  By the time the mistake was clear, and the control was reversed, it was too late, and the first stage of the catastrophe ensued. 

Ill-Informed Management Overrules the Professionals

It is possible that the catastrophe could have been ameliorated if a crucial part of the system were then to have been quickly shut down.  The highest ranking professional on duty ordered it shut down.  However, soon after the events above, a top executive in the corporation, who was nearby only because of all the hoopla surrounding the system's roll out, came on the scene.  He countermanded the order for the shutdown, possibly thinking continuing operation would cost less money and result in less bad publicity.  True disaster then ensued.

Whistle Blowing Suppressed

After the disaster, there were several government hearings.  The top executive denied any knowledge of the decision making that lead to the disaster.  A professional who had not been present when the decisions were made, but was told about them by those who were present, avoided mention of the events above, because the top executive had told him that if he were to have told the truth, the company would have been found negligent, its insurance would not have covered the disaster, and it would have gone bankrupt, and everyone would lose their jobs.  So he never told anyone except first-degree relatives.  The other people who were present for the events above did not testify, for reasons to be discussed below.

So this story has all the familiar elements.  But so have many others.  Why was the suppression of this version of the story (assuming its true, which is not proven) so important?

The Real Story

Let us go through the elements again, this time with quotes from the article in the London, UK, Telegraph:

Introduction and Context

All families have their secrets, but usually about things that don’t matter to anybody else. Not in the case of Louise Patten, though – or The Lady Patten to give her her full title, the wife of former Tory Education minister, Lord (John) Patten, though her own career as one of the first women board directors of a FTSE 100 company, and as a successful author of financial thrillers, means that she has plenty of achievements in her own right.

As a teenager in the 1960s, Patten was let in on a secret by her beloved grandmother, which, if revealed, she was warned, would result in two things. The first was awful – it would destroy the good name of her dead grandfather, Charles Lightoller, awarded the DSC with Bar in the First World War, and a hero again for his part in the evacuation of Dunkirk in 1940. But the second would change history, overturning the authorised version of one of the world’s greatest disasters, the sinking of the Titanic with the loss of 1517 lives in April 1912.

The tension between these two outcomes goes some way to explaining why, for 40 years, Patten kept quiet....

'After the collision,’ Patten goes on, 'my grandfather went down with the Captain and [First Officer] Murdoch to Murdoch’s cabin to get the firearms in case there were riots when loading the lifeboats. That is when they told him what had happened.'

Confusing Terminology and Interface

'Instead of steering Titanic safely round to the left of the iceberg, once it had been spotted dead ahead, the steersman, Robert Hitchins, had panicked and turned it the wrong way.’

At first glance it sounds extraordinary that anyone – much less the man put in charge of the wheel on the maiden voyage of what was then the world’s most expensive ocean liner – could have made such a schoolboy error.

'Titanic was launched at a time when the world was moving from sailing ships to steam ships. My grandfather, like the other senior officers on Titanic, had started out on sailing ships. And on sailing ships, they steered by what is known as “Tiller Orders” which means that if you want to go one way, you push the tiller the other way. [So if you want to go left, you push right.] It sounds counter-intuitive now, but that is what Tiller Orders were. Whereas with “Rudder Orders’ which is what steam ships used, it is like driving a car. You steer the way you want to go. It gets more confusing because, even though Titanic was a steam ship, at that time on the North Atlantic they were still using Tiller Orders. Therefore Murdoch gave the command in Tiller Orders but Hitchins, in a panic, reverted to the Rudder Orders he had been trained in. They only had four minutes to change course and by the time Murdoch spotted Hitchins’ mistake and then tried to rectify it, it was too late.

A Manager Countermanding the Professional

If the steersman Hitchins had made a human error, Bruce Ismay, chairman of the White Star Line, owners of the Titanic, and another survivor of the sinking, gave a lethal order.

'Titanic had hit the iceberg at her most vulnerable point,’ explains Patten, 'but she could probably, my grandfather estimated, have gone on floating for a long time. But Ismay went up on the bridge and didn’t want his massive investment to sit in the middle of the Atlantic either sinking slowly, or being tugged in to port. Not great publicity! So he told the Captain to go Slow Ahead. Titanic was meant to be unsinkable.’

However,

'If Titanic had stood still,’ she demonstrates, 'she would have survived at least until the rescue ship came and no one need have died, but when they drove her 'Slow Ahead’, the pressure of the sea coming through her damaged hull forced the water over the bulkheads and flooded sequentially one watertight compartment after another – and that was why she sank so fast.’

Whistle Blower Suppressed, the Cover Up

Why, though, I puzzle, would Patten’s grandfather, who sounds like a thoroughly honest and brave man, have lied and carried on lying? 'Because,’ she explains, 'when he was on the rescue ship, Bruce Ismay pointed out to my grandfather that if he told the truth, the White Star Line would be judged negligent and its limited liability insurance would be invalid. Ismay pretty much said that the whole company would go bust and everyone would lose their jobs. There was a code of honour among men like my grandfather in those days. So he lied to protect others’ jobs.’

But why didn’t her grandmother speak up after her husband’s death in 1952? 'She was worried about showing this heroic figure to be a liar. And my mother, who also knew the secret and was even uncomfortable with Granny having told me, felt even more strongly about it. She hero-worshipped my grandfather.’

So there this secret sat, locked in a family circle from which Patten is now the only survivor.

Conclusion

The story does seem amazing. I am hardly an expert on the sinking of the Titanic, so should not try to comment on its truth. It does have some plausibility, and provides an explanation for one of the most important and influential disasters of the 20th century that is still poorly understood and a cause for controversy.

In my humble opinion, if it were true, and had it come out earlier, this amazing story would have focused society's concerns on issues that have instead become scourges of our current era, and particularly important, if not frequently enough discussed causes of our health care dysfunction.

The Titanic disaster lead to major changes in numerous safety practices, leading to rules about the adequacy of lifeboats and radio communication, and even swimming proficiency requirements in higher education. (I had to pass a swimming test as a Brown University freshman that was a legacy of the sinking of the Titanic, I was told.) Most of these practices increased the survivability of accidents.

What if the focus was also on the causes of accidents? What if there was a groundswell of advocacy, starting in 1912, against pressure from business and financial leaders on professionals sworn to protect the public's health and safety, and against intimidation of whistle-blowers whose revelations could protect public health and safety? Maybe health care, and many other parts of life, would have turned out better?