The SMRT fiasco - identifying the root causes?

In the midst of the chaos surrounding the Committee of Inquiry proceedings, senior management of the SMRT has of course, very predictably, made all kinds of promises to identify the root cause of what went wrong. Mr Ong Ye Kung, an independent director of the SMRT board has been appointed to do this "root cause analysis".

Fancy words, that sound good. The question is, can they?

The ideas of cause and effect go back a very long time in history. But the concept of root cause analysis can perhaps be traced back in more recent times (about 50 years ago) to when Sakichi Toyoda of Toyota fame, introduced the concept of the 5 Whys in identfying what actually caused something to wrong. The idea of asking whys 5 times to arrive at the root cause was perhaps too simplistic, but at least moved the inquiry beyond just fingering the finger that pulled the trigger, to a more fundamental cause.

Root cause analysis has since then become pretty much an industrial standard of identifying the fundamental causes of any industrial or public health incident. But it is not without its limitations. Dean Gano about 20 years ago pointed out some of the limitations in the cause-effect reasoning. He identified 4 principles of causation that we should take note of :

 1. Causes and effects are the same thing only seen at a different point in time.
 2. Causes and effects are part of an infinite continuum of causes.
 3. Each effect has at least two causes in the form of actions and conditions.
 4. An effect exists only if its causes exist at the same point in time and space.

Points 2 and 3 are particularly useful for us to take note of, i.e. that this whole process is pretty much an infinite continuum, and that apart from the action there are conditions that are involved in causation.

When investigating root cause of any event, the assumptions, prejudices and perspectives of the investigator becomes critically important because they determine the conduct of the investigation and interpretation of the events.

Applied to the SMRT conduct of root cause analysis, we can see that the Chairman did the "right" thing in appointing Mr Ong Ye Kung, an independent director of  the board to lead the investigation. However we should note that Mr Ong, although an independent director, is nevertheless a board member. Can we expect that he will be able to properly identify board related deficiencies? Furthermore, he is a PAP member who was on the teams that wrote the Land Transport White Paper, and  that established the LTA in the first place. How objective will he be in drawing that line of causal continuity back to those original ideas? Certainly the conditions for failure are equally important to the actions/inactions that resulted in the failure.

So I am not holding my breath that they will find the answer. The COI has identified the leads. Here's hoping there will at some point in time, be some real experts who will be capable of a truly independent conduct of the root cause analysis.

The SMRT monster-under-the-bed is emerging......

Day by day as the proceedings of the Committee of Inquiry for the SMRT fiasco plays out in the press, it has become clearer and clearer how big the monster under the Transport Minister's bed really is. This is one big mess. How can it be that the problem of national transport can be privatized to a company that showed such wanton neglect of operational necessities? The long awaited appearance of the beleaguered CEO at the COI really only served to confirm how misplaced the entire SMRT agenda was.  But much as we would like to just hang everything on the pathetic past CEO, Ms Saw, we should not forget she was not the only one responsible for this mess.

She essentially reported to the Chairman of the Board, Mr Koh Yong Guan, an eminent guy, but essentially a money guy. Eyeballing the SMRT 2010 Annual Report, we can see that the priorities of the Board really centred around fiscal prudence and health. Corporate risks were essentially only related to financial risks and not operational risks. Clearly the SMRT mission the Board set out for CEO Saw was really about growing the commercial and financial stature of the organization. Was she incompetent? Obviously not by the evaluations of the SMRT Board. At least not until the claws fell off the track and the poo hit the fans.

But who was behind the Board? Who put all this money people into the Board of an operational unit that was supposed to deliver a world class transport service? And how can it be that the transport regulator LTA can audit the SMRT year after year and find nothing but a bed of roses?

Now of course we know that bed of roses really harboured a huge stinky monster.

But going off on a tangent, as I am wont to do, it should be noted that this SMRT fiasco is really not merely an aberration in an otherwise healthy Singapore. Singapore, notwithstanding all the glowing reports in the mainstream media, is really quite dysfunctional. The sickness comes from the government's fixation on high GDP growth at the expense of everything else. Anything of worth is Singapore is denominated in dollar terms. The SMRT and the transport sector are not the only places where there are grossly misplaced missions. The health sector has been hugely corrupted by the pursuit of the medical dollar at the expense of affordable health care for the public. While lamenting the inadequacy of hospital beds, the Ministry of Health encourages corporatized hospitals to continue to build to cater to high end private patients. Meanwhile the universities chase bloated KPIs that have to do with ranking and research glory, rather than focusing on providing solid and affordable tertiary education for the average Singaporean.

There are monsters hidden under these beds that will, like the SMRT one, eventually emerge one day.

So as we head into the Hougang by-election, here is my plea to the Prime Minister. As a Singaporean I am increasing disillusioned by this overemphasis on wealth and elitist ideals. It is as if Singaporeans are not worthy of consideration and support unless they are megadollar earners. Prime Minister, you are wrong in this. Every Singaporean is worthy of support regardless of whether they are able bodied, able minded or not. Or even if they are just plain not-very-smart.

At this year's National Day Parade, I want to be able to say the pledge and mean it.

The bathtub effect? A Singapore problem.

When Transport Minister Lui Tuck Yew was recently pressed on why newer train systems were breaking down, he attributed this to the "bathtub effect". This is a cutesy metaphor that engineers like to use to give the impression that they have a human side, and that they do take baths.... sometimes. Essentially the metaphor refers to the high frequency of breakdowns in machines early during installation, and then again much later in its life cycle. The breakdown frequencies show a bathtub shaped curve.

The early breakdowns are usually due to the operator being relatively naive. The later breakdowns are due to the expected wear and tear when the machine nears the end of its lifecycle.

By referring to the bathtub effect, Minister Lui is essentially telling us that the SMRT had synced the train systems so well that the old system was failing at the same time as the new ones were. The sides of the two bathtubs were in perfect alignment. Well done, guys! You were precise about this, at least.

There is actually another interpretation of the bathtub effect. This is a metaphor used more by environmental scientists. Essentially here, the bathtub represents that container where the water level is determined by the rate of water flowing in and the rate of water draining from it.

The ENV people know this very well as this is the cause of the frequent 'ponding' observed in recent times, during heavy rainfall.

This is actually a more important interpretation of the bathtub effect, because it explains so many of the problems we see in Singapore nowadays. So much of the Singaporean angst, whether it is about housing, transport, healthcare or education is really about the water level in the bathtub. The capacity of these systems are woefully inadequate compared to the demand. So the water overflows from the bathtub.

One can't help wondering why this is so. Considering the 'excellence' of our civil service and that the government has had uninterrupted power for such a long time, it seems a critical neglect that they have gotten the models all so screwed up. Why they did not anticipate the rate of population growth and did not build enough capacity to cater for this growth, I simply cannot understand. Was it because all these scholars were so blind that they did not see the threat of overflow? Or was it that they were all only concerned about short term KPIs? Let the bathtub overflow on someone else's watch! 

So much for a government that claims credit for long term planning. So, thank you Minister Lui for sharing with us this important metaphor. Now we understand why the bathwater is ponding all over the living room floor.

Was the valve used in National Heart Centre operation approved as a medical device?

While the HSA was conducting their briefing about how they were going to tweak the regulatory processes for low risk devices, we have this bit of exciting news about the groundbreaking operation done at the National Heart Centre.

Exciting because it was the first such operation done in Asia. Essentially, the operation was a minimally invasive insertion of a bioprosthetic (cow tissue in steel) valve to correct for a mitral valve failure. The valve-in-valve design was developed in 2007 when it first underwent clinical studies. In November last year the Edwards SAPIEN valve received a much heralded approval from the FDA. But here is where there is a bit of problem. The FDA approval was only for the use of the valve for aortic valve stenosis, not for correction of the mitral valve. And only in patients who are too ill for open heart surgery. In fact the US FDA had made a note in its approval that the valvular operation, even for aortic stenosis was not without problem - patients had 3 times more chance of developing a stroke.  But there had been no similar FDA approval for a modified valve for mitral valvular disease. Gigamole is not sure if any major regulatory agencies have approved the mitral version of the valve, let alone the HSA.

So here are Gigamole's questions:

a] Did the FDA approve the mitral valve-in-valve as a medical device?
b] Did any regulatory agency world wide approve the mitral valve-in-valve medical device?
c] Did the HSA approve the mitral valve-in-valve medical device?  And if so, on what grounds? If not, what was the approval process for surgeons at the National Heart Centre to go ahead and operate using an FDA and HSA unapproved medical device?

Please do not mistake my questions as being anti-innovation and anti-progress. Devices such as this valve-in-valve device needs to be properly evaluated in terms of risk benefits before use. The aortic version was studied since 2007 before it was approved by the FDA. Although the valve had been modified for mitral valve use also in 2007, this never received the same warm response, and as far as Gigamole is aware, the FDA in its wisdom never gave approval for the mitral valve version. Treating the mitral valve is not as straightforward on terms of risk-benefit assessments as for aortic stenosis. To those who advocate that we blindly follow the FDA's approval must also accept that we should also take guidance from the FDA's tardiness in approving this procedure.

Research misconduct: continuing concerns, and the great wall of silence

As perhaps a sign of the increasing global concern about what appears to be an epidemic of misconduct among the scientific community, the New York Times has published an article titled "A Sharp Rise in Retractions Prompts Calls for Reform" by Carl Zimmer.

In it, Dr Ferric Fang, Editor in Chief of the journal Infection and Immunity is quoted as saying  "Nobody had noticed the whole thing was rotten."

The article further reports that "Dr. Fang became curious how far the rot extended. To find out, he teamed up with a fellow editor at the journal, Dr. Arturo Casadevall of the Albert Einstein College of Medicine in New York. And before long they reached a troubling conclusion: not only that retractions were rising at an alarming rate, but that retractions were just a manifestation of a much more profound problem — “a symptom of a dysfunctional scientific climate,” as Dr. Fang put it."

Should Singapore be concerned? The answer is an obvious "Yes!"

Yet there is this great wall of silence, as if no one wants to talk about it or publicly deal with the problem, potential or real. Alirio Melendez's publications have been under investigation for too long with any resolution. But not only Melendez, a number of other big and not so big names have been flagged out by blogs such as Abnormal Science. In these there are allegations of self plagiarism, image manipulations, data mislabelling etc. Yet there has to date, been no public acknowledgement of these problems, exoneration or evidence of any actions taken. Sadly silence just serves to condone such practices.

I think we owe it to our students and future generations of scientists to deal promptly, impartially and publicly with these problems.

Happy Vaisakhi!

Wishing my Punjabi friends, a very happy Vaisakhi. Have a great time today!

HSA and the regulation of medical devices - an exercise in agenda setting?

The theories of agenda setting are well known, I believe, to all mass comms graduates as well as journalists. Although the formal theories were only formulated about 40 years ago, ideas that the media can influence public opinion have been recognized since the early part of the 20th century.

The recent brouhaha about the regulation of medical devices by the HSA can perhaps be seen in the context of agenda setting. That the media plays an important role in agenda setting is beyond doubt. How the agenda is set however depends on who plays the media. To the media savvy, the media becomes a collaborator in the shaping of public opinion. A media-savvy politician therefore gets a pretty smooth road.

Where HSA failed has been in not recognizing how important the management of public expectations was in the implementation of complex and public-sentiment sensitive policies such as the regulation of medical devices. By defaulting on this, it has willy-nilly allowed the media to set the agenda in a direction contrary to public policy. So, not only has the media been allowed to tell us what issues are important, but it is being allowed to tell us what opinion we should form  about the issue. Note the teaser on the front page of the Straits Times today - "Patients should worry about vanishing medical devices". Really? Vanishing medical devices?

Poor HSA CEO John Lim is in the hot seat now. It seems like it is the fashion nowadays to run down the CEOs! I am waiting for the day when someone flashes an old D&D picture of him on a sedan chair carried by half maked women! But it should be recognized that the move towards regulating medical devices had not been developed overnight, but has been on the stove for about a decade. During this decade, the policy has been deliberated and refined under the guidance of 2 Ministers of Health and 2 Board Chairmen. I guess the second team has been quite unlucky to be on watch when this policy was finally ready to be implemented. But seeing how the SMRT issue developed, it seems highly unlikely even this team will get any credit for the mess. So, sadly, it looks like CEO John Lim will be the one catching the ball.