Regulatory conflicts of interest - lessons for the HSA from SMRT/LTA COI

The recently released findings of the Committee of Inquiry for the SMRT breakdowns has some important lessons for the HSA. Apart from pointing out the lapses in SMRT, it also fingered the failure of the regulator, LTA, in managing the intrinsic conflicts of interest inherent within the workings of the regulator. But the LTA is not alone is this regard. Many, if not all of Singapore's regulatory agencies are stacked full of these conflicts.

The HSA is similarly affected. Gigamole has pointed out these conflicts of interests before. How can a regulator do its job when it has also been tasked with befriending and facilitating growth of the very industry it is supposed to regulate? In some cases, the HSA is itself, also the service provider in the areas where it is supposed to regulate.

 In the recent brouhaha about medical device regulation, the HSA came across looking almost afraid of the industry it is supposed to regulate. Note how very quickly it capitulated to the demands of industrial players. To Gigamole, "regulate with a light touch" really means "I will look the other way while you do your thing. Just don't get into trouble".

In the hurriedly convened "closed" town hall meeting, HSA met up with 370 of the industry players to anxiously reassure them of this "light touch". Conspicuously absent was any representation from any consumer groups. Do patient-consumers not have a voice, and do they not need to be protected? It used to be that we can depend of the Ministry of Health, or its proxy, in the form of a governmental regulatory agency, to have the interests of the public first. But nowadays, this cannot be assumed, because regulators have to be industry friendly, and promote the development of these very industries. And the biomedical industry has become significantly more powerful and insistent of late. The need to "perform" with respect to the Pro-Enterprise Index, speaks volumes.

The LTA had been found wonting because it did not adequately firewall its regulatory functions from the need to also promote. Likewise, Gigamole predicts that it is only a matter of time before the HSA runs into serious problems with major consequences for the patient-consumer if it doesn't make a serious attempt to deconflict these functions.

IVF errors, or negligence?

So it has now been revealed that not only the Thomson Medical Centre was sloppy, but the Gleneagles IVF and the O&G Partners Fertility also did not follow procedures. They did not comply with procedures, and did not provide for a second operator to counter-check.

I don't know..... to my simple mole-mind, this doesn't really qualify for a procedural lapse, or human error. Smacks of negligence to me.

Seems to me that we haven't taken such clinic audits and licensing seriously enough.

IVF "lapses"

I must say I was disappointed that the MOH could not bring itself to go beyond just identifying "lapses" as being the causes of the error. Though it's kinda expected. It doesn;t say very much. We all know that accidents are due to lapses.

What we want really to find out is why those lapses occured. Was there a systemic problem that increased likelihood of lapses. Were the quality assurance procedures adequate? Were there previous audit findings that were not remedied? Were weaknesses in the system identified before but left unattended to for too long?

Human error can often be the consequence of systemic failures.

Investigating aviation errors and IVF mistakes - a fair comparison?

Minister of Health Khaw Boon Wan made an interesting reference to the investigation of aviation errors while commenting or the recent IVF mistake which occurred at the Thomson Medical Centre.

He said: "Like the health sector, the aviation sector used to approach safety and errors through a largely fault-finding approach. When a plane crashed or hit a problem, the first question was to nail down the culprit: who was responsible, was the pilot at fault, was the engineer negligent etc? This used to be their approach a decade or two ago.

But they have since moved away from that approach. Instead, they took a system approach. Each time an adverse event occurs, they will conduct an objective and thorough investigation, not to witch hunt, but to identify the causes, especially if there are systemic flaws. Because they moved away from fault-finding, everyone was open in their comments, resulting in a speedy and accurate assessment of the true situation. Under the previous approach, the tendency was to protect one’s interest, resulting sometimes in cover-ups and the truth became elusive."

It's a very enlightened approach, and one to be applauded, although at some point in time there needs to be some accountability and someone has to take responsibility for not putting in place adequate measures to prevent errors. The MOM comes in hard for employers who put their workers in jeopardy by being negligent in not ensuring adequate workplace safety. In our research laboratories, the principle investigator faces a possible jailable outcome should lab safety measures be violated, or he has been negligent. Should not we expect the same rigour when medical professionals are negligent in situations such as this?

But I digress. The real purpose of this post is to explore the appropriateness or lack of, in the comparison with the investigation of aviation errors.

Avoidance of fault finding and cover-ups are two faces of the same coin. Often breakdowns in the integrity of a system/process extends beyond the party holding the smoking gun. If an error occurs in the regulatory functions, this would be less likely to be flagged out if the investigating team comes from the regulators themselves. In the investigation of aviation errors, to avoid this conflict of interests, an independent body forms the investigating team. Only thus, can the true extent of errors be discovered. If the investigating team is formed by the regulator, it is more than likely that a "fault" will be found only in the party in possession of the smoking gun.

In this instance of the IVF error, the investigating team is the Ministry of Health team. Yet it is the Ministry of Health which audits and regulates this industry. How can the Ministry then identify weaknesses in its own audit/regulatory systems covering the IVF facilities which allowed high likelihood of errors such as this to be committed? This is uncertain.

Should we not require some sort of pre-implantation diagnosis of paternity to be documented as validation of the integrity of the process before the embryo is implanted? Doing so will at least ensure that at the very least, there are no costly mistakes beyond the irreversible step of implantation.

Perhaps the Ministry of Health could consider releasing the last audit findings of Thomson Medical Centre so that the public can gauge if the audit was done with the stringency we expect, and/or the facility failed to act of recommendations.

As the Minister pointed out, this should not be to find fault but to enable everyone to correct all the deficiencies of the system. Following which, we can move on.

Organ trade tenesmus in Malaysia

Malaysia is for living unrelated donors....., or not?

First it was reported that Minister of Health for Malaysia Datuk Seri Liow Tiong Lai said his Ministry was looking at improving the National Transplantation Act which was being drafted to serve as a guideline on unrelated live organ donations.

He said the new law would enable the authorities to monitor live organ donors which at present were encouraged for only family members and relatives of patients.

"We have to be careful because commercialisation of organs is a big problem. The selling and buying of organs is against human principles and not ethical," he said, adding that if non-relatives want to make live organ donations, it should be out of sincerity and not for monetary gains.

Sure sounded very much like Singapore's position a year or two ago.

Then almost in response, the Health Director General Tan Sri Dr Ismail Merican in the 4th November New Straits Times, was reported as saying, "Malaysia is against living unrelated donors donating organs because of the risk of organ trading and trafficking...... If living donation is to be carried out, it should come from genetically, legally or emotionally related donors."

Hmmmm..... a bit of tenesmus there.

Singapore, by the way passed a law allowing compensation of organ donors, effectively allowing living unrelated donors to receive compensation for donating their organs. Not sure if it is just engaging in semantics to suggest that this is essentially organ trading.

What is needed now after more than 18 months of this law, is for MOH to update us with respect to how many such unrelated living donations have been effected, and the details of such donations. One of the major concerns had been the exploitation of poor donors from neighbouring countries, and servicing of wealthy recipients who are no citizens. It would be really nice and reassuring if the MOH to tell us what the numbers are, and how we are actually monitoring/regulating the situation.

Singapore's "first" IVF mix-up?

In the process of being taken over by billionaire Peter Lim, the Thomson Medical Centre gets this unexpected bombshell - a dreaded mix-up in the IVF procesure where the mother's egg had been apparently fertilized by the wrong sperms!

Previous posts had highlighted this error and asked for clarity on this issue with respect to the local situation. Now this dreaded error has been reported in Singapore. It is no comfort to say that the risk is very low. A single accident is one too many already. Patients deserve better.

There needs to be more public assurances about the practices procedures and processes in place that will prevent accidents of this sort.

I think a public 'fessing up of what actually went wrong is needed. Dr Cheng LC of Thomson Medical Centre was quoted to have said: ... the centre's operating procedures "meet all regulatory requirements, and are of the highest international standards".

All very vague. Just what are these regulatory requirements? And are they adequate?

The Ministry of Health should tell us how the various IVF units fare in terms of the procedures and procedural compliance. Or are they never ever audited?

Conjunctions, and the medical school

In astronomy, when heavenly bodies align in space, it is thought that there might be exceptional physical forces that produce changes here on earth. In astrology, such conjunctions are thought to produce various metaphysical changes in energy which have effects on our destinies, etc.

Come February 14 this year there will be an extraordinary conjunction of events.

Other than an obvious fortuitous conjunction of Valentine's Day and Chinese New Year, there are a number of other much lesser known events that we might want to take some time to remember.

In 1942, during the fall of Singapore to the Japanese, a 4th year medical student Yoong Tat Sin, was killed by shrapnel on February 14. This happened at the Tan Tock Seng Hospital. He later died in SGH. That same evening, a group of his friends decided to give him a proper burial on the grounds of the SGH. During the occasion they were attacked by Japanese gunners and 11 students (5 Chinese, 4 Indians, 1 Malay and 1 Eurasian) perished. They were buried in the SGH grounds, after the British surrender on 16 February. An account of this war time tragedy can be found here.

On February 14, 1942, the Japanese had also over-run Alexandra Hospital (then the British Military Hospital) and massacred, bayoneting 250 patients, doctors and nurses. The next day additional groups were taken out and shot. Apparently, Gen Yamashita, upon hearing of this massacre apologised profusely, but it was too late.

The British surrendered on 15 February, 1942. It was also Chinese New Year, then.

February 15 also marks the 83rd anniversary of the College of Medicine Building. It was declared open by the Governor Sir Laurence Nunns Guillemard in 1926. Incidentally the architect of the building PH Keys was also the same chappie who designed Fullerton Building. An account of this, found here.

It is somewhat sad that few remember this history, and the heritage of the medical school and profession has been all but lost. Ironically, in times of deprivation and struggle, the school and profession seem to have had risen to greater heights of glory, than the glass and steel artifices that have been created more recently in times of great wealth.

East vs West - Minister Khaw's endorsement of anecdotal medicine?

I have to confess I was more than a tad disappointed by Minister of Health, Khaw Boon Wan's blog about his positive experience with TCM. No doubt he was narrating a personal experience, but it sounded too much as if he was endorsing an anecdotal approach towards the practice of medicine.

Is this the death knell for evidence-based medicine?

Minister of Health's Blog

It was great to see Minister appearing on his own blog. Congratulations, Sir!

My only grouse is that you do not allow direct comments on your blog. To comment, one has to have a Facebook account to access the Ministry of Health Facebook. Sir, not everybody wants to be on Facebook. So sadly, I will have to pass on commenting on issues on your site.

But still, it's a great start!