Alliance for Patient Safety

Dan Bental:

In 2012 we have published an inclusive report on the entire topic of medical negligence, insurance, risk management and the disciplinary law in the health system. In general, the report included four major chapters. One chapter discussed the national expenditure in matters of medical negligence, we are talking here about estimates of billions, when according to the Marsh Company report we could save here hundreds of millions, and at the present the current situation is that 40% of all the paid compensations are spent on the management of the judicial process and various administrative factors, instead of these amounts reaching the patients. These are hundreds of millions which could be returned to the health system. To the best of my knowledge, nothing was done in this matter.

The second topic was the entire issue of the obligatory insurance of the medical institutions, the connection between private medicine and public medicine, cross-subsidization, serious flows. Here too, nothing was done, to the best of our knowledge.

The third topic is the activity of the risk management systems in medical institutions; all the connections between the hospitals, the inquiries and investigations taking place in the various hospitals and the Ministry of Health.  And the fourth topic was the activity of the Public Ombudsman for the medical professions and the disciplinary complaint process. These are the four topics.

Again, I must say here, to the best of our knowledge not much was done, this is a very painful subject, and a very important one. Our report is in fact a check list; there are 80 pages of it, a check list, what needs to be done, where they should act. To the best of our knowledge it was not done, and Dana here will provide us with more details in regards to the topic of our discussion.

Dana Levi Watstein:

On the issue of the confidentiality of the reports and the medical documents, following the verdict of The Hadassah Medicinal Association vs. Gilad from 1995, which has stipulated that the investigations and the documents drafted in Risk Management may be used in legal and disciplinary procedures, a change occurred in the conduct of the medical system. Whereas until that point in time it was the custom to perform Morbidity and Mortality Meetings in the hospitals, since that verdict, those meetings were reduced, or completely stopped.

The Ministry of Health has answered to the Committee that there is a tool for professional investigations, similar to the investigations tool of air accidents. You should understand the difference though. Unlike the health system, the air force flight crews are protected against lawsuits, and have no concern in providing information, not on events and not on almost events. In the air force this has created a culture of transparency and disclosure. The legal situation is different in the health system, and has led to the opposite results of a fear from disclosing the circumstances of the cases. This issue of fear from disclosing the facts was not resolved as of yet, and it is the main contributing factor to the fear of disclosing the events. The audit has commented on this topic that both ministries, the Ministry of Health and the Ministry of Justice must formulate solutions, return the investigation meetings and examination committees which will allow and provide for learning from the mistakes made, without concern about the exposure of the involved parties.

On the topic of reporting exceptional events; as of the date of the audit, at the minimum the events which necessitate reporting to the Office constituted only a small fraction of the exceptional events occurring in practice in the institutions. There is no binding definition of the Office in regards to which exceptional events must be reported to the Risk Management Units in the institutions, some of the events occurring in the institutions are reported to the insurers, as per the guidelines of the insurers, but not reported to the Office. There is no sharing of information at a national level about exceptional event. The health institutions are collecting important knowledge, but this knowledge is not shared with the Office, or with other medical institutions. There is no anonymous information database which allows physicians to report on exceptional event, without fear, and the same goes for almost events. All this caused harm to the central ability to learn from mistakes made, and damages the ability of the Office to implement procedures and policies resulting from these events.

The Ministry of Health has noted that the mechanism for performing the investigations does exist, however the audit has found several failures on this subject. On the topic of investigation Committees, according to Article 21 of the Patient’s Rights Act, the Committee’s findings are open and may be disclosed in the Court of Law. There is a concern about these disclosures and drawing conclusions from them. And so, a built – in conflict of interests was created between the actions of the investigation committees. We should note that only in a number of states in the US laws were passed to provide confidentiality to these investigation committees.

There is some ambiguity about for which events the setting up of investigation committees is obligatory, and thus it was found that for the three years, between 2008 and 2010 many of the hospitals did not set up any committees whatsoever. For example, in Ichilov, In Sheba, in Wolfson and in Barzilai no committees were established at all, in Beilinson – only one committee, etc. There are no procedures and policies that are binding the hospitals to perform the investigations soon after an event has occurred, who is authorized to conduct such an investigation, how to go about the schedules and time frames. The committees set forth by the ombudsman took action only a long time after the event has occurred and cannot be considered a substitute to the investigations which should take place immediately after the event occurs.

In addition, in the matter of the Quality and Control Committees, according to Article 22, in the three years, between 2008 and 2010 no committees were established at Tel Aviv, Sheba, Asaf Harofeh, Benei Zion, Hillel Yaffe and Ziv hospitals, one committee at Wolfson, etc.

In the matter of learning and training; the Ministry of Health has answered the committee that on the tools used to verify handling the failures is workshops and training sessions. We have commented that there is a number of learning frameworks and there is a need to look into sharing these existing infrastructures between all the institutions.

On the topic of the disciplinary actions; first, we should highlight the fact that only for a small fraction of the events occurring on the ground, actual complaints are submitted to the ombudsman, we are talking here about a small percent. And out of the submitted complaints, only 2% – 4% have an investigation committee appointed, if any. There is no legal definition to the authority and obligation of the ombudsman to summon witnesses or specialists, to the possibilities of appeal about it, about its decisions of in fact setting up an investigation committee or to submit a complaint.

The law proposal being consolidated, as conveyed by the Ministry; we should comment on it that for the purpose of preserving the non-dependability of the Ombudsman and other bodies, as long as the decision about submitting a complaint is left at the hands of the Ministry of Health’s General Manager, actually the meaning of the Ombudsman's independence of judgment is limited. A second matter; if the proposed law will regulate that the findings, ruling and conclusions of the Ombudsman will not be used as evidence in court, the question is whether the testimonies and evidence heard in the investigation committee will be confidential or might be exposed.

Additional matter found is that the clarifying processes in the commission, including the investigation committees, are being conducted for many years, the conclusions are adopted after a long time, which might impair the drawing of conclusions. The Ministry conveyed that the handling process in the commission takes weeks or months and acknowledged that the time gap disrupts the required ability to change. In the audits it came up that the decision about establishing an investigation committee took about six months, until its establishment another six months and the consolidation of its conclusions about a year or two.

Last thing; the audit's report brought up the issue of institutional conflict of interests in the role of the Ministry, in establishing medical negligence of physicians within the investigation committees. The establishing of physicians' negligence, who are the employees of the governmental hospital, might compromise the Ministry with claims submitted due to those events. The State Comptroller commented that in order to preserve the objectivity of the investigation and increase the public's trust it should be considered to transfer the activity of the Ombudsman and the Disciplinary Court out of the Ministry. The subject came up in the discussions in the Ministries in 2001 and here in the committees in 2004. The reply of the Ministry of Health to the subject; it actually explained why it is important that the Ombudsman will be qualified and has medical experience. Without discussing this question the matter does not contradict the transfer of authority and does not preclude the appointment of a Ombudsman out of the Ministry who would be a physician, qualified and experienced in the matter. The question is whether this possibility had been considered; beyond that no reference was given to the possibility of the transferring the Ombudsman out of the Ministry of Health.