Alliance for Patient Safety

2. The bodies entrusted with examining special events in medical treatment at the Ministry of Health

According to the Ministry of Health it holds reports about deaths and special events on which the various  medical institutions are obliged reporting to the Ministry of Health, in accordance with the Medical Administration circular 11/2012 in regards to compulsory report by medical institution on deaths and special events dated 9 / May / 2012, in addition to reports on events which do not require reporting as per stated procedure.

Notifications about deaths and special events are received at the Medical Administration in the Ministry of Health,[1] and we shall review the manner in which the Administration handles these notifications below, the cases passed on for the handling of the Public Complaints Commissioner for the Medical Professions and the Disciplinary Court Unit in the Ministry of Health.

2.1 The Medical Administration at the Ministry of Health

The Medical Administration at the Ministry of Health, the responsible body, inter alia, on the area of medical regulation and compliance of the healthcare system, is the entrusted body for receiving the medical institutions reports in accordance with the Circular in regards to deaths and special events. Upon receipt of a report, the Medical Administration commences a process of investigation of the case and carries out any required completions of materials about the discussed case according to need and circumstances. After completion of the required details a decision is made whether a further inquiry and / or a more in-depth inquiry is called for, and in cases where the answer is yes, the details of the case are passed to the Public Complaints Commissioner for the Medical Professions in the Ministry of Health (hereinafter Public Complaints Commissioner) who handles complaints in the clinical areas.[2]

As it transpires from the Ministry of Health’s website, the decision on transferring the case for investigation by the Public Complaints Commissioner is made in cases where a suspicion arises of an unethical behavior or a deviation from reasonable professional standard within the framework of public and private medicine  versus a medical institution or health professional (physician, nurse, midwife, a geriatric institution, mental health clinic etc.).[3] We should note, that with the exception of the cases received for handling by the Public Complaints Commissioner, according to the Ministry of Health’s website, applications to this body may also arrive from office holders in the police and the State Attorney's office, as well as from the public, and the commissioner may open an inquiry on its own initiative following civil claims and even following news from the media.[4]According to the Ministry of Health, all the claims on the issue of medical negligence received in the Ministry of Health from the various bodies are immediately directed for handling by the Public Complaints Commissioner of the Medical Professions.[5]

We should note, that concurrently with the inquiry conducted by the Medical Administration in regards to every report on death and special event received at the Medical Administration, these reports are conveyed by the administration also for systemic handling in the Treatment Safety Array of the Ministry of Health, which handles promoting the issue of safety treatment since 2011.[6]

2.2. Public Claims Commissioner for the Medical Professions

On the Ministry of Health’s website it is mentioned that the Public Claims Commissioner is authorized to execute judgment with regards to the manner in which a claim is investigated according to the circumstances of the case. We should note, that once commissioner’s work is completed it passes the investigation’s conclusions and its recommendations to the claiming party, to the investigated bodies, and if systemic and personal recommendations exist, these are  also conveyed to the Director General of the Ministry of Health.[7] Below we shall introduce the process’ handling stages by the commissioner of an application, as detailed on the Ministry of Health’s website:

1. Receipt of an application in writing, its study, examining whether it is in the scope of investigation by the commissioner and its input in the computerized system;
2. Sending confirmation of receipt to the applicant or notification that the complaint was passed to another handling body (not indicated which body). As stated in the Ministry of Health’s website, a confirmation on the application receipt and a short briefing about expected response ,will be provided within two weeks. When the duration of the handling of the application changes according to the nature of the claim and in accordance with the need to setup an inquiry committee,[8] about which we shall elaborate later;
3. Gathering information about the case (e.g. medical records) and sending the application to the party against which the claim was submitted [the defendant]. In case no response is received from the defendant within reasonable time (which duration was not indicated online), a reminder is sent to the defendant;
4. Concurrently, the medical and forensic information gathered by the commissioner is examined, and a decision is made to act in one of the following ways:
5. Ending the handling of the application and response to the applicant;
6. Ending the handling of the claim and its transfer to another handling body (not indicated who are the possible bodies);
7. Continuation of the inquiry vis-a-vis the defendant;
8. Receipt of an expert opinion

5. Summons of the defendant and/ or the applicant for a clarification discussion
6. Setup of a an investigation committee

According to the procedures of the Ministry of Health, the setup of an investigation committee will be performed, as a rule, for the investigation of the following events:

• An exceptional event^[9] which ended with a severe medical damage^[10] or anticipated to be severe to the patient and it seems that the result to the patient exceeds considerably from the expected result of normal proceedings in a similar case;
• An event in which it is apparently clear that procedures or clinical guidelines were violated, even if no real harm was caused to the patient due to same.

From the report of the Public Claims Commissioner in regards to a Summary of 100 investigation committees reports – drawing conclusions from exceptional events dated June 2016 it is derived that in every case the discretion of the competent body to decide whether to appoint a committee in cases which do not fall under the qualifying criteria, or not to appoint a committee in cases that do fall under the qualifying criteria (as long as the competent body took care to investigate the case in another way) was reserved.[11] We should note, that in this regard the question is raised on what scope of cases we are dealing with and what are the reasons and considerations for that.

As stated in the Ministry of Health’s website, in cases where the Commissioner decides on appointment of an investigation committee, a notification about it is conveyed to the investigated bodies.[12]

Within the framework of its activity the investigation committee locates experts in the relevant field, summons witnesses [the patient, his / her family members etc.] and medical team members, and informs the involved parties of the right for legal representation for them. The minutes of the discussions in the investigating committee are written down or recorded in a protocol [although partial confidentiality applies on them according to clause 21 of the above mentioned Patient Rights Law]. After examining the topic at hand the investigation committee issues a report with recommendation whether it has reached the conclusion of a medical negligence case which justifies submission of a disciplinary complaint.[13] The Commissioner for Public Complaints attaches his recommendation to this report and passes the matter at hand to the ruling of the Director General of the Ministry of Health.[14]

2.3. The Disciplinary Court Unit of the Ministry of Health

In case the Director General of the Ministry of Health decides on submission of a complaint in regards to said issue, the file will be transferred to the prosecutor of the Ministry of Health and deliberated in the Disciplinary Court Unit of the Ministry of Health, which constitutes part of the legal office of the Ministry and handles disciplinary proceedings against all the medical and paramedical professions pursuant to the applicable legislation of each profession.[15] The disciplinary violations affixed in the applicable legislation are: Severe negligence, behavior not becoming the profession, indictment in a criminal offense, obtaining a license by misrepresentation, ongoing violations of legislation and violation of the Patient Rights Law ruling.[16]

As stated in the Ministry of Health’s website, The disciplinary committee to discuss a specific complaint is set by the Minister of Health and comprises of two professionals and a lawyer. We should note, that in State Comptroller's report 62 stated earlier, it was written that the disciplinary committee comprises of representatives  from the Ministry of Health, the Ministry of Justice, the Medical Association of Israel and lawyers from the legal chamber in the Ministry of Health.[17]

The role of the disciplinary committee is to hear the arguments of the parties, to examine the material of evidence and prepare a factual and normative infrastructure,[18] and she submits its recommendations in regards to following disciplinary means: warning, reprimand, suspension or revoking of a license.[19]

The deliberations in front of the disciplinary committee are public proceedings, unless it had been decided on closed doors due to security or morals reasons.[20] During the deliberations, in which framework the party the complaint has been submitted against is eligible to be represented by an attorney speaking on his / her behalf, the members of the disciplinary committee hear the parties’ arguments, examine the material evidence and pass their recommendations to the ruling by a judge, to whom the authority of the Minister of Health had been delegated, to make a decision on the complaint pursuant to clause 41 of the Physicians Ordinance [old version] 5731 – 1976. The judge is authorized to acquit the physician, to give him a punishment of reprimand, to warn him, to suspend his license for a period up to five years or to revoke his license altogether. The recommendations of the disciplinary committee are conveyed to the Minister of Health, and he has the authority to adopt or reject them.

It is possible to appeal the judge's ruling in the District Court within three months of the day the notification about the ruling was received.[21]

2.4. The state comptroller comments about the status of the Public Complaints Commissioner for the Medical Professions

In report 62 mentioned above the State Comptroller discusses, inter alia, the status of the Public Claims Commissioner for the Medical Professions. The State Comptroller indicates that in the inquiry it conducted it was found that various parts of the commissioner's activity are indeed legally regulated, in various internal instructions and procedures. However, according to the State Comptroller these sources are not regulating the complete scope of its activity and they lack legal definition concerning the authorities and obligations of the Complaints Commissioner as well as of the investigation committees appointed by him.[22]

The State Comptroller is of an opinion that the Ministry of Health has to consider defining the Complaints Commissioner authorities to summon witnesses or experts; to arrange an assigned budget for the activity of the Complaints Commissioner; and to enable a possibility to appeal the Commissioner's decision in regards to the setup of an investigation committee or in regards to the submission of a complaint. In addition, the State Comptroller suggested that the Ministry of Health and the Ministry of Justice will examine whether there is room to transfer the entire activity of the Complaints Commissioner to the Ministry of Justice, the investigation committees as well as the disciplinary deliberation or alternately the activity of the Complaints Commissioner and the investigation committees only. In addition, it was proposed, inter alia, to examine the argument that a physician must head of the inquiry system (that is, in the role of the Public Complaints Commissioner for the Medical Professions) and consider to appoint for the position of the investigation committees members retired medical consultants who are not committed any more to any one medical institution or another.[23] We should note, that in the report Prime Minister's comments to State Comptroller report 62 – Part 1 made public in May 2012, the Ministry of Health advised that "draft proposal for regulating the status of the Commissioner will be submitted to the Director General [Ministry of Health] until the 30^th of April 2012" [the bold face not in the original][24]

In response to the Knesset Research and Information Center as to how The Ministry of Health acted in light of the recommendations of the State Comptroller stated above, the Ministry of Health answered that the legislation memorandum in regards to regulating the independence, authorities and modus operandi of the Public Claims Commissioner is at advanced stages. According to the Office, the memorandum has already been introduced in the former tenures of the government, however not promoted until the present.[25]

 We should note, that in the discussion of the State Audit Committee of the Knesset on 16 / March / 2017 on the topic of "Request for an opinion of the State Comptroller on the subject: concealment and cover-up of negligent medical cases while harming the patients’ population – follow-up session", the Public Complaints Commissioner for the Medical Professions, Dr. Boaz Lev mentioned that in light of the issues raised in the deliberations it is possible that the Ministry of Health will make a change in the legislative memorandum of the said law.[26] Until the submission of this document, some three months after the time of the stated deliberation, the legislative memorandum was not made public yet.

[1] Miri Cohen, Senior area Manager Emergency Services and First Aid, Ministry of Health, letter,19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017)

[2] There

[3] Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance: 19^th March 2017; Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health , letter, 19^th January 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017.

[4] Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance : 19^th March 2017.

[5] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter 19^th January 2017 (Received at the Knesset Research and Information Center on 2^nd March 2017.

[6]There

[7]  Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 ( received at the Knesset Research and Information Center on 2^nd March 2017).

[8] There.

[9] An exceptional event is defined  as " development process or undesired result or unplanned during medical process (and within it all the activities prior the medical process and those coming after it), which resulted in damage or may be resulting in damage to the patient, The Ministry of Health,  Summary Reports of 100 Investigation Committees- Conclusions Drawn from Exceptional Events, Complaints Commission for the Medical Professions, Service Division, Quality Directorate, Service and Safety, June 2016.

[10] Severe medical damage is defined as "death of a patient or causing irreversible severe disability" . There.

[11]  Ministry of Health, Reports Summary of 100 Investigation Committees- Drawing Conclusions from Exceptional Events, Complaints Commission for Medical Professions, Service Division, Quality Directorate, Service and Safety, June 2017.

[12]  Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance: 19^th March 2017.

[13] Ministry of Health, Public Complaints Commissioner for the Medical Professions, entrance: 19^th March 2017.Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017.

[14] There.

[15] Ministry of Health, Courts Disciplinary Unit, entrance: 23 May 2017.

[16]  Ministry of Health, Courts Disciplinary Unit, entrance: 23 May 2017

[17] State Comptroller office, Report 62 for year 2011, May 2012

[18]  Ministry of Health , Courts Disciplinary Unit, entrance: 23^rd May 2017

[19]  There.

[20] Ministry of Health, Courts Disciplinary Unit, entrance: 23 May 2017.

[21] Ministry of Health, Courts Disciplinary Unit, Entrance: 23^rd May 2017; Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health,      letter, 19^th January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[22] State Comptroller's Office, Report 62 for year 2011, May 2012

[23]  There.

[24] Ministry of the Prime Minster, General Inspector for the State Audit Issues division, The remarks of the Prime Minister to the State Comptroller's report 62- first part, May 2012

[25] Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter,19 January 2017 (received at the Knesset Research and Information Center on 2^nd March 2017).

[26] The Committee for State Audit Issues discussion, Request for the opinion of the State Comptroller on the issue: Concealment and Cover-up of Medical Negligence while Causing Damage to Patients Population- follow-up session, 16 March 2016