Alliance for Patient Safety

3. The Ministry of Health data on deaths and events which must be reported and on claims investigations due to medical negligence

In this chapter we wanted to examine the number of reports on exceptional events and on exceptional deaths delivered to the Ministry of Health, vs. the number of claims where a suspicion was raised for medical negligence which were passed to be handles by the Public Claims Commissioner for the Medical Professions and the number of the disciplinary decisions made by the Disciplinary Court Unit of the Ministry of Health handling medical negligence.

According to the Medical Administration circular number 11/2012 in regards to obligatory notification of a medical institute on deaths and exceptional events dated 9 / May / 2012 the must be reported events to the Ministry of Health are as follows:

• Severe and irreversible damage caused to the patient during a medical treatment or afterwards, including death, which apparently cannot be ascribed to the natural / expected process of the patient’s disease;
• Accidental leaving a foreign body behind during surgery or invasive action; an error in surgery including of the wrong organ or limb or of wrong patient;
• Causing a second or a third degree burn during surgery or an invasive action;
• Error in giving of red blood cells, mistaken identification of the patient or a mistake made in ABO blood typing;
• Error in administration of a medication which caused the patient a significant harm including death;
• A suicide attempt of a patient done while being hospitalized or on leave from the hospitalization and ended with a severe and irreversible damage or death;
• The death of a woman during pregnancy or childbirth or within 42 days from date of childbirth and her death within one year after birth if the cause of death is associated with the pregnancy or the childbirth;
• Death of a newborn (who has not been discharged from the hospital) who was born after the beginning of week 32 of the pregnancy, which is not a result of a congenital birth defect;
• An occurrence for which the Director of the medical institutions decided to appoint an investigation committee as intended in clause 21 of the Patient Rights Law 5756 – 1996;
• Cases in which a reoccurring damage to the patient is identified as a result from use of medical technology (surgery method, surgery approach, medical device etc.)[1]

Additional events which must be reported as per stated circular are: severe damage caused to the patient or the employee of the medical institute as a result of a failure of a medical device during medical treatment; severe and irreversible damage caused to the patient in a medical institution's area as a result of a building or infrastructure belonging to the institution; failure or disruption in the operation of an essential service for the proper functioning of a medical institution or part thereof (including electricity, water and medical derivatives); an internal or external emergency situation at the medical institute which influences or may influence its functioning.[2]

The circular determines that a notification on an exceptional event will be delivered in writing to the Medical Administration Director, his deputy or any person appointed by him for taking care of the topic, within 24 hours from the moment the event occurrence was known (if happened on a holiday or on the sabbath – the notification will be delivered within 48 hours). An exceptional event which ended up in death /  brain death will be reported by telephone as well as soon as possible (and no later than 24 hours from the occurrence of the event) to the Medical Administration Director or his deputy.[3]

In addition, the circular specified deaths which must be reported to the Ministry of Health as follows: deaths occurred with 24 hours from admitting a patient for hospitalization or to an Emergency Department, except for death as a result of terminal stage of a chronic, degenerative or other disease; a person who was brought dead to the hospital, except for death as a result of external cause; death during the course of surgery or other invasive procedure or within seven days from the day these were conducted, including cases in which the patient has been discharged for his home ( if he had returned to the hospital or if the death was brought to the attention of the physician in the community); death following surgery or another invasive procedure if the patient did not recover from them prior to his death; death as a result of a suicide attempt performed outside of the medical institution, death of a person less than 30 years old, who did not suffer from a chronic or terminal disease.[4]

According to stated circular, notification about death which must be reported will be delivered to the evaluation department in the quality control division within 14 days from date of death.[5] The report will be conveyed in writing, and the following documents will be attached to it: Summary of death, in case of a patient who was treated in a number of wards during the last hospitalization and the summary of death does not reflect the treatment process in them- all the transfer summaries from the various wards should be attached as well; in case of death in the emergency ward, the referring letter from the family physician and / or the document from Magen David Adom as much as these exist.[6]

3.1. Deaths and Exceptional Events in which Reporting is Mandatory

The Following introduces the data of the Ministry of Health received in response to our inquiry on the number of deaths and exceptional events reports received in the Office between the years 2005 – 2016 in accordance with the circular. In some of the years, the table depicts also the Ministry of Health data on not mandatory to be reported events according to stated circular.

Table no.4; Ministry of Health data on the number of reports on deaths and exceptional events mandatory to be reported 2005-2016[7]

It transpires from the table that in the years 2005 – 2016 some 3,646 reports were received at the Ministry of Health on events which are mandatory to be reported as per the above stated circular and 56,122 reports on exceptional deaths as defined in the circular. The data of the Ministry of Health brought in the table demonstrate that in the years 2005 – 2016 a constant increase of more than 2.5 times occurred in the number of reports in regards to exceptional events obligating reports received by the Ministry of Health, from 190 reports in 2005 to 511 reports in 2016. In the Ministry of Health the attributed this increase to the following causes:

• A direct reporting computerized system was setup in 2005, allowing for direct reporting on exceptional events and special deaths and which according to the Ministry of Health makes it easier for the medical institutions to report and thus increases the number of reports. In the Ministry of health it is noted that the information system is active since 2015 and most the general hospitals and the Community Directorate of the Clalit Medical Services are connected to it. In the Ministry of Health it was noted that they are in the process of implementing the computerized system in additional medical institutions, such as psychiatric and geriatric hospitals as well as in the community, however we have no information about the expected date when the entire relevant medical institution will be connected to the stated system. With regards to institutions which are not yet connected to the computerized system, it was noted in the Ministry of Health that their reporting is submitted via a structured reporting form designated for events and special deaths reporting and is sent to the Ministry of Health mainly be electronic mail.[8]
• The setup of the Treatment Safety Array in the Ministry of Health in 2011, which purpose is engagement in promoting the topic of treatment safety and reducing the number of the safety events through the creation of a safety culture in the medical institutions (the entirety of the hospitals and clinics in the community).[9] According to the Ministry of Health, this array is acting to increase the medical institutions’ awareness to the topic of treatment safety and encouraging reporting of exceptional events thorough, inter alia, the setup of forums for risk managers to engage in knowledge sharing, distribution of safety treatment circulars describing exceptional events, improvement of work processes following reports on exceptional events and training in the field of treatment safety in the medical institutions.
• Encouragement of medical institutions by the Treatment Safety Array to report also on events which are not obligated to be reported about according to the above mentioned circular and on "almost events". It can be seen in the above table that a significant increase has occurred in the number of these reports from 10 reports in 2014 to 159 reports in 2016.[10]

As for reports on special deaths cases it can be seen that while the number of reports in the years 2005 – 2014 has increased between 4,731 reports in 2009 to 5,579 reports in 2011, a certain decrease in the number of reports about deaths in the years 2013 – 2016 can be seen, and the number of reports number moves from 4,465 reports in 2013, to 3,055 reports in 2014. This decrease in the number of reports on special deaths is attributed in the Ministry of Health to the fact that the implementation of the computerized system on deaths has compelled the medical institutions to report only deaths meeting the reporting criteria and therefore the Office receives only reports meeting the criteria defined in the circular and not on every death occurring in a medical institution.[11]

A question is asked on what is the scope of the special deaths of all the deaths in Israel in general, and in the hospitals in particular. From the CBS data it transpires that in 2014 there were 42,170 deaths, out of which about two thirds of them (27,919 deaths) were in hospitals. Given that in 2014 were 3,055 special deaths cases, than the discussed number of deaths was 11% in the hospitals in that year and approx. 7% of all deaths in Israel in that year.[12]

In addition, a question is asked to what extent the data on the number of special deaths and number of deaths correspond to the scope of actual events. The Ministry of Health advised the Knesset Research and Information Center that it is following the execution of the procedures detailed in the Office's circular in regards to the obligation of a medical institution to report o deaths and exceptional events and as specified in the circular: “This procedure is binding for all the medical institutions and they must therefore report on exceptional events and deaths according to the criteria mentioned in the circular. Over the years we can see an increase in the reporting however we assume that under reporting exists (the problem is known worldwide and is not unique to Israel). We have no way to check whether the hospitals are reporting on all the events meeting the criteria[13] [the bold face highlight is not in the original]. In addition, it was stated in the Ministry of Health that they estimate the more severe is the damage caused so the number of the reports is higher and the number of the reporting decreases when the damage caused is less severe.[14] The meaning of which is that the Ministry of Health is also of the opinion that the data it holds does not reflect the actual situation. According to the Ministry of Health, in severe cases where no reporting was submitted as is obligatory, the Ministry of Health is taking sanctions against the institutions according to the circumstances,[15] however, it did not mention what are the sanctions.

According to the Ministry of Health it acts to create an organizational culture which encourages reporting which purpose is systemic learning, in a number of ways, among them are: encouraging the medical institutions to report on events where no obligatory reporting is required, as well as reporting on "almost events" in addition to the creation of close work relations and trust between the departments and the safety units in the medical institutions.[16] The Ministry added that the work of the Treatment Safety Division is performed in confidentiality by the Quality and Control Committee [according to clause 22 of the Patient Rights Law detailed above] in order to lessen the concern derived from conveying the report to the Ministry of Health or conveying the information and organizational learning from exceptional events to external bodies (such as lawyers etc.)

3.2. The Ministry of Health data on the number of investigation committees established to examine suspicion cases of medical negligence

As stated, in cases a decision is made by the Medical Administration in the Ministry of Health that there is a need of an in-depth inquiry of the occurrence, the case details are conveyed from the Medical Administration to the Public Complaints Commissioner for the Medical Professions at the Ministry of Health. The Ministry of Health has submitted to us data on the number of complaints referred to the Commissioner by various bodies where suspicion of medical negligence had been raised as well as the number of investigation committees established in order to examine these cases in the years 2008 – 2016.

Table no. 5: the number of complaints in cases where a suspicion of medical negligence was raised and the number of investigation committees established 2008 – 2016[17]

It transpires from the table that in the years 2008 – 2016 (not including year 2013) more than 1,000 complaints per year were submitted to the Public Commissioner for the Medical Professions on cases in which a suspicion of medical negligence was raised, which add up to a total of 9,369 complaints. We would like to note that in the years 2008 – 2016 some 3,007 reports were submitted to the Medical Administration on events obligating reporting and 40,509 reports on special deaths.

Although in these years some 9,369 complaints were submitted on cases in which suspicion was raised of medical negligence, 320 (3.4%) investigation committees were established, meaning only for 2.04% and up to 4.4% of all complaints submitted in one year for which an investigation committee had been established. We should note, similarly to the findings of the State Comptroller, depicted in report 62 it seems ,inter alia, that indeed in only small part of the complaints cases the Commissioner had decided on appointment of an investigation committee in their matter, since between January 2009 and until the middle of 2011 some 2,790 complaints were submitted to the Public Complaints Commissioner, on which basis he appointed 89 investigation committees (3.1%).[18]

The Ministry of Health and the Public Complaints Commissioner wrote to the State Comptroller in 2011 that the investigation committees provide response to most of the exceptional events reported by the medical institutions, when in cases where a complaint is filed to the police, the Commissioner is precluded from investigating. It has been further mentioned that "The majority of the submitted claims do not justify setting up an investigation committee and these also include complaints about faulty personal relation and on setting appointments. After clarifying the circumstances of the case with the complaining party, the Commissioner decides that the circumstances do not justify further handling; in part of the complaints the Commissioner is authorized to give a remark or general warning with necessitating disciplinary procedures; In an additional part of the complaints the Commissioner consults with the Ministry's medical experts, and in other part consults with medical experts outside of the Ministry, and decides in regards to the handling of the complaint; Only in a small part of the cases, usually the difficult ones, the Commissioner decides to establish an investigation committee.[19] The State Comptroller noted that private lawyers, specializing in the field of medical negligence advised the State Comptroller that in large part of the medical negligence cases civil claims are submitted directly to the Courts without a complaint to the Public Claims Commissioner in the Ministry of Health "this is due to the recommendation of lawyers to their clients not to submit a complaint to the Claims Commissioner, resulting from their concern of non – exhaustion of the disciplinary procedures against the subjected physicians and due to the prolongation of the procedures".[20]

According to the Ministry of Health, the average time duration for the handling of public complaints arriving to the Public Complaints Commissioner for the Medical professions stands at 117 days ( about four months) where the median stands on 84 days ( about two and half months). In 2015, the duration of handling complaints for which it has been decided on clarification through investigation committees took 10 months until their closure.[21]

3.3. Disciplinary Court Unit of the Ministry of Health data

We have no information in how many cases of the 320 investigation committees se forth in the years 2008 – 2016 to examine the complaints about the cases where suspicion was raised of a medical negligence in which it had been decided on transferring the complaint to the Disciplinary Court Unit in the Ministry of Health. According to the State Comptroller report of January 2009 and until middle 2011 the Public Complaints Commissioner had appointed 89 investigation committees following which 64 complaints were submitted to the Disciplinary Court of the Ministry of Health (72%).[22]

The Ministry of Health has presented  us with data on the number of meaningful decisions made in the years 2012 – 2016 and the number of decisions in regards to medical negligence of them. In the specified years some 155 disciplinary decisions were made, where about one fifth out of which (32 decisions) were about negligence files. We should note, that in the stated years (2012 – 2016) 163 investigation committees were set up in order to examine complaints in cases where suspicion of medical negligence were raised.

Table no. 6: The ministry of Health data on meaningful decisions of the Disciplinary Court in the Ministry of Health in regards to medical Negligence, segmented according to the decision made in 2012 – 2016[23]

From the above table it transpires that in the years 2012-2016 out of 32 decisions in negligence files, in 6 cases acquittal was awarded and in 26 cases a penalty was imposed.

Chart no.1: Segmentation of punishment decisions of the Disciplinary Court Unit in cases of medical negligence 2012-2016[24]

In none of the decisions the license of the physician was not revoked. We should note, that we hold no data in regards to the duration of handling of the above stated cases by the Disciplinary Court Unit of the Ministry of Health and on the duration of the suspension of licenses. In addition, we have no information on the number of decisions in which an appeal was submitted on the decision of the Disciplinary Court to the regional Court.

[1] Ministry of Health, circular of Medical Administration no. 11/2012, Mandatory notification by a medical institution on deaths and special events, 9 / May / 2012

[2]   There.

[3] There

[4]  There

[5]  Death that falls under the definition of an event, will be reported as an event and there is no need to report about it also as death. Ministry of Health, Medical Administration circular no. 1/2012, Mandatory notification by a medical institution about deaths and special events, 9^th May 2012.

[6]  There.

[7] Dana Arad, Senior Area Coordinator, Patients Safety, Ministry of Health, letter, conveyed to the Knesset Research and Information Center through Irit Nadav, Coordinator Bureau  B (Deputy Managing Director) , Ministry of Health, 22^nd March 2016

[8] Dana Arad, Senior Area Coordinator, Patients Safety, Ministry of Health, letter May 22, 2012

[9]  Miri Cohen, Senor Area Manager Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017,(received at the Knesset Research and Information Center on March 2, 2017); Faras Haik, lawyer, Senior Coordinator, special events, medical administration, Ministry of Health, meeting, March 16, 2017; the internet site of the Ministry of Health, The Treatment Safety Array, entrance: March 8, 2017. In the internet site of the safety treatment array in the Ministry of Health it is noted that the activity of the safety treatment array is though information collection while cooperating with the medical institutions; locating the bodies and reasons for failures; use of findings as  basis for development of prevention plans and promotion of safety by the aspect learning from events. The internet site of the Ministry of Health, The Treatment Safety Array, entrance: March 6, 2017. According to the Ministry of Health, the Safety Treatment Array is acting under confidentiality and conducts systemic learning processes to improve work processes and prevention of exceptional events. The reports received in the Safety Treatment Array are assembled and studied by professionals and within this framework a preliminary examination is conducted of the hospitalization summary or description of the case and a process is taking place of evaluation whether the occurrence is a result of natural process in the condition of the patient or if it occurred in special circumstances which require a broader clarification. Alongside its current activity, the Safety Treatment Array promotes a proactive approach (initiative), according which medical processes are examined in order to consolidate recommendations for the improvement of the process so as to turn it to a safer one. Miri Cohen, Senior Area Manager Emergency Services and First Aid, Ministry of Health, letter, January 19, 2017 (received at the Knesset Research and Information Center on March 2, 2017).

[10] There.

[11] Dana Arad, Senior Area Manager, Patients Safety, Ministry of Health, letter,  May 22, 2017.

[12]  Naama Rotem, Head Health and Natural Movement Area, Demography and Census Division, Central Bureau of Statistics. Special processing of the Central   Bureau of Statistics conveyed to us by David Landau, Manager Information Distribution and Customers Relations Branch, Central Bureau of Statistics, January 26, 2017.

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

[14] There.

[15] There.

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

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

[18]  The State Comptroller's office,  Report 62 for the year 2011, May 2012.

[19] There.

[20] The State Comptroller's office, Report 62 for the year 2011, page 260, 2012.

[21]  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]  The State Comptroller's office, Report 62 for the year 2011, May 2012.

[23]  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).

[24] There.