Alliance for Patient Safety

1. Medical Negligence Definition and Partial Data about the Phenomenon in Israel

Given that not every error or medical fault is medical negligence, the Knesset Research and Information Center firstly approached the Ministry of Health with the question how the office defines "medical negligence". In response to our inquiry the Ministry of Health replied that medical negligence is "providing medical treatment with deviation from reasonable level of caution"[1] and added that "there is no legal definition for the term medical negligence, however it is conceived as some kind of negligence".

The Office also advised that there are different types of medical negligence which are examined according to different fields of the law[2] [the bold face is not in the original] as follows:

In the civil field, as stated by the Ministry of Health, civil claims submitted due to the tort of negligence are ascribed to the Law of Torts. These claims enable an awarding of a financial compensation in the case where it is proven that damage was done due to the negligent act and when a causal connection had been established between the act and same damage[3]. The negligence injustice is defined in clauses 35 and 36 of the Civil Torts Ordinance (new version) 5728 – 1968".[4] According to clause 35 of the Civil Torts Ordinance negligence is defined as a case in which "a person did a deed that a reasonable person would not have done it under same circumstances, or have not done a deed that a reasonable and intelligent person would have done under same circumstances, or that in a certain occupation did not use the skills or has not taken a degree of caution, that a reasonable, intelligent and qualified person in that occupation would use or take an action in same circumstances- than it is negligence; and if has neglected as said in relation to another person, towards whom under same circumstances he is obliged not to behave as he did, than it is negligence, and the party causing through his negligence damage to other person is doing injustice". According clause 36 of the Civil Torts Ordinance" the obligation stated in clause 35 is imposed towards every person and every asset owner, every time that a reasonable person should have seen in same circumstances in advance that they may during the customary proceedings of things to be injured from deed or a failure to act interpreted in same clause."[5]

In the criminal field: the Ministry of Health has indicated, that negligence alone is not enough to impose criminal responsibility, but only if there is a specific instruction in the Law referring to the violation under discussion here. As stated by the Office, criminal violations that are negligence violations per say, do not exist, but violations that could be performed through negligence, such as: causing death by negligence, causing damage by negligence and more. In the Ministry of Health they referred to clause 338 (a) (7) of the Penal Code 5731 – 1977 which defines reckless action and negligence in medical treatment in the following manner: "doing one of the following in a hasty or negligent way in which it may put at risk a person's life or cause him injury, his sentence is – three years of imprisonment…(7) Providing a medical or a surgical treatment to a person to whom he has obliged oneself to take care of". As stated by the Ministry of Health, if there is sufficient evidence to achieve public interest, then a bill of indictment is submitted in the criminal field against the medical treatment provider who acted negligently, whereas based on the bill of indictment and after the termination of the criminal process a disciplinary process could be opened as well against the accused.[6]

In the disciplinary field: the Ministry of Health stated that a State Attorney's guideline 14.2 on the issue of criminal and disciplinary proceedings against physicians or other medical professions due to professional negligence exists (last updated, as stated in it, on 1 / January / 2003),[7]  which includes instructions on how to act if there is a suspicion to medical negligence. As stated by the Office, at times disciplinary complaint would be submitted to the Minister of Health even prior the termination of the criminal proceedings (in case such proceeding are taking place) where according clause 44a of the Medical Physicians Ordinance [new version] 5731 – 1976 a physician's license can be suspended for a period of up to six months if there is a suspicion that he caused in severe negligence damage or death to a person. This suspension can be prolonged when needed for additional six months.[8]

There is no data held by of the Ministry of Health on the scope of the medical negligence phenomenon in the entire medical system in Israel and including the number of deaths occurrences as a result of medical negligence, and this according to the Ministry is due to the different definitions to the term medical negligence as specified above.[9] The Ministry of Health added and explained that "damaging negligence is determined by means of a Court sentence in which framework the Court panel determines that the treating team has acted in negligence and the patient has been injured as a result. In most cases these are claims submitted years after the alleged negligence occurrence had happened and it brings about real difficulty in locating files of this nature with the passing of years after the termination of the civil proceedings" [the bold face is in the origin].[10] Nonetheless the question is asked whether there is no room to act for the gathering of this information in order that it will be possible to get a complete picture whereas the scope of the medical negligence in Israel . To this it should be added that already in 2011 the State Comptroller called the Ministry of Health "to gather information from a lot of activity done in the Courts in the field of medical negligence".[11]

According the Office they have hold of reports about deaths and exceptional occurrences that the medical institutions are obliged to report to the Ministry of Health as per the Medical Administration circular no. 11/2012 concerning the reporting obligation of a medical institute about deaths and exceptional occurrences dated the 9 / May / 2012 on which we shall further elaborate later in the document.[12] However, as stated earlier not every exceptional occurrence is negligence and therefore it cannot be learned from same about the number of medical negligence occurrences.

Due to lack of data about medical negligence in this chapter we shall introduce data conveyed to us from different sources from which it can only be partially  gleaned about the scope of the phenomenon. We shall present below the data of the Management of the Courts about the scope of the civil claims submitted due to medical negligence, the data of the Ministry of Health and the Ministry of Finance on the number of the claims due to medical negligence submitted to the Courts against governmental medical institutions only and the data of the Central Bureau of Statistics of Israel about deaths where medical negligence could have been involved. We should note,, that the Knesset Research and Information Center has also approached the Israeli Police with the question about data and information it may hold in regards to the number of criminal files opened due to medical negligence in the years 2005 – 2016, however we were answered that there is no data on the issue.[13]

1.1 Management of the Courts data about the scope of civil claims submitted due to medical negligence

In response to the application of the Knesset Research and Information Center the Management of the Courts sent us data about the number of civil claims due to medical negligence submitted against medical institutions in Israel in the years 2010 – 2015 and data about the files in which Court sentence was given.[14]

Table no. 1 – Management of the Courts data about the number of civil claims submitted due to medical negligence against medical institutions in Israel and on the number of claims in which sentence was given in 2010 – 2016[15]

From the data presented in the table above it transpires that in the years 2010 – 2016 overall 10,694 civil claims were submitted due to medical negligence against different medical institutions in Israel, where it can be seen that during the years an increase occurred in the number of claims from 1,109 claims in the year 2010 to 1,985 claims in the year 2015. Further, it transpires from the data that in said years a Court sentence was given in 8,753 claims in rulings in matters of medical negligence – nonetheless, it cannot be deducted from this data about the number of claims per year in which a Court sentence was given since at least in part of the cases these sentences were given about cases submitted in previous years. As stated above, we do not hold any data in regards to how many of the claims were found justified.

1.2. Ministry of Finance and Ministry of Health data on the number of claims due to medical negligence in governmental medical institutions

The Knesset Research and information Center approached the Ministry of Health and the Ministry of Finance with the question what was the number of claims due to medical negligence which were submitted to the Courts in every one of the years 2005 – 2016 against the entire medical institutions in Israel. In response to our request both offices replied that they have data concerning governmental medical institutions only as received from Inbal Insurance Co. Ltd. that is to say, the data does not include the number of claims due to medical negligence in the health maintenance organizations (HMOs) and the hospitals owned by them, as well as in other public health institutions and private health institutions.

In light of the above the presented data is partial data only, since according to the data for the years 2015 – 2016 out of 44 general hospitalization institutions, 11 (including governmental – municipal hospitals) are state owned, and these contain less than half of the hospital admission beds for general hospitalization; out of 12 mental health hospital, 8 are state owned, and these contain 82% of the hospital admission beds for mental health in Israel; out of 296 geriatric institutions, only 5 are state owned, and these contain only 7% of the geriatric hospital admission beds in Israel.[16] It should be noted that the State Comptroller has commented about these numbers to the Ministry of Health in 2011 and according to the State Comptroller "in the audit it was found that the Office [at the Ministry of Health] does not receive copies of the claims submitted against public and private hospitals and against the health maintenance organizations (HMOs) unless a copy is sent to the Public Service Commission [Ministry of Health] as well, and that in contrast to claims for medical negligence submitted against government owned hospitals. Moreover, due to the fact that for a large part of the medical negligence cases civil claims are submitted directly to the Courts and no complaint is submitted to the Complaints Commissioner in the Office. In addition the claims can be deliberated in the Courts for many years to come, and even after their termination their existence will not become known to the Office. It may be therefore be the case that severe system failures which caused exceptional occurrences and damages, will not be corrected."[17]

Next we shall introduce the data of the Ministry of Health and Ministry of Finance on the number of claims due to medical negligence which were submitted against the governmental medical institutions in each of the years 2005 – 2015.[18]

Table no. 2: Ministry of Health and Ministry of Finance data on the number of claims due to medical negligence submitted to the Courts against governmental medical institutions, segmented according type of insured (type of medical institution) 2005-2015[19]

As it transpires from the data of the table above, in the years 2005 – 2016 some 8,372 claims were submitted to the Courts due to medical negligence against the governmental medical institutions. In general in the years 2005 – 2016 a constant increase occurred in the number of claims due to medical negligence against the governmental medical institutions from 597 claims in the year 2005 to 1,008 claims in the year 2015.

Furthermore, it can be indicated that the majority of the negligence claims submitted in same period were submitted against the hospitals for general hospital admission (about 82% of total claims); about 13.4% of the claims were submitted against the health bureaus; about 3.3%of the claims were submitted against mental health hospitals; about 0.75% of the claims against the Ministry of Health and about 0.5% of the claims were submitted against geriatric institutions. Nonetheless, it is important to remember that in the 11 state owned hospitals for general hospitalization there are over 7,000 bed hospital admission beds, in comparison to 2,900 in the governmental hospitals for the mental health and about 1,800 in the governmental geriatric hospitals.[20]

It further transpires from the above table that in the stated period an increase occurred in the number of claims due to medical negligence submitted against every one of the institutions detailed in the above table (with the exception of the Ministry of Health in which a decrease occurred in the number of claims between the years 2013 – 2015). So for instance the number of claims against the general hospitals increased between the years 2005 – 2015 by some 45% from 521 claims in 2005 to 755 claims in 2015 and the number of claims against the health bureaus increased by almost five times from 51 claims in 2005 to 225 claims in 2015. We have no explanation in regards to this increase. In addition it should be noted that no information has been conveyed to us in regards to the amount of claims that were closed and in how many of them compensations were paid.

1.3. The Central Bureau of Statistics data on Deaths in which Medical Negligence might have been involved

Due to the fact that the Ministry of Health holds no data on the number of deaths attributed to medical negligence, the Knesset Research and Information Center approached the Central Bureau of Statistics (hereinafter: the CBS) with the question whether information could be produced out of its data about the number of deaths in each one of the last ten years, which may have occurred due to medical negligence. Prior to introducing the products of the special processing which was done for us in the CBS we shall highlight, that while it is possible to get the impression from the aforesaid data about the total deaths occurrences in which medical negligence might have been involved, it does not constitute certain data on the scope of deaths as a result of medical negligence, since in the rules of the international classification of the diseases (10^th edition) (The International Statistical Classification of Diseases and related Health Problems –Tenth Revision) with which the CBS made use (and in all the member states of the World Health Organization),[21] there is no death cause defined as "negligence" or causes which it is possible to learn directly and unequivocally from them about occurrence of negligence.[22]

Within the framework of symbolization of the death causes according to the international rules of diseases classification (ICD-10) the basic cause of death is selected, that is the cause which had begun the chain of co-morbidities which have led to the death of the patient, and it is used for statistical needs. In addition, in the CBS they also symbolize all the causes or situations recorded in the death certificate (also called multiple symbolizing). The CBS noted that symbolizing the death causes is based on what has been written in the death certificate only, however the CBS corrects the basic cause of death if additional information is received from external body (Israeli Police files, the Institute for Forensic Medicine, the Social Security, IDF) in cases of road accidents, suicide, murder, birth defects, acts of terrorism, IDF fallen soldiers and infant mortality.[23] Information about death occurrences examined or investigated in hospitals or in the health bureaus does not reach the CBS.[24]

The CBS has noted that they have not encountered cases in which the word negligence or medical malpractice were indicated in the death certificate. According to them, there are few cases every year, if at all, of notices in which it had been recorded that the complication was from an iatrogenic source, i.e. caused by the medical team and these cases are usually coded as "mishap / complication during surgery or procedure". Out of all this transpires according to the CBS, that the death notifications is a very limited source for learning on the number of deaths due to medical negligence and information based on this source in regards to the issue of medical negligence leads in their estimate to meaningless underestimation of the issue.[25]

However, the CBS indicated that there are codes which could hint on an occurrence of negligence. In response to our request for special processing of this data the CBS checked groups of codes included in two

chapters of the classification mentioned above; The first group are codes included in chapter 20 "External causes to mortality or morbidity" in which there is a sub group defined as "Complications of medical and surgery care" part of which may, according to the CBS, to hint about negligence, however, as stated above, not in proven way. According to the CBS these codes can appear as the basic death cause and can appear also in the multiple symbolizing. This group includes the following four sub-groups:

1. Adverse effects of medications or biological substances
2. Mishaps (complications) during surgeries and medical care;
3. Mishaps (complications) associated with the use of medical device for diagnosis and care;
4. Complications in surgeries or procedures or an unexpected reaction of the patient, without mentioning mishaps

The CBS indicated that out of the four aforesaid sub-groups, the relevant groups in regards to our a them reference to mishap, however they conveyed to us the data in regards to all the four groups.

The second code group examined by the CBS was the code group included in chapter 19 under the classification "Injuries or poisoning and other damages which are the result of external cause". These include cases in which the basic cause of death is an external cause (such as road accident), however injuries or poisoning and other damages which are the cause of an external cause can appear in the multiple symbolizing.

According to the CBS, the two sub-groups in chapter 19 which might testify on negligence are: poisoning from medicines and biological substances and complications of surgeries and medical treatment. Nonetheless, according to the CBS there is no reference to "mishap" in these codes and therefore it is not possible to know what was the source of the complication.

In the next table we shall introduce the number of deaths classified in the CBS data in the four sub-groups of chapter 20 and the groups of chapter 19, where according to the CBS, the summary of these occurrences, is the maximum number of occurrences in which it is possible to get a hint from the death announcement that there was medical negligence, since every death appears in the table only once.[26]

Table no.3: CBS data on the maximum number of occurrences from which it is possible to get a hint from the death announcement that there might have been medical negligence 2005 – 2014[27]

The data presented in the above table indicates that according to the death announcement ,in the years 2005 – 2016, it might have been that there was medical negligence in 1,892 cases, (out of which, about 29% cases in which it is the said basic cause). If we relate only to the two mishaps codes – mishaps during surgeries/procedures and mishaps with medical device then the number at hand is 42 of the cases (36 cases where the code appears as the basic cause and seven cases where the code appears in the multiple symbolizing). We should indicate that the annual number of deaths in Israel on average stands at about 40,000 deaths.[28]

In addition to this data, the CBS indicated that cause of death named as blood infection could also derive from medical negligence, due to hospital acquired infection occurring in the course of a procedure conducted under inappropriate conditions. We would like to note that in 2014 the number of deaths from blood infection as basic cause stood at 1,864 deaths. According to the CBS, the number of deaths from blood infection increased in the recent years, and today the number of deaths from this cause in Israel is one of the highest in the world. About 4% of the deaths are the result from blood infection and in about 27% of the deaths this cause appears as part of the reasons to the death, although not as basic cause.[29] In hospital deaths the percentage is even higher and in 2014 it stood on about 37.5% from all the deaths in hospitals. The CBS emphasizes that according to the cause recorded on the death certificates there is no way of knowing what is the source of the infection and whether it is a hospital acquired infection or whether it is the result of medical negligence and that the topic is examined and investigated in the hospitals and by the Ministry of Health.[30]

In summary, in this chapter we have presented the partial data existing on medical negligence in Israel, from which it transpires that in the years 2010 – 2016 some 10,694 civil claims were submitted to the Courts due to medical negligence, however it is not clear how many of them were found justified; 8,372 claims were submitted against governmental medical institutions only, however it is not clear to in how many of them compensations were paid; and according to the classification of death certificates by the CBS in the years 2005 – 2014 in some 1,892 cases it had been possible to get a hint from the death certificate that medical negligence might have occurred, however as stated above, according to the CBS the death certificates are very limited source to learn from about the number of death cases from medical negligence and basing the assessments on this source in regards to medical negligence is leading according to their evaluation to a meaningless underestimation of the issue.

Due to lack of data on the number of the medical negligence cases ,the question is asked what is the number of special cases or events during medical care in Israel, how these cases are examined by the Ministry of Health and in how many were suspected or medical negligence was found, and we shall engage in these in the following chapters.

[1][1] We should mention in this regard, that as mentioned in the report o the offices inter-disciplinary report for examining the ways to reduce the public spending due medical negligence claims headed by Ms. Tana Shpanitz in 2005, the decisions and activities of the physician must be based on reasonable judgments and at acceptable level, i.e. the physician must base his decisions on the updated knowledge, supported by the professional literature, on previous experience and everything according to the accepted norms at the time in the medical world. Nonetheless, as mentioned in the report of the committee to examine the responsibility for damage in medical treatment headed by judge Dr. Gabriel Kling of 1999 which had been appointed by the Managing director of the Ministry of Health, it should be remembered, that a physician can make a mistake, and not every mistake in judgment constitutes negligence. The report of the offices inter-disciplinary committee on examining the ways to reduce the public spending due to medical negligence headed by Ms. Tana Shapnitz, 2005 : Report of the committee on examining the responsibility of damage in medical treatment headed by Judge Gabriel Kling, 1999.   

[2] Miri Cohen, manager senior area emergency services and first aid, Ministry of Health, letter 19^th January 2017[ received in the Knesset Research and information Center on 2^nd of March 2017]

[3]  There.

[4]   The report of the offices interdisciplinary committee for examining the ways to reduce public spending  due medical negligence headed by Ms. Tana Shapnitz, 2005; The medical system in Israel, Ms. Bin-Noon, Yitzhak Berlovich , Mordechai Shani, 2010.

[5]   Ordinance of Torts ( new version) -1968

[6] 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)

[7] Ministry of Justice, State Attorney's guidelines, Guideline no. 14.2 – Legal Criminal and Disciplinary Process against Physicians or other Medical Professions Due  Medical Negligence, last revision: 1^st January 2003

[8]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)

[9]  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).

[10] There.

[11]  State Comptroller's office Report 62 for year 2011, page 261, May 2012

[12]  There.

[13]  Chief Superintendent Davidi Grader Sagiv, Statistics Bureau Officer, Measurement and Information Section, Strategic Department, Planning Division, National Headquarters, Israeli Police, letter, 29^th May 2017

[14] Kobi Mashmush, Manager Economy and Statistics Department, Court houses Management, letter , 5^th January 2017

[15] Kobi Mashmush, Manager Economy and Statistics Department, Court Houses Management, letter, 5^th January 2017

[16]Ministry of Health, The hospitalization institutes and the hospitalization admitting units in Israel 2015, part A:Trends in Hospitalization, 2016, Ministry of Health, Information Department, Health Division, Hospitalization Beds and  Licensing Counters , January 2017             

[18] Shlomi Cohen, Manager Government Insurance Division, Ministry of Finance, letter, 6^th June 2017

[19] 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; Yahli Rottenberg, Senior Deputy to the Accountant General, Ministry of Finance, letter 31^st January 2017  

[20]  Ministry of Health, Information Department, Health Division, Hospitalization Beds and Licensing Counters, January 2017

[21] WHO Classifications, accessed on 23^rd May, 2017.

[22]  Naama Rotem, Manager Area Health and Natural Movement, Demography and Census, Central Bureau of Statistics, the special processing by the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customer Relations Branch, Central Bureau of Statistics; 26 January 2017

[23] Nama Rotem ,  Head Area Health and Natural Movement, Demography and Census Division, Central Bureau of Statistics. The special processing of the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customers Relations, Central Bureau of Statistics, 26 January 2017.

[24] There

[25]  Naama Rotem, Head  Area Health and Natural Movement, Demography and Census Division, Central Bureau of Statistics. The special processing of the Central Bureau of Statistics conveyed to us by David Landau, Head Information Distribution and Customer Relations, Central Bureau of Statistics, 26 January 2017.

[26] Naama Rotem, Head Area Health Natural Movement, Demography and Census Division, Central Bureau of Statistics, letter,25^th May 2017.

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

[28] Naama Rotem, Head Area Health Natural Movement, Demography and Census, Central Bureau of Statistics, letter, 25^th May 2017

[29]It should be noted that according to the Central Bureau of Statistics, the increase in the numbers of blood infection as a basic cause is connected to the change in the symbolizing policy and adapting the manual symbolizing done at the Central Bureau of Statistics to the automatic symbolizing done in most countries. Naama Rotem, Head Area Health Natural Movement, Demography and Census Division, Central Bureau of Statistics  The special processing of the Central Bureau of Statistics conveyed to us David Landau, Head Information Distribution and Customers relations Branch, Central Bureau of Statistics, 26^th January 2017.

[30] There.