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The Pattern of Medical Errors and litigations in Saudi Arabia
Jamal S. aljarallah , Norah A.Alr-owais
Introduction
Patient safety is an important issue that is receiving growing attention Worldwide. Reducing the incidence and cost of adverse events has become a priority (1-3). Adverse events (AE) appear in medical literature under different names such as medical errors(4) surgical errors(2) or only errors(5).
There are more than one definition of error in the literature(4,6-7). The Harvard Medical Practice Study defined an adverse event as “an unintended injury that was caused by medical management and that resulted in measurable disability”, whereas negligence was defined as failure to meet the standard of care reasonably expected of an average physician qualified to take care of the patient in question(7). Three types of errors are common: errors due to lapses of memory or slips in attention; errors of judgment in planning (rule-based errors); and errors due to lack of knowledge (knowledge-based errors)(8).
Adverse events and errors are frequent in clinical practice and they contribute to considerable morbidity and mortality(9). In the Harvard Medical Practice study, adverse events occurred in 3.7% of hospitalization and permanent disabling injuries occurred in 2.6% of these patients(10). A French national survey of inpatient adverse events revealed a rate of 6.6 per 1000 days of hospitalization of which 35% were preventable(11).
In New Zealand
The incidence of reported errors per patient seen in general practice per year was 0.24% in Australia
Some specialties are more prone to AE than others such as surgery(2,16-19) as it is a dynamic specialty which is harder to control(19).
Errors occurring in health care are not a disease and cannot be treated or exercised [not clear change word]. They are symptoms of a process in health care that is not functioning smoothly for whatever reason(19). Common causes of AE have been described in the literature as long working hours, sleep deprivation, fatigue, lack of knowledge of medications, lack of information about patients, rule violation, transcription errors and many others(20-22). Patients with long stays in hospital had more adverse events than those with short stays. Regarding causes, 37.8% of AE were caused by an individual, 15.6% had interactive causes. and 9.8% were due to an administrative decision(27).
Health care systems should be designed to ensure patient safety possibly, through three ways: (1) designing the system to prevent errors; (2) designing procedures to make errors visible when they do occur so that they may be intercepted and (3) designing procedures for mitigating the adverse effects of errors when they are not detected and intercepted (23).
To reduce adverse drug events, changes at the bedside and improvement in equipment and computers are effective, but training without action may worsen outcomes(24). Other mechanisms to reduce errors may include: reduced reliance on memory; improved information access; error proofing; standardization; and training(25).
One study has suggested selection of a high-volume hospital as a measure to reduce risk of operative death (17). Good reporting system is a way to learn from mistakes, so it should be well established(26).
Studies on medical errors in Saudi Arabia
The current study was designed to review the lawsuits cases placed against health care professionals by analyzing records of each case in the MLC in various provinces in Saudi Arabia, in order to determine the pattern of medical errors and litigations in Saudi Arabia.
The process of litigation
To understand the process of litigations against health care professionals in Saudi Arabia
Primary Investigation Committees (PIC)
These are formed by the concerned administrative health authority concerned (the Directorate General of Health Affairs, Directors of Health Services, and Deans of Medical Schools).
The committee is formed of three members: A physician, a legal expert and another physicians of a specialty in which the error occurred. The main responsibility of the committee is to interview both the plaintiff and the defendant and to scrutinize the medical records to find out if there was an error. The committee then sends a written decision and recommendation to the authorized person, in case there was an error. If the committee members think that there was no error, they will discuss their findings with the plaintiff, and if he is not convinced, the whole case would be directed to higher committees.
Medical violation committees (MCV)
These committees are formed by the Minister of Health or other Ministers who have health services under their authority. The committees consist of three physicians and a legal expert. These committees are supposed to investigate any malpractice suits and violations of the regulations. They are also concerned with the verification of medical errors, and if there is an error, the concerned committee sends all the documents to the highest committee. The decisions of this committee require approval by the concerned Minister before implementation.
The Medical Jurisprudence Committees(MJC)
These are the highest committees that look at medical malpractice suits. The committees is headed by a judge, and includes in its membership, three physicians (medical teaching staff from one of the medical schools, and two physicians from the Ministry of Health), in addition to a legal expert. In case of malpractice suits against pharmacists, two pharmacists would join the committee; one of them would be a teaching staff from a pharmacy college and the other pharmacist would be nominated by the Minister of Health. The committee is allowed to consult any expert in the field or a specialty related to the case under scrutiny. The committee looks into all the cases in which there is a claim for compensation (indemnity), because of mortality (blood money, or diah) or loss of an organ (indemnity).
The committee would also look at cases raised by the attorney general, even if there is no claim from the patient or his relatives.
The committee will pass its resolution based on a majority vote, provided that the judge is among this majority. The resolution of this committee is independent, final, and can only be appealed for through the Council of Governance within sixty days of issuing the resolution.
Materials and methods
At the time of conducting the study, there were 15 medical jurisprudence committees (MJC), one in each of the twelve regions of the kingdom and three in Riyadh
There were 15 medical violation committee (MVC) (one in each region in the Kingdom).
A pre-designed, pre-coded and tested data sheet was used to collect data from the records of the Medical Violation Committee (MVC), and Medical Jurisprudence Committee (MJC), where trained research assistants recorded the data. The data sheets consisted of information on demographic and clinical details of the case, information about the plaintiff and the defendant, details on the place where the error occurred, information about where the lawsuit was filed / registered, and details about the error itself and its characteristics. Also included were, details about what happened to the lawsuit, whether there was a medical error confirmed or not, and if confirmed what was the final punishment ?
All the records of the medical violation committees were reviewed covering two years (1427 and 1428H [2007-2008]), and records of the medical jurisprudence committees were also reviewed over one year (1427H(2007)).
The data was collected by individuals, who are working in these committees, either as undersecretaries or coordinators. They were trained by the investigators to collect the data, using the data sheets.
Data was entered to a personal computer using SPSS – win program for data analysis, and simple statistics were used. The chi-square test was used for comparisons and correlation and p value of 0 .05 or less was considered significant.
Results:
Review of records over one year of MJC, and over two years of MVC, revealed 642 cases (275 cases from the former, and 367 from the latter).
The average duration between the occurrence of the error and starting the litigation was (29.3+- SD 64.3) weeks, whereas the duration between placing the complaint and resolution of the case was (54.5+-Sd 49.00) weeks, and the duration between resolution of the case and the final approval was (14.1+-SD 29.6) weeks.
Most of the errors reported were from ministry of health hospitals (57.4%), followed by private health care facilities(36.4%),military hospitals (2.6%),and university hospitals(0.8%).
Most of the errors occurred in operating rooms (20.4%), followed by emergency rooms (18.1%), general wards (12.9%), outpatient departments (10.4%), delivery rooms (9.2%), and ICUa (2.9%).
The distribution of the specialties in which errors occurred, was as follows: surgery (25.1%), obstetrics and gynecology (22.3%), medicine (12.5%), pediatrics (7.8%), dentistry (5.9%), otorhinolaryngeology (3%), ophthalmology (1.9%), and family medicine (1.3%) (Fig1).
Most of the deaths occurred in surgery and obstetrics (about 25% for each), followed by medical specialties (17%), and pediatrics (11%). Also, delay in cure occurred more in surgery and obstetrics (46.6%, 47.8%) respectively.
About half of the lawsuit cases studied (46.5%) involved patients in the relatively young age group (20-50 years), but no age group was immune. For example 15% of the cases were infants and 8% were elderly (>65 years).
Table 1 shows that 23.7% asked for administrative punishment, 21.3% for compensation, 18.8% for general rights, and 12.3% placed a complaint asking for blood money (diah).
Close patient relatives or guardians (next of kin) initiated most of the complaints (48.1%), followed by relatives (16.2%), and the patient himself (15.6%).
More than half of the complaints placed for blood money were placed by the next of kin (53.2%), followed by relatives (31.6%). Compensation was requested mainly by next of kin (40.1%), the patient himself (32.8%), and relatives (21.2%). More than half of the requests for administrative punishment were placed by next of kin (52.6%),followed by others(15.1%),and the patient(13.8%).
Request for compensation for loss of an organ or its function represented about one fifth of the complaints (21.3%), and were placed mainly by the next of kin (40.1%), followed by the patient himself (32.8%), and relatives (21.2%) (Table 1).
When a comparison between government and private sector was made, it was found that significantly more complaint were placed for compensation in the private sector (p<0.00001)
In the majority of the complaints (47%), no error could be identified. Error with harm was found in 34.5%, and error with no identified harm occurred in 18.5%(Table 2)
Death occurred in 28% of the cases, although no error was found in 34.1% of these cases. Permanent disability occurred in about 30% of the cases, out of which 22.2% were with no identified error (Table2).
More than 50% of the complaints were placed at the General Directorate of Health, out of which 42% had no error, followed by the Ministry of Health(25%), out of which in two thirds (66.2%) no error could be identified (table 3).
Few complaints were placed at the Royal Cabinet (4%),in the majority of which (56%) no error was identified, and very few complaints were placed at the Deputy Minister of health office (0.8 %)( Table 3).
Table 4 shows that an error and harm was found in about 35% of the cases. In these cases, all the litigations for blood money were included. This was followed by administrative penalties (75%), compensation (60%), monetary fines (59.5%), and in 74% more than one punishment was given to the offender. (Table5).
Table 5 shows that the 39 out of 156 (25%) of the lawsuits that were placed at the office of the Minister of health were, because of a death and 83 out of 338 (24.5%) of the lawsuit placed at the Director General of Health Affairs were because of death. The corresponding rate for Hospital Directors was 20 out of 42 (47.6%). More than half of the lawsuit cases placed at the Royal Cabinet (53.8%) were because of death.
Discussion:
Exploring the problem of medical errors is not an easy task for several reasons. First, access to the records of the various committees was difficult and it could only be accessed through an order from his Excellency the Ex-Minister of Health. Second, there is an increasing sensitivity among the professionals and health care managers in exploring these areas. Third, the response rate from some regions included in the study was far below expectations. The possible reasons for these reservations are probably, the ever increasing emphasis in the media on medical errors, and the prevailing blame culture, which certainly make people more hesitant to discuss medical errors. Because of these reasons it was difficult for the investigators to identify the size of the problem, and it was only possible to collect data by the review of the available records.
The process of litigation against health care professionals in Saudi Arabia
This bureaucratic system affected not only the patients and patient’s relative, but also the health care professional, who will wait for a long time before knowing whether he is guilty or not. However, increasing the number of committees may hasten the litigation process.
Lack of good documentation was an obvious problem in all the MLCs. The exception was, the MJV in Jeddah which started computerization of all the documents. Extending this process to the other committees will probably decrease the difficulty in finding the information.
It is clear, that one of the main reasons for complaints related to administrative actions, which means that patients and patients relative were not satisfied with the quality of care provided to them and their main interest in these cases was that the health care professional be warned for the misconduct or error. One possible reason for their discontent could be the lack of appropriate communication with the patient and or their relative. Improving the communication process may minimize misunderstanding and discontent. Patients and their relatives have the right to know all the details about the disease, the intervention, and the possible complications of both.
Request for compensation represented one fifth of the reasons for complaints. The rules and regulations for health care practice in Saudi Arabia
In about half of the litigations, no errors were found by the MCV and or the MJC. This may reflect the over sensitization of the public to medical errors made by the local media, which could lead to the misunderstanding and misinterpretation of medical and surgical complications as medical errors. There is a great need to have more collaborative work between health care professionals and health care authorities on one side and the media on the other, to help increase the awareness of the journalists and for understanding the reasons of the difference between the two sides in order to regenerate confidence in health care professionals in the kingdom. However, the fifty percent rate of errors found in the cases investigated warrants all possible efforts to overcome the problem.
Permanent disability triggered more lawsuits and complaints, followed by death of the patient. Death is a tragic consequence, and if it is tied to a medical error, it will certainly trigger a complaint, especially if it was not expected or foreseen as an outcome of the medical or surgical intervention. Similarly, permanent disability is tragic. Living with disability as a victim of a medical intervention is difficult to accept and would naturally trigger the patient and or the family’s urge to complain.
The main two specialties that were more liable to litigation in this study were surgery including various sub-specialties, (25%), and obstetrics and Gynecology (22%) and they also contribute to more deaths and delay in cure. This may reflect the high rate of interventional procedures and the need for prompt and instant decision and actions in these specialties, which may put surgeons or obstetricians under greater pressure and stress with relatively less control. This finding conforms to the previous studies in the Kingdom(27,28) and elsewhere (9,10,8) which showed similar results. These specialties are high risk and need good decision making, team performance, appropriate communication, and technical skills. Failure in any of these competencies may end up with adverse consequences and errors. It follows, that there is a great need for better organizational structure and system improvement to help reducing errors in these specialties. As a contributing factor to errors in surgery, system failure was believed to contribute to 86% of the incidents according to another study(16). Factors like inexperience, lack of competence, communication breakdown, excessive workload, are, to mention a few, involved in errors.
It is noteworthy that more than half of the errors were reported from Ministry of Health Hospitals. The Ministry of Health provides health care for about 70% of the population in Saudi Arabia
Patients' relatives and especially the next of kin initiate most of the complaints. This is not surprising since the Saudi community is family-based, and the contribution of the family to patient care is vast.
This extends to the great interest in the fate of health care. Moreover, the feeling of responsibility by the patient's guardian or next of kin explains this phenomenon.
The Director Generals of Health Affairs in different regions receive most of the complaints. This is because they are more accessible to the patients and their relatives. With the Minister Of Health, they play a major role in processing the complaint, and have more responsibility in this regard.
What is surprising is that the Deputy Minister Of Health received the least number of complaints. It is possible that the majority of the public are not well aware that they can place complaints at this level.
It would be more appropriate, in our opinion, to provide more information to the public to place complaints at this level, rather than higher levels. This is supported by the fact that, in this study, about two thirds of the complaints placed at the Minister Of Health office, and more than half of those placed at the royal cabinets revealed no errors.
To save the time of the high official, we believe that complaints should be placed at a lower level in the hierarchy, unless there is an exception .
Doctors involved in medical errors in which blood money or compensation was demanded pay from their own pockets, which
represents a great burden on them. Recently, the Saudi government made it compulsory for all doctors to be insured against medical errors, even if they are not practicing. This will lift the burden off doctors and other health professionals.
In conclusion, this study has explored the pattern of medical errors and litigations in Saudi Arabia Saudi Arabia
Fig 1.The distribution of specialties in which errors occur most
Table 1: Reason(s) for placing the compliant vs. who placed it.
Who placed the complaint? | Blood Money No. (%) | Compensation No. (%) | Administrative Punishment No. (%) | General right No. (%) | General + personal right No. (%) | More than one reason No. (%) | Others No. (%) | Total No. %) |
The patient | 4 (5.1) | 45 ( 32.8) | 21 ( 13.8) | 8 ( 6.6) | 15 ( 15.2) | 6 ( 12.2) | 1 (10) | 100 (15.6) |
Next of kin | 42 ( 53.2) | 55 ( 40.1) | 80 ( 52.6) | 41 ( 33.9) | 63 ( 63.6) | 22 ( 45.0) | 6 ( 60) | 309 (48.1 |
A relative | 25 ( 31.6) | 29 ( 21.2) | 8 ( 5.3) | 17 ( 14.0) | 18 ( 18.2) | 6 ( 12.2) | 0 (0) | 104 (16.2) |
Sponsor | 1 ( 1.3) | 0 (0) | 3 ( 2.0) | 1 ( 0.8) | 1 ( 1) | 0 (0) | 0 (0) | 6 (0.9) |
Attorney general | 1 ( 1.3) | 1 ( 0.7) | 7 ( 4.6) | 26 ( 21.5) | 1 ( 1) | 1 ( 2) | 0 (0) | 37 (5.8) |
The health care institution | 2 ( 2.5) | 1 ( 0.7) | 10 ( 6.6) | 12 ( 9.9) | 1 ( 1) | 0 (0) | 1 ( 10) | 27 (4.2) |
More than one | 0 (0) | 1 (0.7) | 0 (0) | 7 ( 5.8) | 0 (0) | 6 ( 12.2) | 0 (0) | 14 (2.2) |
Others | 4 ( 5.1) | 5 ( 3.6) | 23 ( 15.1) | 9 ( 7.4) | 0 (0) | 8 (16.3) | 2 (20) | 45 (7.0) |
Total | 79 (12.3) | 137 (21.3) | 152 (23.7) | 121 (18.8) | 99 (15.4) | 49 (7.6) | 10 (1.6) | 642 (100) |
Table 2: Relationship between results of investigation and the actual harm that occurred.
Type of harm | Result of Investigation | Total No. (%) | ||
No error No. (%) | Error but no harm No. (%) | Error and harm No. (%) | ||
Death | 60 (34.1) | 10 (5.7) | 106 (60.2) | 176 (27.9) |
Loss of an organ | 8 (34.8) | 2 (8.7) | 13 (56.5) | 23 (3.7) |
Loss of function | 6 (31.6) | 0 (0) | 13 (68.4) | 19 (3.0) |
Permanent disability | 4 (22.2) | 0 (0) | 14 (77.8) | 18 (29.5) |
Temporary disability | 15 (55.6) | 9 (33.3) | 3 (11.1) | 27 (4.3) |
Bleeding | 2 (66.7) | 0 (0) | 1 (33.3) | 3 (0.5) |
Severe pain | 16 (42.1) | 11 (28.9) | 11 (28.9) | 38 (6.0) |
Delay of cure | 23 (38.3) | 15 (25) | 22 (36.7) | 60 (9.5) |
Other harms | 26 (46.4) | 23 (41.1) | 7 (12.5) | 56 (8.9) |
Multiple harms | 8 (30.8) | 5 (19.2) | 13 (50) | 26 (4.1) |
Undefined | 128 (69.2) | 42 (22.7) | 15 (8.1) | 185 (29.3) |
Total | 296 (47.0) | 117 (18.5) | 218 (34.5) | 631 (100) |
Table 3: Results of investigation vs where was the complaint placed.
Where was the complaint placed? | Result of Investigation | Total No. (%) | ||
No error No. (%) | Error but no harm No. (%) | Error and harm No. (%) | ||
Royal cabinet | 14 (56) | 1 (4) | 10 (40) | 25 (4.0) |
Minister of Health | 102 (66.2) | 17 (11.0) | 35 (22.7) | 154 (24.4) |
Deputy Minister of Health | 4 (80) | 0 (0) | 1 (20) | 5 (0.8) |
Director General of Health Affairs | 140 (42.2) | 79 (23.8) | 113 (34.0) | 332 (52.6) |
Hospital Director | 13 (31.0) | 7 (16.7) | 22 (52.4) | 42 (6.7) |
More than one | 2 (7.7) | 5 (19.2) | 19 (73.1) | 26 (4.1) |
Others | 18 (43.9) | 7 (17.1) | 16 (39.0) | 41 (6.5) |
Not defined | 3 (50) | 1 (16.7) | 2 (33.3) | 6 (1.7) |
Total | 296 (46.9) | 117 (18.5) | 218 (34.6) | 631 (100) |
Table 4: Type of punishment (judgment) versus the result of investigation.
Type of sentence (judgment) | Result of Investigation | Total No. (%) | ||
No error No. (%) | Error but no harm No. (%) | Error and harm No. (%) | ||
Blood money (Diah) | 0 (0) | 0 (0) | 10 (100) | 10 (1.6) |
Compensation | 3 (30) | 1 (10) | 6 (60) | 10 (1.6) |
Fine (monterial) | 7 (0.5) | 55 (36.0) | 91 (59.5) | 153 (24.2) |
Fine (administrative) | 2 (66.7) | 1 (33.3) | 0 (0) | 3 (0.5) |
Invalidation of license | 0 (0) | 2 (66.7) | 1 (33.3) | 3 (0.5) |
Warning | 8 (15.1) | 31 (58.5) | 18 ( 34.0) | 57(8.4) |
More than one sentence | 1 (1.4) | 18 (24.3) | 55 (74.3) | 74 (11.7) |
Not defined* | 110 (76.3) | 5 (3.5) | 29 (20.1) | 144 (22.8) |
No conviction | 165 (91.5) | 4 (2.3) | 8 (4.5) | 177 (28.1) |
Total | 296 (47.0) | 117 (18.5) | 218 (34.5) | 631 (100) |
*either the complaint was withdrawn or the case was not yet resolved.
Table 5: Type of harm vs where was the complaint placed.
Where was the compliant placed | Type of harm | Total | |||||||||
Death | Loss | Loss | Permanent disability 1 | Temporary disability 2 | Severe bleeding | Severe pain | Delay of cure | More than | Others | ||
The Royal Cabinet | 14 | 2 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 6 | 26 (4.1) |
Minister of Health | 39 | 5 | 8 | 1 | 4 | 1 | 15 | 19 | 3 | 61 | 156 (24.3) |
Vice Minister of Health | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 5 (0.8) |
Director General of Health Affair | 83 | 11 | 3 | 8 | 18 | 3 | 19 | 28 | 16 | 149 | 338 (52.7) |
More than one | 10 | 2 | 3 | 1 | 0 | 0 | 1 | 2 | 5 | 2 | 26 (4.1) |
Not defined | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 6 (0.9) |
Hospital Director | 20 | 3 | 3 | 1 | 2 | 0 | 1 | 5 | 0 | 7 | 42 (6.6) |
9 | 0 | 3 | 6 | 1 | 0 | 3 | 4 | 1 | 15 | 42 (6.6) | |
Total | 178 (27.8) | 23 (3.5) | 19 (3.1) | 18 (2.8) | 27 (4.2) | 4 (0.6) | 39 (6.1) | 60 (9.4) | 26 (4.1) | 246 (38.3) | 641 (100) |
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