Financial Expenses and “Losses” of the Polish Healthcare System Resulting from the Occurrence of Adverse Events

Background: The globally increasing healthcare expenditures related to the need to treat the consequences of adverse events, as well as the number of claims filed by patients (or their families) and remuneration paid as their result mean that the interest in the subject of adverse event cost management is increasing. An increase in the number of cases concerning medical errors has also occurred in Poland in recent years. The newest statistics from the Ministry of Justice demonstrate that the courts are awarding increasingly higher amounts. The goal of this work was an attempt to approximate, based on our own experiences, the impact of adverse events on the expenditures of the healthcare system in Poland, including the costs of treatment of the consequences of such events, described by the authors as “secondary harm”. Methods: Based on the analysis of 100 cases for compensation for the occurrence of a medical event, an initial estimate of the costs of primary (initial) treatment, which resulted in the occurrence of the adverse event, and the costs of subsequent hospitalisations/stays, which were its consequences. The study was conducted in the period from October 2020 to November of 2021. Results: The statistical analysis of the examined cases enabled establishing that in 62% they concerned women. Only 38% were events which applied to men. The highest number of cases concerned events which occurred in the last years, that is 2018 (35%), 2019 (23%), and 2017 (17%). The most frequent events included those related to incorrect diagnosis (the lack of correct diagnosis), which resulted in appropriate activities not being undertaken and a lack of appropriate treatment, e.g., lack of diagnosis of cancer, myocardial infarction, appendicitis, or fracture (26%). The next one was incorrect surgical treatment (17%)—the consequence of which was most frequently a need for repeated surgery and an incorrect conservative treatment of injuries. The obtained results demonstrate that significantly higher funds are spent by medical entities for “restorative” actions (on average EUR 1433, which attempt to mitigate against the negative consequences of incorrect decisions or actions in the original treatment (average cost of EUR 814)). Conclusions: The consequences of adverse events include not only health-related harm for the patient, but also long-term social, familial, or professional results. The authors of the article are of an opinion that all the conducted analyses and conclusions drawn from them should serve the improvement of patient safety. They also form an initial point for establishing recommendations and advice for the improvement of safety and quality of medical services and the reduction of healthcare-related costs. The authors propose covering the parties injured by an adverse event (subjected to “secondary harm”) with a unique, innovative programme of post-accident health care, “Health Reconstruction”.


Introduction
The globally increasing healthcare expenditures related to the need to treat the consequences of adverse events, as well as the number of claims filed by patients (or their and on the damages paid. The presented article is intended to also raise one aspect that is important for us (beyond the harm to the patient), related to the burden placed on the public healthcare system by the expenses resulting from the treatment of the consequences of such adverse events. The authors of the study have used the term "secondary harm", which for the purpose of this publication was defined by the authors as a medical condition which is not directly related to the original condition of the patient in contact with the healthcare system, but a secondary medical condition which has occurred after the adverse event. The secondary harm is an event, which occurred not at the patient's fault, but through a widely understood adverse event resulting from a diagnostic error, therapeutic error, administrative error, or another fault on the part of the healthcare system, caused by the medical facility's personnel, a specialised organisation, or by a system of private and public facilities serving the patient. The secondary harm is therefore a medical condition which can be directly connected to an event which would not have occurred without the participation of the healthcare system. It is harm with financial consequences for the entire healthcare system (the payer, the National Health Fund, bears the expenses of additional medical procedures which should not occur were the "secondary harm" not caused).
Therefore, in almost every case, the patient should be offered an individual treatment plan prepared for them, appropriate supervision over the process of their return to health, and a selection of appropriate specialists, increasing, e.g., the quality and effectiveness of the restoration of health. Patients frequently do not even know which specialist to contact with their illnesses, and the indications of specialists who do not consult with each other may be mutually exclusive. According to the authors, the main goals should therefore include: - Coordinating and providing aid in the daily functioning of the victim and their family; -Access to high-quality medical, psychological, financial, compensatory, legal, and infrastructural care; -Preventing disabilities and social and professional exclusion (including professional diseases).
The procedure could look as follows ( Figure 1): We cannot forget about such an approach and about analysing the consequences of adverse events. These are not only the closest, direct effects. These are also consequences which may last for years (even until the end of the victim's life and/or after their death in the case of their family) which burden not only the patient, but the entire healthcare system with significant costs.
Based on the analysis of specific cases, an initial estimate is made for the costs of primary (initial) treatment, which resulted in the occurrence of the adverse event, as well as the costs of subsequent hospitalisations/stays, which were its consequences. The assessment of costs applied to the expenditure of the Polish public healthcare system that finances the treatment of patients in medical facilities which have a signed agreement with the National Health Fund (the payer). The calculation was based on National Health Fund (NFZ) directories in force in the year in question, which contained the valuation of individual services by the payer. The longer the treatment, that is, the more additional hospitalisations, studies, and thus services provided, the higher the expenses of the system and its financial burden ("secondary harm").

Methodology
For the purpose of this study, a total of 100 cases for compensation due to an occurrence of an adverse event from the Provincial Committee Adjudicating on Medical Events of the Dolnośląskie Provincial Office in Wroclaw, from judgements of common courts and conducted by one of the law offices in the Opolskie province, were analysed. The analysis covered cases which met the following inclusion criteria: -Assigned to one of the concepts: doctor's error, medical error, or adverse event; -Active or finished during the study period; -Containing data which characterise the event (diagnosis, performed procedures, duration of hospitalization, and the type of ward, harm to patient's health, or patient's death); -Containing information concerning the further treatment of the party injured as a consequence of the event/error (number and type of subsequent visits/hospitalisations); -Containing information about own expenditures of the patient resulting from the occurrence of the event/error.
The study was conducted in the period from October 2020 to November of 2021. For every case, information was collected on: - The patient's age and sex; -Hospitalisations/stays during which an adverse event has occurred, including: (a) Length of hospitalisations/stays (date from-to); (b) Primary diagnosis and co-existing diagnoses acc. to ICD-10 classification; (c) Applied medical procedures acc. to ICD-9 classification.
-Subsequent hospitalisations/stays which are a consequence of the adverse event ("secondary harm"), including: (a) Length of hospitalisations/stays (date from-to); (b) Primary diagnosis and co-existing diagnoses acc. to ICD-10 classification; (c) Applied medical procedures acc. to ICD-9 classification; (d) Interval between hospitalisation/stay caused by the illness, and the diagnosis of "secondary harm"; (e) Time of treatment as a result of the "secondary harm" (if possible to establish); (f) Remaining costs, e.g., public costs (interruption in works, childcare), social costs (disability pension), costs of restoration of health, and damages paid out.
Data on the manner of treatment (procedures and diagnoses, time needed for hospitalisation) of all analysed cases were then compared with the financing conditions made available by the National Health Fund's president, the "NFZ president's regulation" creating the conditions of establishing and performing contracts for hospital treatment, outpatient specialist care, hospital emergency department/admissions desk services, and therapeutic rehabilitation [20]. This listing of the most important treatment parameters has enabled the assigning of every case to a specific settlement version (the DRG group) with the National Health Fund. The payer, depending on patient's age, diagnoses, performed procedures, and the manner of treatment, as well as the duration of the hospitalisation, specifies the amount of income for DRG groups, which the entity providing the medical service receives for performing it. The tariffs in force during a given year for the aforementioned groups are described in attachments to the aforementioned NFZ president's regulations.
Therefore, the examined cases were grouped into appropriate categories depending on the method of treatment and on the actions performed for the patient (conservative treatment, surgical treatment), divided by hospital wards, as well as the manner of admission (emergency or planned treatment). For every analysed case, information is provided about the original stay (primary treatment) related to the main cause for hospital admission, e.g., diagnosing and treatment of emergency events (including heart failure, strokes, and injuries), or planned surgeries (arthroplasty, cataract, or bariatric surgery) during which the adverse event has occurred (according to Polish terminology: medical error, medical event, or hospital infection, etc.). Assigning every patient to a Diagnostic-Related Group (DRG) group enabled the indication of the costs of primary treatment which constitute income for an entity providing medical services, but at the same time a burden for the healthcare system in Poland. These are, however, expenditures which may not be avoided (the entity is required to provide the services in accordance with the contract signed with the payer) regardless of the circumstances, type, and complication of the case. Of course, the fact of occurrence of an adverse event in most cases will result in the generation of additional costs (medication, diagnostics, and repeated procedures) already during the primary treatment; however, due to the restrictions in access to such detailed data, this study did not manage to separate the "above-standard" costs from ordinary costs.
A similar assignment was made for subsequent stays, during which the main reason was the need to treat the patient in relation to the occurrence of an adverse event. Every repeated hospitalisation was assigned to an appropriate DRG group (surgical or conservative), depending on the activities and procedures performed for the patient. The manner of proceeding in many cases has resulted from the type and character of the adverse event, i.e., hospital infection, diagnostic error, or therapy error. In some cases, the treatment was finished (the patient did not feel any further negative consequences of the occurring situation), in other cases, the patients have suffered harm to their health and will never return to full health/physical condition. Therefore, the costs related to further treatment (e.g., rehabilitation, follow-up in specialist clinics) of such patients are not small at all. These include not only the expenses resulting directly from further surgeries/treatments or diagnostics, but also damages and compensation for the harmed patients and their families.
The aforementioned income for the entity is a burden and financial "loss" for the healthcare system, which instead of investing into new technologies must provide funds for the treatment of complications and consequences of adverse events. Without them, subsequent stays would not be necessary at all, and thus additional costs would not be generated in the system. The authors of the study have thus assumed all the elements relating to the treatment of the consequences of the recorder events are an avoidable expense, which could have been eliminated virtually entirely.
All the collected information was entered into an Excel spreadsheet. The statistical analysis necessary for the purpose of this publication was performed using the functions available within that software.

Results
The statistical analysis of the examined cases enabled establishing that in 62% they concerned women. Only 38% were events which applied to men. Age categories of patients divided by sex were presented in Figure 2. Unfortunately, in 11% of cases, there was no information on this subject. In accordance with the "Safe Hospital Safe Patient" report by the Centre for Monitoring of Quality in Healthcare of 2014 [21], a hypothesis was presented that women care for their health more than men. That is why they more frequently receive medical services, which increases the risk of the occurrence of an adverse event during treatment. Additionally, women are characterised by a lower tolerance for treatment failure, which results in a higher share of women among patients seeking compensation through court proceedings. It may be simultaneously conjectured (although there was no such analysis conducted in this study) that women, being better educated, have more knowledge of patient rights, and also of the obligations of medical entities. Thus, they may have a higher awareness of the possible compensation/damages for incorrect treatment and a belief that they are entitled to it. At the same time, the number of assessed claims was analysed for the year during which the adverse event occurred ( Figure 3). It can be clearly seen that the highest number of cases concerned events which occurred in the last few years, that is 2018 (35%), 2019 (23%), and 2017 (17%). Sporadically, cases have concerned claims from much earlier (even from 1997). This is probably related to the growing awareness of patients and their families (knowledge of patient rights, issues of quality, and safety of care), as well as with the operation of province commissions for adverse events since 2012 (which in many cases enables assessing whether an adverse event has occurred or not more rapidly than in the courts). It should be kept in mind that the application has to be filed within a time limit of 1 year since the day on which the applicant has learned about the infection, bodily injury or disorder of health, or the patient's death has occurred. This time limit may also not be longer than 3 years from the day on which the event has occurred. This type of information indicates clearly that over the last few years, a clear upwards trend can be noticed. The consequences of the higher number of proceedings for these kinds of crimes include, among others, the creation of special departments in regional prosecutor's offices (since 2016) and the taking over of some of these cases by the offices of the district prosecutors. With these actions, the quality of procedures concerning medical errors has improved significantly. It may be thus expected that both the number and the value of awarded damages/compensation will be higher. Therefore, the burden on the healthcare system and on the entities which provide medical services will keep increasing.
It should be noted that the decrease in the number of claims in 2020 visible in the study does not only result in the delay in them being filed (up to 3 years form the event), but mainly from the introduction of the state of pandemic emergency within Poland (the Act of 2 March 2020 on special solutions related to preventing, counteracting, and combating COVID-19, other infectious diseases and emergencies caused by them). In accordance with the issued recommendations and guidelines, it was also necessary to limit the number of hospitalised patients, and also to transform wards or even entire hospitals into entities which provide services only to COVID-19 patients. Therefore, in most facilities, patients were admitted only in an emergency (risk to health/life), and the planned services or higher-risk surgeries were cancelled until further notice. Additionally, the feeling of risk resulting from the potential of death caused by a COVID-19 infection has resulted in a decrease in the reportability of patients to hospitals and in the use of medical care from the previous level. Thus, there is a significantly lower number of hospitalisations, and thus of adverse events reported in 2020 and claims resulting from them [22]. Data concerning the type of adverse events to which the compensation claims applied were also analysed. Due to the diversity, they were grouped into 32 more general categories ( Figure 4). The most frequent events included those related to incorrect diagnosis (the lack of correct diagnosis), which resulted in appropriate activities not being undertaken and a lack of appropriate treatment, e.g., lack of diagnosis of cancer, myocardial infarction, appendicitis, or fracture (26%). The next one was incorrect surgical treatment (17%)-the consequence of which was most frequently a need for repeated surgery and an incorrect conservative treatment of injuries (14%).
The aforementioned events most frequently resulted from an incorrect interpretation of symptoms, not using the available diagnostic capabilities (laboratory tests and imaging), a lack of appropriate competences, unjustified delays in commencing therapy or performing surgery (omission), incorrect pharmacological treatment, and organisational weaknesses. Similar results are presented in global publications [19,[23][24][25].
The next step was an assessment of examined cases for the interval between hospitalisation/stay as a result of the primary disease, and the commencement of the treatment of the consequences of an adverse event-the "secondary harm" ( Figure 5). For all analysed cases, the average time was 109.79 days (10 weeks), the median was 37.5 days (6 weeks), and the mode was 1 day (8%). At the same time, the maximum time amounted to 2010 days (288 weeks) and concerned a patient for whom it was necessary to perform a heart transplant surgery due to the lack of correct diagnosis and the lack of implementation of correct treatment. The patient has also a permanently issued disability certificate. It should be noted here that a disability certificate was issued for 18% of cases, in 6% of cases a consequence of the event was the death of the injured party, and for 5% of cases the treatment was not finished until today.  Then, in accordance with the assumptions of the study and based on directories which indicate the amount of financing of services by the National Health Fund, every case was assigned to the appropriate settlement group. This type of activity required the knowledge of the principles of coding and reporting of medical services to the NFZ payer. Assigning was performed both for the primary services (Table 1) and for subsequent services which were the result of the event ( Table 2). This enabled the establishing of the probable costs which were borne by the healthcare system for the treatment of patients for whom the adverse event has occurred. It can be clearly seen that most of the events occurred as part of a stay at the admissions desk/hospital emergency department, and the treatment of the consequences of these events included hospitalisation at a surgical department (surgical treatment was marked with "*"). The occurrence of adverse events has thus implied the need for further, sometimes very long and very expensive treatment. After all, should the aforementioned situations not occur, the hospital stays and consultations would be unnecessary. Additionally, the funds expended on them could have been spent on other patients and procedures. For most cases, a confirmation of the fact of occurrence of an event was practically immediate, which enabled the implementation of immediate treatment, thus reducing future costs. For cases which were identified at a later time, the expenditures for the "restoration" of health were greater, if any actions could be undertaken at all. This study also does not raise the problem of costs generated for extended stays or additional diagnostics performed during the hospitalisation with the adverse event already. It is only restricted to the expenditures related to subsequent visits and the further use of services financed from public funds.  The financial data presented in the study are based on the principles of settlements made between the medical entities and the payer (NFZ) and the diagnosis-related group's (DRG) price lists. We do not possess more precise information related to the detailed costs of treatment and their division depending on the procedure or the type of adverse event. At the same time, a relatively small (only 100 cases) and highly heterogeneous studied group did not enable the use of advanced methods (e.g., data mining, "Black Point Method for Adverse Events"), which would explain in a different manner the relationship between the expenditures of the system and the occurrence of adverse events.
It should be noted that the calculation of the aforementioned costs was based solely on data and information available to the authors on the day the materials were analysed. In cases when the treatment has not finished, only the already known expenses have been taken into account. It may impact the reliability of the obtained results and constitute a limitation of this study in relation to an underestimation of the actual costs of further care and treatment.
The average, mode, and median of the costs of treatment, both primary and secondary, are presented in Figure 6. It can be clearly seen that the average cost of treatment of the consequences of adverse events are almost twice as high compared to the primary disease. The medical entities thus spend more funds on "restorative" actions, which constitute an attempt to protect against the negative consequences of wrong decisions or actions, than on the primary treatment. The presented amounts are also a burden for the entire healthcare system, which instead of focusing on appropriate treatment must finance additional corrective services (e.g., repeated surgeries, rehabilitation) not related to the primary illness. All the costs calculated above related to the treatment of patients as a result of their claims should be also increased by additional costs related to the expenditure for commuting, treatment, or rehabilitation. In our study, it was an average amount of EUR 385.9 (PLN 1782.00).

Discussion
The Supreme Audit Office (NIK), based on information provided by the Patient's Rights Ombudsman, has indicated that in the years 2012-2017, the 16 provincial committees adjudicating on medical events in Poland have received 5604 motions for establishing a medical event [26]. The committees have issued within this time a total of 1133 judgements establishing a medical event and 2111 judgements on the lack of such an event. The NIK also specifies that the 16 committees have received 1468 motions for the reconsideration of a case, and a total of 380 proceedings were discontinued.
At the same time, data from the Ministry of Justice on proceedings for damages handled by common courts since 2011 and damages and claims finally awarded within these courts for harm caused by medical entities [8] are presented in Table 3. The lists indicate that there is not a significant difference in the number of new court proceedings (lack of a growth trend). At the same time, the fact of an extension of the duration of proceedings (according to the CEPEJ methodology) is clearly visible [26], which translates to an increase in the number of cases that are not finished and carry over to subsequent years.
The Ministry of Justice also provides annual data concerning the number of cases and persons who were awarded damages/compensation, and their total amount. Similarly, as in our analysis, the year with the largest number of claims is 2018. In this year, the highest value of awarded compensation was also noted (Table 4).
In 2018, the Organisation for Economic Co-operation and Development (OECD) published a report called "The Economics of Patient Safety: Strengthening a Value-based Approach to Reducing Patient Harm at National Level" [27]. It unequivocally indicates that harm related directly to the provision of health services-in addition to the burden of morbidity, mortality, and disability-also generates high financial costs and burdens to every healthcare system in the world. At the same time, the type and severity of the adverse event have a significant impact on the costs borne by healthcare entities. These expenses are mainly related to additional diagnostics, doctor's consultations, treatment, a longer hospital stay, as well as court proceedings and damages. The presented report also contains an analysis of the costs of adverse events in selected countries and their impact on healthcare resources (Table 5). Its authors report that the financial burden of all categories of adverse events which occur in hospitals is within 0.2-16.5% of the expenditure of public hospitals [28].   When analysing the available publications, it should be noted that adverse event claims focus mainly on surgical activities. According to reports by M. Bolcato, 11 out of 16 cases (69%) from the analysis of judicial and medical disputes belonged to this area. This only confirms the opinion that it is an area of high risk in healthcare. Simultaneously, no specific type of event repeats frequently enough to enable hypothesising that significant critical problems are focused on a single action in a hospital context [2]. Similar conclusions may be drawn from the analysis of our cases.
At the same time, the most frequent indirect causes of medical events indicated by doctors include an insufficient number of staff compared to the number of cases, excessive professional duties, the insufficient experience of medical personnel, and consultations conducted by doctors without specialisations [31]. Additionally, the available publications report that even up to 90% of all events occur on weekends and on holidays, which is closely connected to worse access to diagnostic and imaging examinations on these days, inadequate equipment and medical instrumentation, staffing irregularities at the level of the admissions desk or hospital emergency department that burden doctors with multiple simultaneous duties, and a lack of information flow between various professional groups and organisational units [32].
All the information presented and collected above necessitate the authors of this study to point out a significant problem of adverse events and their effects. Their consequences include not only health-related harm for the patient, but also long-term social, familial, or professional results. Very frequently when assessing, e.g., the costs of treatment of consequences of events, we forget about the "secondary harm". According to the authors, "secondary harm" is a wider concept than an adverse event, since it contains its component, and moreover, it conveys not only medical and non-medical consequences for the person subjected to it and for the patient's family, but also financial, legal, familial, social, and professional consequences. By presenting the occurrence of secondary harm on the time axis, it occurs on the day when the healthcare system allowed the deterioration of the patient's health by inappropriate action or omission.
The authors of the article are also of an opinion that the insurance societies which participate in the process during loss adjustment should ensure the appropriate conduct of loss adjustment proceedings and the payment of benefits related to the patient's claims or patient's family's claims (in case of the patient's death) in order to redress the damage. The obligations of the insurance society should not be restricted only to the payment of benefits, but should also include processes which support medical facilities in the improvement of the quality of performed medical services and present them with reports which demonstrate the effects of the harm and good practices which result from problems concerning events in other medical facilities. This should result in education through the implementation of courses and workshops for the facility's managers and personnel.
Additionally, the authors propose covering the parties injured by an adverse event (subjected to "secondary harm") with a unique, innovative programme of post-accident health care called "Health Reconstruction", resulting in the patient's return to independence. This programme, in addition to a special "health audit" and organisation of a Health Reconstruction process assumes providing the patients with comprehensive medical care, rehabilitation, care services, and psychological support, which will enable a rapid return to health, minimising the effects of the adverse event. Being covered by the programme should be possible right after the event (according to the authors' practice, it is necessary and essential, since only intensive medical and psychological help and support may demonstrate an appropriate direction which minimises the effects of health loss). We are aware of the fact of how important it is to immediately provide appropriate medical help, which is why support provided to the patient by specialists, medical consultants, and lawyers should occur right after the accident. The Health Reconstruction programme, as an answer to the harm which has occurred, would have as its aim the protection of health, and it should be financed from the funds handed over by the insurer or entity responsible for causing the harm (this may occur should the insurance society exceed the guaranteed sum resulting from the insurance policy, and benefits such as damages, compensation, and disability pension should be paid directly by the perpetrator of the event). The scope of the programme should be established based on an agreement regarding a report from a health audit, which would include the necessary services. What is most important is that in addition to the medical activities, the patient is supported in a return to normal life. These actions would include an adaptation to a new profession and other necessary types of support used to ensure that the patient is as able-bodied as possible. It should be also noted that the redress of damage also applies to the family of the injured person (which has died as a result of the adverse event), consisting of psychological and therapeutic aid, help in the organisation of a funeral, or the payment of benefits, that is damages for bereavement, appropriate compensation for the deterioration of material standing, and compensation related to the costs of transport, burial or funeral banquet, and an appropriate pension.
Being aware of the lack of possibility of the complete elimination of adverse events from the healthcare system, as well as the estimated scale of the phenomenon, we are convinced that these types of solutions and practices would enable a reduction in the negative consequences of their occurrence and the generated costs. In the situation of the occurrence of a problem, leaving the patient alone to themselves serves nothing. We think that every injured person should be provided with special care and supervision, a support which will enable implementing, as rapidly as possible, corrective and preventive actions before far reaching consequences.

Conclusions
All the conducted analyses and conclusions drawn from them should serve the improvement of patient safety. They also form an initial point for establishing recommendations and advice for the improvement of safety and quality of medical services and reduction of healthcare-related costs [33][34][35]. The main conclusions include: