MERIS (Medical Error Reporting Information System) as an innovative patient safety intervention: A health policy perspective

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MERIS (Medical Error Reporting Information System) as an innovative patient safety intervention: A health policy perspective Marina Riga a , Athanassios Vozikis b , Yannis Pollalis c , Kyriakos Souliotis d,∗ a Health Economics, School of Economics, Business and International Studies, Department of Economics, University of Piraeus, 80, Karaoli & Dimitriou Street, 18534 Piraeus, Greece b Health Economics and Information Systems, School of Economics, Business and International Studies, Department of Economics, University of Piraeus, 80, Karaoli & Dimitriou Street, 18534 Piraeus, Greece c Strategic Management and Policy, School of Economics, Business and International Studies, Department of Economics, University of Piraeus, 80, Karaoli & Dimitriou Street, 18534 Piraeus, Greece d Health Policy, Faculty of Social Sciences, Department of Social and Educational Policy, University of Peloponnese, Damaskinou & Kolokotroni Str., 20100 Corinth, Greece

a r t i c l e

i n f o

Article history: Received 13 March 2014 Received in revised form 3 December 2014 Accepted 4 December 2014 Keywords: Patient safety Adverse events Medical errors Intensive care unit Reporting system

a b s t r a c t The economic crisis in Greece poses the necessity to resolve problems concerning both the spiralling cost and the quality assurance in the health system. The detection and the analysis of patient adverse events and medical errors are considered crucial elements of this course. The implementation of MERIS embodies a mandatory module, which adopts the trigger tool methodology for measuring adverse events and medical errors an intensive care unit [ICU] environment, and a voluntary one with web-based public reporting methodology. A pilot implementation of MERIS running in a public hospital identified 35 adverse events, with approx. 12 additional hospital days and an extra healthcare cost of D 12,000 per adverse event or of about D 312,000 per annum for ICU costs only. At the same time, the voluntary module unveiled 510 reports on adverse events submitted by citizens or patients. MERIS has been evaluated as a comprehensive and effective system; it succeeded in detecting the main factors that cause adverse events and discloses severe omissions of the Greek health system. MERIS may be incorporated and run efficiently nationally, adapted to the needs and peculiarities of each hospital or clinic. © 2014 Elsevier Ireland Ltd. All rights reserved.

1. Introduction It has been known for many years that medical errors and adverse events exist and compromise patients’ safety and the quality of provided healthcare. The starting point for bringing them to the forefront of public attention was the report of Institute of Medicine [1] titled “To Err is

∗ Corresponding author. Tel.: +30 2107482015; fax: +30 2107485872. E-mail address: [email protected] (K. Souliotis).

Human”, defining an adverse event as “an injury caused by medical management rather than by the underlying disease or condition of the patient”. Soon after, a medical error was determined as “the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems” [2,3]. A recent study, ten years after the IOM’s report, estimates that American citizens dying from medical errors almost doubled [4]. The most recent Euro-barometer survey [5] found that almost half of those surveyed feel that they could

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be harmed by the healthcare system in their country (both by hospital and non-hospital care). Also, the recent WHO Report highlights that 50% to 70% of such harm could have been prevented and caused due to systematic problems in healthcare [6]. European data indicates that the phenomenon seems to be a major problem for health systems, as medical errors occur in 8% to 12% of total hospitalizations [6–9]. The economic burden of adverse events and medical errors is also significant in the Greek health system and it compromises the efforts of recovery from the debt-driven economic crisis [10]. Ordinary attempts to quantify the medical errors and adverse events usually include mandatory or voluntary incident reports, retrospective record reviews and sometimes “bedside” surveillance of procedures. The variety of medical errors and adverse events’ measurement methods, with their advantages and disadvantages, are illustrated in Table 1 [11,12]. The international experience shows that morbidity and mortality conferences, malpractice claims analysis and error reporting systems do not provide highly reliable and accurate data for medical errors and adverse events. There are concerns about the level of their effectiveness, to ensure the provision of safe care [12–14]. Also, the research study by Olsen and colleagues [15] indicates that incident-reporting systems cannot assess precisely the clinical adverse events and it should be in cooperation with other systematic data collection methods. Furthermore, the methods of direct observation and “bedside” surveillance appear to be a time consuming and costly process and to have a relatively limited ability to detect and record all errors [12]. Regarding the landscape of medical error reporting systems worldwide, U.S.A. presents a great diversity of such systems for several years now with a high degree of knowledge, such as the Medical Event Reporting System for Transfusion Medicine [MERS-TM] and the US Pharmacopeia’s MEDMARX Reporting System [11]. On the same track, Australia, Canada and many Western European countries have developed or achieved significant progress in adopting similar medical error reporting systems [11,16,17]. However, even countries with a long history of error reporting have to make reasonable efforts to enhance the philosophy of healthcare quality and patient safety when designing the error reporting systems [18]. In Greece, only a small portion of public hospitals has implemented and operates the Clinical Modules of their Information System (as paper-based health records are still prevalent), so there is a lack of adverse event and medical errors monitoring system and their detection is based on a spontaneous reporting [19]. The scope of this paper is to present and assess the pilot implementation of MERIS which adopts the global standards and is comparable to other error reporting systems with both mandatory and voluntary disclosure modules. It may be incorporated and run effectively and efficiently on the national scene, in several Greek hospitals, adapted to the needs and peculiarities of each clinic.

2. Material and methods MERIS embodies mandatory and voluntary reporting modules that engage physicians, public/private hospitals, citizens and various users. Graph 1 presents the architectural structure of MERIS [11]. All the data are stored to powerful server, maintaining all safeguarding considerations, sharing information locally (by a local area network) or via the web. The key features of MERIS system are illustrated in Table 2. The concept of “trigger” to identify adverse events in the medical record was first introduced by Jick [20] and Classen et al. [21] and more recently used by the Institute for Healthcare Improvement [IHI], which developed the Trigger Tool for Measuring Adverse Drug Events [22]. The mandatory reporting module of MERIS uses twenty-two specially customized and one general ‘trigger’ for possible underlying adverse events, which were developed by experienced doctors specializing in intensive care treatment. The review of the patient’s medical record is a necessary and crucial procedure in order to verify the presence of adverse events, if any (or some) of the triggers arising [23]. The physicians should focus only on a specific part of patient’s medical record where a trigger has been disclosed by MERIS system, in order to identify potential underlying adverse events, associated with this trigger. For a more detailed example of how the trigger tool works, supposing that MERIS revealed that Vitamin K administration is a trigger for possible occurrence of an adverse event, physicians are motivated to further dig deeper into the part of the medical record associated with the medication administration. Table 3 illustrates the coded triggers and their description used in MERIS, based to the recommendations of the IHI Global Trigger Tool [23]. Also, it is possible to adjust the triggers according to the needs and peculiarities of any clinic. Various other variables, such as the medical specialties, the error phase of care, the severity of their consequences, etc. were coded and therefore analysed. The same approach was chosen in order to facilitate at a later stage the root cause analysis [RCA] of the incidents [23]. The mandatory reporting module for the severity classification of errors endorses the National Coordinating Council for Medication Error Reporting and Prevention Index for categorizing errors [24]. Thus, the categories A–D describe incidents that do not cause harm, while categories E–I gather information about adverse events and medical errors, which cause a serious harm or death. However MERIS is designed for recording severity of incidents, even for those that were not the result of a medical malpractice [23,25,26]. Additionally, it is essential to cultivate a “blame-free” culture to the healthcare personnel. Except from staff education, all the accreditations and assurances taken up by medical director and hospital manager can be a useful instrument to enhance the active participation and diminish the fear of punishment for revealing errors. The voluntary reporting module is an open access system, accessible to everyone (citizens, physicians, etc.) who wants to report an adverse event or a “near miss” about

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Table 1 Error measurement methods with their pros and cons. Error measurement method

Advantages

Disadvantages

Morbidity and mortality conferences and autopsy

• Can suggest key factors that led to errors • Familiar to healthcare providers • Analysis of potential causes • Use of recent data

• Bias in the outcome • Focus on diagnostic errors • Infrequent use of the method • Bias in the outcome • Focus on severe errors • Insufficient method practically • Bias in the outcome

Root cause analysis

Malpractice claims analysis

Error reporting systems

Administrative data analysis

• Recording data from multiple perspectives (patients, health care providers, lawyers) • Provide several elements over time • Can be part of the working routine of health professionals • Using readily available data • Inexpensive method

Record review/chart review

• Using readily available data • Usual method

Review of electronic medical record

Observation of patient care

Active clinical surveillance

• Inexpensive method after initial investment • Detects and records errors in real time • Integrates multiple data sources • Accurate and clear data • Provides data otherwise would not be available • Detects several errors “in real time” • Accurate and clear data

• Non-standardized format of source data • Bias in the outcome

• May be based on incomplete and inaccurate information • The data are isolated from the clinical observation • The findings on adverse events are not reliable • Medical records may contain incomplete data • Bias in the outcome • Susceptible to programming and/or data entry errors • Expensive to implement • Time consuming and costly process • Difficulty in training reliable observers • Arises debate on the issue of confidentiality • Potential risk of information overload and disorientation from the target • Time consuming and costly process

Source: [11,12].

her/his experience in the Greek health system, without revealing any personal information. The input data of voluntary module of MERIS is not disclosed and is internally used as a supplementary tool for quality improvement. Also, all the methodological aspects taken into account provide a crucial element in the quality of healthcare

and patient safety, so citizens/patients have an active and empowered role in the Greek health system efficiency improvement [16,27]. The diffusion of the MERIS voluntary reporting module is critical point in order to widespread its existence and contribution. Thus, a lot of effort should be made in

Table 2 Key features of MERIS system. Key features of MERIS system Mandatory reporting module

Voluntary reporting module

• Uses trigger tool methodology • Enables the Root Cause Analysis (RCA)

• Endorses the severity classification of errors • Shares data by a local area network or via the web (see Graph 1) • Statistics data are publicly disclosed over time • Detects and records adverse events and medical errors with their key characteristics and the factors that contributed to their occurrence • Provides patient incident type and description, categories of errors, phases of care and severity • Everyone has an access to report incidents anonymously • Identifies omissions and weaknesses of Health System • Collects near misses • Shares data via the web (see Graph 1)

• Compulsory process for the medical staff • Blame-free system in protected environment encouraging the systematic detecting and recording of incidents • Can be monitored and managed by an independent oversight body

• Statistics data are not disclosed

• The questions are posed in a simple and understandable way • Can be monitored and managed by an independent oversight body

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Graph 1. The architecture of MERIS. Table 3 MERIS triggers. MERIS triggers Codes

Description

ICU01 ICU02 ICU03 ICU04

Positive blood culture Sharp drop in Hct or Hg of 4 units or greater C. difficile infection (CDI) positive Partial thromboplastin time (PTT) & international normalized ratio (INR) Glucose < 50 mg/dl Rising BUN or serum creatinine 2× over baseline X-ray tests for clot or emboli Kayexalate administration Fenistil administration Vitamin K administration Flumazenil (Romazicon) administration Naloxone (Narcan) administration Anti-diarrhoeals & laxative administration Signs coded Pneumonia onset Readmission to the intensive care unit New initiation of hemodialysis In-unit procedures Intubation-mechanical ventilation/re-intubation-mechanical re-ventilation Abrupt medication stop Over-sedation/lethargy/hypotension Other Unknown

ICU05 ICU06 ICU07 ICU08 ICU09 ICU10 ICU11 ICU12 ICU13 ICU14 ICU15 ICU16 ICU17 ICU18 ICU19

ICU20 ICU21 ICU22 ICU00

this direction through posts in printed and electronic press (daily or health issues related), presentations in conferences and scientific fora, debates in TV shows and radio programmes, content reproduction in various social media and also with the aid of word of mouth effect from citizens/patients, physicians, health managers, etc. The MERIS voluntary module has been developed based on methods; recommendations and best practices of voluntary reporting systems used globally and have been customized for the Greek health system. The data set and the functional design of the proposed voluntary reporting module conforms with both the methodology analysis of British National Patient Safety Agency [NPSA] [28] as well as the special Euro-barometer survey with research subjects related to patient safety and quality of healthcare provision [5]. Additionally, it includes important elements (patient incidents type and description, category of error, phase of care and severity) to improve the information provided and the knowledge created for systemic problems in the Greek health system [16]. For the development of our proposed system MERIS which embodies both the mandatory as well as the voluntary module, we combined the experience of implementing the Trigger Tool for Measuring Adverse Drug Events of the Institute for Healthcare Improvement methodology [23], with the less extensively applied methodology of the Intensive Care Unit Adverse Event Trigger Tool of the

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Table 4 Crosstab analysis of adverse events severity by gender.

A–D: No patient harm

E: Temporary harm to the patient and required intervention H: Intervention required sustaining life

Total

Total

Gender

Adverse events severity Male

Female

Count % Within adverse events severity % Of total Count % Within adverse events severity % Of total Count % Within adverse events severity % Of total Count % Within adverse events severity % Of total

6 75.0% 17.1% 12 66.7% 34.3% 5 55.6% 14.3% 23 65.7% 65.7%

VHA/Institute for Healthcare Improvement [29]. MERIS also includes the characteristics of recording and reporting medical errors of Intensive Care Unit Safety Reporting System [ICUSRS] of the Society of Critical Care Medicine [SCCM] [30] and the Critical Incident Reporting in Critical Care of the Council of the Intensive Care Society [31]. At the same time, we adopted the widely accepted classification to major categories of adverse events of Australian Incident Monitoring Study in Intensive Care [AIMS-ICU] [32], in conjunction with the Critical Care Safety Study [CCSS] as part of the Harvard Work Hours and Health Study [33] and the classification as proposed by Intensive Care Unit experts and by the public hospital consultants, where MERIS pilot is being implemented.

2 25.0% 5.7% 6 33.3% 17.1% 4 44.4% 11.4% 12 34.3% 34.3%

8 100.0% 22.9% 18 100.0% 51.4% 9 100.0% 25.7% 35 100.0% 100.0%

3. Results 3.1. Mandatory module results The mandatory system was applied in an ICU environment of a public hospital with 279-bed capacity in Athens area. The pilot implementation in ICU with 9 inpatient beds was undertaken in the period January 2012 to April 2013 and identified 35 adverse events on 31 patients (mean age 64.93 years). Of these patients, 21 (67.7%) were men and 10 (32.3%) were women. Also, men had an average length of stay of around 25.94 days versus 28.40 days for women. Of the 191 patients admitted throughout the year 2012, 26 (14%) experienced one or more adverse events with an average length of stay of 27.54 days and of the 44 patients admitted from January to April 2013, 5 (11%) experienced

Table 5 Crosstab analysis of adverse event classification by gender. Gender

Adverse event classification Male

Total

Female

Associated with vascular lines

Count % Within associated with vascular lines % Of total

7 58.3% 20.0%

5 41.7% 14.3%

12 100.0% 34.3%

Associated with intubation/mechanical ventilation

Count % Within associated with intubation/mechanical ventilation % Of total

10 71.4%

4 28.6%

14 100.0%

28.6%

11.4%

40.0%

Associated with managing of patient care/environment

Count % Within associated with managing of patient care/environment % Of total

2 40.0%

3 60.0%

5 100.0%

5.7%

8.6%

14.3%

Medical devices, disposables related complications

Count % Within medical devices, disposables related complications % Of total

1 100.0%

0 0.0%

1 100.0%

2.9%

0.0%

2.9%

Medication errors

Count % Within medication errors % Of total

3 100.0% 8.6%

0 0.0% 0.0%

3 100.0% 8.6%

Total

Count % Within adverse event causes % Of total

23 65.7% 65.7%

12 34.3% 34.3%

35 100.0% 100.0%

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6 Table 6 Allocation of medical errors’ consequences. Medical errors’ consequences

Frequency

Hypoxemia (Sat < 80%, PO2 < 60 mmHg) Other Blood loss Re-intubation Cardiac arrest Pneumothorax–haemothorax Bradycardia–tachycardia syndrome Greater loss/increase blood pressure

2 11 2 8 1 4 4 3

5.7 31.4 5.7 22.9 2.9 11.4 11.4 8.6

Total

35

100.0

(11.4%). The element “Other” refers to medical errors that do not fit in other categories (Table 6). A cross tabulation analysis on Table 7 shows a vertical column with adverse events classification and a horizontal column with medical errors, which were detected by MERIS in the 35 incidents. As it seems, the category of adverse events associated with intubation/mechanical ventilation related mainly with re-intubation, greater loss/increase blood pressure, hypoxemia (Sat < 80%, PO2 < 60 mmHg), etc. Following, the adverse events associated with vascular lines were responsible for 34 out of 100 medical errors in the ICU environment.

Percent

an adverse event with an average length of stay of 32.4 days. More specifically in 2012, for 26 patients with adverse events, were required approx. 12 additional hospital days, compared to the average length of stay of the total number of patients treated in the ICU. The financial burden because of the extra real cost of these incidents is estimated to D 12,000 per adverse event. This accounts to about D 312,000 annual extra total healthcare cost, only for ICU. Descriptive statistical analysis was performed for the reported incidents and main results shown in the following Tables 4–7. According to our findings, 61% of reported data had over 20 days of hospital stay and 18 cases (51.4%) were attributed to Category E: Temporary harm to the patient and required intervention, where 12 cases (66.7%) referred to male gender (Table 4). Adverse events which were associated with intubation/mechanical ventilation had the highest incidence rates (14 cases, or 40%), where 10 cases referred to male gender (Table 5). Also for the reported events, most of the medical errors were classified as Re-intubation (22.9%), Pneumothorax–haemothorax and Bradycardia–tachycardia syndrome

3.2. Voluntary module results In addition, our research attempts to present in the following Tables 8–9, a comprehensive primary assessment of the voluntary reporting module of MERIS, which refers to the active participation of patients/citizens in the reporting of adverse events, from November 2012 to January 2013. A random sample of 510 reports indicates some quite interesting findings. 48% of the incidents occurred at the treatment phase and 36.5% were detected at the diagnosis stage, with no significant difference amongst gender. However, peak incidents observed in the 25–44 and 45–64 age groups (130 and 168 cases, respectively) (Table 8). Furthermore a cross tabulation analysis undertaken between the healthcare unit type and whether the patients have been informed by the medical staff that an incident had occurred. The findings show that the proportion of patients who had experienced an adverse event and became aware was approx. 50%. In regards to the cross tabulation analysis between adverse events and severity (Table 9), it seems that an incorrect, missed or delayed diagnosis is responsible

Table 7 Crosstab analysis of adverse events and medical errors. Adverse events classification

Medical errors classification Hypoxemia (Sat < 80%, PO2 < 60 mmHg)

Other

Blood loss

ReCardiac arrest intubation

Pneumothorax– haemothorax

Associated with vascular lines

0 0.0%

5 14.3%

2 5.7%

0 0.0%

0 0.0%

4 11.4%

Associated with intubation/mechanical ventilation

2

1

0

7

1

5.7%

2.9%

0.0%

0

2

0

0.0%

5.7%

0

0

Associated with managing of patient care/environment Medical devices, disposables related complications

20.0%

Total Bradycardia– tachycardia syndrome

Greater loss/ increase blood pressure

0 0.0%

1 2.9%

12 34.3%

0

1

2

14

40.0%

2.9%

0.0%

2.9%

5.7%

0

0

0

3

0

0.0%

0.0%

0.0%

0.0%

8.6%

0.0%

0

1

0

0

0

0

1

5

14.3%

0.0%

0.0%

0.0%

2.9%

0.0%

0.0%

0.0%

0.0%

2.9%

Medication errors

0 0.0%

3 8.6%

0 0.0%

0 0.0%

0 0.0%

0 0.0%

0 0.0%

0 0.0%

3 8.6%

Total

2 5.7%

11 31.4%

2 5.7%

8 22.9%

1 2.9%

4 11.4%

4 11.4%

3 8.6%

35 100.0%

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Table 8 Crosstab analysis of error phase of care by age class. Age class

Error phase of care < 15

Total

16–24

25–44

Preventive

Count % Within error phase of care % Of total

10 19.2% 2.0%

11 21.2% 2.2%

16 30.8% 3.1%

11 21.2% 2.2%

4 7.7% 0.8%

52 100.0% 10.2%

Diagnosis

Count % Within error phase of care % Of total

10 5.4% 2.0%

32 17.2% 6.3%

52 28.0% 10.2%

59 31.7% 11.6%

33 17.7% 6.5%

186 100.0% 36.5%

Treatment

Count % Within error phase of care % Of total

17 6.9% 3.3%

37 15.1% 7.3%

55 22.4% 10.8%

88 35.9% 17.3%

48 19.6% 9.4%

245 100.0% 48.0%

Don’t know (DK)

Count % Within error phase of care % Of total

3 11.1% 0.6%

5 18.5% 1.0%

7 25.9% 1.4%

10 37.0% 2.0%

2 7.4% 0.4%

27 100.0% 5.3%

Total

Count % Within error phase of care % Of total

40 7.8% 7.8%

85 16.7% 16.7%

130 25.5% 25.5%

168 32.9% 32.9%

87 17.1% 17.1%

510 100.0% 100.0%

to a large extent, for incidents of temporary harm, for events requiring life-sustaining interventions and for patient deaths. From this, we can extrapolate that the cost increases significantly due to required initial or prolonged hospitalization. Moreover, a great portion of severity associated with permanent patient harm as well as with life-sustaining interventions is due to surgical errors, while at the same time over 70% of the events leading to patient death are due to incorrect, missed or delayed diagnoses and to hospital-acquired infections. 4. Discussion MERIS triggers awareness among personnel for the detection of adverse events and medical errors and their prevention. Therefore, according to the staff declarations, the acceptance, adaptation and the participation of

45–64

>65

personnel for MERIS, is strongly positively assessed. Also, the evaluation shows the advantage of data processing and conclusions, which are produced in real-time, without any blame or confrontation. On the other hand, the methodology of voluntary reporting module, which provides an easy and friendly interface as well as the extracted knowledge, suggests that the patient incident reporting system should be voluntary, trustworthy, blame-free and without recording sensitive personal data (e.g. health providers and patients names). So, with the use of MERIS, patients’ records are reviewed as a mean for continuous assessment of patient safety and quality of healthcare provision. The methodology of mandatory reporting module we used and our findings are consistent and agreed with several surveys according to the international literature. Surveys found that much more medical errors occur in ICUs than in other inpatient care units [34]. This may be due

Table 9 Crosstab analysis of adverse events severity. Severity classification

No patient harm Temporary harm to the patient and required intervention Temporary harm to the patient and required initial or prolonged hospitalization Permanent patient harm Intervention required sustaining life Patient death

Adverse events Hospital infections (%)

Incorrect, missed or delayed diagnoses (%)

Surgical errors (%)

Medication related errors (%)

Medical device or equipment related errors (%)

Other (%)

Don’t know (DK) (%)

Total (%)

3.4 9.4

49.1 44.3

0.9 7.4

25.0 20.1

5.2 7.4

6.0 4.0

10.3 7.4

100.00 100.00

21.0

35.5

12.9

14.5

10.5

2.4

3.2

100.00

4.0

20.0

36.0

16.0

16.0

8.0

15.2

27.3

27.3

15.2

15.2

27.0

44.4

11.1

6.3

4.8

100.00 100.00

4.8

1.6

100.00

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to the organizational complexity of ICUs, the severity of illness of ICU patients, the ICU workload, malpractice lawsuits, etc. [35]. Researchers also highlighted the problem of patient safety in ICU environment, in particular where health services with more difficult structure and organization are provided, resulting in increased potential risk of patient death [36,37]. A study, which took place in an Australian hospital in a 12-bed intensive care unit with 164 patients, indicated that a similar reporting system to MERIS detected more preventable errors than retrospective medical record review, in less time [38]. Also, researchers at the Johns Hopkins University developed a web-based Intensive Care Unit Safety Reporting System [ICUSRS] where 24 incidents were reported during 10 months [30], while MERIS identified 35 during 15 months. Another study with 3,875 reports from 2 hospitals in Southern California mentioned that 21% of incidents occurred in ICUs and a large proportion of events were medication errors, operations failure, patient falls and procedures-related errors [39]. Researchers in another study in hospital of Missouri found that 36.5% of reports were related to procedural complications, 20.2% to medication errors and 7.9% to equipment failure while 9.9% of events required life-sustaining interventions and 3% caused patient death [40]. Moreover, the research study by Rothschild and colleagues [33] showed that 13% of adverse events referred to the Category H: Intervention required sustaining life and the most serious medical errors associated with managing of patient care/environment (slips and lapses) and with medication errors. In our study, errors were mainly associated with failure in procedures and caused temporary harm to the patient requiring intervention. Findings from other studies are consistent with our research outcomes and we can conclude that the adverse events and medical errors that occurred in ICUs are similar, internationally. The key characteristics of MERIS voluntary reporting module are congruent with several national incidentreporting systems in UK, Denmark and Ireland. Though, the majority of those attempts are associated mostly with voluntary medication or vaccine error reporting systems [41], some countries, like UK and Denmark, have launched voluntary public reporting systems [16,42]. We should also point out that recently announced the intention of the Department of Health and Human Services [HHS] of United States to initiate a similar voluntary reporting system addressed to patients and citizens [43]. Moreover, the National Quality Forum [NQF] [44] proposes the main guidelines for voluntary public reporting systems, which are consistent to a large extent with MERIS voluntary reporting module. Among other, NQF recommends the design of a web-based reporting system for ensuring the ease of use and the free accessibility, for the public. NQF, also, underlines that the voluntary reporting system should preserve the elements of transparency and practicality; something that methodology approach of MERIS contains. In addition to, Denmark has established a voluntary reporting system in primary and secondary healthcare, which follows the same methodology as the MERIS voluntary reporting module. Patients, citizens and

healthcare professionals can report on adverse events in a friendly and effective in use environment preserving respondents’ anonymity [45]. It is important to say that systems like MERIS, in no case are intended to be the incentive to blame the health professionals or seek compensation, but these systems exist only for the detection and analysis of medical errors and adverse events in understanding the health system’s omissions and in mapping out policies for the prevention and reduction of these incidents [46]. Multiple studies support the conclusion that Information and Communications Technology [ICT] systems can lead to considerable benefits in patient safety [47]. However, that potential can only be realised and optimal benefits from Health Information Systems [HIS] will only be obtained, if these systems do not merely operate alongside each other but actually if they are implemented in an integrated fashion [48]. This interoperability streamlines healthcare procedures and reduces the cost of managing patient information [49]. In this dimension, our proposed system has been designed and developed to share health information between patients, registries, public authorities and providers for reducing overall health care costs and improving patient safety and health outcomes [50]. Additionally, the incorporation of educational programmes, with subjects on patient safety and on quality improvement could strengthen these efforts [27,51]. The main contribution of our research is that MERIS system, with the use of trigger tool methodology, has comprehensive and clear content, adopts a friendly and lean procedure for detecting, reporting and analysing adverse events and medical errors [52], whilst requires less effort and lower costs than other types of error reporting systems [53]. It is crucial to mention that the implementation phase of MERIS provides also basic recommendations for having a successful, high achieving reporting system. Therefore, a continuous and systematic training of health professionals in the use of the proposed system is essential to enhance their skills in detecting, reporting and analyzing the adverse events and medical errors. Moreover, a significant aspect for the success of MERIS system is the systematic reviews with follow-up data and feedback directly to the medical staff in order to update and upgrade the error reporting process. All these confront the need for the continuous enhancement of quality assurance practices and the establishment of the culture of patient safety. Some of the limitations of this research study include the limited use of ICT technology from health professionals in the ICU, where MERIS pilot is being implemented. This is due to the excessive workload or their unfamiliarity with computer technology and Internet. Besides this, a further reason for having limited number of reported events was the fear of consequences, even though was given to the personnel the assurance that MERIS is a blame-free system. Indeed the Greek health personnel keep a cautious attitude towards medical errors and adverse events reporting due to the imminent risk and fear of litigation [11]. Regarding the limitations of voluntary module, maybe there was a probability of duplicate entries and also a possible exclusion for those citizens/patients who were not

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basic users of computers and Internet. Nevertheless, MERIS could be monitored and managed by an independent oversight body, so these potential limitations can be overcome, easily. The goal reached of our study was to determine whether the MERIS is able to detect, report and analyse the adverse events and medical errors occurring in healthcare system. As a result, this experiential information can be disseminated to other hospitals or clinics, nationally. Also, the Ministry of Health should take the initiative to wider diffuse the mandatory module of MERIS in several hospitals and other specialty units along with making widely known to the public the voluntary process of medical errors reporting. In the future, the next step of MERIS improvement would be to communicate and exchange information with any Hospital Information System (whenever their clinical modules will be implemented in the Greek setting) so as to automate the process of detecting medical errors directly from the Electronic Medical Record [EMR] of each patient. 5. Conclusions It is commonly accepted that health care can cause harm to the patient. But the recognition that the damage may be due to medical error or system failure has arisen gradually. Also, the majority of medical errors are the result of systemic problems in the overall health system and not from the poor performance of medical practice of health professionals [3]. Recent statistics show that in the European Union more than 750,000 cases per year from medical error incidents could be prevented, resulting in over 3.2 million less days of hospitalization, 260,000 less incidents of permanent disability and 95,000 less deaths per year, if the health policy-makers adopt strategies to reduce the adverse events and medical errors [6]. The proposed system MERIS is very important mainly for public health managers and decision makers because it presents all the hidden weaknesses, failures and malpractices existing in the health system, given the limitations of spontaneous reporting systems [11]. However, it is vital to initiate a debate among health decision makers and health professionals for empowering the culture of patient safety and healthcare quality. Any system, even the well designed, requires active participation and the full support of the society. In conclusion, MERIS proved that it has the ability to be incorporated and run effectively and efficiently nationally, rollout to several Greek hospitals, adapted to the needs and peculiarities of each clinic. The existence of a national-wide strategy and the establishment of an integrated organizational structure in order to emphasize the necessity of direct intervention and to address the issue with due seriousness, is crucial. Acknowledgements This research has been co-financed by the European Union (European Social Fund—ESF) and Greek National Funds through the Operational Program “Education and Lifelong Learning” of the National Strategic

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Reference Framework (NSRF)—Research Funding Program: Heracleitus II. Investing in knowledge society through the European Social Fund.

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Please cite this article in press as: Riga M, et al. MERIS (Medical Error Reporting Information System) as an innovative patient safety intervention: A health policy perspective. Health Policy (2014), http://dx.doi.org/10.1016/j.healthpol.2014.12.006