Patient-reported experiences of patient safety incidents need to be utilized more systematically in promoting safe care

Patient-reported experiences of patient safety incidents need to be utilized more systematically... Abstract Objective To analyze patient safety incidents (PSIs) reported by patients and their use in Finnish healthcare organizations. Study Design Cross-sectional study. Setting About 15 Finnish healthcare organizations ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland. Participants The study population included all Finnish patients who had voluntarily reported PSI via web-based system in 2009–15. Main Outcome Measure(s) Quantitative analysis of patients’ safety reports, inductive content analysis of patients’ suggestions to prevent the reoccurrence incidents and how those suggestions were used in healthcare organizations. Results Patients reported 656 PSIs, most of which were classified by the healthcare organizations’ analysts as problems associated with information flow (32.6%) and medications (18%). Most of the incidents (65%) did not cause any harm to patients. About 76% of the reports suggested ways to prevent reoccurrence of PSIs, most of which were feasible, system-based amendments of processes for reviewing or administering treatment, anticipating risks or improving diligence in patient care. However, only 6% had led to practical implementation of corrective actions in the healthcare organizations. Conclusions The results indicate that patients report diverse PSIs and suggest practical systems-based solutions to prevent their reoccurrence. However, patients’ reports rarely lead to corrective actions documented in the registering system, indicating that there is substantial scope to improve utilization of patients’ reports. There is also a need for strong patient safety management, including willingness and commitment of HCPs and leaders to learn from safety incidents. patient experience, patient reporting system, patient safety incident, adverse events, patient participation, experience measure Introduction Despite general intentions to treat patients safely, roughly 10% of patients experience adverse events, with serious consequences for roughly 1% [1, 2], and up to half of these events could be prevented [1]. Thus, there have been intense efforts to improve patient safety in various ways, including enhancement of incident reporting systems [3, 4]. Such systems offer opportunities to identify risks and improve procedures, thereby providing important mechanisms for organizational learning [5–7]. They also can provide valuable insights into reasons why patients may be harmed [3, 5]. However, the reporting systems applied have been found to have several limitations, for example, they detect few patient safety incidents (PSIs) [3], generate too many reports and poorly measure safety performance [3, 5]. Moreover, healthcare is complex, so diverse perspectives (including professionals’, administrators’ and patients’ views) are required for efficient identification of effective interventions to promote safe care [8, 9].“Inter alia”, knowledge of patients’ experiences of adverse events is crucial for improving healthcare safety and quality [10], although they generally seem to have a broader interpretation of patient safety than healthcare professionals (HCPs) [10–12]. Despite its importance, research in this field is sparse [10]. Nevertheless, some studies have shown that patients can provide reliable reports that are potentially rich resources for learning and improvements [10, 13] as well as for evaluating healthcare effectiveness and responsiveness [9]. Some studies also suggest that patients can identify poor and unsafe practices [9, 10] and adverse events [i.a., 8, 13]. The potential value of patients in this respect is not surprising because they observe almost the whole care process, unlike HCPs, and thus have greater opportunities to witness harm, errors and inconsistencies in care. Thus, experiences of patients, and their families, can provide an “early warning system” for care [14, 15]. Nevertheless, patients’ reports are rarely documented in healthcare providers’ reporting systems [16, 17] or medical records [12, 17–19]. Learning from PSIs Previous studies suggest that learning from PSIs might be quite challenging [4, 20] because PSI reports do not provide unambiguous indications of ways to improve safety [20]. Challenges are present at every stage of the incident reporting process from reporting to evaluation of actions [20]. There are also indications that current incident reporting systems mainly lead to “single-loop learning”, i.e. corrections of operational errors, rather than double or triple loop learning that changes the whole patient safety culture and promote reflective learning [21]. Requirements to tackle these challenges include adequate resources for analysis and follow-up actions [1, 4, 22] as well as support from leaders [22, 23]. Despite these challenges, incident reporting can and does trigger improvements in practice [6], leading to changes in care processes, and both the attitudes and knowledge of HCPs [18]. Clearly, more research is needed to evaluate current use of reports in the development of patient safety in healthcare organizations (HCOs) and identify ways to improve their use [24]. Therefore, the aim of this study was to analyze patient-reported PSIs and their use in HCOs. The following three specific research questions were addressed. (1) What kinds of PSIs do patients report? (2) What kinds of suggestions do patients make to prevent the reoccurrence of reported PSIs? (3) What kinds of changes in HCOs have patients’ reports prompted? For convenience, in this article, “patients” include both patients and family members when considering patients’ reports, PSI reporting systems and patients’ suggestions. Methods The PSI reporting system in Finland Finnish HCOs with responsibility to provide social and health services must have a plan for the implementation of patient safety and a reporting system for PSIs [25, 26]. There is no uniform nationwide electronic reporting system, but there is a widely used system, HaiPro, developed in 2007. It is primarily intended for internal use in healthcare units and can be accessed online through HCOs’ websites. A tool for patients to report PSIs was added to the HaiPro system in 2009, thus patients can use the system to report apparent lapses in care or PSIs they have encountered. In the form provided by the tool, patients are asked to answer the following open-ended questions. In what unit/department did the event happen? What happened, how did it happen and what were the consequences? What could be done to prevent such an event happening again? They are also asked to state the date and time of the incident, and whether they want an HCO’s response to their report, so they can also leave their contact information. Submitted patient reports are handled by HCOs’ analysts (e.g. head nurses or patient safety coordinators) in the HaiPro system, which provides a structured approach [27] for analyzing PSIs. This includes national, systematic classification of the following aspects of each PSI: event type, departmental consequences, risk analysis, circumstances and factors contributing to the event, and suggested measures to prevent its reoccurrence. The reporting process is confidential, voluntary and blame-free. After the analysis, each HCO is free to utilize the analyzed data according to its own procedures. Thus, the gathered data are utilized locally. Study context, design and data collection The sources of data considered in this study include the PSI reports submitted by patients between August 2009 and September 2015, from HCOs using the HaiPro system. This kind of data gathering has not often been used before. In most of the previous studies, data have usually been collected by interviewing patients [18, 28, 29], surveys [30] or comparing interview data with patient records [17, 18]. The data cover PSIs reported in settings ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland, covering 47% of the Finnish population in total. There were 930 reports in total, of which 690 had been completely analyzed and processed by the HCOs according to their routine procedures. After removing 11 duplicates, three test reports, and 20 reports that did not relate to patient safety, the final dataset consisted of 656 PSI reports including both numerical and textual information. Data analysis We examined all 656 of the PSI reports in the final dataset. Analysts employed by the HCOs had classified the PSIs described by the patients in the categories shown in Table 1. In this study, we reclassified those assigned to “other” (n = 107) or “not known” (n = 31) categories, forming three new event types: “missing patient”, “related to building” and “related to data protection or patient privacy”. Table 1 Classifies frequencies of patient-reported patient safety incidents (PSIs) (n = 733) Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      Table 1 Classifies frequencies of patient-reported patient safety incidents (PSIs) (n = 733) Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      The PSI reporting system does not categorize patients’ free text descriptions of suggestions regarding ways to prevent reported events happening again. The primary researcher analyzed those descriptions using inductive qualitative content analysis, focusing solely on the manifest content of the qualitative data [31]. All responses were read several times to form general impressions. The analytical process involved back and forth movements between the whole texts, condensed meaning units, categories and sub-themes, i.e. iterative checks for consistency between texts and all levels of interpretation. During the analytical process, the whole research group discussed the material and interpretations several times in efforts to ensure analytical rigor and avoid one-sided insights. The quotations are translations of illustrative passages in numbered PSI reports, providing indications of the study’s credibility. Quantitative data were analyzed using the Statistical Package for Social Sciences 21.0 for Windows (SPSS, Inc., Chicago, IL). Cross-tabulation was used when analyzing connections between event types and nature of the events, consequences for patients, and risk levels of the reported events. Results are presented using frequencies and percentages. Results Reported patient safety incidents Patients described multiple types of PSIs in the 656 analyzed reports (Table 1). Almost one-third of the reported incidents (32.6%) were related to information flow or its management. PSIs described in 132 of the reports (18%) were medication-related, most commonly administering errors (45.5%), followed by prescription errors (22.7%). About 125 PSIs were classified as “other treatment or monitoring”. Of those PSIs, 56% were related to inadequate patient monitoring, 35.2% to inadequate treatment procedures (e.g. a patient being discharged too early, or an IV-needle being left unnecessarily in a patient’s hand when discharged), and 6.4% to nutrition (e.g. a patient being given the wrong diet). As shown in Table 2, roughly two-thirds (67%) of PSIs were near misses and 65.1% caused no reported harm to patients. Table 2 Patient-reported patient safety incidents (PSIs) (n = 733) categorized by event types, nature of the event, consequences to patient and risk level   Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)    Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)  Table 2 Patient-reported patient safety incidents (PSIs) (n = 733) categorized by event types, nature of the event, consequences to patient and risk level   Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)    Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)  Patients' suggested actions to prevent the reoccurrence of experienced PSIs Four overarching themes were identified during the inductive qualitative content analysis of patients’ suggestions (n = 503) regarding ways to prevent reoccurrence of PSIs they had experienced (Table 3).These themes are briefly discussed, and illustrative quotations are provided, in the following text. Table 3 Themes and categories identified by content analysis of patients’ suggestions for preventing recurrence of patient safety incidents (n = 503) Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  Table 3 Themes and categories identified by content analysis of patients’ suggestions for preventing recurrence of patient safety incidents (n = 503) Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  The most frequent theme (43.2%) was designated ‘Checking and reviewing the treatment processes, risk management, reviewing the treatment processes and diligence in patient care’. Suggestions assigned to this theme highlighted the importance of using checklists, paying attention to the quality and adequacy of treatment supplies and equipment as well as HCPs’ familiarity with patients’ illnesses, lab results, allergies, and available information before doctor appointments and during care. ‘Changing ways of working so that the risks are identified in advance and safety incidents are anticipated so that patients are not exposed to similar danger in the future.’ (459) ‘Identification wristbands for ALL patients, and nurses should have to check the patients’ identity before giving medications to them.’ (142) The professionalism and skills of staff were mentioned in 27.2% of the patients’ suggestions. Those suggestions emphasized the importance of ensuring that healthcare staff had the required professional skills not only in normal situations, but also during holidays and staff absences. They also suggested that nurse turnover rates should be reduced to secure information flow, and highlighted the importance of consultation between colleagues. ‘[If they are unsure] medical students should consult older and more experienced doctors. Responsibility for care should not be given to families, even if they are health care professionals.’ (259) ‘I suggest that you check the devices and their status at specified intervals, to ensure that everybody has the same information, both new and existing employees.’ (133) The need for cooperation between patients, family members, parents and professionals was mentioned in 21.1% of the cases. Patients stressed that PSIs could be prevented by listening to patients themselves, parents and family members, and discussing with them issues related to patient care. They wanted to be informed in clear, understandable ways about patients’ care, hospitalization and discharge. The need to treat patients empathetically was also highlighted. ‘The doctor should have listened to us because we have been involved in our father’s care since the early stage of his disease. You should not always assume that the patient can answer everything correctly or tell the healthcare professionals everything.’ (49) Almost a tenth of the suggestions (9.5%) regarded various ways to improve the safety of the healthcare environment. These included, for example, locking exterior doors in units for treating patients with memory impairments, regularly checking the safety of beds and examination tables, and keeping corridors and rooms clear of clutter to avoid patients tripping or falling. Underutilization of PSI reports in the HCOs The actions suggested by the HCOs’ analysts for preventing the reoccurrence of reported events, and their frequencies, are summarized in Table 4. In most (76%) of the cases, the only action suggested by the HCO analyst was “provide information about/discuss what happened”. The suggested discussions had usually taken place in the unit where the PSI occurred (66%). Some case reports (5%) had been sent for handling at a higher level in the HCO, mostly because support from a higher level was required (27%), the case was exceptional (15%), or the reported PSI was severe or frequent (6%). In 10% of the cases, the analyst had not suggested any actions. Table 4 Actions suggested by HCOs’ analysts for preventing reoccurrence of patient-reported PSIs (n, %) Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  Table 4 Actions suggested by HCOs’ analysts for preventing reoccurrence of patient-reported PSIs (n, %) Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  In 9.6% (63) of the cases, the HCOs’ analysts had suggested further actions, mostly related to operating approaches and practices (54%) and/or information delivery and contacting (10%). However, closer examination revealed that in 23 of these 63 cases, there were statements about planning mentioned actions, but no indication of their practical implementation. Thus, only 40 (6%) of the reports triggered documented corrective actions that were implemented in practice to promote safe care (Table 5). Table 5 Implemented corrective actions for preventing reoccurrence of patient-reported PSIs in HCOs (n = 40), (n, %) Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Table 5 Implemented corrective actions for preventing reoccurrence of patient-reported PSIs in HCOs (n = 40), (n, %) Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Discussion The results provide an overview of the state of current patient-reported PSIs and their use in Finland. Most reported PSIs were classified as pertaining to deficiencies in information flow, medication problems or inadequate patient monitoring. Most of them did not cause actual harm to patients, and had been classified as near misses. These results are consistent with previous findings that most patients’ self-reported events concern medication problems [10, 32], poor care co-coordination [33] or healthcare process problems [12], and that consequences are rarely serious or life-threatening [16, 17, 32]. However, although patients’ reports usually concern near-miss events that caused no harm to them, patient experiences should be seen as early warnings of potential adverse events [34, 35], rather than as excessively subjective or mood-orientated and divorced from ‘real’ clinical work [9]. Furthermore, as our results also show, patients can recognize diverse types of PSIs [10, 17], and thus provide important information that would be overlooked if their experiences were not considered in the promotion of safety [13, 14]. Most of the patients who provided reports (503 out of 656) offered multiple suggestions, mostly very practical and feasible, for preventing the kinds of PSI they had encountered. Most of those suggestions concerned system-level changes, such as reviewing treatment processes, risk assessments and checklists, matching measures currently highlighted by healthcare development practitioners and researchers. In addition, one in five of the presented suggestions indicated that incidents could be prevented by better listening to patients, family members or parents, and improving collaboration between them and HCPs. These results are consistent with previous findings [34, 36], and the prevalent view of system-led development of patient safety [37]. Few (40) of the PSI reports triggered documented corrective actions that were implemented in practice to promote safe care in the HCOs. In most cases (76%), HCO analysts’ only proposal to prevent reoccurrence of PSIs was “to provide information about/discuss what had happened”. Furthermore, most of the resulting discussions took place at the unit where the PSI had occurred, and rarely included other parties involved in the process. These results raise questions about why HCOs do not, apparently, exploit patients’ suggestions. There could be several explanations. First, merely informing HCPs about PSIs is not enough to improve safety [38], but this “easy response” may have been due to lack of dedicated time and resources for identifying causes of incidents and appropriate actions to prevent their reoccurrence [3, 4, 22]. Second, some corrective actions that had actually been implemented may not have been entered in the reporting system, although the HCOs had finished processing every report included in our analysis. This suggests that there is also substantial scope for improving the PSI handling process in HCOs, as previously shown [22]. Reporting systems should also support the prioritization of efforts prior to designing improvements, as well as monitoring of improvements. [39]. Third, patient-reported PSIs provide a relatively new perspective in patient safety promotion, and patients have a broader view of PSIs than HCPs. Thus, patient-reported PSIs might be seen as general complaints that should not be taken seriously as critical incidents [15]. Therefore, reports are easy to explain away, especially if the work unit is subjected to a few patient reports. Fourth, the results may reflect HCOs’ absorptive capacity, i.e. their ability to manage and process knowledge to improve performance [40]. As previously shown, if there is no culture of listening to patients, HCOs might fail to appreciate the scale of problems and/or react too slowly, if at all, to raised concerns [41]. Further, if reports are merely handled at unit level, the only attempts to correct or avoid mistakes may be minor fixes and adjustments that do not address root causes of PSIs, therefore similar PSIs may still occur elsewhere in the HCO [40]. Thus, this kind of single-loop learning, which incident reporting systems mainly stimulate [21], does not provide sufficient incentives to improve safety. Hence, it is important that in addition to monitoring harm, HCOs have other tools for monitoring safety on a day-to-day basis, permitting early identification of problems so actions can be taken before they threaten patient safety. Patients’ perspectives can be added to this “sensitivity of operation”, for instance by inviting patients to participate in safety walk-rounds [42]. This study has important practical implications for understanding patient-reported PSIs as a new unique source of patient safety data. Our results add to the existing knowledge, not only highlighting the patients’ capability to report PSIs, but also more importantly, their capability of providing system-based suggestions how to prevent PSIs happening again. Therefore, HCOs should incorporate this data within their current mechanisms for measuring, monitoring and managing risks as a part of safety management. Limitations and strengths Some potential limitations of this study should be noted. First, we reclassified the PSIs classified by the HCO analysts only when the selected event type was “other” or “unknown”. Thus, there could be undetected variation in the HCOs’ handling of reports. Second, patients’ reports might be biased by their reluctance to report problems they experience to those responsible for their care. However, we must recognize that we will never be aware of all the PSIs experienced by patients. Finally, the results’ generalizability is limited by the potential under-reporting of actual PSIs. Nevertheless, despite these potential limitations, our results are corroborated by previous findings. A major strength of this study is that it is the first nationwide study, based on all reports covering 6 years from all the HCOs who had introduced a voluntary web-based system enabling patients to report healthcare errors in Finland. In addition, the data are from reports made by patients and family members themselves. Conclusion Overall, patients’ PSI reports are not sufficiently utilized to improve the safety of care. To maximize opportunities to improve safety, HCOs must effectively utilize all available information to learn about errors and inconsistencies in care. In addition, strong patient safety management is needed, including willingness and commitment of HCPs and leaders to learn from PSIs and promote safe care as one of their organization’s top priorities. Furthermore, although there is quite strong legislative support and updated patient safety strategy to promote safe care in Finland, more attention to monitoring and auditing its implementation is required, especially during times (such as now) of reform of the Finnish healthcare system. Our findings also provide evidence that reporting PSIs and handling them at a unit level is not sufficient to develop safety, and there is a need to use multiple methods to address root causes of PSIs, thereby strengthening the overall patient safety culture. It is also necessary to reconsider the optimum level for processing PSI reports in HCOs to enable optimal organizational learning. Funding This work was supported by the University of Eastern Finland, the Research Committee of the Kuopio University Hospital Catchment Area for the State Research Funding, and through involvement of one of the authors (M.S.) in the European Science Foundation Research Network Programme ‘REFLECTION’-09-RNP-049. Authorship statement All authors M.S., P.P. and H.T. meet the authorship criteria and are in agreement with the content of the manuscript. References 1 Kohn LT, Corrigan JM, Donaldson MS. To Err is Human. 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Patient-reported experiences of patient safety incidents need to be utilized more systematically in promoting safe care

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Abstract

Abstract Objective To analyze patient safety incidents (PSIs) reported by patients and their use in Finnish healthcare organizations. Study Design Cross-sectional study. Setting About 15 Finnish healthcare organizations ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland. Participants The study population included all Finnish patients who had voluntarily reported PSI via web-based system in 2009–15. Main Outcome Measure(s) Quantitative analysis of patients’ safety reports, inductive content analysis of patients’ suggestions to prevent the reoccurrence incidents and how those suggestions were used in healthcare organizations. Results Patients reported 656 PSIs, most of which were classified by the healthcare organizations’ analysts as problems associated with information flow (32.6%) and medications (18%). Most of the incidents (65%) did not cause any harm to patients. About 76% of the reports suggested ways to prevent reoccurrence of PSIs, most of which were feasible, system-based amendments of processes for reviewing or administering treatment, anticipating risks or improving diligence in patient care. However, only 6% had led to practical implementation of corrective actions in the healthcare organizations. Conclusions The results indicate that patients report diverse PSIs and suggest practical systems-based solutions to prevent their reoccurrence. However, patients’ reports rarely lead to corrective actions documented in the registering system, indicating that there is substantial scope to improve utilization of patients’ reports. There is also a need for strong patient safety management, including willingness and commitment of HCPs and leaders to learn from safety incidents. patient experience, patient reporting system, patient safety incident, adverse events, patient participation, experience measure Introduction Despite general intentions to treat patients safely, roughly 10% of patients experience adverse events, with serious consequences for roughly 1% [1, 2], and up to half of these events could be prevented [1]. Thus, there have been intense efforts to improve patient safety in various ways, including enhancement of incident reporting systems [3, 4]. Such systems offer opportunities to identify risks and improve procedures, thereby providing important mechanisms for organizational learning [5–7]. They also can provide valuable insights into reasons why patients may be harmed [3, 5]. However, the reporting systems applied have been found to have several limitations, for example, they detect few patient safety incidents (PSIs) [3], generate too many reports and poorly measure safety performance [3, 5]. Moreover, healthcare is complex, so diverse perspectives (including professionals’, administrators’ and patients’ views) are required for efficient identification of effective interventions to promote safe care [8, 9].“Inter alia”, knowledge of patients’ experiences of adverse events is crucial for improving healthcare safety and quality [10], although they generally seem to have a broader interpretation of patient safety than healthcare professionals (HCPs) [10–12]. Despite its importance, research in this field is sparse [10]. Nevertheless, some studies have shown that patients can provide reliable reports that are potentially rich resources for learning and improvements [10, 13] as well as for evaluating healthcare effectiveness and responsiveness [9]. Some studies also suggest that patients can identify poor and unsafe practices [9, 10] and adverse events [i.a., 8, 13]. The potential value of patients in this respect is not surprising because they observe almost the whole care process, unlike HCPs, and thus have greater opportunities to witness harm, errors and inconsistencies in care. Thus, experiences of patients, and their families, can provide an “early warning system” for care [14, 15]. Nevertheless, patients’ reports are rarely documented in healthcare providers’ reporting systems [16, 17] or medical records [12, 17–19]. Learning from PSIs Previous studies suggest that learning from PSIs might be quite challenging [4, 20] because PSI reports do not provide unambiguous indications of ways to improve safety [20]. Challenges are present at every stage of the incident reporting process from reporting to evaluation of actions [20]. There are also indications that current incident reporting systems mainly lead to “single-loop learning”, i.e. corrections of operational errors, rather than double or triple loop learning that changes the whole patient safety culture and promote reflective learning [21]. Requirements to tackle these challenges include adequate resources for analysis and follow-up actions [1, 4, 22] as well as support from leaders [22, 23]. Despite these challenges, incident reporting can and does trigger improvements in practice [6], leading to changes in care processes, and both the attitudes and knowledge of HCPs [18]. Clearly, more research is needed to evaluate current use of reports in the development of patient safety in healthcare organizations (HCOs) and identify ways to improve their use [24]. Therefore, the aim of this study was to analyze patient-reported PSIs and their use in HCOs. The following three specific research questions were addressed. (1) What kinds of PSIs do patients report? (2) What kinds of suggestions do patients make to prevent the reoccurrence of reported PSIs? (3) What kinds of changes in HCOs have patients’ reports prompted? For convenience, in this article, “patients” include both patients and family members when considering patients’ reports, PSI reporting systems and patients’ suggestions. Methods The PSI reporting system in Finland Finnish HCOs with responsibility to provide social and health services must have a plan for the implementation of patient safety and a reporting system for PSIs [25, 26]. There is no uniform nationwide electronic reporting system, but there is a widely used system, HaiPro, developed in 2007. It is primarily intended for internal use in healthcare units and can be accessed online through HCOs’ websites. A tool for patients to report PSIs was added to the HaiPro system in 2009, thus patients can use the system to report apparent lapses in care or PSIs they have encountered. In the form provided by the tool, patients are asked to answer the following open-ended questions. In what unit/department did the event happen? What happened, how did it happen and what were the consequences? What could be done to prevent such an event happening again? They are also asked to state the date and time of the incident, and whether they want an HCO’s response to their report, so they can also leave their contact information. Submitted patient reports are handled by HCOs’ analysts (e.g. head nurses or patient safety coordinators) in the HaiPro system, which provides a structured approach [27] for analyzing PSIs. This includes national, systematic classification of the following aspects of each PSI: event type, departmental consequences, risk analysis, circumstances and factors contributing to the event, and suggested measures to prevent its reoccurrence. The reporting process is confidential, voluntary and blame-free. After the analysis, each HCO is free to utilize the analyzed data according to its own procedures. Thus, the gathered data are utilized locally. Study context, design and data collection The sources of data considered in this study include the PSI reports submitted by patients between August 2009 and September 2015, from HCOs using the HaiPro system. This kind of data gathering has not often been used before. In most of the previous studies, data have usually been collected by interviewing patients [18, 28, 29], surveys [30] or comparing interview data with patient records [17, 18]. The data cover PSIs reported in settings ranging from specialized hospital care to home care, outpatient and inpatient clinics, and geographically diverse areas of Finland, covering 47% of the Finnish population in total. There were 930 reports in total, of which 690 had been completely analyzed and processed by the HCOs according to their routine procedures. After removing 11 duplicates, three test reports, and 20 reports that did not relate to patient safety, the final dataset consisted of 656 PSI reports including both numerical and textual information. Data analysis We examined all 656 of the PSI reports in the final dataset. Analysts employed by the HCOs had classified the PSIs described by the patients in the categories shown in Table 1. In this study, we reclassified those assigned to “other” (n = 107) or “not known” (n = 31) categories, forming three new event types: “missing patient”, “related to building” and “related to data protection or patient privacy”. Table 1 Classifies frequencies of patient-reported patient safety incidents (PSIs) (n = 733) Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      Table 1 Classifies frequencies of patient-reported patient safety incidents (PSIs) (n = 733) Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      Event type  Number of PSI reports (n)  Event type  Number of PSI reports (n)  Information flow or its management (32.6%)  239  Related to an operative procedure (6%)  44  Related to oral information flow and communications  96  Accident, injury in connection to operation  8  Related to care arrangements  70  Foreign body in a patient; instrument breaking in a patient  2  Related to the assessment of care needs, treatment, examination or procedure  55  Cancellation of a scheduled procedure  2  Related to managing patient data (documentation)  51  Incorrect patient  1      Incorrect operation site  1  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer (18%)  132  Use of an unsterile instrument or unsterile activities  1  Administration  60  Other  29  Prescribing  30  Injury, accident (5.5%)  40  Dispensing  16  Falling down  23  Unexpected reaction in patient  10  Falls from equipment (bed, etc.)  5  Documenting  7  Hit by an object, colliding with an object, a falling object  3  Preparing  2  Pressure or strangling  2  Delivery  1  Start of a fire or a blaze  1  Storing error/problem with storage  1  Other  6  Related to other care or monitoring (17.1%)  125  Related to equipment or use thereof (3.4%)  25  Monitoring patient’s condition  70  Incorrect use of equipment, user error  5  Treatment procedures  44  Malfunction of equipment  4  Nutrition  8  Error in data network  4  Not known  3  Equipment unavailable, in operational, under maintenance, etc.  3      Insufficiently or incorrectly assembled equipment, utensil or instrument  1  Related to diagnosis (7.5%)  55  Other  8  Delayed diagnosis  17      Insufficient diagnosis  15  Related to aseptic/hygiene (2.6%)  19  Incorrect diagnosis  12  Related to aseptic behavior  13  Diagnosis not provided  3  Preparing a patient for procedure  1  Ignored diagnosis  3  Other  5  Other  5      Related to laboratory, imaging or other examination (2.2%)  16  Related to buildings (0.8%)  6  Related to laboratory examination         Incorrectly or insufficiently extracted sample  1  Related to emergency care setting (0.4%)  3   Analysis not conducted  1       Other  3  Missing patient (0.2%)  2  Related to imaging examination or isotope treatment         Unexpected or error-related complication caused to patient  2       Referral to, or order of, incorrect examination  1       Radiation exposure of escort/family member  1       Other  6      Related to physiological, neurophysiological or other patient examination         Unexpected or error-related complication caused to patient  1      Related to an invasive procedure (1.6%)  12      Use of a central venous catheter/arterial catheter, cannula insertion  3      Insertion of tubes, etc. via bodily orifices  2      Puncture (e.g. joint, pulmonary pleurae, bladder)  2      Other  5      Data protection or patient privacy (1.1%)  8      Violence (1 %)  7      Assault, battery or kicking committed by (another) patient  4      Use of a bladed weapon (threat, strike) committed by (another) patient  1      Other  2      The PSI reporting system does not categorize patients’ free text descriptions of suggestions regarding ways to prevent reported events happening again. The primary researcher analyzed those descriptions using inductive qualitative content analysis, focusing solely on the manifest content of the qualitative data [31]. All responses were read several times to form general impressions. The analytical process involved back and forth movements between the whole texts, condensed meaning units, categories and sub-themes, i.e. iterative checks for consistency between texts and all levels of interpretation. During the analytical process, the whole research group discussed the material and interpretations several times in efforts to ensure analytical rigor and avoid one-sided insights. The quotations are translations of illustrative passages in numbered PSI reports, providing indications of the study’s credibility. Quantitative data were analyzed using the Statistical Package for Social Sciences 21.0 for Windows (SPSS, Inc., Chicago, IL). Cross-tabulation was used when analyzing connections between event types and nature of the events, consequences for patients, and risk levels of the reported events. Results are presented using frequencies and percentages. Results Reported patient safety incidents Patients described multiple types of PSIs in the 656 analyzed reports (Table 1). Almost one-third of the reported incidents (32.6%) were related to information flow or its management. PSIs described in 132 of the reports (18%) were medication-related, most commonly administering errors (45.5%), followed by prescription errors (22.7%). About 125 PSIs were classified as “other treatment or monitoring”. Of those PSIs, 56% were related to inadequate patient monitoring, 35.2% to inadequate treatment procedures (e.g. a patient being discharged too early, or an IV-needle being left unnecessarily in a patient’s hand when discharged), and 6.4% to nutrition (e.g. a patient being given the wrong diet). As shown in Table 2, roughly two-thirds (67%) of PSIs were near misses and 65.1% caused no reported harm to patients. Table 2 Patient-reported patient safety incidents (PSIs) (n = 733) categorized by event types, nature of the event, consequences to patient and risk level   Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)    Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)  Table 2 Patient-reported patient safety incidents (PSIs) (n = 733) categorized by event types, nature of the event, consequences to patient and risk level   Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)    Nature of the event  Consequences to the patient  Risk level  Event type  Near-miss f (%)  Happened to patient f (%)  No harm f (%)  Minor harm f (%)  Medium harm f (%)  Serious harm f (%)  Not known f (%)  Not selected f (%)  Insignificant risk f (%)  Low risk f (%)  Moderate risk f (%)  High risk f (%)  Extreme risk f (%)  Not selected f (%)  Information flow or its management  170 (71.1)  69 (28.9)  168 (70.3)  28 (11.7)  10 (4.2)  5 (2.1)  13 (5.4)  15 (6.3)  88 (36.8)  87 (36.4)  23 (9.6)  3 (1.3)  1 (0.4)  37 (15.5)  Related to pharmacotherapy and rehydration therapy, blood transfusion, contrast agent or tracer  86 (65.2)  46 (34.8)  83 (62.9)  15 (11.4)  12 (9.1)  5 (3.8)  10 (7.6)  7 (5.3)  27 (20.5)  64 (48.5)  27 (20.5)  1 (0.8)  2 (1.5)  11 (8.3)  Related to other care or monitoring  82 (65.6)  43 (34.4)  81 (64.8)  14 (11.2)  17 (13.6)  6 (4.8)  5 (4)  2 (1.6)  40 (32)  49 (39.2)  22 (17.6)  3 (2.4)  1 (0.8)  10 (8)  Related to diagnosis  34 (61.8)  21 (38.2)  33 (60)  4 (7.3)  11 (20)  4 (7.3)  1 (1.8)  2 (3.6)  4 (7.3)  25 (45.5)  17 (30.9)  3 (5.5)  1 (1.8)  5 (9.1)  Related to an operative procedure  27 (61.4)  17 (38.6)  24 (54.5)  4 (9.1)  9 (20.5)  2 (4.5)  1 (2.3)  4 (9.1)  13 (29.5)  20 (45.5)  2 (4.5)  2 (4.5)  0  7 (15.9)  Injury, accident  23 (57.5)  17 (42.5)  24 (60)  3 (7.5)  9 (22.5)  1 (2.5)  2 (5)  1 (2.5)  6 (15)  22 (55)  7 (17.5)  2 (5)  0  3 (7.5)  Related to equipment or use thereof  19 (76)  6 (24)  18 (72)  1 (4)  3 (12)  0  0  3 (12)  5 (20)  12 (48)  5 (20)  0  0  3 (12)  Related to asepsis/hygiene  15 (78.9)  4 (21.1)  11 (57.9)  2 (10.5)  1 (5.3)  1 (5.3)  0  4 (21.1)  7 (36.8)  5 (26.3)  4 (21.1)  1 (5.3)  0  2 (10.5)  Related to laboratory, imaging or other examination  11 (68.8)  5 (31.2)  9 (56.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  2 (12.5)  6 (37.5)  5 (31.2)  3 (18.8)  1 (6.2)  0  1 (6.2)  Related to an invasive procedure  4 (33.3)  8 (66.7)  4 (33.3)  1 (8.3)  4 (33.3)  2 (16.7)  1 (8.3)  0  3 (25)  7 (58.3)  0  0  0  2 (16.7)  Data protection or patient privacy  6 (75)  2 (25)  7 (87.5)  1 (12.5)  0  0  0  0  5 (2.5)  1 (12.5)  0  0  0  2 (25)  Violence  5 (71.4)  2 (28.6)  5 (71.4)  0  1 (14.3)  1 (14.3)  0  0  1 (14.3)  1 (14.3)  2 (28.6)  1 (14.3)  0  2 (28.6)  Related to buildings  6 (100)  0 (0)  6 (100)  0  0  0  0  0  5 (83.3)  1 (16.7)          Related to emergency care setting  2 (66.7)  1 (33.3)  2 (66.7)  0  1 (33.3)  0  0    2 (66.7)  0  1 (33.3)  0  0  0  Missing patient  1 (50)  1 (50)  2 (100)  0  0  0  0  0  0  1 (50)  1 (50)  0  0  0  Total f (%)  491 (67.0)  242 (33.0)  477 (65.1)  76 (10.4)  79 (10.8)  27 (3.7)  34 (4.6)  40 (5.4)  212 (28.9)  300 (40.9)  114 (15.6)  17 (2.3)  5 (0.7)  85 (11.6)  Patients' suggested actions to prevent the reoccurrence of experienced PSIs Four overarching themes were identified during the inductive qualitative content analysis of patients’ suggestions (n = 503) regarding ways to prevent reoccurrence of PSIs they had experienced (Table 3).These themes are briefly discussed, and illustrative quotations are provided, in the following text. Table 3 Themes and categories identified by content analysis of patients’ suggestions for preventing recurrence of patient safety incidents (n = 503) Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  Table 3 Themes and categories identified by content analysis of patients’ suggestions for preventing recurrence of patient safety incidents (n = 503) Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  Themes  Category  Checking and reviewing the treatment processes, risk management and diligence in patient care (n = 212, 42.2%)  Checking practices and treatment processes, and use of checklists (n = 76)  Increasing diligence and accuracy of patients’ treatment (n = 59)  Careful familiarization with available patient data before appointments and during care (n = 31)  Asking for patients’ personal identification numbers and names, and use of identification bracelets (n = 15)  Thinking about risks in advance and managing incidents that occur openly and honestly (n = 14)  Following robust and uniform guidelines (n = 13)  Ensuring the adequacy and quality of care supplies (n = 4)  Adequate and skilled/competent healthcare personnel and collegial support (n = 137, 27.2%)  Securing skilled/competent healthcare professional staff (n = 89)  Reducing staff turnover and increasing staffing levels (n = 20)  Improving colleagues’ mutual support and consultation (n = 17)  Improving staff’s training about equipment and how it operates (n = 11)  Cooperation between patients, relatives, parents and professionals (n = 106, 21.1%)  Listening to patients’, relatives’ and parents’ views on patients’ care (n = 49)  Informing patients in a clear and understandable way (n = 28)  Asking for patients’ consent and treating them empathetically (n = 22)  Notifying families and parents when patients are discharged or hospitalized (n = 7)  Safe healthcare environment (n = 48, 9.5 %)  Locking doors, cleaning stairs, checking the functionality and safety of beds and examination tables and ensuring that premises are healthy (n = 34)  Ensuring that patient will not trip or fall (n = 14)  The most frequent theme (43.2%) was designated ‘Checking and reviewing the treatment processes, risk management, reviewing the treatment processes and diligence in patient care’. Suggestions assigned to this theme highlighted the importance of using checklists, paying attention to the quality and adequacy of treatment supplies and equipment as well as HCPs’ familiarity with patients’ illnesses, lab results, allergies, and available information before doctor appointments and during care. ‘Changing ways of working so that the risks are identified in advance and safety incidents are anticipated so that patients are not exposed to similar danger in the future.’ (459) ‘Identification wristbands for ALL patients, and nurses should have to check the patients’ identity before giving medications to them.’ (142) The professionalism and skills of staff were mentioned in 27.2% of the patients’ suggestions. Those suggestions emphasized the importance of ensuring that healthcare staff had the required professional skills not only in normal situations, but also during holidays and staff absences. They also suggested that nurse turnover rates should be reduced to secure information flow, and highlighted the importance of consultation between colleagues. ‘[If they are unsure] medical students should consult older and more experienced doctors. Responsibility for care should not be given to families, even if they are health care professionals.’ (259) ‘I suggest that you check the devices and their status at specified intervals, to ensure that everybody has the same information, both new and existing employees.’ (133) The need for cooperation between patients, family members, parents and professionals was mentioned in 21.1% of the cases. Patients stressed that PSIs could be prevented by listening to patients themselves, parents and family members, and discussing with them issues related to patient care. They wanted to be informed in clear, understandable ways about patients’ care, hospitalization and discharge. The need to treat patients empathetically was also highlighted. ‘The doctor should have listened to us because we have been involved in our father’s care since the early stage of his disease. You should not always assume that the patient can answer everything correctly or tell the healthcare professionals everything.’ (49) Almost a tenth of the suggestions (9.5%) regarded various ways to improve the safety of the healthcare environment. These included, for example, locking exterior doors in units for treating patients with memory impairments, regularly checking the safety of beds and examination tables, and keeping corridors and rooms clear of clutter to avoid patients tripping or falling. Underutilization of PSI reports in the HCOs The actions suggested by the HCOs’ analysts for preventing the reoccurrence of reported events, and their frequencies, are summarized in Table 4. In most (76%) of the cases, the only action suggested by the HCO analyst was “provide information about/discuss what happened”. The suggested discussions had usually taken place in the unit where the PSI occurred (66%). Some case reports (5%) had been sent for handling at a higher level in the HCO, mostly because support from a higher level was required (27%), the case was exceptional (15%), or the reported PSI was severe or frequent (6%). In 10% of the cases, the analyst had not suggested any actions. Table 4 Actions suggested by HCOs’ analysts for preventing reoccurrence of patient-reported PSIs (n, %) Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  Table 4 Actions suggested by HCOs’ analysts for preventing reoccurrence of patient-reported PSIs (n, %) Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  Suggested actions for preventing reoccurrence of an event  n  %  No actions  68  10  Provide information about/discuss what happened  503  76   Within the unit (e.g. a unit/team meeting)  331  66   Send for information to another unit  4  1   Elsewhere outside the unit  50  10   Discussion with others involved in the process  50  10   Not selected  68  13  Bring the matter forward to a higher level  33  5   A severe or often reoccurring problem  2  6   Support is needed for dealing with the matter  9  27   An otherwise uncommon situation  5  15   Other reason  4  12   Not selected  13  40  A corrective action(s) is planned regarding  63  9   Operating approach and practices  34  54   IT and technological systems, devices and equipment  1  2   Information delivery and contacting  6  10   Education and training  4  6   Management  0  0   Other development measure  9  14   Not selected  9  14  In 9.6% (63) of the cases, the HCOs’ analysts had suggested further actions, mostly related to operating approaches and practices (54%) and/or information delivery and contacting (10%). However, closer examination revealed that in 23 of these 63 cases, there were statements about planning mentioned actions, but no indication of their practical implementation. Thus, only 40 (6%) of the reports triggered documented corrective actions that were implemented in practice to promote safe care (Table 5). Table 5 Implemented corrective actions for preventing reoccurrence of patient-reported PSIs in HCOs (n = 40), (n, %) Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Table 5 Implemented corrective actions for preventing reoccurrence of patient-reported PSIs in HCOs (n = 40), (n, %) Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Implemented corrective action(s) regarding  Examples of implemented actions in HCOs  Operating approach and practices (n = 20, 50%)  Following initiated changes, patients’ personal aids were marked with their name and the person responsible for the aids was named in the unit. In the unit oral shift reporting was replaced with silent reporting (every nurse must now collect information about the patients on their own, based on written patient records). The size and clarity of resuscitation protocol posters were increased, and they were placed in the emergency room and doctors’ reception rooms. Following initiated changes in home care, memory disorder patients’ medicines are stored in a locked medicine cabinet and the key for the cabinet is only given to caregivers. A new operating approach was implemented in cataract surgery. Before the lens is installed, both the lens and the side to be cut are confirmed by the doctor. The nurse shows the lens to another nurse, and the doctor confirms that the lens is correct. Following initiated changes, heating pads cannot be used for patients in anesthesia to prevent burns. In addition, micro-heated heating pads were disabled and replaced with heating pads that warm up when a trigger in them is gently bent.  Education and training (n = 1, 2.5%)  Training for nurses to recognize acutely and critically ill patients was started.  Other corrective action(s) (n = 7, 17.5%)  Safety was enhanced by stipulating that nursing home back doors will be locked 24/7. In addition, “missing patient” guidelines were updated and reviewed with the staff and incorporated in the new staff´s orientation program. A unit was transferred to a new and healthy building. More alarm bells were ordered for the department to ensure that they can be immediately replaced if they break.  Not selected (n = 12, 30%)  A Safe Pharmacy Development Project was launched in the Department to reduce drug delivery errors and improve drug safety. Windows were sealed with silicone to prevent entry of cold air. Instructions were modified so women who are giving birth but not being tested for group B streptococcus (GBS) during their pregnancy are given intrapartum antimicrobial prophylaxis. A checklist of safe patient discharge practices was updated in the unit.  Discussion The results provide an overview of the state of current patient-reported PSIs and their use in Finland. Most reported PSIs were classified as pertaining to deficiencies in information flow, medication problems or inadequate patient monitoring. Most of them did not cause actual harm to patients, and had been classified as near misses. These results are consistent with previous findings that most patients’ self-reported events concern medication problems [10, 32], poor care co-coordination [33] or healthcare process problems [12], and that consequences are rarely serious or life-threatening [16, 17, 32]. However, although patients’ reports usually concern near-miss events that caused no harm to them, patient experiences should be seen as early warnings of potential adverse events [34, 35], rather than as excessively subjective or mood-orientated and divorced from ‘real’ clinical work [9]. Furthermore, as our results also show, patients can recognize diverse types of PSIs [10, 17], and thus provide important information that would be overlooked if their experiences were not considered in the promotion of safety [13, 14]. Most of the patients who provided reports (503 out of 656) offered multiple suggestions, mostly very practical and feasible, for preventing the kinds of PSI they had encountered. Most of those suggestions concerned system-level changes, such as reviewing treatment processes, risk assessments and checklists, matching measures currently highlighted by healthcare development practitioners and researchers. In addition, one in five of the presented suggestions indicated that incidents could be prevented by better listening to patients, family members or parents, and improving collaboration between them and HCPs. These results are consistent with previous findings [34, 36], and the prevalent view of system-led development of patient safety [37]. Few (40) of the PSI reports triggered documented corrective actions that were implemented in practice to promote safe care in the HCOs. In most cases (76%), HCO analysts’ only proposal to prevent reoccurrence of PSIs was “to provide information about/discuss what had happened”. Furthermore, most of the resulting discussions took place at the unit where the PSI had occurred, and rarely included other parties involved in the process. These results raise questions about why HCOs do not, apparently, exploit patients’ suggestions. There could be several explanations. First, merely informing HCPs about PSIs is not enough to improve safety [38], but this “easy response” may have been due to lack of dedicated time and resources for identifying causes of incidents and appropriate actions to prevent their reoccurrence [3, 4, 22]. Second, some corrective actions that had actually been implemented may not have been entered in the reporting system, although the HCOs had finished processing every report included in our analysis. This suggests that there is also substantial scope for improving the PSI handling process in HCOs, as previously shown [22]. Reporting systems should also support the prioritization of efforts prior to designing improvements, as well as monitoring of improvements. [39]. Third, patient-reported PSIs provide a relatively new perspective in patient safety promotion, and patients have a broader view of PSIs than HCPs. Thus, patient-reported PSIs might be seen as general complaints that should not be taken seriously as critical incidents [15]. Therefore, reports are easy to explain away, especially if the work unit is subjected to a few patient reports. Fourth, the results may reflect HCOs’ absorptive capacity, i.e. their ability to manage and process knowledge to improve performance [40]. As previously shown, if there is no culture of listening to patients, HCOs might fail to appreciate the scale of problems and/or react too slowly, if at all, to raised concerns [41]. Further, if reports are merely handled at unit level, the only attempts to correct or avoid mistakes may be minor fixes and adjustments that do not address root causes of PSIs, therefore similar PSIs may still occur elsewhere in the HCO [40]. Thus, this kind of single-loop learning, which incident reporting systems mainly stimulate [21], does not provide sufficient incentives to improve safety. Hence, it is important that in addition to monitoring harm, HCOs have other tools for monitoring safety on a day-to-day basis, permitting early identification of problems so actions can be taken before they threaten patient safety. Patients’ perspectives can be added to this “sensitivity of operation”, for instance by inviting patients to participate in safety walk-rounds [42]. This study has important practical implications for understanding patient-reported PSIs as a new unique source of patient safety data. Our results add to the existing knowledge, not only highlighting the patients’ capability to report PSIs, but also more importantly, their capability of providing system-based suggestions how to prevent PSIs happening again. Therefore, HCOs should incorporate this data within their current mechanisms for measuring, monitoring and managing risks as a part of safety management. Limitations and strengths Some potential limitations of this study should be noted. First, we reclassified the PSIs classified by the HCO analysts only when the selected event type was “other” or “unknown”. Thus, there could be undetected variation in the HCOs’ handling of reports. Second, patients’ reports might be biased by their reluctance to report problems they experience to those responsible for their care. However, we must recognize that we will never be aware of all the PSIs experienced by patients. Finally, the results’ generalizability is limited by the potential under-reporting of actual PSIs. Nevertheless, despite these potential limitations, our results are corroborated by previous findings. A major strength of this study is that it is the first nationwide study, based on all reports covering 6 years from all the HCOs who had introduced a voluntary web-based system enabling patients to report healthcare errors in Finland. In addition, the data are from reports made by patients and family members themselves. Conclusion Overall, patients’ PSI reports are not sufficiently utilized to improve the safety of care. To maximize opportunities to improve safety, HCOs must effectively utilize all available information to learn about errors and inconsistencies in care. In addition, strong patient safety management is needed, including willingness and commitment of HCPs and leaders to learn from PSIs and promote safe care as one of their organization’s top priorities. Furthermore, although there is quite strong legislative support and updated patient safety strategy to promote safe care in Finland, more attention to monitoring and auditing its implementation is required, especially during times (such as now) of reform of the Finnish healthcare system. 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International Journal for Quality in Health CareOxford University Press

Published: Apr 16, 2018

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