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Results of a survey on medical error reporting systems in Korean hospitals
International Journal of Medical Informatics (2006) 75, 148—155
Results of a survey on medical error reporting systems in Korean hospitals Jeongeun Kim a,∗, David W. Bates b a
Seoul National University, College of Nursing, Research Institute of Nursing Science, 28 Yongon-dong, Chongno-gu, Seoul, 110-799, Seoul, Republic of Korea b Division of General Internal Medicine, Department of Medicine, Brigham and Women’s Hospital, Clinical and Quality Analysis, Partners Healthcare, and Harvard Medical School, Boston, MA, USA Received 8 June 2005; accepted 15 June 2005 KEYWORDS Safety; Medical errors; Hospital information system (HIS); Hospital incident reporting
∗
Summary Background: Recent data suggest that medical injuries, or adverse events, represent an important international problem, and that many are caused by errors. Spontaneous reporting is the main tool used to detect errors and adverse events in most countries, and reporting systems are believed to be important for improving patient safety. Increasingly, such reporting can be done using information systems, and information systems are widely used in Korea. However, few data are available regarding the use of electronic medical error reporting systems in Korea. Objectives: The objectives of this study were to investigate the present status of reporting system of Korean hospitals, and to compare the current status of medical error reporting systems with that of other health information sub systems. Methods: The chairs of nursing departments of all 283 hospitals nationwide with more than 100 beds were surveyed using a structured questionnaire. The response rate was 35%. In addition, two reports on the national use of health information systems in Korea from 1999 and 2003 were analyzed. Results: Among reporting hospitals (n = 99), medical errors were reported on paper in 75 hospitals (77%), verbally in 30 hospitals (30%), using word processing in 13 hospitals (13%), and using the hospital information system in only three hospitals (3%). In contrast, there was widespread and increasing use of health information technology (HIT) in areas such as medication administration, inpatient and outpatient order entry, and radiology. Conclusions: While HIT is increasingly widely used in Korea in many areas, it is not being used for error reporting. Increasing the use of electronic reporting systems, and systemically evaluating the medical errors and adverse events reported, represent essential steps for reducing systemic errors and improving patient safety. © 2005 Elsevier Ireland Ltd. All rights reserved.
Corresponding author. Tel.: +822 740 8483; fax: +822 765 4103. E-mail address: [email protected] (J. Kim).
1386-5056/$ — see front matter © 2005 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijmedinf.2005.06.005
Results of a survey on medical error reporting systems in Korean hospitals
1. Introduction The Institute of Medicine’s ‘‘To Err Is Human’’ report, issued in November 1999, brought the issue of patient safety into the public eye, and sent shock waves through the U.S. healthcare industry [1]. It suggested that adverse events were causing between 44,000 and 98,000 deaths annually in American hospitals, and that many of these deaths were preventable. Subsequent studies from a number of other countries demonstrate that patient safety is clearly an international problem [2,3]. The causes of these adverse events are often complex. When an individual accident is investigated, it is common to find a number of errors, and it may not be apparent which problem or error actually resulted in the accident. The system of the hospital includes testing, diagnosis, treatment, caring of the patients, control of commodities, and apparatus management, for example. This complexity often makes it difficult or impossible to determine the real causes of an individual accident [4]. The ‘‘To Err Is Human’’ report emphasizes that most medical accidents are the result of system failures, and that to make the healthcare delivery system safer it must be renovated. Systems should ideally both make errors less likely, and catch those that do occur. There are many ways to improve patient safety using information technology [5]. One key for improving safety is improving error and adverse event detection and reporting systems [6]. In small studies, computerized reporting systems have been associated with an increased rate of spontaneous reporting [7], and if reporting is computerized, it dramatically facilitates subsequent evaluation because it is easier to perform analyses and categorize reports in different ways. One university hospital treating more than 25,000 patients annually reported a feasibility study of a computerized voluntary based medical error reporting system in the ambulatory setting [8]. The findings showed that the voluntary based medical error reporting system resulted in a 20-fold increased reporting rate, and physicians reported many of these errors. Also, the study suggested that new medical error reporting systems should combine reporting with analytic functions to facilitate analysis. A study by Furakawa et al. from Japan found that a computerized medical error reporting system was effective and acceptable to providers, and facilitated analysis [9]. In another study, a web-based reporting system was developed and implemented for medical workers of 54 hospitals who were working in neonatal intensive care units [10]. This system was both
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voluntary and anonymous. Evaluation of the feasibility and utility of this approach revealed that it was well received, and effective for identifying a wide variety of medical errors. In addition, the approach facilitated cooperative, multidisciplinary studies. In developing a medical error reporting system, the key factors to consider are the objectives of the system, the barriers to using it, the classification system to be used, the ways the reporting process works, and how the errors will be analyzed [11]. In addition, systems should ideally be nonpunitive, and voluntary, to the extent possible, and with certain exceptions (for example, the ‘‘never’’ events described by the National Quality Forum, which should be publicly reported [12]).
2. Background As a nation, Korea is considered in general to be at the leading edge of adoption of healthcare information systems. One national university hospital had built a complete paperless hospital system by May 2003 and they have operated this system without any difficulties [13]. In addition, many tertiary hospitals have built systems utilizing mobile technology through ubiquitous hospital information systems. Primary care physicians are using computerized clinic management systems and all Koreans are the recipients of the Medicare system. Thus, the medical bills of the hospitals are all sent through electronic data interchange. In contrast, though, efforts to improve patient’s safety through HIS in hospitals are still at an early stage. Detailed information on the current state of medical error reporting systems in Korea was not available. Therefore, as a first step toward building patient safety culture, we performed a survey to assess the current status of medical error reporting systems.
3. Objectives The goals of this study were to investigate the current status of error reporting systems in Korea, and in particular the proportion of hospitals that use HIS to perform this function.
4. Methods All hospitals with more than 100 beds in Korea were included in this study; there were 283 such
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J. Kim, D.W. Bates
hospitals. We developed a structured questionnaire to assess the current status of medical error reporting systems. We wished to describe the current systems that were in place, including the paper systems as well as any computerized systems. Item identification was done by first reviewing the scientific literature in the area, and the survey was then reviewed by three professional informaticians, whose opinions were incorporated. The survey is composed of 17 items; four items to assess the general characteristics of the respondents, seven items about the process of medical error reporting, and six items asking about computerized medical error reporting system utilization. The questionnaires were distributed through the regular mail to the head of the nursing department in each hospital. Responses were anonymous, and to protect anonymity, only a single mailing was done. The survey took place over a 3-month period, between 1st September and 31st December 2003. In addition, two reports, released in 1999 and 2003 [14,15] on ‘‘Information strategic planning for sharing and utilizing patient information among hospitals in Korea’’ were analyzed to assess the current status along with trends in HIS sub systems under operation in the country. The data obtained from the analysis of two reports and our current study data were compared and analyzed.
5. Results 5.1. General characteristics of respondents Overall, head nurses from 99 hospitals out of 283 returned the questionnaire, for a response rate of 35%. The general characteristics of respondents are shown in Table 1, and Table 2 shows the department that is responsible for the medical error reporting and risk management.
Table 2
General characteristics of respondents
Variables
Items
N (%)
Categories N = 99
Training hospitals General hospitals
18 (18.2) 81 (81.8)
Number of beds N = 98
Under 200 201—400 401—600 601—800 801—1000 Over 1001
9 37 20 15 10 7
(9.18) (37.76) (20.41) (15.31) (10.20) (7.14)
Average number of inpatients/day N = 82
Under 100 101—500 501—1000 Over 1001
34 29 18 1
(41.46) (35.37) (21.95) (1.22)
5.2. Status of the medical error reporting system utilization in tertiary and general hospitals in Korea Of the 99 hospitals reporting, 74 hospitals (76%) had an official channel for reporting medical errors, while 24 hospitals (25%) responded that they do not have an official channel for medical error reporting. In addition, 46 hospitals (47%) said that they had a special department to handle medical error reporting. In 72 (91%) hospitals, top executives of the hospitals receive reports from section heads of the related department on medical error reporting. Administrators of seven hospitals (9%) report the results from medical error reporting to their top executives. The policy of having a front-line provider report a medical error directly to their top executives was in place in four hospitals (5%). With respect to providing anonymity for those reporting a medical error, 10 hospitals (10%) responded very positively, 44 hospitals (45%) responded positively, and 44 hospitals (45%) said that they did
Name of department responsible for report N = 41
Financial department Administration QI General affairs Medical accident committee Nursing administration Others Total
Table 1
Name of departments
N (%)
Financial department/nursing administration Clinical administration, administration, administration chair, administration supports-medical accident CQI team, safety control in QA team, QIA, QI group, QI team, Risk management, QA team General affairs, general affairs medical accidents, well-fairs Measure committee for medical accident, coordinating committee for medical dispute, managing committee for medical problems Nursing administration Exclusive charge for medical accident, personnel committee
12 (29.27) 7 (17.07) 7 (17.07) 5 (12.19) 4 (9.76) 3 (7.32) 3 (7.32) 41 (100)
Results of a survey on medical error reporting systems in Korean hospitals not allow anonymous reporting. Seventy-five hospitals require an official written document when a medical error is reported (77%), whereas 30 hospitals allow verbal reports (30%). Thirteen hospitals use computers to produce official documents (13%), but only three hospitals currently use computerized medical error reporting systems (3%). There was substantial congruence regarding which items require a report among hospitals. These were transfusion accidents in 97 hospitals (98%), adverse drug events in 95 (96%), falls in 95 (96%), operation accidents in 91 (92%), anesthesia accidents in 82 (83%), and nosocomial infections in 77 (78%). Miscellaneous accidents that are supposed to be reported are procedure related accident (burns, decubitus ulcer, phlebitis, etc.), medical equipment-related accidents such as intravenous catheter or infusion pump malfunction, and claims for medical services. Regarding sharing of error reports with management, three hospitals (3%) gave very positive answers, three hospitals (3%) say that they have a system for doing this but that it is not in operation, and 88 hospitals (94%) answered that they do not have a system. The items generally included in medical error reporting system are types of medical error, how the error is being managed and a description on the future strategies that can be used to manage or prevent such errors in the future. Among 13 hospitals, which responded for this question, seven (54%) agreed that computer reporting is easier than using paper reporting, six (46%) responded that there is no difference, and no one answered that computer reporting is more difficult than paper reporting. Eight respondents (62%) said that the frequency of reporting was same in the case of computer reporting, four (31%) said that the frequency has increased, and one person (8%) said that the frequency of reporting is decreased when using the computer system. The gains or advantages that hospitals get through utilizing medical error reporting system are attentive employees (10 people, 71%), improving the quality of treatment (nine people, 64%), better grade in terms of outside evaluation (four people, 29%), good reputation (two people, 14%), and improving reporting skill along with accurate reporting (see Table 3).
5.3. Changes in implementation of HIS sub systems by types of hospitals and categories of work In addition, we compared two reports about the implementation of HIS in Korean hospitals nation-
151
wide to assess the baseline status of HIS use, and also to identify the changes in use between two periods (Tables 4 and 5). These data document large increases between 1999 and 2003 for many HIS sub systems, e.g. for medication administration, outpatient physician order entry, inpatient physician order entry, radiology information systems, laboratory information systems, and special clinic management systems. Many of these HIS sub systems increased between 30 and 40% over this interval. A remarkable growth was seen in PACS from 6.9 to 39.6% because of support from Korean government. Administrative systems and referral systems showed a decrease in percentage of institutions having these HIS sub systems from 1999 to 2003. The reasons for this decrease in percentage may be due to misunderstanding of the corresponding hospitals or it may be that identical hospitals did not participate in this study. The EMR percentage was 11.4% in 1999, and 11.2% in 2003. This difference may be for similar reasons. EMRs are still emerging in Korea, although quite a few hospitals now do have a paperless EMR. Generally the proportions of subsystems among hospitals were statistically different between the two periods, but the proportions for the clerical affairs and insurance claiming systems were not, probably because these subsystems were actively utilized from the beginning of computer utilization in hospitals.
6. Discussion These results demonstrate that there exists substantial room for improvement in medical error reporting systems in Korea. A quarter of hospitals had no official channel for medical error reporting. Only 10% of hospitals in Korea always accept medical error reporting with anonymity, which may well hinder the immediate reporting process. Verbal and written medical error reporting systems coexist in many hospitals. Only 3% of hospitals use their HIS systems for medical error reporting, even though use of HIS overall in Korean hospitals is fairly advanced compared with many other countries. In addition, the analyses show that hospitals utilizing the medical error reporting system include a variety of items, and while there is general agreement about many categories, the individual items are not well standardized. These results suggest that the medical authority of Korea should attempt to reach a consensus around the definition of medical errors and adverse events and make this available to hospitals.
152 Table 3
J. Kim, D.W. Bates Present status of medical error reporting system utilization
Variables
Items
N (%)
Official reporting procedures of medical error (N = 98)
Yes
74 (75.51)
No
24 (24.49)
Responsible department of error reporting (N = 97)
Yes No
46 (47.42) 51 (52.58)
Responsible staffs (N = 79) (multiple responses)
Head of the department Administrative officer The person himself/herself
72 (91.14) 7 (8.86) 4 (5.06)
Guarantee of anonymity of reporter (N = 98)
Always Usually but not always Never
10 (10.20) 44 (44.90) 44 (44.90)
Reporting methods (N = 98) (multiple responses)
Paper reporting Verbal reporting Word processing Hospital information system
75 30 13 3
Type of medical errors that are mandatory (N = 99) (multiple responses)
Transfusion errors
97 (97.98)
Medication errors Falls Operation accidents Anesthesia accidents Hospital infection
95 95 91 82 77
Current status of error reporting system operation/utilization (N = 94)
Actively utilized
(76.53) (30.30) (13.27) (3.06)
(95.96) (95.96) (91.92) (82.83) (77.78)
3 (3.19)
Utilized but not very active Not operated
3 (3.19) 88 (93.62)
Items of error reporting system (N = 6)
Types of medical errors Medical error management procedures Medical error management outcomes
6 (100.00) 6 (100.00) 6 (100.00)
Ease of use of error reporting system (N = 13)
Easier than paper reporting Same as paper reporting More difficult than paper reporting
7 (53.85) 6 (46.15) 0 (0.00)
Effects of error reporting system for frequency of reporting (N = 13)
No changes
8 (61.54)
Increase in number of error reporting Decrease in number of error reporting
4 (30.77) 1 (7.69)
Gains by the error reporting system operation (N = 14) (multiple responses)
Table 4
1999 2003
Medical staffs’ attention was heightened
10 (71.43)
Quality of medical services was improved Evaluation outcomes by the outer credentialing authorities was heightened Better reputation by the clients
9 (64.29) 4 (28.57) 2 (14.29)
Types of participating hospitals N (%) Training hospitals
General hospitals
Hospitals
Clinics/others
Total
12 (9.5) 19 (12.9)
30 (23.8) 81 (55.1)
30 (23.8) 43 (29.3)
54 (42.9) 4 (2.7)
126 (100.0) 147 (100.00)
Results of a survey on medical error reporting systems in Korean hospitals Table 5
153
Changes in implementation of HIS sub systems by types of hospitals and categories of work (%)
Clerical affairs Insurance Delayed payment Medication administration record Administrative system Outpatient physician order entry system Inpatient physician order entry system Radiology information system Laboratory information system Special clinic management system PACS Referral system EMR
Training hospitals
General hospitals
Hospitals
Clinics/ others
Total
1999
2003
1999
2003
1999
2003
1999
2003
1999
2003
100.0 100.0 — 83.3 91.7 81.8 81.8 83.3 83.3 83.3 16.7 75.0 16.7
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 94.7 63.2 63.2 10.5
96.9 96.9 — 78.1 93.8 46.9 43.8 51.6 50.0 46.9 6.5 41.4 —
96.3 97.5 85.3 87.5 86.3 81.5 81.5 82.5 79.0 76.9 43.4 31.5 6.9
96.0 87.5 — 42.9 87.5 22.7 18.2 23.8 23.8 15.0 5.0 9.5 9.5
95.3 88.4 69.0 65.9 59.0 68.3 65.9 63.4 61.0 40.0 20.0 15.0 17.9
74.5 74.5 — 20.5 13.2 41.3 8.6 2.8 19.4 3.3 5.9 16.7 21.6
100.0 100.0 100.0 50.0 75.0 50.0 50.0 50.0 50.0 50.0 50.0 — 25.0
87.6 85.8 — 50.5 64.0 44.0 31.4 33.3 38.7 32.3 6.9 30.1 11.4
96.6 95.2 82.1 81.9 80.3 79.3 78.6 78.5 75.9 75.2 39.6 30.1 11.2
Our main purpose in this evaluation was to contrast the current IT and error reporting systems between Korea and the U.S. Similar comparisons across other nations would also be of great interest. For example, while few published data are available, based on recent visits by one of the authors (D.W.B.) we suspect the situation in Japan and Taiwan is relatively comparable to that in Korea. In Australia, in contrast, spontaneous national reporting of errors has been in place for some time, while electronic records in hospitals have lagged behind, relatively speaking [16]. In America, the medical community is currently struggling toward implementing medical error reporting and prevention systems. Many methodological issues remain to be addressed, for example helping reporters accurately distinguish between nosocomial and community-acquired infections. Reporting systems are required in hospitals by the Joint Commission on Accreditation of Healthcare Organization (JCAHO), which in particular mandates that sentinel events be reported. Sentinel events are particularly serious adverse events. Beginning in 1995, nationwide sentinel event cases have been collected by JCAHO, although a number of other reporting systems predated this one. In the sentinel event database, the annual number of reports continues to increase with time, but most believe that the reported cases are only the tip of the iceberg. The sentinel event structure is useful for the most serious adverse events; for errors and near-misses, other structures are used, with the intent to use these reports as ‘‘free lessons.’’ For example, the Veterans Hospitals adopted what has been a highly successful medical error reporting system without punitive action in 1997. The Amer-
ican Hospital Association (AHA) is considering recommending adoption of this approach more broadly [17]. In November of 1999, the Department of Veterans Affairs in America established the ‘‘National Center for Patient Safety.’’ The number of near miss or close calls increased 900 times in comparison with the previous year in the NCPS, but this is believed to likely be associated with a much higher level of patient safety. In June 2002 the American Hospital Association distributed NCPS data from the VA to all hospitals in America as an example. Essentially all hospitals now have in place error reporting systems, and the errors and adverse events reported can be analyzed to develop and prioritize among patient safety interventions. Our study revealed that the current status of development and implementation of HIS in Korea is on the level of developed countries, but the use of electronic medical error reporting systems is going on in only a few hospitals. In order to improve the quality of medical service, the ‘‘Hospital Service Evaluation Program’’, was initiated in 1994 under the Council of Medical Safety reform. The ‘‘Hospital Service Evaluation Program’’ was renamed as the ‘‘Hospital Evaluation Program’’ under the medical law, article 47, clause 2 of Korea. The article says: ‘‘the Minister of Health and Welfare should evaluate hospitals in order to promote the quality of medical service and the article is made under the order of president of Korea.’’ This article was passed in March of 2002. The guidelines for the hospital evaluation program distributed by the Korean government in 2004 included evaluation criteria on nosocomial infection control and medication administration
154 related to the patient safety along with quality improvement and patient safety. Thus, management of safety-related accident and affirmation of patient safety are items to be evaluated in hospital evaluations. The safety-related accidents were defined as: falls, slips, wrong patient/surgery/site, suicide, and adverse drug events [18]. Also released was a statement saying that patient safety in medical facilities will be improved in the future through adoption of medical error reporting systems as an obligation and standard [19]. Even though medical error reporting is done systematically as an obligation in medical facilities, one has to remember that the mandatory reporting of medical errors and adverse events is only a beginning, and should not replace spontaneous or voluntary reporting. Generally obligatory or mandatory reporting is essential for serious issues such as wrong-site surgery, or fatal adverse drug events, but fortunately such serious adverse events represent only a small proportion of the safety-related issues that occur. For errors, nearmisses, and less serious adverse events, voluntary anonymous medical error reporting systems with no punitive action are likely superior to obligatory medical error reporting systems. The reason that the voluntary anonymous reporting system is better than that of the obligatory is that one can report the error with detailed fashion without any omission because no punitive action is attached to the reporting, and much higher rates of reports are obtained [20]. In implementing and operating patient safety programs in medical facilities, voluntary reporting systems represent an essential component. But achieving higher levels of safety requires much more than good reporting systems; it will in addition require fundamental redesign of many of the processes in the healthcare system, which will in turn require attention to building a strong safety culture [12]. Hospital authorities should put patient safety as a top priority if safety is to be substantially improved.
7. Conclusions Spontaneous reporting is the main tool used today to measure patient safety in most institutions, and having a robust system in place is believed to be essential for developing a strong patient safety climate [12]. Ideally, such reporting should be nonpunitive. Reports can be analyzed to help prioritize among the many potential patient safety interventions. We suggest that:
J. Kim, D.W. Bates (1) reporting of errors and adverse events should go through a well-described, official channel; (2) such reports will be most useful if they utilize a standard model in terms of content of report, formalism, and procedures and this standard model should be shared among hospitals; (3) as a mean of medical error reporting, HIS should be utilized instead of written or verbal reports. If these measures are implemented, we believe that these reports will be increasingly useful for improving patient safety in Korea and other similar countries. Summary points • What was known before the study i. Spontaneous reports represent an important tool for improving patient safety; ii. If reporting is computerized, it dramatically facilitates subsequent evaluation because it is easier to perform analyses and categorize reports; iii. Detailed information on the current state of medical error reporting systems in Korea was not available even though almost all of the Korean hospitals already had HIS’s in operation. • What the study has added to our knowledge i. A quarter of hospitals had no official channel for medical error reporting, and only 10% of hospitals in Korea always accepted medical error reporting with anonymity, which may well hinder the immediate reporting process; ii. Only 3% of hospitals use their HIS systems for medical error reporting, even though use of HIS overall in Korean hospitals is fairly advanced compared with many other countries; iii. The results suggest that the medical authority of Korea should attempt to reach a consensus around the definition of medical errors and adverse events and make this available using computerized HIS.
Acknowledgement This work was supported by Korean Research Foundation Grant (KRF-2003-042-E00135).
Results of a survey on medical error reporting systems in Korean hospitals
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Results of a survey on medical error reporting systems in Korean hospitals Jeongeun Kim a,∗, David W. Bates b a
Seoul National University, College of Nursing, Research Institute of Nursing Science, 28 Yongon-dong, Chongno-gu, Seoul, 110-799, Seoul, Republic of Korea b Division of General Internal Medicine, Department of Medicine, Brigham and Women’s Hospital, Clinical and Quality Analysis, Partners Healthcare, and Harvard Medical School, Boston, MA, USA Received 8 June 2005; accepted 15 June 2005 KEYWORDS Safety; Medical errors; Hospital information system (HIS); Hospital incident reporting
∗
Summary Background: Recent data suggest that medical injuries, or adverse events, represent an important international problem, and that many are caused by errors. Spontaneous reporting is the main tool used to detect errors and adverse events in most countries, and reporting systems are believed to be important for improving patient safety. Increasingly, such reporting can be done using information systems, and information systems are widely used in Korea. However, few data are available regarding the use of electronic medical error reporting systems in Korea. Objectives: The objectives of this study were to investigate the present status of reporting system of Korean hospitals, and to compare the current status of medical error reporting systems with that of other health information sub systems. Methods: The chairs of nursing departments of all 283 hospitals nationwide with more than 100 beds were surveyed using a structured questionnaire. The response rate was 35%. In addition, two reports on the national use of health information systems in Korea from 1999 and 2003 were analyzed. Results: Among reporting hospitals (n = 99), medical errors were reported on paper in 75 hospitals (77%), verbally in 30 hospitals (30%), using word processing in 13 hospitals (13%), and using the hospital information system in only three hospitals (3%). In contrast, there was widespread and increasing use of health information technology (HIT) in areas such as medication administration, inpatient and outpatient order entry, and radiology. Conclusions: While HIT is increasingly widely used in Korea in many areas, it is not being used for error reporting. Increasing the use of electronic reporting systems, and systemically evaluating the medical errors and adverse events reported, represent essential steps for reducing systemic errors and improving patient safety. © 2005 Elsevier Ireland Ltd. All rights reserved.
Corresponding author. Tel.: +822 740 8483; fax: +822 765 4103. E-mail address: [email protected] (J. Kim).
1386-5056/$ — see front matter © 2005 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.ijmedinf.2005.06.005
Results of a survey on medical error reporting systems in Korean hospitals
1. Introduction The Institute of Medicine’s ‘‘To Err Is Human’’ report, issued in November 1999, brought the issue of patient safety into the public eye, and sent shock waves through the U.S. healthcare industry [1]. It suggested that adverse events were causing between 44,000 and 98,000 deaths annually in American hospitals, and that many of these deaths were preventable. Subsequent studies from a number of other countries demonstrate that patient safety is clearly an international problem [2,3]. The causes of these adverse events are often complex. When an individual accident is investigated, it is common to find a number of errors, and it may not be apparent which problem or error actually resulted in the accident. The system of the hospital includes testing, diagnosis, treatment, caring of the patients, control of commodities, and apparatus management, for example. This complexity often makes it difficult or impossible to determine the real causes of an individual accident [4]. The ‘‘To Err Is Human’’ report emphasizes that most medical accidents are the result of system failures, and that to make the healthcare delivery system safer it must be renovated. Systems should ideally both make errors less likely, and catch those that do occur. There are many ways to improve patient safety using information technology [5]. One key for improving safety is improving error and adverse event detection and reporting systems [6]. In small studies, computerized reporting systems have been associated with an increased rate of spontaneous reporting [7], and if reporting is computerized, it dramatically facilitates subsequent evaluation because it is easier to perform analyses and categorize reports in different ways. One university hospital treating more than 25,000 patients annually reported a feasibility study of a computerized voluntary based medical error reporting system in the ambulatory setting [8]. The findings showed that the voluntary based medical error reporting system resulted in a 20-fold increased reporting rate, and physicians reported many of these errors. Also, the study suggested that new medical error reporting systems should combine reporting with analytic functions to facilitate analysis. A study by Furakawa et al. from Japan found that a computerized medical error reporting system was effective and acceptable to providers, and facilitated analysis [9]. In another study, a web-based reporting system was developed and implemented for medical workers of 54 hospitals who were working in neonatal intensive care units [10]. This system was both
149
voluntary and anonymous. Evaluation of the feasibility and utility of this approach revealed that it was well received, and effective for identifying a wide variety of medical errors. In addition, the approach facilitated cooperative, multidisciplinary studies. In developing a medical error reporting system, the key factors to consider are the objectives of the system, the barriers to using it, the classification system to be used, the ways the reporting process works, and how the errors will be analyzed [11]. In addition, systems should ideally be nonpunitive, and voluntary, to the extent possible, and with certain exceptions (for example, the ‘‘never’’ events described by the National Quality Forum, which should be publicly reported [12]).
2. Background As a nation, Korea is considered in general to be at the leading edge of adoption of healthcare information systems. One national university hospital had built a complete paperless hospital system by May 2003 and they have operated this system without any difficulties [13]. In addition, many tertiary hospitals have built systems utilizing mobile technology through ubiquitous hospital information systems. Primary care physicians are using computerized clinic management systems and all Koreans are the recipients of the Medicare system. Thus, the medical bills of the hospitals are all sent through electronic data interchange. In contrast, though, efforts to improve patient’s safety through HIS in hospitals are still at an early stage. Detailed information on the current state of medical error reporting systems in Korea was not available. Therefore, as a first step toward building patient safety culture, we performed a survey to assess the current status of medical error reporting systems.
3. Objectives The goals of this study were to investigate the current status of error reporting systems in Korea, and in particular the proportion of hospitals that use HIS to perform this function.
4. Methods All hospitals with more than 100 beds in Korea were included in this study; there were 283 such
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J. Kim, D.W. Bates
hospitals. We developed a structured questionnaire to assess the current status of medical error reporting systems. We wished to describe the current systems that were in place, including the paper systems as well as any computerized systems. Item identification was done by first reviewing the scientific literature in the area, and the survey was then reviewed by three professional informaticians, whose opinions were incorporated. The survey is composed of 17 items; four items to assess the general characteristics of the respondents, seven items about the process of medical error reporting, and six items asking about computerized medical error reporting system utilization. The questionnaires were distributed through the regular mail to the head of the nursing department in each hospital. Responses were anonymous, and to protect anonymity, only a single mailing was done. The survey took place over a 3-month period, between 1st September and 31st December 2003. In addition, two reports, released in 1999 and 2003 [14,15] on ‘‘Information strategic planning for sharing and utilizing patient information among hospitals in Korea’’ were analyzed to assess the current status along with trends in HIS sub systems under operation in the country. The data obtained from the analysis of two reports and our current study data were compared and analyzed.
5. Results 5.1. General characteristics of respondents Overall, head nurses from 99 hospitals out of 283 returned the questionnaire, for a response rate of 35%. The general characteristics of respondents are shown in Table 1, and Table 2 shows the department that is responsible for the medical error reporting and risk management.
Table 2
General characteristics of respondents
Variables
Items
N (%)
Categories N = 99
Training hospitals General hospitals
18 (18.2) 81 (81.8)
Number of beds N = 98
Under 200 201—400 401—600 601—800 801—1000 Over 1001
9 37 20 15 10 7
(9.18) (37.76) (20.41) (15.31) (10.20) (7.14)
Average number of inpatients/day N = 82
Under 100 101—500 501—1000 Over 1001
34 29 18 1
(41.46) (35.37) (21.95) (1.22)
5.2. Status of the medical error reporting system utilization in tertiary and general hospitals in Korea Of the 99 hospitals reporting, 74 hospitals (76%) had an official channel for reporting medical errors, while 24 hospitals (25%) responded that they do not have an official channel for medical error reporting. In addition, 46 hospitals (47%) said that they had a special department to handle medical error reporting. In 72 (91%) hospitals, top executives of the hospitals receive reports from section heads of the related department on medical error reporting. Administrators of seven hospitals (9%) report the results from medical error reporting to their top executives. The policy of having a front-line provider report a medical error directly to their top executives was in place in four hospitals (5%). With respect to providing anonymity for those reporting a medical error, 10 hospitals (10%) responded very positively, 44 hospitals (45%) responded positively, and 44 hospitals (45%) said that they did
Name of department responsible for report N = 41
Financial department Administration QI General affairs Medical accident committee Nursing administration Others Total
Table 1
Name of departments
N (%)
Financial department/nursing administration Clinical administration, administration, administration chair, administration supports-medical accident CQI team, safety control in QA team, QIA, QI group, QI team, Risk management, QA team General affairs, general affairs medical accidents, well-fairs Measure committee for medical accident, coordinating committee for medical dispute, managing committee for medical problems Nursing administration Exclusive charge for medical accident, personnel committee
12 (29.27) 7 (17.07) 7 (17.07) 5 (12.19) 4 (9.76) 3 (7.32) 3 (7.32) 41 (100)
Results of a survey on medical error reporting systems in Korean hospitals not allow anonymous reporting. Seventy-five hospitals require an official written document when a medical error is reported (77%), whereas 30 hospitals allow verbal reports (30%). Thirteen hospitals use computers to produce official documents (13%), but only three hospitals currently use computerized medical error reporting systems (3%). There was substantial congruence regarding which items require a report among hospitals. These were transfusion accidents in 97 hospitals (98%), adverse drug events in 95 (96%), falls in 95 (96%), operation accidents in 91 (92%), anesthesia accidents in 82 (83%), and nosocomial infections in 77 (78%). Miscellaneous accidents that are supposed to be reported are procedure related accident (burns, decubitus ulcer, phlebitis, etc.), medical equipment-related accidents such as intravenous catheter or infusion pump malfunction, and claims for medical services. Regarding sharing of error reports with management, three hospitals (3%) gave very positive answers, three hospitals (3%) say that they have a system for doing this but that it is not in operation, and 88 hospitals (94%) answered that they do not have a system. The items generally included in medical error reporting system are types of medical error, how the error is being managed and a description on the future strategies that can be used to manage or prevent such errors in the future. Among 13 hospitals, which responded for this question, seven (54%) agreed that computer reporting is easier than using paper reporting, six (46%) responded that there is no difference, and no one answered that computer reporting is more difficult than paper reporting. Eight respondents (62%) said that the frequency of reporting was same in the case of computer reporting, four (31%) said that the frequency has increased, and one person (8%) said that the frequency of reporting is decreased when using the computer system. The gains or advantages that hospitals get through utilizing medical error reporting system are attentive employees (10 people, 71%), improving the quality of treatment (nine people, 64%), better grade in terms of outside evaluation (four people, 29%), good reputation (two people, 14%), and improving reporting skill along with accurate reporting (see Table 3).
5.3. Changes in implementation of HIS sub systems by types of hospitals and categories of work In addition, we compared two reports about the implementation of HIS in Korean hospitals nation-
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wide to assess the baseline status of HIS use, and also to identify the changes in use between two periods (Tables 4 and 5). These data document large increases between 1999 and 2003 for many HIS sub systems, e.g. for medication administration, outpatient physician order entry, inpatient physician order entry, radiology information systems, laboratory information systems, and special clinic management systems. Many of these HIS sub systems increased between 30 and 40% over this interval. A remarkable growth was seen in PACS from 6.9 to 39.6% because of support from Korean government. Administrative systems and referral systems showed a decrease in percentage of institutions having these HIS sub systems from 1999 to 2003. The reasons for this decrease in percentage may be due to misunderstanding of the corresponding hospitals or it may be that identical hospitals did not participate in this study. The EMR percentage was 11.4% in 1999, and 11.2% in 2003. This difference may be for similar reasons. EMRs are still emerging in Korea, although quite a few hospitals now do have a paperless EMR. Generally the proportions of subsystems among hospitals were statistically different between the two periods, but the proportions for the clerical affairs and insurance claiming systems were not, probably because these subsystems were actively utilized from the beginning of computer utilization in hospitals.
6. Discussion These results demonstrate that there exists substantial room for improvement in medical error reporting systems in Korea. A quarter of hospitals had no official channel for medical error reporting. Only 10% of hospitals in Korea always accept medical error reporting with anonymity, which may well hinder the immediate reporting process. Verbal and written medical error reporting systems coexist in many hospitals. Only 3% of hospitals use their HIS systems for medical error reporting, even though use of HIS overall in Korean hospitals is fairly advanced compared with many other countries. In addition, the analyses show that hospitals utilizing the medical error reporting system include a variety of items, and while there is general agreement about many categories, the individual items are not well standardized. These results suggest that the medical authority of Korea should attempt to reach a consensus around the definition of medical errors and adverse events and make this available to hospitals.
152 Table 3
J. Kim, D.W. Bates Present status of medical error reporting system utilization
Variables
Items
N (%)
Official reporting procedures of medical error (N = 98)
Yes
74 (75.51)
No
24 (24.49)
Responsible department of error reporting (N = 97)
Yes No
46 (47.42) 51 (52.58)
Responsible staffs (N = 79) (multiple responses)
Head of the department Administrative officer The person himself/herself
72 (91.14) 7 (8.86) 4 (5.06)
Guarantee of anonymity of reporter (N = 98)
Always Usually but not always Never
10 (10.20) 44 (44.90) 44 (44.90)
Reporting methods (N = 98) (multiple responses)
Paper reporting Verbal reporting Word processing Hospital information system
75 30 13 3
Type of medical errors that are mandatory (N = 99) (multiple responses)
Transfusion errors
97 (97.98)
Medication errors Falls Operation accidents Anesthesia accidents Hospital infection
95 95 91 82 77
Current status of error reporting system operation/utilization (N = 94)
Actively utilized
(76.53) (30.30) (13.27) (3.06)
(95.96) (95.96) (91.92) (82.83) (77.78)
3 (3.19)
Utilized but not very active Not operated
3 (3.19) 88 (93.62)
Items of error reporting system (N = 6)
Types of medical errors Medical error management procedures Medical error management outcomes
6 (100.00) 6 (100.00) 6 (100.00)
Ease of use of error reporting system (N = 13)
Easier than paper reporting Same as paper reporting More difficult than paper reporting
7 (53.85) 6 (46.15) 0 (0.00)
Effects of error reporting system for frequency of reporting (N = 13)
No changes
8 (61.54)
Increase in number of error reporting Decrease in number of error reporting
4 (30.77) 1 (7.69)
Gains by the error reporting system operation (N = 14) (multiple responses)
Table 4
1999 2003
Medical staffs’ attention was heightened
10 (71.43)
Quality of medical services was improved Evaluation outcomes by the outer credentialing authorities was heightened Better reputation by the clients
9 (64.29) 4 (28.57) 2 (14.29)
Types of participating hospitals N (%) Training hospitals
General hospitals
Hospitals
Clinics/others
Total
12 (9.5) 19 (12.9)
30 (23.8) 81 (55.1)
30 (23.8) 43 (29.3)
54 (42.9) 4 (2.7)
126 (100.0) 147 (100.00)
Results of a survey on medical error reporting systems in Korean hospitals Table 5
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Changes in implementation of HIS sub systems by types of hospitals and categories of work (%)
Clerical affairs Insurance Delayed payment Medication administration record Administrative system Outpatient physician order entry system Inpatient physician order entry system Radiology information system Laboratory information system Special clinic management system PACS Referral system EMR
Training hospitals
General hospitals
Hospitals
Clinics/ others
Total
1999
2003
1999
2003
1999
2003
1999
2003
1999
2003
100.0 100.0 — 83.3 91.7 81.8 81.8 83.3 83.3 83.3 16.7 75.0 16.7
100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 94.7 63.2 63.2 10.5
96.9 96.9 — 78.1 93.8 46.9 43.8 51.6 50.0 46.9 6.5 41.4 —
96.3 97.5 85.3 87.5 86.3 81.5 81.5 82.5 79.0 76.9 43.4 31.5 6.9
96.0 87.5 — 42.9 87.5 22.7 18.2 23.8 23.8 15.0 5.0 9.5 9.5
95.3 88.4 69.0 65.9 59.0 68.3 65.9 63.4 61.0 40.0 20.0 15.0 17.9
74.5 74.5 — 20.5 13.2 41.3 8.6 2.8 19.4 3.3 5.9 16.7 21.6
100.0 100.0 100.0 50.0 75.0 50.0 50.0 50.0 50.0 50.0 50.0 — 25.0
87.6 85.8 — 50.5 64.0 44.0 31.4 33.3 38.7 32.3 6.9 30.1 11.4
96.6 95.2 82.1 81.9 80.3 79.3 78.6 78.5 75.9 75.2 39.6 30.1 11.2
Our main purpose in this evaluation was to contrast the current IT and error reporting systems between Korea and the U.S. Similar comparisons across other nations would also be of great interest. For example, while few published data are available, based on recent visits by one of the authors (D.W.B.) we suspect the situation in Japan and Taiwan is relatively comparable to that in Korea. In Australia, in contrast, spontaneous national reporting of errors has been in place for some time, while electronic records in hospitals have lagged behind, relatively speaking [16]. In America, the medical community is currently struggling toward implementing medical error reporting and prevention systems. Many methodological issues remain to be addressed, for example helping reporters accurately distinguish between nosocomial and community-acquired infections. Reporting systems are required in hospitals by the Joint Commission on Accreditation of Healthcare Organization (JCAHO), which in particular mandates that sentinel events be reported. Sentinel events are particularly serious adverse events. Beginning in 1995, nationwide sentinel event cases have been collected by JCAHO, although a number of other reporting systems predated this one. In the sentinel event database, the annual number of reports continues to increase with time, but most believe that the reported cases are only the tip of the iceberg. The sentinel event structure is useful for the most serious adverse events; for errors and near-misses, other structures are used, with the intent to use these reports as ‘‘free lessons.’’ For example, the Veterans Hospitals adopted what has been a highly successful medical error reporting system without punitive action in 1997. The Amer-
ican Hospital Association (AHA) is considering recommending adoption of this approach more broadly [17]. In November of 1999, the Department of Veterans Affairs in America established the ‘‘National Center for Patient Safety.’’ The number of near miss or close calls increased 900 times in comparison with the previous year in the NCPS, but this is believed to likely be associated with a much higher level of patient safety. In June 2002 the American Hospital Association distributed NCPS data from the VA to all hospitals in America as an example. Essentially all hospitals now have in place error reporting systems, and the errors and adverse events reported can be analyzed to develop and prioritize among patient safety interventions. Our study revealed that the current status of development and implementation of HIS in Korea is on the level of developed countries, but the use of electronic medical error reporting systems is going on in only a few hospitals. In order to improve the quality of medical service, the ‘‘Hospital Service Evaluation Program’’, was initiated in 1994 under the Council of Medical Safety reform. The ‘‘Hospital Service Evaluation Program’’ was renamed as the ‘‘Hospital Evaluation Program’’ under the medical law, article 47, clause 2 of Korea. The article says: ‘‘the Minister of Health and Welfare should evaluate hospitals in order to promote the quality of medical service and the article is made under the order of president of Korea.’’ This article was passed in March of 2002. The guidelines for the hospital evaluation program distributed by the Korean government in 2004 included evaluation criteria on nosocomial infection control and medication administration
154 related to the patient safety along with quality improvement and patient safety. Thus, management of safety-related accident and affirmation of patient safety are items to be evaluated in hospital evaluations. The safety-related accidents were defined as: falls, slips, wrong patient/surgery/site, suicide, and adverse drug events [18]. Also released was a statement saying that patient safety in medical facilities will be improved in the future through adoption of medical error reporting systems as an obligation and standard [19]. Even though medical error reporting is done systematically as an obligation in medical facilities, one has to remember that the mandatory reporting of medical errors and adverse events is only a beginning, and should not replace spontaneous or voluntary reporting. Generally obligatory or mandatory reporting is essential for serious issues such as wrong-site surgery, or fatal adverse drug events, but fortunately such serious adverse events represent only a small proportion of the safety-related issues that occur. For errors, nearmisses, and less serious adverse events, voluntary anonymous medical error reporting systems with no punitive action are likely superior to obligatory medical error reporting systems. The reason that the voluntary anonymous reporting system is better than that of the obligatory is that one can report the error with detailed fashion without any omission because no punitive action is attached to the reporting, and much higher rates of reports are obtained [20]. In implementing and operating patient safety programs in medical facilities, voluntary reporting systems represent an essential component. But achieving higher levels of safety requires much more than good reporting systems; it will in addition require fundamental redesign of many of the processes in the healthcare system, which will in turn require attention to building a strong safety culture [12]. Hospital authorities should put patient safety as a top priority if safety is to be substantially improved.
7. Conclusions Spontaneous reporting is the main tool used today to measure patient safety in most institutions, and having a robust system in place is believed to be essential for developing a strong patient safety climate [12]. Ideally, such reporting should be nonpunitive. Reports can be analyzed to help prioritize among the many potential patient safety interventions. We suggest that:
J. Kim, D.W. Bates (1) reporting of errors and adverse events should go through a well-described, official channel; (2) such reports will be most useful if they utilize a standard model in terms of content of report, formalism, and procedures and this standard model should be shared among hospitals; (3) as a mean of medical error reporting, HIS should be utilized instead of written or verbal reports. If these measures are implemented, we believe that these reports will be increasingly useful for improving patient safety in Korea and other similar countries. Summary points • What was known before the study i. Spontaneous reports represent an important tool for improving patient safety; ii. If reporting is computerized, it dramatically facilitates subsequent evaluation because it is easier to perform analyses and categorize reports; iii. Detailed information on the current state of medical error reporting systems in Korea was not available even though almost all of the Korean hospitals already had HIS’s in operation. • What the study has added to our knowledge i. A quarter of hospitals had no official channel for medical error reporting, and only 10% of hospitals in Korea always accepted medical error reporting with anonymity, which may well hinder the immediate reporting process; ii. Only 3% of hospitals use their HIS systems for medical error reporting, even though use of HIS overall in Korean hospitals is fairly advanced compared with many other countries; iii. The results suggest that the medical authority of Korea should attempt to reach a consensus around the definition of medical errors and adverse events and make this available using computerized HIS.
Acknowledgement This work was supported by Korean Research Foundation Grant (KRF-2003-042-E00135).
Results of a survey on medical error reporting systems in Korean hospitals
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