Browsing by Subject "patient safety"

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  • Palojoki, Sari; Makela, Matti; Lehtonen, Lasse; Saranto, Kaija (2017)
    The aim of this study was to analyse electronic health record-related patient safety incidents in the patient safety incident reporting database in fully digital hospitals in Finland. We compare Finnish data to similar international data and discuss their content with regard to the literature. We analysed the types of electronic health record-related patient safety incidents that occurred at 23 hospitals during a 2-year period. A procedure of taxonomy mapping served to allow comparisons. This study represents a rare examination of patient safety risks in a fully digital environment. The proportion of electronic health record-related incidents was markedly higher in our study than in previous studies with similar data. Human-computer interaction problems were the most frequently reported. The results show the possibility of error arising from the complex interaction between clinicians and computers.
  • Jamsa, JO; Uutela, KH; Tapper, AM; Lehtonen, L (2021)
    Background Alarm fatigue is hypothesized to be caused by vast amount of patient monitor alarms. Objectives were to study the frequency and types of patient monitor alarms, to evaluate alarm fatigue, and to find unit specific alarm threshold values in a university hospital emergency department. Methods We retrospectively gathered alarm data from 9 September to 6 October 2019, in Jorvi Hospital Emergency department, Finland. The department treats surgical, internal and general medicine patients aged 16 and older. The number of patients is on average 4600 to 5000 per month. Eight out of 46 monitors were used for data gathering and the monitored modalities included electrocardiography, respiratory rate, blood pressure, and pulse oximetry. Results Total number of alarms in the study monitors was 28 176. Number of acknowledged alarms (ie acknowledgement indicator pressed in the monitor) was 695 (2.5%). The most common alarm types were: Respiratory rate high, 9077 (32.2%), pulse oximetry low, 4572 (16.2%) and pulse oximetry probe off, 4036 (14.3%). Number of alarms with duration under 10 s was 14 936 (53%). Number of individual alarm sounds was 105 000, 469 per monitor per day. Of respiratory rate high alarms, 2846 (31.4%) had initial value below 30 breaths min(-1). Of pulse oximetry low alarms, 2421 (53.0%) had initial value above 88%. Conclusions Alarm sound load, from individual alarm sounds, was nearly continuous in an emergency department observation room equipped with nine monitors. Intervention by the staff to the alarms was infrequent. More than half of the alarms were momentary.
  • Syyrilä, Tiina; Vehviläinen-Julkunen, Katri; Härkänen, Marja (2020)
    Abstract Aim To identify the types and frequencies of communication issues (communication pairs, person related, institutional, structural, process, and prescription-related issues) detected in medication incident reports and to compare communication issues that caused moderate or serious harm to patients. Background Communication issues have been found to be amongst the main contributing factors of medication incidents, thus necessitating communication enhancement. Design A sequential exploratory mixed-method design. Methods Medication incident reports from Finland (n=500) for the year 2015 in which communication was marked as a contributing factor were used as the data source. Indicator phrases were used for searching communication issues from free texts of incident reports. The detected issues were analysed statistically, qualitatively, and considering the harm caused to the patient. Citations from free texts were extracted as evidence of issues and were classified following main categories of indicator phrases. The EQUATOR?s SRQR checklist was followed in reporting. Results Twenty-eight communication pairs were identified, with nurse-nurse (68.2%; n=341), nurse-physician (41.6%; n=208), and nurse-patient (9.6%; n=48) pairs being the most frequent. Communication issues existed mostly within unit (76.6%, n=383). The most commonly identified issues were digital communication (68.2%; n=341), lack of communication within a team (39.6%; n=198), false assumptions about work processes (25.6%; n=128) and being unaware of guidelines (25.0%; n=125). Collegial feedback, and communication from patients and relatives were the preventing issues. Moderate harm cases were often linked with lack of communication within the unit, digital communication and not following guidelines. Conclusions The interventions should be prioritized to (a) enhancing communication about work-processes, (b) verbal communication about digital prescriptions between professionals, (c) feedback among professionals, and (f) encouraging patients to communicate about medication. Relevance to clinical practice Upon identifying the most harmful and frequent communication issues, interventions to strengthen medication safety can be implemented.
  • Virtanen, Sonja; Kapp, Karmen; Rautamo, Maria M; Lotta, Schepel; Linden-Lahti, Carita; Cruz, Cristina D.; Tammela, Päivi (2021)
    Parenteral products must be compounded using an aseptic technique to ensure sterility of the medicine. We compared the effect of three clinical environments as compounding areas as well as different aseptic techniques on the sterility of the compounded parenteral product. Clinical pharmacists and pediatric nurses compounded 220 samples in total in three clinical environments: a patient room, a medicine room and biological safety cabinet. The study combined four methods: observation, environmental monitoring (settle plates), monitoring of personnel (finger dab plates) and sterility testing (membrane filtration). Of the compounded samples, 99% were sterile and no significant differences emerged between the clinical environments. Based on the settle plates, the biological safety cabinet was the only area that fulfilled the requirements for eliminating microbial contamination. Most of the steps on the observation form for aseptic techniques were followed. All participants disinfected their hands, wore gloves and disinfected the septum of the vial. Non-contaminated finger dab plates were mostly detected after compounding in the biological safety cabinet. Aseptic techniques were followed relatively well in all environments. However, these results emphasize the importance of good aseptic techniques and support the recommendation of compounding parenteral products in biological safety cabinets in clinical environments.
  • Jämsä, Juho; Palojoki, Sari; Lehtonen, Lasse; Tapper, Anna-Maija (Helsingin yliopisto, 2018)
    Objectives: To determine if and in what ways serious patient safety incidents differ from non-serious patient safety incidents. Methods: Statistical analysis was performed on patient safety incident reports that were reported in 2015 in Finland’s largest hospital district (Helsinki and Uusimaa, HUS). Reports were divided into two groups: non-serious incidents and serious incidents. Differences between groups were studied from several types of categorically divided information. Results: Of the total amount of reports (15 863) 1 % were serious incidents (175). Serious and non-serious incidents differed significantly from each other. Serious incidents concerning laboratory, imaging or medical equipment were more common. On the other hand incidents concerning medication, infusion, blood transfusion, were less frequent. In serious incidents the proportion of doctors reporting was greater and contributing factors were better recognized, the most common of them being working of procedures. Conclusions: In the future, special attention should be given to the particular aspects of serious patient safety incidents, such as safe use of medical equipment, training and handling of procedures. Root cause analysis is an effective way to handle serious incidents and enables the prevention of their reoccurrence. However, a systematic follow of the root cause analysis should be developed.
  • Jämsä, J.O.; Palojoki, S.H.; Lehtonen, L.; Tapper, A.-M. (2018)
    OBJECTIVES: To determine if and in what ways serious patient safety incidents differ from nonserious patient safety incidents. METHODS: Statistical analysis was performed on patient safety incident reports that were reported in 2015 in Finland's largest hospital district (Helsinki and Uusimaa, HUS). Reports were divided into two groups: nonserious incidents and serious incidents. Differences between groups were studied from several types of categorically divided information. RESULTS: Of the total number of reports (15,863), 1% were serious incidents (175). Serious and nonserious incidents differed significantly from each other. Serious incidents concerning laboratory, imaging, or medical equipment were more common. On the other hand, incidents concerning medication, infusion, and blood transfusion were less frequent. In serious incidents, the proportion of doctors reporting was greater, and contributing factors were better recognized, the most common being working of procedures. CONCLUSIONS: In the future, special attention should be given to the particular aspects of serious patient safety incidents, such as safe use of medical equipment, training, and handling of procedures. Root cause analysis is an effective way to handle serious incidents and enables the prevention of their reoccurrence. However, a systematic follow-up of the root cause analysis should be developed. © 2018 American Society for Health Care Risk Management of the American Hospital Association.
  • Hussein, Zahra (Helsingfors universitet, 2018)
    Drug shortages have become a global issue and reasons for drug shortages are several and multifactorial. Definition of drug shortages is not unambiguous. However, in literature are numerous different suggestions to determine the phenomenon of drug shortages. This study provides more focused information on drug shortages and the reasons behind them. The study was performed in cooperation with Orion Corporation. The aim of this study was to explore the in-depth reasons behind medicine shortages from the perspective of one European pharmaceutical company with special focus on Finland, Germany, the United Kingdom and Sweden. Interviews of the company employees were used to achieve this aim and build a few case studies. Further the aim was to investigate in-depth reasons for drug shortages using data from case studies. Case studies were provided by Orion since this enabled use of unpublished information compare the case studies with relevant legal and regulatory measures in the European pharmaceutical framework which influence drug shortages. Reviewing available data from literature and from EUDRA GMDP database for drug shortages and investigate if the data is detailed enough to understand in-depth reasons for drug shortages. Based on the interview results the most common reasons behind drug shortages in Europe are mainly pharmaceutical market structure 38%. It contains many different factors, such as small stock size, local and foreign manufacturing issues, logistics and distribution issues, changes in demand and regulatory issues. However, the manufacturing (33%) or regulatory (29%) reasons are almost as numerous as pharmaceutical market structure issues. Pharmaceutical market structure issues include most common reasons which are categorized in supply-related and demand-related reasons. According to this study supply-related reasons are more common (73%) than demand-related reasons (27%). Some reasons behind drug shortages overlap and often cause a domino effect, whilst other are unique or stand alone, like reasons resulting from natural disasters. The results of this study seem generalizable because the EUDRA GDMP database shows same results and case studies illustrative same reasons behind drug shortages. This study provides more focused information on drug shortages and the reasons behind them from the perspective of pharmaceutical company and authorities.
  • Liukka, Mari; Hupli, Markku; Turunen, Hannele (2018)
    AimThe aim of this study was to determine whether elements of transformational leadership are present in nursing managers' actions following adverse events. BackgroundTransformational leadership exerts a positive influence on organisational culture and patient safety. MethodEleven nursing managers were interviewed individually using a semi-structured format. Data were analysed using inductive content analysis. ResultsFour themes emerged relating to nursing managers' actions following adverse events: patient-centredness as a principle for common action, courage to reform operational models to prevent future adverse events, nursing staff's encouragement of open and blame-free discussion, and challenge to recognize adverse events. ConclusionNursing managers must understand their responsibilities and the importance of making it clear to staff that patient-centredness should be evident in all health care actions. Nursing managers must also recognize the need to ensure that staff treat patients' interests as the top priority. Implications for Nursing ManagementIf an adverse event occurs, the situation should be discussed with the nursing staff and any unique aspects of the event must be accounted for. Nursing managers must have the skill to motivate and empower staff to find new ways to work, to prevent adverse events and to promote patient safety.
  • Helmiö, Paivi; Saarinen, Riitta; Aaltonen, Leena-Maija; Lehtonen, Lasse; Blomgren, Karin (2018)
    Objective: To assess patient injury characteristics and contributing factors in otology. Methods: Data on the accepted patient-injury claims involving otorhinolaryngology (ORL), closed between 2001 and 2011, from the Finnish Patient Insurance Centre registry was retrieved. We included all injuries concerning otology, with evaluation and classification of their causes and types. Results: During the 10-year study period, a total of 44 claims were accepted as compensated patient injuries in otology. From a total of 233 patient injuries in all ORL, this amounted to 19%. In outpatient care, occurred 12 (27%) injuries and in surgical procedures 32 (73%). Five (11%) patients were children. Errors in surgical technique were identified as the primary cause of the injury in 22 (69%) operation-related cases. Failure to remove all auricular tampons or packing in postoperative control was a contributing factor in 4 (13%) injuries, a facial nerve was damaged in 9 (28%) operations, and in 12 (38%) patients, the injury resulted in severe hearing loss or deafness. Six patients (21%) needed one or more re-operations related to the injury, of which two were due to an incomplete primary operation. Conclusion: Typical compensated patient injuries in operative otology resulted from common complications of common operations in high volume centres.
  • Linden-Lahti, Carita; Kivivuori, Sanna-Maria; Lehtonen, Lasse; Schepel, Lotta (2022)
    Closed-loop electronic medication management systems (EMMS) have been seen as a potential technology to prevent medication errors (MEs), although the research on them is still limited. The aim of this paper was to describe the changes in reported MEs in Helsinki University Hospital (HUS) during and after implementing an EPIC-based electronic health record system (APOTTI), with the first features of a closed-loop EMMS. MEs reported from January 2018 to May 2021 were analysed to identify changes in ME trends with quantitative analysis. Severe MEs were also analysed via qualitative content analysis. A total of 30% (n = 23,492/79,272) of all reported patient safety incidents were MEs. Implementation phases momentarily increased the ME reporting, which soon decreased back to the earlier level. Administration and dispensing errors decreased, but medication reconciliation, ordering, and prescribing errors increased. The ranking of the TOP 10 medications related to MEs remained relatively stable. There were 92 severe MEs related to APOTTI (43% of all severe MEs). The majority of these (55%, n = 53) were related to use and user skills, 24% (n = 23) were technical failures and flaws, and 21% (n = 21) were related to both. Using EMMS required major changes in the medication process and new technical systems and technology. Our medication-use process is approaching a closed-loop system, which seems to provide safer dispensing and administration of medications. However, medication reconciliation, ordering, and prescribing still need to be improved.
  • Pakarainen, Leena (Helsingfors universitet, 2016)
    Healthcare professionals in patient care, including practical nurses, need medicines in-formation in their work. One strategic goal in national Medicines Information Strategy in Finland is to make sure, that healthcare professionals use reliable information sources and services. One part of the national medicines information network in Finland is work-ing group on medicines information for healthcare professionals. It's central aim is to advance availability of reliable medicines information in different environments in social- and healthcare. Objective of this study was to explore medicines information sources and needs among practical nurses. This study concentrated on practical nurses who work in atypical areas of medical care (for example at school and day care), homecare and social care and were members of The Finnish Union of Practical Nurses. Survey was made in co-operation by working group on medicines information for healthcare professionals and The Finnish Union of Practical Nurses. The survey was carried out in December 2013 - January 2014 by e-mail. The random sample consisted of 1 000 practical nurses. The material was analyzed using direct distributions, cross tabulation, Kruskal-Wallis -test and Mann-Whitney U-test. Open ended questions were analyzed by qualitative methods. The response rate was 67 (n = 666). The most commonly utilized medicines information among practical nurses were package leaflets (PL) and medical database Terveysportti. Those sources were also the most preferred ones. Practical nurses reported they would like to have additional medicines information about drug-drug interactions (86 %) and adverse effects (63 %). Information was also needed about generic drugs. The majority of practical nurses in this study were satisfied with current medicines information sources. Additional information about pharmacological treatment was needed by respondents, 14 % daily and 31 % weekly. 82 % of respondents would benefit from pharmacy's services in their work. 64 % of practical nurses had always or usually and 28 % had never mobile device for information seeking. 73 % of practical nurses took part in education concerning pharmacological care less than once in one to two years. Package leaflets and Terveysportti were the most commonly utilized and preferred medicines information sources. There is still need for detailed information about practical nurses' medicines information sources in various working environments.
  • Sjöblom, Annika (Helsingfors universitet, 2015)
    Background: Medication errors are the most important individual factor that jeopardizes patient safety in human care. The patient's medication process is a chain of successive operations which involves different health care providers and the medicine user. All the stages of the medication process are susceptible to the medication errors. Medication errors are approached from the system's point of view by James Reason`s (1990) theory of Human Error. Instead of blaming individuals the theory concentrates on developing operations models which enable identification of medication errors in the organizations. The development of medication safety culture in the human medication has led to systems which tolerate human mistakes and prevent errors. The increasing number of animals and pets and their changing status in the society have raised discussion about the medication safety in veterinary care. Little research has been conducted in this field. Objective: The objective of the study was to identify the most typical veterinary medication errors and their root causes. The medication management processes of veterinary care can be developed safer by becoming aware of the root causes of medication errors. Study design and data: All the cases investigated by the Assessment Board for Damages in Veterinary Practice in 2002-2013 considering medication errors (n=79) were analysed with the help of the structured data collection sheet by using descriptive statistics. The most typical cases were studied more in detail by using simplified Root Cause Analysis (RCA). Results: The medication errors found were related to the care of dogs (n=34), horses (n=26), bovines (n=10), cats (n=7) and pigs (n=2). The most general therapeutic groups that had caused medication errors were antibacterials for systemic use (17% of all the medicines related to the medication errors), NSAIDs and antirheumatic drugs (12%), neuroleptics and tranquillizers (12%), and analgesics (12%). Of the drugs, 39% were high alert medicines. Of the errors, 36% were related to the off label use (usage deviating from the summary of product characteristics, SPC). The error types which appeared most commonly in the cases were wrong route of administration (18% of all the medication errors), wrong dose (16%) and untreated diagnosed conditions left without the medicine by the veterinarian (15%). Because of the character of the data the majority of the medication errors occurred in the beginning of the medication process. It was estimated that 81% of the medication errors would have been preventable. Some of the root causes found were the lack of the commitment to the established care practice, environmental factors, communication problems, availability of tools, hurry and factors related to management, information and staff. Conclusion: The material of Assessment Board for Damages in Veterinary Practice gives valuable information about the veterinary medication errors. It is possible to influence the root causes of veterinary medication errors by paying attention to the management related factors and communication in veterinary care and improving access to therapeutic guidelines and electronic databases, and by expanding the electronic prescribing to veterinary care. The highest priority is to get Pharmaca Fennica Veterinaria to an electronic form.
  • Kuitunen, Sini (Helsingfors universitet, 2014)
    The role of community pharmacy is to ensure and promote medication safety in treatment of outpatients. In Finland a national four-year medication safety program Apila was launched in 2012. The Apila program aims to improve medication safety with pharmaceutical counselling and followup, support development and implementation of new tools and practices promoting medication safety, increase awareness of medication safety as part of patient safety and increase co-operation between community pharmacies and other social- and healthcare services. The objective of this study was to investigate medication safety situation of Finnish pharmacies in the beginning of Apila program. Research data was collected electronically at the end of 2012 by using a two structured survey instruments. Target of the study was the whole pharmaceutical staff of Finnish community pharmacies. There were two separated study samples. Survey instruments were alike for both samples with the exception of one section. One survey was sent to all independent pharmacy owners (n=593) and managers of university pharmacies (n=18). The other survey was sent to one member of pharmaceutical staff in every community pharmacy (n=618) and university pharmacies (n=17). The response-rate of pharmacy owners (O) was 39 % (n=241) and response-rate of pharmaceutical staff (S) was 29 % (n=182). Representativeness of data was good compared to standard population. According to study the barriers built into the dispensing process worked well. Verifying dose (O: 100 %, S: 98 %), interactions (O: 97 %, S: 94 %) and duplicated medications (O: 79 %, S: 70 %) was a common part of dispensing process. Over half of pharmacies had a written standard operating procedure to medication counselling given when dispensing prescribed (O: 74 %, S: 60 %) and over the counter medicines (O: 60 %, S: 60 %). About 90 % of the pharmacies had a standard operating procedure to reporting and managing dispensing errors (O: 92 %, S: 84 %). According to almost all respondents (O: 96 %, S: 91 %) medication errors were reported in their workplace. Though discussing dispensing errors with whole staff (O: 73 %, S: 53 %) and changing course of action after managing dispensing errors (O: 85 %, S: 63 %) was not as common. The respondents were of the opinion that pharmacy had closer co-operation with home care and social services than with health care services. Some pharmacies had agreed with local healthcare how to manage interactions (O: 39 %, S: 23 %), contraindications (O: 36 %, S: 19 %) and prescribing errors (O: 28 %, S: 15 %) discovered in pharmacy. The study indicates that Finnish community pharmacies have good abilities to identify medication related problems. Co-operation between community pharmacies and other social- and health care services should be promoted, because it seems to be superficial. The biggest challenges in risk management are complete invocation of data collected through error reporting and including medication safety audits into quality management. Pharmacy owners' answers to the questionnaire were more positive than staff members', which indicates that actions to promote medication safety should be made more visible. Coordination of medication safety should be emphasized both national and individual pharmacy level. Low response-rates weaken the reliability of the study, but the results are suggestive.
  • Granfors, Eija (Helsingfors universitet, 2015)
    In hospital care many medicines should be usually prepared before they are administered to patients. In Finland Finnish Medicines Agency (Fimea) gives regulatory requirements and instructions for preparation of medicines in hospital pharmacies and action in hospital pharmacies is strictly controlled regularly by Fimea. According to Fimea's instructions hospital pharmacies should also ensure that medicines are prepared properly before they are administered to the patients in hospital wards. Preparing of medicines in hospital wards should be done in accordance with instructions given from the hospital pharmacy. Medicines should be prepared by using aseptic technique in order to protect patient safety. Aim of this study was to develop an assessment tool which can be used to assess the quality of ward- prepared medicines. The assessment tool should be suitable for self-assessment and external audit. Aim of the assessment tool is to ensure the safety of preparation of medicines in the wards and at the end improve patient safety. For the assessment tool ISMP Guidelines for safe preparation of sterile compounds were translated to Finnish. The assessment tool was then developed from the translated ISMP-guideline and other literature. The assessment tool was validated by using two-rounded Delphi-method. Delphi-method is a consensus method in which selected experts evaluate the data. At the first Delphi-round suitability and feasibility of the tool were evaluated and new items were created based on the consensus of experts. At the second round the feasibility of the tool items, which were developed by the first round, were evaluated once again. A total of 19 experts were participated to the Delphi-rounds. After the Delphi-rounds the developed assessment tool contained 64 items for safe preparing of medicines in hospital wards. The developed assessment tool reviews the entire process of preparing medicines and it can be used to identify which items are not followed in preparing of medicines before administering to patients in hospital wards. The developed assessment tool for safe preparation of medicines in hospital wards can be used widely in Finnish hospitals in order to ensure the quality of preparing medicines and detect the deficiencies and errors in preparation processes. By detecting deficiencies and errors in preparing medicines, they can be corrected and processes can be modified appropriate. In this way patient safety can be improved.
  • Eronen, Anna-Kaisa (Helsingfors universitet, 2016)
    Medication safety meaning the safety of using medication is an important part of patient safety. Medication errors are the most common preventable threats of patient safety. Medication errors can occur in all stages of the medication process. Rather than blaming individuals involved in the process, incidents should be evaluated based on system thinking with an aim of identifying system and process-based weaknesses allowing errors to happen. James Reason's human error theory provides a good framework to investigate the topic from this perspective. The objective of this study was to gather information on the medication errors based on the Patient Insurance Centre 2013-2014 data of compensated medication errors. One of the aims was to identify different types of medication errors and gather information on their backgrounds and drugs involved. Another aim was to investigate the causes behind the medication errors and the views of the people involved on the contributin factors of these errors. Additionally the study aimed at identifying situations where interprofessional collaboration could have prevented medication errors from occurring. Finally the results of the study were also compared with the results of the earlier studies done using similar data. The data of the study consisted of 205 cases where medication error had caused compensated patient injury. Factors behind the errors were analyzed using descriptive statistics. The examples of most common cases were investigated more in depth through simplified root-cause analysis. Content analyses were used to gather information on the views of the people involved in errors as well as on the possibilities of preventing errors through interprofessional collaboration. The most frequent error type was omission of medication. The majority of the errors occurred in the early stages of the process when decisions on medication and treatment were done. There were altogether 250 drugs in the data out of which 98 different active ingredients were identified. Antithrombotic agents were the most common therapeutic group causing medication errors. 37% of all drugs included in data were classified as high alert medicines. More efficient use of the interprofessional collaboration could have prevented several medication errors. The number of medication errors had somewhat increased compared to earlier studies but the profiles of errors were very similar. The data of Patient Insurance Centre provides valuable information on medication errors across Finland. More accurate information on factors leading to medication errors could be obtained by improving voluntary nationwide reporting. This would make it easier to develop operating models that improve patient safety.
  • Vuokko, Riikka; Vakkuri, Anne; Palojoki, Sari (2022)
    Background: Currently, there is no holistic theoretical approach available for guiding classification development. On the basis of our recent classification development research in the area of patient safety in health information technology, this focus area would benefit from a more systematic approach. Although some valuable theoretical and methodological approaches have been presented, classification development literature typically is limited to methodological development in a specific domain or is practically oriented. Objective: The main purposes of this study are to fill the methodological gap in classification development research by exploring possible elements of systematic development based on previous literature and to promote sustainable and well-grounded classification outcomes by identifying a set of recommended elements. Specifically, the aim is to answer the following question: what are the main elements for systematic classification development based on research evidence and our use case? Methods: This study applied a qualitative research approach. On the basis of previous literature, preliminary elements for classification development were specified, as follows: defining a concept model, documenting the development process, incorporating multidisciplinary expertise, validating results, and maintaining the classification. The elements were compiled as guiding principles for the research process and tested in the case of patient safety incidents (n=501). Results: The results illustrate classification development based on the chosen elements, with 4 examples of technology-induced errors. Examples from the use case regard usability, system downtime, clinical workflow, and medication section problems. The study results confirm and thus suggest that a more comprehensive and theory-based systematic approach promotes well-grounded classification work by enhancing transparency and possibilities for assessing the development process. Conclusions: We recommend further testing the preliminary main elements presented in this study. The research presented herein could serve as a basis for future work. Our recently developed classification and the use case presented here serve as examples. Data retrieved from, for example, other type of electronic health records and use contexts could refine and validate the suggested methodological approach.
  • Palojoki, Sari; Saranto, Kaija; Lehtonen, Lasse (2019)
    The European Union Medical Device Directive 2007/47/EC1 defines software with a medical purpose as a medical device. The implementation of health information technology suffers from patient safety problems that require effective post-market surveillance. The purpose of this study was to review, classify and discuss the incident data submitted to a nationwide database of the Finnish National Competent Authority with other forms of data. We analysed incident reports submitted to the authority database by users of electronic health records from 2010 to 2015. We identified 138 valid reports. Adverse events associated with electronic health record vulnerabilities, clustered around certain error types, cause serious harm and occur in all types of healthcare settings. The low rate of reported incidents raises questions about not only the challenges associated with medical software oversight but also the obstacles for reporting.
  • Kuitunen, Sini Karoliina; Niittynen, Ilona; Airaksinen, Marja; Holmström, Anna-Riia (2021)
    Objectives Intravenous medication delivery is a complex process that poses systemic risks of errors. The objective of our study was to identify systemic defenses that can prevent in-hospital intravenous (IV) medication errors. Methods A systematic review adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines was conducted. We searched MEDLINE (Ovid), Scopus, CINAHL, and EMB reviews for articles published between January 2005 and June 2016. Peer-reviewed journal articles published in English were included. Two reviewers independently selected articles according to a predetermined PICO tool. The quality of studies was assessed using the Grading of Recommendations Assessment, Development and Evaluation system, and the evidence was analyzed using qualitative content analysis. Results Forty-six studies from 11 countries were included in the analysis. We identified systemic defenses related to administration (n = 24 studies), prescribing (n = 8), preparation (n = 6), treatment monitoring (n = 2), and dispensing (n = 1). In addition, 5 studies explored defenses related to multiple stages of the drug delivery process. Systemic defenses including features of closed-loop medication management systems appeared in 61% of the studies, with smart pumps being the defense most widely studied (24%). The evidence quality of the included articles was limited, as 83% were graded as low quality, 13% were of moderate quality, and only 4% were of high quality. Conclusions In-hospital IV medication processes are developing toward closed-loop medication management systems. Our study provides health care organizations with preliminary knowledge about systemic defenses that can prevent IV medication errors, but more rigorous evidence is needed. There is a need for further studies to explore combinations of different systemic defenses and their effectiveness in error prevention throughout the drug delivery process.
  • Malmstrom, Tomi; Harjola, Veli-Pekka; Torkki, Paulus; Kumpulainen, Salla; Malmström, Raija (2017)
    Correct assessment of patient urgency is critical to ensuring patient safety in emergency departments (EDs). Although significant time and effort have been devoted to developing triage systems, less attention has been paid to the development of quality control. The aim of this study is to introduce and test observation technique, which enables identifying of patient groups at risk of erroneous assessment in triage. The introduced technique is aimed to be less laborious to use than existing triage quality control methods. The study developed an observation technique for identifying patients with possible erroneous assessments in triage. Data sample for the observation technique is carried out with survey form filled in by nurse. Hospital ED with similar to 74 000 patient visits annually. Consecutive adult patients in an ED for baseline study period of 14 days (1774 patients) in 2010 and control study period of 4 days (541 patients) in 2012. Triage observation technique for continuous improvement of triage performance. Primary measures of triage improvement were triage accuracy and nurses' ability to predict patient admissions. With the observation technique the ED staff was able to identify patient groups at risk for erroneous triage. Under-triage related mostly to patients with chest pain, shortness of breath, collapse, stomach pain and infections. Instead injures and muscular skeletal symptoms were seldom undertriaged even though they are common. EDs can control triage quality with simple observation technique. The usability of observation technique and triage quality improvement process were good.
  • Howard, Ian; Cameron, Peter; Wallis, Lee; Castrén, Maaret; Lindström, Veronica (2020)
    Introduction In South Africa (SA), prehospital emergency care is delivered by emergency medical services (EMS) across the country. Within these services, quality systems are in their infancy, and issues regarding transparency, reliability and contextual relevance have been cited as common concerns, exacerbated by poor communication, and ineffective leadership. As a result, we undertook a study to assess the current state of quality systems in EMS in SA, so as to determine priorities for initial focus regarding their development. Methods A multiple exploratory case study design was used that employed the Institute for Healthcare Improvement's 18-point Quality Program Assessment Tool as both a formative assessment and semistructured interview guide using four provincial government EMS and one national private service. Results Services generally scored higher for structure and planning. Measurement and improvement were found to be more dependent on utilisation and perceived mandate. There was a relatively strong focus on clinical quality assessment within the private service, whereas in the provincial systems, measures were exclusively restricted to call times with little focus on clinical care. Staff engagement and programme evaluation were generally among the lowest scores. A multitude of contextual factors were identified that affected the effectiveness of quality systems, centred around leadership, vision and mission, and quality system infrastructure and capacity, guided by the need for comprehensive yet pragmatic strategic policies and standards. Conclusion Understanding and accounting for these factors will be key to ensuring both successful implementation and ongoing utilisation of healthcare quality systems in emergency care. The result will not only provide a more efficient and effective service, but also positively impact patient safety and quality of care of the services delivered. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.